The percutaneous coronary intervention prior to transcatheter aortic valve implantation (ACTIVATION) trial: study protocol for a randomized controlled trial

Muhammed Zeeshan Khawaja*, Duolao Wang, Stuart Pocock, Simon Robert Redwood, Martyn Thomas

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

77 Citations (Scopus)

Abstract

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.

Original languageEnglish
Article number300
Number of pages8
JournalTrials
Volume15
DOIs
Publication statusPublished - 24 Jul 2014

Keywords

  • Transcatheter aortic valve implantation
  • Percutaneous coronary intervention
  • Aortic stenosis
  • Coronary
  • END-POINT DEFINITIONS
  • HIGH-RISK PATIENTS
  • ARTERY-DISEASE
  • CLINICAL-TRIALS
  • STENT THROMBOSIS
  • POOLED ANALYSIS
  • STENOSIS
  • OUTCOMES
  • REPLACEMENT
  • REGISTRY

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