Study Evaluates ARC-HBR Criteria to Identify High-Bleeding-Risk PCI Patients

November 11, 2019—An all-comers registry evaluated the application of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria for identifying patients with very high bleeding risk (HBR) after percutaneous coronary intervention (PCI). The study was published by Masahiro Natsuaki, MD, et al on behalf of the CREDO-Kyoto PCI/CABG registry cohort-2 investigators in Circulation: Cardiovascular Interventions.

The background of the study is that the ARC-HBR has recently been proposed to standardize the definition of HBR, which was arbitrarily defined as a Bleeding Academic Research Consortium 3 or 5 bleeding ≥ 4% at 1 year. However, the prevalence and the expected bleeding event rate of HBR patients defined by ARC-HBR criteria are currently unknown in the real-world PCI practice.

As summarized in Circulation: Cardiovascular Interventions, the investigators applied the ARC-HBR criteria in the CREDO-Kyoto registry cohort-2.

The multicenter registry enrolled 13,058 consecutive patients who underwent their first PCI. The primary bleeding endpoint was defined as GUSTO moderate/severe bleeding. There were 5,570 (43%) patients in the HBR group and 7,488 patients in the no-HBR group.

The investigators reported that the cumulative incidence of the primary bleeding endpoint was much higher in the HBR group than in the no-HBR group: 10.4% versus 3.4% at 1 year and 18.9% versus 6.6% at 5 years (P < .0001).

Additionally, they found that the presence of each ARC-HBR major or even minor criterion, in isolation, with the exception of liver cirrhosis and previous ischemic stroke, was also associated with major bleeding risk higher than 4% at 1 year.

Finally, the cumulative 5-year incidence of the primary bleeding endpoint became incrementally higher as the number of the ARC-HBR major criteria increased: ≥ three majors, 49.9%; two majors, 30.6%; one major, 18.5%; ≥ two minors, 14.7%; and no HBR, 6.6% (P < .0001).

ARC-HBR criteria successfully identified those patients with very HBR after PCI, who represented 43% of patients in this all-comers registry, concluded the investigators in Circulation: Cardiovascular Interventions.