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Stents are needed in up to 50 % of all peripheral interventions where PTA with plain or drug-coated balloons alone will not reopen the vessel sufficiently. Nevertheless, the restenosis rate of stents is still a major limitation of peripheral arterial interventions. Drug-coated balloons potentially overcome the problem of in-stent restenosis when used for postdilatation after primary nitinol stenting in the SFA and PI segment.
The Freeway Stent Study is a prospective, randomized, international trial started in 15 centers in Germany and Austria. 200 patients will be enrolled and randomized equally to primary nitinol stenting followed by either DCB (Freeway™) or plain balloon postdilatation. Primary endpoint is clinically driven target lesion revascularization (TLR) at 6 months, secondary endpoints include further clinical and safety evaluations like shift in Rutherford classification and ABI, LLL, patency rate and MAE.
Over 170 patients have been enrolled to date, of which over 130 have finished the 6 months and 100 the 12 months follow-up. The results highly favor the use of Freeway™ DCB over plain balloon based on clinically driven TLR (only 2.9 % vs. 11.9 % at 6 months and 9.1 % vs. 18.0 % at 12 months). This is supported by a statistically significant better clinical outcome for PAD patients treated with DCB as postdilatation device regarding primary patency rate, ABI and Rutherford classification at six months.
The use of DCB as postdilatation device is investigated in a new approach to decrease the restenosis rate after nitinol stenting in the SFA and PI segment. The latest interim results of the Freeway Stent Study show that DCB might significantly lower the in-stent restenosis rate in the treatment of PAD patients.