Patients with CAD undergoing TAVR may also benefit from angioplasty
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Key takeaways:
- In patients with coronary artery disease undergoing TAVR, those who also had angioplasty had better outcomes than those who did not.
- The results were driven by heart attack and urgent revascularization.
In patients with coronary artery disease and severe aortic stenosis undergoing transcatheter aortic valve replacement, those who also had PCI had better outcomes than those who had their CAD managed conservatively, researchers reported.
The investigator-initiated NOTION-3 trial, presented at the European Society of Cardiology Congress and simultaneously published in The New England Journal of Medicine. Jacob Lønborg, MD, PhD, DMSc, consultant in the department of cardiology at Copenhagen University Hospital–Rigshospitalet in Copenhagen, Denmark, and colleagues randomly assigned 455 patients with severe symptomatic aortic stenosis and at least one coronary artery stenosis with fractional flow reserve of 0.8 or less or percent diameter stenosis of at least 90% to undergo TAVR for the aortic stenosis and either PCI or conservative treatment for the CAD.
“Severe aortic stenosis is the most common heart valve disease requiring intervention,” Lønborg said at a press conference. “For elderly patients, regardless of their underlying surgical risk, the standard of care is to perform [TAVR]. Severe aortic stenosis and coronary artery disease frequently coexist and, today, around 50% of the [TAVR] population is also treated with PCI. However, as it stands today, we have no recommendations whatsoever to perform the PCI in these patients.”
The median age of the patients was 82 years, the median Society of Thoracic Surgeons Procedural Risk of Mortality score was 3% and approximately one-third were women.
PCI beneficial in this population
At a median follow-up of 2 years, the primary outcome of major adverse cardiac events, defined as all-cause death, MI or urgent revascularization, occurred in 26% of the PCI group compared with 36% of the conservative group (HR = 0.71; 95% CI, 0.51-0.99; P = .04), Lønborg said at the press conference.
The results were driven by MI (7% vs. 14%; HR = 0.54; 95% CI, 0.3-0.97; P = .04) and urgent revascularization (2% vs. 11%; HR = 0.2; 95% CI, 0.08-0.51; P < .01), but not all-cause death (PCI, 23%; conservative, 27%; HR = 0.85; 95% CI, 0.59-1.23; P = .4), he said.
Bleeding events were more common in the PCI group (28% vs. 20%; HR = 1.51; 95% CI, 1.03-2.22), and 3% of the PCI group had procedure-related complications, according to the researchers.
The PCI group had PCI of all lesions meeting the inclusion criteria — the recommendation was to perform PCI before TAVR, and Lønborg said that happened 74% of the time — and received lifelong aspirin and 6 months of clopidogrel after PCI, while the conservative group could not have planned PCI, received lifelong aspirin and, before the results of the POPular TAVI trial were released in 2020, received 3 months of clopidogrel after TAVR, Lønborg said during a presentation.
‘Marked reduction’ in MI
“The key message from the NOTION-3 trial is that performing PCI in patients undergoing [TAVR] significantly reduced death, myocardial infarction or urgent revascularization compared with [TAVR] alone,” Lønborg said at the press conference. “To us, the marked reduction in the number of heart attacks with PCI was surprising. As expected, there was more bleeding with PCI. We believe that for patients treated with [TAVR] who also have significant coronary artery disease, performing PCI should be the standard of care in the future.”
While trials such as COURAGE and ISCHEMIA did not find that PCI plus medical therapy outperformed medical therapy alone in patients with stable CAD, the patients in NOTION-3 had more severe disease — “either a positive FFR or a tight stenosis” — than the patients in those trials, Lønborg said at the press conference.
“Nearly 60% of patients had a diameter stenosis of at least 90%,” he said. “We know that from previous trials, the more ischemia, the more tight lesions, the more benefit you get from treating that lesion. Also, we followed the patients for up to 5 years, and to see the benefits of PCI, you need to follow the patients for a long time.”
Reference:
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Lønborg J, et al. Hot line 5. Presented at: European Society of Cardiology Congress; Aug. 30-Sept. 2, 2024; London (hybrid meeting).
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