Key result
Drug-coated stents significantly reduced the primary safety composite of cardiac death, myocardial infarction, or stent thrombosis compared to bare metal stents (HR 0.72) in ARC-defined high bleeding risk patients.
Why the study?
Patients at high bleeding risk have traditionally been underrepresented in pivotal DES trials.
Does a biolimus A9-coated drug-coated stent reduce cardiac death, MI, or stent thrombosis compared to a bare metal stent in ARC-defined high bleeding risk patients undergoing PCI with 30 days of DAPT?
Observational (n=3,635)
Yes
Does a biolimus A9-coated drug-coated stent reduce cardiac death, MI, or stent thrombosis compared to a bare metal stent in ARC-defined high bleeding risk patients undergoing PCI with 30 days of DAPT?
Hazard Ratio: 0.72 (95% CI 0.57–0.91)
Absolute Event Rate: 9.8% vs 13.8%
p-value: p=0.006
In ARC-defined high bleeding risk patients undergoing PCI with 1-month DAPT, drug-coated stents significantly reduced the composite of cardiac death, MI, or stent thrombosis compared to bare metal stents.
May support DCS over BMS for ARC-HBR patients on short DAPT; leaves open need for dedicated randomized confirmation.
BACKGROUND: More effective and progressively safer generations of drug-elut-ing stents (DES) have replaced bare metal stents (BMS) in rou-tine clinical practice. However, patients considered to be at high bleeding risk (HBR) have traditionally been underrepresented in pivotal DES trials. AIMS: The aim of this study was to model the safety and effectiveness of drug-coated stents (DCS) versus BMS in HBR patients according to the Academic Research Consortium (ARC) criteria. METHODS: Participants from the LEADERS FREE (LF) and LEADERS FREE II (LFII) studies were pooled into one data set. Participants were treated with 30 days of DAPT. The primary safety (composite of cardiac death, myocardial infarction, or stent thrombosis) and effectiveness (target lesion revascularisation) endpoints were compared between DCS and BMS in the subgroup of patients satisfying the ARC-HBR definition using propensity-score modelling. RESULTS: From the 3,635 participants included in the combined LF and LFII data set, 2,898 (79.7%) satisfied the ARC-HBR criteria (DCS: 1,923; BMS: 975). The primary safety endpoint occurred in 184 (9.8%) and in 132 (13.8%) participants in the DCS and BMS groups, respectively (adjusted HR 0.72, 95% CI: 0.57-0.91; p=0.006). The risk of the primary effectiveness endpoint was also significantly lower with DCS (6.2%) versus BMS (8.8%) (adjusted HR 0.70, 95% CI: 0.52-0.94; p=0.016). The safety and effectiveness of DCS versus BMS were consistent according to ARC-HBR status (p for interaction=0.206 and 0.260, respectively). CONCLUSIONS: DCS are safer and more effective than BMS in an ARC-defined HBR population.
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Marquis‐Gravel et al. (2021) conducted an observational in High bleeding risk undergoing percutaneous coronary intervention (n=3,635). Drug-coated stents vs. Bare metal stents was evaluated on Primary safety endpoint (composite of cardiac death, myocardial infarction, or stent thrombosis) (HR 0.72, 95% CI 0.57-0.91, p=0.006). Drug-coated stents significantly reduced the primary safety composite of cardiac death, myocardial infarction, or stent thrombosis compared to bare metal stents (HR 0.72) in ARC-defined high bleeding risk patients.
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