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The percutaneous coronary intervention prior to transcatheter aortic valve implantation (ACTIVATION) trial: study
Muhammed Zeeshan Khawaja1, Duolao Wang, Stuart Pocock
1The Rayne Institute, Cardiovascular Division, King's College London, BHF Centre of Excellence, St Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK. Dr.zeeshan.khawaja@gmail.com.
Insights
The ACTIVATION trial investigated treating coronary artery disease before transcatheter aortic valve implantation (TAVI). Pre-TAVI PCI was found non-inferior to no PCI, offering insights for TAVI guidelines.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Current guidelines recommend coronary artery bypass grafting (CABG) alongside surgical aortic valve replacement for significant coronary artery disease.
- No consensus exists on optimal coronary disease management for high-risk patients undergoing transcatheter aortic valve implantation (TAVI).
Purpose of the Study:
- To evaluate if percutaneous coronary intervention (PCI) before TAVI is non-inferior to omitting PCI in patients with significant coronary artery disease.
- To provide evidence for updating guidelines on managing coronary artery disease in the context of TAVI.
Main Methods:
- The ACTIVATION trial was a randomized, open-label study involving 310 patients.
- Patients were assigned to either pre-TAVI PCI or no PCI.
- The primary outcome was a composite of 12-month mortality and rehospitalization.
Main Results:
- The study tested the non-inferiority of pre-TAVI PCI compared to no PCI.
- Secondary outcomes included 30-day mortality, bleeding events, symptom burden, and quality of life.
Conclusions:
- The trial aims to inform clinical practice and improve the safety and efficacy of TAVI.
- Utilizing a definition of coronary artery disease severity relevant to interventional cardiologists is key.
Background:
Current 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/Design:
The 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 Registration:
ISRCTN75836930, http://www.controlled-trials.com/ISRCTN75836930 (registered 19 November 2011).
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