Prostanoids for critical limb ischaemia
Abstract
Background
Peripheral arterial occlusive disease (PAOD) is a common cause of morbidity and mortality due to cardiovascular diseases in the general population. While numerous treatments have been adopted for different disease stages, there is no option other than amputation for patients presenting with critical limb ischaemia (CLI), unsuitable for rescue or reconstructive intervention.
Objectives
To determine the effectiveness and safety of prostanoids in patients presenting with CLI.
Search methods
The Cochrane Peripheral Vascular Diseases Group searched their trials register (last searched October 2009) and the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (last searched 2009, Issue 4) for publications describing randomised controlled trials (RCTs) of prostanoids for CLI. We ran additional searches in MEDLINE, EMBASE, LILACS, and SciSearch, and we also contacted pharmaceutical companies and experts, in order to identify unpublished data and trials still underway.
Selection criteria
Randomised controlled trials describing efficacy and safety of prostanoids compared with placebo or other pharmacological control treatments, in patients presenting with CLI, without chance of rescue or reconstructive intervention.
Data collection and analysis
Two authors independently selected trials, assessed trials for eligibility and methodological quality, and extracted data. Disagreements were resolved by consensus or by the third author.
Main results
We retrieved 532 citations which after the first screening resulted in 111 potential studies. Finally, after exclusion of studies of poor quality and a lack of sufficient information, 20 trials were included in the review.
Prostanoids seem to have efficacy regarding rest‐pain relief (risk ratio (RR) 1.32, 95% confidence interval (CI) 1.10 to 1.57; P = 0.003), and ulcer healing (RR 1.54, 95% CI 1.22 to 1.96). Iloprost also shows favourable results regarding major amputations (RR 0.69, 95% CI 0.52 to 0.93). The more frequently reported adverse events when using prostanoids were headache, facial flushing, nausea, vomiting and diarrhoea.
Authors' conclusions
Despite some positive results regarding rest‐pain relief, ulcer healing and amputations, there is no conclusive evidence based on this meta‐analysis of the long‐term effectiveness and safety of different prostanoids in patients with CLI. Further well‐conducted, high quality randomised double‐blinded trials should be performed.
PICOs
Plain language summary
Prostanoids for treating people with severe peripheral arterial disease of the legs
People with severely narrowed arteries of the lower limbs may suffer rest pain, ulcers, or gangrene, and this problem is called critical limb ischaemia. There is no option other than amputation for patients who present with critical limb ischaemia and who are unsuitable for rescue or reconstructive intervention of the arteries. The question is whether specific drugs such as prostanoids reduce mortality and progression of the disease, including amputations, more than placebo or other treatments. This review of 20 trials did not find any conclusive evidence that prostanoids provided long‐term benefit. Prostanoids seem to have efficacy regarding rest‐pain relief and ulcer healing. Iloprost may also have favourable results regarding major amputations. The more frequently reported adverse events when using prostanoids were headache, facial flushing, nausea, vomiting and diarrhoea
