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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Impact of Stable Versus Unstable Coronary Artery Disease on 1-Year Outcome in Elective Patients Undergoing Multivessel Revascularization With Sirolimus-Eluting Stents

A Subanalysis of the ARTS II Trial

Marco Valgimigli, MD, PhD^_*, Keith Dawkins, MD, FRCP, FACC, Carlos Macaya, MD, FACC, Bernard de Bruyne, MD, PhD, Emmanuel Teiger, MD, PhD^||, Jean Fajadet, MD^¶, Richardt Gert, MD^#, Stefano De Servi, MD^_**, Angelo Ramondo, MD, Kristel Wittebols, MSc, Hans-Peter Stoll, MD, Tessa A.M. Rademaker, MSc and Patrick W. Serruys, MD, PhD, FACC^_*,_*

^_* Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
Wessex Cardiac Unit, Southampton University Hospital, Southampton, United Kingdom
Hospital Clinico San Carlos, Madrid, Spain
Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium
^|| CHU Henri Mondor, Paris, France
^¶ Clinique Pasteur, Toulouse, France
^# Segerberger Kliniken, Bad Segeberg, Germany
^_** Ospedale Civile di Legnano, Legnano, Italy
Azienda Ospedaliera Padova, Padova, Italy
Cordis Corporation, a Johnson & Johnson company, Miami Lakes, Florida
Cardialysis B.V., Rotterdam, the Netherlands.

Manuscript received March 30, 2006; revised manuscript received May 31, 2006, accepted June 26, 2006.

^_* Reprint requests and correspondene: Prof. Patrick W. Serruys, Head of Interventional Cardiology, Ba 583, Thoraxcenter, Erasmus Medical Center, Dr. Molewaterplein 40, 3015 GD, Rotterdam, the Netherlands. (Email: p.w.j.c.serruys{at}erasmusmc.nl).

OBJECTIVES: We sought to evaluate the impact of unstable coronary artery disease (CAD) on short- and mid-term outcomes in patients with multivessel disease treated by multiple sirolimus-eluting stents (SES) as part of ARTS II (Arterial Revascularization Therapies Study Part II).

BACKGROUND: The differential safety/efficacy profile of SES when implanted in patients with unstable angina (UA) in comparison with stable angina (SA) undergoing multivessel intervention is largely unknown.

METHODS: Between February 2003 and November 2003, 607 patients at 45 participating centers were treated; 221 of them (36%) presented with UA.

RESULTS: At 30 days, the cumulative rate of death, myocardial infarction—defined as any creatine kinase (CK)/CK-myocardial band elevation beyond the upper limit of normal—cerebrovascular accident, and repeat revascularization (i.e., major adverse cardiac and cerebrovascular events [MACCEs]) was 19.9% in both groups. Angiographic subacute stent occlusion was documented in 1 (0.5%) and 4 (1%) patients in the UA and SA groups, respectively. At 1 year, the cumulative incidence of MACCEs was 27.1% in the UA and 24.9% in the SA group (p = 0.56). Two late occlusions occurred, both in the SA group. After adjustment for baseline and procedural characteristics, the presence of UA was not identified as an independent predictor of MACCE (hazard ratio 0.94; 95% confidence interval 0.41 to 2.12; p = 0.88). These findings remained consistent after increasing the CK/CK-myocardial band threshold to define periprocedural myocardial infarction up to at least 3 or 5 times the upper limit of normal.

CONCLUSIONS: In ARTS II, an unstable clinical presentation did not exert a negative impact on short- and mid-term outcome after SES implantation for multivessel disease. (ARTS II Trial; http://clinicaltrials.gov/ct/show/NCT00235170?order=1; NCT00235170 [ClinicalTrials.gov] ).

Abbreviations and Acronyms   ACS = acute coronary syndrome   BMS = bare-metal stent   CVA = cerebrovascular accident   CK-MB = creatine kinase-myocardial band   DES = drug-eluting stent   HR = hazard ratio   MACCE = major adverse cardiac and cerebrovascular event   MI = myocardial infarction   SES = sirolimus-eluting stent   TVR = target vessel revascularization

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