Coronary Artery Disease Clinical Trial
Official title:
Strategies for Revascularization in Patients Undergoing Heart Valve Surgery With Concomitant Coronary Artery Disease. AngIography vs Fractional Flow Reserve
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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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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