VIVA Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, presents the data summary below in conjunction with our Late-Breaking Clinical Trials Livestream on June 25, 2020.
Presenter: William Gray, MD
Long-term clinical outcomes of patients treated with Stellarex DCB compared with standard PTA through 4 years
This is a prospective, multi-center, RCT conducted in the EU. Patients included those indicated for treatment of the SFA and/or popliteal artery. The study utilized core laboratories and a CEC for adjudication. Primary safety endpoint was freedom from device- and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and CD-TLR through 12 months. Primary endpoint was patency, defined as the absence of target lesion restenosis determined by duplex ultrasound PSVR of ≤ 2.5 and freedom from CD-TLR at 12 months.
Follow up office visits were conducted through 36 months and included clinical/functional assessments and adverse events. Telephone visits occurred at 48 months. Key outcomes included safety and CD-TLR assessments.
294 patients were randomized to treatment with a Stellarex DCB or an uncoated PTA. There were no differences in baseline patient and lesion characteristics between the Stellarex DCB and PTA arms. Primary patency assessed through 3 years was higher for the DCB cohort compared with PTA (67.5% vs. 59.9%, respectively P=0.05). At 48 months, primary safety endpoint was 66.3% (110/166) in the DCB group and 62.5% (35/56) in the PTA group. Target limb major amputation rate was similar (DCB: 0.6% and PTA: 0.0%) for both groups. CD-TLR through 48 months was lower in the DCB group (33.1% vs. 37.5%, respectively; P=0.551). K-M analysis of all-cause mortality showed no difference in curves between the groups (DCB: 84.4% vs. PTA: 86.1%; P=0.925).
Stellarex DCB demonstrated a safe and efficacious profile compared with PTA through 4 years. Stellarex DCB-treated patients had a lower CD-TLR compared with the control arm. Consistent with previous assessments and the US Pivotal RCT data, no difference in mortality was observed at 4 years between Stellarex DCB and PTA cohorts.
About VIVA Physicians
VIVA Physicians, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, strives to be the premier educator in the field. Our team of specialists in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery is driven by the passion to advance the field and improve patient outcomes. Educational events presented by VIVA Physicians have a distinct spirit of collegiality attained by synergizing collective talents to promote awareness and innovative therapeutic options for vascular disease worldwide. To learn more about VIVA Physicians, visit www.vivaphysicians.org.
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