LEADERS FREE: Safety, efficacy of polymer-free drug-coated stent maintained at 2 years

WASHINGTON — A polymer-free drug-coated stent maintained better safety and efficacy vs. bare-metal stents at 2 years in patients at high risk for bleeding, according to data presented at TCT 2016.

The stent types did not have a significant difference in bleeding and coronary thrombotic events, and had comparable mortality risk, according to the findings, which were simultaneously published in the Journal of the American College of Cardiology.

“Current guidelines — U.S. and Europe — usually recommend [BMS] with 1-month [dual antiplatelet therapy] or a drug-eluting stent of the second generation with a shortened DAPT,” Philip Urban, MD, director of invasive cardiology at La Tour Hospital in Geneva, Switzerland, said at a press conference. “The important thing to realize is that these patients are not all-comers because they usually can’t take guideline-recommended 6- to 12-month DAPT.”

The prospective, double blind study included 2,466 patients with high bleeding risk undergoing PCI from 68 sites who were randomly assigned to a polymer-free drug-coated stent (DCS; BioFreedom, Biosensors International) or a BMS (Gazelle, Biosensors International), followed by DAPT for 1 month. At 2 years, 98.1% of patients completed follow-up.

The primary endpoint for safety was a composite of cardiac death, MI or stent thrombosis.

The primary efficacy endpoint was clinically driven target lesion revascularization.

At 2 years, the primary safety endpoint occurred in 147 patients assigned DCS (12.6%) and 180 patients assigned BMS (15.3%; HR = 0.8; 95% CI, 0.64-0.99), according to Urban and colleagues.

There was an occurrence of clinically driven target lesion revascularization in 77 patients with DCS (6.8%) and 136 patients with BMS (12%; HR = 0.54%; 95% CI, 0.41-0.72).

Major bleeding occurred in 8.9% assigned DCS and 9.2% of patients assigned BMS (P = .95), and a coronary thrombotic event (MI or stent thrombosis) occurred in 8.2% of patients with DCS and 10.6% with BMS (P = .045), according to the results.

At 1 year after a major bleed and 1 year after a thrombotic event, mortality was 27.1% and 26.3%, respectively.

In a multivariable analysis, major bleeding was associated with age older than 75 years, anemia, raised plasma creatinine and planned long-term coagulation at the 2-year point.

Age, anemia, congestive HF, multivessel disease, number of stents implanted and use of BMS were all correlates of the primary safety endpoint, the researchers wrote.

A limitation is that the results may not apply to patients not at high risk for bleeding, who are likely to tolerate longer courses of DAPT, they wrote.

“High bleeding risk patients suffer from a persistently high incidence of bleeding and thrombotic events, both of which are associated with a high and similar mortality over a 1-year period,” Urban said. “Identification of predictors of both the composite primary safety event and major bleeding may help design future trials of DAPT duration for high bleeding risk patients.” – by Dave Quaile

References:

Urban P, et al. First Report Investigations 1. Presented at: TCT Scientific Symposium; Oct. 29-Nov. 2, 2016; Washington.

Garot P, et al. J Am Coll Cardiol. 2016;doi:10.1016/j.jacc.2016.10.009.

Disclosure: The study was funded by Biosensors International. Urban reports receiving consultant fees/honoraria from Abbott Vascular, Biosensors International, Edwards Lifesciences and Sinomed.