Less Mortality with Paclitaxel-Coated Balloon vs. Stent in DES Restenosis

A paclitaxel-coated balloon (PCB) was associated with lower all-cause mortality at 2 years compared with a paclitaxel-eluting stent (PES) for treatment of drug-eluting stent (DES) restenosis, according to findings from the PEPCAD China ISR trial.

In the intention-to-treat population, those assigned to the PCB (SeQuent Please, B. Braun Melsungen AG; n=107) had a 2-year all-cause mortality rate of 0 vs. 4.9% (P=.03) for the group assigned PES (Taxus Liberté, Boston Scientific; n=102). Yelin Zhao, MSc, from Fu Wai Hospital, National Center for Cardiovascular Devices, Beijing, China, and colleagues conducted the randomized, single blind, prospective, multicenter trial.

Most outcomes similar

Results did not significantly differ between groups at 9 months in terms of the primary endpoint of in-segment late lumen loss (PCB group, 0.46 mm ± 51 mm; PES group, 0.55 mm ± 0.61 mm; P<.0005 for noninferiority), percent diameter stenosis (PCB group, 29 ± 21.3%; PES group, 30.8 ± 25.3%; P=.59) or binary restenosis (PCB group, 18.6%; PES group, 23.8%; P=.39). Additionally, there were no significant differences between the groups in any other outcomes, including cardiac death, MI, ischemia-driven target lesion revascularization (TLR), overall TLR, target vessel revascularization, target lesion failure (TLF) and stent thrombosis (see Figure).

Between 1 year and 2 years, no adverse ischemic events were observed in the PCB group except for one non-target vessel revascularization. Of the five all-cause deaths in the PES group at 2 years, two were cardiac with possible stent thrombosis, and three were noncardiac — two of those caused by hemorrhagic stroke, Zhao said. “That might suggest that PES treatment may cause an increased possibility of death and thrombosis,” she said. “The hemorrhagic stroke might be related to [the longer duration of] dual antiplatelet therapy. These are our assumptions, but we don’t have enough power to detect these.”

Older age was an independent predictor of TLF (HR 2.3; 95% CI 1.088-4.865; P=.029) and all-cause death or MI (HR 3.376; 95% CI 1.148-9.928; P=.027), while hyperlipidemia (HR 4.582; 95% CI 1.551-13.535; P=.006) and restenosis pattern (HR 3.103; 95% CI 1.098-8.772; P=.033) were independent predictors of all-cause death or MI.

Safety and efficacy demonstrated

“The treatment of [DES restenosis] is still challenging,” Zhao said. “There is no established best strategy. ISAR-DESIRE 3 revealed that … PCB could be a useful treatment for patients with restenosis after implantation of a limus-eluting stent.” She added that PEPCAD China ISR “demonstrates the safety and efficacy of PCB angioplasty and noninferiority vs. PES treatment in a non-European study population in need of ISR treatment after limus-eluting stent failure.”

Disclosures:

• Zhao reports no relevant conflicts of interest.