Drug-Eluting Stents versus Bare-Metal Stents in Patients with Coronary Artery Disease

A new randomized trial studying the effects of stents in large coronary arteries found that there were no significant differences in rates of death or myocardial infarction for patients who received sirolimus-eluting, everolimus-eluting, or bare-metal stents. The findings from the study were recently published online in the New England Journal of Medicine [2010;10.1056/NEJMoa/1009406]. Researchers wanted to investigate any differences between drug-eluting stents and bare-metal stents in patients with coronary artery disease in large arteries because previous data have suggested that patients requiring stents in large arteries may be at an increased risk for late cardiac events after percutaneous intervention if they receive a first-generation drug-eluting stent as opposed to a bare-metal stent. However, research into this area has been limited, and most studies comparing drug-eluting and bare-metal stents have been conducted on small-vessel stenting. In BASKET-PROVE (BASKET-Prospective Validation Examination), a randomized, multicenter study, researchers examined the efficacy of first-generation sirolimus-eluting stents, bare-metal stents, and second-generation everolimus-eluting stents over a 2-year period in patients requiring stents that were ≥3.0 mm in diameter. Eligible patients were selected from participating centers in Switzerland, Denmark, Austria, and Italy. To be included, patients needed to have chronic or acute coronary disease and undergo angioplasty with stenting in a large artery. Participants in the study (n=2314) were randomly assigned to 1 of the 3 stent options. All those in the study were also prescribed aspirin at a daily dose of 75 to 100 mg indefinitely and clopidogrel at a daily dose of 75 mg for 1 year after initial loading doses. Researchers sent follow-up questionnaires at the 12- and 24-month marks of the study. The primary end point of the BASKET-PROVE study was death from cardiac causes or nonfatal myocardial infarction at 2 years. Researchers also identified secondary study outcomes, including the efficacy of target-vessel revascularization and late death from cardiac causes or nonfatal myocardial infarction occurring between 7 and 24 months after the intervention. When evaluating the primary end point, researchers found that at the 2-year mark there were no significant differences between patients receiving either drug-eluting or bare-metal stents. Based on the findings, the primary end point was seen in 2.6% of patients receiving sirolimus-eluting stents, 3.2% of patients receiving everolimus-eluting stents, and 4.8% of those patients receiving bare-metal stents. The study’s authors also reported that there was no significant difference in the rates of stent thrombosis among the 3 groups. However, researchers did find that there was a significant difference in the rates of target-vessel revascularization. Those patients who received either sirolimus-eluting or everolimus-eluting stents had a significantly reduced rate (3.7% and 3.1%, respectively) of target-vessel revascularization when compared with those who had bare-metal stents (8.9%). There was no significant difference, however, between either type of drug-eluting stent. In conclusion, the researchers noted that there was no significant difference in terms of late death from cardiac causes or nonfatal myocardial infarction at the 2-year point in the study for any group. They also did not find any significant differences in the event rates between first-generation drug-eluting stents and the second-generation drug-eluting stents when used in large arteries. They acknowledged, however, that the rate of cardiac events in the study was substantially lower than anticipated and that the trial was underpowered to detect small differences in events. This low incidence rate could be due to longer experience using drug-eluting stents, differences in patient selection, improvements in perioperative management, the recommendation of dual-antiplatelet therapy, or because no paclitaxel-eluting stents were used in the trial.