Drug Eluting Stent (DES) in Primary Angioplasty

Acute Myocardial Infarction Clinical Trial

— PASEO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00759850
• Other study ID #: AOM_DES01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 24, 2008
• Last updated: September 24, 2008
• Start date: October 2003
• Est. completion date: December 2007

Study information

• Verified date: September 2008
• Source: San Giuseppe Moscati Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: December 2007
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
Italy	U.O. Cardiologia/UTIC	Avellino

Sponsors (1)

Lead Sponsor	Collaborator
San Giuseppe Moscati Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end point was target lesion revascularization (TLR) at 1-year follow-up		1 year	No
Secondary	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	Yes