Leave It Be: PCI for Stable CAD Before or With TAVR Does Not Lower Mortality Risk

SAN FRANCISCO, CA—For patients with severe aortic stenosis and concomitant stable coronary artery disease, a new study suggests that interventional cardiologists can leave the lesions alone and simply proceed with the transcatheter aortic valve replacement.

In a new meta-analysis presented this week at TCT 2019, investigators reported that revascularization in conjunction with TAVR failed to reduce the risk of death, stroke, or MI at 30 days, and failed to lower the risk of death at 1 year, when compared with TAVR alone in patients with stable CAD.

“PCI with TAVR in patients with stable concomitant coronary artery disease does not confer any benefit,” said senior investigator Ankur Kalra, MD (Cleveland Clinic, OH). “In our institution, we’ve actually started to treat these stable coronary lesions like we treat stable coronary artery disease. So, optimal medical therapy. If a beta-blocker is indicated, we prescribe one, but otherwise statin therapy, good antianginal therapy, and then just offering these patients transcatheter aortic valve replacement.”

Rishi Puri, MD, PhD (Cleveland Clinic, OH), one of the study’s co-authors, said the field has “started to come full circle.” When TAVR first began, there was a lot of emphasis on eliminating significant proximal epicardial coronary disease if it was detected in the TAVR workup. Now the data suggest physicians don’t need to treat the identified lesion if the patient doesn’t present with ischemic symptoms. Unless the patient has angina, LV dysfunction with an ischemic component, or there is a concern about future coronary access given the type of valve selected, Puri said he will leave coronary lesions be.

“In other words, the indications to revascularize in the setting of TAVR are not that different than in someone who doesn’t have significant valve disease,” he told TCTMD. “We’ve done a number of cases where we’ve been a bit more conservative, especially in some higher-risk older patients who present with dyspnea, significant three-vessel disease, and supercalcified annuli. We know they’re going to benefit from TAVR, so we simply put the valve in and let them go.”

PCI Not Mandatory

Incident coronary artery disease is quite prevalent in patients with aortic stenosis, with roughly 50% of TAVR-eligible patients also having coronary disease. In the surgical realm, which is where TAVR has derived some of its current practice, the classic teaching had been to treat everything in need of fixing—the aortic valve and coronary arteries—once the chest was open, but it’s largely unknown if PCI prior to or at the time of TAVR confers any additional benefit in patients with stable CAD, said Kalra.

The meta-analysis, which was published simultaneously in the American Journal of Cardiology, included 11 studies with 5,188 patients (mean age 82.4 years; 52.6% female). Of these, revascularization was performed prior to TAVR in five studies and concomitant to TAVR in one study. For the remaining 5 studies, it was a mix of PCI performed prior to and concomitant with the transcatheter valve replacement.

In 10 studies, there was no significant difference in the risk of all-cause mortality at 30 days between those undergoing TAVR and PCI and those treated with TAVR alone. When the analysis was restricted to patients with significant coronary artery disease (defined as ≥ 70% stenosis), there was also no difference in mortality for those treated with PCI and TAVR. Additionally, there was no difference in risk of death at 1 year between those treated with PCI and TAVR versus those undergoing TAVR alone. With respect to MI, stroke, and acute kidney injury, there was also no benefit for patients treated with PCI.

Both Kalra and Puri stressed there are currently no randomized trial data to address question of revascularization before or concomitant with TAVR. As such, whether or not to revascularize patients with concomitant coronary disease and aortic stenosis has remained a vexing question for interventional cardiologists. “If someone is asymptomatic and you have incident coronary artery disease, what are you doing with revascularization?” asked Kalra. “You’re not going to improve longevity, you’re not going to prevent an MI. . . . You don’t want to subject somebody to a procedure they don’t require. There are inherent risks with every procedure, as low as the risks may be.”

He added that the rate of long-term restenosis with second-generation drug-eluting stents remains in the 5% to 7% range.

That said, as TAVR moves into younger, lower-risk patients, accessing the coronary arteries once the transcatheter valve is implanted may be more of a problem as patients age and their coronary artery disease progresses. “I worry about it,” Kalra told TCTMD. “You don’t want to be the one who put a valve in and then there’s this problem of delayed coronary obstruction and now we want to reaccess the coronaries and it’s an issue. On the contrary, I also don’t want to be the person who put a stent in just because there was a lesion and we were offering TAVR.”

Counseling the Referring Physician

Gilbert Tang, MD (Icahn School of Medicine at Mount Sinai, New York, NY), who moderated the session, questioned how best to counsel patients with both coronary artery disease and aortic stenosis, asking: “Of course, there are people out there who are stable with no angina symptoms, but how do you counsel the patient? You’re going to do a diagnostic cath before they undergo TAVR and if you find some results—what’s the clinical implication?”

For Kalra, it can be a greater challenge to counsel the referring cardiologist because they would prefer their patient undergo revascularization. He stressed their results should not be interpreted as a blanket statement against revascularizing patients undergoing TAVR, but if the physician is comfortable the lesion is not going to cause problems during the procedure or after they will leave it alone. “The decision should be individualized for each patient’s anatomy,” he said. “There needs to a discussion with the heart team, which involves the referring cardiologist, and the interventionalist needs to be on board.”

Pavel Cervinka, MD, PhD (Masaryk University, Czech Republic), who attended the presentation, questioned how the results from the meta-analysis have altered clinical practice at the Cleveland Clinic. “If you see a left main stenosis, or proximal LAD stenosis, of 80% but the patient is asymptomatic, do you leave it? Really?” he asked. Kalra said he will stent a lesion in the ostial left main artery but has not treated proximal LAD lesions. “If it’s a single discrete proximal LAD—a stable-looking lesion—we’ve been fine leaving it behind,” he said.

Alan Yeung, MD (Stanford University, CA), who co-moderated the session with Tang, said PCI before or concomitant with TAVR is a tricky subject given the heterogeneity of coronary artery disease, as well as the variability in patient risk profiles. “There are very high-risk patients where coronary artery disease is not going to be their demise,” he said, noting that aortic stenosis and heart failure will likely be the cause of death. “If you move into low-risk patients it may be different than in the high-risk setting. . . . But the message is clear: you don’t automatically have to fix coronary disease. In different circumstances, you may decide to do one thing or another.”