Objectives: We aimed to investigate, in patients with ST-segment elevation myocardial infarction (STEMI), whether the previously reported clinical benefits of sirolimus-eluting stent(s) (SES) in terms of reducing a major adverse cardiac and cerebrovascular event (MACCE) compared with bare-metal stent(s) (BMS) were maintained over a 5-year time period.
Background: In the prospective single-centre randomized DEBATER trial, SES significantly reduced the rate of MACCE in STEMI patients within 1 year compared with BMS, mainly driven by a reduction of target lesion revascularization. Randomized data on the long-term safety and efficacy of SES in STEMI patients are conflicting and limited.
Patients and methods: Between January 2006 and May 2008, a total of 907 STEMI patients were randomized to receive SES or BMS. The primary endpoint was MACCE defined as the composite of death, myocardial infarction, stroke, repeat revascularization and bleeding. Five-year follow-up data were collected by reviewing hospital records, telephone calls and a written questionnaire.
Results: At 5 years, the rate of MACCE between the SES group and the BMS group was no longer significantly different (33.3 vs. 39.3%, P=0.12). The cumulative incidence of death and myocardial infarction was similar in both groups (11.0 vs. 9.7%, P=0.51). Repeat revascularization was performed in 21.1 and 25.8% of patients, respectively (P=0.12). The rate of very late stent thrombosis (1–5 years of follow-up) was very low in both groups (2.0 vs. 0.7%, P=0.12).
Conclusion: The benefits of SES in STEMI patients in terms of reducing MACCE faded over time. We found no safety concerns in terms of SES in the long term, with extremely low rates of very late stent thrombosis.
aDepartment of Cardiology, Catharina Hospital Eindhoven
bDepartment of Biomedical Engineering, Eindhoven University of Technology, Eindhoven
cAcademic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
Correspondence to Nico H.J. Pijls, MD, PhD, Department of Cardiology, Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 EJ Eindhoven, the Netherlands Tel: +31 40 239 7004; fax: +31 40 244 7885; e-mail: firstname.lastname@example.org
Received February 4, 2014
Received in revised form February 20, 2014
Accepted March 9, 2014