RESTEM: a percutaneous coronary intervention 'real world' registry in the drug-eluting stent era

Area of Science:

• Cardiology
• Interventional Cardiology
• Biomaterials in Medicine

Background:

• Sirolimus-eluting stents (SESs) are used to reduce in-stent restenosis after percutaneous coronary interventions (PCIs).
• The long-term clinical outcomes and effectiveness of SESs in complex patient populations remain under investigation.
• The RESTEM Registry prospectively collected data on 5524 patients undergoing PCI over 20 months, with up to 2 years of follow-up.

Purpose of the Study:

• To evaluate the comparative effectiveness of SESs versus bare metal stents (BMS) in a large, real-world patient cohort.
• To assess the impact of SESs on major adverse cardiac events, including death, myocardial infarction, and revascularization procedures.
• To determine the durability of SES benefits over a two-year follow-up period.

Main Methods:

• Prospective, multicenter registry (RESTEM Registry) of consecutive patients undergoing PCI.
• Comparison of outcomes between patients treated with SESs, BMS, or other techniques.
• Statistical analysis using multivariate models to adjust for baseline characteristics and potential confounders.
• Primary endpoint: composite of death, acute myocardial infarction, unstable angina, and revascularizations. Secondary endpoints included target vessel revascularization (TVR) and other clinical events.

Main Results:

• At one year, SESs showed no significant advantage in the primary composite endpoint but a slight benefit in revascularizations and a consistent advantage in TVR compared to BMS.
• At two years, SESs maintained a significant advantage in TVR and a slight benefit in revascularizations, but did not reduce overall mortality or other clinical events.
• The benefits of SESs, particularly in reducing TVRs, were primarily observed within the first year post-PCI and diminished in the second year.
• No excess of deaths, acute myocardial infarctions, or late stent thrombosis was observed with SES implantation compared to BMS.

Conclusions:

• Sirolimus-eluting stents effectively reduce target vessel revascularizations, particularly within the first year after percutaneous coronary intervention.
• The observed advantage of SESs in reducing revascularizations is not associated with a reduction in overall mortality or other major adverse cardiac events.
• The benefits of SESs appear to be time-limited, with outcomes becoming similar to bare metal stents in the second year post-procedure.
• The RESTEM Registry data do not support concerns regarding increased late adverse events with SES implantation.