August 18, 2026Journal of the American College of Cardiology
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
Key result
Sirolimus-eluting stents show higher 5-year MACCE than CABG at ~28% vs 21%, but beat BMS.
- P=0.02
- n=1,812
Why the study?
Does sirolimus-eluting stent implantation improve 5-year clinical outcomes compared to CABG and bare-metal stenting in patients with multivessel coronary artery disease?
Population
1,812 patients with multivessel de novo coronary artery lesions
Comparison
Sirolimus-eluting stent (SES) implantation vs Coronary artery bypass graft and bare-metal…
Design
Cohort
Follow-up
5 years
Authors
Discussion
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Implication
In patients with multivessel coronary disease, sirolimus-eluting stents demonstrated a 5-year MACCE rate that was higher than CABG but lower than bare-metal stenting, with a comparable safety record to CABG.
Key Points
- To evaluate the 5-year safety, efficacy, and clinical outcomes of sirolimus-eluting stents in patients with multivessel coronary artery disease compared with historical coronary artery bypass graft and bare-metal stent cohorts.
- Conducted a nonrandomized trial (ARTS II) enrolling 607 patients with multivessel disease treated with Cypher sirolimus-eluting stents, requiring at least one-third to have 3-vessel disease.
- Compared 5-year outcomes using identical protocols and endpoints against the randomized ARTS I trial cohorts comprising 1,205 patients receiving coronary artery bypass graft (CABG) or bare-metal stenting (BMS).
- At 5 years, event-free survival for death, stroke, or myocardial infarction was 87.1% in the sirolimus-eluting stent cohort, compared to 86.0% for CABG (p = 0.1) and 81.9% for BMS (p = 0.007).
- The 5-year major adverse cardiac and cerebrovascular event rate was 27.5% with sirolimus-eluting stents, significantly higher than CABG (21.1%, p = 0.02) and significantly lower than BMS (41.5%, p < 0.001).
- Definite stent thrombosis had a 5-year cumulative incidence of 3.8%, accounting for 32% (56 of 176) of all major adverse cardiac events observed in the sirolimus-eluting stent group.
Study Design
Type
Cohort (n=1,812)
Structured PICO
Does sirolimus-eluting stent implantation improve 5-year clinical outcomes compared to CABG and bare-metal stenting in patients with multivessel coronary artery disease?
P
Population
1,812 patients with multivessel coronary artery disease (607 receiving sirolimus-eluting stents, compared to 1,205 historical controls receiving CABG or bare-metal stents), followed for 5 years.
E
Exposure
Sirolimus-eluting stent (SES) implantation
C
Comparator
Coronary artery bypass graft (CABG) and bare-metal stenting (BMS) from the historical ARTS I trial
O
Outcome
5-year major adverse cardiac and cerebrovascular event (MACCE) rate and death/stroke/myocardial infarction event-free survivalcomposite
Main Result
Absolute Event Rate: 27.5% vs 21.1%
p-value: p=0.02
In patients with multivessel coronary disease, sirolimus-eluting stents demonstrated a 5-year MACCE rate that was higher than CABG but lower than bare-metal stenting, with a comparable safety record to CABG.
Cite This Study
Serruys et al. (2010) conducted a cohort in Multivessel De Novo Coronary Artery Lesions (n=1,812). Sirolimus-eluting stents (SES) vs. Coronary artery bypass graft (CABG) and bare-metal stenting (BMS) was evaluated on Major adverse cardiac and cerebrovascular events (MACCE) (p=0.02). Sirolimus-eluting stents yielded a 5-year MACCE rate of 27.5%, which was higher than CABG (21.1%, p=0.02) but lower than bare-metal stenting (41.5%, p<0.001).