Deferred PCI Safe for TAVI Patients With Coronary Disease

NEW ORLEANS — For coronary artery disease patients undergoing transcatheter aortic valve implantation (TAVI), waiting to see if percutaneous coronary intervention (PCI) was also needed led to similar outcomes as doing both TAVI and PCI upfront, the randomized PRO-TAVI trial showed.

Among nearly 500 patients, 24% of those who underwent PCI only if clinically indicated after TAVI experienced the primary composite outcome of all-cause mortality, myocardial infarction, stroke, and major bleeding at 1 year compared with 26% of those who underwent PCI before TAVI (HR 0.89, 95% CI 0.62-1.28, P=0.0008 for non-inferiority).

Deferral of PCI also resulted in substantial reduction in major bleeding (6.2% vs 14.8% with PCI before TAVI; HR 0.39, 95% CI 0.21-0.73), reported Michiel Voskuil, MD, PhD, of the University Medical Centre Utrecht in the Netherlands, at the American College of Cardiology (ACC) annual meeting.

“These findings suggest that an initial conservative strategy can be appropriate in selected patients,” Voskuil and colleagues concluded in their study, which was also published in The Lancet.

“Still, for every individual patient, a comprehensive assessment of bleeding and ischemic risks should be done by the local heart team before decision,” Voskuil added at the late-breaking clinical trial session.

Up to half of patients referred for TAVI also have coronary artery disease, with guidelines suggesting PCI before TAVI is reasonable.

While surgical valve replacement routinely includes coronary artery bypass grafting for substantial coronary disease, the balance of risk and benefit is different in the interventional cardiology realm, noted Philippe Garot, MD, and Mariama Akodad, MD, PhD, both of the Institut Cardiovasculaire Paris Sud in Massy, France, in an accompanying editorial.

“PCI adds procedural complexity and usually requires intensified antithrombotic therapy in an older and often frail population already susceptible to bleeding complications,” they wrote. “In a population with a mean age above 80 years, this reduction in hemorrhagic events is clinically meaningful.”

Notably, only about 1 in 10 patients in the deferred PCI group actually underwent the procedure by 1 year of follow-up.

“When PCI was required, it was performed safely after TAVI without major procedural complications,” Garot and Akodad pointed out. “These observations challenge the reflex to treat angiographically pronounced lesions before valve implantation simply because they are present.”

The trial included 466 patients seen for severe aortic stenosis and substantial coronary artery disease who were scheduled to undergo TAVI at 12 hospitals in the Netherlands. They were randomly assigned to open-label deferral of PCI or PCI before TAVI. Median age of the participants was 81 years, and 36% were women.

The trial excluded patients with unprotected left main disease, and those enrolled at relatively low coronary complexity (median SYNTAX score 10).

Taken together with prior findings from the NOTION-3 trial that had shown PCI reduced myocardial infarction and urgent revascularization when done before TAVI, “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,” Garot and Akodad concluded. “Clinical presentation, lesion severity, symptom burden, physiological assessment, bleeding risk, and the anticipated feasibility of coronary access after valve implantation all influence that decision.”

ACC study discussant Wayne Batchelor, MD, MHS, of Inova Heart and Vascular Institute in Fairfax, Virginia, noted that the wide 4% margin for noninferiority in the primary endpoint was a limitation of the trial. “The good news in your study is there was not even a hint of an adverse effect from delaying going in the wrong direction,” he said.

“Although we know from the ISCHEMIA trial, certainly without aortic valve disease, it’s quite safe to treat them conservatively, but there’s still an expectation [among patients] in the United States that we do something, we either survey them, do a stress test,” Batchelor said.

Voskuil responded that “a lot of these patients, that may be a Dutch thing, are quite neutral actually. And if you tell them, ‘Yes, there is a blockage in your coronary artery, but we think your critical artery valve stenosis is the main thing driving your outcome. We can treat it now, check you, and if needed we can do PCI afterwards,’ they accept it quite easily, I must say, and have no questions.”

Batchelor agreed that the trial “helps us reassure patients that it is actually probably OK in certain scenarios to defer and watch and wait and go ahead and get the TAVI done and not contaminate it with other contrast and other issues that you might do in a concomitant procedure.”