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Erik E. Debing, MD, PhD, Discusses the IN.PACT Belgian Diabetic Drug-Coated Balloon Trial
The Belgian IN.PACT Trial of Paclitaxel-Coated Drug-Coated Balloon vs Plain Old Balloon Angioplasty was undertaken across sites in Belgium to demonstrate the efficacy of the paclitaxel-coated balloon to inhibit restenosis in a diabetic population. At the 41st annual VEITHSymposium, Erik E. Debing, MD, PhD, presented mid-term results from the trial. Vascular Disease Management asked Dr. Debing to share details about the results.
Q: Could you describe the goals of the trial?
A: The Belgian diabetic IN.PACT trial is a randomized, multicenter investigator-initiated study with the aim of demonstrating the efficacy of a paclitaxel-coated balloon to inhibit restenosis of the superficial femoral artery (SFA), the popliteal artery and below-the-knee arteries, especially in the diabetic population.
Q: What were the primary endpoints and secondary endpoints?
A: The primary endpoints are the 6-month mean and binary restenosis rates and the secondary endpoints are the clinically driven target lesion revascularization and clinical success at 1 and 6 months. We included diabetic patients with CLI Rutherford classification from 3 to 5, we included more than 50% stenotic lesions or less than 5cm occlusions for SFA, and more than 50% stenotic or less than 10cm occlusions for popliteal arteries and below the knee arteries. Also, the diameter of the vessels must be between 2 and 7 mm. Exclusions for the study are in-stent restenosis, it is very important to note that this kind of pathology is excluded from the study.
Q: What is the current status of the study?
A: In total, 11 high-volume centers are participating in the study, including 5 university hospitals in Belgium. We have randomized 105 patients, of them 52 were treated with the drug-coated balloon and 53 were treated with uncoated balloon. Right now we have the 6-month results for 44 patients for the uncoated balloon group and 42 patients for the coated balloon group.
The patients’ characteristics are equally divided between both groups. Also, the lesion characteristics and procedure dates were the same for both groups. The outcomes – there were trends toward better clinical 6-month outcomes in the drug-coated balloon group compared to controls.
The main findings of the study were that the mean restenosis is low, better, in the drug-coated balloon group compared to the controls. Also the binary restenosis of more than 50% is better in the drug-coated balloon group compared to controls. On the other hand we did not detect that clinically driven TLR is better in the drug-coated balloon group compared to controls.
Q: Why was it important to study this device for diabetic patients?
A: All the other trials are mixed patients – smokers, hypertensive, diabetic - we designed this study to have a homogeneous group of only the diabetic patients. Diabetic patients also have more distal angiopathies compared to other groups, so that is the main reason.
Q: How did the recall of the IN.PACT Amphirion balloon affect the study?
A: That was a problem. A year ago there was a recall of the Medtronic IN.PACT Amphirion DEB for below-the-knee disease based on results of the INPACT DEEP Trial in November 2013, we had to stop with inclusion of patients with below-the-knee lesions, so after that date we included only patients with lesions of the SFA and popliteal artery.
Q: What further study should be done in the future?
A: I think that drug-eluting balloons work for SFA and popliteal artery but in the future we need to do randomized trials for below-the-knee arterial lesions.
Editor’s note: Erik E. Debing, MD, PhD, is from the Department of Vascular Surgery at the Brussels Centre for Cardiovascular Diseases in Belgium. Dr. Debing reports consulting fees or honoraria from C.R. Bard, Abbott Vascular, Daiichi-Sankyo, Boehringer Ingelheim, and Boston Scientific as well as research grants from Medtronic.
