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Eur J Vasc Endovasc Surg. 2014 Sep;48(3):285-91. doi: 10.1016/j.ejvs.2014.05.012. Epub 2014 Jun 22.

Endovascular repair of acute uncomplicated aortic type B dissection promotes aortic remodelling: 1 year results of the ADSORB trial.

Author information

1
Department of Vascular and Endovascular Surgery, University Clinics, University of Cologne, Cologne, Germany. Electronic address: jan.brunkwall@uk-koeln.de.
2
Section of Vascular Surgery, Department of Surgery, University of Regensburg, Department of Vascular Surgery, Klinikum Nuernberg, Nuremberg, Germany.
3
Department of Cardiovasc Surgery Antonius Hospital, Nieuwegein, The Netherlands.
4
Department of Vascular Surgery, St Guys Hospital, London, UK.

Erratum in

  • Eur J Vasc Endovasc Surg. 2015 Jul;50(1):130. Böckler, D [removed]; von Tenng-Kobligk, H [corrected to von Tengg-Kobligk, H].

Abstract

OBJECTIVES:

Uncomplicated acute type B aortic dissection (AD) treated conservatively has a 10% 30-day mortality and up to 25% need intervention within 4 years. In complicated AD, stent grafts have been encouraging. The aim of the present prospective randomised trial was to compare best medical treatment (BMT) with BMT and Gore TAG stent graft in patients with uncomplicated AD. The primary endpoint was a combination of incomplete/no false lumen thrombosis, aortic dilatation, or aortic rupture at 1 year.

METHODS:

The AD history had to be less than 14 days, and exclusion criteria were rupture, impending rupture, malperfusion. Of the 61 patients randomised, 80% were DeBakey type IIIB.

RESULTS:

Thirty-one patients were randomised to the BMT group and 30 to the BMT+TAG group. Mean age was 63 years for both groups. The left subclavian artery was completely covered in 47% and in part in 17% of the cases. During the first 30 days, no deaths occurred in either group, but there were three crossovers from the BMT to the BMT+TAG group, all due to progression of disease within 1 week. There were two withdrawals from the BMT+TAG group. At the 1-year follow up there had been another two failures in the BMT group: one malperfusion and one aneurysm formation (p = .056 for all). One death occurred in the BMT+TAG group. For the overall endpoint BMT+TAG was significantly different from BMT only (p < .001). Incomplete false lumen thrombosis, was found in 13 (43%) of the TAG+BMT group and 30 (97%) of the BMT group (p < .001). The false lumen reduced in size in the BMT+TAG group (p < .001) whereas in the BMT group it increased. The true lumen increased in the BMT+TAG (p < .001) whereas in the BMT group it remained unchanged. The overall transverse diameter was the same at the beginning and after 1 year in the BMT group (42.1 mm), but in the BMT+TAG it decreased (38.8 mm; p = .062).

CONCLUSIONS:

Uncomplicated AD can be safely treated with the Gore TAG device. Remodelling with thrombosis of the false lumen and reduction of its diameter is induced by the stent graft, but long term results are needed.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00742274.

KEYWORDS:

Acute type B dissection; Remodelling; Stent graft; Thrombosis; Uncomplicated

PMID:
24962744
DOI:
10.1016/j.ejvs.2014.05.012
[Indexed for MEDLINE]
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