According to new clinical data presented at ACC.12 – the 61st Annual Scientific Session & Expo of the American College of Cardiology (ACC) – the Resolute drug-eluting stent (DES) from Medtronic maintains a powerful and persistent treatment effect for a wide variety of patients with coronary artery disease, including those with diabetes mellitus, through two years of follow-up.
The latest data on this novel heart stent, which received approval from the FDA in February 2012 with a first-of-its-kind indication for the treatment of coronary artery disease in patients with diabetes, come from the RESOLUTE US clinical study and two pooled analyses of the entire Resolute clinical programme – one on safety measures for all patients (RESOLUTE Pooled Safety), the other for all patients with diabetes (RESOLUTE Pooled Diabetes).
Highlights of the two-year data include low rates of target lesion failure, target lesion revascularisation and definite/probable stent thrombosis. Laura Mauri, Harvard Clinical Research Institute and Brigham and Women’s Hospital in Boston, presented the two-year results from RESOLUTE US; Jorge Belardi, Cardiovascular Institute of Buenos Aires, Argentina, the two-year update for RESOLUTE Pooled Safety; and Alan Yeung, of the Stanford University School of Medicine in Palo Alto, the two-year update for RESOLUTE Pooled Diabetes.
“What is particularly striking about the two-year outcomes from the Resolute clinical programme is the device’s consistently strong performance and low event rates in such a wide variety and high number of patients,” explained Mauri, a national co-principal investigator of RESOLUTE US like Yeung and Martin Leon, of the Cardiovascular Research Foundation and NewYork-Presbyterian Hospital/Columbia University Medical Center in New York. “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 two years of patient follow-up continue to impress.”
RESOLUTE US enrolled 1,402 patients across 128 US-based clinical trial sites. The two-year results among 1,359 patients include low rates of target lesion failure (7.3%), clinically-driven target lesion revascularisation (4.3%), and definite/probable stent thrombosis (0.2%).
These powerful clinical results were achieved despite 34% of the patients having diabetes. Among the 474 patients with diabetes in RESOLUTE US, the Resolute DES showed consistently low two-year rates of target lesion failure (8.9%) and clinically-driven target lesion revascularisation (5.7%) and no definite/probable stent thrombosis.
The global RESOLUTE clinical programme consisted of a large randomised controlled trial and a series of confirmatory single-arm studies involving nearly 250 sites in 32 countries. In total, the programme enrolled 5,130 patients who received a Resolute DES; about one third (n=1,535) of these patients had diabetes, a proportion that mirrors the US patient mix for percutaneous coronary intervention.
For the pooled analyses related to safety and diabetes presented at ACC.12, two-year data on more than 5,000 patients from the RESOLUTE programme 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 stent thrombosis.
The two-year update to RESOLUTE Pooled Safety showed very low rates of clinically-driven target lesion revascularisation (4.7%) and definite/probable stent thrombosis (0.9%), despite 46% of the patients in the RESOLUTE programme being considered complex.
The two-year update to RESOLUTE Pooled Diabetes, which presents clinical outcomes in patients with and without diabetes who received a Resolute DES, shows consistently low event rates out to two years despite the higher-risk nature of the diabetes patient population. For example, the update presents clinically-driven target lesion revascularisation and definite/probable stent thrombosis rates for the standard-risk diabetes patients, a cohort pre-specified for analysis by the FDA in order to obtain the device’s diabetes indication.