Clinical trial NCT00759850: Drug Eluting Stent (DES) in Primary Angioplasty
Official title: PaclitAxel or Sirolimus-Eluting Stent vs Bare Metal Stent in Primary Angioplasty (PASEO) Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Myocardial Infarction
Keywords: Acute Myocardial Infarction
Drug Eluting Stent
Primary PCI
Lead sponsor: San Giuseppe Moscati Hospital
Sponsor class: OTHER
First posted: 2008-09-25
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: The primary end point was target lesion revascularization (TLR) at 1-year follow-up
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: 2 year
Other outcomes:
Locations:
city: Avellino
country: Italy
facility: U.O. Cardiologia/UTIC
Study officials:
affiliation: Division of Cardiology A.O. Moscati Avellino Italy
name: Emilio Di Lorenzo, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Di Lorenzo E, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Pagliuca MR, Stanco G, Rosato G, De Luca G. Benefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial. Am Heart J. 2009 Oct;158(4):e43-50. doi: 10.1016/j.ahj.2009.03.016.
citation: Di Lorenzo E, De Luca G, Sauro R, Varricchio A, Capasso M, Lanzillo T, Manganelli F, Mariello C, Siano F, Pagliuca MR, Stanco G, Rosato G. The PASEO (PaclitAxel or Sirolimus-Eluting Stent Versus Bare Metal Stent in Primary Angioplasty) Randomized Trial. JACC Cardiovasc Interv. 2009 Jun;2(6):515-23. doi: 10.1016/j.jcin.2009.03.012.