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The PASEO (PaclitAxel or Sirolimus-Eluting Stent Versus Bare Metal Stent in Primary Angioplasty) Randomized Trial

Emilio Di Lorenzo, MD, PhD^_*,_*, Giuseppe De Luca, MD, PhD^,, Rosario Sauro, MD^_*, Attilio Varricchio, MD, PhD^_*, Michele Capasso, MD^_*, Tonino Lanzillo, MD^_*, Fiore Manganelli, MD^_*, Ciro Mariello, MD^_*, Francesco Siano, MD^_*, Maria Rosaria Pagliuca, MD^_*, Giovanni Stanco, MD^_*, Giuseppe Rosato, MD^_*

^_* Division of Cardiology, Ospedale "S.G. Moscati," Avellino, Italy
Division of Cardiology, Ospedale "Maggiore della Carità,", Eastern Piedmont University, Novara, Italy
Centro di Biotecnologie per la Ricerca Medica Applicata (BRMA), Eastern Piedmont University, Novara, Italy

^_* Reprint requests and correspondence: Dr. Emilio Di Lorenzo, Division of Cardiology, Laboratory of Cardiac Catheterization and Interventional Cardiology, S.G. Moscati Hospital, Via Otranto, 83100 Avellino, Italy (Email: emidilorenzo{at}tin.it).

Objectives: The aim of this study was to evaluate the benefits of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) as compared with bare-metal stents (BMS) in patients undergoing primary angioplasty.

Background: Recent concerns have emerged on the potential higher risk of stent thrombosis after drug-eluting stent implantation, especially among ST-segment elevation myocardial infarction (STEMI) patients.

Methods: We randomly assigned STEMI patients admitted within 12 h of symptom onset undergoing primary angioplasty and stent implantation to BMS, PES, or SES. The primary study end point was target lesion revascularization at 1-year follow-up. All patients were reviewed at our outpatient clinic or by telephone interview at 6, 12, and 24 months.

Results: From October 2003 to December 2005, 270 STEMI patients undergoing primary angioplasty were randomized to BMS (n = 90), PES (n = 90), or SES (n = 90). No patient was lost to follow-up. As compared with BMS (14.4%), both PES (4.4%, p = 0.023) and SES (3.3%, p = 0.016) were associated with a significant reduction in target lesion revascularization at 1-year follow-up. At 2-year follow-up no difference was observed in terms of death, reinfarction, and combined death and/or reinfarction, but as compared with BMS, both PES and SES were associated with significant benefits in major adverse cardiac events (PES: 16.7%, p = 0.015; SES: 15.6%, p = 0.009, respectively).

Conclusions: This study shows that among STEMI patients undergoing primary angioplasty, both SES and PES are safe and associated with significant benefits in terms of target lesion revascularization up to the 2-year follow-up. Thus, until the results of further large randomized trials with long-term follow-up become available, drug-eluting stents may be considered for STEMI patients undergoing primary angioplasty. (PaclitAxel or Sirolimus-Eluting Stent versus Bare Metal Stent in Primary Angioplasty [PASEO] Randomized Trial; NCT00759850)

Key Words: percutaneous coronary intervention • ST-segment elevation myocardial infarction • drug-eluting stents

Abbreviations and Acronyms   BMS = bare-metal stent(s)   DES = drug-eluting stent(s)   PCI = percutaneous coronary intervention   PES = paclitaxel-eluting stent(s)   SES = sirolimus-eluting stent(s)   STEMI = ST-segment elevation myocardial infarction   TLR = target lesion revascularization   TVR = target vessel revascularization

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