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.
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.
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.
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).
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).