Polymer-Free DES Also Show Efficacy in Anticoagulated Patients with High Risk for Bleeding

Patients who receive chronic anticoagulation therapy and then undergo angioplasty are frequently discharged on a triple anti-thrombotic scheme that usually includes aspirin, clopidogrel, and warfarin.

The optimal duration of this indication remains unclear, particularly for patients at high bleeding risk. According to expert consensus, patients receiving chronic anticoagulation may receive from 1 to 12 months of dual antiplatelet therapy, depending on clinical presentation, risk for thrombosis, risk for bleeding, and type of stent used.

This discussion is very relevant because 5%-7% of all patients who undergo angioplasty are anticoagulated.

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The LEADERS FREE (A Randomized Clinical Evaluation of the BioFreedom Stent) trial was designed to compare the safety and efficacy of 1 month of dual antiplatelet therapy after the implantation of a polymer-free biolimus-A9-eluting stent vs. a bare-metal stent (BMS) with an identical scaffold in patients with at least 1 risk factor for bleeding, such as advanced age, anticoagulation, recent bleeding, anemia, chronic renal insufficiency, or cancer. Global study results demonstrated the superior safety and efficacy of polymer-free drug-eluting stents (DES). Now there are results for the pre-specified subgroup of patients receiving chronic anticoagulation therapy.

Four hundred patients in the polymer-free-DES group and 376 in the BMS group were discharged on chronic anticoagulation (almost all due to atrial fibrillation).

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At 2 years, the rates of clinically driven revascularization were 7.5% for the polymer-free-DES group versus 11.2% for the BMS group (hazard ratio [HR]: 0.63; 95% confidence interval [CI]: 0.40 to 1.01; p = 0.0514). The safety endpoint was 14.4% vs. 15% (p = ns), respectively, and the rates of major bleeding were 10.7% vs. 12.9% (p = ns).

Conclusion

The superior efficacy of polymer-free biolimus-eluting stents is also confirmed in patients receiving chronic anticoagulation. Despite a very short and absolutely necessary course of dual antiplatelet therapy, the rates of major bleeding were high in both groups.

Editorial

Despite a very short and absolutely necessary course of dual antiplatelet therapy, the rates of major bleeding were very high in both groups, which matches the results from the ISARTRIPLE and WOEST trials. The fact that this short term receiving dual antiplatelet therapy is unsuitable for this elderly population at high risk for bleeding seems obvious.

The exclusion of the appendage or the combination of new anticoagulant agents with clopidogrel alone might be good alternatives to the triple anti-thrombotic scheme.

Original title: Safety and Efficacy of Polymer-Free Biolimus A9–Coated Versus Bare-Metal Stents in Orally Anticoagulated Patients. 2-Year Results of the LEADERS FREE Oral Anticoagulation Substudy.

Reference: Didier Carrié et al. JACC Cardiovasc Interv. 2017 Aug 28;10(16):1633-1642.

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