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| Name | Class |
|---|---|
| VZW Cardiovascular Research Center Aalst | OTHER |
| Catharina Ziekenhuis Eindhoven | OTHER |
| Golden Jubilee National Hospital | OTHER_GOV |
| University of California, Irvine |
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The purpose of this study is to determine whether Fractional flow reserve (FFR, (coronary pressure wire-based index for assessing the ischemic potential of a coronary lesion)-guided percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease (CAD) will result in similar outcomes to coronary artery bypass graft surgery (CABG).
The FAME 3 trial is a multicenter, international, randomized, controlled noninferiority trial. All patients with multivessel CAD (not involving the left main) will be screened by the site's Heart Team (including but not limited to an interventional cardiologist, cardiac surgeon and research coordinator). If all agree that the patient can be treated either with FFR-guided PCI or CABG, and all inclusion criteria are met and no exclusion criteria are met, then the patient will be randomized.
Baseline clinical, functional, laboratory and electrocardiographic data will be obtained. Patients will receive treatment within 4 weeks of randomization. Patients randomized to CABG will receive state of the art therapy at the discretion of the local surgeon with a strong emphasis on arterial revascularization. Patients undergoing PCI will have FFR measured with a St. Jude Medical coronary pressure wire across all lesions. If the FFR is ≤0.80, then PCI will be performed with the Medtronic Resolute Integrity drug-eluting stent (DES) as per usual routine. If the FFR is >0.80 then PCI will be deferred.
All patients will receive medical therapy as per published guidelines. Patients will follow-up at 1 and 6 months, and 1 and 3 years with an evaluation of clinical status, functional status, medications and events. Follow-up may be extended to 5 years, if funding allows.
Core lab analyses will include formal quantitative coronary angiography (QCA) of the baseline angiograms with calculation of the Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score and Functional SYNTAX Score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FFR guided PCI | Active Comparator | Patients undergoing PCI will have FFR measured with a St. Jude Medical coronary pressure wire across all lesions. If the FFR is ≤0.80, then PCI will be performed with the Medtronic Resolute Integrity (or Onyx) drug-eluting stent (DES) as per usual routine. If the FFR is >0.80 then PCI will be deferred. Only those sites with prior experience measuring FFR will be included in the FAME 3 trial. These patients in whom FFR of a particular lesion was not possible will be included in all analyses based on the intention to treat principle. |
|
| CABG | Active Comparator | CABG will be performed as per clinical routine at each participating center. Both off-pump and on-pump surgery are acceptable, as long as the surgeon and the site are experienced in the particular technique. An internal mammary graft to the LAD should be attempted in all cases, if feasible. Complete arterial revascularization is strongly recommended, however, each center should use a conduit strategy with which they are most comfortable. All vessels ≥ 1,5 mm in diameter and with ≥ 50% stenosis should be bypassed, if technically feasible. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFR guided PCI | Procedure |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| MACCE | Death, MI, stroke and any repeat revascularization (MACCE) will be evaluated at 1 year, where subjects contribute data from time of randomization until the occurrence of MACCE or one year follow-up, whichever occurs first. Subjects who die or are lost to follow up before 1 year will be censored at their last recorded activity. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Key Secondary Outcome: Composite of Death From Any Cause, Myocardial Infarction, or Stroke | Death, MI, or stroke at 3-year follow-up | 3 years |
| Number of Participants Experiencing Death, MI, or Stroke |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William F Fearon, MD | Stanford University | Study Chair |
| Nico HJ Pijls, MD, PhD | Catharina Hospital Eindhoven, The Netherlands | Principal Investigator |
| Bernard De Bruyne, MD, PhD | VZW Cardiovascular Research Center Aalst | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palo Alto VA | Palo Alto | California | United States | |||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26386784 | Background | Zimmermann FM, De Bruyne B, Pijls NH, Desai M, Oldroyd KG, Park SJ, Reardon MJ, Wendler O, Woo J, Yeung AC, Fearon WF. Rationale and design of the Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) 3 Trial: a comparison of fractional flow reserve-guided percutaneous coronary intervention and coronary artery bypass graft surgery in patients with multivessel coronary artery disease. Am Heart J. 2015 Oct;170(4):619-626.e2. doi: 10.1016/j.ahj.2015.06.024. Epub 2015 Jul 9. | |
| 31207442 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | FFR Guided PCI | Patients undergoing Percutaneous Coronary Intervention (PCI) will have Fractional Flow Reserve (FFR) measured with a St. Jude Medical coronary pressure wire across all lesions. If the FFR is ≤0.80, then PCI will be performed with the Medtronic Resolute Integrity (or Onyx) drug-eluting stent as per usual routine. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 27, 2018 |
Not provided
| OTHER |
| Medtronic | INDUSTRY |
| Abbott Medical Devices | INDUSTRY |
| Genae | INDUSTRY |
| King's College Hospital NHS Trust | OTHER |
| Houston Methodist DeBakey Heart & Vascular Center | OTHER |
Not provided
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| CABG |
| Procedure |
Coronary Artery Bypass Graft Surgery (CABG) |
|
| Resolute Integrity Stent | Device | Durable polymer zotarolimus-eluting stent |
|
| Resolute Onyx Stent | Device | Durable polymer zotarolimus-eluting stent |
|
Subjects who died or are lost to follow up before this time were censored at their last recorded activity.
| 1 year |
| Death | Death evaluated excluding patients lost to follow-up from each arm | 1 year |
| Number of Participants Experiencing Myocardial Infarction | MI evaluated excluding patients lost to follow-up from each arm | 1 year |
| Number of Participants Experiencing Stroke | Stroke evaluated excluding patients lost to follow-up from each arm. | 1 year |
| Number of Participants Requiring Repeat Revascularization | Any repeat revascularization evaluated excluding patients lost to follow-up from each arm | 1 year |
| Number of Participants Experiencing BARC Type 3-5 Bleeding | Bleeding Academic Research Consortium (BARC) type 3-5 indicates severe bleeding. | 1 year |
| Number of Participants Experiencing Acute Kidney Injury | 1 year |
| Number of Participants Experiencing Atrial Fibrillation or Clinically Significant Arrhythmia | 1 year |
| Number of Participants Experiencing Definite Stent Thrombosis | 1 year |
| Number of Participants Experiencing Definite Symptomatic Graft Occlusion | 1 year |
| Number of Participants Requiring Rehospitalization Within 30 Days | 30 days |
| MACCE | Death, MI, stroke and any repeat revascularization (MACCE) rate at 5 years | 5 years |
| Death, MI, or Stroke at 5 Years | Death, MI, or stroke at 5 years | 5 years |
| Individual Components of Primary Outcome | Individual components of primary outcome: number of participants experiencing death, myocardial infarction, and stroke | At year 3 |
| Individual Components of Primary Outcome | Individual components of primary outcome: number of participants experiencing death, myocardial infarction, and stroke | At year 5 |
| Stanford |
| California |
| 94305-2004 |
| United States |
| Atlanta VA Medical Center | Decatur | Georgia | United States |
| Jesse Brown VA Medical Center | Chicago | Illinois | United States |
| University of Kansas Medical Center | Lawrence | Kansas | United States |
| Lexinton VA | Lexington | Kentucky | United States |
| University of Kentucky Medical Center | Lexington | Kentucky | United States |
| Baystate Medical Center | Springfield | Massachusetts | United States |
| HealthEast St. Joseph's Hospital | Saint Paul | Minnesota | United States |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | United States |
| Centennial Heart | Nashville | Tennessee | United States |
| Houston Methodist Hospital | Houston | Texas | United States |
| University of Virginia | Charlottesville | Virginia | United States |
| Peninsula Health | Frankston | Australia |
| St. Vincent's Hospital Melbourne | Melbourne | Australia |
| Concord Hospital | Sydney | Australia |
| Royal North Shore | Sydney | Australia |
| University of Sydney | Sydney | Australia |
| Cardiovascular Center Aalst | Aalst | 9300 Aalst | Belgium |
| Le'Centre Hospitalier de l'Universite de Montreal | Montreal | Canada |
| York PCI Group INC | Ontario | Canada |
| University of Ottawa Heart Institute | Ottawa | Canada |
| Masaryk University and University Hospital Brno | Brno | Czechia |
| Rigshospitalet University Hospital | Copenhagen | Denmark |
| Cardiovascular Hospital | Lyon | France |
| Hungarian Institute of Cardiology | Budapest | Hungary |
| Vilnius University Hospital Santariskiu Klinikos | Vilnius | Lithuania |
| Catharina Hospital Eindhoven | Eindhoven | 5623 EJ | Netherlands |
| HagaZiekenhuis | The Hague | Netherlands |
| Isala Klinieken | Zwolle | Netherlands |
| Waikato Hospital | Hamilton | New Zealand |
| Stavanger University Hospital | Stavanger | Norway |
| University Clinical Center of Serbia | Belgrade | Serbia |
| Clinical Center Kragujevac | Kragujevac | Serbia |
| Asan Medical Center | Seoul | South Korea |
| Sahlgrenska University Hospital | Gothenburg | Sweden |
| Danderyds Sjukhus | Stockholm | Sweden |
| Karolinska Institutet, Dep of clinical science and education, Södersjukhuset | Stockholm | Sweden |
| Wales Heart Research Institute | Cardiff | United Kingdom |
| University Hospitals Coventry and Warwickshire | Coventry and Warwickshire | United Kingdom |
| Golden Jubilee National Hospital | Glasgow | United Kingdom |
| Kings College Hospital | London | United Kingdom |
| St. Thomas' Hospital | London | United Kingdom |
| Wythenshawe Hospital | Manchester | United Kingdom |
| Oxford University Hospital NHS Trust | Oxford | United Kingdom |
| Southampton University Hospitals NHS Trust | Southhampton | United Kingdom |
| Background |
| Zimmermann FM, De Bruyne B, Pijls NHJ, Desai M, Oldroyd KG, Reardon MJ, Wendler O, Woo J, Yeung AC, Fearon WF. A protocol update of the Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) 3 trial: A comparison of fractional flow reserve-guided percutaneous coronary intervention and coronary artery bypass graft surgery in patients with multivessel coronary artery disease. Am Heart J. 2019 Aug;214:156-157. doi: 10.1016/j.ahj.2019.04.012. Epub 2019 Apr 29. No abstract available. |
| 34735046 | Result | Fearon WF, Zimmermann FM, De Bruyne B, Piroth Z, van Straten AHM, Szekely L, Davidavicius G, Kalinauskas G, Mansour S, Kharbanda R, Ostlund-Papadogeorgos N, Aminian A, Oldroyd KG, Al-Attar N, Jagic N, Dambrink JE, Kala P, Angeras O, MacCarthy P, Wendler O, Casselman F, Witt N, Mavromatis K, Miner SES, Sarma J, Engstrom T, Christiansen EH, Tonino PAL, Reardon MJ, Lu D, Ding VY, Kobayashi Y, Hlatky MA, Mahaffey KW, Desai M, Woo YJ, Yeung AC, Pijls NHJ; FAME 3 Investigators. Fractional Flow Reserve-Guided PCI as Compared with Coronary Bypass Surgery. N Engl J Med. 2022 Jan 13;386(2):128-137. doi: 10.1056/NEJMoa2112299. Epub 2021 Nov 4. |
| 40174598 | Result | Fearon WF, Zimmermann FM, Ding VY, Takahashi K, Piroth Z, van Straten AHM, Szekely L, Davidavicius G, Kalinauskas G, Mansour S, Kharbanda R, Ostlund-Papadogeorgos N, Aminian A, Oldroyd KG, Al-Attar N, Jagic N, Dambrink JE, Kala P, Angeras O, MacCarthy P, Wendler O, Casselman F, Witt N, Mavromatis K, Miner SES, Sarma J, Engstrom T, Christiansen EH, Tonino PAL, Reardon MJ, Otsuki H, Kobayashi Y, Hlatky MA, Mahaffey KW, Desai M, Woo YJ, Yeung AC, Pijls NHJ, De Bruyne B. Outcomes after fractional flow reserve-guided percutaneous coronary intervention versus coronary artery bypass grafting (FAME 3): 5-year follow-up of a multicentre, open-label, randomised trial. Lancet. 2025 Apr 26;405(10488):1481-1490. doi: 10.1016/S0140-6736(25)00505-7. Epub 2025 Mar 30. |
| 40240081 | Derived | Takahashi K, Otsuki H, Zimmermann FM, Ding VY, Piroth Z, Oldroyd KG, Wendler O, Reardon MJ, Desai M, Woo YJ, Yeung AC, De Bruyne B, Pijls NHJ, Fearon WF; FAME 3 Trial Investigators. Outcomes After CABG Compared With FFR-Guided PCI in Patients Presenting With Acute Coronary Syndrome. JACC Cardiovasc Interv. 2025 Apr 14;18(7):838-848. doi: 10.1016/j.jcin.2025.01.434. |
| 40072460 | Derived | Takahashi K, Otsuki H, Zimmermann FM, Ding VY, Engstrom T, Horsted Thyregod HG, Beleslin B, Putnik S, Tapp L, Barker T, Redwood S, Young C, Bech GJ, Hoohenkerk GJF, De Bruyne B, Pijls NHJ, Fearon WF; FAME 3 Trial Investigators. FFR-Guided Percutaneous Coronary Intervention vs Coronary Artery Bypass Grafting in Patients With Diabetes. JAMA Cardiol. 2025 Jun 1;10(6):603-608. doi: 10.1001/jamacardio.2025.0095. |
| 39641725 | Derived | Takahashi K, Otsuki H, Zimmermann FM, Ding VY, Oldroyd KG, Wendler O, Reardon MJ, Woo YJ, Yeung AC, Pijls NHJ, De Bruyne B, Fearon WF; FAME 3 Trial Investigators. Sex Differences in Patients Undergoing FFR-Guided PCI or CABG in the FAME 3 Trial. JACC Cardiovasc Interv. 2025 Jan 27;18(2):157-167. doi: 10.1016/j.jcin.2024.09.030. Epub 2024 Dec 4. |
| 39502029 | Derived | Otsuki H, Takahashi K, Zimmermann FM, Mavromatis K, Aminian A, Jagic N, Dambrink JE, Kala P, MacCarthy P, Witt N, Kobayashi Y, Takahashi T, Woo YJ, Yeung AC, De Bruyne B, Pijls NHJ, Fearon WF; FAME 3 Trial Investigators. Impact of a Chronic Total Occlusion on Outcomes After FFR-Guided PCI or Coronary Bypass Surgery: A FAME 3 Substudy. Circ Cardiovasc Interv. 2024 Nov;17(11):e014300. doi: 10.1161/CIRCINTERVENTIONS.124.014300. Epub 2024 Nov 6. |
| 37602376 | Derived | Zimmermann FM, Ding VY, Pijls NHJ, Piroth Z, van Straten AHM, Szekely L, Davidavicius G, Kalinauskas G, Mansour S, Kharbanda R, Ostlund-Papadogeorgos N, Aminian A, Oldroyd KG, Al-Attar N, Jagic N, Dambrink JE, Kala P, Angeras O, MacCarthy P, Wendler O, Casselman F, Witt N, Mavromatis K, Miner SES, Sarma J, Engstrom T, Christiansen EH, Tonino PAL, Reardon MJ, Otsuki H, Kobayashi Y, Hlatky MA, Mahaffey KW, Desai M, Woo YJ, Yeung AC, De Bruyne B, Fearon WF; FAME 3 Investigators. Fractional Flow Reserve-Guided PCI or Coronary Bypass Surgery for 3-Vessel Coronary Artery Disease: 3-Year Follow-Up of the FAME 3 Trial. Circulation. 2023 Sep 19;148(12):950-958. doi: 10.1161/CIRCULATIONAHA.123.065770. Epub 2023 Aug 21. |
| 36121706 | Derived | Piroth Z, Otsuki H, Zimmermann FM, Ferenci T, Keulards DCJ, Yeung AC, Pijls NHJ, De Bruyne B, Fearon WF. Prognostic Value of Measuring Fractional Flow Reserve After Percutaneous Coronary Intervention in Patients With Complex Coronary Artery Disease: Insights From the FAME 3 Trial. Circ Cardiovasc Interv. 2022 Nov;15(11):884-891. doi: 10.1161/CIRCINTERVENTIONS.122.012542. Epub 2022 Sep 19. |
| 35369704 | Derived | Fearon WF, Zimmermann FM, Ding VY, Zelis JM, Piroth Z, Davidavicius G, Mansour S, Kharbanda R, Ostlund-Papadogeorgos N, Oldroyd KG, Wendler O, Reardon MJ, Woo YJ, Yeung AC, Pijls NHJ, De Bruyne B, Desai M, Hlatky MA; FAME 3 Investigators. Quality of Life After Fractional Flow Reserve-Guided PCI Compared With Coronary Bypass Surgery. Circulation. 2022 May 31;145(22):1655-1662. doi: 10.1161/CIRCULATIONAHA.122.060049. Epub 2022 Apr 2. |
| CABG |
Coronary-artery bypass grafting (CABG) performed per clinical routine (both off-pump and on-pump surgery acceptable). |
| Underwent alternate procedure | Due to patient/physician refusal to undergo/perform procedure or an acute event leading to an alternative treatment |
|
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | FFR Guided PCI | Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent. |
| BG001 | CABG | CABG performed per clinical routine (both off-pump and on-pump surgery acceptable). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Diabetes | Count of Participants | Participants |
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| Hypertension | Count of Participants | Participants |
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| Smoking Status | Count of Participants | Participants |
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| Family history of coronary artery disease | Count of Participants | Participants |
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| Previous myocardial infarction | Count of Participants | Participants |
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| Previous PCI | Count of Participants | Participants |
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| History of transient ischemic attack (TIA) or cerebral vascular accident (CVA) | Count of Participants | Participants |
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| Kidney disease | Count of Participants | Participants |
| ||||||||||||||||
| Noninvasive test for ischemia | Count of Participants | Participants |
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| Left ventricular ejection fraction (LVEF) ≤50% | Count of Participants | Participants |
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| Hospitalized with Non-ST elevation-acute coronary syndrome (NSTE-ACS) | Count of Participants | Participants |
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| 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 | MACCE | Death, MI, stroke and any repeat revascularization (MACCE) will be evaluated at 1 year, where subjects contribute data from time of randomization until the occurrence of MACCE or one year follow-up, whichever occurs first. Subjects who die or are lost to follow up before 1 year will be censored at their last recorded activity. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Key Secondary Outcome: Composite of Death From Any Cause, Myocardial Infarction, or Stroke | Death, MI, or stroke at 3-year follow-up | FFR-guided PCI vs CABG | Posted | Count of Participants | Participants | 3 years |
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| Secondary | Number of Participants Experiencing Death, MI, or Stroke | Subjects who died or are lost to follow up before this time were censored at their last recorded activity. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Death | Death evaluated excluding patients lost to follow-up from each arm | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants Experiencing Myocardial Infarction | MI evaluated excluding patients lost to follow-up from each arm | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants Experiencing Stroke | Stroke evaluated excluding patients lost to follow-up from each arm. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants Requiring Repeat Revascularization | Any repeat revascularization evaluated excluding patients lost to follow-up from each arm | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants Experiencing BARC Type 3-5 Bleeding | Bleeding Academic Research Consortium (BARC) type 3-5 indicates severe bleeding. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants Experiencing Acute Kidney Injury | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants Experiencing Atrial Fibrillation or Clinically Significant Arrhythmia | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants Experiencing Definite Stent Thrombosis | Outcome not assessed in CABG group (did not receive stent). | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants Experiencing Definite Symptomatic Graft Occlusion | Outcome not assessed in FFR guided PCI group (did not receive CABG). | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants Requiring Rehospitalization Within 30 Days | Posted | Count of Participants | Participants | 30 days |
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| Secondary | MACCE | Death, MI, stroke and any repeat revascularization (MACCE) rate at 5 years | Intention-to-Treat Population | Posted | Count of Participants | Participants | 5 years |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Death, MI, or Stroke at 5 Years | Death, MI, or stroke at 5 years | Intention-to-Treat Population | Posted | Count of Participants | Participants | 5 years |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Individual Components of Primary Outcome | Individual components of primary outcome: number of participants experiencing death, myocardial infarction, and stroke | FFR-guided PCI | Posted | Count of Participants | Participants | At year 3 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Individual Components of Primary Outcome | Individual components of primary outcome: number of participants experiencing death, myocardial infarction, and stroke | FFR-guided PCI | Posted | Count of Participants | Participants | At year 5 |
|
|
5 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FFR Guided PCI | Patients undergoing PCI with measured FFR ≤0.80 have PCI performed with Medtronic Resolute Integrity (or Onyx) drug-eluting stent. | 53 | 757 | 119 | 757 | 112 | 757 |
| EG001 | CABG | CABG performed per clinical routine (both off-pump and on-pump surgery acceptable). | 51 | 743 | 101 | 743 | 55 | 743 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death, MI or stroke | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Repeat revascularization | Cardiac disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Fearon, MD | Stanford University | 650-725-2621 | wfearon@stanford.edu |
| Nov 19, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| Male |
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| Non-white |
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| Insulin-dependent |
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| Non-insulin-dependent |
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| Previous tobacco user |
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