Stephan Windecker1, Michael Haude2, Franz-Josef Neumann2, Karl Stangl2, Bernhard Witzenbichler2, Ton Slagboom2, Manel Sabaté2, Javier Goicolea2, Paul Barragan2, Stéphane Cook2, Christophe Piot2, Gert Richardt2, Béla Merkely2, Henrik Schneider2, Johannes Bilger2, Paul Erne2, Ron Waksman2, Serge Zaugg2, Peter Jüni2, Thierry Lefèvre2. 1. From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.); Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany (M.H.); Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany (F.-J.N.); Charité-Campus Mitte, Berlin, Germany (K.S.); Charité Campus Benjamin Franklin, Berlin, Germany (B.W.); Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands (T.S.); Hospital Clínic, Thorax Institute, Barcelona, Spain (M.S.); IDIBAPS, University of Barcelona, Barcelona, Spain (M.S.); Hospital Puerta de Hierro, Madrid, Spain (J.G.); Polyclinique les Fleurs, Ollioules, France (P.B.); Hospital and University Fribourg, Switzerland (S.C.); University of Montpellier, Montpellier Cedex 5, France (C.P.); Segeberger Kliniken, Bad Segeberg, Germany (G.R.); Semmelweis University Heart and Vascular Center, Budapest, Hungary (B.M.); Universitätsklinikum Rostock, Rostock, Germany (H.S.); Klinikum Nürnberg Süd, Nürnberg, Germany (J.B.); Lucerne Canton Hospital, Lucerne, Switzerland (P.E.); MedStar Health Research Institute, Washington, DC (R.W.); Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland (S.Z., P.J.); and ICPS, Massy, France (T.L.). stephan.windecker@insel.ch. 2. From the Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.); Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany (M.H.); Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany (F.-J.N.); Charité-Campus Mitte, Berlin, Germany (K.S.); Charité Campus Benjamin Franklin, Berlin, Germany (B.W.); Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands (T.S.); Hospital Clínic, Thorax Institute, Barcelona, Spain (M.S.); IDIBAPS, University of Barcelona, Barcelona, Spain (M.S.); Hospital Puerta de Hierro, Madrid, Spain (J.G.); Polyclinique les Fleurs, Ollioules, France (P.B.); Hospital and University Fribourg, Switzerland (S.C.); University of Montpellier, Montpellier Cedex 5, France (C.P.); Segeberger Kliniken, Bad Segeberg, Germany (G.R.); Semmelweis University Heart and Vascular Center, Budapest, Hungary (B.M.); Universitätsklinikum Rostock, Rostock, Germany (H.S.); Klinikum Nürnberg Süd, Nürnberg, Germany (J.B.); Lucerne Canton Hospital, Lucerne, Switzerland (P.E.); MedStar Health Research Institute, Washington, DC (R.W.); Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland (S.Z., P.J.); and ICPS, Massy, France (T.L.).
Abstract
BACKGROUND: Biodegradable polymers for release of antiproliferative drugs from drug-eluting stents aim to improve vascular healing. We assessed noninferiority of a novel ultrathin strut drug-eluting stent releasing sirolimus from a biodegradable polymer (Orsiro, O-SES) compared with the durable polymer Xience Prime everolimus-eluting stent (X-EES) in terms of the primary end point in-stent late lumen loss at 9 months. METHODS AND RESULTS:A total of 452 patients were randomly assigned 2:1 to treatment with O-SES (298 patients, 332 lesions) orX-EES (154 patients, 173 lesions) in a multicenter, noninferiority trial. The primary end point was in-stent late loss at 9 months. O-SES was noninferior to X-EES for the primary end point (0.10±0.32 versus 0.11±0.29 mm; difference=0.00063 mm; 95% confidence interval, -0.06 to 0.07; Pnoninferiority<0.0001). Clinical outcome showed similar rates of target-lesion failure at 1 year (O-SES 6.5% versus X-EES 8.0%; hazard ratio=0.82; 95% confidence interval, 0.40-1.68; log-rank test: P=0.58) without cases of stent thrombosis. A subgroup of patients (n=55) underwent serial optical coherence tomography at 9 months, which demonstrated similar neointimal thickness among lesions allocated to O-SES and X-EES (0.10±0.04 mm versus 0.11±0.04 mm; -0.01 [-0.04, -0.01]; P=0.37). Another subgroup of patients (n=56) underwent serial intravascular ultrasound at baseline and 9 months indicating a potential difference in neointimal area at follow-up (O-SES, 0.16±0.33 mm(2) versus X-EES, 0.43±0.56 mm(2); P=0.04). CONCLUSIONS: Compared with durable polymer X-EES, novel biodegradable polymer-based O-SES was found noninferior for the primary end point in-stent late lumen loss at 9 months. Clinical event rates were comparable without cases of stent thrombosis throughout 1 year of follow-up. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01356888.
RCT Entities:
BACKGROUND: Biodegradable polymers for release of antiproliferative drugs from drug-eluting stents aim to improve vascular healing. We assessed noninferiority of a novel ultrathin strut drug-eluting stent releasing sirolimus from a biodegradable polymer (Orsiro, O-SES) compared with the durable polymer Xience Prime everolimus-eluting stent (X-EES) in terms of the primary end point in-stent late lumen loss at 9 months. METHODS AND RESULTS: A total of 452 patients were randomly assigned 2:1 to treatment with O-SES (298 patients, 332 lesions) or X-EES (154 patients, 173 lesions) in a multicenter, noninferiority trial. The primary end point was in-stent late loss at 9 months. O-SES was noninferior to X-EES for the primary end point (0.10±0.32 versus 0.11±0.29 mm; difference=0.00063 mm; 95% confidence interval, -0.06 to 0.07; Pnoninferiority<0.0001). Clinical outcome showed similar rates of target-lesion failure at 1 year (O-SES 6.5% versus X-EES 8.0%; hazard ratio=0.82; 95% confidence interval, 0.40-1.68; log-rank test: P=0.58) without cases of stent thrombosis. A subgroup of patients (n=55) underwent serial optical coherence tomography at 9 months, which demonstrated similar neointimal thickness among lesions allocated to O-SES and X-EES (0.10±0.04 mm versus 0.11±0.04 mm; -0.01 [-0.04, -0.01]; P=0.37). Another subgroup of patients (n=56) underwent serial intravascular ultrasound at baseline and 9 months indicating a potential difference in neointimal area at follow-up (O-SES, 0.16±0.33 mm(2) versus X-EES, 0.43±0.56 mm(2); P=0.04). CONCLUSIONS: Compared with durable polymer X-EES, novel biodegradable polymer-based O-SES was found noninferior for the primary end point in-stent late lumen loss at 9 months. Clinical event rates were comparable without cases of stent thrombosis throughout 1 year of follow-up. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01356888.
Authors: Roger J Guillory; Alexander A Oliver; Emma Davis; Elisha J Earley; Jaroslaw W Drelich; Jeremy Goldman Journal: JOM (1989) Date: 2019-02-12 Impact factor: 2.471
Authors: Alexandra J Lansky; Adnan Kastrati; Elazer R Edelman; Helen Parise; Vivian G Ng; John Ormiston; William Wijns; Robert A Byrne Journal: Am J Cardiol Date: 2015-12-07 Impact factor: 2.778