Long-Term Follow-up and Mortality Rate of Patients of the Randomized Freeway Stent Study.

PURPOSE: This follow-up study was designed as a reopen of the completed Freeway Stent Study and collected mortality and clinical outcome data for at least 5 years after enrollment to evaluate long-term patient safety and treatment efficacy. The primary study enrolled 204 patients with stenosis or occlusion in the superficial femoral artery and proximal popliteal artery. Patients were randomized to primary nitinol stenting followed by standard PTA or primary nitinol stenting followed by FREEWAY™ paclitaxel-eluting balloon PTA. METHODS: Previous patients were recontacted by phone or during a routine hospital visit, and medical records were reviewed. Vital and clinical status information was collected. RESULTS: No increased late mortality was observed at 5 years, with an all-cause mortality rate of 12.0% in the FREEWAY drug-eluting balloon group versus 15.0% in the non-paclitaxel PTA group. No accumulation of any cause of death was observed in either group, nor was there any correlation with the dose of paclitaxel used. Freedom from clinically driven target lesion revascularization at 5 years was significantly higher in the FREEWAY drug eluting balloon group (85.3%) compared to standard PTA group (72.7%) Log-rank p = 0.032. CONCLUSION: The safety results presented support the recent conclusions that the use of paclitaxel technology does not lead to an increase in mortality. At the same time, the efficacy results clearly demonstrate that the potential benefits of drug-eluting balloon treatment are maintained over a 5-year period.

The Randomized Freeway Stent Study: Drug-Eluting Balloons Outperform Standard Balloon Angioplasty for Postdilatation of Nitinol Stents in the SFA and PI Segment.

PURPOSE: The prospective randomized multicenter Freeway study evaluated the possible hemodynamic and clinical benefits of primary stent insertion followed by percutaneous transluminal angioplasty (PTA) with drug-eluting balloons (DEB) over post-stent insertion PTA with standard balloons in the treatment of symptomatic femoropopliteal arteriosclerotic lesions. METHODS: In total, 204 patients in 13 centers in Germany and Austria were enrolled and randomized to primary stenting followed by either FREEWAY™ drug-eluting balloon or standard PTA balloon angioplasty. The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) at 6 months; the secondary endpoints include TLR rate at 12 months and primary patency, shift in Rutherford classification, ankle-brachial index (ABI) and major adverse events (MAE) at 6 and 12 months. Lesion characteristics and vessel patency were analyzed by an independent and blinded corelab. RESULTS: At 6-month and 12-month follow-up, TLR rate was lower in the DEB arm compared to standard PTA but did not reach statistical significance (4.1% vs. 9.0% p = 0.234 and 7.9% vs. 17.7% p = 0.064, respectively). Primary patency was significantly better for patients treated with the DEB at 6 months (90.3% vs. 69.8% p = 0.001) and 12 months (77.4% vs. 61.0% p = 0.027). Improvement in Rutherford classifications was likewise significantly better for patients in the DEB group at 6 (94.9% vs. 84.3% p = 0.027) and 12 months (95.5% vs. 79.9% p = 0.003). The percentage of patients with an improved ABI of 1.0-1.2 was significantly higher in the DEB group compared to the PTA group at 6 months (55.3% vs. 35.3%; p = 0.015) but without significant difference at 12 months (48.2% vs. 32.9%; p = 0.055). At 6 months, rate of major adverse events (MAE) was 1% in both arms, and at 12 months 2.2% for the DEB and 3.8% for the PTA group. CONCLUSION: The Freeway Stent Study shows that the usage of DEB as a restenosis prophylaxis seems to be safe and feasible. The 12-month follow-up results give a clear sign in favor of the DEB group.