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

Study Description

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

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease; Valvular Heart Disease	Procedure: FFR-guided surgical revascularization; Procedure: Angio-guided surgical revascularization	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 502 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Strategies for Revascularization in Patients Undergoing Heart Valve Surgery With Concomitant Coronary Artery Disease. AngIography vs Fractional Flow Reserve
• Study Start Date: July 2016
• Estimated Primary Completion Date: January 2021
• Estimated Study Completion Date: August 2021

Arms and Interventions

Arm	Intervention/treatment
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.	Procedure: FFR-guided surgical revascularization; Other Name: Fractional Flow Reserve-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.	Procedure: Angio-guided surgical revascularization; Other Name: Coronary artery bypass graft guided by angiographic-only assessment of severity stenosis

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

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

Other Outcome Measures:

1. 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
2. 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.
3. 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
4. Total circulatory bypass time [ Time Frame: expected maximum of 300 minutes ]
   measured in minutes
5. Total cross-clamp time [ Time Frame: expected maximum of 300 minutes ]
   measured in minutes
6. 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
7. 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.
8. 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
9. 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
10. 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
11. Anginal status [ Time Frame: 12 months ]
    Symptomatic status as defined canadian cardiac society (CCS) anginal status score
12. Heart failure symptoms [ Time Frame: 12 months ]
    Symptomatic status as defined per New York Heart Association (NYHA) score

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Ruben Ramos, MD; +351963156910; ruben.a.b.ramos@gmail.com

Contact: Mafalda Selas, RN; +351213594000

Locations

Portugal

Hospital Santa Marta, centro Hospitalar Lisboa Central; Recruiting

Lisbon, Portugal, 1169-024

Contact: Ruben Ramos, MD +351963156910 ruben.a.b.ramos@gmail.com

Contact: Mafalda Selas, RN +351213594000 mafalda.selas@gmail.com

Principal Investigator: Ruben Ramos, MD

Sponsors and Collaborators

Portuguese Society of Cardiology

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

More Information

• Responsible Party: Portuguese Society of Cardiology
• ClinicalTrials.gov Identifier: NCT02173860
• Other Study ID Numbers: SAVEIT351
• First Posted: June 25, 2014
• Last Update Posted: October 21, 2016
• Last Verified: October 2016

Keywords provided by Portuguese Society of Cardiology:

Coronary artery disease; Valvular heart disease; Fractional flow reserve; Coronary artery bypass surgery; Coronary graft failure or patency

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Heart Valve Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases