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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Multivessel Coronary Revascularization in Patients With and Without Diabetes Mellitus

3-Year Follow-Up of the ARTS-II (Arterial Revascularization Therapies Study–Part II) Trial

Joost Daemen, MD^_*, Karl Heinz Kuck, MD, Carlos Macaya, MD, Victor LeGrand, MD, Maarten Vrolix, MD^||, Didier Carrie, MD^¶, Imad Sheiban, MD^#, Maarten Jan Suttorp, MD^_**, Pascal Vranckx, MD, Tessa Rademaker, MSc, Dick Goedhart, PhD, Monique Schuijer, PhD, Kristel Wittebols, MSc, Nathalie Macours, PhD, Hans Peter Stoll, MD, Patrick W. Serruys, MD, PhD^_*,_* on behalf of the ARTS-II Investigators

^_* Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
Hospital St. Georg, Hamburg, Germany
Hospital Clinico San Carlos, Madrid, Spain
CHU Sart Tilman, Liege, Belgium
^|| Ziekenhuis Oost Limburg, Genk, Belgium
^¶ CHY Popital de Rangueil, Toulouse, France
^# Azienda Ospedaliera San Giovanni Batista, Torino, Italy
^_** Sint Antonius Hospital Nieuwegein, Nieuwegein, the Netherlands
Hospital Virga Jesse, Hasselt, Belgium
Cardialysis B.V., Rotterdam, the Netherlands
Cordis Clinical Research Europe, Waterloo, Belgium

Manuscript received June 16, 2008; revised manuscript received August 14, 2008, accepted September 2, 2008.

^_* Reprint requests and correspondence: Prof. 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 was to assess the 3-year outcome of coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) using sirolimus-eluting stents (SES) in patients who had multivessel coronary artery disease with and without diabetes mellitus.

Background: The optimal method of revascularization in diabetic patients remains in dispute.

Methods: The ARTS-II (Arterial Revascularization Therapies Study–Part II) trial is a single-arm study (n = 607) that included 159 diabetic patients treated with SES whose 3-year clinical outcome was compared with that of the historical diabetic and nondiabetic arms of the randomized ARTS-I trial (n = 1,205, including 96 diabetic patients in the CABG arm and 112 in the PCI arm).

Results: At 3 years, among nondiabetic patients, the incidence of the primary composite of death, CVA, myocardial infarction (MI), and repeat revascularization (major adverse cardiac and cerebrovascular events [MACCE]), was significantly lower in ARTS-II than in ARTS-I PCI (adjusted odds ratio [OR]: 0.41; 95% confidence interval [CI]: 0.26 to 0.64) and similar to ARTS-I CABG. The ARTS-II patients were at significantly lower risk for death, CVA, and MI as compared with both the ARTS-I PCI (adjusted OR: 0.55; 95% CI: 0.34 to 0.91) and ARTS-I CABG patients (adjusted OR: 0.56; 95% CI: 0.35 to 0.92). Among diabetic patients, the incidence of MACCE in ARTS-II was similar to that of both PCI and CABG in ARTS-I. Conversely, the incidence of death, CVA, and MI was significantly lower in ARTS-II than in ARTS-I PCI (adjusted OR: 0.67; 95% CI: 0.27 to 1.65) and was similar to that of ARTS-I CABG.

Conclusions: At 3 years, PCI using SES for patients with multivessel coronary artery disease seems to be safer and more efficacious than PCI using bare-metal stents, irrespective of the diabetic status of the patient. Hence, PCI using SES appears to be a valuable alternative to CABG for both diabetic and nondiabetic patients.

Key Words: coronary stents • sirolimus-eluting stent • diabetes • all-comers • coronary artery bypass graft surgery

Abbreviations and Acronyms   BMS = bare-metal stent(s)   CABG = coronary artery bypass graft surgery   CI = confidence interval   CK-MB = creatine kinase-myocardial band   CVA = cerebrovascular accident   DES = drug-eluting stent(s)   MACCE = major adverse cardiac and cerebrovascular event(s)   MI = myocardial infarction   OR = odds ratio   PCI = percutaneous coronary intervention   SES = sirolimus-eluting stent(s)

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