Strategies for Revascularization in Patients Undergoing Heart Valve Surgery With Concomitant Coronary Artery Disease

Not Applicable

• Conditions: Valvular Heart Disease; Coronary Artery Disease
• Interventions: Procedure: FFR-guided surgical revascularization; Procedure: Angio-guided surgical revascularization

• Registration Number: NCT02173860
• Lead Sponsor: Portuguese Society of Cardiology

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-06-19
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-25
• Study Start: 2016-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-20
• Last Update Posted: 2016-10-21
• Primary Completion: 2021-01
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 502

Inclusion Criteria

• Age > 18 years
• Severe heart valve disease with indication for an elective cardiac with a St. Jude Medical Heart Valve
• Concomitant significant CAD (at least one epicardial vessel with a stenosis> 50%)
• Willing and able to provide informed written consent

Exclusion Criteria

• Previous CABG
• Angiographic significant lesion involving left main lesion (patient is still eligible if right coronary artery is candidate for FFR measurement and surgical revascularization)
• All lesions in extremely tortuous or calcified coronary vessels
• Recent myocardial infarction (< 30 days)
• Cardiogenic shock or clinical instability (i.e. NYHA 4, uncontrolled arrhythmias, unexplained hypotension severe bradycardia or any other medical condition considered as a sign of instability by the assisting physician)
• Severe left ventricular dysfunction (EF < 35%)
• Pregnant or are planning to become pregnant during the duration of the investigation
• Chronic renal dysfunction as defined as estimated glomerular filtration rate < 60 ml/min
• Life expectancy < 12 months
• Currently participating in any other clinical investigation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FFR-guided revascularization	FFR-guided surgical revascularization	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.
Angio-guided revascularization	Angio-guided surgical revascularization	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.

Primary Outcome Measures

Name	Time	Method
MACCE	12 months	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.
Graft failure	12 months	Graft patency as assessed by CCTA scheduled at 12 months. Graft status can also be assessed by invasive coronary angiography if clinically indicated.

Secondary Outcome Measures

Name	Time	Method
MACCE	6 months	death, nonfatal myocardial infarction, unplanned revascularization and stroke

Trial Locations

Locations (1)

Hospital Santa Marta, centro Hospitalar Lisboa Central; 🇵🇹 Lisbon, Portugal