Drug-Eluting Stents vs. Bare Metal Stents In Saphenous Ve... | NCT01121224

Status Module

Description Module

Brief Summary

Patients who have undergone coronary bypass surgery have had a vein removed from the leg and implanted in the chest to "bypass" blockages in the coronary arteries. These veins are called saphenous vein grafts or SVGs. SVGs often develop blockages that can cause chest pain and heart attacks. SVG blockages can be opened by using small balloons and stents (metal coils that keep the artery open). Two types of stents are currently used: bare metal stents (BMS) and drug-eluting stents (DES). Both BMS and DES are made of metal. DES are also coated with a drug that releases into the wall of the blood vessel to prevent scar tissue from forming and re-narrowing the vessel. Both stents have advantages and disadvantages: DES require taking special blood thinners (called thienopyridines, such as clopidogrel or prasugrel) longer than bare metal stent and could have more bleeding but are also less likely to renarrow. Both BMS and DES are routinely being used in SVGs, but it is not known which one is better. Neither bare metal (except for an outdated model) nor drug-eluting stents are FDA approved for use in SVGs. The purpose of CSP#571 is to compare the outcomes after DES vs. BMS use in SVGs.

In CSP#571 patients who need stenting of SVG blockages will be randomized to receive DES or BMS in a 1:1 ratio. Per standard practice, patients will receive 12 months of an open label thienopyridine if they have acute coronary syndrome (ACS), or if they have another clinical reason for needing the medication. Patients without ACS who receive DES also need to take 12 months of a thienopyridine whether or not they are in the study, but non-ACS patients who receive a BMS do not. In order to make sure patients do not know which stent they received, non-ACS patients who received BMS will receive 1 month of open label thienopyridine followed by 11 months of blinded placebo, while those who received DES will receive 1 month of open label thienopyridine followed by 11 months of blinded clopidogrel, which is a thienopyridine.

All study patients will be followed in the clinic for at least 1 year after their stenting procedure to see if there is a difference in the rate of cardiac death, heart attack, or any procedure that is required in order to increase the flow of blood to and from the heart between the BMS and DES groups.

Detailed Description

VA Cooperative Studies Program #571 is designed to prospectively evaluate the efficacy of drug-eluting stents (DES) in reducing aortocoronary saphenous vein bypass graft (SVG) failure when compared to bare metal stents (BMS) in patients undergoing stenting of de novo SVG lesions.

SVGs often develop luminal stenoses that are most commonly treated with stent implantation. Approximately 60,000-100,000 percutaneous SVG interventions are performed annually in the USA. Two types of coronary stents are currently available: bare metal stents and drug eluting stents. Bare metal stents are the standard of care for the percutaneous treatment of SVG lesions, but are limited by high rates of in-stent restenosis (as high as 51% after 12 months) often leading to repeat percutaneous or surgical SVG treatments. Drug-eluting stents have been shown to significantly reduce in-stent restenosis and the need for repeat target vessel and lesion revascularization in native coronary arteries, yet their efficacy in SVGs is not well studied, with conflicting results from various small studies. The proposed Cooperative Studies Program study will be the first large prospective, randomized, multicenter, blinded clinical trial comparing DES and BMS in SVG lesions. It will provide critical knowledge to assist the cardiac interventionalist in selecting the optimum stent type for these challenging lesions.

Patients undergoing clinically-indicated stenting of de novo SVG lesions will be randomized in a 1:1 ratio to DES or BMS. To ensure blinding to the type of stent used, of the patients who do not present with an acute coronary syndrome and do not require 12 months of dual antiplatelet therapy, those who receive DES will receive 11 months of clopidogrel and those who receive BMS will receive 11 months of matching placebo. After stenting, patients will be followed clinically for a minimum of one year to determine the 12-month incidence of target vessel failure (TVF, primary study endpoint). TVF will be defined as the composite of cardiac death, target vessel myocardial infarction and target vessel revascularization, and is the primary clinical endpoint used in all FDA-approved DES pivotal trials. Coronary angiography and intervention during follow-up will only be performed if clinically-indicated (no mandatory angiographic follow-up). Secondary endpoints include: 1) clinical outcomes other than TVF (procedural success; post-procedural myocardial infarction; post-procedural bleeding; all cause death and cardiac death; follow-up myocardial infarction; stent thrombosis; target lesion revascularization; target vessel revascularization; non-target vessel revascularization; the composite endpoint of death, myocardial infarction, and target vessel revascularization (patient-oriented composite endpoint according to the FDA guidance document on DES studies); the composite endpoint of cardiac death, target vessel myocardial infarction, and target lesion revascularization (device-oriented composite endpoint for target lesion failure); and stroke); and 2) incremental cost-effectiveness of DES relative to BMS. A tertiary endpoint is in-stent neointima proliferation as measured by intravascular ultrasonography.

Based on published studies, the investigators estimate the 12-month TVF rate in the BMS arm to be 30%. The investigators hypothesize that DES will reduce TVF to 18% (40% relative reduction). Assuming two-year accrual and one interim assessment, a total sample size of about 520 patients will be needed to detect this difference with 90% power, using a two-sided 5% significance level. Assuming an intake rate of 1 patient per month per VA Medical Center, the investigators will need 22 participating sites. However, the investigators will begin the study with 25 sites to protect against a site dropout rate of 10%.

Percutaneous treatment of SVG lesions is of particular importance to the VA system because many Veterans have undergone and continue to undergo coronary artery bypass graft surgery. Every year, approximately 12-15% of percutaneous coronary interventions performed within the VA system are performed in SVGs, at a cost of approximately $15,000-$20,000 per procedure; DES are currently used in approximately half of SVG interventions. Because of (a) the high prevalence and high cost of SVG stenting, (b) DES cost two- to three- fold more than BMS and often require prolonged ( 12 months) thienopyridine administration to prevent late stent thrombosis, and (c) DES may have increased risk for late and very late stent thrombosis, a catastrophic complication with high mortality, the proposed study will have considerable impact on the clinical practice of SVG lesion stenting, patient satisfaction, and financial burden of health care systems (both within and outside the VA), regardless of whether the results are positive (DES offer significantly superior health benefits to patients than BMS), or negative (DES do not offer significantly superior health benefits to patients than BMS). Due to decreasing profits and increasing competition, DES manufacturers are not planning to ever fund a SVG DES study. The VA system with its Cooperative Studies Program is uniquely suited to conduct the proposed study.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BMS Group	Active Comparator	Patients who receive a bare metal stent in the saphenous vein graft target lesion(s).	Device: Bare Metal Stent Drug: Placebo Drug: Thienopyridine (open-label)
DES Group	Experimental	Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s).	Device: Drug-Eluting Stent Drug: Blinded clopidogrel Drug: Thienopyridine (open-label)

Name	Type	Description	Arm Group Labels	Other Names
Bare Metal Stent	Device	Patients receive one or more bare metal stents in the saphenous vein graft target lesion.	BMS Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Target Vessel Failure (TVF), Defined as the Composite of Cardiac Death		12 months
Number of Participants With Target Vessel Failure (TVF), Defined as the Target Vessel Myocardial Infarction		12 months
Number of Participants With Target Vessel Failure (TVF), Defined as the Target Vessel Revascularization		12 months

Secondary Outcomes

Measure	Description	Time Frame
Incremental Cost-effectiveness of DES Relative to BMS		12 months
Procedural Success	The procedural success rate and the incidence of post-procedural myocardial infarction and post-procedural GUSTO moderate or severe bleeding were compared between the DES and BMS groups by the difference between two independent proportions. Cumulative incidence curves and stratified log-rank tests were used to compare the two stent groups on the incidence of the secondary clinical outcomes listed above. When appropriate, competing risks analyses with plots of cumulative incidence curves and comparisons of cumulative incidences with Gray's test and Fine and Gray's methods were done. Proportional hazards regression for sub-distributions of competing risks were also done. SAS 9.2 (TS2M3; SAS Institute, Cary, NC, USA) and R version 3.4.4 were used for the analyses.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years
Need for percutaneous coronary intervention of a 50-99% de novo SVG lesion that is between 2.25 and 4.5 mm in diameter and that is considered to cause clinical or functional ischemia
Intent to use a distal embolic protection device
Agrees to participate and to take prescribed medications as instructed
Has provided informed consent and agrees to participate

Exclusion Criteria:

Planned non-cardiac surgery within the following 12 months
Presentation with an ST-segment elevation acute myocardial infarction
Target SVG is the last remaining vessel or is the "left main" equivalent
Any previous percutaneous treatment of the target lesion (with balloon angioplasty, stent, intravascular brachytherapy etc)
Any previous percutaneous treatment of the target vessel (of a lesion different than the target lesion) within the prior 12 months
Hemorrhagic diatheses, or refusal to receive blood transfusions
Warfarin administration required for the next 12 months and patient considered to be at high risk of bleeding with triple anticoagulation/antiplatelet therapy
Recent positive pregnancy test, breast-feeding, or possibility of a future pregnancy (defined as no prior hysterectomy or as <5 years elapsing since last menstrual period)
Coexisting conditions that limit life expectancy to less than 12 months
History of an allergic reaction or significant sensitivity to drugs such as sirolimus, paclitaxel, zotarolimus, or everolimus included in various DES. History of an allergic reaction or significant sensitivity to L-605 cobalt chromium alloy (cobalt, silicon, chromium, tungsten, manganese, iron, nickel), F562 cobalt chromium alloy (cobalt, chromium, nickel), 316L surgical stainless steel (iron, chromium, nickel, and molybdenum), or MP35N cobalt-based alloy (cobalt, nickel, chromium, molybdenum, titanium, iron, silicon, and manganese), or components of the platinum chromium alloy stent.
Allergy to clopidogrel in patients who do not present with an acute coronary syndrome (ACS), where ACS is defined as cardiac ischemic symptoms occurring at rest and 1 of the following 3 criteria: electrocardiographic changes suggestive of ischemia (ST-segment elevation or depression 1 mm in 2 contiguous leads, or new left bundle branch block, or posterior myocardial infarction); positive biomarker indicating myocardial necrosis (troponin I or T or creatine kinase-MB greater than the upper limit of normal); or coronary revascularization performed during hospitalization triggered by the cardiac ischemic symptoms
Participating in another interventional randomized trial (required condition for all CSP studies) for which dual enrollment with DIVA is not approved

Name	Affiliation	Role
Emmanouil S Brilakis, MD PhD	VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX	Study Chair
Subhash Banerjee, MD	VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Southern Arizona VA Health Care System, Tucson, AZ		Tucson	Arizona	85723	United States
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34736721	Derived	Xenogiannis I, Rangan BV, Uyeda L, Banerjee S, Edson R, Bhatt DL, Goldman S, Holmes DR Jr, Rao SV, Shunk K, Mavromatis K, Ramanathan K, Bavry AA, McFalls EO, Garcia S, Thai H, Uretsky BF, Latif F, Armstrong E, Ortiz J, Jneid H, Liu J, Aggrawal K, Conner TA, Wagner T, Karacsonyi J, Ventura B, Alsleben A, Lu Y, Shih MC, Brilakis ES. In-Stent Restenosis in Saphenous Vein Grafts (from the DIVA Trial). Am J Cardiol. 2022 Jan 1;162:24-30. doi: 10.1016/j.amjcard.2021.09.024. Epub 2021 Nov 1.
32019343

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Bare Metal Stent Group	Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	BMS Group	Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
BG001	DES Group	Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00068.2± 7.7 BG00169.0± 7.4 BG00268.6± 7.6

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000 BG0012 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00014 BG00116 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Caucasian	BG000254 BG001263 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000305 BG001292 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Target Vessel Failure (TVF), Defined as the Composite of Cardiac Death

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	BMS Group	Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	DES Group	Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Units	Counts
Participants	OG000305 OG001292

Title

Denominators

Categories

Title	Measurements
	OG00016 OG00117

Primary

Number of Participants With Target Vessel Failure (TVF), Defined as the Target Vessel Myocardial Infarction

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Bare Metal Stent Group	Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	Drug Eluting Stent Group	Patients who receive a drug-eluting stent (DES) in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive Bare Metal Stent (BMS) or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Primary

Number of Participants With Target Vessel Failure (TVF), Defined as the Target Vessel Revascularization

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Bare Metal Stent Group	Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	Drug Eluting Stent Group	Patients who receive a drug-eluting stent (DES) in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive Bare Metal Stent (BMS) or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Secondary

Incremental Cost-effectiveness of DES Relative to BMS

Posted

Mean

Standard Error

U.S. Dollars

12 months

ID	Title	Description
OG000	Bare Metal Stent Group	Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	Drug Eluting Stent Group	Patients who receive a drug-eluting stent (DES) in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive Bare Metal Stent (BMS) or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Secondary

Procedural Success

The procedural success rate and the incidence of post-procedural myocardial infarction and post-procedural GUSTO moderate or severe bleeding were compared between the DES and BMS groups by the difference between two independent proportions. Cumulative incidence curves and stratified log-rank tests were used to compare the two stent groups on the incidence of the secondary clinical outcomes listed above. When appropriate, competing risks analyses with plots of cumulative incidence curves and comparisons of cumulative incidences with Gray's test and Fine and Gray's methods were done. Proportional hazards regression for sub-distributions of competing risks were also done. SAS 9.2 (TS2M3; SAS Institute, Cary, NC, USA) and R version 3.4.4 were used for the analyses.

Posted

Count of Participants

Participants

Discharge from Index Hospitalization (an average of 36 hours)

ID	Title	Description
OG000	Bare Metal Stent Group	Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	Drug Eluting Stent Group

Secondary

Number of Participant Deaths (All Cause and Cardiac). All Deaths Will be Considered Cardiac Unless an Unequivocal Non-cardiac Cause Can be Established.

Posted

Count of Participants

Participants

Entire Duration of Follow-up (median 2.7 years)

ID	Title	Description
OG000	BMS Group	Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	DES Group	Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Secondary

Number of Participants With Myocardial Infarction (MI)

Posted

Count of Participants

Participants

Entire Duration of Follow-up (median 2.7 years)

ID	Title	Description
OG000	BMS Group	Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	DES Group	Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Secondary

Number of Participants With Definite Stent Thrombosis as Defined Using the Academic Research Consortium (ARC) Definition

Definite stent thrombosis will be considered to have occurred by either angiographic or pathologic confirmation.

Angiographic Confirmation of Stent Thrombosis will be defined as the presence of thrombus originating in a study stent, or in the segment 5mm proximal or distal to the stent AND fulfillment of at least one of the following 5 criteria within a 48 hour time window:

Acute onset of ischemic symptoms at rest
New ischemic ECG changes suggestive of acute ischemia
Rise and fall of cardiac biomarkers
Nonocclusive intracoronary thrombus seen in multiple projections, or persistence of contrast material within the lumen, or a visible embolization of intraluminal material downstream
Occlusive intracoronary thrombus Pathological Confirmation of stent thrombosis will be defined as evidence of recent thrombus with the stent determined at autopsy or via examination of tissue retrieved following thrombectomy.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	BMS Group	Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Secondary

Number of Participants With Target Vessel Revascularization (TVR)

Posted

Count of Participants

Participants

Entire Duration of Follow-up (median 2.7 years)

ID	Title	Description
OG000	BMS Group	Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	DES Group	Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Secondary

Patient-Oriented Composite Endpoint Will be Used as Secondary Outcome

The patient-oriented composite endpoint is defined as the composite of all-cause death, any myocardial infarction and target vessel revascularization.

Target vessel (SVG) revascularization (TVR) will be defined as any repeat percutaneous intervention or surgical bypass of any segment of the target SVG and the native coronary vessel distal to the SVG anastomosis. Non-target vessel revascularization will be defined as any repeat percutaneous intervention or surgical bypass of any SVG or any native coronary vessel apart from the target SVG and the native coronary artery supplied by the target SVG.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Bare Metal Stent Group	Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	Drug Eluting Stent Group	Patients who receive a drug-eluting stent (DES) in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive Bare Metal Stent (BMS) or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Secondary

In Patients Who Clinically Require Follow-up Angiography, Two Angiographic Endpoints Will be Assessed: (a) In-segment Binary Restenosis and (b) Angiographic Late In-segment Luminal Loss.

This outcome is for the in-segment binary restenosis.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Bare Metal Stent Group	Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	Drug Eluting Stent Group	Patients who receive a drug-eluting stent (DES) in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive Bare Metal Stent (BMS) or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Secondary

Number of Participants With Stroke

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Bare Metal Stent Group	Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	Drug Eluting Stent Group	Patients who receive a drug-eluting stent (DES) in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive Bare Metal Stent (BMS) or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Secondary

Incremental Cost-effectiveness Ratios (ICERs) for Subgroups of Patients, Such as Those With Highest Risk of Restenosis, Tallies of Cost by Type, and a Cost-outcomes Analysis Such as Cost Per Restenosis Avoided.

Posted

Mean

Standard Error

U.S. Dollars

12 months

ID	Title	Description
OG000	Diabetes	Interaction effects of this DES Subgroup
OG001	Number of Lesions (1 Lesion)	Interaction effects of this DES Subgroup
OG002	Number of Lesions (2 or More Lesions)	Interaction effects of this DES Subgroup
OG003	Stent Diameter (2.25 to Less Than 3)	Interaction effects of this DES Subgroup
OG004	Stent Diameter (3 to Less Than 3.5)	Interaction effects of this DES Subgroup
OG005

Secondary

In-stent Neointima Proliferation as Measured by Intravascular Ultrasonography

The study did not collect information needed from the IVUS procedures to calculate neointima proliferation.

Posted

12 months

ID	Title	Description
OG000	Bare Metal Stent Group	Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	Drug Eluting Stent Group	Patients who receive a drug-eluting stent (DES) in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive Bare Metal Stent (BMS) or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Secondary

Number of Participants With Target Lesion Revascularization (TLR)

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	BMS Group	Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	DES Group	Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Secondary

Number of Participants With Target Vessel Myocardial Infarction

Posted

Count of Participants

Participants

Entire Duration of Follow-up (median 2.7 years)

ID	Title	Description
OG000	BMS Group	Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	DES Group	Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Secondary

Number of Participants With Any Revascularization

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	BMS Group	Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	DES Group	Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Secondary

Number of Participants With Definite or Probable Stent Thrombosis

Definite stent thrombosis will be considered to have occurred by either angiographic or pathologic confirmation.

Probable Stent Thrombosis will clinically be considered to have occurred after index Saphenous Vein aortocoronary bypass Graft (SVG) stenting (the Percutaneous Coronary Intervention (PCI) immediately after randomization) in the following cases: a) any unexplained death within the first 30 days OR b) Irrespective of the time after the index procedure, any MI which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

Posted

Count of Participants

Participants

Entire Duration of Follow-up (median 2.7 years)

ID	Title	Description
OG000	BMS Group	Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	DES Group	Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Secondary

Procedural Complications (Post-procedural Myocardial Infarction and Post-procedural Bleeding)

Incidence of post-procedural myocardial infarction and post-procedural GUSTO moderate or severe bleeding were compared between the DES and BMS groups by the difference between two independent proportions. Cumulative incidence curves and stratified log-rank tests were used to compare the two stent groups on the incidence of the secondary clinical outcomes listed above. When appropriate, competing risks analyses with plots of cumulative incidence curves and comparisons of cumulative incidences with Gray's test and Fine and Gray's methods were done. Proportional hazards regression for sub-distributions of competing risks were also done. SAS 9.2 (TS2M3; SAS Institute, Cary, NC, USA) and R version 3.4.4 were used for the analyses.

Posted

Count of Participants

Participants

Discharge from Index Hospitalization (an average of 36 hours)

ID	Title	Description
OG000	Bare Metal Stent Group	Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	Drug Eluting Stent Group

Secondary

Device-oriented Composite Endpoint of Target Lesion Failure Will be Used as a Secondary Outcome

The Device-oriented composite endpoint of Target lesion failure is defined as the composite of cardiac or unknown death, target vessel myocardial infarction, and target lesion revascularization.

Target lesion revascularization (TLR) will be defined as any repeat percutaneous intervention of the target SVG lesion or bypass surgery of the target SVG lesion performed for restenosis or other complication of the target lesion. The target lesion will be defined as the treated SVG segment from 5 mm proximal to the stent to 5 mm distal to the stent.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Bare Metal Stent Group	Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	Drug Eluting Stent Group	Patients who receive a drug-eluting stent (DES) in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive Bare Metal Stent (BMS) or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Secondary

Number of Participants With Target Lesion Revascularization (TLR)

Posted

Count of Participants

Participants

Entire Duration of Follow-up (median 2.7 years)

ID	Title	Description
OG000	BMS Group	Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	DES Group	Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Secondary

Number of Participants With Non-Target Revascularization

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Bare Metal Stent Group	Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	Drug Eluting Stent Group	Patients who receive a drug-eluting stent (DES) in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive Bare Metal Stent (BMS) or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Secondary

Number of Participants With Non-Target Revascularization

Posted

Count of Participants

Participants

Entire Duration of Follow-up (median 2.7 years)

ID	Title	Description
OG000	Bare Metal Stent Group	Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	Drug Eluting Stent Group	Patients who receive a drug-eluting stent (DES) in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive Bare Metal Stent (BMS) or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Secondary

Patient-oriented (for Target Lesion Failure) Composite Endpoints Will be Used as Secondary Outcomes as Proposed by Cutlip et al, and as Recommended in the Draft FDA Guidance for Industry Statement.

The patient-oriented composite endpoint is defined as the composite endpoint of any death, any myocardial infarction, or target vessel revascularization.

Posted

Count of Participants

Participants

Entire Duration of Follow-up (median 2.7 years)

ID	Title	Description
OG000	Bare Metal Stent Group	Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	Drug Eluting Stent Group	Patients who receive a drug-eluting stent (DES) in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive Bare Metal Stent (BMS) or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Secondary

Device-oriented (for Target Lesion Failure) Composite Endpoints Will be Used as Secondary Outcomes as Proposed by Cutlip et al, and as Recommended in the Draft FDA Guidance for Industry Statement.

The device-oriented composite endpoint for target lesion failure is defined as the composite endpoint of cardiac death, target vessel myocardial infarction, or target lesion revascularization.

Posted

Count of Participants

Participants

Entire Duration of Follow-up (median 2.7 years)

ID	Title	Description
OG000	Bare Metal Stent Group	Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	Drug Eluting Stent Group	Patients who receive a drug-eluting stent (DES) in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive Bare Metal Stent (BMS) or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Secondary

Number of Participants With Stroke

Posted

Count of Participants

Participants

Entire Duration of Follow-up (median 2.7 years)

ID	Title	Description
OG000	Bare Metal Stent Group	Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	Drug Eluting Stent Group	Patients who receive a drug-eluting stent (DES) in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive Bare Metal Stent (BMS) or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Secondary

Quality Adjusted Life Years of DES Relative to BMS

Posted

Mean

Standard Error

years

12 months

ID	Title	Description
OG000	Bare Metal Stent Group	Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	Drug Eluting Stent Group	Patients who receive a drug-eluting stent (DES) in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive Bare Metal Stent (BMS) or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Secondary

Quality Adjusted Life Years for Subgroups of Patients

Posted

Mean

Standard Error

years

12 months

ID	Title	Description
OG000	Diabetes	Interaction effects of this DES Subgroup
OG001	Number of Lesions (1 Lesion)	Interaction effects of this DES Subgroup
OG002	Number of Lesions (2 or More Lesions)	Interaction effects of this DES Subgroup
OG003	Stent Diameter (2.25 to Less Than 3)	Interaction effects of this DES Subgroup
OG004	Stent Diameter (3 to Less Than 3.5)	Interaction effects of this DES Subgroup
OG005	Stent Diameter (3.5 to Less Than 4)

Secondary

In Patients Who Clinically Require Follow-up Angiography, Two Angiographic Endpoints Will be Assessed: (a) In-segment Binary Restenosis and (b) Angiographic Late In-segment Luminal Loss.

This outcome is for the angiographic late in-segment luminal loss.

Posted

Mean

Standard Deviation

lesions

12 months

ID	Title	Description
OG000	Bare Metal Stent Group	Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
OG001	Drug Eluting Stent Group	Patients who receive a drug-eluting stent (DES) in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive Bare Metal Stent (BMS) or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	BMS Group	Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	58	305	244	305	18	305
EG001	DES Group	Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	57	292	231	292	12	292

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ACS/MI	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG000166 events100 affected305 at risk EG001142 events92 affected292 at risk
Stroke	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG00018 events17 affected305 at risk EG00118 events14 affected292 at risk
Bleed	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG00041 events29 affected305 at risk EG00136 events28 affected292 at risk
Stent Thrombosis	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG00018 events17 affected305 at risk EG00111 events11 affected292 at risk
Other	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG000866 events219 affected305 at risk EG001859 events216 affected292 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Barrett's oesophagus	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected305 at risk EG0010 events0 affected292 at risk
Chest pain	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected305 at risk EG0010 events0 affected292 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected305 at risk EG0010 events0 affected292 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected305 at risk EG0010 events0 affected292 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected305 at risk EG0010 events0 affected292 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0007 events7 affected305 at risk EG0016 events4 affected292 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected305 at risk EG0011 events1 affected292 at risk
Haematoma	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected305 at risk EG0011 events1 affected292 at risk
Haematuria	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected305 at risk EG0012 events2 affected292 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected305 at risk EG0010 events0 affected292 at risk
Headache	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected305 at risk EG0011 events1 affected292 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected305 at risk EG0011 events1 affected292 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected305 at risk EG0011 events1 affected292 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected305 at risk EG0011 events1 affected292 at risk

ID	Term
D015607	Stents
D019736	Prostheses and Implants
D004864	Equipment and Supplies
D013988	Ticlopidine
D058924	Thienopyridines
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Term
D054855	Drug-Eluting Stents
D000077144	Clopidogrel
C446540	thienopyridine