At EuroPCR 2013 in Paris, France (21–24 May), three separate analyses have addressed one of the most common clinical challenges in the treatment of complex coronary artery disease and showed that the the Resolute drug-eluting stent from Medtronic has performed strongly in coronary bifurcation lesions over the long term.
According to a press release, investigators pooled the results of nearly 3500 “real-world” patients who received a Resolute stent as participants in two studies— RESOLUTE All-Comers and RESOLUTE International. Ran Kornowski of the Rabin Medical Center andTel Aviv University in Israel presented the analysis at EuroPCR.
From a total of 3489 patients, 703 patients (20%) presented with at least one bifurcation lesion. According to the results, at three years of follow-up, the Resolute drug-eluting stent showed excellent clinical results, with no statistical differences between patients with and without bifurcation lesions. Rates of clinically-driven target lesion revascularisation (ie. repeat procedure), for example, were low and comparable for both groups: 6.9% vs. 5.4% (p=0.104), respectively.
Approved by the US Food and Drug Administration (FDA) in 2012, the Resolute Integrity stent is not indicated for the treatment of bifurcation lesions in the United States. The CE mark labelling, however, has included an indication for bifurcation lesions.
Confirmatory study
In a separate, independent “real-world” multi-centre registry that included 9 sites in Italy, 527 patients with bifurcation lesions were treated with the Resolute stent using mainly the “provisional-T-stenting technique.”
Recently presented by Francesco Burzotta from the Catholic University of the Sacred Heart in Rome, Italy, 2-year follow-up results from this confirmatory study also showed low target lesion revascularisation rates for these patients at 5.1%. Of note, the long-term clinical outcome was similarly good across patients with different anatomical complexity of treated bifurcation lesions.
“Bifurcations remain a common challenge in today’s practice due to anatomical variability and lesion complexity,” said Burzotta. “Nevertheless, the ‘provisional-T-stenting technique’ may be facilitated by specific technical characteristics of some contemporary drug-eluting stents. Results from multiple analyses demonstrate that use of the Resolute stent to treat bifurcated lesions may be associated with promising long-term clinical results in a wide variety cases.”
One potential explanation that supports the strong clinical data on the Resolute stent in bifurcations is the device’s conformability and wall apposition even after side branch treatment, which represents a critical success factor in treating these complex and highly variable lesion, according to a company release.
In another EuroPCR presentation, Peter Mortier, from Ghent University in Belgium shared the results of an independent analysis comparing different drug-eluting stent platforms in bifurcation lesions using computer models. Mortier’s analysis found that the Resolute Integrity stent showed significantly less stent-strut malapposition (ie. lack of contact between stent struts and artery wall) compared to the Promus Element and Xience Prime stent platforms from Boston Scientific and Abbott, respectively.
