TAVI Patients Seem to Pay No Penalty for Obstructive CAD

Patients who have obstructive coronary artery disease on top of symptomatic severe aortic stenosis (AS) have no worse survival, quality of life, or other clinical outcomes 3 years after TAVI, according to a new post hoc analysis of the SCOPE I trial.

Moreover, performing PCI around the time of TAVI did not lead to improvements in any outcomes.

Obstructive CAD was seen in more than half (51%) of patients enrolled in SCOPE I, which failed to meet its noninferiority endpoint comparing the investigational Acurate Neo device (Boston Scientific) with Sapien 3 (Edwards Lifesciences). “These results suggest that the presence of obstructive coronary artery disease does not, in principle, diminish the overall benefit of TAVI,” investigator Daijiro Tomii, MD (Bern University Hospital, Inselspital, Switzerland), told TCTMD.

Giuseppe Tarantini MD, PhD (University Medical School of Padua, Italy), who was not involved in the study, said he was “more reassured than surprised” by the findings.

“What did stand out—especially when thinking with a more ‘surgical mindset’—is that performing PCI around the time of TAVR did not appear to offer a clear clinical advantage,” he said in an email. “Given how ingrained the ‘fix everything while you’re there’ philosophy is in SAVR + CABG, it is striking to see that in TAVR candidates with stable CAD, an up-front revascularization strategy is not automatically beneficial and can even expose very elderly, high-bleeding-risk patients to unnecessary harm.”

SCOPE I Analysis

The study, published online today in JAMA Network Open, included 732 patients (mean age 82 years; 56.8% female) with symptomatic severe AS undergoing TAVI who had a mean STS-PROM score of 4.3%. Of the 373 patients with obstructive CAD, 38.6% underwent elective PCI during the periprocedural period, including 95.1% prior to TAVI (median 41 days).

Three years after TAVI, the presence of obstructive CAD did not have any statistically significant effect on quality of life: baseline median overall Kansas City Cardiomyopathy Questionnaire (KCCQ) scores were 54.2 in those with CAD and 55.2 in those without, and these increased to 79.7 and 82.3, respectively. Likewise, there were no differences in patients’ risks of all-cause mortality (24.7% vs 22.3%; adjusted HR 0.97; 95% CI 0.66-1.43) or cardiovascular mortality (17.6% vs 15.5%; adjusted HR 0.87; 95% CI 0.54-1.42). Both groups also had similar rates of VARC-3 clinical efficacy (52.1% vs 53.4%; adjusted RR 1.1; 95% CI 0.92-1.32), defined as freedom from all-cause mortality, all stroke, hospitalization for procedure- or valve-related causes, and unfavorable outcome.

There were trends, however, toward higher risks of MI (5.5% vs 1.1%; adjusted HR 3.83; 95% CI 0.96-15.31) and unplanned PCI (2.2% vs 0.3%; RR 7.69; 95% CI 0.97-61.2) in patients with obstructive CAD.

Notably, clinical outcomes did not differ between patients who received PCI and those who did not, with the exception of a numerically higher risk of BARC type 3 or 5 bleeding (adjusted HR 1.7; 95% CI 0.98-2.94).

“[The] findings suggest that a tailored approach may be essential in the treatment of TAVR candidates with severe AS and CAD,” the authors write.

No Need to Rush PCI

Data from the NOTION-3 trial previously showed that, compared with guideline-directed medical therapy, PCI prior to TAVI can lower the risk of MACE in patients with stable CAD, but that result was driven by a need for coronary revascularization, leaving some clinicians questioning the optimal strategy still. Another observational study suggested that obstructive CAD is better left alone prior to TAVI.

A review paper published last year, which included several authors of the current analysis, previously acknowledged to TCTMD that there remain more questions than answers for patients with concomitant AS and CAD.

In an accompanying editorial, Eric Warner, MD, and Rishi Puri, MD, PhD (both Cleveland Clinic, OH), write: “The management of CAD in TAVR candidates remains an evolving field that requires further investigation to elucidate which patients may benefit from PCI, and equally importantly, when to offer PCI. The current evidence suggests stable patients with CAD needing TAVR can safely be deferred for PCI, with TAVR performed in the context of single antiplatelet therapy.”

The “most balanced overall strategy” that could improve LV remodeling while limiting the risk of bleeding, they add, might include close clinical surveillance for symptoms post-TAVI and keeping a “low threshold for PCI” in lesions in vessels at least 2.5 mm in diameter that are “visually 90% or greater in angiographic severity in the first 6 months.”

For Tarantini, more work needs to be done identifying which lesions benefit from PCI in the periprocedural period. “Severe AS alters physiology, so integrating anatomy with functional significance remains an open area for research,” he said. “Another unresolved point is timing—whether PCI should be staged before, combined with, or deferred until after TAVR, once hemodynamics stabilize and symptoms can be reassessed.”

Yet another challenge relates to “the ischemia-bleeding balance,” Tarantini said. “Given how common high bleeding risk is in this population, understanding when PCI truly adds value—and how to tailor antithrombotic therapy—is essential.”

Valve choice will also undoubtedly influence revascularization strategies, he added.

In terms of clinical practice, Tarantini would like to see “a more consistent, heart team-friendly approach to CAD in TAVR candidates . . . that blends clinical presentation, lesion severity, physiology, bleeding risk, frailty, and valve selection.” He also said guidelines should “better distinguish between the surgical and transcatheter philosophies [since] in TAVR patients, selective PCI guided by severity and symptoms is usually safer than routine upfront revascularization.”

Both Tarantini and Tomii emphasized the importance of including quality-of-life endpoints in future studies of these patients.

“The next step isn’t more revascularization—it’s better selection, better timing, and better alignment with what patients actually need,” Tarantini concluded.