Lars J J Bolt1, Attila G Krasznai2, Tim A Sigterman3, Cornelis J J M Sikkink2, Geert Willem H Schurink4, Lee H Bouwman2. 1. Department of Surgery, Zuyderland Medical Center, Heerlen, the Netherlands. Electronic address: l.bolt@zuyderland.nl. 2. Department of Surgery, Zuyderland Medical Center, Heerlen, the Netherlands. 3. Department of Surgery, VieCuri Medical Center, Venlo, the Netherlands. 4. Department of Surgery, Maastricht University Medical Center, Maastricht, the Netherlands.
Abstract
BACKGROUND:Percutaneous transluminal angioplasty (PTA) requires the use of nephrotoxic contrast. Patients with chronic kidney disease are more prone to develop contrast-induced nephropathy after utilization of contrast. Doppler ultrasound (duplex)-guided PTA (DuPTA) is a novel technique and has recently proven to be a successful alternative to conventional PTA in the treatment of iliac stenotic disease, without the use of contrast. In this randomized controlled trial, we evaluated whether DuPTA is as effective as conventional PTA in the treatment of iliac arterial stenotic disease. METHODS:From June 2013 till January 2017, 142 patients with symptomatic peripheral arterial disease (PAD), with significant (>70%) iliac stenotic lesions (both isolated and patients with multilevel disease without treatment of other lesions), were randomized to receive either conventional PTA or DuPTA of the iliac lesion, regardless of renal function. All patients received an ankle-brachial index, arterial mapping with duplex, and magnetic resonance angiography in the pre-operative work-up. Primary end point was procedural success, defined as passing the guidewire through the stenotic lesion and performing a PTA, with or without stenting. Reduction in peak systolic velocity (PSV) of ≥50% after successful PTA was required in the DuPTA group. Angiographic reduction of more than 50% was required in the interventional group. Decrease in PSV was evaluated in both groups 4 weeks post-procedure. RESULTS: Passing of the guidewire through the stenotic lesion was achieved in 96.5% of the DuPTA group and 98.8% of the PTA group (P = 0.34). Although PSV decreased significantly in both groups 4 weeks post-operative, PSV reduction ≥50% was significantly higher in the DuPTA group, respectively 78% vs. 58% in the PTA group (P < 0.01). The utilization of stents was significantly greater in the DuPTA group (52% vs. 18%, P < 0.01). After correction of potential confounders, significant difference in ≥50% PSV reduction remained; technical success did not differ significantly. CONCLUSIONS:DuPTA is a feasible alternative to conventional PTA in the treatment of PAD on the iliac anatomic level. Duplex examination before removal of the guidewire is recommended to evaluate adequate decrease in PSV and identify potential recoil.
RCT Entities:
BACKGROUND: Percutaneous transluminal angioplasty (PTA) requires the use of nephrotoxic contrast. Patients with chronic kidney disease are more prone to develop contrast-induced nephropathy after utilization of contrast. Doppler ultrasound (duplex)-guided PTA (DuPTA) is a novel technique and has recently proven to be a successful alternative to conventional PTA in the treatment of iliac stenotic disease, without the use of contrast. In this randomized controlled trial, we evaluated whether DuPTA is as effective as conventional PTA in the treatment of iliac arterial stenotic disease. METHODS: From June 2013 till January 2017, 142 patients with symptomatic peripheral arterial disease (PAD), with significant (>70%) iliac stenotic lesions (both isolated and patients with multilevel disease without treatment of other lesions), were randomized to receive either conventional PTA or DuPTA of the iliac lesion, regardless of renal function. All patients received an ankle-brachial index, arterial mapping with duplex, and magnetic resonance angiography in the pre-operative work-up. Primary end point was procedural success, defined as passing the guidewire through the stenotic lesion and performing a PTA, with or without stenting. Reduction in peak systolic velocity (PSV) of ≥50% after successful PTA was required in the DuPTA group. Angiographic reduction of more than 50% was required in the interventional group. Decrease in PSV was evaluated in both groups 4 weeks post-procedure. RESULTS: Passing of the guidewire through the stenotic lesion was achieved in 96.5% of the DuPTA group and 98.8% of the PTA group (P = 0.34). Although PSV decreased significantly in both groups 4 weeks post-operative, PSV reduction ≥50% was significantly higher in the DuPTA group, respectively 78% vs. 58% in the PTA group (P < 0.01). The utilization of stents was significantly greater in the DuPTA group (52% vs. 18%, P < 0.01). After correction of potential confounders, significant difference in ≥50% PSV reduction remained; technical success did not differ significantly. CONCLUSIONS:DuPTA is a feasible alternative to conventional PTA in the treatment of PAD on the iliac anatomic level. Duplex examination before removal of the guidewire is recommended to evaluate adequate decrease in PSV and identify potential recoil.