Stenting Before TAVR Helps Fit Patients but Adds Bleeding Risk Without Benefit in Frail Ones
A NOTION-3 substudy finds PCI cut cardiac events in nonfrail TAVR patients, but frail patients had more bleeding and no clinical benefit.
Summary
Many older adults with severe aortic stenosis also have coronary artery disease. The NOTION-3 trial previously showed that stenting blocked arteries (PCI) alongside transcatheter aortic valve replacement (TAVR) lowered major adverse cardiac events. This substudy asked whether frail patients benefit equally. Researchers estimated frailty after the fact using baseline data on symptoms, daily function, and quality of life. Of 407 patients with frailty data, 130 (32%) were frail. In nonfrail patients, PCI cut major cardiac events from 33% to 15% over a median of 2 years, with fewer deaths, heart attacks, and urgent revascularizations. In frail patients, PCI showed no benefit but more than doubled bleeding risk. The findings suggest frailty may help guide whether to stent before TAVR, though larger prospective studies are needed to confirm this.
Detailed Summary
Aortic stenosis and coronary artery disease often occur together in older adults. Whether to stent coronary blockages at the time of TAVR has been debated. The NOTION-3 trial showed that adding PCI reduced major adverse cardiac events overall, but frailty strongly shapes outcomes in older patients, so it was unclear whether the benefit extended to them.
This substudy analyzed NOTION-3, an international, open-label, randomized trial of patients with severe aortic stenosis and coronary artery disease undergoing TAVR. Participants were randomized to PCI or conservative treatment. Researchers calculated a frailty score after the fact from baseline data on symptom-related limitations, daily function, and quality of life. The primary endpoint combined death, myocardial infarction, and urgent revascularization. Bleeding and acute kidney injury were safety endpoints.
Frailty data were available for 407 patients (90%), and 130 (32%) were classified as frail. Over a median follow-up of 2 years, PCI in nonfrail patients reduced the primary endpoint from 33% to 15% (HR 0.42; 95% CI 0.25-0.69). It also lowered all-cause death, MI, and urgent revascularization. Frail patients saw no such differences, and PCI was associated with more than twice the bleeding risk (HR 2.51; 95% CI 1.23-5.11).
These results suggest that frailty could help individualize decisions about revascularization in TAVR candidates. Fit patients appear to gain meaningfully from PCI, whereas frail patients may face harm without clear benefit.
Important caveats apply. Frailty was derived post hoc from a calculated score rather than a validated frailty tool, and the subgroup analysis was not prespecified for randomization. The trial was open-label, and the authors note that larger prospective studies are needed to confirm these findings.
Key Findings
- Frailty data were available for 407 patients; 130 (32%) were classified as frail using a post hoc calculated score.
- In nonfrail patients, PCI cut major cardiac events from 33% to 15% (HR 0.42; 95% CI 0.25-0.69).
- In nonfrail patients, PCI also lowered all-cause death, myocardial infarction, and urgent revascularization.
- Frail patients showed no difference in clinical outcomes with PCI versus conservative treatment.
- Frail patients undergoing PCI had more than double the bleeding risk (HR 2.51; 95% CI 1.23-5.11).
Methodology
This is a post hoc substudy of NOTION-3, an international, open-label, randomized superiority trial in which patients with severe aortic stenosis and coronary artery disease undergoing TAVR were assigned 1:1 to PCI or conservative treatment. Frailty was calculated from baseline symptom limitations, daily function, and quality of life. The primary endpoint was death, MI, or urgent revascularization, with bleeding and acute kidney injury as safety endpoints.
Study Limitations
Frailty was assessed post hoc using a derived score instead of a validated frailty instrument, and the subgroup was not a randomized stratification, so the analysis is exploratory. The open-label design and the smaller frail subgroup (130 patients) limit statistical power and precision. The authors state that larger prospective studies are needed for confirmation. Only the abstract was available for this summary.
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