Lessons from Studies with Bare Metal Stents

Randomized Studies

Five randomized trials have compared stenting with CABG for multivessel disease: ARTS,35 36 SoS,37 ERACI-2,38,39 MASS-2,40 and AWESOME.41

ARTS was the largest trial comparing PCI with CABG for treatment of multivessel disease.35,36 ARTS included a total of 1205 patients with at least two de novo lesions that were located in different vessels and territories, not including the left main coronary artery. Acute MI, but not unstable angina, was an exclusion criterion. Patients could be included if the cardiac surgeon and interventional cardiologist agreed that the same extent of revascularization could be achieved by either technique. Six hundred patients were randomly assigned to stenting and 605 to bypass surgery; 67% of the patients had a double-vessel disease, and 32% had triple-vessel disease. At 1 year, there was no significant difference between the stent group and the CABG group in terms of the incidence of death (2.5% vs. 2.8%; relative risk [RR] = 0.89; 95% CI: 0.45 to 1.77), cerebrovascular accident (1.5% vs. 2.0%; RR = 0.78; 95% CI: 0.34 to 1.76), or MI (5.3% vs. 4.0%; RR = 1.29; 95% CI: 0.80 to 2.06). The 5-year follow-up of the ARTS trial has now been published.35 At 5 years, the incidence of death was 8% in the stent group versus 7.6% in the CABG group (RR = 1.05; 95% CI: 0.71 to 1.55; P = .83). Likewise, there was no significant difference in cerebrovascular accident (3.8% vs. 3.5%; RR = 1.10; 95% CI: 0.62 to 1.97; P = .76), Q-wave MI (6.7% vs. 5.6%; RR = 1.19; 95% CI: 0.76 to 1.85; P = .47), non-Q-wave MI (1.8% vs. 0.8%; RR = 2.22; 95% CI: 0.78 to 6.35; P = .14), or the composite thereof (18.2% vs. 14.9%; RR = 1.22; 95% CI: 0.95 to 1.58; P = .14) (Fig. 6-5). Consistent with the findings at 1 year, however, there was a significant difference in the incidence of repeat revascularization, and this had widened over time (30.3% vs. 8.8%; RR = 3.46; 95% CI: 2.61 to 4.60; P < .001). In the stent group, 10.5% of the revascularizations involved CABG, compared with 1.2% in the CABG group. In summary, the 5-year outcome with respect to the serious end points of death, MI, and cerebrovascular accident was similar for both the nonsurgical approach and the surgical approach. With the primarily catheter-based approach, there was a 90% chance of avoiding CABG during the subsequent 5 years, with similar outcome in relation to the end points, but at the

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