دورية أكاديمية
Directional atherectomy before paclitaxel coated balloon angioplasty in complex femoropopliteal disease: The VIVA REALITY study.
| العنوان: | Directional atherectomy before paclitaxel coated balloon angioplasty in complex femoropopliteal disease: The VIVA REALITY study. |
|---|---|
| المؤلفون: | Rocha-Singh KJ; Department of Cardiology, Prairie Heart Institute at St. John's Hospital, Springfield, Illinois, USA., Sachar R; Department of Cardiology, Rex Medical Center, Raleigh, North Carolina, USA., DeRubertis BG; Division of Vascular and Endovascular Surgery, University of California, Los Angeles Medical Center, Los Angeles, California, USA., Nolte-Ernsting CCA; Department of Interventional Radiology, Evangelic Hospital Muelheim an der Ruhr, Muelheim an der Ruhr, Germany., Winscott JG; Department of Cardiology, University of Mississippi, Jackson, Mississippi, USA., Krishnan P; Department of Cardiology, Mt. Sinai Medical Center, New York, New York, USA., Scott EC; Department of Vascular Surgery, The Iowa Clinic, West Des Moines, Iowa, USA., Garcia LA; Department of Cardiology, Steward St. Elizabeth Medical Center, Boston, Massachusetts, USA., Baeriswyl JL; Division of Clinical Statistics, Clinlogix LLC, Lower Gwynedd, Pennsylvania, USA., Ansel G; Department of Cardiology, OhioHealth Riverside Methodist Hospital, Columbus, Ohio, USA., Rosenfield K; Department of Cardiology, Massachusetts General Hospital, Boston, Massachusetts, USA., Zeller T; Department of Angiology, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany. |
| مؤلفون مشاركون: | REALITY Investigators |
| المصدر: | Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions [Catheter Cardiovasc Interv] 2021 Sep; Vol. 98 (3), pp. 549-558. Date of Electronic Publication: 2021 Jun 03. |
| نوع المنشور: | Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Wiley-Liss Country of Publication: United States NLM ID: 100884139 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1522-726X (Electronic) Linking ISSN: 15221946 NLM ISO Abbreviation: Catheter Cardiovasc Interv Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: New York, NY : Wiley-Liss, c1999- |
| مواضيع طبية MeSH: | Angioplasty, Balloon*/adverse effects , Cardiovascular Agents*/adverse effects , Peripheral Arterial Disease*/diagnostic imaging , Peripheral Arterial Disease*/therapy, Atherectomy/adverse effects ; Coated Materials, Biocompatible ; Femoral Artery/diagnostic imaging ; Humans ; Paclitaxel/adverse effects ; Popliteal Artery/diagnostic imaging ; Time Factors ; Treatment Outcome ; Vascular Patency |
| مستخلص: | Background: Drug coated balloon (DCB) angioplasty significantly reduces reintervention rates in patients with symptomatic femoropopliteal peripheral artery disease (PAD). However, stand-alone DCB use in long, severely calcified lesions is frequently associated with vessel recoil and/or high-grade dissections necessitating provisional stent implantation. Objectives: Assess the safety and effectiveness of a vessel preparation strategy with directional atherectomy (DA) prior to DCB angioplasty in patients with symptomatic severely calcified femoropopliteal PAD. Methods: REALITY (NCT02850107) prospectively enrolled subjects at 13 multinational centers with 8-36 cm femoropopliteal stenoses or occlusions with bilateral vessel wall calcification treated with DA prior to DCB angioplasty. The primary effectiveness endpoint was 12-month primary patency, and the primary safety endpoint was freedom from major adverse events through 30 days. Independent angiographic and duplex core laboratories assessed outcomes and a Clinical Events Committee adjudicated events. Results: A total of 102 subjects were enrolled; one lesion was treated per subject. The mean lesion length was 17.9 ± 8.1 cm, 39.0% were chronic total occlusions (mean lesion length 22.6 ± 8.6 cm); 86.2% of lesions exhibited moderate to severe bilateral calcification. Provisional stents were implanted in 8.8% (9/102) of subjects. Twelve-month primary patency rate was 76.7% (66/86) and freedom from CD-TLR rate was 92.6% (87/94). No device or procedure related deaths and one index-limb major amputation were reported. Conclusions: Plaque excision with DA in patients with symptomatic severely calcified femoropopliteal arterial disease prior to DCB angioplasty is a safe and effective treatment strategy with a low provisional stent rate. (© 2021 Wiley Periodicals LLC.) |
| References: | Gerhard-Herman M, Gornik H, Barrett C, et al. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: executive summary. J Am Coll Cardiol. 2017;69:1465-1508. Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty on the leg. N Engl J Med. 2008;358:689-699. Rosenfield K, Jaff MR, White CJ, et al. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med. 2015;373:15-153. Tepe G, Laird J, Schneider P, et al. Drug-coated balloon v. 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. Krishnan P, Faries P, Niazi K, et al. Stellarex drug-coated balloon for treatment of femoropopliteal disease. Twelve-month outcomes from the randomized ILLUMENATE pivotal and pharmacokinetic studies. Circulation. 2017;136:1102-1113. Micari A, Vadala G, Castriota F, et al. 1-year results of paclitaxel-coated balloons for long femoropopliteal artery disease. Evidence from the SFA-long study. JACC Cardiovasc Interv. 2016;9:950-956. Tepe G, Beschorner U, Ruether C, et al. Drug-eluting balloon therapy for femoropopliteal occlusive disease: predictors of outcome with a special emphasis on calcium. J Endovasc Ther. 2015;22:727-733. Scheinert D, Micari M, Brodmann M, et al. Drug-coated balloon treatment for femoropopliteal artery disease: the IN. PACT global study long lesion imaging cohort. Circ Cardiovasc Interv. 2018;11:e005654. Zeller T, Rastan A, Sixt S, et al. Long-term results after directional atherectomy of femoro-popliteal lesions. J Am Coll Cardiol. 2006;48:1573-1578. McKinsey J, Zeller T, Rocha-Singh K, Jaff M, Garcia L. Lower extremity revascularization using directional atherectomy. 12-month prospective results of the DEFINITVE LE study. J Am Coll Cardiol Interv. 2014;7:923-933. Li J, Tzafriri A, Patel S, Parikh S. Mechanisms underlying drug delivery in peripheral arteries. Intervent Cardiol Clin. 2017;6:197-216. Zeller T, Jaff M, Rocha-Singh K, Tepe G. Directional atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis and maintain vessel patency. Twelve-month results for the DEFINITIVE AR study. Circ Cardiovasc Interv. 2017;10:e004848. https://doi.org/10.1161/CIRCINTERVENTIONS.116.004848. Rocha-Singh K, Zeller T, Jaff MR. Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv. 2014;83:212-220. Sage A, Tintut Y, Demer L. Regulatory mechanisms in vascular calcification. Nat Rev Cardiol. 2010;7:528-536. Karwowski W, Naumnik B, Szczepanski M, Mysliwiec M. The mechanism of vascular calcification - a systematic review. Med Sci Monit. 2012;18:1-11. Tzafriri A, Garcia-Polite F, Zani B, et al. Calcified plaque modification alters local drug delivery in the treatment of peripheral atherosclerosis. J Control Release. 2017;264:203-210. Fanelli F, Cannavale A, Gazzetti M, et al. Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Intervent Radiol. 2014;37:898-907. Cioppa A, Stabile E, Popusoi G, et al. Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon: one-year single centre clinical results. Cardiovasc Revasc Med. 2012;13:219-223. Cioppa A, Stabile E, Salemme L, et al. Combined use of directional atherectomy and drug-coated balloon for the endovascular treatment of common femoral artery disease: immedicate and one-year outcomes. EuroIntervention. 2017;12:1789-1794. Stavroulakis K, Bisdas T, Torsello G, Stachmann A, Schwindt A. Combined directional atherectomy and drug-eluting balloon angioplasty for isolated popliteal artery lesions in patients with peripheral arterial disease. J Endovasc Ther. 2015;22:847-854. Stavroulakis K, Schwindt A, Torsello G, et al. Directional atherectomy with antirestenotic therapy vs drug-coated balloon angioplasty alone for common femoral artery atherosclerotic disease. J Endovasc Ther. 2018;25:92-99. Okuno S, Iida O, Shiraki T, et al. Impact of calcification on clinical outcomes after endovascular therapy for superficial femoral artery disease: assessment using the peripheral artery calcification scoring system. J Endovasc Ther. 2016;23:73-737. Herisson F, Heyman MF, Chetiveaux M, et al. Carotid and femoral atherosclerotic plaque show different morphology. Atherosclerosis. 2011;216:348-354. Mintz G, Popma J, Pichard A, et al. Patterns of calcification in coronary artery disease. A statistical analysis of intravascular ultrasound and coronary angiography in 1155 lesions. Circulation. 1995;91:1959-1965. Yin D, Maehara A, Shimshak T, et al. Intravascular ultrasound validation of contemporary angiographic scores evaluating the severity of calcification in peripheral arteries. J Endovasc Ther. 2017;24:478-487. Patel M, Conte M, Cutlip E, et al. Evaluation and treatment of patients with lower extremity peripheral artery disease. Consensus definitions from peripheral academic research consortium (PARC). J Am Coll Cardiol. 2015;65:931-941. Roberts D, Niazi K, Miller W, et al. Effective endovascular treatment of calcified femoropopliteal disease with directional atherectomy and distal embolic protection: final results of the DEFINITIVE Ca++ trial. Catheter Cardiovasc Interv. 2014;84:236-244. Tzafriri R, Muraj B, Garcai-Polite F, et al. Balloon based drug coating delivery to the artery wall is dictated by micro-morphology and angioplasty pressure gradients. Biomaterials. 2020;260:120337. https://doi.org/10.1016/j.biomaterials.2020.120337. Norgren L, Hiatt W, Dormandy J, Nehler M, Harris K, TASC II Working Group. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45:5-67. |
| معلومات مُعتمدة: | VIVA Physicians, Inc; Medtronic, Inc |
| فهرسة مساهمة: | Keywords: directional atherectomy; drug coated balloons; peripheral arterial disease |
| سلسلة جزيئية: | ClinicalTrials.gov NCT02850107 |
| المشرفين على المادة: | 0 (Cardiovascular Agents) 0 (Coated Materials, Biocompatible) P88XT4IS4D (Paclitaxel) |
| تواريخ الأحداث: | Date Created: 20210603 Date Completed: 20211019 Latest Revision: 20211019 |
| رمز التحديث: | 20240628 |
| DOI: | 10.1002/ccd.29777 |
| PMID: | 34080792 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder كن أول من يترك تعليقا!