In May, VDM published an interview with Ronald Caputo, MD, a principal investigator for the RESOLUTE US study, about the February 2013 FDA approval of longer lengths of Medtronic’s Resolute Integrity drug-eluting stent (DES). The 34-mm and 38-mm lengths of the stent in diameters of 3.0 mm, 3.5 mm, and 4.0 mm were approved with an indication for patients with diabetes. These longer lengths enable the treatment of long coronary lesions. Approval was based on data from the global RESOLUTE clinical program, specifically an analysis of 1-year outcomes in patients with long coronary lesions who participated in the RESOLUTE US and RESOLUTE Asia studies.
Dr. Caputo noted that the Resolute Integrity DES is the first and only DES with an indication to treat patients with diabetes. He added that there are indications that the device does not yet have in the United States that could be helpful to patient outcomes.
“The limitations of this device remain similar to the broad limitations for all currently used DES,” said Dr. Caputo. “In my opinion, the biggest limitation is the continued requirement for extended dual antiplatelet therapy, although that appears to be changing in Europe.”
And news coming from EuroPCR reminds the vascular therapy community of the stent’s broader indications in Europe. In the United States, the Resolute Integrity stent does not have an indication for the treatment of bifurcation lesions, but in Europe it does. Investigators have pooled results of nearly 3,500 patients who received a Resolute stent as part of the RESOLUTE All-Comers and RESOLUTE International studies. Dr. Ran Kornowski of the Rabin Medical Center and Tel Aviv University in Israel will present the analysis at EuroPCR tomorrow, May 23, 2013. According to a press release from Medtronic, 20% of patients presented with at least on bifurcation lesion, and at 3 years follow-up, the Resolute DES showed no statistical differences between patients with and without bifurcation lesions. Results include rates of clinically-driven target lesion revascularization (i.e. repeat procedure), which were low and comparable for both groups: 6.9% vs 5.4% (P=.104), respectively.
More about Resolute Integrity.