Deferring PCI Until After TAVI Safe, Reduces Bleeding: PRO-TAVI

NEW ORLEANS, LA—For patients with both coronary artery disease and aortic stenosis who are slated for TAVI, deferring revascularization is a safe strategy, according to new data from the PRO-TAVI trial.

Among more than 400 patients enrolled, the rate of all-cause mortality, MI, stroke, and major bleeding at 1 year in those assigned to undergo PCI before TAVI was noninferior to the rate in those assigned to wait (26% vs 23%; HR 0.89; 95% CI 0.62-1.28; P = 0.0008 for noninferiority).

“The PRO-TAVI trial [is] the first trial that shows noninferiority of the deferral of standard PCI before TAVI,” said Michiel Voskuil, MD, PhD (University Medical Centre Utrecht, Netherlands), who presented the findings Sunday at the American College of Cardiology 2026 Scientific Session. “Second, we show that the deferral of PCI before TAVI leads to a substantial reduction in the number of major bleeds. Third, which is of course important still for every individual patient, a comprehensive assessment of bleeding and ischemic risks should be done by the local heart teams before the decision for each patient.”

The results were simultaneously published in the Lancet with first author Ronak Delewi, MD (Amsterdam University Medical Center, the Netherlands).

PRO-TAVI Findings

Societal recommendations for patients with concomitant coronary artery disease and severe aortic stenosis are limited. The most recent European Society of Cardiology/European Association for Cardio-Thoracic Surgery valvular heart disease guidelines include a class IIa (level of evidence B) recommendation for PCI to be considered in patients with ≥ 90% coronary artery stenosis in segments with a reference diameter ≥ 2.5 mm. In 2023, the European Association of Percutaneous Cardiovascular Interventions published a consensus statement that recommends PCI before TAVI in patients with severe CAD, but emphasizes basing the decision on patient anatomy and lesion complexity. 

The PRO-TAVI researchers randomized 466 patients (median age 81 years; 36% female) slated for TAVI at one of 12 Dutch centers between 2021 and 2024 to undergo PCI first or to wait. The median STS-PROM score was 3.1%, and the median SYNTAX score was 10. Most patients (93%) assigned to PCI first had the revascularization performed before TAVI, while 7% received it concomitantly. Only 11% of those in the deferral arm ended up receiving PCI within the 1-year study period, after a median 87 days post-TAVI.

The main study findings held consistent in subgroup analyses, with the exception that deferring PCI at the time of TAVI was favored in those whose structural procedures used nontransfemoral access. However, researchers urged caution in interpreting this underpowered finding.

Major bleeding less frequently occurred in the deferral group compared with those receiving PCI first (6% vs 15%; HR 0.39; 95% CI 0.21-0.73). Numerically fewer patients randomized to deferred PCI had major access site-related bleeding as well (3% vs 9%).

‘Outside the Box’ Thinking

Wayne Batchelor, MD (Inova Health System, Fairfax, VA), who served as the discussant for PRO-TAVI, commended the researchers for “thinking outside the box” with this trial.

“These studies that look at strategies, and especially deferral strategies, are fascinating, and I think we need to do more of them,” he said. “In interventional cardiology, we tend to be driven by things that make us want to do more and not less.”

As recently as a few years ago, little data existed regarding how to treat patients with both CAD and aortic stenosis, but it’s a common presentation, especially among older individuals. In 2020, ACTIVATION showed no advantage to performing PCI before TAVI. On the other hand, the NOTION-3 trial suggested there was a reduction in MACE after a median of 2 years if patients were treated with PCI first, but a subgroup analysis pointed to a benefit only in those with a diameter stenosis 90% or greater. Observational studies have demonstrated that obstructive CAD may not need to be treated before TAVI, and this was also seen in a post hoc analysis of the SCOPE I trial.

In a large analysis of the TVT Registry, the 3-year rate of all-cause mortality and stroke remained similar regardless if PCI was performed before, during, or after TAVI. Abhijeet Dhoble, MD, MPH (University of Texas Health Science Center at Houston, TX), lead investigator of that study, told TCTMD the PRO-TAVI data reinforce most of the evidence in this space and will “absolutely” change his practice. The fact that researchers allowed for PCI after TAVI in the deferral group was the biggest difference between PRO-TAVI and NOTION-3, he said. This important distinction likely explained the discrepant outcomes.

Also, Voskuil added, PRO-TAVI included major bleeding in its primary endpoint, while NOTION-3 did not. “But I think if you zoom in on the data, it’s not that different,” he said.

In an accompanying editorial, Philippe Garot, MD, and Mariama Akodad, MD, PhD (both Institut Cardiovasculaire Paris Sud, Massy, France), write that “comparison with NOTION-3 is particularly instructive. Taken together, these trials suggest that the central question is no longer whether PCI should routinely precede TAVI, but rather which patients benefit from revascularization and when it should be performed.”

Many factors influence this decision, they continue. “Recent work exploring physiology-guided PCI in this population underscores the continuing uncertainty surrounding optimal lesion assessment in the setting of severe aortic stenosis.”

‘Less Is More’

S. Chris Malaisrie, MD (Northwestern University, Chicago, IL), commenting on the results for the media, said they show that “less is more,” especially given that so few patients randomized to deferral ended up receiving PCI at all.

“We still need to know what’s going on with the coronaries” because these older patients are likely not going to be sent for CABG, he continued. “But if we generalize this to other younger patients, I still want to know the status of the coronaries because we’re ready to do bypasses for lesions that exist.”

To TCTMD, Voskuil said the PRO-TAVI results are relevant mostly for older patients, and not necessarily the entire landscape of US practice. “That’s why I pointed out the median age of the patient population included,” he said. “If you look at the US population now, it’s much younger, so that’s why the results apply to the elderly TAVI patients, but not for the spectrum.”

Dhoble said the findings apply to a wide swath of the patients he treats. “Our average age here is a little less than the PRO-TAVI trial,” he said. “However, this is a very common dilemma, and knowing that you can defer the significant lesions up until after the TAVR is very reassuring.”

What might be different, Dhoble continued, is that he typically would perform some kind of functional assessment of the lesions after TAVI, either with FFR or a noninvasive stress test, and that wasn’t as common in the PRO-TAVI trial.

Going forward, he’d like to see more work done examining specific lesion types and patient subsets that would benefit from deferral more than others.

“This really adds incrementally to our knowledge base, and it helps us reassure patients that it is actually probably okay in certain scenarios to defer and watch and wait,” Batchelor said. “We’ll go ahead and get the TAVR done and not contaminate it with other contrast and other issues that you might do in a concomitant procedure.”

“PRO-TAVI reminds us that in many patients undergoing TAVI, coronary disease does not demand immediate correction,” conclude editorialists Garot and Akodad. “Treating the valve first and intervening on the coronaries only when necessary, might be both safer and sufficient.”