IN.PACT AV Access Randomized Trial of Drug-Coated Balloons for Dysfunctional Arteriovenous Fistulae: Clinical Outcomes through 36 Months.
J Vasc Interv Radiol
; 34(12): 2093-2102.e7, 2023 12.
Article
em En
| MEDLINE
| ID: mdl-37460061
ABSTRACT
PURPOSE:
To present the 36-month outcomes of the prospective randomized IN.PACT AV Access study of participants with obstructive de novo or restenotic native upper extremity arteriovenous dialysis fistula lesions treated with drug-coated balloon (DCBs) or standard percutaneous transluminal angioplasty (PTA) following successful high-pressure PTA. MATERIALS ANDMETHODS:
Participants at 29 international sites were randomized 11 to receive an IN.PACT AV DCB (n = 170) or undergo PTA (n = 160). The outcomes through 36 months included target lesion primary patency (TLPP) and access circuit primary patency (ACPP) (composites of clinically driven target lesion or access circuit revascularization and/or access circuit thrombosis), number of reinterventions, and serious adverse events involving the access circuit.RESULTS:
TLPP was 52.1% in the DCB group compared with 36.7% in the PTA group through 24 months and 43.1% in the DCB group compared with 28.6% in the PTA group through 36 months (both log-rank P < .001). ACPP was 39.4% in the DCB group compared with 25.3% in the PTA group through 24 months and 26.4% in the DCB group compared with 16.6% in the PTA group through 36 months (both log-rank P < .001). Cumulative incidence of access circuit thrombosis through 36 months was 8.2% in the DCB group compared with 18.3% in the PTA group (log-rank P = .040). Cumulative incidence of mortality through 36 months was 26.6% in the DCB group compared with 30.8% in the PTA group (log-rank P = .71).CONCLUSIONS:
This study demonstrated superior TLPP and ACPP with DCBs compared with PTA, with no difference in mortality through 3 years. Access circuit thrombosis was statistically significantly higher in the PTA group at 3 years.
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Base de dados:
MEDLINE
Assunto principal:
Trombose
/
Angioplastia com Balão
/
Doença Arterial Periférica
/
Dispositivos de Acesso Vascular
Tipo de estudo:
Clinical_trials
Limite:
Humans
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article