IN.PACT AV Access Randomized Trial : 12-Month Clinical Results Demonstrating the Sustained Treatment Effect of Drug-Coated Balloons
Copyright © 2022 SIR. Published by Elsevier Inc. All rights reserved..
PURPOSE: To present the 12-month outcomes of the IN.PACT AV Access Study, a prospective, single-blind trial enrolling participants with obstructive de novo or restenotic native upper extremity arteriovenous dialysis fistula lesions treated with a drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA).
MATERIALS AND METHODS: After successful high-pressure PTA, participants at 29 international sites were randomized 1:1 to treatment with an IN.PACT AV DCB (n = 170) or standard uncoated PTA (n = 160). Outcomes at 12 months include target lesion primary patency (TLPP), defined as freedom from clinically driven target lesion revascularization or access circuit thrombosis; access circuit primary patency; number of reinterventions; and adverse events involving the access circuit.
RESULTS: At 12 months, TLPP was 63.8% (90/141) in the DCB group compared with 43.6% (61/140) in the PTA group (P < .001). The total number of reinterventions required to maintain TLPP through 360 days was 93 in the DCB group and 144 in the PTA group, with a 35.4% reduction in reinterventions when DCB was used. Access circuit thrombosis occurred in 2.9% (4/138) of the participants in the DCB group and in 6.2% (8/129) of those in the PTA group (P = .19). Time to TLPP was assessed using a multivariable analysis to identify the factors associated with loss of patency. The treatment device was the independent predictor with the largest effect, with a hazard ratio of 0.42 (95% confidence interval, 0.29-0.60; P < .001).
CONCLUSIONS: TLPP was statistically significantly higher with DCBs than with standard PTA at 12 months, demonstrating the sustained and superior effectiveness of this device for the treatment of dysfunctional arteriovenous dialysis fistulae.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:33 |
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| Enthalten in: |
Journal of vascular and interventional radiology : JVIR - 33(2022), 8 vom: 01. Aug., Seite 884-894.e7 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Holden, Andrew [VerfasserIn] |
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| Links: |
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| Themen: |
Coated Materials, Biocompatible |
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| Anmerkungen: |
Date Completed 02.08.2022 Date Revised 21.08.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.jvir.2022.03.606 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Holden, Andrew |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a IN.PACT AV Access Randomized Trial |b 12-Month Clinical Results Demonstrating the Sustained Treatment Effect of Drug-Coated Balloons |
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| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2022 SIR. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a PURPOSE: To present the 12-month outcomes of the IN.PACT AV Access Study, a prospective, single-blind trial enrolling participants with obstructive de novo or restenotic native upper extremity arteriovenous dialysis fistula lesions treated with a drug-coated balloon (DCB) or percutaneous transluminal angioplasty (PTA) | ||
| 520 | |a MATERIALS AND METHODS: After successful high-pressure PTA, participants at 29 international sites were randomized 1:1 to treatment with an IN.PACT AV DCB (n = 170) or standard uncoated PTA (n = 160). Outcomes at 12 months include target lesion primary patency (TLPP), defined as freedom from clinically driven target lesion revascularization or access circuit thrombosis; access circuit primary patency; number of reinterventions; and adverse events involving the access circuit | ||
| 520 | |a RESULTS: At 12 months, TLPP was 63.8% (90/141) in the DCB group compared with 43.6% (61/140) in the PTA group (P < .001). The total number of reinterventions required to maintain TLPP through 360 days was 93 in the DCB group and 144 in the PTA group, with a 35.4% reduction in reinterventions when DCB was used. Access circuit thrombosis occurred in 2.9% (4/138) of the participants in the DCB group and in 6.2% (8/129) of those in the PTA group (P = .19). Time to TLPP was assessed using a multivariable analysis to identify the factors associated with loss of patency. The treatment device was the independent predictor with the largest effect, with a hazard ratio of 0.42 (95% confidence interval, 0.29-0.60; P < .001) | ||
| 520 | |a CONCLUSIONS: TLPP was statistically significantly higher with DCBs than with standard PTA at 12 months, demonstrating the sustained and superior effectiveness of this device for the treatment of dysfunctional arteriovenous dialysis fistulae | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 7 | |a Coated Materials, Biocompatible |2 NLM | |
| 700 | 1 | |a Haruguchi, Hiroaki |e verfasserin |4 aut | |
| 700 | 1 | |a Suemitsu, Kotaro |e verfasserin |4 aut | |
| 700 | 1 | |a Isogai, Naoko |e verfasserin |4 aut | |
| 700 | 1 | |a Ross, John |e verfasserin |4 aut | |
| 700 | 1 | |a Hull, Jeffrey |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Hong |e verfasserin |4 aut | |
| 700 | 1 | |a Seamans, Jennifer |e verfasserin |4 aut | |
| 700 | 1 | |a Lookstein, Robert |e verfasserin |4 aut | |
| 700 | 0 | |a IN.PACT AV Access Investigators |e verfasserin |4 aut | |
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