Nicolas W Shammas, Gail Shammas, Lori Christensen, Sue Jones-Miller
{"title":"喷射流动脉粥样硬化切除术与紫杉醇涂层气球:前瞻性随机喷射游骑兵研究的两年结果。","authors":"Nicolas W Shammas, Gail Shammas, Lori Christensen, Sue Jones-Miller","doi":"10.2147/VHRM.S403177","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The JET-RANGER study (NCT03206762) was a multicenter (11 US centers) randomized trial, core lab adjudicated, designed to demonstrate the superiority of Jetstream + Paclitaxel coated balloon (JET+PCB) versus angioplasty (PTA) + PCB in treating femoropopliteal (FP) arterial disease. The one-year primary endpoint of JET-RANGER has been recently published. The 2-year outcome data are presented in this report.</p><p><strong>Methods: </strong>There were 43 patients who completed the 1-year follow-up. Two were lost to follow-up and one died prior to the 2-year follow-up, resulting in 40 patients. Fifteen patients were randomized to PTA+PCB and 25 patients to JET +PCB. Kaplan Meier Survival analysis was performed to estimate the freedom from TLR. Bailout stenting was not considered a TLR in this analysis. Statistical significance was determined by a p-value < 0.05.</p><p><strong>Results: </strong>Freedom from TLR was similar between the 2 groups at 2 years. There was also no significant difference in the change of ABI between the PTA + PCB and JET + PCB from baseline at 6-months, (p-value = 0.7890), 1-year (p-value = 0.4070), and 2-year (p-value=0.7410). There was also no statistical difference between the JET + PCB and PTA + PCB arms for RCC improvement by one or more category, (p-value= 1.000). There were no minor or major amputations for either arm throughout the 2-year follow up. One JET + PCB patient died before the 2-year specified window.</p><p><strong>Conclusion: </strong>JET + PCB had similar freedom from TLR and improvement in ABI and RCC at 2-year follow-up when compared to PTA + PCB with no difference in amputation or mortality between the 2 arms.</p><p><strong>Clinical trial registration: </strong>NCT03206762.</p>","PeriodicalId":23597,"journal":{"name":"Vascular Health and Risk Management","volume":"19 ","pages":"133-137"},"PeriodicalIF":2.6000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/68/6f/vhrm-19-133.PMC10015974.pdf","citationCount":"0","resultStr":"{\"title\":\"Jetstream Atherectomy with Paclitaxel-Coated Balloons: Two-Year Outcome of the Prospective Randomized JET-RANGER Study.\",\"authors\":\"Nicolas W Shammas, Gail Shammas, Lori Christensen, Sue Jones-Miller\",\"doi\":\"10.2147/VHRM.S403177\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The JET-RANGER study (NCT03206762) was a multicenter (11 US centers) randomized trial, core lab adjudicated, designed to demonstrate the superiority of Jetstream + Paclitaxel coated balloon (JET+PCB) versus angioplasty (PTA) + PCB in treating femoropopliteal (FP) arterial disease. The one-year primary endpoint of JET-RANGER has been recently published. The 2-year outcome data are presented in this report.</p><p><strong>Methods: </strong>There were 43 patients who completed the 1-year follow-up. Two were lost to follow-up and one died prior to the 2-year follow-up, resulting in 40 patients. Fifteen patients were randomized to PTA+PCB and 25 patients to JET +PCB. Kaplan Meier Survival analysis was performed to estimate the freedom from TLR. Bailout stenting was not considered a TLR in this analysis. Statistical significance was determined by a p-value < 0.05.</p><p><strong>Results: </strong>Freedom from TLR was similar between the 2 groups at 2 years. There was also no significant difference in the change of ABI between the PTA + PCB and JET + PCB from baseline at 6-months, (p-value = 0.7890), 1-year (p-value = 0.4070), and 2-year (p-value=0.7410). There was also no statistical difference between the JET + PCB and PTA + PCB arms for RCC improvement by one or more category, (p-value= 1.000). There were no minor or major amputations for either arm throughout the 2-year follow up. One JET + PCB patient died before the 2-year specified window.</p><p><strong>Conclusion: </strong>JET + PCB had similar freedom from TLR and improvement in ABI and RCC at 2-year follow-up when compared to PTA + PCB with no difference in amputation or mortality between the 2 arms.</p><p><strong>Clinical trial registration: </strong>NCT03206762.</p>\",\"PeriodicalId\":23597,\"journal\":{\"name\":\"Vascular Health and Risk Management\",\"volume\":\"19 \",\"pages\":\"133-137\"},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2023-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/68/6f/vhrm-19-133.PMC10015974.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Vascular Health and Risk Management\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2147/VHRM.S403177\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"PERIPHERAL VASCULAR DISEASE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Vascular Health and Risk Management","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2147/VHRM.S403177","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
Jetstream Atherectomy with Paclitaxel-Coated Balloons: Two-Year Outcome of the Prospective Randomized JET-RANGER Study.
Background: The JET-RANGER study (NCT03206762) was a multicenter (11 US centers) randomized trial, core lab adjudicated, designed to demonstrate the superiority of Jetstream + Paclitaxel coated balloon (JET+PCB) versus angioplasty (PTA) + PCB in treating femoropopliteal (FP) arterial disease. The one-year primary endpoint of JET-RANGER has been recently published. The 2-year outcome data are presented in this report.
Methods: There were 43 patients who completed the 1-year follow-up. Two were lost to follow-up and one died prior to the 2-year follow-up, resulting in 40 patients. Fifteen patients were randomized to PTA+PCB and 25 patients to JET +PCB. Kaplan Meier Survival analysis was performed to estimate the freedom from TLR. Bailout stenting was not considered a TLR in this analysis. Statistical significance was determined by a p-value < 0.05.
Results: Freedom from TLR was similar between the 2 groups at 2 years. There was also no significant difference in the change of ABI between the PTA + PCB and JET + PCB from baseline at 6-months, (p-value = 0.7890), 1-year (p-value = 0.4070), and 2-year (p-value=0.7410). There was also no statistical difference between the JET + PCB and PTA + PCB arms for RCC improvement by one or more category, (p-value= 1.000). There were no minor or major amputations for either arm throughout the 2-year follow up. One JET + PCB patient died before the 2-year specified window.
Conclusion: JET + PCB had similar freedom from TLR and improvement in ABI and RCC at 2-year follow-up when compared to PTA + PCB with no difference in amputation or mortality between the 2 arms.
期刊介绍：
An international, peer-reviewed journal of therapeutics and risk management, focusing on concise rapid reporting of clinical studies on the processes involved in the maintenance of vascular health; the monitoring, prevention, and treatment of vascular disease and its sequelae; and the involvement of metabolic disorders, particularly diabetes. In addition, the journal will also seek to define drug usage in terms of ultimate uptake and acceptance by the patient and healthcare professional.
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