Everolimus Stent in Myocardial Infarction - Full Text View

Purpose

Randomized trial to test the efficacy and safety of newer Drug Eluting Stent generation in patient with acute myocardial infarction treated with primary percutaneous coronary intervention (PCI)

Condition	Intervention	Phase
Acute Myocardial Infarction	Device: everolimus eluting stent Device: sirolimus eluting stent	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With ST Elevation Myocardial Infarction (STEMI) (RaCES-MI Trial)

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

Drug Information available for: Sirolimus Everolimus Temsirolimus

U.S. FDA Resources

Further study details as provided by San Giuseppe Moscati Hospital:

Primary Outcome Measures:

cardiac death, reinfarction and Target Vessel Revascularization (TVR) [ Time Frame: 36 MONTHS ] [ Designated as safety issue: No ]
Any death of cardiac origin, any myocardial infarction and any new revascularization of the infarct related artery

Secondary Outcome Measures:

cardiac death, reinfarction, Target Vessel Revascularization (TVR) and definite/probable stent thrombosis [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Enrollment:	500
Study Start Date:	April 2007
Study Completion Date:	June 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: everolimus eluting stent second generation drug eluting stent	Device: everolimus eluting stent experimental arm of a comparison between drug eluting stents Other Name: XIENCE V Abbott Vascular
Active Comparator: sirolimus eluting stent first generation drug eluting stent	Device: sirolimus eluting stent control arm of a comparison between drug eluting stents Other Name: CYPHER Johnson & Johnson

Detailed Description:

The efficacy and safety of drug-eluting stents (DES) in the treatment of coronary artery disease is well established. It is well known that Drug Eluting Stent (DES) have dramatically decreased Restenosis rates for both on-label and off-label indications. However, the concern for increased (late) stent thrombosis is still present DES implantation in patient with acute myocardial infarction is still controversial because acute coronary lesion presents the highest possible thrombotic burden Newer DES with new antiproliferative drugs and more biocompatible polymers have shown a significant reduction of (late) stent thrombosis in patients in stable condition.

Aim of the study was to asses the long term efficacy and safety on second generation everolimus eluting stent compared with first generation sirolimus eluting stent

Eligibility

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

Criteria

Inclusion Criteria:

All ST segment elevation myocardial infarction (STEMI) patients eligible for primary 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684982

Locations

Italy
Division of Cardiology AO Moscati
Avellino, Italy, 83100

Sponsors and Collaborators

San Giuseppe Moscati Hospital

Investigators

Principal Investigator:	EMILIO DI LORENZO, MD PHD	AO MOSCATI AVELLINO ITALY
Study Director:	ROSARIO SAURO, MD	AO MOSCATI AVELLINO ITALY

More Information

Publications:

De Luca G, Dirksen MT, Spaulding C, Kelbaek H, Schalij M, Thuesen L, van der Hoeven B, Vink MA, Kaiser C, Musto C, Chechi T, Spaziani G, Díaz de la Llera LS, Pasceri V, Di Lorenzo E, Violini R, Cortese G, Suryapranata H, Stone GW; Drug-Eluting Stent in Primary Angioplasty (DESERT) Cooperation. Drug-eluting vs bare-metal stents in primary angioplasty: a pooled patient-level meta-analysis of randomized trials. Arch Intern Med. 2012 Apr 23;172(8):611-21; discussion 621-2. Review.

Di Lorenzo E, Carbone G, Sauro L, Casafina A, Capasso M, Sauro R. Bare-metal stents versus drug-eluting stents for primary angioplasty: long-term outcome. Curr Cardiol Rep. 2011 Oct;13(5):459-64. Review.

Dibra A, Tiroch K, Schulz S, Kelbaek H, Spaulding C, Laarman GJ, Valgimigli M, Di Lorenzo E, Kaiser C, Tierala I, Mehilli J, Campo G, Thuesen L, Vink MA, Schalij MJ, Violini R, Schömig A, Kastrati A. Drug-eluting stents in acute myocardial infarction: updated meta-analysis of randomized trials. Clin Res Cardiol. 2010 Jun;99(6):345-57. Epub 2010 Mar 11.

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.

Hofma SH, Brouwer J, Velders MA, Van't Hof AW, Smits PC, Queré M, de Vries CJ, van Boven AJ. Second-Generation Everolimus-Eluting Stents Versus First-Generation Sirolimus-Eluting Stents in Acute Myocardial Infarction: 1-Year Results of the Randomized XAMI (XienceV Stent vs. Cypher Stent in Primary PCI for Acute Myocardial Infarction) Trial. J Am Coll Cardiol. 2012 Jul 31;60(5):381-7. PubMed PMID: 22835668.

Sabate M, Cequier A, Iñiguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Gómez-Hospital JA, Baz JA, Martin-Yuste V, van Geuns RJ, Alfonso F, Bordes P, Tebaldi M, Masotti M, Silvestro A, Backx B, Brugaletta S, van Es GA, Serruys PW. Everolimus-eluting stent versus bare-metal stent in ST-segment elevation myocardial infarction (EXAMINATION): 1 year results of a randomised controlled trial. Lancet. 2012 Aug 31. [Epub ahead of print]

Responsible Party:	Emilio Di Lorenzo MD PhD, Chief Interventional Cardiology, San Giuseppe Moscati Hospital
ClinicalTrials.gov Identifier:	NCT01684982 History of Changes
Other Study ID Numbers:	DiLOR_2012
Study First Received:	September 11, 2012
Last Updated:	April 1, 2013
Health Authority:	Italy: Ethics Committee

Keywords provided by San Giuseppe Moscati Hospital:

Primary PCI
Drug Eluting Stent

Additional relevant MeSH terms:

Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Sirolimus
Everolimus

Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 22, 2013

Everolimus Stent in Myocardial Infarction (RaCES-MI)