DRASTICO Study Compares Drug-Eluting Technologies in Femoropopliteal Lesions
July 17, 2019—Findings from the DRASTICO study, which compared drug-coated balloons (DCBs) and drug-eluting stents (DESs) for treating complex femoropopliteal arterial lesions, were published by Francesco Liistro, MD, et al in Journal of the American College of Cardiology (JACC; 2019;74:205–215).
According to the investigators, DRASTICO sought to evaluate paclitaxel-eluting balloon angioplasty with provisional use of nitinol stents versus systematic implantation of paclitaxel-eluting stents for the treatment of femoropopliteal de novo lesions in patients at high risk for femoropopliteal restenosis.
As summarized in JACC, the study was composed of 192 patients with either intermittent claudication or critical limb ischemia, who were undergoing femoropopliteal intervention to treat 240 lesions in 225 limbs.
After successful target lesion predilation, the patients were randomly assigned 1:1 to treatment with a DCB (n = 96) or DES (n = 96). Diabetes and critical limb ischemia were present in > 50% in both groups. The mean lesion length was 14 cm, and baseline target lesion occlusion was present in approximately 60% of cases in both groups.
The study's primary endpoint was 12-month target lesion binary restenosis, assessed using Doppler ultrasound. Secondary endpoints were freedom from target lesion revascularization and freedom from major amputation.
The investigators found that the systematic DES strategy yielded larger postprocedural minimal luminal diameters and a lower incidence of residual dissection compared with the DCB strategy, in which nitinol stents were used in only 21% of the lesions. Additionally, investigators reported:
- Target lesion restenosis at 12 months was observed in 22% of DCB patients versus 21% of DES patients (P = .9).
- Clinically driven target lesion revascularization was necessary in 14% of DCB patients versus 17% of DES patients (P = .5).
With similar rates of restenosis and clinically driven target lesion revascularization, DCB was not superior to DES in treating complex femoropopliteal lesions in a high-risk population, concluded the investigators in JACC.
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