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Vessel and balloon sizing in the IN.PACT AV access trial: post-hoc analysis of procedural characteristics and
Andrew Holden1, Hiroaki Haruguchi2, Kotaro Suemitsu3
1Department of Interventional Radiology, Auckland Hospital, Auckland, New Zealand. Andrew.Holden@TeWhatuOra.govt.nz.
Insights
Optimizing drug-coated balloon (DCB) sizing for dysfunctional arteriovenous fistulas may improve patient outcomes. Further research is needed to establish ideal DCB sizing strategies for hemodialysis access.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Nephrology
Background:
- Drug-coated balloons (DCBs) show promise for treating dysfunctional arteriovenous fistulas (AVFs) in hemodialysis patients.
- Optimal patient and lesion profiles for DCB treatment remain unclear.
- Pivotal trials with core lab adjudication are valuable for hypothesis generation regarding intra-procedural characteristics.
Purpose of the Study:
- To explore the relationship between core lab adjudicated vessel sizing and target lesion primary patency (TLPP) outcomes.
- To investigate if intra-procedural vessel sizing impacts DCB effectiveness in AVF treatment.
Main Methods:
- Analysis of data from the IN.PACT AV Access Trial, a randomized study comparing DCB and percutaneous transluminal angioplasty (PTA).
- Post-hoc analysis focusing on core lab adjudicated reference vessel diameter (RVD).
- Patients were stratified into groups based on median RVD to assess TLPP outcomes up to 36 months.
Main Results:
- The IN.PACT AV Access Trial randomized 330 patients (170 DCB, 160 PTA).
- This exploratory analysis examined vessel sizing in relation to TLPP outcomes.
- Participants were grouped by median reference vessel diameter (RVD).
Conclusions:
- Intra-procedural sizing decisions for DCBs may positively influence outcomes in patients with dysfunctional fistula lesions.
- Further prospective studies are warranted to define optimal DCB sizing strategies.
Background:
Drug-coated balloons (DCBs) have demonstrated effectiveness and safety in the treatment of dysfunctional arteriovenous fistulas used for hemodialysis in larger randomized studies; however, the patient and lesion profiles that have the best DCB outcomes remain undefined. Pivotal trials with core lab adjudication are ideal to generate hypotheses for future studies of intra-procedural characteristics given they include both site-reported and independently assessed data. The IN.PACT AV Access Trial randomized 330 patients 1:1 to treatment with a DCB (n = 170) or uncoated percutaneous transluminal angioplasty (PTA; n = 160). This exploratory post-hoc analysis investigated core lab adjudicated vessel sizing in the context of target lesion primary patency (TLPP) outcomes through 36 months. Participants were split into groups by median reference vessel diameter (RVD).
Results:
The IN.PACT AV Access Trial randomized 330 patients 1:1 to treatment with a DCB (n = 170) or uncoated percutaneous transluminal angioplasty (PTA; n = 160). This exploratory post-hoc analysis investigated core lab adjudicated vessel sizing in the context of target lesion primary patency (TLPP) outcomes through 36 months. Participants were split into groups by median reference vessel diameter (RVD).
Conclusions:
This post hoc analysis identified that intra-procedural sizing decisions have the potential to positively impact outcomes in patients with dysfunctional fistula lesions. These findings warrant further prospective evaluation to define optimal DCB sizing strategies.
Trial Registration:
NCT03041467 . Registered 25 April 2017.
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