ILLUMENATE Pivotal and Pharmacokinetic Studies Published for Spectranetics' Stellarex DCB
August 2, 2017—The 12-month outcomes from the randomized ILLUMENATE Pivotal and Pharmacokinetic (PK) studies of the Stellarex drug-coated balloon (DCB; Spectranetics Corporation) for the treatment of femoropopliteal disease were published online ahead of print by Prakash Krishnan, MD, et al in Circulation.
In the ILLUMENATE Pivotal study, 300 symptomatic patients with Rutherford class 2–4 disease were randomized to the Stellarex DCB (n = 200) or standard percutaneous transluminal angioplasty (PTA; n = 100). The study's 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 through 12 months. Primary patency through 12 months was the primary effectiveness endpoint.
In the ILLUMENATE PK study, plasma concentrations of paclitaxel were measured after last DCB deployment; at 1, 4, and 24 hours; and at 7 and 14 days postprocedure until no longer detectable.
In Circulation, the investigators reported that baseline characteristics were similar between groups in the ILLUMENATE Pivotal study (50% had diabetes, 41% were women, mean lesion length was 8.3 cm, and 44% of lesions were severely calcified).
The primary safety endpoint was met in both arms (92.1% for DCB vs 83.2% for PTA; P = .025 for superiority), and the primary patency rate was significantly higher with DCB as compared with PTA (76.3% vs 57.6%, respectively; P = .003). Kaplan-Meier estimates of primary patency at day 365 were 82.3% for DCB as compared with 70.9% for PTA (P = .002).
The investigators found that the rate of clinically driven target lesion revascularization was significantly lower in the DCB group compared with the PTA group (7.9% vs 16.8%; P = .023). Improvements in ankle-brachial index, Rutherford class, and quality of life were comparable, but the PTA group required twice as many revascularizations.
With regard to PK outcomes, 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).
The Stellarex DCB demonstrated superior safety and effectiveness as compared to PTA, and plasma paclitaxel levels decreased to low levels within 1 hour, concluded the investigators in Circulation.
On July 26, Spectranetics announced receipt of US Food and Drug Administration premarket approval of the Stellarex DCB, which is designed to restore and maintain blood flow to the superficial femoral and popliteal arteries in patients with peripheral artery disease. United States regulatory approval was supported by the ILLUMENATE clinical studies, which evaluated the safety and efficacy of the Stellarex DCB platform. On June 28, Royal Philips and Spectranetics announced that they have entered into a definitive merger agreement under which Philips will tender offers to shareholders for all issued and outstanding shares of Spectranetics in a deal estimated at €1.9 billion.