This article is more than 5 years old. Information may no longer be current.
DCB outperforms PTA in treating femoropoliteal disease
A new drug-coated balloon demonstrated superior patency in treating femoropoliteal disease compared with percutaneous transluminal angioplasty, according to 1-year results of two studies recently published in Circulation.
Clinical outcomes of different DCBs often vary due to differences in excipients, paclitaxel dose and coating morphologies, according to the study background.
Prakash Krishnan, MD, from the Icahn School of Medicine at Mount Sinai, and colleagues conducted two studies investigating the pharmacokinetic and clinical outcomes of the DCB (Stellarex, Spectranetics), which recently received FDA approval.
ILLUMINATE Pivotal
The multicenter, single-blind, randomized controlled ILLUMENATE Pivotal study was designed to assess the safety and efficacy outcomes of the DCB compared with the noncoated percutaneous transluminal angioplasty (PTA) in patients with symptoms of claudication and rest pain as a result of femoropopliteal artery disease.
The study included 300 symptomatic patients who were randomly assigned to DCB or PTA.
The primary safety endpoints of the study included freedom from device and procedural death at 30 days and freedom from target limb major amputation and clinically driven target lesion revascularization at 12 months.
The primary efficacy endpoint was primary patency at 12 months.
Of the patients included in the study, 50% had diabetes, 41% were women, mean lesion length was 8.3 cm and 44% of lesions were severely calcified.
The study met its primary safety endpoint (DCB, 92.1%; PTA, 83.2%; P for superiority = .025) and the primary patency rate was higher with DCB (76.3% vs. 57.6%; P = .003).
Primary patency per Kaplan-Meier estimates at 12 months was 82.3% and 70.9% for DCB and PTA, respectively (P = .002).
Clinically driven TLR rates were lower in the DCB cohort (7.9% vs. 16.8%; P = .023), according to the researchers.
Although improvements in ankle-brachial index, Rutherford class, and quality of life were comparable between the groups, revascularizations were twice as common in the PTA cohort.
ILLUMINATE PK study
According to Krishnan and colleagues, the prospective, single-arm, multicenter ILLUMINATE PK study was conducted to describe the pharmacokinetics of paclitaxel in the blood delivered from the DCB.
The study measured paclitaxel plasma concentrations after last DCB deployment and at prespecified times until no longer detectable.
The study showed that 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 ng/mL).
“This is the second randomized trial of Stellarex DCB with similar outcomes, validating early conclusions and demonstrating consistency across cohorts and geographies,” the researchers wrote. “The strong safety profile and the superior patency as compared with PTA and the low rate of clinically driven target lesion revascularizations make this DCB a valuable treatment for patients with superficial femoral and popliteal artery disease.” – by Dave Quaile
Disclosures: The study was funded by Spectranetics. Krishnan reports consulting for Abbott, C.R. Bard Peripheral Vascular, Medtronic and Spectranetics. Please see the study for all other authors’ relevant financial disclosures.