Pros and cons of PreTAVR PCI, ACTIVATION trial attempts at clearing the confusion

In the latest issue of JACC Cardiovascular Interventions, Patterson et al report the results of the first randomized controlled trial (ACTIVATION trial) designed to compare PCI versus no PCI in TAVR candidates with significant CAD. Observed rates of death and rehospitalization at 1 year were similar between PCI and no PCI prior to TAVR; however, the noninferiority margin was not met, and PCI resulted in a higher incidence of bleeding.

Current American College of Cardiology/American Heart Association guidelines state that PCI is reasonable for critical lesions in proximal coronary vessels, based on limited data, and recommend individualizing treatment. The decision to perform coronary revascularization in TAVR trials is generally left to the operators' discretion, and there is no proof of its appropriateness.

The aim of ACTIVATION trial was to demonstrate the noninferiority of PCI with regard to a composite endpoint of all-cause mortality and rehospitalization at 1 year, with a prespecified noninferiority margin of 7.5%.

At 17 centers, 235 patients underwent randomization. The primary composite outcome at 1 year showed no significant difference between the two randomised arms. The primary endpoint was narrowly missed, with a difference of -2.5% and the upper boundary of the 95% 1-sided confidence limit reaching 8.5% ( P = 0.067). Importantly, PCI was associated with a significant increase in the 1-year incidence of any bleed and a trend to a higher rate of major bleeding and acute kidney injury (AKI).

So what should be our approach according to current knowledge?

Petronio et al write in an accompanying editorial, "In our opinion, the decision to revascularize TAVR candidates should be modulated according to 4 key issues: life expectancy, severity and location of coronary stenosis, patient's bleeding risk, and likelihood of coronary access preservation following TAVR". They present an algorithmic approach for better patient selection who should undergo pre TAVR PCI as shown in figure 1.

In conclusion, the issue of whether, when, and how to revascularize CAD in TAVR candidates is still open and debatable. The ACTIVATION trial constitutes a new, valuable piece of information in this fast-changing scenario.

Source: JACC Cardiovascular Interventions:

1. doi: 10.1016/j.jcin.2021.06.041.
2. doi: 10.1016/j.jcin.2021.07.021.