RESOLUTE

April 4, 2011—Medtronic, Inc. (Minneapolis, MN) announced the presentation of results from two major clinical studies demonstrating that the company's Resolute drug-eluting stent (DES) provides a positive and persistent treatment effect for a variety of patients with coronary artery disease. The Resolute DES elutes the drug zotarolimus.

According to Medtronic, 1-year results of RESOLUTE US were presented and published online ahead of print in the Journal of the American College of Cardiology. Two-year results of RESOLUTE All Comers were presented and published in The Lancet (2011;377:1241–1247).

Medtronic noted that these studies are key components of the comprehensive RESOLUTE clinical program, which has enrolled more than 5,000 patients across a combination of randomized controlled and single-arm trials conducted around the world.

The new data from RESOLUTE US complete Medtronic's submission to the US Food and Drug Administration (FDA) for premarket approval (PMA) of the Resolute DES. Currently, the device is an investigational device in the United States. The FDA's decision is expected in the first half of 2012, Medtronic advised.

According to Medtronic, 1-year results of the 1,402-patient RESOLUTE US study include low rates of target lesion failure (TLF, 4.7%), clinically driven target lesion revascularization (2.8%), and definite/probable stent thrombosis (0.1%) through 12 months of follow-up. The company stated that these clinical results were achieved despite 34% of the patients in the study having diabetes, which typically correlates with higher event rates and represents an underserved patient population.

RESOLUTE US is a prospective single-arm study evaluating the safety and efficacy of the Resolute DES in a United States patient population. It is composed of four substudies based on stent diameter and length: 2.25 to 3.5 mm clinical, 2.25 to 3.5 mm angio/intravenous ultrasound, 4-mm angio, and 38-mm clinical. The first three substudies of RESOLUTE US comprise a clinical cohort of 1,242 patients and an angiographic cohort of 160 patients. All three have completed enrollment and have met their prespecified primary endpoints. The 38-mm substudy is still enrolling patients.

Medtronic stated that the design of RESOLUTE US, with its four substudies, will enable the FDA to evaluate the safety and efficacy of the entire size matrix of the Resolute DES, from diameters of 2.25 to 4 mm and lengths of 8 to 38 mm. Total enrollment in RESOLUTE US will exceed 1,500 patients. The RESOLUTE clinical program will enroll a total of more than 5,000 patients worldwide, the company stated.

Two-year results of the 2,292-patient RESOLUTE All Comers study indicate that the Resolute DES continues to match the Xience V DES (Abbott Vascular, Santa Clara, CA) at 2 years of follow-up.

On the primary endpoint of TLF, originally assessed at 1-year, the rates at 2 years remain statistically equivalent for the two devices: 11.2% TLF for Resolute, 10.7% TLF for Xience (P = .736). In addition, the rates of definite/probable very late stent thrombosis between 1 and 2 years were identical and low for each stent at 0.3%, with no statistical difference between the two stents in cumulative stent thrombosis through 2 years.

The company stated that with very few exclusion criteria, the study accepted virtually “all comers,” making the results highly representative of routine clinical practice. Nearly 70% of the patients in RESOLUTE All Comers were considered complex. By meeting the study's primary noninferiority endpoint of TLF at 1 year, the Resolute DES was shown to match the Xience V DES on an important clinical outcome.