Strategies for Revascularization in Patients Undergoing Heart Valve Surgery With Concomitant Coronary Artery Disease (SAVE-IT)

• ClinicalTrials.gov Identifier: NCT02173860
• Recruitment Status: Unknown
• First Posted: June 25, 2014
• Last Update Posted: October 21, 2016
• Sponsor: Portuguese Society of Cardiology
• Collaborator: Abbott Medical Devices
• Information provided by (Responsible Party): Portuguese Society of Cardiology

Tracking Information

• First Submitted Date: June 19, 2014
• First Posted Date: June 25, 2014
• Last Update Posted Date: October 21, 2016
• Study Start Date: July 2016
• Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 20, 2016)

• MACCE [ Time Frame: 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 [ Time Frame: 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.

Original Primary Outcome Measures (submitted: June 23, 2014)

• MACCE [ Time Frame: 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 [ Time Frame: 12 months ]
  Graft patency as assessed by CCTA scheduled at 12 months. Graft status can also be assessed by invasive coronary angiography if clinicaly indicated.

Current Secondary Outcome Measures (submitted: June 23, 2014)

• MACCE [ Time Frame: 1 month ]
  death, nonfatal myocardial infarction, unplanned revascularization and stroke
• MACCE [ Time Frame: 6 months ]
  death, nonfatal myocardial infarction, unplanned revascularization and stroke

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: October 20, 2016)

• Post operative atrial fibrillation rate [ Time Frame: Participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks ]
  Occurrence of any documented episode of symptomatic or asymptomatic episode of atrial fibrillation
• Post operative ICU stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks ]
  From cardiac surgery end to transfer to intermediate care unit or ward. Measured in hours.
• Hospitalization period [ Time Frame: expected average of ten days ]
  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
• Total circulatory bypass time [ Time Frame: expected maximum of 300 minutes ]
  measured in minutes
• Total cross-clamp time [ Time Frame: expected maximum of 300 minutes ]
  measured in minutes
• Acute renal injury [ Time Frame: to post-operative day 4 ]
  Percentage decline in glomerular filtration rate at post-operative day 4 as compared to pre-operative glomerular filtration rate
• Blood transfusion [ Time Frame: participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks ]
  Number of units of red blood cells transfused.
• Duration of mechanical ventilation [ Time Frame: participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks ]
  Total duration of mechanical ventilatory support. Repeated intubation will be included
• Time to inotropic weaning [ Time Frame: participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks ]
  Total time spent with inotropic support. Recurrent use will be quantified
• Use of intra-aortic balloon pump (IABP) [ Time Frame: participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks ]
  Number of patients requiring mechanical hemodynamic support with IABP
• Anginal status [ Time Frame: 12 months ]
  Symptomatic status as defined canadian cardiac society (CCS) anginal status score
• Heart failure symptoms [ Time Frame: 12 months ]
  Symptomatic status as defined per New York Heart Association (NYHA) score

Original Other Pre-specified Outcome Measures (submitted: June 23, 2014)

• Post operative atrial fibrillation rate [ Time Frame: Participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks ]
  Occurrence of any documented episode of symptomatic or asymptomatic episode of atrial fibrillation
• Post operative ICU stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks ]
  From cardiac surgery end to transfer to intermediate care unit or ward. Measured in hours.
• Hospitalization period [ Time Frame: expected avarege of ten days ]
  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
• Total circulatory bypass time [ Time Frame: expected maximum of 300 minutes ]
  measured in minutes
• Total cross-clamp time [ Time Frame: expected maximum of 300 minutes ]
  measured in minutes
• Acute renal injury [ Time Frame: to post-operative day 4 ]
  Percentage decline in glomerular filtration rate at post-operative day 4 as compared to pre-operative glomerular filtration rate
• Blood transfusion [ Time Frame: participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks ]
  Number of units of red blood cells transfused.
• Duration of mechanical ventilation [ Time Frame: participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks ]
  Total duration of mechanical ventilatory support. Repeated intubation will be included
• Time to inotropic weaning [ Time Frame: participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks ]
  Total time spent with inotropic support. Recurrent use will be quantified
• Use of intra-aortic balloon pump (IABP) [ Time Frame: participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks ]
  Number of patients requiring mechanical hemodynamic support with IABP
• Anginal status [ Time Frame: 12 months ]
  Symptomatic status as defined canadian cardiac society (CCS) anginal status score
• Heart failure symptoms [ Time Frame: 12 months ]
  Symptomatic status as defined per New York Heart Association (NYHA) score

Descriptive Information

• Brief Title: 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
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Coronary Artery Disease
• Valvular Heart Disease

Intervention

• Procedure: FFR-guided surgical revascularization
  Other Name: Fractional Flow Reserve-Guided surgical revascularization
• Procedure: Angio-guided surgical revascularization
  Other Name: Coronary artery bypass graft guided by angiographic-only assessment of severity stenosis

Study Arms

• Active Comparator: FFR-guided 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.
  Intervention: Procedure: FFR-guided surgical revascularization
• Active Comparator: Angio-guided 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.
  Intervention: Procedure: Angio-guided surgical revascularization

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 23, 2014): 502
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2021
• Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Portugal

Administrative Information

• NCT Number: NCT02173860
• Other Study ID Numbers: SAVEIT351
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Portuguese Society of Cardiology
• Original Responsible Party: Same as current
• Current Study Sponsor: Portuguese Society of Cardiology
• Original Study Sponsor: Same as current
• Collaborators: Abbott Medical Devices

Investigators

• Principal Investigator: Ruben Ramos, MD; Hospital Santa Marta, Centro Hospitalar Lisboa Central
• Principal Investigator: Sergio Batista, MD; Hospital Fernando da Fonseca
• Principal Investigator: 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

• PRS Account: Portuguese Society of Cardiology
• Verification Date: October 2016