Validation of the Academic Research Consortium High Bleeding Risk (ARC-HBR) criteria in patients undergoing
Yusuke Tomoi1, Shoichi Kuramitsu1, Tomohiro Shinozaki2
1Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan.
Insights
Most peripheral artery disease patients undergoing endovascular therapy with drug-coated devices meet high bleeding risk criteria. Major bleeding significantly increases mortality risk, suggesting ARC-HBR criteria aid risk stratification in these patients.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Vascular Surgery
Background:
- Uncertainty exists regarding the applicability of Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria in peripheral artery disease (PAD) patients undergoing endovascular therapy (EVT).
- Contemporary drug-coated devices (DCD) are increasingly used for femoropopliteal artery lesions in PAD patients.
Purpose of the Study:
- To evaluate the utility of ARC-HBR criteria for risk stratification in PAD patients undergoing EVT with DCD.
- To assess the incidence of major bleeding events in PAD patients treated with DCD and their correlation with ARC-HBR criteria.
Main Methods:
- Retrospective analysis of 542 consecutive PAD patients undergoing EVT with DCD for femoropopliteal lesions from May 2012 to December 2019.
- Primary endpoint: Major bleeding events (Bleeding Academic Research Consortium type 3 or 5).
- Stratification of patients based on ARC-HBR criteria and analysis of bleeding event rates and mortality risk.
Main Results:
- 80.3% of patients met the ARC-HBR criteria.
- The 5-year incidence of major bleeding was significantly higher in the high bleeding risk (HBR) group (31.9%) compared to the non-HBR group (2.3%) (p<0.001).
- Major bleeding events were associated with a 5.4-fold increased mortality risk (aHR: 5.42) and predictors included severe chronic kidney disease, heart failure, and severe anemia.
Conclusions:
- A high proportion of PAD patients undergoing EVT with DCD meet ARC-HBR criteria, indicating their potential relevance.
- The ARC-HBR criteria may be valuable for identifying PAD patients at increased risk of mortality following EVT with DCD.
- Risk stratification using ARC-HBR criteria can guide clinical decision-making and management strategies in this patient population.
Background:
It remains unclear whether the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria could apply to peripheral artery disease (PAD) patients undergoing endovascular therapy (EVT).
Aims:
We sought to evaluate the application of the ARC-HBR criteria to PAD patients undergoing EVT with contemporary drug-coated devices (DCD) for femoropopliteal artery lesions.
Methods:
Between May 2012 and December 2019, 542 consecutive patients undergoing EVT with DCD for femoropopliteal artery lesions were retrospectively analysed. The primary study endpoint was major bleeding events, defined as Bleeding Academic Research Consortium type 3 or 5.
Results:
Of 542 patients, 435 (80.3%) were stratified into the HBR group. The cumulative 5-year incidence of major bleeding events was significantly higher in the HBR group than in the non-HBR group (31.9% vs 2.3%; p<0.001). The 5-year major bleeding event rate gradually increased with the number of ARC-HBR criteria (≥2 major criteria: 48.6%, 1 major: 33.1%, ≥2 minor: 12.9%, and non-HBR: 2.3%; p<0.001). Major bleeding events were associated with a 5.4-fold increased risk of mortality (adjusted hazard ratio: 5.42, 95% confidence interval: 2.91-10.1; p<0.001). Severe chronic kidney disease, heart failure, and severe anaemia were predictors of major bleeding events.
Conclusions:
80.3% of PAD patients undergoing EVT for femoropopliteal artery lesions with contemporary drug-coated devices met the ARC-HBR criteria. Given that major bleeding events remarkably increased the risk of mortality after EVT, the ARC-HBR criteria might be helpful for the risk stratification of PAD patients who undergo EVT with contemporary DCD.
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