Trial reportJournal of endovascular therapy : an official journal of the International Society of Endovascular Specialists2018
Drug-Coated Balloon vs Standard Percutaneous Transluminal Angioplasty for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Proximal Popliteal Arteries: One-Year Results of the MDT-2113 SFA Japan Randomized Trial.
Trial report in Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01947478 (Randomized Trial of MDT-2113 Drug-Eluting Balloon), which is not on this map. Cited by 38 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized Trial of MDT-2113 Drug-Eluting Balloon (DEB) vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery
Who cites it
38 citing papers in PubMed, 4 syntheses or guidelines pooled it, 99 citations in OpenAlex.
- Endovascular revascularization strategies for aortoiliac and femoropopliteal artery disease: a meta-analysis.European heart journal · 2023Pooled it
- Safety of paclitaxel-coated devices in the femoropopliteal arteries: A systematic review and meta-analysis.PloS one · 2022Pooled it
- Association of Survival With Femoropopliteal Artery Revascularization With Drug-Coated Devices.JAMA cardiology · 2019Pooled it
- Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Journal of the American Heart Association · 2018Pooled it
- Methodology of the BIOPACT RCT, a Multi-center, Randomized, Non-inferiority Trial Evaluating Safety and Efficacy of Passeo-18 Lux Drug-Coated Balloon (DCB) of Biotronik Compared to the Medtronic IN.PACT Admiral DCB in the Treatment of Subjects with Lesions of the Femoropopliteal Artery.Cardiovascular and interventional radiology · 2022Trial
- One-year results for Japanese patients in RANGER II SFA.Heart and vessels · 2022Trial
- 24-Month Efficacy and Safety Results from Japanese Patients in the IMPERIAL Randomized Study of the Eluvia Drug-Eluting Stent and the Zilver PTX Drug-Coated Stent.Cardiovascular and interventional radiology · 2021Trial
- Three-Year Results of the IN.PACT SFA Japan Trial Comparing Drug-Coated Balloons With Percutaneous Transluminal Angioplasty.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2020Trial
- Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2020Trial
- IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug-Coated Balloon in a Chinese Patient Population.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2019Trial
- Long-Term Clinical Effectiveness of a Drug-Coated Balloon for the Treatment of Femoropopliteal Lesions.Circulation. Cardiovascular interventions · 2019Trial
- Drug-coated balloon versus uncoated percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery: 2-year results of the MDT-2113 SFA Japan randomized trial.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2019Trial
- Comparative Efficacy of Endovascular Interventions for Peripheral Artery Disease: A Systematic Review and Network Meta-Analysis.Cardiovascular and interventional radiology · 2026Review
- Intravascular Imaging and Pathological Features of Drug-Coated Balloon Angioplasty in Atherosclerotic Porcine Peripheral Arteries.Journal of atherosclerosis and thrombosis · 2025Article
- Impact of Femoropopliteal Drug-Coated Balloon Use on Clinical Outcomes in Patients With Chronic Limb-Threatening Ischemia.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025Observational
- Factors associated with recurrence after drug-coated balloon therapy for femoropopliteal in-stent restenosis.Heart and vessels · 2025Observational
- INtravaScular OptIcal Frequency Domain ImaGing EvaluaTion of the Femoropopliteal Lesion With JETSTREAM Atherectomy (INSIGHT JETSTREAM).Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025Article
- Clinical outcome of low-dose and high-dose drug-coated balloon angioplasty with intraplaque wiring for femoropopliteal chronic total occlusion lesions.Cardiovascular intervention and therapeutics · 2025Article
- Comparison of Endovascular Interventions for the Treatment of Superficial Femoral Artery Disease: A Network Meta-analysis.Journal of the Society for Cardiovascular Angiography & Interventions · 2025Review
- Difference in one-year late lumen loss between high- and low-dose paclitaxel-coated balloons for femoropopliteal disease.Heart and vessels · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo assess the safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) for the treatment of de novo and native artery restenotic lesions in the superficial femoral and proximal popliteal arteries vs percutaneous transluminal angioplasty (PTA) with an uncoated balloon in a Japanese cohort.
methodsMDT-2113 SFA Japan ( ClinicalTrials.gov identifier NCT01947478) is an independently adjudicated, prospective, randomized, single-blinded trial that randomized (2:1) 100 patients (mean age 73.6±7.0 years; 76 men) from 11 Japanese centers to treatment with DCB (n=68) or PTA (n=32). Baseline characteristics were similar between the groups, including mean lesion length (9.15±5.85 and 8.89±6.01 cm for the DCB and PTA groups, respectively). The primary effectiveness outcome was primary patency at 12 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis as determined by duplex ultrasonography. The safety endpoint was a composite of 30-day device- and procedure-related death and target limb major amputation and clinically-driven target vessel revascularization within 12 months.
resultsPatients treated with DCBs exhibited superior 12-month primary patency (89%) compared to patients treated with PTA (48%, p<0.001). The 12-month CD-TLR rate was 3% for DCB vs 19% for PTA (p=0.012). There were no device- or procedure-related deaths, major amputations, or thromboses in either group. Quality-of-life measures showed sustained improvement from baseline to 12 months in both groups.
conclusionResults from the MDT-2113 SFA Japan trial showed superior treatment effect for DCB vs PTA, with excellent patency and low CD-TLR rates. These results are consistent with other IN.PACT SFA DCB trials and demonstrate the safety and effectiveness of this DCB for the treatment of femoropopliteal lesions in this Japanese cohort.
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