Safety and Efficacy of Sirolimus- and Paclitaxel-Eluting Coronary Stents

doi:10.1056/NEJMoa067193

Volume 356:998-1008		March 8, 2007		Number 10

Safety and Efficacy of Sirolimus- and Paclitaxel-Eluting Coronary Stents

Gregg W. Stone, M.D., Jeffrey W. Moses, M.D., Stephen G. Ellis, M.D., Joachim Schofer, M.D., Keith D. Dawkins, M.D., Marie-Claude Morice, M.D., Antonio Colombo, M.D., Erick Schampaert, M.D., Eberhard Grube, M.D., Ajay J. Kirtane, M.D., Donald E. Cutlip, M.D., Martin Fahy, M.Sc., Stuart J. Pocock, Ph.D., Roxana Mehran, M.D., and Martin B. Leon, M.D.

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Deutscher Abstract

TRANSLATED TITLE: Sicherheit und Wirksamkeit von Sirolimus und Paclitaxel freisetzenden Koronarstents

Hintergrund Die Sicherheit von Drug-Eluting-Stents (wirkstofffreisetzendenStents) ist durch jüngste Berichte über gehäufteStentthrombosen, Myokardinfarkte und Todesfälle in Fragegestellt worden. Diese Untersuchungen waren aufgrund ihrer unzureichendenGröße, der Verwendung historischer Kontrollen, einerbegrenzten Dauer der Nachbeobachtung und eines ungenügendenZugangs zu den Originaldaten nicht überzeugend.

Methoden Wir führten eine gepoolte Analyse von Daten ausvier Doppelblindstudien durch, in denen 1748 Patienten fürdie Behandlung mit Sirolimus freisetzenden Stents oder unbeschichtetenMetallstents (Bare-Metal-Stents) randomisiert wurden, und fünfDoppelblindstudien, in denen 3513 Patienten für die Behandlungmit Paclitaxel freisetzenden Stents oder unbeschichteten Stentsrandomisiert wurden. Anschließend analysierten wir diewichtigsten klinischen Endpunkte der Studien.

Ergebnisse Die 4-Jahres-Raten der Stentthrombose betrugen 1,2%in der Sirolimus-Stent-Gruppe versus 0,6% in der Bare-Metal–Stent-Gruppe(p=0,20) und 1,3% in der Paclitaxel-Stent-Gruppe versus 0,9%in der Bare-Metal–Stent-Gruppe (p=0,30). Nach 1 Jahr tratenjedoch bei den Patienten mit Sirolimus freisetzenden Stentsfünf Episoden von Stentthrombosen versus keine bei denPatienten mit unbeschichteten Stents (p=0,025) und neun Episodenbei Patienten mit Paclitaxel freisetzenden Stents versus zweibei Patienten mit unbeschichteten Stents auf (p=0,028). Die4-Jahres-Raten der Zielgefäßrevaskularisation warensowohl in der Sirolimus-Stent-Gruppe als auch in der Paclitaxel-Stent-Gruppedeutlich niedriger als in den Gruppen mit unbeschichteten Stents.Die Sterbe- und Myokardinfarktraten unterschieden sich nichtsignifikant zwischen den Gruppen mit Drug-Eluting-Stents unddenen mit unbeschichteten Metallstents.

Schlussfolgerungen Stentthrombosen nach 1 Jahr waren sowohlbei Sirolimus freisetzenden als auch bei Paclitaxel freisetzendenStents häufiger als bei unbeschichteten Stents. Beide Drug-Eluting-Stentswaren mit einer deutlichen Reduktion der Zielgefäßrevaskularisationenverbunden. Es bestanden keine signifikanten Unterschiede inden kumulativen Sterbe- oder Myokardinfarktraten nach 4 Jahren.

Source Information

From Columbia University Medical Center and the Cardiovascular Research Foundation, New York (G.W.S., J.W.M., A.J.K., M.F., R.M., M.B.L.); Cleveland Clinic, Cleveland (S.G.E.); Hamburg University Cardiovascular Center, Hamburg, Germany (J.S.); Southampton University Hospital, Southampton, United Kingdom (K.D.D.); Institut Cardiovasculaire Paris Sud, Massy, France (M.-C.M.); San Raffaele Hospital, Milan (A.C.); Hôpital du Sacre-Coeur de Montréal, Montreal (E.S.); Heart Center Siegburg, Siegburg, Germany (E.G.); Harvard Clinical Research Institute, Boston (D.E.C.); and the London School of Hygiene and Tropical Medicine, London (S.J.P.).

This article (10.1056/NEJMoa067193) was published at www.nejm.org on February 12, 2007.

Address reprint requests to Dr. Stone at Columbia University Medical Center, Cardiovascular Research Foundation, 111 E. 59th St., 11th Fl., New York, NY 10022, or at gs2184{at}columbia.edu.

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