The RANGER II superficial femoral artery trial: 1-year results of the long lesion cohort

Herman Schroë, Ravish Sachar, Koen Keirse, Yoshimitsu Soga, Marianne Brodmann, Vikram Rao, Martin Werner, Andrew Holden, Louis Lopez, Prakash Krishnan, Juan Diaz-Cartelle, Herman Schroë, Ravish Sachar, Koen Keirse, Yoshimitsu Soga, Marianne Brodmann, Vikram Rao, Martin Werner, Andrew Holden, Louis Lopez, Prakash Krishnan, Juan Diaz-Cartelle

Abstract

Background: The objective of the RANGER II SFA long lesion cohort analysis was to evaluate the safety and effectiveness of the Ranger drug-coated balloon (DCB) in patients with lesion lengths greater than 100 mm.

Methods: Patients from the RANGER II SFA randomized controlled trial and long balloon sub-study were included in the long lesion cohort if their baseline lesion measurement was > 100 mm and if they had been treated with a RANGER DCB. Patients had symptomatic lower limb peripheral artery disease and Rutherford classification 2-4 symptomatology. The endpoints of interest included the 12-month target lesion primary patency and freedom from major adverse events (MAEs).Additional patient outcomes including changes in Rutherford classification were also evaluated.

Results: A total of 129 patients met the inclusion criteria and were included in the long lesion cohort. Mean lesion length was 144.5 ± 31.7 mm. Seventy-five lesions had Peripheral Arterial Calcium Scoring System (PACSS) grades 3 (33.3%, 43/129) and 4 (24.8%, 32/129). The Kaplan-Meier estimate of the primary patency rate at 12 months was 88.0%. The rate of freedom from MAEs at 12 months was 95.1% (117/123; 95% CI: 89.7%, 98.2%); all MAEs were clinically driven target lesion revascularization (4.9%, 6/123). The 12-month mortality rate was 2.4% (3/125).

Conclusions: Patients with lesions > 100 mm treated with Ranger DCBs demonstrated excellent 1-year safety and efficacy results, comparable to those of the overall RANGER II SFA randomized clinical trial. This suggests that the Ranger DCB can provide consistent results regardless of lesion length. (ClinicalTrials.gov Identifier: NCT03064126).

Keywords: drug-coated balloon (DCB); endovascular therapy; femoropopliteal arterial segment; long lesions; paclitaxel.

Conflict of interest statement

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr Schroë is a consultant for Boston Scientific. Dr Sachar is a consultant for Boston Scientific and Medtronic; in the last 24 months he has received research funding from Boston Scientific, Medtronic, Terumo, and Gore; he is a shareholder of Contego Medical. Dr Keirse has no relevant disclosures. Dr Soga has no relevant disclosures. Dr Brodmann is a consultant for BD Bard, Philips, Medtronic, Boston Scientific, Shockwave, Cook Medical, Cagent Vascular, Bayer Healthcare, Biotronik, Reflow Medical. Dr Rao has no relevant disclosures. Dr Werner has no relevant disclosures. Dr Holden is a Clinical Investigator and Medical Advisory Board Member for Boston Scientific. Dr Lopez has no relevant disclosures. Dr Krishnan has no relevant disclosures. Dr Diaz-Cartelle is a Medical Director at Boston Scientific.

Figures

Figure 1.
Figure 1.
RANGER II superficial femoral artery (SFA) long lesion patient cohort. The pooled long lesion cohort comprises patients from the RANGER II SFA RCT and long balloon sub-study who were treated with the DCB and who had a lesion length ⩾ 100 mm. DCB, drug-coated balloon; PTA, percutaneous transluminal angioplasty; RCT, randomized controlled trial.
Figure 2.
Figure 2.
Kaplan–Meier curves of (A) primary patency and(B) freedom from target lesion revascularization (TLR) for the long lesion cohort. Patency based on the time-to-event of TLR and/or 12-month duplex ultrasound patency failure.
Figure 3.
Figure 3.
Rutherford category over 12 months post-procedure in the long lesion cohort. Colors represent the Rutherford categories.
Figure 4.
Figure 4.
Lesion lengths in pivotal DCB trials,– and studies of ‘long’ lesions.,,, Reported mean lesion length (SD) and minimum and maximum lengths per study eligibility criteria shown. The COMPARE study stratified enrollment by lesion length and included 276 patients with lesions > 10 cm. Maximum lesion length for both the RANGER II SFA RCT and long balloon sub-study contributing to the long lesion cohort was 180 mm. *DCB group shown. DCB, drug-coated balloon; SFA, superficial femoral artery; RCT, randomized controlled trial.

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Source: PubMed

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