Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement

Launched by UNIVERSITY OF BRITISH COLUMBIA · Nov 17, 2020

Keywords

ClinConnect Summary

The COMPLETE TAVR study is investigating the best way to treat patients who have both severe aortic stenosis and coronary artery disease (CAD) when they undergo a procedure called transcatheter aortic valve replacement (TAVR). The study aims to find out if a method called complete revascularization, where doctors use a special procedure to open blocked arteries, is better than just using medications alone to manage heart health. This is particularly important as more patients with lower risk are receiving TAVR, and understanding how to best address any additional heart issues is crucial for improving outcomes.

To be eligible for this study, participants should have symptoms of aortic valve stenosis and at least one significant blockage in their coronary arteries that can be treated. They must also have undergone TAVR successfully within the last 96 hours. All participants will receive standard medical care, which includes medications and lifestyle advice to manage their heart health. Depending on their random assignment, some may receive additional procedures to open their blocked arteries, while others will be treated with medications only. This study is designed to provide valuable information on how to improve care for patients facing both aortic stenosis and coronary artery disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - Symptomatic aortic valve stenosis prior to TAVR (NYHA Functional Class ≥ 2 OR Abnormal exercise test with severe SOB, abnormal BP response, or arrhythmia)
• • AND
• • - CAD defined as: at least 1 coronary artery lesion of ≥70% visual angiographic diameter stenosis in a native segment ≥2.5 mm in diameter that is not a CTO and is amenable to treatment with PCI
• • AND
• • - Consensus by the Local Multidisciplinary Heart Team that the patient is suitable for elective transfemoral TAVR with a balloon expandable transcatheter heart valve AND would receive a bypass with an anastomosis distal to the coronary artery lesion(s) if they were undergoing SAVR.
• Local Multidisciplinary Heart Teams are expected to follow current clinical guidelines for selection of patients for TAVR with an eligible patient generally expected to have:
• • \[AVA ≤ 1.0 cm2 OR AVA index ≤ 0.6 cm2/m2\]
• • OR
• • \[Jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg\]
• • OR
• • patients without these criteria may undergo TAVR if the Local Multidisciplinary Heart Team concludes it is appropriate.
• • AND
• • - Successful transfemoral TAVR, defined as the implantation of a single transcatheter aortic valve within the past 96 hours with freedom from more than minimal aortic insufficiency, stroke, or major vascular complications.
• Exclusion Criteria:
• • PCI already performed within 90 days prior to TAVR or at the same time as the index transfemoral TAVR procedure
• • Planned PCI of coronary artery lesion(s)
• • Planned surgical revascularization of coronary artery lesion(s)
• • Non-cardiovascular co-morbidity reducing life expectancy to \< 5 years
• • Any factor precluding 5-year follow-up
• • Prior coronary artery bypass grafting surgery or surgical valve replacement
• • Severe mitral regurgitation (\> 3+)
• • Severe left ventricular dysfunction (LVEF \< 30%)
• • Low coronary takeoff (high risk for coronary obstruction)
• • Acute myocardial infarction within 90 days
• • Stroke or transient ischemic attack within 90 days
• • Renal insufficiency (eGFR \< 30 ml/min) and/or renal replacement Rx
• • Hemodynamic or respiratory instability