Studies with Bare Metal Stents

Of the studies comparing bare metal stents with bypass surgery, ARTS, AWESOME, and ERACI-2 reported subgroup analyses for diabetics (Fig. 6-9).

Of the 1205 patients included in ARTS, 112 diabetics were randomly assigned to stent implantation and 69 to bypass surgery.69 The incidence of major adverse events during hospital stay was similar in both groups except for stroke, which was significantly more frequent in the surgical patients than in the interventional patients (0% vs. 4.2%; P = .04). During 1-year follow-up, this trend continued to prevail (1.8% vs. 6.3%; P = .10). Mortality during 1-year follow-up, however, was higher in the stent group (6.3%) than in the surgical group (3.1%) although statistical significance was missed (P = .294). The incidence of MI was also higher by trend in the PCI group than in the CABG group (6.3% vs. 3.1%; P = .294). As in the entire ARTS cohort, the need for repeat intervention (mostly catheter intervention) was significantly higher in the PCI group than in the CABG group. Overall event-free survival of diabetics during 1-year follow-up after stent implantation was significantly lower than after surgery (63.4% vs. 84.4%; P < .05). Notably, in the PCI group, there was a significant difference in event-free survival between diabetics and nondiabetics (63.4% vs. 76.2%) which was not present in the surgical group. In the aggregate, ARTS suggested CABG as the preferred treatment for multivessel disease in diabetics. Nevertheless, the number of diabetics included in ARTS was too low to allow definite conclusions.

ARTS included a patient cohort with low to intermediate risk for CABG. The AWESOME study addressed patients with a high risk for CABG (see earlier discussion). The number of diabetics included in AWESOME was 144 in the randomized study, 89 in the patient choice registry, and 525 in the physician choice registry.70 In the randomized study, the 4-year mortality rate for diabetics after PCI was not significantly different than after CABG, with the point estimates favoring the former (19% vs. 28%; P = .27). Similar results were obtained in the patient choice registry (11% vs. 15%; P = .73) and in the physician choice registry (29% vs. 27%; P = .77). The results of AWESOME, therefore, suggest that, in diabetic patients with multivessel disease and refractory angina who have an increased risk for CABG, coronary stent implantation is a safe alternative to surgical revascularization.

The combined analysis of the 90 diabetics in ERACI (without stent) and ERACI-2 (with stent) demonstrated no benefit of CABG during 1-year follow-up, compared with PCI. The composite end point of death and MI was somewhat higher in the surgical group than in the stent group (6.5% vs. 4.5% and 13% vs. 4.5%, respectively). Because of the low number of patients included in ERACI and the short follow-up period, these data should be interpreted cautiously.

The only large registry that addressed stent-supported PCI versus bypass surgery in patients with diabetes, APPROACH, did not reveal any benefit of CABG compared with PCI.71

Odds ratio

PTCA ERACI I and Stent and II



PCI better

2.0 2.5 CABG better



Figure 6-9. Odds ratios for mortality after stenting versus coronary artery bypass grafting (CABG) in the diabetic cohorts of ERACI-1, ERACI-2, ARTS, and AWESOME. The horizontal lines represent 95% confidence intervals. PCI, percutaneous coronary intervention; PTCA, percutaneous transluminal coronary angioplasty.

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