Author + information
- Received September 2, 2009
- Revision received November 11, 2009
- Accepted November 30, 2009
- Published online March 16, 2010.
- 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
- ↵*Reprint requests and correspondence:
Dr. Patrick W. Serruys, Thoraxcenter, Ba-583, ‘s Gravendijkwal 230, 3015 CE Rotterdam, the Netherlands
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.
Ms. Wittebols and Dr. Stoll are employees of Cordis Clinical Research. Dr. Hamm is a consultant for Cordis and Medtronic, and has received research support from Boston Scientific.
- Received September 2, 2009.
- Revision received November 11, 2009.
- Accepted November 30, 2009.
- American College of Cardiology Foundation