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5-year clinical outcomes of the ARTS II (Arterial Revascularization Therapies Study II) of the sirolimus-eluting stent in the treatment of patients with multivessel de novo coronary artery lesions.
J Am Coll Cardiol. 2010 Mar 16; 55(11):1093-101.JACC

Abstract

OBJECTIVES

The purpose of this study is to compare the 5-year clinical outcomes, safety, and efficacy of sirolimus-eluting stents (SES) in the ARTS II (Arterial Revascularization Therapies Study II) with the outcomes of coronary artery bypass graft (CABG) and bare-metal stenting (BMS) from the ARTS I.

BACKGROUND

The long-term outcomes after SES implantation in patients with multivessel disease remains to be established.

METHODS

The ARTS I was a randomized trial of 1,205 patients with multivessel disease comparing CABG and BMS. The ARTS II study was a nonrandomized trial with the Cypher sirolimus-eluting stent (Cordis, a Johnson & Johnson Company, Warren, New Jersey), applying the same inclusion and exclusion criteria, end points, and protocol definitions. The ARTS II trial enrolled 607 patients, with an attempt to enroll at least one-third of patients with 3-vessel disease.

RESULTS

At 5-year, the death/stroke/myocardial infarction event-free survival rate was 87.1% in ARTS II SES, versus 86.0% (p = 0.1) and 81.9% (p = 0.007) in ARTS I CABG and BMS cohorts, respectively. The 5-year major adverse cardiac and cerebrovascular event (MACCE) rate in ARTS II (27.5%) was significantly higher than ARTS I CABG (21.1%, p = 0.02), and lower than in ARTS I BMS (41.5%, p < 0.001). The cumulative incidence of definite stent thrombosis was 3.8%. Thirty-two percent (56 of 176) of major adverse cardiac events (MACE) at 5 years were related to possible, probable, or definite stent thrombosis.

CONCLUSIONS

At 5 years, SES had a safety record comparable to CABG and superior to BMS, and a MACCE rate that was higher than in patients treated with CABG, and lower than in those treated with BMS. Approximately one-third of the events seen with SES could be prevented through the elimination of early, late, and very late stent thrombosis.

Authors+Show Affiliations

Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. p.w.j.c.serruys@erasmusmc.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study

Language

eng

PubMed ID

20171036

Citation

Serruys, Patrick W., et al. "5-year Clinical Outcomes of the ARTS II (Arterial Revascularization Therapies Study II) of the Sirolimus-eluting Stent in the Treatment of Patients With Multivessel De Novo Coronary Artery Lesions." Journal of the American College of Cardiology, vol. 55, no. 11, 2010, pp. 1093-101.
Serruys PW, Onuma Y, Garg S, et al. 5-year clinical outcomes of the ARTS II (Arterial Revascularization Therapies Study II) of the sirolimus-eluting stent in the treatment of patients with multivessel de novo coronary artery lesions. J Am Coll Cardiol. 2010;55(11):1093-101.
Serruys, P. W., Onuma, Y., Garg, S., Vranckx, P., De Bruyne, B., Morice, M. C., Colombo, A., Macaya, C., Richardt, G., Fajadet, J., Hamm, C., Schuijer, M., Rademaker, T., Wittebols, K., & Stoll, H. P. (2010). 5-year clinical outcomes of the ARTS II (Arterial Revascularization Therapies Study II) of the sirolimus-eluting stent in the treatment of patients with multivessel de novo coronary artery lesions. Journal of the American College of Cardiology, 55(11), 1093-101. https://doi.org/10.1016/j.jacc.2009.11.049
Serruys PW, et al. 5-year Clinical Outcomes of the ARTS II (Arterial Revascularization Therapies Study II) of the Sirolimus-eluting Stent in the Treatment of Patients With Multivessel De Novo Coronary Artery Lesions. J Am Coll Cardiol. 2010 Mar 16;55(11):1093-101. PubMed PMID: 20171036.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 5-year clinical outcomes of the ARTS II (Arterial Revascularization Therapies Study II) of the sirolimus-eluting stent in the treatment of patients with multivessel de novo coronary artery lesions. AU - Serruys,Patrick W, AU - Onuma,Yoshinobu, AU - Garg,Scot, AU - Vranckx,Pascal, AU - De Bruyne,Bernard, AU - Morice,Marie-Claude, AU - Colombo,Antonio, AU - Macaya,Carlos, AU - Richardt,Gert, AU - Fajadet,Jean, AU - Hamm,Christian, AU - Schuijer,Monique, AU - Rademaker,Tessa, AU - Wittebols,Kristel, AU - Stoll,Hans Peter, AU - ,, Y1 - 2010/02/18/ PY - 2009/09/02/received PY - 2009/11/11/revised PY - 2009/11/30/accepted PY - 2010/2/23/entrez PY - 2010/2/23/pubmed PY - 2010/4/13/medline SP - 1093 EP - 101 JF - Journal of the American College of Cardiology JO - J. Am. Coll. Cardiol. VL - 55 IS - 11 N2 - OBJECTIVES: The purpose of this study is to compare the 5-year clinical outcomes, safety, and efficacy of sirolimus-eluting stents (SES) in the ARTS II (Arterial Revascularization Therapies Study II) with the outcomes of coronary artery bypass graft (CABG) and bare-metal stenting (BMS) from the ARTS I. BACKGROUND: The long-term outcomes after SES implantation in patients with multivessel disease remains to be established. METHODS: The ARTS I was a randomized trial of 1,205 patients with multivessel disease comparing CABG and BMS. The ARTS II study was a nonrandomized trial with the Cypher sirolimus-eluting stent (Cordis, a Johnson & Johnson Company, Warren, New Jersey), applying the same inclusion and exclusion criteria, end points, and protocol definitions. The ARTS II trial enrolled 607 patients, with an attempt to enroll at least one-third of patients with 3-vessel disease. RESULTS: At 5-year, the death/stroke/myocardial infarction event-free survival rate was 87.1% in ARTS II SES, versus 86.0% (p = 0.1) and 81.9% (p = 0.007) in ARTS I CABG and BMS cohorts, respectively. The 5-year major adverse cardiac and cerebrovascular event (MACCE) rate in ARTS II (27.5%) was significantly higher than ARTS I CABG (21.1%, p = 0.02), and lower than in ARTS I BMS (41.5%, p < 0.001). The cumulative incidence of definite stent thrombosis was 3.8%. Thirty-two percent (56 of 176) of major adverse cardiac events (MACE) at 5 years were related to possible, probable, or definite stent thrombosis. CONCLUSIONS: At 5 years, SES had a safety record comparable to CABG and superior to BMS, and a MACCE rate that was higher than in patients treated with CABG, and lower than in those treated with BMS. Approximately one-third of the events seen with SES could be prevented through the elimination of early, late, and very late stent thrombosis. SN - 1558-3597 UR - https://www.unboundmedicine.com/medline/citation/20171036/5_year_clinical_outcomes_of_the_ARTS_II__Arterial_Revascularization_Therapies_Study_II__of_the_sirolimus_eluting_stent_in_the_treatment_of_patients_with_multivessel_de_novo_coronary_artery_lesions_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0735-1097(09)04145-X DB - PRIME DP - Unbound Medicine ER -