Drug Eluting Stent (DES) in Primary Angioplasty - Full Text View

Sponsored by:	San Giuseppe Moscati Hospital
Information provided by:	San Giuseppe Moscati Hospital
ClinicalTrials.gov Identifier:	NCT00759850

Purpose

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).

Condition	Intervention	Phase
Acute Myocardial Infarction	Device: Drug Eluting Stent (DES)	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	PaclitAxel or Sirolimus-Eluting Stent vs Bare Metal Stent in Primary Angioplasty (PASEO) Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Heart Attack

U.S. FDA Resources

Further study details as provided by San Giuseppe Moscati Hospital:

Primary Outcome Measures:

The primary end point was target lesion revascularization (TLR) at 1-year follow-up [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

Enrollment:	270
Study Start Date:	October 2003
Study Completion Date:	December 2007
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Patient with ST elevation myocardial infarction randomly assigned to receive a Bare Metal Stent n=90)	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.
B: Experimental Patient with ST elevation myocardial infarction randomly assigned to receive a Paclitaxel Eluting Stent (n=90)	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.
C: Experimental Patient with ST elevation myocardial infarction randomly assigned to receive a Sirolimus Eluting Stent (n=90)	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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759850

Locations

Italy
U.O. Cardiologia/UTIC
Avellino, Italy, 83100

Sponsors and Collaborators

San Giuseppe Moscati Hospital

Investigators

Principal Investigator:

Emilio Di Lorenzo, MD PhD

Division of Cardiology A.O. Moscati Avellino Italy

More Information

No publications provided by San Giuseppe Moscati Hospital

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Division Of Cardiology ( Emilio Di Lorenzo MD PhD )
Study ID Numbers:	AOM_DES01
Study First Received:	September 24, 2008
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00759850 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by San Giuseppe Moscati Hospital:

Acute Myocardial Infarction
Drug Eluting Stent
Primary PCI

Study placed in the following topic categories:

Sirolimus
Necrosis
Heart Diseases
Aspirin
Paclitaxel
Clopidogrel

Myocardial Ischemia
Benzocaine
Vascular Diseases
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases

Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on September 11, 2009