Academic Journal
The IN.PACT DEEP Clinical Drug-Coated Balloon Trial 5-Year Outcomes
| العنوان: | The IN.PACT DEEP Clinical Drug-Coated Balloon Trial 5-Year Outcomes |
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| المؤلفون: | Zeller, Thomas, Micari, Antonio, Scheinert, Dierk, Baumgartner, Iris, Bosiers, Marc, Vermassen, Frank E. G., Banyai, Martin, Shishehbor, Mehdi H., Wang, Hong, Brodmann, Marianne |
| المصدر: | IN PACT DEEP Trial Investigators , Zeller , T , Micari , A , Scheinert , D , Baumgartner , I , Bosiers , M , Vermassen , F E G , Banyai , M , Shishehbor , M H , Wang , H & Brodmann , M 2020 , ' The IN.PACT DEEP Clinical Drug-Coated Balloon Trial 5-Year Outcomes ' , Jacc-Cardiovascular interventions , vol. 13 , no. 4 , pp. 431-443 . https://doi.org/10.1016/j.jcin.2019.10.059 |
| سنة النشر: | 2020 |
| المجموعة: | University of Groningen research database |
| مصطلحات موضوعية: | amputation, CD-TLR, drug-coated balloon, infrapopliteal, IN.PACT DEEP, mortality, paclitaxel, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, CRITICAL LIMB ISCHEMIA, PERIPHERAL ARTERY-DISEASE, LONG-TERM OUTCOMES, ATHEROSCLEROTIC LESIONS, INFRAPOPLITEAL ARTERIES, POPLITEAL ARTERIES, ELUTING BALLOON, REVASCULARIZATION, INTERVENTIONS |
| الوصف: | OBJECTIVES The goal of this study was to evaluate the 5-year follow-up data of the IN.PACT DEEP (Randomized IN.PACT Amphirion Drug-Coated Balloon [DCB] vs. Standard Percutaneous Transluminal Angioplasty [PTA] for the Treatment of Below-the-Knee Critical Limb Ischemia [CLI]) trial. BACKGROUND Initial studies from randomized controlled trials have shown comparable short-term outcomes of DCB angioplasty versus PTA in patients with CLI with infrapopliteal disease. However, the long-term safety and effectiveness of DCB angioplasty remain unknown in this patient population. METHODS IN.PACT DEEP was an independently adjudicated prospective, multicenter, randomized controlled trial that enrolled 358 subjects with CLI. Subjects were randomized 2:1 to DCB angioplasty or PTA. Assessments through 5 years included freedom from clinically driven target lesion revascularization, amputation, and all-cause death. Additional assessments were conducted to identify risk factors for death and major amputation, including paclitaxel dose tercile. RESULTS Freedom from clinically driven target lesion revascularization through 5 years was 70.9% and 76.0% (log-rank p = 0.406), and the incidence of the safety composite endpoint was 59.8% and 57.5% (log-rank p = 0.309) in the DCB angioplasty and PTA groups, respectively. The rate of major amputation was 15.4% for DCB angioplasty compared with 10.6% for PTA (log-rank p = 0.108). Given the recent concern regarding a late mortality signal in patients treated with paclitaxel-coated devices, additional analyses from this study showed no increase in all-cause mortality with DCB angioplasty (39.4%) compared with PTA (44.9%) (log-rank p = 0.727). Predictors of mortality included age, Rutherford category >4, and previous revascularization but not paclitaxel by dose tercile. CONCLUSIONS Tibial artery revascularization in patients with CLI using DCB angioplasty resulted in comparable long-term safety and effectiveness as PTA. Paclitaxel exposure was not related to increased risk for amputation or ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| DOI: | 10.1016/j.jcin.2019.10.059 |
| الاتاحة: | https://hdl.handle.net/11370/c4c9a389-c5aa-4d27-bc92-283b2053165b https://research.rug.nl/en/publications/c4c9a389-c5aa-4d27-bc92-283b2053165b https://doi.org/10.1016/j.jcin.2019.10.059 https://pure.rug.nl/ws/files/157949772/The_IN.PACT_DEEP_Clinical_Drug_Coated_Balloon_Trial_5_Year_Outcomes.pdf |
| Rights: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.962AC15D |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/j.jcin.2019.10.059 |
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