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

NCT00759850 Phase 2/Phase 3 COMPLETED

Stent implantation is the best treatment in patients with acute myocardial infarction (STEMI) referred for primary angioplasty (pPCI). However the occurrence of in stent restenosis is responsible for the need of repeat intervention. Both Sirolimus-eluting stents (SES) and Paclitaxel-eluting stents (PES) have been proven to virtually abolish in-stent restenosis in elective patients in simple e more complex lesions. Both SES and PES have raised concerns regarding occurrence of late stent thrombosis, especially in complex lesion subsets or in high risk patients. The PaclitAxel or Sirolimus-Eluting Stent vs Bare Metal Stent in primary angioplasty (PASEO) trial was a prospective, single-center, randomized trial evaluating the benefits of SES or PES as compared to BMS implantation in patients undergoing primary angioplasty for acute STEMI. From 1 October 2003 we randomized with 1:1:1 ratio, 270 patients with STEMI and treated with pPCI, to implantation of a bare metal stent (BMS n=90), PES (n=90) or SES (n=90).

Details

Lead sponsor	San Giuseppe Moscati Hospital
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	270
Start date	2003-10
Completion	2007-12

Conditions

• Acute Myocardial Infarction

Interventions

• Drug Eluting Stent (DES)

Primary outcomes

• The primary end point was target lesion revascularization (TLR) at 1-year follow-up — 1 year

Countries

Italy