1-Year Results From the RANGER II SFA Randomized Trial of the Ranger Drug-Coated Balloon

Sachar, Ravish; Soga, Yoshimitsu; Ansari, Mohammad; Kozuki, Amane; Lopez, Louis; Brodmann, Marianne; Schröe, Herman; Ramanath, Vijay S.; Diaz‐Cartelle, Juan; Zeller, Thomas; Investigators, Ranger Ii Sfa

doi:10.1016/j.jcin.2021.03.021

Cited by 46 publications

(27 citation statements)

References 27 publications

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“…We believe that this may depends on the antithrombotic effect of rivaroxaban. In the Ranger II SFA study published in 2021, the rate of TLR during the 12-month follow-up period was 5.5% (14/256), which was close to the results of this study ( 29 ). In another study, Yoshioka analyzed factors associated with paclitaxel-eluting stent (PES) and DCB-related restenosis for 1-year after femoropopliteal artery surgery ( 14 ).…”

Section: Discussionsupporting

confidence: 90%

Neutrophil-to-Lymphocyte Ratio Predicts Restenosis After Drug-Coated Balloon Therapy for Femoropopliteal Artery Lesions: A Retrospective Study

Wang¹,

Lei²,

Gu³

et al. 2022

Front. Cardiovasc. Med.

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BackgroundPeripheral artery disease (PAD) is a common atherosclerotic vascular disease. The use of drug-coated balloon (DCB) for the treatment of femoropopliteal artery disease has gradually increased. A certain percentage of patients developed target lesion restenosis after DCB treatment of the femoral popliteal artery. The neutrophil-to-lymphocyte ratio (NLR) is closely related to the level of inflammatory activity and has predictive value for atherosclerotic vascular disease. This study aimed to analyze the relationship between NLR and 1-year restenosis after DCB for femoropopliteal artery disease.MethodsPatients with femoropopliteal artery disease who were treated with DCBs at our hospital from May 2016 to December 2020 were retrospectively included. Baseline data during the patient’s first hospital stay and data during follow-up were collected. Demographic data, laboratory test results, lesion examination results, and major adverse events during the follow-up period were collected. Logistic regression was used to analyze the factors associated with restenosis after DCB.ResultsA total of 117 patients were included. During 1-year follow-up, 19 cases (16.2%) of restenosis were detected. Five of these patients (4.3% of total included patients) were readmitted for symptomatic ischemia. No deaths or amputations occurred. Baseline NLR in patients with restenosis was higher than that in patients without restenosis (2.4 (2.1, 3.4) vs. 1.8 (1.3, 2.3), P < 0.001). Logistic univariate and multivariate analysis showed that baseline hs-CRP level (OR = 1.10, 95%CI: 1.05–1.34), lesion length (OR = 1.04, 95%CI: 1.02–1.27), use of rivaroxaban (OR = 1.08, 95%CI: 1.05–1.39), NLR (OR = 1.47, 95%CI: 1.13–2.48), LDL-C level (OR = 1.25, 95%CI: 1.05–1.52), and diabetes (OR = 1.25, 95%CI: 1.05–1.52) = 1.18, 95%CI: 1.06–1.66) were predictors of restenosis.ConclusionBaseline NLR before DCB can predict the risk of restenosis after surgery.

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Section: Discussionsupporting

confidence: 90%

Neutrophil-to-Lymphocyte Ratio Predicts Restenosis After Drug-Coated Balloon Therapy for Femoropopliteal Artery Lesions: A Retrospective Study

Wang¹,

Lei²,

Gu³

et al. 2022

Front. Cardiovasc. Med.

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“…Additional details regarding randomization and masking in RANGER II have been previously published. 13 Procedures Procedure descriptions were previously published. 13 Briefly, the Ranger DCB was used in accordance with the directions for use included with the device.…”

Section: Randomization and Maskingmentioning

confidence: 99%

“… 10 , 11 The recently published RANGER II SFA randomized controlled trial (RCT) demonstrated that the Ranger DCB had significantly better effectiveness than standard PTA through 1 year of follow-up, with a good safety profile. 13 …”

Section: Introductionmentioning

confidence: 99%

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

Schröe

Sachar

Keirse³

et al. 2022

Vasc Med

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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)

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“…3 Ranger DCB demonstrated consistent results with nearly 90% patency at 12-months in the RANGERT II SFA and COMPARE Trials and is built on the 0.018 inch balloon platform with 0.018-and 0.014-inch guidewire compatibility. 8 Twisting of peripheral balloon during below the knee artery intervention has been reported, but twisting of DCB for treating FP artery disease has not been described before. 7 This may be caused by several reasons.…”

Section: Discussionmentioning

confidence: 99%

“…For revascularization of the FP artery, EVT plays a primary role and DCB are widely used with better clinical results than POBA 3 . Ranger DCB demonstrated consistent results with nearly 90% patency at 12‐months in the RANGERT II SFA and COMPARE Trials and is built on the 0.018 inch balloon platform with 0.018‐ and 0.014‐inch guidewire compatibility 8 7 …”

Section: Discussionmentioning

confidence: 99%

Twisting of the Ranger drug‐coated balloon for treating superficial femoral artery disease

Kim

Choi

Kim

et al. 2022

Clinical Case Reports

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1-Year Results From the RANGER II SFA Randomized Trial of the Ranger Drug-Coated Balloon

Cited by 46 publications

References 27 publications

Neutrophil-to-Lymphocyte Ratio Predicts Restenosis After Drug-Coated Balloon Therapy for Femoropopliteal Artery Lesions: A Retrospective Study

Neutrophil-to-Lymphocyte Ratio Predicts Restenosis After Drug-Coated Balloon Therapy for Femoropopliteal Artery Lesions: A Retrospective Study

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

Twisting of the Ranger drug‐coated balloon for treating superficial femoral artery disease

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