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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
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The purpose of this study is to determine whether, in patients undergoing elective valvular heart surgery, revascularization of concomitant coronary artery disease (CAD) guided by FFR (Fractional flow reserve) would be superior to standard angiography-guided-revascularization approach on major efficacy and safety outcomes
The SAVE-IT trial is a multicenter, international, randomized, controlled, superiority trial. Patients scheduled to undergo elective valvular heart surgery will be screened for presence of concomitant coronary artery disease (CAD) by invasive coronary angiography. Patients with a stenosis > 50% in at least one epicardial vessel (excluding left main) considered suitable for surgical revascularization will be randomized to FFR guided- or standard angiography-guided surgical revascularization. A proportion of patients with no concomitant CAD will be followed in a parallel registry
Baseline clinical, laboratory, electrocardiographic and echocardiographic data will be obtained. Coronary anatomy severity will be assessed by quantitative coronary angiography (QCA) and Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (Syntax) score. Surgical risk will be assessed by Euroscore. Patients randomized to FFR-guided arm will have functional severity of the angiographic stenosis assessed by a St. Jude Medical coronary pressure wire measurement under hyperemic conditions using intravenous or intracoronary adenosine administration. If the FFR is ≤0.8 then a graft will be placed distal to the coronary stenosis. If the FFR is >0.8 no grafting will be performed to the epicardial vessel containing the stenosis. Patients will receive cardiac surgery no later than 8 weeks after randomization.
Peri-operative data will be collected. Clinical follow-up data will be collected at 1, 6 and 12 month after surgery. Graft patency at 12 months will be assessed by cardiac computed angiography (CCTA) for all patients who received at least one graft, except if an invasive coronary angiography has been performed in the preceding 3 months based on clinical grounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FFR-guided revascularization | Active Comparator | Patients with valvular heart disease scheduled for elective cardiac surgery and concomitant significant coronary artery disease will have FFR measured with a St. Jude Medical coronary pressure wire across all lesions in vessels pre-specified as suitable for surgical revascularization. If the FFR is ≤0.80, then CABG will be performed. If the FFR is >0.80 then no graft will be placed in that particular vessel. Patients in whom FFR of a particular lesion is not possible can be included if at least one additional lesion is suitable for FFR measurement and grafting. |
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| Angio-guided revascularization | Active Comparator | Concomitant CABG will be performed as per clinical routine in all vessels with at least one stenosis > 50%. The vessel should be pre-specified as suitable for surgical revascularization before randomization. An internal mammary graft to the LAD should be attempted in all cases, if possible. Further revascularization strategy is left to the discretion of each center. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFR-guided surgical revascularization | Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| MACCE | Composite endpoint of death, nonfatal myocardial infarction, unplanned revascularization and stroke at 12 months. Subjects who die or are lost to follow up before 1 year will be censored at their last recorded activity. | 12 months |
| Graft failure | Graft patency as assessed by CCTA scheduled at 12 months. Graft status can also be assessed by invasive coronary angiography if clinically indicated. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| MACCE | death, nonfatal myocardial infarction, unplanned revascularization and stroke | 1 month |
| MACCE | death, nonfatal myocardial infarction, unplanned revascularization and stroke |
| Measure | Description | Time Frame |
|---|---|---|
| Post operative atrial fibrillation rate | Occurrence of any documented episode of symptomatic or asymptomatic episode of atrial fibrillation | Participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks |
| Post operative ICU stay |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruben Ramos, MD | Contact | +351963156910 | ruben.a.b.ramos@gmail.com | |
| Mafalda Selas, RN | Contact | +351213594000 |
| Name | Affiliation | Role |
|---|---|---|
| Ruben Ramos, MD | Hospital Santa Marta, Centro Hospitalar Lisboa Central | Principal Investigator |
| Sergio Batista, MD | Hospital Fernando da Fonseca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Santa Marta, centro Hospitalar Lisboa Central | Recruiting | Lisbon | Lisbon District | 1169-024 | Portugal |
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| Angio-guided surgical revascularization | Procedure |
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| 6 months |
From cardiac surgery end to transfer to intermediate care unit or ward. Measured in hours. |
| participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks |
| Hospitalization period | From cardiac surgery to hospital discharge. Measured in days.From date of cardiac surgery until the date of first hospital discharge assessed up to 8 weeks | expected average of ten days |
| Total circulatory bypass time | measured in minutes | expected maximum of 300 minutes |
| Total cross-clamp time | measured in minutes | expected maximum of 300 minutes |
| Acute renal injury | Percentage decline in glomerular filtration rate at post-operative day 4 as compared to pre-operative glomerular filtration rate | to post-operative day 4 |
| Blood transfusion | Number of units of red blood cells transfused. | participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks |
| Duration of mechanical ventilation | Total duration of mechanical ventilatory support. Repeated intubation will be included | participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks |
| Time to inotropic weaning | Total time spent with inotropic support. Recurrent use will be quantified | participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks |
| Use of intra-aortic balloon pump (IABP) | Number of patients requiring mechanical hemodynamic support with IABP | participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks |
| Anginal status | Symptomatic status as defined canadian cardiac society (CCS) anginal status score | 12 months |
| Heart failure symptoms | Symptomatic status as defined per New York Heart Association (NYHA) score | 12 months |
| Luis Raposo, MD |
| Hospital de Santa Cruz, Centro Hospitalar de Lisboa Central |
| Principal Investigator |
| Emanuele Barbato, PhD | Olzv-Aalst Clinic | Principal Investigator |
| Colin Berry, PhD | Golden Jubilee National Hospital | Principal Investigator |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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