NCT00759850

Drug Eluting Stent (DES) in Primary Angioplasty

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: San Giuseppe Moscati Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	Drug Eluting Stent (DES)	Open-label randomization was performed after initial angiography by the treating physician when eligibility criteria were met. All patients received in the CCU 70U/Kg i.v. bolus of UFH plus 1000U/h infusion (to maintain an ACT of at least 200 seconds), aspirin intravenously (500 mg) and clopidogrel (300 mg loading dose). All patients received upstream Gp IIb-IIIa inhibitors administration as a routine adjunctive therapy before primary PCI. Postinterventional antiplatelet therapy for all patients included in the three study group, consisted of aspirin (100 mg) indefinitely and clopidogrel (75 mg for six months). Stenting procedures were performed according to standard techniques. The number and length of stents, and the type of BMS to be implanted, were left to the operator's discretion. The operator was allowed to implant DES to cover the entire length of the lesion with coverage of the entire stented segment and of 5 mm proximal and distal segments.

Timeline

• Start date: 2003-10-01
• Primary completion: 2005-10-01
• Completion: 2007-12-01
• First posted: 2008-09-25
• Last updated: 2008-09-25

Locations

1 site across 1 country: Italy