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DCB safe, effective for treatment of below-the-knee lesions at 6 months
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CHICAGO —A drug-coated balloon percutaneous transluminal angioplasty catheter designed to treat below-the-knee lesions was effective and had a safety profile comparable to an existing DCB, according to early data from the global Lutonix DCB BTK Registry.
Jihad A. Mustapha, MD, FACC, FSCAI, director of cardiovascular research at Metro Health, University of Michigan Health in Wyoming, Michigan, reported the data at AMP: The Amputation Prevention Symposium.
The prospective, multicenter, single-arm registry was designed to assess the safety, efficacy and clinical outcomes of the Lutonix 014 DCB (Bard Peripheral Vascular) for treatment of stenosis or occlusion of native below-the-knee arteries in a heterogeneous, real-world population. The researchers plan to enroll up to 500 patients with claudication or Rutherford category 3 to 5 critical limb ischemia and de novo lesions with more than 70% stenosis in a below-the-knee artery. Enrollment will occur at up to 35 international sites.
The primary safety endpoint is freedom from perioperative death and below-the-knee major adverse limb events, including all-cause death, above-ankle amputation and major reintervention of the index limb, at 30 days. The primary efficacy endpoint is freedom from target lesion reintervention at 6 months.
Follow-up will occur at 1, 6, 12 and 24 months.
According to interim data, a significant proportion of patients were free from primary safety events at 30 days (98.6%; 95% CI, 96.3-99.5) and at 6 months (96%; 95% CI, 92.4-97.9). Additionally, most patients did not experience additional adverse events. The rate of freedom from all-cause death was 91.2%, freedom from major amputation was 97.1%, freedom from reintervention for thrombosis or thrombolysis was 95.2% and freedom from target vessel reintervention was 88%. There were also no cases of reintervention for distal embolization and no unexpected device- or drug-related events.
Similarly, the DCB demonstrated considerable efficacy, with high rates of freedom from target lesion reintervention at 30 days (98.6%; 95% CI, 96.4-99.5) and at 6 months (87.9%; 95% CI, 82.5-91.7).
At baseline, the mean age of patients was 73 years. Other baseline characteristics included a higher ratio of men to women (71.3% vs. 28.7%), about a quarter of the cohort with a BMI of at least 30 kg/m2 (24.6%) and high rates of hypertension (86.9%), dyslipidemia (61.8%), current/previous smoking (50.6%) and diabetes (62.7%).
About 75% of patients were Rutherford category 4 and 5, with about 24% of patients being Rutherford category 3. Lesions were most commonly found in the anterior tibial artery (50.3%), mean total target lesion length was 123 mm and mean reference vessel diameter was 2.7 mm. Calcification was mild to moderate in 66.9% of patients and severe in 22.2% of patients.
“Currently, this is the only below-the-knee multicenter, ongoing registry study. At 6 months, the data show that the safety profile of the Lutonix 014 DCB is consistent with the safety profile of the Lutonix 035 in peripheral artery disease,” Mustapha said during his presentation. “There is a positive side to use of DCB below-the-knee in these patients. This is still an ongoing trial, and hopefully we can show the 1-year results next year.” – by Melissa Foster
Reference:
Mustapha JA. General Session 4: Aortic iliac and below: Where do we stand? Presented at: AMP: The Amputation Prevention Symposium; Aug. 9-12, 2017; Chicago.
Disclosure: Mustapha reports being a consultant for Abbott Vascular, Bard Peripheral Vascular, Boston Scientific, Cardiovascular Systems Inc., Medtronic, Spectranetics and Terumo Medical.