Norwegian Randomised Trial of Laparoscopic versus Open Aortobifemoral Bypass: The Norwegian Laparoscopic Aortic Surgery Trial (NLAST)

Syed S H Kazmi; Mehdi Sahba; Erik Mulder Pettersen; Anne H Krog; Morten W Fagerland; Jon Otto Sundhagen

doi:10.1016/j.ejvs.2025.09.046

Norwegian Randomised Trial of Laparoscopic versus Open Aortobifemoral Bypass: The Norwegian Laparoscopic Aortic Surgery Trial (NLAST)

Eur J Vasc Endovasc Surg. 2025 Nov 7:S1078-5884(25)00932-3. doi: 10.1016/j.ejvs.2025.09.046. Online ahead of print.

Authors

Syed S H Kazmi¹, Mehdi Sahba², Erik Mulder Pettersen³, Anne H Krog⁴, Morten W Fagerland⁵, Jon Otto Sundhagen⁴

Affiliations

¹ Department of Vascular Surgery, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway. Electronic address: sshkazmi@gmail.com.
² Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway; Department of Vascular Surgery, Østfold Central Hospital, Kalnes, Norway.
³ Department of Vascular Surgery, Sørlandet Hospital, Kristiansand, Norway.
⁴ Department of Vascular Surgery, Oslo University Hospital, Oslo, Norway.
⁵ Oslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Oslo, Norway.

PMID: 41207501
DOI: 10.1016/j.ejvs.2025.09.046

Abstract

Objective: This study aimed to compare post-operative complications after laparoscopic and open aortobifemoral bypass (ABFB) for aorto-iliac occlusive disease (AIOD).

Methods: The Norwegian Laparoscopic Aortic Surgery Trial (NLAST) is a multicentre, non-blinded, parallel group, randomised controlled superiority trial. The trial was funded by Oslo University Hospital and conducted at three Norwegian public hospitals between March 2013 and November 2022. In this randomised study, 126 patients with TransAtlantic InterSociety Consensus II (TASC II) type D lesions, with debilitating lifestyle limiting intermittent claudication or chronic limb threatening ischaemia, clinically classified as Fontaine IIb or worse, were randomised in a 1:1 ratio to either laparoscopic ABFB (n = 63) or open ABFB (n = 63) (ClinicalTrials.gov ID NCT01793662). The primary outcome was post-operative complications, including systemic, vascular, and local complications, during a follow up of 2.9 years. The primary analysis was conducted on an intention to treat basis, with an additional supporting analysis performed per protocol.

Results: Allocated surgery was performed in 62 (98%) and 60 (95%) individuals in the laparoscopic and open ABFB groups, respectively. Post-operative complications occurred in 21/62 patients (34%) in the laparoscopic group and 44/60 patients (73%) in the open ABFB group (difference -40 percentage points, 95% confidence interval -54 - -22; p < .001), during a mean follow up of 3.6 ± 2.5 years. The 30 day mortality rate was 2% (1/62) and 2% (1/60) for laparoscopic and open ABFB, respectively. Limb based primary patency, primary assisted patency, and secondary patency rates at one year were 98%, 98%, and 98% for laparoscopic ABFB and 95%, 96%, and 96% for open ABFB, respectively. At two years the rates were 98%, 98%, and 98% for laparoscopic ABFB and 94%, 95%, and 95% for open ABFB.

Conclusion: Patients with AIOD, TASC II type D lesions have significantly fewer post-operative complications after laparoscopic than open ABFB.

Keywords: Aorto-iliac occlusive disease; Aortobifemoral bypass; Intermittent claudication; Laparoscopy.

Associated data

ClinicalTrials.gov/NCT01793662