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ENDURE: Next-generation DCB shows promise in patients with PAD
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WASHINGTON — Among patients with peripheral artery disease, a second-generation drug-coated balloon appears to yield positive safety and efficacy outcomes, according to findings from the ENDURE trial presented at TCT 2016.
Mehdi H. Shishehbor, DO, MPH, PhD, director of endovascular services at Cleveland Clinic, and colleagues evaluated 67 patients (mean age, 69 years; range, 53 to 92 years; 60% men; 70 lesions) with femoropopliteal disease enrolled at four sites in Germany and New Zealand. Patients identified for inclusion had reference vessel diameter of 4.5 mm to 6 mm and Rutherford class 3 to 5 PAD.
The primary endpoints included late lumen loss, patency as assessed by duplex ultrasound, clinically driven target lesion revascularization, survival, major amputation and clinical improvement. Core lab was used to adjudicate all angiograms, whereas duplex ultrasound was adjudicated by Yale and VasCore. Predilatation before use of the second-generation DCB (Chocolate Touch, QT Vascular/TriReme Medical) was not required. The findings were simultaneously published in the Journal of the American College of Cardiology.
Shishehbor, a member of the Cardiology Today’s Intervention Editorial Board, and colleagues found that most patients had Rutherford class 3 disease (92.6%) with an ankle-brachial index of 0.66 ± 0.28. Three percent of patients had Rutherford class 4 disease, and 4.5% had class 5. Moderate to severe calcification with mean lesion length of 7.3 cm was present in 54% of patients. Technical success (delivery without geographic miss) was 100%. Flow-limiting dissections were seen in 0% of patients, and one (1.4%) bailout stenting occurred.
The 6-month rate of clinically driven TLR was 1.7% (1/60), with no amputations, one death and average Rutherford class improvement of 2.5 classes. In the core lab adjudication of 54 duplex ultrasounds, there was a 6-month patency rate of 90% per-protocol, and 87% overall. Late lumen loss was 0.16 mm in the 49 patients for whom angiographic follow-up was available.
“The ENDURE trial revealed excellent safety and efficacy at 6 months with 90% patency by core lab adjudicated duplex [ultrasound],” Shishehbor said.
Cumulative 12-month data from ENDURE also was presented. The researchers compared the performance of the Chocolate Touch DCB in that study to the 12-month performance of the IN.PACT Admiral DCB (Medtronic) in its Investigational Device Exemption (IDE) study.
At 360 days, the Chocolate Touch had an 89.9% patency rate vs. 89.8% patency for the IN.PACT Admiral balloon. At 390 days, the Chocolate Touch DCB had a 77.1% patency rate vs. 78.4% for the IN.PACT Admiral DCB. In the IN.PACT Admiral IDE study, standard percutaneous transluminal angioplasty achieved a 68.6% patency at 360 days and 49.5% patency at 390 days.
The following per-protocol adverse events were documented with the Chocolate Touch DCB at 12 months: four events of clinically driven TLR; zero amputations; and one all-cause death.
Shishehbor said the FDA has approved a Chocolate Touch DCB IDE study, which will assess outcomes of patients randomly assigned to the Chocolate Touch DCB or the Lutonix DCB (Bard Peripheral Vascular). This will be the first head-to-head study of DCBs, he said. – by Jennifer Byrne
References:
Shishehbor MH, et al. Session II. Peripheral Vascular Disease Technologies 1. Presented at: TCT Scientific Symposium; Oct. 29-Nov. 2, 2016; Washington, D.C.
Shishehbor MH, et al. J Am Coll Cardiol. 2016;doi:10.1016/j.jacc.2016.09.806.
Disclosure: Shishehbor reports no relevant financial disclosures.