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Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain

2019; Lippincott Williams & Wilkins; Volume: 12; Issue: 1 Linguagem: Inglês

10.1161/circinterventions.118.007730

1941-7632

Thomas Zeller, Marianne Brodmann, Antonio Micari, Koen Keirse, Patrick Peeters, Gunnar Tepe, Dierk Scheinert, Michael R. Jaff, Krishna J. Rocha‐Singh, Pei Li, Randy Schmahl, Gary M. Ansel,

Orthopaedic implants and arthroplasty

HomeCirculation: Cardiovascular InterventionsVol. 12, No. 1Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBDrug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest PainOne-Year Results of the IN.PACT Global Real-World Study Thomas Zeller, MD, Marianne Brodmann, MD, Antonio Micari, MD, PhD, Koen Keirse, MD, Patrick Peeters, MD, Gunnar Tepe, MD, Dierk Scheinert, MD, Michael R. Jaff, DO, Krishna J. Rocha-Singh, MD, Pei Li, PhD, Randy Schmahl, MSC, Gary M. Ansel, MD and For the IN.PACT Global Study Investigators Thomas ZellerThomas Zeller Thomas Zeller, MD, Universitäts-Herzzentrum Freiburg—Bad Krozingen, Klinik Kardiologie und Angiologie II, Südring 15, Bad Krozingen 79189, Germany. Email E-mail Address: [email protected] Universitäts-Herzzentrum Freiburg—Bad Krozingen, Germany (T.Z.). , Marianne BrodmannMarianne Brodmann Division of Angiology, Department of Internal Medicine, Medical University, Graz, Austria (M.B.). , Antonio MicariAntonio Micari GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy (A.M.). , Koen KeirseKoen Keirse Department of Vascular Surgery, Regional Hospital Heilig Hart Tienen, Belgium (K.K.). , Patrick PeetersPatrick Peeters Imelda Hospital, Bonheiden, Belgium (P.P.). , Gunnar TepeGunnar Tepe RoMed Klinikum, Department of Diagnostic and Interventional Radiology, Rosenheim, Germany (G.T.). , Dierk ScheinertDierk Scheinert Division of Interventional Angiology, University Hospital Leipzig, Germany (D.S.). , Michael R. JaffMichael R. Jaff Massachusetts General Hospital, Boston (M.R.J.). , Krishna J. Rocha-SinghKrishna J. Rocha-Singh Prairie Heart Institute, Springfield, IL (K.J.R.-S.). , Pei LiPei Li Medtronic, Minneapolis, MN (P.L.). , Randy SchmahlRandy Schmahl Medtronic, Bakken Research Center BV, Maastrict, the Netherlands (R.S.). , Gary M. AnselGary M. Ansel Department of Medicine, Ohio Health/Riverside Methodist Hospital, Columbus (G.M.A.). and For the IN.PACT Global Study Investigators Originally published11 Jan 2019https://doi.org/10.1161/CIRCINTERVENTIONS.118.007730Circulation: Cardiovascular Interventions. 2019;12:e007730Randomized controlled trials have reported safe and effective treatment of femoropopliteal artery lesions with drug-coated balloons (DCBs).1,2 This prospective, international, multicenter, single arm, independently adjudicated study evaluated 1-year outcomes of the paclitaxel-coated IN.PACT Admiral DCB in a real-world patient cohort with lifestyle-limiting claudication and ischemic rest pain (Rutherford Class 2–4). De novo, restenotic, or in-stent restenotic (ISR) lesions ≥2 cm in the femoropopliteal artery were included in this study. Subjects received angioplasty with the IN.PACT Admiral DCB during the index procedure; DCB inflation was at least 60 seconds. Predilatation, postdilatation, and placement of a stent were at the discretion of the investigator; other adjunctive devices were not allowed.The primary efficacy end point was freedom from clinically driven target lesion revascularization (CD-TLR) within 12 months, defined by reintervention within the target lesion(s) because of symptoms or ankle-brachial index decrease of ≥20% or >0.15 when compared with postindex procedure ankle-brachial index. The primary safety composite end point was freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and CD-TVR within 12 months. An independent Clinical Events Committee adjudicated all major adverse events, including CD-TLR.The Kaplan-Meier method was used to evaluate time-to-event data for freedom from CD-TLR over the 12-month follow-up period. The outcome analysis was performed at a subject level. For event rates that were expressed as a proportion, the number of subjects with an event was the numerator and the total number of subjects with an event or at least 330 days of clinical follow-up was the denominator.The IN.PACT Global Study (URL: https://www.clinicaltrials.gov. Unique identifier: NCT01609296) enrolled 1535 subjects, with 1406 subjects and 1773 lesions in the predefined clinical cohort analysis from 59 sites in 25 countries.Mean patient age was 68.6±10.1 years. The mean lesion length was 12.09±9.54 cm, including 35.5% chronic total occlusions. Among all lesions, 74.3% were de novo, 7.7% were restenotic (nonstented), and 18.0% were ISR. The majority (68.7%) of lesions were calcified with 10.2% severely calcified. Predilatation was performed in 78.0% (n=1097/1406) of subjects. Provisional stents were implanted in 21.2% (n=373/1761) of lesions.Follow-up compliance at 1 year was 85.3% (1097 subjects in window and 83 subjects outside window). Seventy-one subjects withdrew, 49 died, and 106 missed their visit.Twelve-month freedom from CD-TLR using Kaplan-Meier analysis was 92.6% (Figure [A]). The rate of CD-TLR at 12 months was 7.5%. The mean time to first CD-TLR was 163.4±109.8 days. Considering the lesion and patient population complexity of the clinical cohort, the 1-year freedom from CD-TLR of 92.6% compares favorably with the outcomes of other DCB randomized controlled trials and registries.1Download figureDownload PowerPointFigure. Twelve-month freedom from clinically driven target lesion revascularization (CD-TLR) using Kaplan-Meier analysis and predictors of CD-TLR using multivariable analysis.A, Kaplan-Meier curve of freedom from CD-TLR in the clinical cohort. Number at risk represents the number at the beginning of the 30-d window before each follow-up interval. B, Baseline predictors of CD-TLR in the clinical cohort through 12 mo. *Multivariable predictors were chosen by a stepwise procedure using an entry criterion of 0.15 and a stay criterion of 0.10. ‡Because of protocol violations, 1 Rutherford class 1 subject and 36 Rutherford class 5 subjects were enrolled and included in the analysis.Changes in Rutherford Class between baseline and 12 months were statistically significant (P<0.001). Mean ankle-brachial index was 0.678±0.218 at baseline (N=1395 target limbs) and 0.910±0.213 (N=1148 target limbs) at 12 months. Mean change in ankle-brachial index from baseline was 0.233±0.252 (N=1069 target limbs, P<0.001).The 12-month primary safety composite end point was achieved in 1207 of 1311 subjects (92.1%). Major adverse events were reported in 12.0% (n=157/1311) of subjects. Thrombosis occurred in 2.9% (n=38/1311) of subjects, and the rate of CD-TVR was 8.1% (n=106/1311). Major target limb amputation was required in 0.2% (n=3/1311) subjects, and the rate of all-cause death was 3.5% (n=46/1311 subjects).Based on a Cox regression analysis, increasing lesion length, chronic total occlusion ≥5 cm, coronary artery disease, and baseline Rutherford Class ≥4 were associated with increased risk of requiring CD-TLR by 12 months (Figure [B]). Age, reference vessel diameter, and target lesion location (superficial femoral artery versus other) were associated with reduced risk of requiring TLR.Only 3 single-center studies of DCBs to date have identified predictors of TLR on initial treatment with a DCB. Schmidt et al3 showed male sex, severe lesion calcification, and obesity as predictors of reintervention. Jang et al4 showed lesion length and baseline Rutherford Class 6 as predictors of binary restenosis. Finally, Grotti et al5 identified Tosaka Class III ISR as a predictor of reintervention in a cohort of 44 patients with femoropopliteal ISR. Further analyses are necessary to make more definitive conclusions about characteristics that lead to restenosis long-term.The highest reintervention rate in this study was found for chronic total occlusions (11.3%), whereas the rates for long lesions (6.0%) and ISR (7.3%) were within the range of 7.5% for the entire clinical cohort. This underlines the wide therapeutic role of the IN.PACT Admiral DCB.Limitations of this study included lack of core-lab adjudicated imaging for the entire cohort. This was a single arm study that did not include control groups or other endovascular modalities, thus limiting comparability to other treatment options.The 1-year outcomes from the prospective, multicenter, multinational, single arm IN.PACT Global Study demonstrate the clinical efficacy and safety of treatment with the IN.PACT Admiral DCB following short-term antiproliferative drug release in a cohort of real-world patients with lifestyle-limiting claudication and rest pain confirming the randomized controlled trial outcomes.2AcknowledgmentsWe thank Eric Fernandez, MD, Azah Tabah, PhD, and Bridget Wall, PhD, for technical review of this letter, and Paula Soto, PhD and Zachary Harrelson, PhD of Meridius Health Communications Inc, San Diego, CA for providing medical writing support, which was funded by Medtronic Inc, Minneapolis, MN in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).Sources of FundingThis study was supported by Medtronic.DisclosuresDr Zeller has received speaking honoraria from Abbott Vascular, Bard Peripheral Vascular, Biotronik, Boston Scientific Corp, Cook Medical, Cordis Corp, GLG, Gore & Associates, Medtronic, Philips, Spectranetics, Straub Medical, TriReme, Veryan, and VIVA Physicians; is a consultant for Abbott Vascular, Bard Peripheral Vascular, Boston Scientific Corp, Cook Medical, Gore & Associates, Medtronic, and Spectranetics and his clinic has received study funds or funds for research or clinical trials from 480 Biomedical, Abbott Vascular, B. Braun, Bard Peripheral Vascular, Bayer Pharma, Biotronik, Caveo Med, Contego Medical, Cook Medical, CSI, Gore & Associates, Innora, Intact Vascular, Medtronic, Mercator, Philips, Pluristem, Shockwave, Spectranetics, Terumo, TriReme, and Veryan. Dr Brodmann has received speaking honoraria from Bard Peripheral Vascular, Biotronik, Medtronic, Spectranetics, and Viva Physicians; and is a consultant for Bard Peripheral Vascular, Biotronik, Medtronic, and Spectranetics. Dr Micari is a compensated consultant for Medtronic and Boston Scientific Corp. Dr Tepe has received research grants from Medtronic and is a compensated advisory board member for Medtronic. Dr Scheinert is a compensated consultant for Abbott Vascular, Biotronik, Boston Scientific Corp, Cook Medical, Cordis, CR Bard, Gardia Medical, Hemoteq, Medtronic, Ostial Inc, TriReme Medical and Trivascular. Dr Jaff is a noncompensated advisor for Medtronic; and an Equity Investor in PQ Bypass. Dr Rocha-Singh is a compensated consultant for Medtronic, Zimmer-BioMet, ROX Medical, Alucent Medical; a compensated board member of VIVA Physicians, a 501 c 3 not-for-profit education and research organization; and an Equity Investor in PQ Bypass. Dr Li and R. Schmahl are full-time employees of Medtronic. Dr Ansel is an advisor for Abbott Vascular, Boston Scientific Corp, Medtronic, Philips & Volcano Philips, and Gore & Associates; a compensated board member of VIVA Physicians, a 501 c 3 not-for-profit education and research organization; is an Equity Investor in Embolitech and Primacea; and is the recipient of royalties from Cook Medical. The other authors report no conflicts.Footnoteshttps://www.ahajournals.org/journal/circinterventionsThomas Zeller, MD, Universitäts-Herzzentrum Freiburg—Bad Krozingen, Klinik Kardiologie und Angiologie II, Südring 15, Bad Krozingen 79189, Germany. Email thomas.[email protected]deReferences1. Schlager O, Gschwandtner ME, Willfort-Ehringer A, Wolf F, Loewe C, Koppensteiner R, Lichtenberg M. Drug coated balloons in the superficial femoral artery.J Cardiovasc Surg (Torino). 2018; 59:60–69. doi: 10.23736/S0021-9509.17.10214-4MedlineGoogle Scholar2. Tepe G, Laird J, Schneider P, Brodmann M, Krishnan P, Micari A, Metzger C, Scheinert D, Zeller T, Cohen DJ, Snead DB, Alexander B, Landini M, Jaff MR; IN.PACT SFA Trial Investigators. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial.Circulation. 2015; 131:495–502. doi: 10.1161/CIRCULATIONAHA.114.011004LinkGoogle Scholar3. Schmidt A, Piorkowski M, Görner H, Steiner S, Bausback Y, Scheinert S, Banning-Eichenseer U, Staab H, Branzan D, Varcoe RL, Scheinert D. Drug-coated balloons for complex femoropopliteal lesions: 2-year results of a real-world registry.JACC Cardiovasc Interv. 2016; 9:715–724. doi: 10.1016/j.jcin.2015.12.267CrossrefMedlineGoogle Scholar4. Jang SJ, Hsieh CA, Huang HL, Juang JM, Chou HH, Tsao CY, Wu TY, Ko YL. Feasibility and clinical outcomes of peripheral drug-coated balloon in high-risk patients with femoropopliteal disease.PLoS One. 2015; 10:e0143658. doi: 10.1371/journal.pone.0143658CrossrefMedlineGoogle Scholar5. Grotti S, Liistro F, Angioli P, Ducci K, Falsini G, Porto I, Ricci L, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Paclitaxel-eluting balloon vs standard angioplasty to reduce restenosis in diabetic patients with in-stent restenosis of the superficial femoral and proximal popliteal arteries: three-year results of the DEBATE-ISR study.J Endovasc Ther. 2016; 23:52–57. doi: 10.1177/1526602815614555CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Soga Y, Iida O, Fujihara M, Kawasaki D, Saito S, Urasawa K, Yokoi H, Fernandez E, Guo J and Nakamura M (2021) Real-World Clinical Outcomes of IN.PACT Admiral Drug-Coated Balloon for Femoropopliteal Artery Disease ― 12-Month Results From Japan Post-Market Surveillance Study ―, Circulation Journal, 10.1253/circj.CJ-21-0491, 85:12, (2149-2156), Online publication date: 25-Nov-2021. Mietz S, Lehmann T and Teichgräber U (2020) Multivariable Regression Analysis of Clinical Data from the Randomized-Controlled EffPac Trial: Efficacy of Femoropopliteal Drug-Coated Balloon Angioplasty, CardioVascular and Interventional Radiology, 10.1007/s00270-020-02452-2, 43:6, (840-849), Online publication date: 1-Jun-2020. Torsello G, Stavroulakis K, Brodmann M, Micari A, Tepe G, Veroux P, Benko A, Choi D, Vermassen F, Jaff M, Guo J, Dobranszki R, Zeller T, Zeller T, Torsello G, Tepe G, Peeters P, Scheinert D, Bosiers M, Maene L, Micari A, Do D, Hendriks J, Keirse K, Brodmann M, Merkely B, Lardenoije J, Ruzsa Z, Vogel B, Veroux P, Albuquerque e Castro J, Periard D, Ludyga T, Midy D, Choi D, Lansink W, Ketelsen D, Dubenec S, Banyai M, Chakfe N, Xaver Roithinger F, Trani C, Mansour H, Rha S, Vermassen F, Belenky A, Spak L, Chalmers N, Benko A, Kum S, Won J, Vozar M, Teng Tan K, Labib M, Borst G, Do Y, Teijink J, Gomez J, Falkowski A, Ferreira L, Matela J, Lee S, Verhoeven B, Mannheim D, Nessi F, Vulev I, Vries J, Maly R, Kavteladze Z, Turner D, Mendiz O, Kolvenbach R, Karnabatidis D, Cuellar C, Venermo M, Velicka L and Lundberg G (2020) Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort, Journal of Endovascular Therapy, 10.1177/1526602820931477, 27:5, (693-705), Online publication date: 1-Oct-2020. Shishehbor M, Schneider P, Zeller T, Razavi M, Laird J, Wang H, Tieché C, Parikh S, Iida O and Jaff M (2019) Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts, Journal of Vascular Surgery, 10.1016/j.jvs.2019.02.030, 70:4, (1177-1191.e9), Online publication date: 1-Oct-2019. January 2019Vol 12, Issue 1 Advertisement Article InformationMetrics © 2019 American Heart Association, Inc.https://doi.org/10.1161/CIRCINTERVENTIONS.118.007730PMID: 30630355 Originally publishedJanuary 11, 2019 Keywordsdrug-coated balloonsangioplastyperipheral artery diseasepaclitaxelPDF download Advertisement SubjectsPeripheral Vascular Disease