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

Last updated: October 20, 2016
Sponsor: Portuguese Society of Cardiology
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Heart Valve Disease

Hypercholesterolemia

Treatment

N/A

Clinical Study ID

NCT02173860
SAVEIT351
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > 18 years

  • Severe heart valve disease with indication for an elective cardiac with a St. JudeMedical Heart Valve

  • Concomitant significant CAD (at least one epicardial vessel with a stenosis> 50%)

  • Willing and able to provide informed written consent

Exclusion

Exclusion Criteria:

  • Previous CABG

  • Angiographic significant lesion involving left main lesion (patient is still eligibleif right coronary artery is candidate for FFR measurement and surgicalrevascularization)

  • 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 consideredas 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 < 60ml/min

  • Life expectancy < 12 months

  • Currently participating in any other clinical investigation

Study Design

Total Participants: 502
Study Start date:
July 01, 2016
Estimated Completion Date:
August 31, 2021

Study 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.

Connect with a study center

  • Hospital Santa Marta, centro Hospitalar Lisboa Central

    Lisbon, 1169-024
    Portugal

    Active - Recruiting

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