MUNICH — In patients with an indication for a percutaneous coronary intervention (PCI) and a transcatheter aortic valve implantation (TAVI), outcomes are similar whether TAVI is performed before PCI or the other way around, according to the first major randomized trial to address this question.

Guidelines recommend sequential PCI and TAVI for those who need both, and PCI is widely performed first, the researchers said.

In the study designed to test the noninferiority of a TAVI-first strategy, 22.2% of patients who were randomly assigned to the experimental arm had an adverse primary endpoint event vs 24.2% of those who were randomly assigned to the PCI-first strategy. The difference easily met the predefined criterion for noninferiority (P < .001), reported Barbara E. Stähli, MD, professor of cardiology at the University Heart Center in Zurich, Switzerland.

Yet the strategies were not wholly equivalent. Fewer patients in the TAVI-first group ultimately underwent PCI, Stähli said.

“This was not because coronary access was impaired after TAVI. Rather, once the valve had been treated, the clinical decision about whether PCI was still necessary sometimes changed,” she said.

Stähli presented the results of the trial, called TAVI-PCI, at the European Society of Cardiology (ESC) Congress 2026. The findings were simultaneously published in The New England Journal of Medicine.

Lower Bleeding Rates

The study also associated TAVI-first with lower numerical rates of life-threatening, disabling, or major bleeding (6.6% vs 9.7%) and acute kidney injury (4.7% vs 6.4%), although Stähli called for “cautious interpretation” and further data to verify whether these potential differences in safety are meaningful.

In TAVI-PCI, 986 patients with severe aortic stenosis and concomitant coronary artery disease, with indications for both TAVI and PCI were randomly assigned at 48 centers in Europe. The primary endpoint, assessed at 1 year, was a composite of death from any cause; nonfatal myocardial infarction; ischemia-driven revascularization, rehospitalization related to the valve, procedure, or heart failure; and major bleeding.

Some key exclusions included previously treated aortic stenosis, prior coronary artery bypass grafting, or recent myocardial infarction. Patients with SYNTAX scores of 33 or higher also were excluded. The mean age of those randomly assigned was 82 years. 

Regardless of strategy, both procedures had to be completed within 45 days, according to the study protocol. The time interval between procedures was longer in the group randomized to the TAVI-first strategy (27 vs 13 days), but the relative delay was not considered relevant.

For the primary outcome, the lower rate of major adverse cardiovascular events (MACE) in the TAVI-first arm translated into a 10% numerical risk reduction by hazard ratio (HR), but the difference was not significant (HR, 0.9; 95% CI, 0.69-1.38).

When the components of MACE were compared individually as secondary endpoints by treatment strategy, there were no significant differences. This included any of the bleeding endpoints assessed individually.

TAVI-PCI has addressed an important clinical question, said Stähli, who noted that almost half of the patients who need TAVI also have coronary artery disease. She cited data suggesting that up to 20% of patients undergoing TAVI also undergo PCI within a similar time period.

ESC-invited discussant Julinda Mehilli, MD, cardiologist and researcher associated with the Landshut-Achdorf Clinic in the Department of Cardiology of Regensburg University in Regensburg, Germany, agreed this was an important trial and praised its design. She concurred that it had adequate power and patients to address the question.

She also suggested that the results are generally consistent with a recently published systematic review and Bayesian analysis of three randomized controlled trials that looked at the safety of PCI when performed prior to TAVI. However, she identified limitations and questions that still need answers.

Among the limitations, she noted the mean age of 82 years is not only considerably older than many other TAVI trials but also 6-7 years older than the average age at which these procedures are performed in Germany. She indicated this might be relevant when considering if these results are generalizable.

Of questions that this study raised, she speculated that different results might have been generated if all PCIs were guided by functional angiography. Instead, PCI was guided by fractional flow reserve (FFR) in only about one third of patients.

This point is relevant to the recently published FAITAVI trial. Mehilli said the study showed that if “FFR-guided angiography is performed in PCI around TAVI, you will have fewer interventions — 60% rather than 95% — and particularly you will have much fewer patients in need of PCI after TAVI,” she said. The reduction in PCI in the FAITAVI trial was attributed by Mehilli to the observation that FFRs “often normalize after completion of TAVI.”

Mehilli also wondered how revascularization of all significant non-culprit lesions would affect outcomes in general and in relation to a TAVI- or PCI-first strategy. She said this question should be addressed by the ongoing COMPLETE-2 trial, which is expected to generate results in 2027.

This investigator-initiated study did not receive funding from a commercial source. Stähli reported funding from Edwards Lifesciences to her institution. Mehilli reported financial relationships with Abbott Vascular, Edwards Lifesciences, Novo Nordisk, and SMT.

Ted Bosworth, a career medical writer based in New York City, has been covering advances in clinical medicine, including cardiology, for several decades.