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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Sirolimus-Eluting Stents Versus Bare-Metal Stents in Patients With ST-Segment Elevation Myocardial Infarction: 9-Month Angiographic and Intravascular Ultrasound Results and 12-Month Clinical Outcome

Results From the MISSION! Intervention Study

Bas L. van der Hoeven, MD^_*, Su-San Liem, MD^_*, J. Wouter Jukema, MD, PhD^_*,1, Navin Suraphakdee, MD^_*, Hein Putter, MSc, PhD, Jouke Dijkstra, MSc, PhD, Douwe E. Atsma, MD, PhD^_*, Marianne Bootsma, MD, PhD^_*, Katja Zeppenfeld, MD, PhD^_*, Pranobe V. Oemrawsingh, MD, PhD^_*, Ernst E. van der Wall, MD, PhD^_* and Martin J. Schalij, MD, PhD^_*,_*

^_* Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands
Department of Medical Statistics and Bio-Informatics, Leiden University Medical Center, Leiden, the Netherlands
Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands.

Manuscript received June 11, 2007; revised manuscript received September 13, 2007, accepted September 17, 2007.

^_* Reprint requests and correspondence: Dr. Martin J. Schalij, Department of Cardiology, C5-P, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, the Netherlands. (Email: m.j.schalij{at}lumc.nl).

Objectives: Our purpose was to evaluate the efficacy and safety of drug-eluting stents in the setting of primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI).

Background: There is inconsistent and limited evidence about the efficacy and safety of drug-eluting stents in STEMI patients.

Methods: A single-blind, single-center, randomized study was performed to compare bare-metal stents (BMS) with sirolimus-eluting stents (SES) in 310 STEMI patients. The primary end point was in-segment late luminal loss (LLL) at 9 months. Secondary end points included late stent malapposition (LSM) at 9 months as determined by intravascular ultrasound imaging and clinical events at 12 months.

Results: In-segment LLL was 0.68 ± 0.57 mm in the BMS group and 0.12 ± 0.43 mm in the SES group with a mean difference of 0.56 mm, 95% confidence interval 0.43 to 0.68 mm (p < 0.001). Late stent malapposition at 9 months was present in 12.5% BMS patients and in 37.5% SES patients (p < 0.001). Event-free survival at 12 months was 73.6% in BMS patients and 86.0% in SES patients (p = 0.01). The target-vessel-failure-free survival was 84.7% in the BMS group and 93.0% in the SES group (p = 0.02), mainly because of a higher target lesion revascularization rate in BMS patients (11.3% vs. 3.2%; p = 0.006). Rates of death, myocardial infarction, and stent thrombosis were not different.

Conclusions: Sirolimus-eluting stent implantation in STEMI patients is associated with a favorable midterm clinical and angiographic outcome compared with treatment with BMS. However, LSM raises concern about the long-term safety of SES in STEMI patients (MISSION!; ISRCTN62825862).

Abbreviations and Acronyms   BMS = bare-metal stent(s)   CI = confidence interval   HR = hazard ratio   IVUS = intravascular ultrasound   LLL = late luminal loss   LSM = late stent malapposition   MI = myocardial infarction   MLD = minimal luminal diameter   PCI = percutaneous coronary intervention   QCA = quantitative coronary angiography   SES = sirolimus-eluting stent(s)   STEMI = ST-segment elevation myocardial infarction

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