The percutaneous coronary intervention prior to transcatheter aortic valve implantation (ACTIVATION) trial: study protocol for a randomized controlled trial
Why the study?
Is percutaneous coronary intervention prior to TAVI non-inferior to no PCI for the composite of 12-month mortality and rehospitalization in high-risk patients requiring TAVI with significant coronary artery disease?
Population
310 high-risk patients requiring transcatheter aortic valve implantation with significant coronary artery…
Comparison
Percutaneous coronary intervention prior to TAVI vs No PCI prior to TAVI
Design
Other, randomized, open-label
Follow-up
12 months
Authors
Discussion
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Member takes
Implication
The role of pre-TAVI PCI remains unresolved; this protocol launches the first randomized non-inferiority trial to address it.
Structured PICO
Is percutaneous coronary intervention prior to TAVI non-inferior to no PCI for the composite of 12-month mortality and rehospitalization in high-risk patients requiring TAVI with significant coronary artery disease?
P
Population
310 high-risk patients requiring transcatheter aortic valve implantation (TAVI) with significant coronary artery disease (defined as ≥1 lesion of ≥70% severity in a major epicardial vessel or 50% in a vein graft or protected left main stem lesion)
I
Intervention
Percutaneous coronary intervention (PCI) prior to TAVI
C
Comparator
No PCI prior to TAVI
O
Outcome
Composite of 12-month mortality and rehospitalizationcomposite
This study protocol outlines a randomized trial to determine if performing PCI prior to TAVI is non-inferior to no PCI in high-risk patients with significant coronary artery disease.
Cite This Study
Khawaja et al. (2014) studied this question.