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SAFE-DCB: High procedural success, few events in DCB registry
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According to an interim analysis from a registry presented at VIVA 17, a drug-coated balloon was safe and effective at 12 months.
Edward Y. Woo, MD , FACS , presented an interim analysis of 627 patients with de novo or restenotic lesions up to 150 mm in the native superficial femoral or popliteal arteries from the SAFE-DCB registry who had achieved 12-month follow-up after treatment with the DCB (Lutonix 035, Bard Peripheral Vascular). The registry includes 1,006 patients, 968 of whom fulfilled all study requirements.
During the procedure, 72.2% of patients required only one balloon, with 22.2% requiring two balloons, 5.3% requiring three, 0.3% requiring four and 3.7% having major flow-limiting dissection, said Woo, director of the MedStar Regional Vascular Program, chairman of the department of vascular surgery at MedStar Washington Hospital Center and professor of surgery at Georgetown University.
The primary endpoint of freedom from target lesion revascularization at 12 months was met in 90.8% of patients (95% CI, 88.1-93.1), Woo said.
The second primary endpoint of freedom from composite safety events, defined as device- or procedure-related perioperative death, target limb major amputation or target vessel revascularization, at 30 days was met in 98.5% of patients (95% CI, 97.3-99.3), he said.
Acute device and procedural success was achieved in 91.4% of patients, and freedom from TVR at 12 months was achieved in 88.2%, according to the researchers.
“Preliminary 12-month results demonstrate a high rate of acute procedural and device success,” Woo said at a press conference. “These are preliminary results and we look forward to getting full results on all patients.”
Patients will be followed up to 3 years, he said, noting future analyses will attempt to identify characteristics predicting TLR.
“This corroborates the strong results seen with DCB in this treatment arm in a real-world experience, where it’s not completely controlled by the parameters of an IDE study,” Woo said at the press conference. – by Erik Swain
Reference:
Woo EY, et al. Late-Breaking Clinical Trials. Presented at: VIVA 17; Sept. 11-14, 2017; Las Vegas.
Disclosure: The study was funded by Bard Peripheral Vascular. Woo reports he has consulted for Bard Peripheral Vascular and Endologix and consulted for and received honoraria from W.L. Gore & Associates.
Perspective
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Mark W. Burket, MD
It is encouraging that in a real-world population, there was a rate of freedom from TLR of just over 90% at 12 months. One concern is that some DCB trials have shown that results can look one way after 365 days, but a completely different way after a 30-day window beyond that. I would like to see those data, but if these results hold up, it is a positive development.
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