VIVA 2011: PACIFIER 6-Month Results for Drug-Coated Balloons Versus Uncoated Balloons

October 18, 2011—At the VIVA 2011: Vascular Interventional Advances meeting in Las Vegas, Nevada, Michael Werk, MD, presented 6-month results from PACIFIER, a multicenter, randomized trial evaluating the prevention of restenosis with paclitaxel-coated balloon catheters in treating stenosis or occlusion of femoropopliteal arteries.

The PACIFIER study included two treatment arms and randomized enrollment of 91 patients at three centers. The inclusion criteria were clinical Rutherford stage 2 to 5, occlusion or hemodynamic relevant stenosis (≥ 70% diameter) of femoropopliteal arteries, and successful guidewire passage. Each patient received treatment for one to three lesions with one to five uncoated (Pacific Xtreme, Medtronic Invatec, Frauenfeld, Switzerland) or paclitaxel-coated (In.Pact Pacific, Medtronic Invatec) balloon catheters that were strictly controlled with respect to paclitaxel content before and after use. The primary endpoint was late lumen loss at 6-month follow-up as evaluated by an independent blinded core laboratory. Trial enrollment was between March 2010 and February 2011, and clinical follow-up was at 6, 12, and 24 months, respectively.

Dr. Werk reported that 91 patients were included in the study: 47 patients were treated with the uncoated balloon, and 44 patients were treated with the drug-coated balloon (DCB). The mean age was 70 years. The lesion characteristics included maximum length ≤ 30 cm, 20% occlusion, and 25% restenosis or in-stent restenosis. All patients were successfully treated. The suppression of neointimal hyperplasia was confirmed with significantly lower late lumen loss 6 months postprocedure in the DCB arm versus the uncoated balloon arm (-0.05 mm vs 0.61 mm; P < .003). Consequently, binary restenosis and target lesion revascularization (TLR) rates were lower in the DCB arm (10% and 7.3%) than in the uncoated balloon arm (31% and 22%; P = .03 and P = .06). Amputation did not occur in either group. Two patients died in the uncoated balloon arm (no deaths occurred in the DCB arm). Provisional stent rates were low in both arms at 21% and 34% in the DCB and uncoated balloon arms, respectively (P = .17).

While longer-term follow-up results are awaited, 6-month findings from PACIFIER demonstrated an overall significant improvement in angiographic late lumen loss and binary restenosis, with a trend of lower TLR rates and a significantly lower rate of overall major adverse events (death, amputation, and TLR) with DCBs versus uncoated balloons. These results confirm paclitaxel-coated balloons as a viable, stand-alone therapy for the femoropopliteal arteries, with a low rate of provisional stenting, concluded Dr. Werk.