ACTIVATION Trial Findings

Delhi: Pre-procedure PCI versus no PCI in patients undergoing TAVR having significant coronary artery disease (CAD) did not result in better chances of survival or decrease in re-hospitalization risk, reveals findings from ACTIVATION Trial. The findings of the study were presented at the PCR Valves e-Course 2020 by Simon Redwood, from King's College London, England.

ACTIVATION is the first randomized trial of percutaneous coronary intervention (PCI) versus no PCI in patients with severe aortic stenosis and CAD undergoing transcatheter aortic valve replacement (TAVR). The trial found no difference in one-year mortality or rehospitalisation from PCI prior to TAVR.

The trial was conducted across 17 sites in the UK, Germany, and France. It enrolled patients having severe, symptomatic aortic stenosis as well as at least one proximal stenosis of > 70% in a major epicardial coronary artery, suitable for PCI. More than two thirds of patients had single-vessel disease and most of the rest had two-vessel CAD. It excluded patients with active bleeds, left main disease, a recent ACS, or class III-IV angina. Enrollment was done from late 2012 until January 2019 when practice changes the facility -- total trial participation at 235 was shy of the 310 originally planned for the study.

Key findings of the study include:

• One year after TAVR, the primary endpoint of death/rehospitalization had occurred in 41.5% of the patients who underwent preprocedure PCI and in 44% of patients who did not.
• That event rate was similar, although the criteria for noninferiority was not met.
• A total of 16 deaths occurred in the PCI group compared with 14 in the no-PCI group.
• Rehospitalizations were 41 and 39, respectively.
• Bleeds, however, were higher in the PCI group: 44.5% versus 28.4%.
• The majority of that difference was in less severe bleeds with no significant difference in major bleeding. The difference in bleeds was likely due to the use of post-procedure dual antiplatelet therapy.

"Performing PCI prior to TAVR if a patient is found to have at least one significant coronary stenosis does not improve their chances of surviving or staying out of hospital over the next 12 months," concluded the authors.

The study, "The percutaneous coronary intervention prior to transcatheter aortic valve implantation (ACTIVATION) trial," was presented at the PCR Valves e-Course 2020.