Original Title: Drug-Coated Balloons for Complex Femoropopliteal Lesions2-Year Results of a Real-World Registry.
Reference: Andrej Schmidt et al. J Am CollCardiolIntv. 2016;9(7):715-724.
The superiority of drug coated balloons compared to conventional balloons in femoropopliteal lesions have been shown by randomized studies, but only in short and simple lesions. The efficacy of drug coated balloons in more complex lesions with high restenosis rate remains unclear.
Patency, target lesion revascularization, clinical improvement and safety were retrospectively analyzed in 260 patients (280 limbs) treated with paclitaxel drug coated balloon vs. Admiral DCB (Medtronic, Minneapolis, Minnesota)followed up for nearly two years. Restenosis predictors were identified by logistic regression.
Lesions were de novo lesions in 51.7% of patients, 11.1% were restenosis and 37.2% were instent restenosis.Meanlesion length was 24.0 ± 10.2 cm with 65.3% total occlusion.
Kaplan Meier estimates for primary patencywere 79.2% and 53.7% for all lesions at 1 and2 years respectively, while freedom from target lesion revascularization was 85.4% and 68.6%.
Primary patency for instent restenosis treatment was 76.6% and 48.6% at 1 and 2 years, respectively.
Rutherford category improved a mean of 3.3from baselineto 1.2 at one year and to 1.1at 2 years.
Major amputation rate at 2 years was 2.1%. There were no adverse events attributable to the DEB.
Conclusion
These results suggest that drug eluting balloons are safe and effective to delay, rather than prevent, restenosis in long, complex lesions in femoropopliteal territory.
