NEW YORK (Reuters Health) – Patients with sirolimus-eluting stent (SES) restenosis may be better managed with balloon angioplasty using a paclitaxel-coated balloon (PEB) catheter rather than conventional balloon angioplasty, results of a small randomized clinical study suggest.

In the study of 50 patients with SES restenosis, the PEB catheter provided better clinical and angiographic outcomes than conventional balloon angioplasty.

Writing in the February issue of JACC: Cardiovascular Interventions, cardiologists from Kurashiki Central Hospital, Kurashiki, Japan, note that drug-eluting stents (DES) are now considered standard fare for coronary in-stent restenosis. However, when restenosis occurs, repeat stenting with a DES is associated with a high risk of failure, they point out.

In a recent pilot prospective double-blind randomized study, the treatment of bare-metal stent (BMS) restenosis with a PEB catheter showed a “surprisingly” lower late lumen loss at 6 months and fewer major adverse cardiac events for up to 2 years compared with conventional balloon angioplasty. Yet, there currently are no data to support PEB in the treatment of DES restenosis.

This prompted Dr. Seiji Habara and colleagues to conduct a prospective randomized study in 50 patients with SES restenosis; 25 were assigned to a PEB group and 25 to a conventional balloon angioplasty group; 23 and 24 patients, respectively, underwent the 6-month angiographic assessment.

The PEB angioplasty catheter used in the study was the SeQuent Please balloon catheter (B. Braun Melsungen AG, Vascular Systems, Berlin, Germany).

According to the researchers, there was less in-segment late lumen loss (the primary end point) in the PEB group than in the conventional balloon angioplasty group (0.18 millimeters vs 0.72 millimeters; P = 0.001)

The incidence of recurrent restenosis was also lower in the PEB group than in the conventional balloon angioplasty group (8.7% vs 62.5%; P = 0.0001), as was target lesion revascularization (4.3% vs 41.7%: P = 0.003).

In addition, cumulative survival free of major adverse cardiac events was significantly better in the PEB group than in the conventional balloon angioplasty group (96% vs 60%; P = 0.005).

It appears from this study, Dr. Habara and colleagues say, that PEB “might be more effective for the treatment of nonfocal DES restenosis.”

Limitations of the study include its single-center design, relatively small sample size, and limited clinical and angiographic follow-up time (6 months), the researchers say, adding that they are “eagerly awaiting further long-term data.

J Am Coll Cardiol Intv 2011;4:149-154.