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Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk
Philip Urban1, Ian T Meredith, Alexandre Abizaid
1From Hôpital de la Tour, Geneva (P.U.), Triemli Hospital, Zurich (F.E.), and Biosensors Europe, Morges (S.G., H.-P.S.) - all in Switzerland; MonashHeart and Monash University, Melbourne, VIC, Australia (I.T.M.); Instituto Dante Pazzanese de Cardiologia, São Paulo (A.A.); London School of Hygiene and Tropical Medicine, London (S.J.P., J.G.), the Dorset Heart Centre Royal Bournemouth Hospital, Bournemouth (S.T.), and West of Scotland Regional Heart and Lung Centre Golden Jubilee National Hospital, Glasgow (K.O.) - all in the United Kingdom; Toulouse Rangueil Hospital, Toulouse (D.C.), Pôle Santé République, Clermont-Ferrand (J.L.), Clinique de la Fontaine, Dijon (P.B.), Hôpital Claude Galien, Institut Cardiovasculaire Paris Sud (ICPS), Générale de Santé, Quincy-sous-Sénart (P.G.), Clinique Saint Hilaire, Rouen (J.B.), Groupe Hospitalier Mutualiste de Grenoble, Grenoble (M.A.), and ICPS, Générale de Santé, Massy (M.-C.M.) - all in France; Contilia Heart and Vascular Center, Elisabeth Krankenhaus, Essen (C.N.), and Herzzentrum Segeberger Kliniken, Bad Segeberg (G.R.) - both in Germany; Complejo Hospital Meixoeiro, Vigo, (A.I.), and Arrixaca University Hospital, Murcia (M.V.-C.) - both in Spain; and the Institute Jantung Negara, Kuala Lumpur, Malaysia (R.Z.).
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 underwent 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% confidence 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. (Funded by Biosensors Europe; LEADERS FREE ClinicalTrials.gov number, NCT01623180.).
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