Trial reportCirculation. Cardiovascular interventions2018
Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries: Long-Term Results of the IN.PACT SFA Randomized Trial.
3 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph
Trial report in Circulation. Cardiovascular interventions, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 78 papers, 7 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 7 pooled it
27.9field-weighted citation impact, top 1% of its field
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 IN.PACT Admiral(TM) Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease
Randomized Trial of IN.PACT (Paclitaxel) Admiral Drug-Coated Balloon (DCB) vs. Standard Percutaneous Transluminal Angioplasty (PTA) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA)
Randomized Controlled Trial of Paclitaxel Drug-coated Balloons vs. Nitinol Stent for Femoropopliteal Obstructions - The PAVENST Trial
Who cites it
78 citing papers in PubMed, 7 syntheses or guidelines pooled it, 215 citations in OpenAlex.
- Integrative bioinformatics frameworks for abdominal aortic aneurysm using GWAS meta-analysis, biological network construction, and structural modeling.Scientific reports · 2025Pooled it
- Robustness of Longitudinal Safety and Efficacy After Paclitaxel-Based Endovascular Therapy for Treatment of Femoro-Popliteal Artery Occlusive Disease: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials.Annals of vascular surgery · 2024Pooled it
- Endovascular revascularization strategies for aortoiliac and femoropopliteal artery disease: a meta-analysis.European heart journal · 2023Pooled it
- Update on paclitaxel for femoral-popliteal occlusive disease in the 15 months following a summary level meta-analysis demonstrated increased risk of late mortality and dose response to paclitaxel.Journal of vascular surgery · 2021Pooled it
- Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years.Circulation · 2019Pooled 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
- Twenty-Four-Month Outcomes of Intravascular Ultrasound-Guided Drug-Coated Balloon Angioplasty for Femoropopliteal Artery Disease.Journal of the American Heart Association · 2025Trial
- 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
- One-year results of drug-coated balloons for long and occlusive Femoropopliteal artery disease: a single-arm trial.BMC cardiovascular disorders · 2020Trial
- 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
- Assessment of Recurrence Patterns and Treatment Strategies for Reintervention after Paclitaxel-Coated Balloon Angioplasty in Femoropopliteal Artery Diseases: Results of the ASTRA Study.Journal of atherosclerosis and thrombosis · 2026Article
- Safety of paclitaxel-coated devices in patients with peripheral artery disease: an updated systematic review and meta-analysis of randomized controlled trials.EClinicalMedicine · 2026Article
- The ups and downs of paclitaxel-coated balloons and paclitaxel eluting stents: do the conclusions of SWEDEPAD 2 change our practice? Should we be concerned about mortality (again)?CVIR endovascular · 2026Article
- Drug-Coated Balloon Angioplasty for de Novo Subclavian Artery Stenosis: Mid-Term Outcomes and Independent Risk Factors for Restenosis.Vascular health and risk management · 2026Article
- Nationwide Study of the Outcome of Treatment of Lower Extremity Atherosclerotic Lesions With Endovascular Surgery With or Without Drug Eluting Methods in Patients With Diabetes.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2025Observational
- Long-term effects of statin and anticoagulant therapy on restenosis after drug-coated balloon angioplasty for femoropopliteal artery disease: results from the POPCORN registry.Cardiovascular intervention and therapeutics · 2025Observational
18 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
14 authors at 1 institution in 1 country.
Peter A SchneiderFrom the Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, HI (P.A.S.); Adventist Heart and Vascular Institute, St Helena Hospital, CA (J.R.L.); Department of Diagnostic and Interventional Radiology, RoMed Klinikum, Rosenheim, Germany (G.T.); Department of Internal Medicine, Division of Angiology, Medical University, Graz, Austria (M.B.); Angiology Division, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany (T.Z.); Department of Angiology, University Hospital Leipzig, Germany (D.S.); Wellmont Holston Valley Medical Center, Kingsport, TN (C.M.); GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy (A.M.); North Carolina Heart and Vascular, UNC-REX Health Care, Raleigh, NC (R.S.); Newton-Wellesley Hospital, MA (M.R.J.); Medtronic, Santa Rosa, CA (H.W., M.S.H.); and Icahn School of Medicine, Mount Sinai Medical Center, New York, NY (P.K.). peterschneidermd@aol.com.
John R LairdFrom the Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, HI (P.A.S.); Adventist Heart and Vascular Institute, St Helena Hospital, CA (J.R.L.); Department of Diagnostic and Interventional Radiology, RoMed Klinikum, Rosenheim, Germany (G.T.); Department of Internal Medicine, Division of Angiology, Medical University, Graz, Austria (M.B.); Angiology Division, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany (T.Z.); Department of Angiology, University Hospital Leipzig, Germany (D.S.); Wellmont Holston Valley Medical Center, Kingsport, TN (C.M.); GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy (A.M.); North Carolina Heart and Vascular, UNC-REX Health Care, Raleigh, NC (R.S.); Newton-Wellesley Hospital, MA (M.R.J.); Medtronic, Santa Rosa, CA (H.W., M.S.H.); and Icahn School of Medicine, Mount Sinai Medical Center, New York, NY (P.K.).
Gunnar TepeFrom the Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, HI (P.A.S.); Adventist Heart and Vascular Institute, St Helena Hospital, CA (J.R.L.); Department of Diagnostic and Interventional Radiology, RoMed Klinikum, Rosenheim, Germany (G.T.); Department of Internal Medicine, Division of Angiology, Medical University, Graz, Austria (M.B.); Angiology Division, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany (T.Z.); Department of Angiology, University Hospital Leipzig, Germany (D.S.); Wellmont Holston Valley Medical Center, Kingsport, TN (C.M.); GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy (A.M.); North Carolina Heart and Vascular, UNC-REX Health Care, Raleigh, NC (R.S.); Newton-Wellesley Hospital, MA (M.R.J.); Medtronic, Santa Rosa, CA (H.W., M.S.H.); and Icahn School of Medicine, Mount Sinai Medical Center, New York, NY (P.K.).
Marianne BrodmannFrom the Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, HI (P.A.S.); Adventist Heart and Vascular Institute, St Helena Hospital, CA (J.R.L.); Department of Diagnostic and Interventional Radiology, RoMed Klinikum, Rosenheim, Germany (G.T.); Department of Internal Medicine, Division of Angiology, Medical University, Graz, Austria (M.B.); Angiology Division, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany (T.Z.); Department of Angiology, University Hospital Leipzig, Germany (D.S.); Wellmont Holston Valley Medical Center, Kingsport, TN (C.M.); GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy (A.M.); North Carolina Heart and Vascular, UNC-REX Health Care, Raleigh, NC (R.S.); Newton-Wellesley Hospital, MA (M.R.J.); Medtronic, Santa Rosa, CA (H.W., M.S.H.); and Icahn School of Medicine, Mount Sinai Medical Center, New York, NY (P.K.).
Thomas ZellerFrom the Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, HI (P.A.S.); Adventist Heart and Vascular Institute, St Helena Hospital, CA (J.R.L.); Department of Diagnostic and Interventional Radiology, RoMed Klinikum, Rosenheim, Germany (G.T.); Department of Internal Medicine, Division of Angiology, Medical University, Graz, Austria (M.B.); Angiology Division, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany (T.Z.); Department of Angiology, University Hospital Leipzig, Germany (D.S.); Wellmont Holston Valley Medical Center, Kingsport, TN (C.M.); GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy (A.M.); North Carolina Heart and Vascular, UNC-REX Health Care, Raleigh, NC (R.S.); Newton-Wellesley Hospital, MA (M.R.J.); Medtronic, Santa Rosa, CA (H.W., M.S.H.); and Icahn School of Medicine, Mount Sinai Medical Center, New York, NY (P.K.).
Dierk ScheinertFrom the Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, HI (P.A.S.); Adventist Heart and Vascular Institute, St Helena Hospital, CA (J.R.L.); Department of Diagnostic and Interventional Radiology, RoMed Klinikum, Rosenheim, Germany (G.T.); Department of Internal Medicine, Division of Angiology, Medical University, Graz, Austria (M.B.); Angiology Division, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany (T.Z.); Department of Angiology, University Hospital Leipzig, Germany (D.S.); Wellmont Holston Valley Medical Center, Kingsport, TN (C.M.); GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy (A.M.); North Carolina Heart and Vascular, UNC-REX Health Care, Raleigh, NC (R.S.); Newton-Wellesley Hospital, MA (M.R.J.); Medtronic, Santa Rosa, CA (H.W., M.S.H.); and Icahn School of Medicine, Mount Sinai Medical Center, New York, NY (P.K.).
Christopher MetzgerFrom the Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, HI (P.A.S.); Adventist Heart and Vascular Institute, St Helena Hospital, CA (J.R.L.); Department of Diagnostic and Interventional Radiology, RoMed Klinikum, Rosenheim, Germany (G.T.); Department of Internal Medicine, Division of Angiology, Medical University, Graz, Austria (M.B.); Angiology Division, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany (T.Z.); Department of Angiology, University Hospital Leipzig, Germany (D.S.); Wellmont Holston Valley Medical Center, Kingsport, TN (C.M.); GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy (A.M.); North Carolina Heart and Vascular, UNC-REX Health Care, Raleigh, NC (R.S.); Newton-Wellesley Hospital, MA (M.R.J.); Medtronic, Santa Rosa, CA (H.W., M.S.H.); and Icahn School of Medicine, Mount Sinai Medical Center, New York, NY (P.K.).
Antonio MicariFrom the Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, HI (P.A.S.); Adventist Heart and Vascular Institute, St Helena Hospital, CA (J.R.L.); Department of Diagnostic and Interventional Radiology, RoMed Klinikum, Rosenheim, Germany (G.T.); Department of Internal Medicine, Division of Angiology, Medical University, Graz, Austria (M.B.); Angiology Division, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany (T.Z.); Department of Angiology, University Hospital Leipzig, Germany (D.S.); Wellmont Holston Valley Medical Center, Kingsport, TN (C.M.); GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy (A.M.); North Carolina Heart and Vascular, UNC-REX Health Care, Raleigh, NC (R.S.); Newton-Wellesley Hospital, MA (M.R.J.); Medtronic, Santa Rosa, CA (H.W., M.S.H.); and Icahn School of Medicine, Mount Sinai Medical Center, New York, NY (P.K.).
Ravish SacharFrom the Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, HI (P.A.S.); Adventist Heart and Vascular Institute, St Helena Hospital, CA (J.R.L.); Department of Diagnostic and Interventional Radiology, RoMed Klinikum, Rosenheim, Germany (G.T.); Department of Internal Medicine, Division of Angiology, Medical University, Graz, Austria (M.B.); Angiology Division, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany (T.Z.); Department of Angiology, University Hospital Leipzig, Germany (D.S.); Wellmont Holston Valley Medical Center, Kingsport, TN (C.M.); GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy (A.M.); North Carolina Heart and Vascular, UNC-REX Health Care, Raleigh, NC (R.S.); Newton-Wellesley Hospital, MA (M.R.J.); Medtronic, Santa Rosa, CA (H.W., M.S.H.); and Icahn School of Medicine, Mount Sinai Medical Center, New York, NY (P.K.).
Michael R JaffFrom the Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, HI (P.A.S.); Adventist Heart and Vascular Institute, St Helena Hospital, CA (J.R.L.); Department of Diagnostic and Interventional Radiology, RoMed Klinikum, Rosenheim, Germany (G.T.); Department of Internal Medicine, Division of Angiology, Medical University, Graz, Austria (M.B.); Angiology Division, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany (T.Z.); Department of Angiology, University Hospital Leipzig, Germany (D.S.); Wellmont Holston Valley Medical Center, Kingsport, TN (C.M.); GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy (A.M.); North Carolina Heart and Vascular, UNC-REX Health Care, Raleigh, NC (R.S.); Newton-Wellesley Hospital, MA (M.R.J.); Medtronic, Santa Rosa, CA (H.W., M.S.H.); and Icahn School of Medicine, Mount Sinai Medical Center, New York, NY (P.K.).
Hong WangFrom the Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, HI (P.A.S.); Adventist Heart and Vascular Institute, St Helena Hospital, CA (J.R.L.); Department of Diagnostic and Interventional Radiology, RoMed Klinikum, Rosenheim, Germany (G.T.); Department of Internal Medicine, Division of Angiology, Medical University, Graz, Austria (M.B.); Angiology Division, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany (T.Z.); Department of Angiology, University Hospital Leipzig, Germany (D.S.); Wellmont Holston Valley Medical Center, Kingsport, TN (C.M.); GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy (A.M.); North Carolina Heart and Vascular, UNC-REX Health Care, Raleigh, NC (R.S.); Newton-Wellesley Hospital, MA (M.R.J.); Medtronic, Santa Rosa, CA (H.W., M.S.H.); and Icahn School of Medicine, Mount Sinai Medical Center, New York, NY (P.K.).
Melissa S HasenbankFrom the Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, HI (P.A.S.); Adventist Heart and Vascular Institute, St Helena Hospital, CA (J.R.L.); Department of Diagnostic and Interventional Radiology, RoMed Klinikum, Rosenheim, Germany (G.T.); Department of Internal Medicine, Division of Angiology, Medical University, Graz, Austria (M.B.); Angiology Division, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany (T.Z.); Department of Angiology, University Hospital Leipzig, Germany (D.S.); Wellmont Holston Valley Medical Center, Kingsport, TN (C.M.); GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy (A.M.); North Carolina Heart and Vascular, UNC-REX Health Care, Raleigh, NC (R.S.); Newton-Wellesley Hospital, MA (M.R.J.); Medtronic, Santa Rosa, CA (H.W., M.S.H.); and Icahn School of Medicine, Mount Sinai Medical Center, New York, NY (P.K.).
Prakash KrishnanFrom the Hawaii Permanente Medical Group, Kaiser Foundation Hospital, Honolulu, HI (P.A.S.); Adventist Heart and Vascular Institute, St Helena Hospital, CA (J.R.L.); Department of Diagnostic and Interventional Radiology, RoMed Klinikum, Rosenheim, Germany (G.T.); Department of Internal Medicine, Division of Angiology, Medical University, Graz, Austria (M.B.); Angiology Division, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany (T.Z.); Department of Angiology, University Hospital Leipzig, Germany (D.S.); Wellmont Holston Valley Medical Center, Kingsport, TN (C.M.); GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy (A.M.); North Carolina Heart and Vascular, UNC-REX Health Care, Raleigh, NC (R.S.); Newton-Wellesley Hospital, MA (M.R.J.); Medtronic, Santa Rosa, CA (H.W., M.S.H.); and Icahn School of Medicine, Mount Sinai Medical Center, New York, NY (P.K.).
IN.PACT SFA Trial Investigators
Universitäts-Herzzentrum Freiburg-Bad Krozingen · DE
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRandomized controlled trials have reported favorable 1-year outcomes with drug-coated balloons (DCBs) for the treatment of symptomatic peripheral arterial disease when compared with standard percutaneous transluminal angioplasty (PTA). Evidence remains limited on the durability of the treatment effect with DCBs in the longer term. METHODS AND
resultsIN.PACT SFA is a single-blind, randomized trial (Randomized Trial of IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty [PTA] Balloon Catheter vs Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery [SFA] and/or Proximal Popliteal Artery [PPA]) that enrolled 331 patients with symptomatic (Rutherford 2-4) femoropopliteal lesions up to 18 cm in length. Patients were randomized 2:1 to receive treatment with DCB or PTA. The 36-month assessments included primary patency, freedom from clinically driven target lesion revascularization, major adverse events, and functional outcomes. At 36 months, primary patency remained significantly higher among patients treated with DCB compared with PTA (69.5% versus 45.1%; log rank
conclusionsThree-year results demonstrate a durable and superior treatment effect among patients treated with DCB versus standard PTA, with significantly higher primary patency and lower clinically driven target lesion revascularization, resulting in similar functional improvements with reduced need for repeat interventions. CLINICAL
trial registrationURL: http://www.clinicaltrials.gov. Unique identifiers: NCT01175850 for IN.PACT SFA phase I in the European Union and NCT01566461 for IN.PACT SFA phase II in the United States.
Indexed as
Coated Materials, BiocompatibleFemoral ArteryPopliteal ArteryVascular Access DevicesAgedAngioplasty, BalloonCardiovascular AgentsEquipment DesignEuropeFemaleHumansMaleMiddle AgedPaclitaxelPeripheral Arterial DiseaseProspective StudiesCardiovascular AgentsCoated Materials, BiocompatiblePaclitaxelangioplastyperipheral arterial diseasetarget lesion revascularization
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.