Abstract
BackgroundCurrent guidelines recommend treatment of significant coronary artery disease by concomitant coronary artery bypass grafting (CABG) in patients undergoing surgical aortic valve replacement. However there is no consensus as to how best to treat coronary disease in high-risk patients requiring transcatheter aortic valve implantation (TAVI).Methods/DesignThe percutaneous coronary intervention prior to transcatheter aortic valve implantation (ACTIVATION) trial is a randomized, controlled open-label trial of 310 patients randomized to treatment of significant coronary artery disease by percutaneous coronary intervention (PCI - test arm) or no PCI (control arm). Significant coronary disease is defined as ≥1 lesion of ≥70% severity in a major epicardial vessel or 50% in a vein graft or protected left main stem lesion. The trial tests the hypothesis that the strategy of performing pre-TAVI PCI is non-inferior to not treating such coronary stenoses with PCI prior to TAVI, with a composite primary outcome of 12-month mortality and rehospitalization. Secondary outcomes include efficacy end-points such as 30-day mortality, safety endpoints including bleeding, burden of symptoms, and quality of life (assessed using the Seattle Angina Questionnaire and the Kansas City Cardiomyopathy Questionnaire).In conclusion, we hope that using a definition of coronary artery disease severity closer to that used in everyday practice by interventional cardiologists - rather than the 50% severity used in surgical guidelines - will provide robust evidence to direct guidelines regarding TAVI therapy and improve its safety and efficacy profile of this developing technique.Trial registrationISRCTN75836930, http://www.controlled-trials.com/ISRCTN75836930 (registered 19 November 2011).
Highlights
Current guidelines recommend treatment of significant coronary artery disease by concomitant coronary artery bypass grafting (CABG) in patients undergoing surgical aortic valve replacement
Considerations in pre-transcatheter aortic valve implantation percutaneous coronary intervention Among the possible advantages of revascularization prior to TAVI may be a protective effect against the ischemic burden of the procedure, including as it does periods of hypotension
Hypothesis, design and end points ACTIVATION is a prospective, randomized, open-label trial that aims to test the hypothesis that revascularization of significant coronary artery disease by Percutaneous coronary intervention (PCI) prior to TAVI (Test arm) will result in a rate of mortality and rehospitalization at 12 months that is non-inferior to TAVI without such revascularization
Summary
Transcatheter aortic valve implantation (TAVI) has moved into the cardiology mainstream with rapid acceptance of this new technology since the first implant in 2002 [1]. The presence of concomitant CAD has been associated with adverse procedural outcomes in sAVR [10,11] and in TAVI [5] In this higher risk cohort, with a mean age in excess of the ‘normal’ population with chronic stable angina, we must carefully evaluate any coronary artery lesion’s significance in terms of the possibly greater risks of PCI and the impact on the planned valvular intervention. There has been a rapid, global expansion in the use of TAVI to treat aortic stenosis in patients who are not candidates for sAVR The efficacy of this technique has been successfully demonstrated in randomized, controlled trials [28,29] and in large registries [30,31], and there is a need to improve patient safety and outcome, including how to manage patients with concomitant CAD. Its findings will help define the optimum revascularization strategy in this procedure and help create evidence-based guidelines on this controversial issue
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