Drug-Coated Stent Still Effective For High Bleeding-Risk Patients

The authors of a new study have found that the use of a polymer-free drug-coated stent continues to be linked to improved outcomes by the second year for patients at high risk of bleeding.

The researchers determined that the BioFreedom metallic stent from Biosensors, a 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 these patients.
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The investigators analyzed 2-year outcomes to determine whether these benefits are maintained, conducting a prospective, multicenter, double-blind trial that randomly assigned 2466 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, according to the authors, who added that the primary efficacy endpoint was clinically driven target lesion revascularization.

At 2 years, the primary safety endpoint had occurred in 147 DCS and 180 BMS patients, while clinically driven target lesion revascularization occurred in 77 DCS and 136 BMS patients. Major bleeding occurred in 8.9% of DCS patients and 9.2% of BMS patients, and a coronary thrombotic event (myocardial infarction and/or stent thrombosis) occurred in 8.2% of DCS patients and 10.6% of BMS patients. In addition, 1-year mortality was 27.1% for a major bleed and 26.3% for a thrombotic event. 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.

"'One size fits all' no longer applies for dual antiplatelet therapy (DAPT) duration after coronary stent implantation," said study coauthor Philip Urban, MD, an interventional cardiologist at Hôpital de la Tour in Switzerland. "We are gradually moving from a stent-centered to a patient-centered antithrombotic treatment. For primary care physicians, choices therefore, hopefully, appear more rational, but life has become a little more complex."

—Mark McGraw

Reference:

Garot P, Morice M-C, Tresukosol D, et al; LEADERS FREE Investigators. Two-year outcomes of high bleeding risk patients after polymer-free drug-coated stents [published online January 10, 2017]. J Am Coll Cardiol. doi:10.1016/j.jacc.2016.10.009.