Brief Title
Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement
Official Title
A Randomized, Comparative Effectiveness Study of Staged Complete Revascularization With Percutaneous Coronary Intervention to Treat Coronary Artery Disease vs Medical Management Alone in Patients With Symptomatic Aortic Valve Stenosis Undergoing Elective Transfemoral Transcatheter Aortic Valve Replacement: The COMPLETE TAVR Study
Brief Summary
Patients undergoing transcatheter aortic valve replacement (TAVR) often have concomitant coronary artery disease (CAD) which may adversely affect prognosis. There is uncertainty about the benefits and the optimal timing of revascularization for such patients. There is currently clinical equipoise regarding the management of concomitant CAD in patients undergoing TAVR. Some centers perform routine revascularization with percutaneous coronary intervention (PCI) (either before or after TAVR), while others follow an alternative strategy of medical management. The potential benefits and optimal timing of PCI in these patients are unknown. As TAVR expands to lower risk patients, and potentially becomes the preferred therapy for the majority of patients with severe aortic stenosis, the optimal management of concomitant coronary artery disease will be of increasing importance. The COMPLETE TAVR study will determine whether, on a background of guideline-directed medical therapy, a strategy of complete revascularization involving staged PCI using drug eluting stents to treat all suitable coronary artery lesions is superior to a strategy of medical therapy alone in reducing the composite outcome of Cardiovascular Death, new Myocardial Infarction, Ischemia-driven Revascularization or Hospitalization for Unstable Angina or Heart Failure. The study will be a randomized, multicenter, open-label trial with blinded adjudication of outcomes. Patients will be screened and consented for elective transfemoral TAVR and randomized within 24 hours of successful balloon expandable TAVR. Complete Revascularization: Staged PCI using third generation drug eluting stents to treat all suitable coronary artery lesions in vessels that are at least 2.5 mm in diameter and that are amenable to treatment with PCI and have a >70% visual angiographic diameter stenosis. Staged PCI can occur any time from 1 to 45 days post successful transfemoral TAVR. Vs. Medical Therapy Alone: No further revascularization of coronary artery lesions. All patients, regardless of randomized treatment allocation, will receive guideline-directed medical therapy consisting of risk factor modification and use of evidence-based therapies The COMPLETE TAVR study will help address the current lack of evidence in this area. It will likely impact both the global delivery of health care and the management and clinical outcomes of all patients undergoing TAVR with concomitant CAD.
Study Type
Interventional
Primary Outcome
Composite of Cardiovascular Death or New Myocardial Infarction or Ischemia-Driven Revascularization or Hospitalization for Unstable Angina or Heart Failure
Secondary Outcome
Cardiovascular Death
Condition
Aortic Stenosis
Intervention
Percutaneous Coronary Intervention (PCI)
Study Arms / Comparison Groups
Complete Revascularization
Description: Routine PCI (percutaneous coronary intervention) of all suitable coronary artery stenoses of >70% in vessels ≥2.5mm in diameter.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
4000
Start Date
December 8, 2020
Completion Date
April 1, 2026
Primary Completion Date
April 1, 2026
Eligibility Criteria
Inclusion Criteria: - Men and women with severe symptomatic aortic valve stenosis defined as: [aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2] AND [Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg] AND [NYHA Functional Class ≥ 2 OR abnormal exercise test with severe SOB, abnormal blood pressure response, or arrhythmia] AND - Coronary artery disease defined as: (at least 1 coronary artery lesion of >70% visual angiographic diameter stenosis in a vessel that is at least 2.5 mm in diameter and that is amenable to treatment with percutaneous coronary intervention (PCI)) AND - Consensus by the Multidisciplinary Heart Team that the patient is suitable for elective transfemoral transcatheter aortic valve replacement (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 surgical aortic valve replacement. AND - Succcessful TAVR with balloon-expandable transcatheter heart valve within the past 24 hr. Exclusion Criteria: - PCI already performed within 90 days or during elective transfemoral TAVR - Planned revascularization of coronary artery lesion(s) - Planned surgical revascularization - 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 - Aortic annulus diameter < 16 mm or > 28 mm (3D imaging) - Severe aortic regurgitation (> 3+) or mitral regurgitation (> 3+) - Severe left ventricular dysfunction (LVEF < 30%) - Severe calcification of aortic valvar complex (esp. left ventricular outflow tract) - Vascular anatomy not suitable for safe femoral access - Low coronary takeoff (high risk for obstruction) - Acute myocardial infarction within 1 month - Stroke or transient ischemic attack within 90 days - Renal insufficiency (eGFR < 30 ml/min) and/or renal replacement Rx - Hemodynamic or respiratory instability - Frailty (objective assessment as per the essential frailty toolset)
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
David A Wood, MD, 604-875-4111, [email protected]
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT04634240
Organization ID
H20-00968
Responsible Party
Principal Investigator
Study Sponsor
University of British Columbia
Study Sponsor
David A Wood, MD, Principal Investigator, CCI-CIC, University of British Columbia
Verification Date
November 2020