Original title: Drug-Eluting Balloon in Peripheral Intervention for the Superficial Femoral Artery. The DEBATE-SFA Randomized Trial (Drug Eluting Balloon in Peripheral Intervention for Superficial Femoral Artery). Reference: Liistro, F, el tal. J Am Coll Cardiol Intv 2013;6(12):1295-1302

The current treatment of choice in the femoropopliteal area is angioplasty, however, this procedure has a high rate of restenosis (between 40% and 60%) at 12 months. Therefore, we have developed new technologies such as pharmacological balloon (DEB) although its utility has not been fully demonstrated.

In this study 104 patients (110 lower limbs with 110 lesions) were included and were randomized 1:1 to DEB plus stent versus conventional balloon plus BMS. All had lesions or total occlusions of at least 40 mm in the superficial femoral or popliteal artery. Have at least one infrapatelar patent vessel was a condition for entering the study (in the case of injuries that these do not exceed 70%). The characteristics of the populations were similar with a mean age of 75 years and over 70 % were diabetic.

All had intermittent claudication Class 3 or higher Rutherford. The lesion length was close to 100 mm and 57% also received infrapatelar angioplasty. Procedural success was similar in both groups and there were no major complications intra-hospital. At 12 months follow-up 2 patients from DEB group pass away (1 for heart failure and other for sepsis) and 1 from conventional balloon group (for sudden death), no major amputations were recorded. Restenosis was lower in those receiving DEB (17 % versus 47 % p = 0.008) as well as in the specific subgroup of lesions ≥ 100 mm (21 % versus 62 % p = 0.01) or in total occlusions. Clinical improvement in monitoring Rutherford class 2 was higher in the DEB + stent group (81.8 % versus 54.5 % p = 0.02). 

Conclusion

Balloon pre-dilatation prior to stent placement compared with conventional balloon plus stent in superficial femoral artery complex lesions reduces restenosis and revascularization at 12 months. The reduction in restenosis is maintained even in longer lesions or total occlusions. 

Comment

This randomized study demonstrates, as in the RESILENT trial, a decrease in re-interventions both long lesions and total occlusions; however, there was no difference in major events with the use of drug-eluting balloons. While this is a study of an acceptable number of patients would be needed to assess DEB over patients with more complex lesions involving the infra patellar area and with intermittent claudication Rutherford class >4, which is a real challenge in our practice daily.

Courtesy of Dr Carlos Fava
Interventional cardiologist
Fundación Favaloro – Argentina

Dr. Carlos Fava para SOLACI.ORG