Comparison of drug-eluting and Bare-metal stents for primary percutaneous coronary intervention with or without Abciximab in ST-segment elevation myocardial infarction DEBATER : the Eindhoven Reperfusion Study

Objectives The goal of this study was to demonstrate superiority of sirolimus-eluting stents (SES) over baremetal stents (BMS) and of abciximab over no abciximab in primary percutaneous coronary intervention (PCI). Background Drug-eluting stents (DES) are increasingly used in primary PCI, but the recommendations for use in primary PCI are based on a few randomized controlled trials with selected patients. The usefulness of abciximab in primary PCI is not established. Methods Nine hundred seven patients referred to the Catharina Hospital were randomized to SES or BMS, and to abciximab or no abciximab in a prospective, randomized, open 2 X 2 factorial trial with blinded evaluation. Primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), defined as the composite of death, myocardial infarction (MI), stroke, repeat revascularization, and bleeding at 1 year (stent arm) and the composite of death, target vessel MI, target vessel revascularization (TVR), and bleeding at 30 days (abciximab arm). Results At 1 year, the rate of MACCE was lower in the SES arm (16.5% vs. 25.8%, p = 0.001), mainly driven by less repeat revascularization (9.8% vs. 16.8%; p = 0.003) and without influencing the cumulative incidence of death and MI (5.2% vs. 5.8%; p = 0.68). At 30 days, the rate of the composite of death, target vessel MI, TVR, and bleeding was lower in the abciximab arm (8.2% vs. 12.4%, p = 0.04), mainly driven by less TVR due to less stent thrombosis (1.2% vs.7.4%, p <0.001). However, bleeding complications occurred more frequently in the abciximab group (5.7% vs. 2.8%, p = 0.03). Conclusions Primary PCI with SES reduces adverse events at 1 year, mainly by reduction of repeat revascularization, whereas abciximab reduces early stent thrombosis, at the expense of more bleeding complications. (Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Elevation Myocardial Infarction [DEBATER]; NCT00986050) (J Am Coll Cardiol Intv 2012;5:313-22) (C) 2012 by the American College of Cardiology Foundatio

Long-term comparison of sirolimus-eluting and bare-metal stents in ST-segment elevation myocardial infarction

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