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