This editorial refers to ‘Biolimus-A9 polymer-free coated stent in high bleeding risk patients with acute coronary syndrome: a Leaders Free ACS substudy’, by C.K. Naber et al ., doi:10.1093/eurheartj/ehw203
Last year, the Leaders Free trial report was perceived in the interventional cardiology community as one of the most clinically relevant studies in recent history.1 The study clearly addressed a high bleeding risk (HBR) population including patients with 13 pre-defined clinical criteria at age ≥75 years or those with co-morbidities such as renal failure and oral anticoagulation therapy. The HBR patients undergoing percutaneous coronary intervention (PCI) also possess thrombo-ischaemic risks of stent thrombosis and future atherothrombotic events, which used to pose a clinical dilemma for physicians in the choice of stent type and antithrombotic regimens for HBR patients: a drug-eluting stent (DES) and relatively long dual antiplatelet therapy (DAPT) with additional bleeding risk and decreased ischaemic risk vs. bare-metal stent (BMS) and short DAPT with increased ischaemic (restenotic) risk and less additional bleeding risk.2 The Leaders Free study with 2466 patients provided a solution to the dilemma, demonstrating that the specific biolimus A9-eluting polymer-free stent (BA9-DCS) with a 1-month DAPT was safer and more efficacious than the BMS with the same DAPT regimen, with similar rates of bleeding events. Of note, the subgroup analysis showed that in patients presenting with acute coronary syndrome (ACS), the treatment effects of the two devices were different.
In this issue of the journal, Naber and colleagues provided further insights into the ACS population from the Leaders Free trials.3 In 659 HBR patients presenting with ACS at entry (BA9-DCS, 330; BM, 329), treatment with BA9-DCS and 1-month DAPT …
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Felice Gragnano, Dik Heg, Anna Franzone, Eugène McFadden, Sergio Leonardi, Raffaele Piccolo, Pascal Vranckx, Mattia Branca, Patrick W. Serruys, Edouard Benit, Christoph Liebetrau, Luc Janssens, Maurizio Ferrario, Aleksander Żurakowski, Roberto Diletti, Marcello Dominici, Kurt Huber, Ton Slagboom, Paweł Buszman, Leonardo Bolognese, Carlo Tumscitz, Krzysztof Bryniarski,
Manel Sabaté, Lorenz Räber, Dik Heg, Salvatore Brugaletta, Henning Kelbæk, Ángel Cequier, Miodrag Ostojić, Andrés Íñiguez, David Tüller, Antonio Serra, Andreas Baumbach, Clemens von Birgelen, Rosana Hernández‐Antolín, Marco Roffi, Vicente Mainar, Marco Valgimigli, Patrick W. Serruys, Peter Jüni, Stephan Windecker
Bernard Chevalier, Patrick W. Serruys, Sigmund Silber, Eulogio Garcı́a, Harry Suryapranata, Karl Eugen Hauptmann, William Wijns, Gerhard Schüler, Farzin Fath‐Ordoubadi, Stephen G. Worthley, Leif Thuesen, Ian T. Meredith, Marco Bressers, Hirofumi Nagai, Dragica Paunovic
PubMed
Adel Aminian,
Mathias Vrolix,
Ivo Petrov,
Scot Garg,
Christoph Naber,
Janusz Prokopczuk,
Christian Hamm,
Philippe Gabríel Steg,
Peter Jüni,
Stephan Windecker,
Marco Valgimigli
European Heart Journal - Cardiovascular Pharmacotherapy
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