Benefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial.

BACKGROUND

Drug-eluting stent (DES) may offer benefits in terms of repeat revascularization, which may be counterbalanced by a potential higher risk of stent thrombosis, especially among patients with STEMI. No data have been reported so far on the long-term benefits and safety of DES in STEMI. The aim of the current study was to evaluate the short- and long-term benefits of sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) as compared to bare-metal stent (BMS) in patients undergoing primary angioplasty.

METHODS

Consecutive patients with STEMI admitted within 12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-hour primary percutaneous coronary intervention capability were randomly assigned to BMS, PES, and SES. All patients received upstream glycoprotein IIb-IIIa inhibitors. Primary end point was target-lesion revascularization at 1-year follow-up. Secondary end points were (1) cumulative combined incidence of death and/or reinfarction; (2) cumulative incidence of in-stent thrombosis; and (3) major adverse cardiac events (MACE) (combined death and/or reinfarction and/or target lesion revascularization [TLR]) at long-term follow-up (up to 4 years). No patient was lost to follow-up.

RESULTS

From October 1, 2003, to December 2005, 270 patients with STEMI were randomized to BMS (n = 90), PES (n = 90), or SES (n = 90). Procedural success was obtained in 93% to 95% of patients. Follow-up data were available for all patients. As compared to BMS (14.4%), both PES (4.4%, hazard ratio [HR] 0.29, 95% CI 0.095-0.89, P = .023) and SES (3.3%, HR 0.21, 95% CI 0.06-0.75, P = .016) were associated with a significant reduction in TLR at 1-year follow-up (primary study end point). At long-term follow-up (1,233 +/- 215 days), no difference was observed in terms of death, reinfarction, and combined death and/or reinfarction, but as compared to BMS (21.1%), both PES (6.7%, HR 0.29, 95% CI 0.12-0.73, P = .008) and SES (5.6%, HR 0.24, 95% CI 0.09-0.63, P = .002), respectively, were associated with a significant reduction in TLR.

CONCLUSIONS

This study shows that among patients with STEMI undergoing primary angioplasty, both SES and PES are safe and associated with significant benefits in terms of TLR up to 4 years' follow-up, as compared to BMS. Thus, until the results of further large randomized trials with long-term follow-up become available, DES may be considered among patients with STEMI undergoing primary angioplasty.