What is the clinical evidence from this study?

Study design: Cohort. Population: Symptomatic severe aortic stenosis (n=787). Intervention: ARC-HBR positive status vs. ARC-HBR negative status. Primary outcome: Major or life-threatening bleeding (BARC type 3 or 5) at 12 months (Risk difference 1.67%, 95% CI -2.72 to 6.06, p=0.46).

August 1, 2022Open Access

Bleeding risk differences after TAVR according to the ARC-HBR criteria: insights from SCOPE 2

Key Result

ARC-HBR positive status did not significantly increase the rate of BARC 3-5 bleeding at 1 year compared to ARC-HBR negative status in patients undergoing TAVR (7.7% vs 6.1%, risk difference 1.67%, p=0.46).

Study Design

Type

Cohort (n=787)

Blinding

Open-label

Multicenter

Yes

Structured PICO

Does the ARC-HBR criteria predict major bleeding in patients undergoing TAVR?

Population

787 older adults with symptomatic severe aortic stenosis undergoing TAVR, stratified by ARC-HBR criteria, followed for 12 months.

Exposure

High Bleeding Risk (ARC-HBR positive) status based on ARC-HBR criteria

Comparator

Non-High Bleeding Risk (ARC-HBR negative) status

Outcome

Major or life-threatening bleeding (BARC type 3 or 5) at 12 monthssafety

The ARC-HBR criteria, originally designed for PCI, failed to identify patients at higher risk for major bleeding after TAVR, suggesting the need for TAVR-specific bleeding risk criteria.

Main Result

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

Limitations

Post hoc subgroup analysis of a trial not powered for comparative assessment of bleedings nor for this patient stratification
Some ARC-HBR criteria were not captured in the trial or were criteria for exclusion
Ischaemic strokes and transient ischaemic attacks were classified as minor criteria in the absence of timing of the events

Abstract

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 his-tory 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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