Trial reportCirculation. Cardiovascular interventions2017
Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency: Twelve-Month Results of the DEFINITIVE AR Study.
2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph
Trial report in Circulation. Cardiovascular interventions, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 80 papers, 5 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed, 5 pooled it
–field-weighted citation impact
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.
Directional AthErectomy Followed by a PaclItaxel-Coated BallooN to InhibiT RestenosIs and Maintain Vessel PatEncy: A Pilot Study of Anti-Restenosis Treatment
The THOR IDE Study
Who cites it
80 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- Paving the Way: a Systematic Review and Meta-Analysis of Randomized Controlled Trials of Atherectomy as Vessel Preparation Prior to Balloon Angioplasty in Peripheral Arterial Disease.Cardiovascular and interventional radiology · 2026Pooled it
- Drug-coated balloon alone versus atherectomy plus drug-coated balloon for treatment of femoropopliteal atherosclerotic disease: a meta-analysis.Journal of cardiothoracic surgery · 2026Pooled it
- The efficacy and safety of atherectomy combined with drug-coated balloon angioplasty vs. drug-coated balloon angioplasty for the treatment of lower extremity artery disease: a systematic review and meta-analysis.Frontiers in cardiovascular medicine · 2024Pooled it
- Endovascular revascularization strategies for aortoiliac and femoropopliteal artery disease: a meta-analysis.European heart journal · 2023Pooled it
- Atherectomy for peripheral arterial disease.The Cochrane database of systematic reviews · 2020Pooled it
- Jetstream Atherectomy with Paclitaxel-Coated Balloons: Two-Year Outcome of the Prospective Randomized JET-RANGER Study.Vascular health and risk management · 2023Trial
- Jetstream Atherectomy Followed by Paclitaxel-Coated Balloons versus Balloon Angioplasty Followed by Paclitaxel-Coated Balloons: Twelve-Month Exploratory Results of the Prospective Randomized JET-RANGER Study.Vascular health and risk management · 2022Trial
- 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
- Endovascular Therapy for Femoropopliteal Artery Lesions Involving the Popliteal Artery: 1-Year Outcomes from a Real-World Multicenter Registry.Cardiovascular and interventional radiology · 2026Article
- Contemporary Endovascular Treatment of Femoropopliteal Disease: Lesion Preparation, Antiproliferative Therapies, and Emerging Technologies.Journal of clinical medicine · 2026Review
- The Role of Atherectomy in Lesion Preparation for Peripheral Artery Disease: Evolution of Technologies, Available Devices, and Contemporary Evidence.Reviews in cardiovascular medicine · 2026Review
- Atherectomy Followed by Drug-Coated Balloon Angioplasty Versus Surgery for Symptomatic Deep Femoral Artery Arteriosclerotic Disease.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2026Article
- Directional Atherectomy Versus Plain Old Balloon Angioplasty for Vessel Preparation Before Drug-Coated Balloon Treatment in Moderate-to-Severe Calcified Lesions.Cardiovascular and interventional radiology · 2026Article
- A novel technique for preventing distal embolism during endovascular therapy for femoropopliteal lesions: The flow-controlled anti-embolic technique.Journal of vascular surgery cases and innovative techniques · 2026Article
- Peri-procedural and 6-month outcomes of rotational atherectomy for highly calcified femoropopliteal lesions from Japanese postmarketing surveillance.Heart and vessels · 2026Observational
- Clinical outcomes of directional atherectomy versus plain balloon angioplasty as vessel preparation prior to drug-coated balloon treatment for femoropopliteal occlusive disease.Scientific reports · 2026Observational
- Determinants of Peri-Procedural Mechanical Complications During Peripheral Endovascular Revascularization: Insights from Single-Center Experience.Life (Basel, Switzerland) · 2026Article
- Endovascular management of superficial femoral artery chronic total occlusions: Influence of lesion complexity and popliteal access on the efficacy of rotational atherectomy plus drug-coated balloon versus drug-coated balloon alone.Journal of clinical imaging science · 2026Article
- Published Evidence on Peripheral Atherectomy: A Meta-analysis and Systematic Literature Review of More Than 300 Original Investigations.Journal of the Society for Cardiovascular Angiography & Interventions · 2025Review
- Algorithm for the Revascularization of Infrainguinal Arterial Disease.Vascular specialist international · 2025Review
20 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Thomas ZellerFrom the Universitäts-Herzzentrum Bad Krozingen, Germany (T.Z.); Sankt Getrauden-Krankenhaus, Berlin, Germany (R.L.); Prairie Heart Institute at St. John's Hospital, Springfield, IL (K.J.R.-S.); VasCore-the Vascular Ultrasound Core Laboratory, Massachusetts General Hospital, Boston (M.R.J.); SRH Klinikum Karlsbad-Langensteinbach, Germany (E.B.); Clinic for Angiology, University Hospital Zurich, Switzerland (B.A.-V.); Zakład Leczniczy Angio-Medicus, Krakow, Poland (M.K.); Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium (P.P.); Department of Interventional Angiology, University Hospital Leipzig, Germany (D.S.); University Hospital Muenster, Klinik for Vascular and Endovascular Surgery, Germany (G. Torsello); Swiss Cardiovascular Center, Division of Angiology, University Hospital, Inselspital Bern, Switzerland (S.S.); and Klinikum Rosenheim, Germany (G. Tepe). thomas.zeller@universitaets-herzzentrum.de.
Ralf LanghoffFrom the Universitäts-Herzzentrum Bad Krozingen, Germany (T.Z.); Sankt Getrauden-Krankenhaus, Berlin, Germany (R.L.); Prairie Heart Institute at St. John's Hospital, Springfield, IL (K.J.R.-S.); VasCore-the Vascular Ultrasound Core Laboratory, Massachusetts General Hospital, Boston (M.R.J.); SRH Klinikum Karlsbad-Langensteinbach, Germany (E.B.); Clinic for Angiology, University Hospital Zurich, Switzerland (B.A.-V.); Zakład Leczniczy Angio-Medicus, Krakow, Poland (M.K.); Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium (P.P.); Department of Interventional Angiology, University Hospital Leipzig, Germany (D.S.); University Hospital Muenster, Klinik for Vascular and Endovascular Surgery, Germany (G. Torsello); Swiss Cardiovascular Center, Division of Angiology, University Hospital, Inselspital Bern, Switzerland (S.S.); and Klinikum Rosenheim, Germany (G. Tepe).
Krishna J Rocha-SinghFrom the Universitäts-Herzzentrum Bad Krozingen, Germany (T.Z.); Sankt Getrauden-Krankenhaus, Berlin, Germany (R.L.); Prairie Heart Institute at St. John's Hospital, Springfield, IL (K.J.R.-S.); VasCore-the Vascular Ultrasound Core Laboratory, Massachusetts General Hospital, Boston (M.R.J.); SRH Klinikum Karlsbad-Langensteinbach, Germany (E.B.); Clinic for Angiology, University Hospital Zurich, Switzerland (B.A.-V.); Zakład Leczniczy Angio-Medicus, Krakow, Poland (M.K.); Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium (P.P.); Department of Interventional Angiology, University Hospital Leipzig, Germany (D.S.); University Hospital Muenster, Klinik for Vascular and Endovascular Surgery, Germany (G. Torsello); Swiss Cardiovascular Center, Division of Angiology, University Hospital, Inselspital Bern, Switzerland (S.S.); and Klinikum Rosenheim, Germany (G. Tepe).
Michael R JaffFrom the Universitäts-Herzzentrum Bad Krozingen, Germany (T.Z.); Sankt Getrauden-Krankenhaus, Berlin, Germany (R.L.); Prairie Heart Institute at St. John's Hospital, Springfield, IL (K.J.R.-S.); VasCore-the Vascular Ultrasound Core Laboratory, Massachusetts General Hospital, Boston (M.R.J.); SRH Klinikum Karlsbad-Langensteinbach, Germany (E.B.); Clinic for Angiology, University Hospital Zurich, Switzerland (B.A.-V.); Zakład Leczniczy Angio-Medicus, Krakow, Poland (M.K.); Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium (P.P.); Department of Interventional Angiology, University Hospital Leipzig, Germany (D.S.); University Hospital Muenster, Klinik for Vascular and Endovascular Surgery, Germany (G. Torsello); Swiss Cardiovascular Center, Division of Angiology, University Hospital, Inselspital Bern, Switzerland (S.S.); and Klinikum Rosenheim, Germany (G. Tepe).
Erwin BlessingFrom the Universitäts-Herzzentrum Bad Krozingen, Germany (T.Z.); Sankt Getrauden-Krankenhaus, Berlin, Germany (R.L.); Prairie Heart Institute at St. John's Hospital, Springfield, IL (K.J.R.-S.); VasCore-the Vascular Ultrasound Core Laboratory, Massachusetts General Hospital, Boston (M.R.J.); SRH Klinikum Karlsbad-Langensteinbach, Germany (E.B.); Clinic for Angiology, University Hospital Zurich, Switzerland (B.A.-V.); Zakład Leczniczy Angio-Medicus, Krakow, Poland (M.K.); Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium (P.P.); Department of Interventional Angiology, University Hospital Leipzig, Germany (D.S.); University Hospital Muenster, Klinik for Vascular and Endovascular Surgery, Germany (G. Torsello); Swiss Cardiovascular Center, Division of Angiology, University Hospital, Inselspital Bern, Switzerland (S.S.); and Klinikum Rosenheim, Germany (G. Tepe).
Beatrice Amann-VestiFrom the Universitäts-Herzzentrum Bad Krozingen, Germany (T.Z.); Sankt Getrauden-Krankenhaus, Berlin, Germany (R.L.); Prairie Heart Institute at St. John's Hospital, Springfield, IL (K.J.R.-S.); VasCore-the Vascular Ultrasound Core Laboratory, Massachusetts General Hospital, Boston (M.R.J.); SRH Klinikum Karlsbad-Langensteinbach, Germany (E.B.); Clinic for Angiology, University Hospital Zurich, Switzerland (B.A.-V.); Zakład Leczniczy Angio-Medicus, Krakow, Poland (M.K.); Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium (P.P.); Department of Interventional Angiology, University Hospital Leipzig, Germany (D.S.); University Hospital Muenster, Klinik for Vascular and Endovascular Surgery, Germany (G. Torsello); Swiss Cardiovascular Center, Division of Angiology, University Hospital, Inselspital Bern, Switzerland (S.S.); and Klinikum Rosenheim, Germany (G. Tepe).
Marek KrzanowskiFrom the Universitäts-Herzzentrum Bad Krozingen, Germany (T.Z.); Sankt Getrauden-Krankenhaus, Berlin, Germany (R.L.); Prairie Heart Institute at St. John's Hospital, Springfield, IL (K.J.R.-S.); VasCore-the Vascular Ultrasound Core Laboratory, Massachusetts General Hospital, Boston (M.R.J.); SRH Klinikum Karlsbad-Langensteinbach, Germany (E.B.); Clinic for Angiology, University Hospital Zurich, Switzerland (B.A.-V.); Zakład Leczniczy Angio-Medicus, Krakow, Poland (M.K.); Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium (P.P.); Department of Interventional Angiology, University Hospital Leipzig, Germany (D.S.); University Hospital Muenster, Klinik for Vascular and Endovascular Surgery, Germany (G. Torsello); Swiss Cardiovascular Center, Division of Angiology, University Hospital, Inselspital Bern, Switzerland (S.S.); and Klinikum Rosenheim, Germany (G. Tepe).
Patrick PeetersFrom the Universitäts-Herzzentrum Bad Krozingen, Germany (T.Z.); Sankt Getrauden-Krankenhaus, Berlin, Germany (R.L.); Prairie Heart Institute at St. John's Hospital, Springfield, IL (K.J.R.-S.); VasCore-the Vascular Ultrasound Core Laboratory, Massachusetts General Hospital, Boston (M.R.J.); SRH Klinikum Karlsbad-Langensteinbach, Germany (E.B.); Clinic for Angiology, University Hospital Zurich, Switzerland (B.A.-V.); Zakład Leczniczy Angio-Medicus, Krakow, Poland (M.K.); Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium (P.P.); Department of Interventional Angiology, University Hospital Leipzig, Germany (D.S.); University Hospital Muenster, Klinik for Vascular and Endovascular Surgery, Germany (G. Torsello); Swiss Cardiovascular Center, Division of Angiology, University Hospital, Inselspital Bern, Switzerland (S.S.); and Klinikum Rosenheim, Germany (G. Tepe).
Dierk ScheinertFrom the Universitäts-Herzzentrum Bad Krozingen, Germany (T.Z.); Sankt Getrauden-Krankenhaus, Berlin, Germany (R.L.); Prairie Heart Institute at St. John's Hospital, Springfield, IL (K.J.R.-S.); VasCore-the Vascular Ultrasound Core Laboratory, Massachusetts General Hospital, Boston (M.R.J.); SRH Klinikum Karlsbad-Langensteinbach, Germany (E.B.); Clinic for Angiology, University Hospital Zurich, Switzerland (B.A.-V.); Zakład Leczniczy Angio-Medicus, Krakow, Poland (M.K.); Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium (P.P.); Department of Interventional Angiology, University Hospital Leipzig, Germany (D.S.); University Hospital Muenster, Klinik for Vascular and Endovascular Surgery, Germany (G. Torsello); Swiss Cardiovascular Center, Division of Angiology, University Hospital, Inselspital Bern, Switzerland (S.S.); and Klinikum Rosenheim, Germany (G. Tepe).
Giovanni TorselloFrom the Universitäts-Herzzentrum Bad Krozingen, Germany (T.Z.); Sankt Getrauden-Krankenhaus, Berlin, Germany (R.L.); Prairie Heart Institute at St. John's Hospital, Springfield, IL (K.J.R.-S.); VasCore-the Vascular Ultrasound Core Laboratory, Massachusetts General Hospital, Boston (M.R.J.); SRH Klinikum Karlsbad-Langensteinbach, Germany (E.B.); Clinic for Angiology, University Hospital Zurich, Switzerland (B.A.-V.); Zakład Leczniczy Angio-Medicus, Krakow, Poland (M.K.); Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium (P.P.); Department of Interventional Angiology, University Hospital Leipzig, Germany (D.S.); University Hospital Muenster, Klinik for Vascular and Endovascular Surgery, Germany (G. Torsello); Swiss Cardiovascular Center, Division of Angiology, University Hospital, Inselspital Bern, Switzerland (S.S.); and Klinikum Rosenheim, Germany (G. Tepe).
Sebastian SixtFrom the Universitäts-Herzzentrum Bad Krozingen, Germany (T.Z.); Sankt Getrauden-Krankenhaus, Berlin, Germany (R.L.); Prairie Heart Institute at St. John's Hospital, Springfield, IL (K.J.R.-S.); VasCore-the Vascular Ultrasound Core Laboratory, Massachusetts General Hospital, Boston (M.R.J.); SRH Klinikum Karlsbad-Langensteinbach, Germany (E.B.); Clinic for Angiology, University Hospital Zurich, Switzerland (B.A.-V.); Zakład Leczniczy Angio-Medicus, Krakow, Poland (M.K.); Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium (P.P.); Department of Interventional Angiology, University Hospital Leipzig, Germany (D.S.); University Hospital Muenster, Klinik for Vascular and Endovascular Surgery, Germany (G. Torsello); Swiss Cardiovascular Center, Division of Angiology, University Hospital, Inselspital Bern, Switzerland (S.S.); and Klinikum Rosenheim, Germany (G. Tepe).
Gunnar TepeFrom the Universitäts-Herzzentrum Bad Krozingen, Germany (T.Z.); Sankt Getrauden-Krankenhaus, Berlin, Germany (R.L.); Prairie Heart Institute at St. John's Hospital, Springfield, IL (K.J.R.-S.); VasCore-the Vascular Ultrasound Core Laboratory, Massachusetts General Hospital, Boston (M.R.J.); SRH Klinikum Karlsbad-Langensteinbach, Germany (E.B.); Clinic for Angiology, University Hospital Zurich, Switzerland (B.A.-V.); Zakład Leczniczy Angio-Medicus, Krakow, Poland (M.K.); Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium (P.P.); Department of Interventional Angiology, University Hospital Leipzig, Germany (D.S.); University Hospital Muenster, Klinik for Vascular and Endovascular Surgery, Germany (G. Torsello); Swiss Cardiovascular Center, Division of Angiology, University Hospital, Inselspital Bern, Switzerland (S.S.); and Klinikum Rosenheim, Germany (G. Tepe).
DEFINITIVE AR Investigators
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundStudies assessing drug-coated balloons (DCB) for the treatment of femoropopliteal artery disease are encouraging. However, challenging lesions, such as severely calcified, remain difficult to treat with DCB alone. Vessel preparation with directional atherectomy (DA) potentially improves outcomes of DCB. METHODS AND
resultsDEFINITIVE AR study (Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency-A Pilot Study of Anti-Restenosis Treatment) was a multicenter randomized trial designed to estimate the effect of DA before DCB to facilitate the development of future end point-driven randomized studies. One hundred two patients with claudication or rest pain were randomly assigned 1:1 to DA+DCB (n=48) or DCB alone (n=54), and 19 additional patients with severely calcified lesions were treated with DA+DCB. Mean lesion length was 11.2±4.0 cm for DA+DCB and 9.7±4.1 cm for DCB (
conclusionsDA+DCB treatment was effective and safe, but the study was not powered to show significant differences between the 2 methods of revascularization in 1-year follow-up. An adequately powered randomized trial is warranted. CLINICAL
trial registrationhttp://www.clinicaltrials.gov. Unique Identifier: NCT01366482.
Indexed as
AtherectomyCoated Materials, BiocompatibleVascular Access DevicesVascular PatencyAgedAngioplasty, BalloonCardiovascular AgentsEquipment DesignEuropeFemaleHumansIntermittent ClaudicationMaleMiddle AgedPaclitaxelPeripheral Arterial DiseaseCardiovascular AgentsCoated Materials, BiocompatiblePaclitaxelatherectomydirectional atherectomydrug-eluting balloonpaclitaxelperipheral artery diseaseplaque modification
Identifiers
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Registered trials
NCT01366482ClinicalTrials.gov
NCT05916950ClinicalTrials.gov
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.