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

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)

The safety and efficacy of ‘going long’

“…1 The mean lesion length was 144.5 ± 31.7 mm, which is more ‘real-world’ given that most RCTs in this vascular bed (SFA) limit lesion length to 80 mm. 1 There were an impressive 32.6% total occlusions included, and calcification as graded by the Peripheral Arterial Calcium Scoring System (PACSS) was significant in 58.1% of the patients (grades 3 or 4), which is again illustrative of more ‘real-world’ contemporary SFA lesions.…”

“…These are standard outcomes and are comparable to other studies in the field.Though small compared to many coronary interventional trials, a total of 129 patients met criteria for this cohort, which is comparable to many contemporary peripheral DCB trials. 1 The mean lesion length was 144.5 ± 31.7 mm, which is more 'real-world' given that most RCTs in this vascular bed (SFA) limit lesion length to 80 mm. 1 There were an impressive 32.6% total occlusions included, and calcification as graded by the Peripheral Arterial Calcium Scoring System (PACSS) was significant in 58.1% of the patients (grades 3 or 4), which is again illustrative of more 'real-world' contemporary SFA lesions.It is in the outcomes of this study where things diverge from other similar studies.…”

“…The most remarkable outcome reported in this cohort is the low provisional stenting rate of 7.0% despite enrolling patients with long lesions. 1 This low rate of bailout stenting (note that bare-metal stents were required) is remarkable and underscores the techniques and patience of the operators. A DCB inflation time of 3 minutes was required, which often can tack up most dissections, but also try the patience of the operators.…”

“…Schroë and colleagues report a rather impressive primary patency in this study of 88% at 12 months with a very low adverse event rate of 4.9%, which was entirely accounted for by clinically driven target lesion revascularization (CD-TLR). 1 To the interventionalist, outside of mortality, CD-TLR is the most important endpoint, as it reports how many patients needed to come back for repeat procedures -the bane of our existence in this vascular bed. A CD-TLR rate this low, as reported in this study, is unique given the length of lesions included.The most important outcome to report in any DCB trial in today's climate is mortality, which in this study was very low at 2.4% (3/125) at 12 months.…”

“…In this issue of Vascular Medicine , Schroë and colleagues present the 12-month results of the long lesion cohort from the RANGER II Superficial Femoral Artery (SFA) Trial (ClinicalTrials.gov identifier: NCT03064126). 1 This cohort is composed of patients who were in the original RANGER II SFA randomized controlled trial (RCT) plus the long balloon substudy, had a baseline lesion measurement > 100 mm, and were treated with a Ranger drug-coated balloon (DCB; Boston Scientific, Natick, MA, USA). This cohort contained symptomatic patients with Rutherford classification 2–4 disease.…”