CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY
5-Year Clinical Outcomes of the ARTS II (Arterial Revascularization Therapies Study II) of the Sirolimus-Eluting Stent in the Treatment of Patients With Multivessel De Novo Coronary Artery Lesions
Patrick W. Serruys, MD, PhD*,*,
Yoshinobu Onuma, MD*,
Scot Garg, MBChB*,
Pascal Vranckx, MD ,
Bernard De Bruyne, MD, PhD ,
Marie-Claude Morice, MD ,
Antonio Colombo, MD||,
Carlos Macaya, MD¶,
Gert Richardt, MD#,
Jean Fajadet, MD**,
Christian Hamm, MD,
Monique Schuijer, PhD,
Tessa Rademaker, MSc,
Kristel Wittebols, MSc,
Hans Peter Stoll, MD ARTS II Investigators
* Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
Hartcentrum, Hasselt, Belgium
Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium
Cardiovascular Institute, Paris, France
|| San Raffaele Hospital, Milan, Italy
¶ Hospital Clinico San Carlos, Madrid, Spain
# Segeberger Kliniken GmbH, Bad Segeberg, Germany
** Clinique Pasteur, Toulouse, France
Kerckhof-Klinik, Bad Nauheim, Germany
Cardialysis BV, Rotterdam, the Netherlands
Cordis Clinical Research EMEA, a Johnson and Johnson Company, Waterloo, Belgium
Manuscript received September 2, 2009;
revised manuscript received November 11, 2009,
accepted November 30, 2009.
* Reprint requests and correspondence: Dr. Patrick W. Serruys, Thoraxcenter, Ba-583, ‘s Gravendijkwal 230, 3015 CE Rotterdam, the Netherlands (Email: p.w.j.c.serruys{at}erasmusmc.nl).
Objectives: The purpose of this study is to compare the 5-year clinical outcomes, safety, and efficacy of sirolimus-eluting stents (SES) in the ARTS II (Arterial Revascularization Therapies Study II) with the outcomes of coronary artery bypass graft (CABG) and bare-metal stenting (BMS) from the ARTS I.
Background: The long-term outcomes after SES implantation in patients with multivessel disease remains to be established.
Methods: The ARTS I was a randomized trial of 1,205 patients with multivessel disease comparing CABG and BMS. The ARTS II study was a nonrandomized trial with the Cypher sirolimus-eluting stent (Cordis, a Johnson & Johnson Company, Warren, New Jersey), applying the same inclusion and exclusion criteria, end points, and protocol definitions. The ARTS II trial enrolled 607 patients, with an attempt to enroll at least one-third of patients with 3-vessel disease.
Results: At 5-year, the death/stroke/myocardial infarction event-free survival rate was 87.1% in ARTS II SES, versus 86.0% (p = 0.1) and 81.9% (p = 0.007) in ARTS I CABG and BMS cohorts, respectively. The 5-year major adverse cardiac and cerebrovascular event (MACCE) rate in ARTS II (27.5%) was significantly higher than ARTS I CABG (21.1%, p = 0.02), and lower than in ARTS I BMS (41.5%, p < 0.001). The cumulative incidence of definite stent thrombosis was 3.8%. Thirty-two percent (56 of 176) of major adverse cardiac events (MACE) at 5 years were related to possible, probable, or definite stent thrombosis.
Conclusions: At 5 years, SES had a safety record comparable to CABG and superior to BMS, and a MACCE rate that was higher than in patients treated with CABG, and lower than in those treated with BMS. Approximately one-third of the events seen with SES could be prevented through the elimination of early, late, and very late stent thrombosis.
Key Words: multivessel disease • sirolimus-eluting stent • long-term outcomes
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Abbreviations and Acronyms
| | ARC = Academic Research Consortium | | BMS = bare-metal stent(s) | | CABG = coronary artery bypass graft | | CVA = cerebrovascular accident | | DES = drug-eluting stent(s) | | MACCE = major adverse cardiac and cerebrovascular event(s) | | MACE = major adverse cardiac event(s) | | MI = myocardial infarction | | OR = odds ratio | | PCI = percutaneous coronary intervention | | SES = sirolimus-eluting stent(s) | | ST = stent thrombosis |
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