The zotarolimus-eluting coronary stent, approved last month, can be used for the treatment of patients with symptomatic heart disease, including those with diabetes, the manufacturer announced.
The approval of the stent, which will be marketed by Medtronic as the Resolute Integrity zotarolimus-eluting coronary stent, is indicated for "improving coronary luminal diameters in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions of length less than or equal to 27 mm in native coronary arteries with reference vessel diameters of 2.25 mm to 4.20 mm," according to the company website.
About one-third (1,535) of the patients who have received the Resolute Integrity drug-eluting stent (DES) in clinical trials had diabetes, according to aMedtronic press release announcing the approval. Among these trials was the RESOLUTE US study, a multicenter study of 1,402 patients (34% had diabetes) who received the Resolute Integrity DES. At 1 year, the target lesion failure rate was 4.7%, the clinically driven target lesion revascularization rate was 2.8%, and the definite/probable stent thrombosis rate was 0.1%, the release said.
Another study, the Resolute All-Comers trial, a noninferiority study of 2,292 patients with chronic, stable coronary artery disease or acute coronary syndromes, found that the Resolute Integrity DES was noninferior to the everolimus-eluting stent (Abbott Xience V). The primary end point, target lesion failure (death from cardiac causes, any MI, or clinically indicated target lesion vascularization) within 12 months was about 8% in both groups. The study had minimal exclusion criteria, about 23% of those enrolled had diabetes, and 66% had at least one off-label criterion for stent placement (N. Engl. J. Med 2010;363:136-46).
The Medtronic press release refers to a prespecified analysis of patients with diabetes who received a Resolute DES in RESOLUTE studies, which found that at 1-year follow-up, the rates of target lesion failure (6.6%), target lesion revascularization (3.4%), and definite/probable stent thrombosis (0.3%) were low.
In an interview, Dr. Bruce Bode, an endocrinologist in group practice in Atlanta, said that the approval of the Resolute Integrity stent marks the first time patients with diabetes have been included in the approval of a coronary stent – and is unique because there is now an approved coronary stent that had a similar failure rate in patients with and those without diabetes in studies.
Because of the results of the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial of patients with type 2 diabetes and heart disease, published in 2009, coronary artery bypass grafting has been considered preferable in patients with diabetes, because of better outcomes among those who underwent surgery in that study, he noted (N. Engl. J. Med. 2009;360:2503-15).
Dr. Bode is a consultant to Medtronic. He is affiliated with Piedmont Hospital, a RESOLUTE study site, but he was not an investigator in those studies.
The Resolute All-Comers and RESOLUTE US studies are sponsored by Medtronic.