Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk
Philip Urban, Ian T Meredith, Alexandre Abizaid, Stuart J Pocock, Didier Carrié, Christoph Naber, Janusz Lipiecki, Gert Richardt, Andres Iñiguez, Philippe Brunel, Mariano Valdes-Chavarri, Philippe Garot, Suneel Talwar, Jacques Berland, Mohamed Abdellaoui, Franz Eberli, Keith Oldroyd, Robaayah Zambahari, John Gregson, Samantha Greene, Hans-Peter Stoll, Marie-Claude Morice, LEADERS FREE Investigators, Luc Bilodeau, Mariano Valdes-Chavarri, Alaide Chieffo, Haim Danenberg, Franz Eberli, Marcel Gosselink, Keith Oldroyd, Robayaah Zambahari, Janusz Lipiecki, Philippe Brunel, Philippe Garot, Jacques Berland, Mohamed Abdellaoui, Didier Carrié, Thomas Hovasse, Luc Maillard, Christian Spaulding, Marc Bedossa, Jean Fajadet, Eric Maupas, Marc Eric Moulichon, Eric Van Belle, Suneel Talwar, Ian B A Menown, Keith Oldroyd, Jonathan Byrne, Simon Redwood, Azfar Zaman, David Hildick-Smith, Mark De Belder, Ever Grech, Philip Strike, Piers Clifford, Simon James Walsh, Gert Richardt, Philip Lurz, Florian Krackhardt, Franz-Josef Neumann, Werner Jung, Christoph Naber, Andres Iñiguez, Mariano Valdes-Chavarri, Agustin Albarran, Raul Moreno, Roberto Violini, Corrado Tamburino, Antonio Bartorelli, Maurizio Tespili, Silvio Klugmann, Antonio Colombo, Franz Eberli, Oliver Gaemperli, Eric Eeckhout, Tiziano Moccetti, Philip Urban, Paul Ong, Lim Soo Teik, Chan Koo Hui, Evald H Christiansen, Thomas Engström, Stephen Lee, Robayaah Zambahari, Ian Meredith, Darren Walters, Damras Tresukosol, Stefan Verheye, Christophe Dubois, Ran Kornowski, Haim Danenberg, Shmuel Banai, Andrejs Erglis, Rune Wiseth, Marcel Gosselink, Luc Bilodeau, Sonny Dandona, David Foley, Irene Lang, Philip Urban, Ian T Meredith, Alexandre Abizaid, Stuart J Pocock, Didier Carrié, Christoph Naber, Janusz Lipiecki, Gert Richardt, Andres Iñiguez, Philippe Brunel, Mariano Valdes-Chavarri, Philippe Garot, Suneel Talwar, Jacques Berland, Mohamed Abdellaoui, Franz Eberli, Keith Oldroyd, Robaayah Zambahari, John Gregson, Samantha Greene, Hans-Peter Stoll, Marie-Claude Morice, LEADERS FREE Investigators, Luc Bilodeau, Mariano Valdes-Chavarri, Alaide Chieffo, Haim Danenberg, Franz Eberli, Marcel Gosselink, Keith Oldroyd, Robayaah Zambahari, Janusz Lipiecki, Philippe Brunel, Philippe Garot, Jacques Berland, Mohamed Abdellaoui, Didier Carrié, Thomas Hovasse, Luc Maillard, Christian Spaulding, Marc Bedossa, Jean Fajadet, Eric Maupas, Marc Eric Moulichon, Eric Van Belle, Suneel Talwar, Ian B A Menown, Keith Oldroyd, Jonathan Byrne, Simon Redwood, Azfar Zaman, David Hildick-Smith, Mark De Belder, Ever Grech, Philip Strike, Piers Clifford, Simon James Walsh, Gert Richardt, Philip Lurz, Florian Krackhardt, Franz-Josef Neumann, Werner Jung, Christoph Naber, Andres Iñiguez, Mariano Valdes-Chavarri, Agustin Albarran, Raul Moreno, Roberto Violini, Corrado Tamburino, Antonio Bartorelli, Maurizio Tespili, Silvio Klugmann, Antonio Colombo, Franz Eberli, Oliver Gaemperli, Eric Eeckhout, Tiziano Moccetti, Philip Urban, Paul Ong, Lim Soo Teik, Chan Koo Hui, Evald H Christiansen, Thomas Engström, Stephen Lee, Robayaah Zambahari, Ian Meredith, Darren Walters, Damras Tresukosol, Stefan Verheye, Christophe Dubois, Ran Kornowski, Haim Danenberg, Shmuel Banai, Andrejs Erglis, Rune Wiseth, Marcel Gosselink, Luc Bilodeau, Sonny Dandona, David Foley, Irene Lang
Abstract
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.).
Source: PubMed