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Long-term comparison of sirolimus-eluting and bare-metal stents in ST-segment elevation myocardial infarction
Inge Wijnbergen1, Jan Tijssen, Guus Brueren
1aDepartment of Cardiology, Catharina Hospital Eindhoven bDepartment of Biomedical Engineering, Eindhoven University of Technology, Eindhoven cAcademic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
Insights
The initial benefits of sirolimus-eluting stents (SES) for ST-segment elevation myocardial infarction (STEMI) patients diminished over 5 years. Long-term safety was confirmed, with very low rates of very late stent thrombosis in both SES and bare-metal stents (BMS).
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Sirolimus-eluting stents (SES) initially showed reduced major adverse cardiac and cerebrovascular events (MACCE) in ST-segment elevation myocardial infarction (STEMI) patients compared to bare-metal stents (BMS).
- Existing randomized data on the long-term safety and efficacy of SES in STEMI patients are limited and conflicting.
Purpose of the Study:
- To evaluate if the early clinical benefits of SES in STEMI patients persist over a 5-year follow-up period.
- To compare the long-term safety and efficacy of SES versus BMS in STEMI patients.
Main Methods:
- A prospective, single-center randomized trial (DEBATER) involving 907 STEMI patients randomized to SES or BMS.
- Primary endpoint: MACCE (composite of death, myocardial infarction, stroke, repeat revascularization, bleeding).
- Five-year follow-up data collected via hospital records, phone calls, and questionnaires.
Main Results:
- At 5 years, no significant difference in MACCE rates between SES and BMS groups (33.3% vs. 39.3%, P=0.12).
- Cumulative incidence of death and myocardial infarction was similar (11.0% vs. 9.7%, P=0.51).
- Very late stent thrombosis rates were low in both groups (2.0% vs. 0.7%, P=0.12).
Conclusions:
- The initial benefit of SES in reducing MACCE in STEMI patients faded by the 5-year follow-up.
- No long-term safety concerns were identified for SES, with very low rates of very late stent thrombosis observed.
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.
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