ACTIVATION (PercutAneous Coronary inTervention prIor to transcatheter aortic VAlve implantaTION): A Randomized...

Area of Science:

• Cardiology
• Interventional Cardiology
• Cardiac Surgery

Background:

• Transcatheter aortic valve replacement (TAVR) is a key treatment for severe symptomatic aortic stenosis.
• Significant coronary artery disease (CAD) is common in TAVR patients, but optimal management strategy remains unclear.
• Percutaneous coronary intervention (PCI) carries risks, and randomized data comparing PCI before TAVR versus no PCI are lacking.

Purpose of the Study:

• To evaluate if performing PCI before TAVR in patients with significant CAD yields noninferior clinical outcomes compared to TAVR without prior PCI.
• To assess the composite endpoint of all-cause death or rehospitalization at one year post-procedure.

Main Methods:

• A randomized controlled trial involving 235 patients with severe aortic stenosis and significant CAD (Canadian Cardiovascular Society class ≤2 angina).
• Patients were assigned to either PCI before TAVR or no PCI (control arm).
• The primary endpoint was assessed using noninferiority testing with a prespecified margin of 7.5% in the intention-to-treat population.

Main Results:

• The primary composite endpoint occurred in 41.5% of the PCI arm and 44.0% of the no-PCI arm at one year; noninferiority was not met (P=0.067).
• Mortality rates were similar: 13.4% in the PCI arm versus 12.1% in the no-PCI arm.
• No significant differences were observed in stroke, myocardial infarction, or acute kidney injury, but bleeding rates were higher in the PCI arm (P=0.021).

Conclusions:

• PCI prior to TAVR did not demonstrate noninferiority regarding the composite endpoint of death or rehospitalization at one year.
• While clinical outcomes were similar between groups, PCI was associated with an increased risk of bleeding.
• Current evidence suggests that routine PCI before TAVR in patients with significant CAD may not be beneficial and increases bleeding complications.