A three-year follow-up subset analysis presented as a late-breaking clinical trial at EuroPCR 2007 showed that the Cypher Sirolimus-eluting Coronary Stent had results comparable to coronary artery bypass grafting (CABG or bypass surgery) and better outcomes than bare metal stents (BMS) in diabetic patients with blockages in two or more coronary arteries.
The Cypher Stent results in the diabetic population of the Arts II Study showed no significant difference in major adverse cardiac and cerebrovascular events (MACCE) compared to the CABG arm of the ARTS I Study. In addition, the analysis showed that the Cypher Stent performed significantly better than the BMS arm of the Arts I study, as 47.3 per cent of the patients who received a BMS experienced a MACCE event after three years. These findings are significant as MACCE - comprised of death, stroke, myocardial infarction (heart attack) and the need for repeat revascularization (re-treatment) of the blocked artery - was the primary endpoint of the Arts II study.
Sponsored by Cordis Corporation, the Arts II study was designed to determine whether the clinical and cost-effectiveness outcomes with the Cypher Stent in 607 patients with multivessel coronary disease were non-inferior to the results obtained in the Arts I study, which was conducted in 1997 and included 605 patients treated with bypass surgery and 600 patients treated with a BMS. In the diabetic subgroup analysis, investigators compared the findings for the 159 diabetic patients in the Arts II study to those from the Arts I study, which included 96 diabetic patients treated with bypass surgery and 112 treated with a BMS. The risk profile of the patients in the Arts II study was significantly higher compared to the risk profile of the patients in the Arts I study.
"Patients with multivessel disease and diabetes represent some of the most complex cases to treat," said Keith D Dawkins, M.D, from Southampton University Hospital, who presented the analysis at EuroPCR 2007. "These findings suggest that the Cypher Stent may be a viable, less invasive treatment alternative for these very challenging cases."
After three years of follow-up, the overall patient population treated with the Cypher Stent in the Arts II study also continued to show similar rates of freedom from MACCE than the patients treated with bypass surgery in the Arts I study. Specifically, 80.6 per cent of the overall patient population who received the Cypher Stent remained free of MACCE, compared to 83.8 per cent of the patients who underwent bypass surgery.
Additionally, the Cypher Stent performed considerably better than the Arts I BMS arm in the same endpoint, as 66.0 per cent of the patients who received a BMS did not experience a MACCE event after three years. The difference between the Cypher Stent arm and the BMS arm reached statistical significance.
"Close to 30 years ago, balloon angioplasty transformed the treatment paradigm for patients with coronary artery disease," said David E. Kandzari, M.D,chief medical officer, Cordis cardiology division of Cordis Corporation. "This three-year analysis suggests that balloon angioplasty combined with the Cypher Stent may be a viable alternative to bypass surgery for non-diabetic and diabetic patients with multivessel coronary disease."