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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

2-Year Clinical Outcomes After Implantation of Sirolimus-Eluting, Paclitaxel-Eluting, and Bare-Metal Coronary Stents

Results From the WDHR (Western Denmark Heart Registry)

Anne Kaltoft, MD, PhD^_*,_*, Lisette Okkels Jensen, MD, PhD, Michael Maeng, MD, PhD^_*, Hans Henrik Tilsted, MD, Per Thayssen, MD, DMSci, Morten Bøttcher, MD, PhD^_*, Jens Flensted Lassen, MD, PhD^_*, Lars Romer Krusell, MD^_*, Klaus Rasmussen, MD, DMSci^,, Knud Nørregaard Hansen, MD^_*, Lars Pedersen, MSc^||, Søren Paaske Johnsen, MD, PhD^,||, Henrik Toft Sørensen, MD, PhD, DMSci^||,¶ and Leif Thuesen, MD, DMSci^_*

^_* Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark
Department of Cardiology, Odense University Hospital, Odense, Denmark
Department of Cardiology, Aarhus University Hospital, Aalborg Hospital, Aalborg, Denmark
Center for Cardiovascular Research, Aarhus University Hospital, Aalborg Hospital, Aalborg, Denmark
^|| Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark
^¶ Department of Epidemiology, Boston University, Boston, Massachusetts

Manuscript received July 1, 2008; revised manuscript received September 22, 2008, accepted September 22, 2008.

^_* Reprint requests and correspondence: Dr. Anne Kaltoft, Department of Cardiology, Aarhus University Hospital, Skejby, Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark (Email: annekaltoft{at}stofanet.dk).

Objectives: This registry study assessed the safety and efficacy of the 2 types of drug-eluting stents (DES), sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), compared with bare-metal stents (BMS).

Background: Drug-eluting stents may increase the risk of stent thrombosis (ST), myocardial infarction (MI), and death.

Methods: A total of 12,395 consecutive patients with coronary intervention and stent implantation recorded in the Western Denmark Heart Registry from January 2002 through June 2005 were followed up for 2 years. Data on death and MI were ascertained from national medical databases. We used Cox regression analysis to control for confounding.

Results: The 2-year incidence of definite ST was 0.64% in BMS patients, 0.79% in DES patients (adjusted relative risk [RR]: 1.09; 95% confidence interval [CI]: 0.72 to 1.65), 0.50% in SES patients (adjusted RR: 0.63, 95% CI: 0.35 to 1.15), and 1.30% in PES patients (adjusted RR: 1.82, 95% CI: 1.13 to 2.94). The incidence of MI was 3.8% in BMS-treated patients, 4.5% in DES-treated patients (adjusted RR: 1.24, 95% CI: 1.02 to 1.51), 4.1% in SES-treated patients (adjusted RR: 1.15, 95% CI: 0.91 to 1.47), and 5.3% in PES-treated patients (adjusted RR: 1.38, 95% CI: 1.06 to 1.81). Whereas overall 2-year adjusted mortality was similar in the BMS and the 2 DES stent groups, 12- to 24-month mortality was higher in patients treated with PES (RR 1.46, 95% CI: 1.02 to 2.09). Target lesion revascularization was reduced in both DES groups.

Conclusions: During 2 years of follow-up, patients treated with PES had an increased risk of ST and MI compared with those treated with BMS and SES. Mortality after 12 months was also increased in PES patients.

Key Words: stent thrombosis • drug-eluting stents • Cypher • Taxus

Abbreviations and Acronyms   ARC = Academic Research Consortium   BMS = bare-metal stent(s)   CI = confidence interval   DES = drug-eluting stent(s)   HR = hazard ratio   MI = myocardial infarction   PCI = percutaneous coronary intervention   PES = paclitaxel-eluting stent(s)   RR = relative risk   SES = sirolimus-eluting stent(s)   STEMI = ST-segment elevation myocardial infarction   TLR = target lesion revascularization   WDHR = Western Denmark Heart Registry

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