Cath Lab Digest

In a recent issue of JACC (Journal of the American College of Cardiology), Schmidt et al published an interesting clinical study on the use of drug-eluting balloon angioplasty for treatment of long-lesion infrapopliteal arterial occlusive disease.¹ There were 104 patients and 109 limbs treated; critical ischemia was the indication for intervention in the vast majority (82.6%). The device used was the IN.PACT Amphirion paclitaxel-eluting balloon catheter (Medtronic, Minneapolis, Minnesota). Mean lesion length of the treated lesions was 176 mm. Clinical and angiographic follow up at 3 months, and clinical assessment at 1 year were performed and carefully recorded.

Angiography of 84 treated arteries at 3 months showed restenosis in 27.4% (8.3% were totally occluded), mostly focal in nature. At 1 year, clinical improvement was sustained in 91.2% of cases. Limb salvage rate was 95.6% for patients with critical ischemia. These results suggest significant, if not dramatic, improvement when compared with historical outcomes of standard balloon angioplasty. The authors also concluded that randomized clinical trials would be necessary to confirm these impressions and substantiate clinical outcome improvements.

This paper contains a great deal of information on a whole new class of devices that remains unproven. It also represents one of the first truly serious attempts at generating important data on the performance of drug-eluting balloon technology. But it is only a good beginning. In any case, I think this new treatment option has the potential to revolutionize interventional capabilities below the knee. As such, it is deserving of our close attention and discussion. Stay tuned – and read the whole paper if possible!

¹ Schmidt A, Piorkowski M, Werner M, et al. First experience with drug-eluting balloons in infrapopliteal arteries: Restenosis rate and clinical outcome. J Am Coll Cardiol 2011;58:1105-1109.