Home > Interventional Cardiology, Journal Club > Journal Club 25 November 2015

Journal Club 25 November 2015

Paper

Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk

Presenter

VF

Summary

BACKGROUND

Patients at high risk for bleeding who undergo percutaneous coronary intervention (PCI) often receive bare-metal stents followed by 1 month of dual antiplatelet therapy. We studied a polymer-free and carrier-free drug-coated stent that transfers umirolimus (also known as biolimus A9), a highly lipophilic sirolimus analogue, into the vessel wall over a period of 1 month.

METHODS

In a randomized, double-blind trial, we compared the drug-coated stent with a very similar bare-metal stent in patients with a high risk of bleeding who under-went PCI. All patients received 1 month of dual antiplatelet therapy. The primary safety end point, tested for both noninferiority and superiority, was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy end point was clinically driven target-lesion revascularization.

RESULTS

We enrolled 2466 patients. At 390 days, the primary safety end point had occurred in 112 patients (9.4%) in the drug-coated–stent group and in 154 patients (12.9%) in the bare-metal–stent group (risk difference, −3.6 percentage points; 95% confi-dence interval [CI], −6.1 to −1.0; hazard ratio, 0.71; 95% CI, 0.56 to 0.91; P<0.001 for noninferiority and P = 0.005 for superiority). During the same time period, clinically driven target-lesion revascularization was needed in 59 patients (5.1%) in the drug-coated–stent group and in 113 patients (9.8%) in the bare-metal–stent group (risk difference, −4.8 percentage points; 95% CI, −6.9 to −2.6; hazard ratio, 0.50; 95% CI, 0.37 to 0.69; P<0.001).

CONCLUSIONS

Among patients at high risk for bleeding who underwent PCI, a polymer-free umirolimus-coated stent was superior to a bare-metal stent with respect to the primary safety and efficacy end points when used with a 1-month course of dual antiplatelet therapy.

Supplementary Material

Supplementary material is available here.

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