Patients undergoing percutaneous coronary intervention (PCI) during preprocedural transcatheter aortic valve replacement (TAVR) workup are at higher risk for late bleeding events (LBEs), defined as >30 days after TAVR, a new study shows.
The rates can reach as high as 8% through 2-year follow-up, with gastrointestinal and neurological bleeding being the most commonly observed. Early (<30 days) major bleeding and antiplatelet–anticoagulation combination were identified as independent risk factors for LBE.
The data were reported by Marisa Avvedimento, MD, Quebec Heart and Lung Institute, Laval University, Quebec City, in a manuscript published Monday online in JACC: Cardiovascular Interventions.
Coronary artery disease (CAD) is frequently detected in patients undergoing TAVR. The debate over coronary evaluation and PCI decisions persists, with a growing emphasis on treating younger, lower-risk patients, highlighting its importance. PCI requires antiplatelet use, which is linked to higher early bleeding risk post-TAVR but lacks a discernible clinical impact beyond 30 days.
This multicenter study included 1,457 patients from 15 centers from Canada, Europe and Brazil who underwent PCI up to 3 months before TAVR as part of pre-TAVR workup and survived 30 days after TAVR. Their mean age was 81 ± 7 years; 41.5% females, Society of Thoracic Surgeons score 5.7%. The patients’ mean SYNTAX score was 12 ± 9 points, 1.5 ±- 0.8 vessels were treated for each patient, and complete revascularization was achieved in 75% of cases.
The median time from PCI to TAVR was 31 days. Within a median follow-up of 23 months, 116 patients (7.9%) experienced LBEs. The majority of these bleeds were classified as major according to Valve Academic Research Consortium 2 criteria (63, 54.3%), with 32 (27.6%) being categorized as life-threatening or causing disability.
Two Independent risk factors for LBEs were identified: preprocedural (within the first 30 days after TAVR) bleeding (hazard ratio [HR] 2.00; 95% confidence interval [CI] 1.10-3.62) and the combined use of antiplatelets and anticoagulants (HR 1.72; 95%, CI 1.19-2.49). Notably, individuals who experienced LBEs had a higher mortality risk at 4-year follow-up compared to those who did not bleed (44% vs. 36%, P=0.034). Furthermore, LBE itself emerged as an independent predictor for all-cause mortality following TAVR (HR 1.39; 95% CI 1.05 – 1.83; P=0.02). Late stroke was associated with increased risk of death as well (HR 1.85; CI 1.28-2.68)
The study's limitations include its retrospective nature, potential unmeasured confounders and the absence of pre-specified analyses.
Writing in an accompanying editorial, Paolo Calabrò, MD, PhD, and Felice Gragnano, MD, University of Campania “Luigi Vanvitelli,” Caserta, Italy, pointed out that a pooled analysis from the PARTNER trial showed fourfold increased mortality in patient with major late bleeding. The editorialists recommended approaching the results with caution, acknowledging the study's limitations. They also noted that the observed connection between early and late bleeding aligns with the general principle that "patients who experience bleeding once are at a greater risk of bleeding again."
Suggesting it is possible that by eliminating the source or predisposing factor for early bleeding, we may anticipate a reduction in the occurrence of late bleeding. The commenters emphasized that, in the study, there was no evident factor identified as a strong predictor of late bleeding risk, except for the use of antithrombotic therapy.
They concluded that, “The emerging clinical space of PCI-TAVR is exciting but requires further evidence to be fully captured and navigated.”
Avvedimento M, Campelo-Parada F, Munoz-Garcia E, et al. Late Bleeding Events in Patients Undergoing Percutaneous Coronary Intervention in the Workup Pre-TAVR. JACC Cardiovasc Interv. 2023;16:2153–2164.
Calabrò P, Gragnano F. Bleeding in Patients Undergoing PCI and TAVR: Combining Coronary and Valve Procedures Raises New Challenges. JACC Cardiovasc Interv. 2023;16:2165–2168.
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