Original Investigation
2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents

https://doi.org/10.1016/j.jacc.2016.10.009Get rights and content
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Abstract

Background

A 1-year follow-up, polymer-free metallic stent coated with biolimus-A9 followed by 1-month dual antiplatelet therapy is safer and more effective than a bare-metal stent (BMS) for patients with high risk of bleeding.

Objectives

This study analyzed 2-year outcomes to determine whether these benefits are maintained.

Methods

In a prospective, multicenter, double-blind trial, we randomized 2,466 high bleeding risk patients to receive a drug-coated stent (DCS) or a BMS followed by 1-month dual antiplatelet therapy. The primary safety endpoint was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy endpoint was clinically driven target lesion revascularization.

Results

At 2 years, the primary safety endpoint had occurred in 147 DCS and 180 BMS patients (15.3%) (hazard ratio: 0.80; 95% confidence interval: 0.64 to 0.99; p = 0.039). Clinically driven target lesion revascularization occurred for 77 DCS and 136 BMS patients (12.0%) (hazard ratio: 0.54; 95% confidence interval: 0.41 to 0.72; p < 0.0001). Major bleeding occurred in 8.9% of DCS and 9.2% of BMS patients (p = 0.95), and a coronary thrombotic event (myocardial infarction and/or stent thrombosis) occurred in 8.2% of DCS and 10.6% of BMS patients (p = 0.045). One-year mortality was 27.1% for a major bleed and 26.3% for a thrombotic event. At 2 years, multivariate correlates of major bleeding were age >75 years, anemia, raised plasma creatinine, and planned long-term anticoagulation. Correlates of the primary safety endpoint were age, anemia, congestive heart failure, multivessel disease, number of stents implanted, and use of a BMS rather than a DCS.

Conclusions

Safety and efficacy benefits of DCS over BMS were maintained for 2 years in high bleeding risk patients. Rates of major bleeding and coronary thrombotic events were no different and were associated with a substantial and comparable mortality risk. (A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent Versus the Gazelle Bare Metal Stent in Patients With High Risk of Bleeding [LEADERS FREE]; NCT01623180)

Key Words

bare-metal stent
bleeding
drug-coated stent
dual antiplatelet therapy
thrombosis

Abbreviations and Acronyms

BARC
Bleeding Academic Research Consortium
BMS
bare-metal stents
CI
confidence interval
DAPT
dual antiplatelet therapy
DCS
drug-coated stent(s)
DES
drug-eluting stent(s)
HBR
high bleeding risk
HR
hazard ratio
PCI
percutaneous coronary intervention

Cited by (0)

All financial support for the trial was provided by the sponsor, Biosensors Europe. Dr. Pocock has received consulting fees from Biosensors. Dr. Meredith has received consulting fees, proctor fees, and honoraria from Boston Scientific; and has received consulting fees and honoraria from Medtronic. Dr. Abizaid has received research grants from Abbott Vascular, Medtronic, Elixir, and Riva. Dr. Menown has received grants to his institution from Biosensors, Boston Scientific, Meril Life, and Orbus Neich; and has received conference sponsorship from Biosensors. Dr. Christiansen has received grants to his institution from Biosensors. Dr. Gregson has received consulting fees and research grants from Biosensors. Drs. Copt and Stroll are full-time employees of Biosensors. Dr. Windhövel is a full-time employee of Cardiovascular European Research Center, the clinical research organization that ran the trial. Ms. Greene has received consulting fees from Biosensors. Dr. Urban has received consulting fees from Biosensors. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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