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

TL;DR

A long-term follow-up of a stent study found no increased mortality and better treatment outcomes with a drug-eluting balloon over five years.

Contribution

This study provides 5-year safety and efficacy data on paclitaxel-eluting balloon use in treating arterial stenosis.

Findings

No increased late mortality was observed at 5 years in the paclitaxel group.

Freedom from revascularization was significantly higher in the drug-eluting balloon group.

Paclitaxel use showed no correlation with increased mortality or cause of death.

Abstract

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.

Previous patients were recontacted by phone or during a routine hospital visit, and medical records were reviewed. Vital and clinical status information was collected.

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.

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.

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