Drug Eluting Stent (DES) in Primary Angioplasty

Phase 2

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Device: Drug Eluting Stent (DES)

• Registration Number: NCT00759850
• Lead Sponsor: San Giuseppe Moscati Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2005-10
• Study Completion: 2007-12
• Status Verified: 2008-09
• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-24
• Last Update Submitted: 2008-09-24
• Study First Posted: 2008-09-25
• Last Update Posted: 2008-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• Clinical symptoms of STEMI, with initial onset of chest pain within the past 12 hours, an ECG demonstrating > 0.1 mV ST-segment elevation in 2 or more contiguous leads or documented new left bundle-branch block and were suitable candidates for percutaneous revascularization.

Exclusion Criteria

• Active internal bleeding or a history of bleeding diathesis within the previous 30 days
• An history of intracranial hemorrhage
• Intracranial neoplasm
• Arteriovenous malformation or aneurysm
• Known allergy to sirolimus
• Paclitaxel
• Heparin, aspirin, or clopidogrel
• An history of stroke within 30 days or any history of hemorrhagic stroke
• History, symptoms, or findings suggestive of aortic dissection, fibrinolytic therapy within 24 hours
• History of thrombocytopenia, pregnancy, patients on warfarin or acenocoumarol within the last seven days
• Inability to obtain the informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Drug Eluting Stent (DES)	Patient with ST elevation myocardial infarction randomly assigned to receive a Bare Metal Stent n=90)
B	Drug Eluting Stent (DES)	Patient with ST elevation myocardial infarction randomly assigned to receive a Paclitaxel Eluting Stent (n=90)
C	Drug Eluting Stent (DES)	Patient with ST elevation myocardial infarction randomly assigned to receive a Sirolimus Eluting Stent (n=90)

Primary Outcome Measures

Name	Time	Method
The primary end point was target lesion revascularization (TLR) at 1-year follow-up	1 year

Secondary Outcome Measures

Name	Time	Method
Cumulative combined incidence of death and/or reinfarction at 2 year; Cumulative incidence of in-stent thrombosis at 2 year; 3) Major Adverse Cardiac Events (MACE) (combined death and/or reinfarction and/or TLR) at 2 years	2 year

Trial Locations

Locations (1)

U.O. Cardiologia/UTIC; 🇮🇹 Avellino, Italy