Drug-Eluting Stents as Safe as Bare-Metal Stents and More Effective in Large Coronary Arteries

Chicago—Drug-eluting stents (sirolimus-eluting and everolimus-eluting) were found as safe as a baremetal stent in large arteries of patients with coronary heart disease in the BASKET-PROVE (Basel Stent Kosten-Effektivitäts Trial Prospective Evaluation Examination) study. No evidence of late stent thrombosis was seen with both drug-eluting stents. Both drug-eluting stents had superior efficacy compared with the bare-metal stent, and the 2 types of drug-eluting stents had comparable efficacy and safety. “In a contemporary setting, BASKET-PROVE failed to show late safety problems [with drug-eluting stents] in patients with large coronary arteries. Our results imply that drug-eluting stents may be used without evidence of increased late cardiac events and that both the first-generation and second-generation drug-eluting stents can be used similarly in patients with large coronary arteries,” said Christoph Kaiser, MD, of University Hospital Basel in Switzerland. Dr. Kaiser reported results of the study at a late-breaking clinical trials session during the AHA meeting. A drug-eluting stent requires 12 months of dual antiplatelet therapy, with increased bleeding risk and increased cost, whereas a bare-metal stent is given with clopidogrel and aspirin for 30 days. This should be discussed with patients when making treatment decisions about which type of stent to use, Dr. Kaiser told the audience. Two years following stent implantation, the rate of myocardial infarction or death was 2.6% in patients receiving sirolimus-eluting stents, 3.2% in those treated with everolimus-eluting stents, and 4.8% in those who received bare-metal stents. BASKET-PROVE was a prospective, randomized, 11-center, 4-country study that enrolled 2314 consecutive patients from March 2007 until May 2008 regardless of indication for percutaneous coronary intervention (PCI). About three quarters of patients were male with a mean age of 66 years. About 63% had hypertension, 61% to 65% had hypercholesterolemia, about 32% were current smokers, about 12% had prior myocardial infarction, and about 15% had prior PCI or coronary artery bypass graft surgery. About one third had stable angina, one third had unstable angina/non–ST-elevation myocardial infarction, and the remaining one third had ST-elevation myocardial infarction. About 43% had multivessel coronary disease, about 52% were treated in the left anterior descending artery, and the mean number of stented lesions was about 1.5. Stents were used “off label” in about 76% of patients. At 24 months, no significant difference was observed between the 3 groups for cardiac death/myocardial infarction, or for any secondary end point (cardiac death, nonfatal myocardial infarction, and stent thrombosis). Patients in the bare-metal stent arm had higher rates of target-vessel revascularization compared with drug-eluting stents: 3.7% for sirolimus-eluting stents, 3.1% for everolimus-eluting stents, and 8.9% for bare-metal stents. “The take-home message of this trial is that in individuals who require stents in large arteries, I am less concerned now about late effects of drug-eluting stents. There will be a reduction in target-vessel revascularization with drug-eluting stents, [vs bare-metal stents],” said Elliott Antman, MD, Brigham and Women’s Hospital in Boston, Massachusetts. Dr. Antman moderated a press conference where Dr. Kaiser presented these results.