Key result
ARC-HBR positive status did not significantly identify TAVR patients at higher risk for BARC 3-5 bleeding at 1 year compared with ARC-HBR negative status (7.7% vs 6.1%; risk difference 1.67%; P=0.46).
Why the study?
ARC-HBR conditions were defined for PCI-related bleeding, prompting further exploration of their role in the setting of TAVR.
Does ARC-HBR positive status predict higher BARC 3-5 bleeding in patients undergoing TAVR?
Cohort (n=787)
Does ARC-HBR positive status predict higher BARC 3-5 bleeding in patients undergoing TAVR?
Effect estimate: risk difference 1.67% (95% CI -2.72 to 6.06)
Absolute Event Rate: 7.7% vs 6.1%
p-value: p=0.46
The ARC-HBR criteria failed to identify a subgroup of TAVR patients at higher risk for bleeding, indicating a need for TAVR-specific bleeding risk criteria.
ARC-HBR criteria may stratify bleeding risk in TAVR patients; leaves open utility for guiding therapy pending prospective validation.
BACKGROUND: The Academic Research Consortium - High Bleeding Risk (ARC-HBR) initiative defined conditions associated with percutaneous coronary intervention (PCI)-related bleeding. AIMS: We sought to further explore these HBR conditions in the setting of transcatheter aortic valve replacement (TAVR). METHODS: Patients from the SCOPE 2 trial were stratified by their bleeding risk status based on the ARC-HBR definitions. Baseline and procedural characteristics, as well as key clinical outcomes including Bleeding Academic Research Consortium (BARC) 3-5 bleeding, were compared in ARC-HBR positive (HBR+) and ARC-HBR negative (HBR-) patients. RESULTS: Of 787 patients randomised in SCOPE 2 and included in this study, 633 were HBR+ (80.4%). Compared with HBR- patients, those HBR+ were older and more frequently presented with diabetes, a history of coronary artery disease, atrial fibrillation, prior cerebrovascular accident, and a Society of Thoracic Surgeons predicted risk of 30-day mortality (STS-PROM) (4.9±2.9% vs 3.3%±2.1%; p<0.0001). In addition, HBR+ patients were more frequently on oral anticoagulation therapy. At 1 year, HBR+ patients had higher rates of all-cause death (12.4% vs 4.3%, respectively, risk difference 8.09%; 95% confidence interval [CI]: 3.76-12.41; p=0.0002); the rates of BARC 3-5 type bleeding were relatively high but not statistically different compared with HBR- patients (7.7% vs 6.1%, risk difference 1.67%; 95% CI: -2.72 to 6.06; p=0.46). Subgroup analyses for bleeding events showed no significant interaction in terms of STS-PROM score, age, or medications. CONCLUSIONS: The ARC-HBR criteria failed to isolate a subgroup of patients at higher bleeding risk in TAVR patients from a randomised trial. These findings have potential implications, especially for the selection of post-TAVR antithrombotic regimens based on individual bleeding-risk profiles. Specific HBR criteria should be defined for TAVR patients.
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Garot et al. (2022) conducted a cohort in Transcatheter aortic valve replacement (TAVR) (n=787). ARC-HBR positive status vs. ARC-HBR negative status was evaluated on BARC 3-5 type bleeding at 1 year (risk difference 1.67%, 95% CI -2.72 to 6.06, p=0.46). ARC-HBR positive status did not significantly identify TAVR patients at higher risk for BARC 3-5 bleeding at 1 year compared with ARC-HBR negative status (7.7% vs 6.1%; risk difference 1.67%; P=0.46).
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