RandomIzed AmPhirion DEEP DEB vs. StAndard PTA for the Treatment of Below the Knee CriTical Limb Ischemia - IN.PACT DEEP
The optimal treatment of critical limb ischemia due to infrapopliteal arterial disease is unknown since repeat revascularization procedures remain high. The aim of the current trial was to assess the safety and efficacy of a drug-eluting balloon vs. standard balloon angioplasty.
Drug-eluting balloon angioplasty would improve target lesion revascularization/late lumen loss and major adverse events.
- Subjects with critical limb ischemia due to infrapopliteal arterial disease
Number of enrollees: 358
Duration of follow-up: 12 months
Mean patient age: 73 years
Percentage female: 24%
- Co-primary efficacy endpoints assessed at 12 months:
- Clinically driven target lesion revascularization
- Late lumen loss
- Primary safety endpoint assessed at 6 months:
- All-cause mortality, major amputation, or clinically driven target lesion revascularization
Patients with critical limb ischemia due to infrapopliteal arterial disease were randomized 2:1 to paclitaxel-eluting balloon angioplasty (n = 239) vs. standard balloon angioplasty (n = 119).
A total of 358 patients were randomized. The mean age was 73 years, 76% were diabetic, 90% had hypertension, 15% were smokers, 33% had previous coronary revascularization, and 84% were Rutherford class 5.
Lesion length was 10 cm in the drug-eluting balloon group vs. 13 cm in the balloon angioplasty group (p = 0.002). Vessel diameter was 2.5 mm vs. 2.4 mm (p = 0.30), stenting occurred in 3.9% vs. 2.6% (p = 0.45), procedural complications occurred in 10% vs. 3% (p = 0.035), and post-procedure dissections occurred in 12% vs. 19% (p = 0.046), respectively, for drug-eluting balloon vs. balloon angioplasty.
At 12 months, clinically driven target lesion revascularization occurred in 11.9% of the drug-eluting balloon group vs. 13.5% of the balloon angioplasty group (p = 0.68). Late lumen loss was 0.61 in the drug-eluting balloon group vs. 0.62 in the balloon angioplasty group (p = 0.95).
At 6 months, all-cause mortality, major amputation, or target lesion revascularization occurred in 17.7% in the drug-eluting balloon group vs. 15.8% in the balloon angioplasty group (p for noninferiority = 0.021). Major amputation occurred in 8.8% in the drug-eluting balloon group vs. 3.6% in the balloon angioplasty group (p = 0.08).
Among patients with critical limb ischemia due to infrapopliteal arterial disease, a paclitaxel-eluting balloon resulted in similar target lesion revascularization and late lumen loss compared with standard balloon angioplasty. While drug-eluting balloon angioplasty vs. standard balloon angioplasty was noninferior with respect to major adverse safety events, there was a trend toward more amputations with this device.
It is unknown why a drug-eluting balloon would have resulted in a nonsignificant increase in amputations; however, a chance finding remains a possibility. Based on these results, the sponsor decided to remove this device from the market. The treatment of infrapopliteal arterial disease remains challenging.
Zeller T, Baumgartner I, Scheinert D, et al. Drug-Eluting Balloon Versus Standard Balloon Angioplasty for Infrapopliteal Arterial Revascularization in Critical Limb Ischemia: 12-Month Results From the IN.PACT DEEP Randomized Trial. J Am Coll Cardiol 2014;64:1568-76.
Keywords: Paclitaxel, Follow-Up Studies, Ischemia, Amputation, Angioplasty, Balloon, Coronary, Hypertension, Diabetes Mellitus, Peripheral Vascular Diseases, Stents
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