Meeting News CoveragePerspective

Paclitaxel DCB may be more effective at treating paclitaxel DES restenosis

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.

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.

    Perspective
    Ajay Kirtane

    Ajay Kirtane

    It is clear that the use of a DCB, particularly if we had it in the United States to treat in-stent restenosis, would be advantageous because you avoid having to put in another stent. Data from ISAR-DESIRE 3 presented at TCT this past year showed that treating in-stent restenosis with a paclitaxel-eluting balloon was similar to treating it with a paclitaxel-eluting stent. What’s interesting about this present analysis is that it seemed that the paclitaxel-eluting DCB was more efficacious in patients initially treated with a paclitaxel-eluting stent rather than a -limus eluting one. Intuitively, one might surmise that a paclitaxel-eluting DCB might have the best efficacy in the more focal restenoses of a -limus eluting stent rather than for a restenosis of a prior paclitaxel-eluting stent. But in this case the opposite occurred.

    Looking at the overall numbers of this preliminary study, the main issue is that if there had been one additional TLR event in the DCB group the difference might no longer be clinically significant. So this has to be considered hypothesis-generating, and we need larger studies to sort that out. However, it did look like DCB performed well in patients with more diffuse restenosis than the paclitaxel-eluting stent group, which is encouraging.

    • Ajay Kirtane, MD, SM
    • Spokesman for SCAI Columbia University/New York-Presbyterian Hospital

    Disclosures: Kirtane reports no relevant financial disclosures.

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