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• W4221036718 abstract "HomeRadiologyVol. 304, No. 1 PreviousNext Original ResearchFree AccessVascular and Interventional RadiologyFemoropopliteal Drug-coated Balloon Angioplasty: Long-term Results of the Randomized EffPac TrialUlf Teichgräber , Thomas Lehmann, René Aschenbach, Markus Thieme, Thomas Zeller, Ulrich Beschorner, Dierk ScheinertUlf Teichgräber , Thomas Lehmann, René Aschenbach, Markus Thieme, Thomas Zeller, Ulrich Beschorner, Dierk ScheinertAuthor AffiliationsFrom the Department of Radiology, Friedrich-Schiller University, Jena University Hospital, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); Department of Angiology, Cardiology, Diabetology, Regiomed-Vascular Center, Sonneberg, Germany (M.T); University Heart Center Freiburg Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); and Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.).Address correspondence to U.T. (e-mail: [email protected]).Ulf Teichgräber Thomas LehmannRené AschenbachMarkus ThiemeThomas ZellerUlrich BeschornerDierk ScheinertPublished Online:Mar 22 2022https://doi.org/10.1148/radiol.212622MoreSectionsPDF ToolsImage ViewerAdd to favoritesCiteTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinked In AbstractDownload as PowerPointIntroductionBare-metal stent placement is the current standard of care in the femoropopliteal artery segment (1), particularly in long occluded and severely calcified lesions. However, treatment with drug-coated balloon (DCB) angioplasty is increasing mainly due to concern about in-stent restenosis. Despite its increasing use, the sustainability and long-term effectiveness of DCB angioplasty remain to be demonstrated. Also, the long-term safety of paclitaxel-coated balloons is still debatable. The Effectiveness of Paclitaxel-coated Luminor Balloon Catheter Versus Uncoated Balloon Catheter in the Arteria Femoralis Superficialis (EffPac) trial is an ongoing, multicenter, randomized, controlled trial that has shown superiority of DCB angioplasty over conventional balloon angioplasty (also called plain old balloon angioplasty [POBA]) regarding 6-month late lumen loss (primary end point) and primary patency and freedom from clinically driven target lesion revascularization (TLR) for up to 24 months. Midterm all-cause mortality was comparable between treatment groups (2,3). In this article, we present the long-term (42-month) outcomes of the EffPac trial.Materials and MethodsDetailed study design of the EffPac trial (ClinicalTrials.gov registration number: NCT02540018) has been previously reported (4). The study had been approved by the responsible ethic committees. Between September 2015 and December 2016, 171 consecutive patients with symptomatic superficial femoral or popliteal artery disease were randomly allocated to undergo either POBA or DCB angioplasty (Fig 1). Long-term outcomes to be reported on include primary patency, freedom from clinically driven TLR, clinical improvement, hemodynamic improvement, and amputation-free survival at 42 months. We applied the Wilcoxon-signed rank test, Mann-Whitney U test, and, within the frame of Kaplan-Meier analyses, the log-rank test. A two-sided P value of .05 indicated statistical significance (XLSTAT version 2015.6.01.24026, Addinsoft).Figure 1: Flow diagram of participant allocation, follow-up, and analysis. ABI = ankle-brachial index, DCB = drug-coated balloon, DUS = duplex US, PA = popliteal artery, POBA = plain old balloon angioplasty, SFA = superficial femoral artery.Figure 1:Download as PowerPointOpen in Image Viewer ResultsBefore treatment, 97% of participants (166 of 171) experienced claudication. The average lesion length was 6 cm. Occlusion occurred in 23% (39 of 171) and severe calcification in 8% (13 of 171) of the lesions. At 42 months, clinical follow-up was completed in 60% of participants (103 of 171), and vital status was obtained from 89% of participants (152 of 171). Primary patency was achieved in 70% of participants who underwent DCB angioplasty and 60% of participants who underwent POBA (log-rank: P = .01) (Fig 2A). Freedom from clinically driven TLR was attained in 90% of participants who underwent DCB angioplasty and 78% who underwent POBA (log-rank: P = .02) (Fig 2B). A total of 89% of participants (46 of 52) who underwent DCB angioplasty and 73% (37 of 51) who underwent POBA improved by at least one Rutherford category with no need for clinically driven TLR (primary clinical improvement: P = .04). Secondary clinical improvement was 96% (50 of 52) after DCB angioplasty and 94% (48 of 51) after POBA (P = .98) (Fig 2C). Overall, when including participants who underwent repeated revascularization, median Rutherford category improved to 1 (IQR: 0–2) after DCB angioplasty (P < .001) and to 0 (IQR: 0–2) after POBA (P < .001). Primary hemodynamic improvement occurred in 46% of participants (18 of 39) who underwent DCB angioplasty and in 46% of participants (16 of 35) who underwent POBA (P = .97). From baseline, ankle-brachial index improved by 0.09 ± 0.28 to 0.84 ± 0.22 after DCB angioplasty (P = .06) and by 0.12 ± 0.35 to 0.87 ± 0.22 after POBA (P = .003) (Fig 3). There was no evidence of differences in improvement of the ankle-brachial index between DCB angioplasty and POBA groups (P = .41). Amputation-free survival was comparable between DCB angioplasty and POBA groups (96% vs 92%, P = .20) (Fig 2D). None of the participants needed major amputation, and one participant of each group underwent minor amputation (POBA: at 9 months; DCB angioplasty: at 38 months). Ten participants died (seven in the POBA group and three in the DCB angioplasty group) (3), with two deaths after the 24-month follow-up among participants who underwent DCB angioplasty (at 31 and 34 months for an unknown reason and diabetic coma, respectively).Figure 2: (A, B, D) Kaplan-Meier curves and (C) bar chart show clinical and morphologic 42-month outcomes following drug-coated balloon (DCB) angioplasty versus plain old balloon angioplasty (POBA). Shown are 42-month estimates of primary patency (A), freedom from clinically driven target lesion revascularization (TLR) (B), clinical improvement (C), and amputation-free survival (D) in 171 participants. Amputation-free survival refers to the composite of all-cause mortality and major target limb amputation.Figure 2:Download as PowerPointOpen in Image Viewer Figure 3: Box and whisker plot shows hemodynamic improvement at 42 months following drug-coated balloon (DCB) angioplasty versus plain old balloon angioplasty (POBA). Box plots indicate median and IQR. Whiskers end with the lowest and highest data points. Dots represent means with their corresponding 95% CI. ABI = ankle-brachial index.Figure 3:Download as PowerPointOpen in Image Viewer DiscussionIn the randomized EffPac clinical trial, long-term (42-month) evaluation of drug-coated balloon (DCB) angioplasty revealed continued superiority in effectiveness over plain old balloon angioplasty with no safety concerns. However, compared with midterm results, survival curves show a diminishing advantage of DCB angioplasty over time, possibly implying a future “late catch-up” that might be evidenced at the upcoming 5-year follow-up. Clinical and hemodynamic improvement continued in both groups, though to a lesser extent than at midterm follow-up (3). With DCB angioplasty, the primary patency rate of the EffPac trial was similar to that previously reported for above-knee graft patency in patients with claudication (Swedish vascular registry [5]: patency approximately 65% at 3 years; graft failure and urgent reoperation = 36% [79 of 220 patients] and 15% [33 of 220 patients] for up to 7 years, respectively), although autologous vein grafts achieved patency rates of approximately 85% and did not require urgent reoperation. Long-term results after DCB angioplasty were also comparable to self-expanding stent implantation in lesions measuring 80 mm or smaller (133 patients) (Durability II trial [6]: 3-year primary patency = 71%; freedom from clinically driven target lesion revascularization = 80%).Disclosures of conflicts of interest: U.T. No relevant relationships. T.L. No relevant relationships. R.A. No relevant relationships. M.T. No relevant relationships. T.Z. Study patient fees for institutional grants for research, clinical trial, or drug studies from University of Jena; institutional grants for research, clinical trial, or drug studies from Bard Peripheral Vascular, Veryan, Biotronik, Cook Medical, Gore & Associates, Medtronic, Philips, Terumo, TriReme, Shockwave, Med Alliance, Intact Vascular, B. Braun; CSI, Boston Scientific, University of Jena, Pluristem, Philips, PQ Bypass; consulting fees from Boston Scientific, CSI, Gore & Associates, Medtronic, Veryan, Philips-Intact Vascular, Shockwave, Bayer, Vesper Medical, VentureMed, ANT; payment or honoraria from Abbott Vascular, BIBA Medical, Biotronik, Boston Scientific, Cook Medical, Efemoral, Gore & Associates, Medtronic, Philips-Spectranetics, Shockwave, Veryan; support for attending meetings and/or travel from Abbott Vascular, BIBA Medical, Biotronik, Boston Scientific, Cook Medical, Efemoral, Gore & Associates, Medtronic, Philips-Spectranetics, Shockwave, Veryan; participant on advisory board for Boston Scientific, CSI, Gore & Associates, Medtronic, Veryan, Philips-Intact Vascular, Shockwave, Bayer, Vesper Medical, VentureMed, ANT; stock or stock options in QT Medical. U.B. No relevant relationships. D.S. Consulting fees from Abbott, Acotec, Alvimedica, Bayer, Boston Scientific, Cook Medical, CR Bard, iVascular, Medtronic, Philips, Upstream Peripheral Technologies; payment or honoraria from Abbott, Acotec, Alvimedica, Bayer, Boston Scientific, Cook Medical, CR Bard, iVascular, Medtronic, Philips, Upstream Peripheral Technologies.Author ContributionsAuthor contributions: Guarantors of integrity of entire study, U.T., D.S.; study concepts/study design or data acquisition or data analysis/interpretation, all authors; manuscript drafting or manuscript revision for important intellectual content, all authors; approval of final version of submitted manuscript, all authors; agrees to ensure any questions related to the work are appropriately resolved, all authors; literature research, U.T., R.A., U.B., D.S.; clinical studies, U.T., R.A., T.Z., U.B., D.S.; statistical analysis, T.L., R.A., D.S.; and manuscript editing, U.T., R.A., M.T., T.Z., U.B., D.S.Supported by iVascular S.L.U., Barcelona, Spain, and Endoscout, Freiburg, Germany.Data sharing. Data generated or analyzed during the study are available from the corresponding author by request.References1. Aboyans V, Ricco JB, Bartelink MEL, et al. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries Endorsed by: the European Stroke Organization (ESO) The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS).Eur Heart J2018;39(9):763–816. Crossref, Medline, Google Scholar2. Teichgräber U, Lehmann T, Aschenbach R, et al. Drug-coated Balloon Angioplasty of Femoropopliteal Lesions Maintained Superior Efficacy over Conventional Balloon: 2-year Results of the Randomized EffPac Trial. Radiology 2020;295(2):478–487. Link, Google Scholar3. Teichgräber U, Lehmann T, Aschenbach R, et al. Two-year Review on Mortality and Morbidity after Femoropopliteal Drug-coated Balloon Angioplasty in the Randomized EffPac Trial. Radiology 2020;296(3):638–640. Link, Google Scholar4. Teichgräber U, Aschenbach R, Scheinert D, et al. The effectiveness of the paclitaxel-coated Luminor balloon catheter versus an uncoated balloon catheter in superficial femoral and popliteal arteries in preventing vessel restenosis or reocclusion: study protocol for a randomized controlled trial. Trials 2016;17(1):52.[Published correction appears in Trials 2017;18(1):193.]. Crossref, Medline, Google Scholar5. Berglund J, Björck M, Elfström J; SWEDVASC Femoro-popliteal Study Group. Long-term results of above knee femoro-popliteal bypass depend on indication for surgery and graft-material. Eur J Vasc Endovasc Surg 2005;29(4):412–418. Crossref, Medline, Google Scholar6. Rocha-Singh KJ, Bosiers M, Schultz G, et al. A single stent strategy in patients with lifestyle limiting claudication: 3-year results from the Durability II trial. Catheter Cardiovasc Interv 2015;86(1):164–170. Crossref, Medline, Google ScholarArticle HistoryReceived: Oct 22 2021Revision requested: Nov 26 2021Revision received: Dec 14 2021Accepted: Dec 31 2021Published online: Mar 22 2022Published in print: July 2022 FiguresReferencesRelatedDetailsCited ByLong-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac TrialUlfTeichgräber, ThomasLehmann, MajaIngwersen, RenéAschenbach, ThomasZeller, KlausBrechtel, ErwinBlessing, MichaelLichtenberg, Petervon Flotow, BrittaHeilmeier, SebastianSixt, SteffenBrucks, ChristianErbel, UlrichBeschorner, MichaelWerk, VicençRiambau, AndreasWienke, ChristofKlumb, MarkusThieme, DierkScheinert2022 | CardioVascular and Interventional Radiology, Vol. 45, No. 12Recommended Articles Drug-coated Balloon Angioplasty of Femoropopliteal Lesions Maintained Superior Efficacy over Conventional Balloon: 2-year Results of the Randomized EffPac TrialRadiology2020Volume: 295Issue: 2pp. 478-487Two-year Review on Mortality and Morbidity after Femoropopliteal Drug-coated Balloon Angioplasty in the Randomized EffPac TrialRadiology2020Volume: 296Issue: 3pp. 638-640Hemodialysis Arteriovenous Fistula and Graft Stenoses: Randomized Trial Comparing Drug-eluting Balloon Angioplasty with Conventional AngioplastyRadiology2018Volume: 289Issue: 1pp. 238-247Randomized Controlled Trial Comparing Drug-coated Balloon Angioplasty versus Conventional Balloon Angioplasty for Treating Below-the-Knee Arteries in Critical Limb Ischemia: The SINGA-PACLI TrialRadiology2021Volume: 300Issue: 3pp. 715-724Roles of Trauma CT and CTA in Salvaging the Threatened or Mangled ExtremityRadioGraphics2022Volume: 42Issue: 2pp. E50-E67See More RSNA Education Exhibits Making Sense of Stents: An Evidence-Based Review of Classes of Arterial StentsDigital Posters2022Ultrasound of Peripheral Arteries: An Update on Technique, Protocols, Interpretation and ApplicationsDigital Posters2022A Walk-through Lower Limb Arteries: Atherosclerosis And BeyondDigital Posters2021 RSNA Case Collection Persistent Sciatic ArteryRSNA Case Collection2022Persistent Sciatic Artery AneurysmRSNA Case Collection2021Aortoiliac Occlusive Disease RSNA Case Collection2021 Vol. 304, No. 1 Metrics Altmetric Score PDF download" @default.
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• W4221036718 title "Femoropopliteal Drug-coated Balloon Angioplasty: Long-term Results of the Randomized EffPac Trial" @default.
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