PCI During or After TAVR No Riskier Than PCI Before Valve Replacement
Investigators say there is little information to guide the timing of PCI, but these new data suggest it’s safe before, with, or after TAVR.
CHICAGO, IL—There are no significant differences in the risk of major adverse cardiovascular and cerebrovascular events among patients who undergo PCI prior to, during, or after transcatheter aortic valve replacement for severe aortic stenosis, according to a new analysis presented at TVT 2019.
While very few patients were treated with PCI in the 2 months after TAVR, the rate of MACCE-free survival in this group was similar when compared with patients who underwent revascularization in the 60 days prior to their transcatheter valve replacement, say investigators.
“Anywhere from 50% to 70% of patients undergoing TAVR also have existing coronary artery disease and right now this area is something that really hasn’t been studied too much,” lead investigator Arnav Kumar, MD (Emory University School of Medicine, Atlanta, GA), told TCTMD.
In fact, the timing of coronary revascularization in patients with severe aortic stenosis requiring aortic valve replacement is a subject of debate. While there are no solid recommendations, the consensus from experts is that PCI should be performed before TAVR, or at the time of TAVR, as long as the risk of the procedure doesn’t outweigh the benefits. The timing of PCI, however, is highly individualized and based on clinical and anatomical variables.
Pointing to the surgical data, Kumar noted that patients with coexisting coronary artery disease and aortic stenosis treated with surgical aortic valve replacement alone have a higher risk of mortality when compared with patients who undergo combined aortic valve replacement/CABG surgery. “The survival benefit is even there 10 years after the index procedure,” said Kumar. While performing PCI at the same time of TAVR is safe and feasible, there are no long-term studies assessing clinical outcomes in these patients, he added.
Higher Stroke Risk With Warfarin
The present study included 3,982 patients who underwent TAVR for severe aortic stenosis at three high-volume US centers. Of these patients, 10% underwent both PCI and TAVR. For the 380 patients treated with both TAVR and PCI, 327 underwent PCI in the year before transcatheter valve replacement while 15 patients underwent PCI in the 60 days after TAVR. Just 38 patients were treated with same-day PCI and TAVR. The average patient age was 81 years and the mean STS score was 8%.
In terms of PCI, 44%, 20%, and 32% of lesions were in the left anterior descending, left circumflex, and right coronary arteries, respectively. In total, 13% of patients had multivessel disease and nearly 80% were treated with a drug-eluting stent. With TAVR, 93% received a balloon-expandable valve and 79% were treated with transfemoral access.
After a mean follow-up of 2 years, 34% of patients had died and 40% had experienced a major clinical event. Stroke occurred in 6% of patients and 4% required repeat revascularization. In the 380 patients, the timing of PCI—either before or with/after TAVR—had no impact on the rate of MACCE-free survival; a propensity-matched analysis of 159 patients yielded similar results. Finally, in the analysis restricted to patients treated with PCI in the 2 months prior to and after TAVR, there was no difference in clinical outcomes.
Previous CABG surgery, a higher body mass index, and statin use were associated with a lower risk of all-cause mortality at 2 years, while use of warfarin was associated with a fourfold higher risk of stroke even after adjusting for clinical variables.
“The patients treated with Coumadin did not do well,” said Kumar, suggesting that antiplatelet therapy is more critical than anticoagulation in patients undergoing PCI and TAVR. He said many TAVR patients are now being treated with aspirin alone after the procedure and noted that the GALILEO trial testing the use of rivaroxaban (Xarelto; Bayer/Janssen) after TAVR was halted because of increased risks of all-cause mortality, thromboembolic events, and bleeding.
‘A Big Surprise for Us’
Albert Markus Kasel, MD, PhD (German Heart Center, Munich), who moderated the session, said he was surprised by the higher stroke rate in patients treated with warfarin.
“To be honest, it was a big surprise for us,” said Kumar. “When we went back and looked at the data, 54 patients were treated with Coumadin after TAVR, and of those, 44 were also treated with aspirin. . . . In my mind, I think it has to do with the higher bleeding rates.” They have not yet analyzed whether the increased strokes observed in the warfarin-treated patients were hemorrhagic or ischemic, although Kumar suspects the risk is attributable to hemorrhagic stroke.
To TCTMD, Kasel said physicians frequently encounter patients with severe aortic stenosis who also have underlying coronary artery disease. “It’s a big question as to when to do the PCI,” he said. “You can do it before, but it also depends on the device you plan to use. Some valves have safe coronary access after implantation, but with some valves it’s not as certain you can get to the coronary arteries.”
Additionally, as operators begin performing TAVR more frequently in younger, lower-risk patients, they will be forced to grapple with treating underlying coronary disease.
“Often we only treated the main problem, which was aortic stenosis and we’d leave the coronary arteries,” he said, referring to older, higher-risk patients. In younger patients who undergo a full diagnostic examination prior to TAVR, coronary artery disease is frequently encountered. “If there is significant coronary stenosis then we have to treat everything for the prognosis of the patient,” said Kasel. “There the best strategy is to start with the coronary arteries.”
If there is significant coronary stenosis then we have to treat everything for the prognosis of the patient. There the best strategy is to start with the coronary arteries. Albert Markus Kasel
Looking to the future, Kumar said there is a need for new diagnostic tools in patients with CAD and severe aortic stenosis, especially as TAVR moves into the low-risk setting.
“For the trials, it was almost mandatory for patients to undergo a pre-TAVR angiogram so that we could look at the severity of underlying coronary disease,” he said. “In the low-risk patients, where it’s been shown they clearly benefit from TAVR, and they probably don’t have a lot of calcification or a lot of comorbid conditions, it’s probably time we focus on just doing a coronary CT instead. Everybody gets a CT [for TAVR] so it might be time to move away from the angiogram and develop protocols that look at the coronaries as well as the valves.”
The current measurements to help guide PCI, such as fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR), can also be challenging in patients with severe aortic stenosis. “In aortic stenosis, the end-diastolic pressures are so high that the flow and pressure gradient measurements are not very reliable,” said Kumar. Use of FFR/iFR CT, or even an assessment of intracoronary shear stress, would help operators gain a better understanding of CAD severity, he said.
Kumar A. Adverse clinical outcomes among patients undergoing both PCI and TAVR: a multicenter study. Presented at: TVT 2019. June 13, 2019. Chicago, IL.
- Kumar and Basel report no relevant conflicts of interest.