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In 51 hospitals in six European countries 713 patients requiring below-knee amputation for ischaemic disease were studied prospectively. The patients were allocated randomly to receive standard postoperative treatment or standard treatment plus intravenous infusion of the prostacyclin analogue iloprost for 6 h per day over 14-21 days. Healing of the amputation stump and the need for reamputation at a higher level were similar in the two groups. Overall at 3 months 59 per cent of stumps had healed, 19 per cent of patients had required reamputation at a higher level, 11 per cent had died and the remaining 11 per cent remained with unhealed stumps. Preoperative characteristics were analysed as possible risk factors or markers for primary healing, reamputation and death. Previous arterial reopening procedures (surgical or radiological) almost doubled the chances of primary stump healing (P < 0.05). The surgeon's assessment of the likelihood of healing was wrong in 21 per cent of cases in which the operating surgeon thought that healing would probably occur and in 52 per cent of those in which it was thought healing was improbable.

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Pioglitazone HCl, a new thiazolidinedione (TZD), has been developed for the treatment of type 2 diabetes. The drug was tested in several trials that included over 5,000 subjects. Of these, over 3,500 subjects received active treatment. At doses between 15±45 mg pioglitazone was well tolerated with dropouts due to adverse events being similar in pioglitazone and placebo groups. The main side effect of treatment was mild to moderate peripheral oedema. Oedema was not associated with signs or symptoms of congestive cardiac failure, and there was no excess of adverse events in the cardiovascular system in the pioglitazone-treated patients. Weight increases were seen during treatment with pioglitazone, with most weight gain in the early period of the treatment, which then stabilised. It has been shown to be due to increases in subcutaneous fat. Despite weight gain, the favourable effects of pioglitazone on glycaemic control and lipids were maintained. In laboratory tests, small decreases in haemoglobin and haematocrit were seen due to haemodilution. However, anaemia was not reported more often with pioglitazone than with placebo and no patients were discontinued due to anaemia associated with pioglitazone. A thorough analysis of results of liver tests revealed no evidence of hepatotoxicity with pioglitazone. The safety profile of pioglitazone demonstrated by clinical trials is supported further by safety data from the market in USA and Japan, where the drug has been widely prescribed for over a year. A safety and tolerability profile, similar to that seen in clinical trials, has been reported.

Background Clinical complexity is increasingly prevalent among patients with atrial fibrillation (AF). The ‘Atrial fibrillation Better Care’ (ABC) pathway approach has been proposed to streamline a more holistic and integrated approach to AF care; however, there are limited data on its usefulness among clinically complex patients. We aim to determine the impact of ABC pathway in a contemporary cohort of clinically complex AF patients. Methods From the ESC-EHRA EORP-AF General Long-Term Registry, we analysed clinically complex AF patients, defined as the presence of frailty, multimorbidity and/or polypharmacy. A K-medoids cluster analysis was performed to identify different groups of clinical complexity. The impact of an ABC-adherent approach on major outcomes was analysed through Cox-regression analyses and delay of event (DoE) analyses. Results Among 9966 AF patients included, 8289 (83.1%) were clinically complex. Adherence to the ABC pathway in the clinically complex group reduced the risk of all-cause death (adjusted HR [aHR]: 0.72, 95%CI 0.58–0.91), major adverse cardiovascular events (MACEs; aHR: 0.68, 95%CI 0.52–0.87) and composite outcome (aHR: 0.70, 95%CI: 0.58–0.85). Adherence to the ABC pathway was associated with a significant reduction in the risk of death (aHR: 0.74, 95%CI 0.56–0.98) and composite outcome (aHR: 0.76, 95%CI 0.60–0.96) also in the high-complexity cluster; similar trends were observed for MACEs. In DoE analyses, an ABC-adherent approach resulted in significant gains in event-free survival for all the outcomes investigated in clinically complex patients. Based on absolute risk reduction at 1 year of follow-up, the number needed to treat for ABC pathway adherence was 24 for all-cause death, 31 for MACEs and 20 for the composite outcome. Conclusions An ABC-adherent approach reduces the risk of major outcomes in clinically complex AF patients. Ensuring adherence to the ABC pathway is essential to improve clinical outcomes among clinically complex AF patients.