Two-Year Data Presented for Medtronic's Resolute DES

March 24, 2012—Medtronic, Inc. (Minneapolis, MN) announced that new clinical data for the company's Resolute drug-eluting stent (DES) were presented at the American College of Cardiology's 61st annual scientific session. The company stated that at 2-year follow-up, the device demonstrated maintained efficacy for a wide variety of patients with coronary artery disease, including those with diabetes mellitus.

The new data are from the RESOLUTE US clinical study and two pooled analyses of the entire Resolute clinical program—one on safety measures for all patients (RESOLUTE Pooled Safety), and the other for all patients with diabetes (RESOLUTE Pooled Diabetes). The Resolute DES received approval from the US Food and Drug Administration (FDA) last month with an indication for the treatment of coronary artery disease in patients with diabetes mellitus, advised the company.

According to Medtronic, highlights of the 2-year data include low rates of target lesion failure (TLF), target lesion revascularization (TLR), and definite/probable stent thrombosis (def/prob ST).

Laura Mauri, MD, served as a National Co-Principal Investigator of RESOLUTE US along with Alan Yeung, MD, and Martin Leon, MD. Dr. Mauri presented the 2-year results from RESOLUTE US. Jorge Belardi, MD, presented the 2-year update for RESOLUTE Pooled Safety. Dr. Yeung presented the 2-year update for RESOLUTE Pooled Diabetes.

“What's particularly striking about the 2-year outcomes from the Resolute clinical program is the device's consistently strong performance and low event rates in such a wide variety and high number of patients,” commented Dr. Laurie. “The Resolute DES yields excellent outcomes in patients with and without diabetes mellitus, and that's a factor of significant clinical relevance given the large number of diabetes patients that undergo percutaneous coronary intervention each year. Its safety and efficacy data at 2 years of patient follow-up continue to impress.”

RESOLUTE US enrolled 1,402 patients across 128 United States-based clinical trial sites. The 2-year results among 1,359 patients included low rates of TLF (7.3%), clinically driven TLR (4.3%), and def/prob ST (0.2%).

Medtronic noted that these clinical results were achieved with 34% of the patients having diabetes mellitus, which typically drives higher event rates. Among the 474 patients with diabetes in RESOLUTE US, the Resolute DES showed consistently low 2-year rates of TLF (8.9%) and clinically driven TLR (5.7%), and no def/prob ST (0.0%).

Medtronic stated that the global RESOLUTE clinical program consisted of a large randomized controlled trial and a series of confirmatory single-arm studies involving nearly 250 sites in 32 countries. In total, the program enrolled 5,130 patients who received a Resolute DES; approximately one third (n = 1,535) of these patients had diabetes, a proportion that mirrors the patient mix in the United States for percutaneous coronary intervention.

For the pooled analyses related to safety and diabetes, 2-year data on more than 5,000 patients from the RESOLUTE program who received a Resolute DES were included. Individual trials, while powered for many composite endpoints, are often underpowered to show real differences for low frequency but clinically important adverse events such as ST, noted Medtronic.

The 2-year update to RESOLUTE Pooled Safety showed very low rates of clinically driven TLR (4.7%) and def/prob ST (0.9%), even though 46% of the patients in the RESOLUTE program were considered complex.

The 2-year update to RESOLUTE Pooled Diabetes, which presents clinical outcomes in patients with and without diabetes who received a Resolute DES, showed consistently low event rates out to 2 years despite the higher-risk nature of the diabetes patient population. For example, the update presents clinically driven TLR and def/prob ST rates for the standard-risk diabetes patients, a cohort prespecified for analysis by the FDA in order to obtain the device's diabetes indication.

In the RESOLUTE pooled standard-risk cohort (N = 2,781), patients with diabetes (n = 878) showed a 4.8% rate of clinically driven TLR and a 0.3% rate of def/prob ST. Patients with diabetes (n = 1,903) show a 3.4% rate of clinically driven TLR and a 0.4% rate of def/prob ST, Medtronic reported.