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Pros and cons of PreTAVR PCI, ACTIVATION trial attempts at clearing the confusion
Figure 1. Algorithmic approach for appropriate patient selection for pre-TAVR PCI.
The prevalence of coronary artery disease (CAD) among TAVR recipients is quite high, reaching up to 80%. Percutaneous coronary intervention (PCI) in such patients undergoing TAVR is not without risk, and there are no randomized data to inform clinical practice.
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:
- doi: 10.1016/j.jcin.2021.06.041.
- doi: 10.1016/j.jcin.2021.07.021.
MBBS, MD , DM Cardiology
Dr Abhimanyu Uppal completed his M. B. B. S and M. D. in internal medicine from the SMS Medical College in Jaipur. He got selected for D. M. Cardiology course in the prestigious G. B. Pant Institute, New Delhi in 2017. After completing his D. M. Degree he continues to work as Post DM senior resident in G. B. pant hospital. He is actively involved in various research activities of the department and has assisted and performed a multitude of cardiac procedures under the guidance of esteemed faculty of this Institute. He can be contacted at editorial@medicaldialogues.in.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: editorial@medicaldialogues.in. Contact no. 011-43720751