Clinical trial NCT01182649: Everolimus Stent in Patients With Coronary Artery Disease (CAD)
Official title: Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Coronary Atherosclerosis
Keywords: Drug Eluting Stents
Everolimus Eluting Stent
Coronary Angioplasty
Lead sponsor: San Giuseppe Moscati Hospital
Sponsor class: OTHER
First posted: 2010-08-17
Enrollment: 600
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: Aim of the study is to compare the everolimus eluting stent and sirolimus eluting stent in all comers PCI eligible patients

Detailed description: Compared with the currently available first-generation drug-eluting stents (DES), second-generation DES have been designed with the goal of improving safety and efficacy. Everolimus, a sirolimus analogue, is released from a open cell, thin-strut, cobalt-chromium frame. A significant reduction in cardiac events was noted in patients with the everolimus-eluting stent compared with those who had a paclitaxel-eluting stent. Sirolimus eluting stent was the first available drug eluting stent and is the most tested. Therefore the investigators compared the safety and efficacy of the everolimus-eluting and sirolimus eluting stents in unselected patients in real world practice.

Eligibility criteria: Inclusion Criteria:

* All patients with coronary artery disease eligible for percutaneous coronary intervention (PCI)

Exclusion Criteria:

* Contraindication to dual antiplatelet therapy for 12 months
* Known allergy to sirolimus or everolimus
* Major surgical procedure planned within 1 month
* History, symptoms, or findings suggestive of aortic dissection.
* Participation in other trials
* Pregnancy

Primary outcomes:
measure: Target Vessel Revascularization
timeFrame: 2 year
Secondary outcomes:
measure: cardiac death
timeFrame: 2 year
measure: non fatal myocardial infarction
timeFrame: 2 year
measure: stent thrombosis
timeFrame: 2 year
Other outcomes:
Locations:
city: Avellino
country: Italy
facility: Division of Cardiology Aorn Moscati
Study officials:
affiliation: DIVISION OF CARDIOLOGY AORN MOSCATI AVELLINO ITALY
name: EMILIO DI LORENZO, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stone GW, Rizvi A, Newman W, Mastali K, Wang JC, Caputo R, Doostzadeh J, Cao S, Simonton CA, Sudhir K, Lansky AJ, Cutlip DE, Kereiakes DJ; SPIRIT IV Investigators. Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. N Engl J Med. 2010 May 6;362(18):1663-74. doi: 10.1056/NEJMoa0910496.
citation: Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010 Jan 16;375(9710):201-9. doi: 10.1016/S0140-6736(09)62127-9. Epub 2010 Jan 7.
citation: Caixeta A, Leon MB, Lansky AJ, Nikolsky E, Aoki J, Moses JW, Schofer J, Morice MC, Schampaert E, Kirtane AJ, Popma JJ, Parise H, Fahy M, Mehran R. 5-year clinical outcomes after sirolimus-eluting stent implantation insights from a patient-level pooled analysis of 4 randomized trials comparing sirolimus-eluting stents with bare-metal stents. J Am Coll Cardiol. 2009 Sep 1;54(10):894-902. doi: 10.1016/j.jacc.2009.04.077.
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.