Abstract
BackgroundThis study assessed the effectiveness and safety of bosentan when administered to thromboangiitis obliterans (Buerger's disease) patients.MethodsA clinical pilot study was designed in which patients with ulcer and/or pain at rest were treated with bosentan p.o. at a dose of 62.5 mg twice daily during the first month, which was thereafter up-titrated to 125 mg twice daily. The study endpoints were clinical improvement rate, major or minor amputation rate, haemodynamic changes, changes in endothelial function and angiographic changes.ResultsSeven out of 12 patients were male (58%). Median age was 39 years (range 29-49). The median follow-up was 20 months (range 11-40). All patients were smokers. With bosentan treatment, new ischaemic lesions were observed in only one patient. Overall, clinical improvement was observed in 12 of the 13 extremities (92%). Only two out of 13 extremities underwent amputation (one major and one minor) after bosentan treatment. After being assessed by digital arteriography with subtraction or angio-magnetic resonance imaging, an increase of distal flow was observed in 10 out of the 12 patients. All patients experienced a statistically significant improvement in their BAFMD values (mean: 1.8 at baseline; 6.6 at the end of the treatment; 12.7 three months after the end of the treatment; p < 0.01).ConclusionBosentan treatment may result in an improvement of clinical, angiographic and endothelial function outcomes. Bosentan should be investigated further in the management of TAO patients. Larger studies are required to confirm these results.Trial RegistrationClinicalTrials.gov: NCT01447550
Highlights
This study assessed the effectiveness and safety of bosentan when administered to thromboangiitis obliterans (Buerger’s disease) patients
Patients In order to be included in the study, the patients had to have a previous diagnosis of thromboangiitis obliterans (TAO), fulfilling the Shionoya criteria [10]: 1) onset of distal ischaemic symptoms in one extremity before the age of 50 years, 2) smoker or history of smoking, 3) distal ischaemia of the extremity confirmed by a non-invasive test, 4) absence of thrombophilia, autoimmune disease, diabetes, hyperlipidaemia, trauma or a proximal source of underlying embolism, 5) arterial tree proximal to the distal segment of the healthy superficial femoral artery, and 6) occlusive distal disease with specific elements or actual pathological findings demonstrated angiographically or by means of angio-magnetic resonance imaging
We considered a ratio < 0.7 in DBI, RBI and Ulnar/Brachial Index (UBI) as an indicator of an inadequate blood perfusion in the upper limb [11,12,13]
Summary
This study assessed the effectiveness and safety of bosentan when administered to thromboangiitis obliterans (Buerger’s disease) patients. Buerger’s disease, known as thromboangiitis obliterans (TAO), is a thrombotic, occlusive, non-atherosclerotic, segmental vasculitis of small and medium-sized arteries and veins, which may involve both upper and lower extremities. Intermittent claudication and, in more advanced cases, pain at rest are the predominant clinical symptoms. Clinical course is characterised by alternating periods of exacerbation with periods of remission. Angiographic studies reveal a distal and segmental involvement of the vasculature of the extremities. Recanalisation is frequently demonstrated, showing a typical image (corkscrew collateral vessels) [3]. Skin disorders such as migrating phlebitis or Raynaud-like colour changes may be associated with TAO
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