Medtronic Announces Data from RESOLUTE Clinical Program

September 22, 2010—Medtronic, Inc. (Minneapolis, MN) announced that the latest findings from the company's RESOLUTE clinical program, which is evaluating its Endeavor Resolute zotarolimus-eluting coronary stent system, were released at the Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC. The data included 1-year results for RESOLUTE International, two subsets from RESOLUTE All Comers, and 4-year results for the RESOLUTE feasibility study.

RESOLUTE International is a prospective, multicenter single-arm study with a composite primary endpoint of cardiac death and target vessel myocardial infarction at 1 year postimplant. Secondary endpoints include ischemia-driven target lesion revascularization (TLR) and Academic Research Consortium–defined definite or probable stent thrombosis.

RESOLUTE International enrolled 2,349 patients at 88 sites from 17 countries in Europe, Asia, Africa, and Latin America. This all-comers study population allowed for patient types and lesion characteristics that are typically underrepresented in clinical trials. To promote diversity in the study population, no single site was allowed to enroll more than 60 patients.

The primary endpoint of the rate of cardiac death or target vessel myocardial infarction was 4.1% at 1-year follow-up. On the secondary endpoints, clinically indicated TLR occurred in 3.4% of patients and a 0.9% rate of stent thrombosis. The company stated that these event rates are low compared with other similar clinical trial, especially for an all-comers population with a relatively high number of patients with complex disease. These rates are also consistent with the finding in the RESOLUTE All Comers pivotal trial, which Patrick W. Serruys, MD, et al published in the New England Journal of Medicine (2010;363:136–146).

Also at the conference, Medtronic released the results from two patient subsets from RESOLUTE All Comers: acute myocardial infarction and multivessel intervention. This randomized controlled trial compared the Resolute DES and the Xience V DES (Abbott Vascular, Santa Clara, CA). The study enrolled an all-comers population of 2,292 patients at 17 sites in Europe. By meeting the composite primary endpoint of target lesion failure (TLF) at 1 year, the Resolute DES was shown to match the Xience V in safety and efficacy.

In the acute myocardial infarction subset, defined by ST-segment elevation myocardial infarction within 12 hours of the procedure, there was a statistically equivalent but numerically lower rate of TLF in the Resolute arm versus the Xience arm (3.3% vs 7.1%; P = .17). In the multivessel intervention subset, there was also a statistically equivalent but numerically lower rate of TLF in the Resolute arm versus the Xience arm (9.6% vs 11.3%; P = .55). Results for these two subsets were similar in RESOLUTE International.

Finally, 4-year data from the original first-in-man RESOLUTE feasibility study showed stable clinical efficacy, with a 2.3% TLR rate and no stent thrombosis.

Medtronic advised that the Resolute DES is not yet commercially available in the United States, Canada, or Japan. In the United States, the device is being evaluated in the 1,400-patient RESOLUTE US clinical study, which completed enrollment in December 2009. The device has been available in international markets since receiving CE Mark approval in 2007.