Everolimus Stent in Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

— RaCES-MI  

Official title:

Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With ST Elevation Myocardial Infarction (STEMI) (RaCES-MI Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684982
• Other study ID #: DiLOR_2012
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2012
• Last updated: April 1, 2013
• Start date: April 2007
• Est. completion date: June 2012

Study information

• Verified date: April 2013
• Source: San Giuseppe Moscati Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Contraindication to dual antiplatelet therapy for 12 months

2. Known allergy to sirolimus or everolimus

3. Major surgical procedure planned within 1 month.

4. History, symptoms, or findings suggestive of aortic dissection.

5. Participation in other trials

6. Pregnancy.

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:
• everolimus eluting stent
experimental arm of a comparison between drug eluting stents
• sirolimus eluting stent
control arm of a comparison between drug eluting stents

Locations

Country	Name	City	State
Italy	Division of Cardiology AO Moscati	Avellino

Sponsors (1)

Lead Sponsor	Collaborator
San Giuseppe Moscati Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. doi: 10.1001/archinternmed.2012.758. Review. — View Citation

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. doi: 10.1007/s11886-011-0207-0. Review. — View 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. — View Citation

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. doi: 10.1007/s00392-010-0133-y. Epub 2010 Mar 11. — View Citation

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. doi: 10.1016/j.jacc.2012.01.073. — View Citation

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 Oct 27;380(9852):1482-90. doi: 10.1016/S0140-6736(12)61223-9. Epub 2012 Sep 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac death, reinfarction and Target Vessel Revascularization (TVR)	Any death of cardiac origin, any myocardial infarction and any new revascularization of the infarct related artery	36 MONTHS	No
Secondary	cardiac death, reinfarction, Target Vessel Revascularization (TVR) and definite/probable stent thrombosis		36 months	Yes