IN.PACT AV Access Randomized Trial of Drug-Coated Balloons for Dysfunctional Arteriovenous Fistulae: Clinical Outcomes through 36 Months

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 and methods: Participants at 29 international sites were randomized 1:1 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.

Figure 1.

Consolidated Standards of Reporting Trials diagram. A total of 330 participants were randomized 1:1 to receive percutaneous transluminal angioplasty with a drug-coated balloon or a standard percutaneous transluminal angioplasty balloon.

Figure 2.

(a) Target lesion primary patency through 36 months. (b) Target lesion primary patency through 36 months with median survival time. An independent and blinded clinical events committee adjudicated all events. The definition of target lesion primary patency was freedom from clinically driven target lesion revascularization or access circuit thrombosis. An event was designated to be a clinically driven target lesion revascularization if the target lesion had ≥50% diameter stenosis (per angiographic core laboratory assessment) in the presence of clinical or physiologic abnormalities that indicate dialysis access dysfunction or a ≥70% stenosis without the presence of clinical or physiologic abnormalities indicating dialysis access dysfunction. DCB = drug-coated balloon; PTA = percutaneous transluminal angioplasty.

Figure 3.

Access circuit primary patency through 36 months. Access circuit primary patency was defined as freedom from reintervention in the access circuit or access circuit thrombosis after the index procedure. An independent and blinded clinical events committee adjudicated all events. DCB = drug-coated balloon; PTA = percutaneous transluminal angioplasty.

Figure 4.

Cumulative incidence of access circuit thrombosis through 36 months. Thrombosis events involving the access circuit were adjudicated by the independent and blinded clinical events committee. DCB = drug-coated balloon; PTA = percutaneous transluminal angioplasty.

Figure 5.

Cumulative incidence of all-cause mortality through 36 months. An independent and blinded clinical events committee adjudicated all events. DCB = drug-coated balloon; PTA = percutaneous transluminal angioplasty.

Figure 6.

Outcome comparisons for endovascular treatment of arteriovenous fistulae through 2 and 3 years. For inclusion on this chart, studies were required to report the target lesion primary patency outcomes of endovascular treatment of dysfunctional arteriovenous fistulae; they did not include arteriovenous grafts, lesions within a stent (in-stent restenosis), or lesions in central veins, and all enrolled over 100 patients. Definitions varied across studies; this chart is provided as a reference. CEC = clinical events committee; DCB = drug-coated balloon; PTA = percutaneous transluminal angioplasty.