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

Patrick W. Serruys, Yoshinobu Onuma, Scot Garg, Pascal Vranckx, Bernard De Bruyne, Marie Claude Morice, Antonio Colombo, Carlos Macaya, Gert Richardt, Jean Fajadet, Christian Hamm, Monique Schuijer, Tessa Rademaker, Kristel Wittebols, Hans Peter Stoll

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)1093-1101
Number of pages9
JournalJournal of the American College of Cardiology
Volume55
Issue number11
DOIs
Publication statusPublished - Mar 16 2010

Fingerprint

Sirolimus
Stents
Coronary Vessels
Coronary Artery Bypass
Metals
Transplants
Thrombosis
Therapeutics
Safety
Disease-Free Survival
Survival Rate
Stroke
Myocardial Infarction
Incidence

Keywords

  • long-term outcomes
  • multivessel disease
  • sirolimus-eluting stent

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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. / Serruys, Patrick W.; Onuma, Yoshinobu; Garg, Scot; Vranckx, Pascal; De Bruyne, Bernard; Morice, Marie Claude; Colombo, Antonio; Macaya, Carlos; Richardt, Gert; Fajadet, Jean; Hamm, Christian; Schuijer, Monique; Rademaker, Tessa; Wittebols, Kristel; Stoll, Hans Peter.

In: Journal of the American College of Cardiology, Vol. 55, No. 11, 16.03.2010, p. 1093-1101.

Research output: Contribution to journalArticle

Serruys, PW, Onuma, Y, Garg, S, Vranckx, P, De Bruyne, B, Morice, MC, Colombo, A, Macaya, C, Richardt, G, Fajadet, J, Hamm, C, Schuijer, M, Rademaker, T, Wittebols, K & Stoll, HP 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, vol. 55, no. 11, pp. 1093-1101. https://doi.org/10.1016/j.jacc.2009.11.049
Serruys, Patrick W. ; Onuma, Yoshinobu ; Garg, Scot ; Vranckx, Pascal ; De Bruyne, Bernard ; Morice, Marie Claude ; Colombo, Antonio ; Macaya, Carlos ; Richardt, Gert ; Fajadet, Jean ; Hamm, Christian ; Schuijer, Monique ; Rademaker, Tessa ; Wittebols, Kristel ; Stoll, Hans Peter. / 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. In: Journal of the American College of Cardiology. 2010 ; Vol. 55, No. 11. pp. 1093-1101.
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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.",
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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

PY - 2010/3/16

Y1 - 2010/3/16

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.

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KW - long-term outcomes

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