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

Coronary Artery Disease Clinical Trial

— SAVE-IT  

Official title:

Strategies for Revascularization in Patients Undergoing Heart Valve Surgery With Concomitant Coronary Artery Disease. AngIography vs Fractional Flow Reserve

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02173860
• Other study ID #: SAVEIT351
• Status: Recruiting
• Phase: N/A
• First received: June 19, 2014
• Last updated: October 20, 2016
• Start date: July 2016
• Est. completion date: August 2021

Study information

• Verified date: October 2016
• Source: Portuguese Society of Cardiology
• Contact: Ruben Ramos, MD
• Phone: +351963156910
• Email: ruben.a.b.ramos[@]gmail.com
• Is FDA regulated: No
• Health authority: Portugal: Ethics Committee for Clinical Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 502
• Est. completion date: August 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Heart Valve Diseases
• Myocardial Ischemia
• Valvular Heart Disease

Intervention

Procedure:
• FFR-guided surgical revascularization

• Angio-guided surgical revascularization

Locations

Country	Name	City	State
Portugal	Hospital Santa Marta, centro Hospitalar Lisboa Central	Lisbon

Sponsors (2)

Lead Sponsor	Collaborator
Portuguese Society of Cardiology	St. Jude Medical

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post operative atrial fibrillation rate	Occurrence of any documented episode of symptomatic or asymptomatic episode of atrial fibrillation	Participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks	No
Other	Post operative ICU stay	From cardiac surgery end to transfer to intermediate care unit or ward. Measured in hours.	participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks	No
Other	Hospitalization period	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	expected average of ten days	No
Other	Total circulatory bypass time	measured in minutes	expected maximum of 300 minutes	No
Other	Total cross-clamp time	measured in minutes	expected maximum of 300 minutes	No
Other	Acute renal injury	Percentage decline in glomerular filtration rate at post-operative day 4 as compared to pre-operative glomerular filtration rate	to post-operative day 4	No
Other	Blood transfusion	Number of units of red blood cells transfused.	participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks	No
Other	Duration of mechanical ventilation	Total duration of mechanical ventilatory support. Repeated intubation will be included	participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks	No
Other	Time to inotropic weaning	Total time spent with inotropic support. Recurrent use will be quantified	participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks	No
Other	Use of intra-aortic balloon pump (IABP)	Number of patients requiring mechanical hemodynamic support with IABP	participants will be followed for the duration of hospital stay, an expected maximum of 4 weeks	Yes
Other	Anginal status	Symptomatic status as defined canadian cardiac society (CCS) anginal status score	12 months	No
Other	Heart failure symptoms	Symptomatic status as defined per New York Heart Association (NYHA) score	12 months	No
Primary	MACCE	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.	12 months	No
Primary	Graft failure	Graft patency as assessed by CCTA scheduled at 12 months. Graft status can also be assessed by invasive coronary angiography if clinically indicated.	12 months	No
Secondary	MACCE	death, nonfatal myocardial infarction, unplanned revascularization and stroke	1 month	Yes
Secondary	MACCE	death, nonfatal myocardial infarction, unplanned revascularization and stroke	6 months	No