WASHINGTON — The use of a second-generation paclitaxel drug-coated balloon resulted in better mid-term clinical outcomes in patients with paclitaxel drug-eluting stent restenosis when compared with patients with -limus DES restenosis, according to a subanalysis of the Valentines I trial.
“This suggests the efficacy of localized paclitaxel delivery to overcome paclitaxel resistance but not -limus resistance due to different mechanisms of DES failure,” Joshua P. Loh, MD, and fellow investigators wrote in the top 10 abstract presented at Cardiovascular Research Technologies.
In the trial, researchers enrolled 250 patients with in-stent restenosis, of whom 74 (29.6%) had DES restenosis. Patients underwent balloon angioplasty followed by treatment with a drug-coated balloon (DCB; Dior). Researchers compared clinical outcomes of patients with paclitaxel DES restenosis (n= 34; 41 lesions) with patients with -limus (sirolimus, everolimus and zotarolimus) DES restenosis (n=42; 43 lesions).
Overall, baseline characteristics were similar between groups. Results indicated that there was a more diffuse pattern of restenosis in paclitaxel vs. -limus DES restenosis (50% vs. 26.8%; P=.032).
At follow-up (mean, 231± 43 days), MACCE was higher in the -limus DES restenosis group (23.8% vs. 0%; P=.002), which was attributed mainly to the rate of target vessel revascularization (18.6% vs. 0%; P=.006), although target lesion revascularization was also higher in the -limus group (14% vs. 0%; P=.027). Differences in MI and vessel thrombosis did not reach statistical significance.
For more information:
Loh JP. CRT-1: Paclitaxel Drug-Coated Balloon for the Treatment of Drug-Eluting Stent In-stent Restenosis: Subanalysis Results of the Valentines I Trial. Presented at: Cardiovascular Research Technologies; Feb. 23-26, 2013; Washington.
Disclosure: Loh reports no relevant financial disclosures.