PARIS, France—Using paclitaxel-eluting balloons to treat drug-eluting stent (DES) restenosis is a noninferior alternative to paclitaxel-eluting stents (PES), obviating the need for additional stent layers, according to data from the PEPCAD China ISR trial presented May 23 at EuroPCR 2013.
For the trial, Run-Lin Gao, MD, of Fu Wai Hospital (Beijing, China), and Jun-Bo Ge, MD, of Zhongshan Hospital (Shanghai, China), and colleagues enrolled 220 patients with DES restenosis, mostly from limus-eluting stents. Patients were randomized at 17 Chinese centers to treatment with either the SeQuent Please paclitaxel-eluting balloon (n = 110; B. Braun Melsungen AG, Berlin, Germany) or the Taxus Liberte PES (n = 110; Boston Scientific, Natick, MA).
Baseline characteristics were similar in both groups, with the exception of a higher rate of prior MI in the SeQuent Please patients (48.6% vs. 34.9%; P = 0.0411).
For procedural results, in-device acute gain was greater with Taxus (1.70 mm vs. 1.54 mm; P = 0.0085), as was in-device minimum lumen diameter (MLD; 2.56 mm vs. 2.39 mm; P = 0.0026). In-device diameter stenosis, meanwhile, was greater with SeQuent Please (10.5% vs. 7.1%; P = 0.0002).
Late Loss Results Noninferior
The primary endpoint of in-segment late loss at 9 months was 0.46 ± 0.51 mm with SeQuent Please and 0.55 ± 0.61 mm with Taxus for a difference of -0.06 mm (95% CI -0.23 to 0.10), which fell within the margin for noninferiority (P = 0.0005 for noninferiority; P = 0.3157 for superiority).
Other angiographic outcomes also were similar at 9 months between the groups (table 1).
Table 1. Angiographic Outcomes at 9 Months
SeQuent Please(n = 91)
Taxus Liberte(n = 81)
The rate of TLF at 12 months was similar in patients receiving SeQuent Please (15.5%) or Taxus (17.5%; P = 0.6969), as were each of the component endpoints including target-vessel MI (2.7% vs. 6.8%; P = 0.2030), ischemia-driven TLR (13.6% vs. 11.7%; P = 0.6629) and definite/probable stent thrombosis (0.9% vs. 1.0%; P = 1.00). There were no cardiac deaths.
“The present study demonstrates that for treatment of DES restenosis, paclitaxel-eluting balloon is noninferior to repeat stenting with Taxus paclitaxel-eluting stents in terms of safety and efficacy,” Dr. Gao concluded. “Treatment with paclitaxel-eluting balloons should be a better alternative for DES restenosis than repeat implantation of a drug-eluting stent by avoiding additional stent layers.”
An audience member commented that late lumen loss is not a good comparison point when 2 devices are as different as DES and drug-eluting balloons. Dr. Gao responded that other secondary angiographic endpoints were assessed, including diameter stenosis and postprocedure in-device MLD, which was larger with Taxus.
Another audience member noted that the late lumen loss results were relatively high compared with those usually found with BMS. Dr. Gao responded that late loss is generally higher with both DES and drug-eluting balloons compared with BMS.
Patients were included with DES restenosis Mehran type I-VI, reference vessel diameter of 2.5 mm to 4.0 mm, and lesion length ≤ 30 mm. Diameter stenosis of ≥ 70% were included, or ≥ 50% with documented myocardial ischemia.