Clinical trial NCT02173860: Strategies for Revascularization in Patients Undergoing Heart Valve Surgery With Concomitant Coronary Artery Disease
Official title: Strategies for Revascularization in Patients Undergoing Heart Valve Surgery With Concomitant Coronary Artery Disease. AngIography vs Fractional Flow Reserve
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Valvular Heart Disease
Keywords: Coronary artery disease
Valvular heart disease
Fractional flow reserve
Coronary artery bypass surgery
Coronary graft failure or patency
Lead sponsor: Portuguese Society of Cardiology
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2014-06-25
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: MACCE
timeFrame: 12 months
measure: Graft failure
timeFrame: 12 months
Secondary outcomes:
measure: MACCE
timeFrame: 1 month
measure: MACCE
timeFrame: 6 months
Other outcomes:
measure: Post operative atrial fibrillation rate
timeFrame: Participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks
measure: Post operative ICU stay
timeFrame: participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks
measure: Hospitalization period
timeFrame: expected average of ten days
measure: Total circulatory bypass time
timeFrame: expected maximum of 300 minutes
measure: Total cross-clamp time
timeFrame: expected maximum of 300 minutes
measure: Acute renal injury
timeFrame: to post-operative day 4
measure: Blood transfusion
timeFrame: participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks
measure: Duration of mechanical ventilation
timeFrame: participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks
measure: Time to inotropic weaning
timeFrame: participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks
measure: Use of intra-aortic balloon pump (IABP)
timeFrame: participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks
measure: Anginal status
timeFrame: 12 months
measure: Heart failure symptoms
timeFrame: 12 months
Locations:
city: Lisbon
country: Portugal
facility: Hospital Santa Marta, centro Hospitalar Lisboa Central
Study officials:
affiliation: Hospital Santa Marta, Centro Hospitalar Lisboa Central
name: Ruben Ramos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Fernando da Fonseca
name: Sergio Batista, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Santa Cruz, Centro Hospitalar de Lisboa Central
name: Luis Raposo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Olzv-Aalst Clinic
name: Emanuele Barbato, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Golden Jubilee National Hospital
name: Colin Berry, PhD
role: PRINCIPAL_INVESTIGATOR
References: