Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease: 12-Month Outcomes from the Randomized ILLUMENATE Pivotal and Pharmacokinetic Studies
Background—Drug-coated balloons (DCB) are a predominant revascularization therapy for symptomatic femoropopliteal artery disease. Due to differences in excipients, paclitaxel dose and coating morphologies, varying clinical outcomes have been observed with different DCBs. We report the results of two studies investigating the pharmacokinetic (PK) and clinical outcomes of a new DCB to treat femoropopliteal disease.
Methods—In the ILLUMENATE Pivotal Study, 300 symptomatic patients (Rutherford class 2-4), were randomized to DCB (N=200) or standard angioplasty (PTA) (N=100). The primary safety endpoint was freedom from device- and procedure-related death through 30 days, and freedom from target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) through 12-months. The primary effectiveness endpoint was primary patency through 12-months. In the ILLUMENATE PK study, paclitaxel plasma concentrations were measured after last DCB deployment and at pre-specified times (1, 4, 24 hours and at 7 and 14 days post-procedure) until no longer detectable.
Results—In the Pivotal study, baseline characteristics were similar between groups; 50% had diabetes, 41% were women, mean lesion length was 8.3cm and 44% were severely calcified. The primary safety endpoint was met (92.1% for DCB vs. 83.2% for PTA, p=0.025 for superiority) and the primary patency rate was significantly higher with DCB (76.3% for DCB vs. 57.6% for PTA, p=0.003). Primary patency per Kaplan Meier estimates at day 365 was 82.3% for DCB vs. 70.9% for PTA (p=0.002). The rate of CD-TLR was significantly lower in the DCB cohort (7.9% vs. 16.8%, p=0.023). Improvements in ankle brachial index, Rutherford class, and quality of life were comparable, but the PTA cohort required twice as many revascularizations. PK outcomes showed all patients had detectable paclitaxel levels after DCB deployment that declined within the first hour (54.4±116.9 ng/mL to 1.4±1.0 ng/mL).
Conclusions—The Stellarex DCB demonstrates superior safety and effectiveness as compared to PTA, and plasma levels of paclitaxel fall to low levels within one hour.
- Received April 12, 2017.
- Revision received May 24, 2017.
- Accepted June 21, 2017.
Circulation is published on behalf of the American Heart Association, Inc., by Wolters Kluwer. This is an open access article under the terms of the Creative Commons Attribution Non-Commercial-NoDervis License (http://creativecommons.org/licenses/by-nc-nd/3.0/), which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is noncommercial, and no modifications or adaptations are made.