SAN FRANCISCO, CA—For revascularization of restenotic lesions in drug-eluting stents (DES), angioplasty with a paclitaxel-coated balloon reduces late lumen loss and major adverse events at 6 months compared with conventional angioplasty using uncoated balloons, according to results of the randomized multicenter PEPCAD-DES trial.

The findings were presented by Harald Rittger, MD, of the University of Erlangen (Erlangen, Germany), November 11, 2011, at the annual Transcatheter Cardiovascular Therapeutics scientific symposium.

Researchers at 6 German centers randomized 110 patients with in-stent restenosis in multiple types of DES in a 2:1 fashion to angioplasty with a paclitaxel-coated balloon (SeQuent Please, B. Braun Vascular Systems, Berlin, Germany; n = 72) or conventional balloon angioplasty (n = 38). All patients were prescribed 6 months of dual antiplatelet therapy.

At 6-month angiographic follow-up, the primary endpoint of late luminal loss was lower in patients treated with paclitaxel-coated balloons compared with those treated with uncoated balloons (0.43 ± 0.61 mm vs. 1.03 ± 0.77 mm; P < 0.001). Other angiographic endpoints including minimal lumen diameter (MLD), percent diameter stenosis, and rate of binary restenosis also favored the paclitaxel-coated balloon group in both the target lesion and the total segment (table 1).

Table 1. Angiographic Follow-up at 6 Months

In addition, at 6 months, clinical outcomes including TLR, cardiac death, and MACE (composite of cardiac death, target vessel MI, and TLR) were reduced in the paclitaxel-coated balloon arm vs. the uncoated balloon arm, but there was no difference in rates of MI (figure 1).

Dr. Rittger noted that although the use of DES decreases the risk of restenosis compared with BMS, restenosis remains common due to increasing use of DES in patients with complex lesions. At least for treatment of DES restenosis, angioplasty with a paclitaxel-coated balloon significantly reduces late loss and the risk of MACE, he concluded.

Study Details

The treatment groups were well matched for baseline characteristics except that the paclitaxel-coated balloon group was older (69.8 ± 10.8 years vs. 64.0 ± 11.3 years; P = 0.02). In addition, in paclitaxel-coated balloon patients, restenosis was more likely to be located in the circumflex artery (32.0% vs. 4.9%; P = 0.005). 

All patients received predilatation with an inflation time of about 40 seconds and a pressure of 15.1 atm. In both groups, the length of the balloon was chosen to overlap the stenotic segment at least 2 mm at the proximal and distal margins. 

 

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Source:
Rittger H. A prospective, randomized trial of a paclitaxel coated balloon vs. uncoated balloon angioplasty in patients with drug-eluting stent restenosis: PEPCAD-DES study. Presented at: Transcatheter Cardiovascular Therapeutics 2011; November 11, 2011; San Francisco, CA.

 

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