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Randomized comparison of everolimus-eluting stents and sirolimus-eluting stents in patients with ST elevation myocardial infarction: RACES-MI trial.
JACC Cardiovasc Interv. 2014 Aug; 7(8):849-56.JC

Abstract

OBJECTIVES

The aim of the current study was to compare everolimus-eluting stents (EES) with sirolimus-eluting stents (SES) in patients undergoing primary angioplasty.

BACKGROUND

Drug-eluting stents may offer benefits in terms of repeat revascularization. However, as shown for first-generation drug-eluting stents, they may be counterbalanced by a potential higher risk of stent thrombosis, especially among patients with ST-segment elevation myocardial infarction (STEMI). No data have been reported so far on the long-term benefits and safety of the new generation of drug-eluting stents in STEMI.

METHODS

Consecutive STEMI patients admitted within 12 h of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-h primary percutaneous coronary intervention capability were randomly assigned to SES or EES. The primary endpoint was a major adverse cardiac event at 3-year follow-up. The secondary endpoints were death, reinfarction, definite or probable stent thrombosis, and target vessel revascularization at 3-year follow-up. No patient was lost to follow-up.

RESULTS

From April 2007 to May 2009, 500 patients with STEMI were randomized to EES (n = 250) or SES (n = 250). No difference was observed in terms of baseline demographic and clinical characteristics between the groups. No difference was observed between the groups in terms of number of implanted stents per patient or total stent length. However, a larger reference diameter was observed with SES (3.35 ± 0.51 mm vs. 3.25 ± 0.51 mm, p = 0.001), whereas patients randomized to EES more often received glycoprotein IIb/IIIa inhibitors (54.4% vs. 42.4%, p = 0.006). Follow-up data were available in all patients (1,095 ± 159 days). No significant difference was observed between EES and SES in major adverse cardiac events (16% vs. 20.8%, adjusted hazard ratio [HR]: 0.75 [95% confidence interval (CI): 0.5 to 1.13], p = 0.17), cardiac death (4.4% vs. 5.6%, adjusted HR: 0.77 [95% CI: 0.35 to 1.71], p = 0.53), recurrent MI (6.4% vs. 10%, adjusted HR: 0.62 [95% CI: 0.33 to 1.16], p = 0.13), and target vessel revascularization (4.8% vs. 4.8%, adjusted HR: 1.00 [95% CI: 0.45 to 2.32], p = 0.99). However, EES was associated with a significant reduction in stent thrombosis (1.6% vs. 5.2%, adjusted HR: 0.3 [95% CI: 0.1 to 0.92], p = 0.035).

CONCLUSIONS

This study shows that among STEMI patients undergoing primary angioplasty, EES has similar efficacy as SES, but is associated with a significant reduction in stent thrombosis. (Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With ST Elevation Myocardial Infarction [RACES-MI]; NCT01684982).

Authors+Show Affiliations

Division of Cardiology, "S.G. Moscati", Avellino, Italy.Division of Cardiology, "S.G. Moscati", Avellino, Italy.Division of Cardiology, "S.G. Moscati", Avellino, Italy.Division of Cardiology, "S.G. Moscati", Avellino, Italy.Division of Cardiology, "S.G. Moscati", Avellino, Italy.Division of Cardiology, "S.G. Moscati", Avellino, Italy.Division of Cardiology, "S.G. Moscati", Avellino, Italy.Division of Cardiology, "S.G. Moscati", Avellino, Italy.Division of Cardiology, "S.G. Moscati", Avellino, Italy.Division of Cardiology, "S.G. Moscati", Avellino, Italy.Division of Cardiology, "S.G. Moscati", Avellino, Italy.Department of Cardiology, University Medical Center St. Radboud, Nijmegen, the Netherlands.Division of Cardiology, Ospedale "Maggiore della Carità", Eastern Piedmont University, Novara, Italy; Centro di Biotecnologie per la Ricerca Medica Applicata, Eastern Piedmont University, Novara, Italy. Electronic address: giuseppe.deluca@med.unipmn.it.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

25147029

Citation

Di Lorenzo, Emilio, et al. "Randomized Comparison of Everolimus-eluting Stents and Sirolimus-eluting Stents in Patients With ST Elevation Myocardial Infarction: RACES-MI Trial." JACC. Cardiovascular Interventions, vol. 7, no. 8, 2014, pp. 849-56.
Di Lorenzo E, Sauro R, Varricchio A, et al. Randomized comparison of everolimus-eluting stents and sirolimus-eluting stents in patients with ST elevation myocardial infarction: RACES-MI trial. JACC Cardiovasc Interv. 2014;7(8):849-56.
Di Lorenzo, E., Sauro, R., Varricchio, A., Capasso, M., Lanzillo, T., Manganelli, F., Carbone, G., Lanni, F., Pagliuca, M. R., Stanco, G., Rosato, G., Suryapranata, H., & De Luca, G. (2014). Randomized comparison of everolimus-eluting stents and sirolimus-eluting stents in patients with ST elevation myocardial infarction: RACES-MI trial. JACC. Cardiovascular Interventions, 7(8), 849-56. https://doi.org/10.1016/j.jcin.2014.02.016
Di Lorenzo E, et al. Randomized Comparison of Everolimus-eluting Stents and Sirolimus-eluting Stents in Patients With ST Elevation Myocardial Infarction: RACES-MI Trial. JACC Cardiovasc Interv. 2014;7(8):849-56. PubMed PMID: 25147029.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized comparison of everolimus-eluting stents and sirolimus-eluting stents in patients with ST elevation myocardial infarction: RACES-MI trial. AU - Di Lorenzo,Emilio, AU - Sauro,Rosario, AU - Varricchio,Attilio, AU - Capasso,Michele, AU - Lanzillo,Tonino, AU - Manganelli,Fiore, AU - Carbone,Giannignazio, AU - Lanni,Francesca, AU - Pagliuca,Maria Rosaria, AU - Stanco,Giovanni, AU - Rosato,Giuseppe, AU - Suryapranata,Harry, AU - De Luca,Giuseppe, PY - 2014/01/02/received PY - 2014/02/07/revised PY - 2014/02/13/accepted PY - 2014/8/23/entrez PY - 2014/8/26/pubmed PY - 2016/2/24/medline KW - ST-segment elevation myocardial infarction KW - everolimus-eluting stent(s) KW - primary angioplasty KW - sirolimus-eluting stent(s) KW - stent thrombosis SP - 849 EP - 56 JF - JACC. Cardiovascular interventions JO - JACC Cardiovasc Interv VL - 7 IS - 8 N2 - OBJECTIVES: The aim of the current study was to compare everolimus-eluting stents (EES) with sirolimus-eluting stents (SES) in patients undergoing primary angioplasty. BACKGROUND: Drug-eluting stents may offer benefits in terms of repeat revascularization. However, as shown for first-generation drug-eluting stents, they may be counterbalanced by a potential higher risk of stent thrombosis, especially among patients with ST-segment elevation myocardial infarction (STEMI). No data have been reported so far on the long-term benefits and safety of the new generation of drug-eluting stents in STEMI. METHODS: Consecutive STEMI patients admitted within 12 h of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-h primary percutaneous coronary intervention capability were randomly assigned to SES or EES. The primary endpoint was a major adverse cardiac event at 3-year follow-up. The secondary endpoints were death, reinfarction, definite or probable stent thrombosis, and target vessel revascularization at 3-year follow-up. No patient was lost to follow-up. RESULTS: From April 2007 to May 2009, 500 patients with STEMI were randomized to EES (n = 250) or SES (n = 250). No difference was observed in terms of baseline demographic and clinical characteristics between the groups. No difference was observed between the groups in terms of number of implanted stents per patient or total stent length. However, a larger reference diameter was observed with SES (3.35 ± 0.51 mm vs. 3.25 ± 0.51 mm, p = 0.001), whereas patients randomized to EES more often received glycoprotein IIb/IIIa inhibitors (54.4% vs. 42.4%, p = 0.006). Follow-up data were available in all patients (1,095 ± 159 days). No significant difference was observed between EES and SES in major adverse cardiac events (16% vs. 20.8%, adjusted hazard ratio [HR]: 0.75 [95% confidence interval (CI): 0.5 to 1.13], p = 0.17), cardiac death (4.4% vs. 5.6%, adjusted HR: 0.77 [95% CI: 0.35 to 1.71], p = 0.53), recurrent MI (6.4% vs. 10%, adjusted HR: 0.62 [95% CI: 0.33 to 1.16], p = 0.13), and target vessel revascularization (4.8% vs. 4.8%, adjusted HR: 1.00 [95% CI: 0.45 to 2.32], p = 0.99). However, EES was associated with a significant reduction in stent thrombosis (1.6% vs. 5.2%, adjusted HR: 0.3 [95% CI: 0.1 to 0.92], p = 0.035). CONCLUSIONS: This study shows that among STEMI patients undergoing primary angioplasty, EES has similar efficacy as SES, but is associated with a significant reduction in stent thrombosis. (Randomized Comparison of Everolimus Eluting Stents and Sirolimus Eluting Stent in Patients With ST Elevation Myocardial Infarction [RACES-MI]; NCT01684982). SN - 1876-7605 UR - https://www.unboundmedicine.com/medline/citation/25147029/Randomized_comparison_of_everolimus_eluting_stents_and_sirolimus_eluting_stents_in_patients_with_ST_elevation_myocardial_infarction:_RACES_MI_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1936-8798(14)00920-0 DB - PRIME DP - Unbound Medicine ER -