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Randomized Controlled Trial
. 2017 Sep 19;136(12):1102-1113.
doi: 10.1161/CIRCULATIONAHA.117.028893. Epub 2017 Jul 20.

Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease: Twelve-Month Outcomes From the Randomized ILLUMENATE Pivotal and Pharmacokinetic Studies

Prakash Krishnan  1 , Peter Faries  2 , Khusrow Niazi  2 , Ash Jain  2 , Ravish Sachar  2 , William B Bachinsky  2 , Joseph Cardenas  2 , Martin Werner  2 , Marianne Brodmann  2 , J A Mustapha  2 , Carlos Mena-Hurtado  2 , Michael R Jaff  2 , Andrew H Holden  2 , Sean P Lyden  2
Affiliations
Randomized Controlled Trial

Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease: Twelve-Month Outcomes From the Randomized ILLUMENATE Pivotal and Pharmacokinetic Studies

Prakash Krishnan et al. Circulation. .

Abstract

Background: Drug-coated balloons (DCBs) are a predominant revascularization therapy for symptomatic femoropopliteal artery disease. Because of the differences in excipients, paclitaxel dose, and coating morphologies, varying clinical outcomes have been observed with different DCBs. We report the results of 2 studies investigating the pharmacokinetic and clinical outcomes of a new DCB to treat femoropopliteal disease.

Methods: In the ILLUMENATE Pivotal Study (Prospective, Randomized, Single-Blind, U.S. Multi-Center Study to Evaluate Treatment of Obstructive Superficial Femoral Artery or Popliteal Lesions With A Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon), 300 symptomatic patients (Rutherford class 2-4) were randomly assigned to DCB (n=200) or standard angioplasty (percutaneous transluminal angioplasty [PTA]) (n=100). The primary safety end point 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. The primary effectiveness end point was primary patency through 12 months. In the ILLUMENATE PK study (Pharmacokinetic Study of the Stellarex Drug-Coated Angioplasty Balloon), paclitaxel plasma concentrations were measured after last DCB deployment and at prespecified times (at 1, 4, 24 hours and at 7 and 14 days postprocedure) until no longer detectable.

Results: In the ILLUMENATE Pivotal Study, baseline characteristics were similar between groups: 50% had diabetes mellitus, 41% were women, mean lesion length was 8.3 cm, and 44% were severely calcified. The primary safety end point was met (92.1% for DCB versus 83.2% for PTA, P=0.025 for superiority) and the primary patency rate was significantly higher with DCB (76.3% for DCB versus 57.6% for PTA, P=0.003). Primary patency per Kaplan-Meier estimates at day 365 was 82.3% for DCB versus 70.9% for PTA (P=0.002). The rate of clinically driven target lesion revascularization was significantly lower in the DCB cohort (7.9% versus 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. Pharmacokinetic outcomes 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±1.0 ng/mL).

Conclusions: The data demonstrate superior safety and effectiveness of the Stellarex DCB in comparison with PTA, and plasma levels of paclitaxel fall to low levels within 1 hour.

Clinical trial registration: URL: http://clinicaltrials.gov. Unique identifiers: NCT01858428 and NCT01912937.

Keywords: angioplasty; drug-eluting balloon; femoropopliteal; intermittent claudication; paclitaxel; peripheral arterial disease.

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Figures

Figure 1.
Figure 1.
Serum paclitaxel concentrations from the ILLUMENATE PK study (Pharmacokinetic Study of the Stellarex Drug-Coated Angioplasty Balloon). Individual paclitaxel concentrations at each time point are shown. Mean paclitaxel concentrations declined rapidly within the first hour (54.4±116.9 ng/mL to 1.4±1.0 ng/mL), followed by a gradual decline to 0.3±0.1 ng/mL over 24 hours.
Figure 2.
Figure 2.
CONSORT patient flow diagram. DCB indicates drug-coated balloon; ITT, intent-to-treat; LTFU, lost to follow-up; and PTA, percutaneous transluminal angioplasty.
Figure 3.
Figure 3.
Primary patency through 1 year. Comparing DCB with PTA, primary patency was 82.3% versus 70.9% at day 365 (P=0.002 by log-rank test). CI indicates confidence interval; DCB, drug-coated balloon; and PTA, percutaneous transluminal angioplasty.
Figure 4.
Figure 4.
Freedom from clinically driven target lesion revascularization through 1 year. Comparing DCB with PTA, freedom from clinically driven target lesion revascularization was 93.6% versus 87.3% at day 365 (P=0.025 by log-rank test). CI indicates confidence interval; DCB, drug-coated balloon; PTA, percutaneous transluminal angioplasty; and TLR, target lesion revascularization.
See this image and copyright information in PMC

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