Effects of iloprost on pain-free walking distance and clinical outcome in patients with severe stage IIb peripheral arterial disease: the FADOI 2bPILOT Study.

BACKGROUND: Patients with peripheral arterial disease (PAD) at stage IIb, pain-free walking distance (PFWD) less than 100 m and unsuitable for revascularization have both impaired quality of life and severe clinical outcome. Aim of the study was to evaluate the efficacy of the prostacyclin analogue iloprost, added to standard therapy, in these patients. MATERIAL AND METHODS: Patients were randomized to receive standard medical therapy (Group A) or standard therapy plus iloprost (Group B), for 1 year. Iloprost was administered for 10 days every 3 months. Treadmill test was performed every 3 months, in Group B before starting the 10-day iloprost cycle. RESULTS: Fifty patients in Group A and 51 in Group B were enrolled. Mean baseline and 12-month PFWD values were 75.4 ± 21.3 and 128.9 ± 62.9 for iloprost group and 70.3 ± 21.6 and 99.6 ± 62.6 m for controls. Patients treated with iloprost had significantly higher PFWD at 9 and 12 months. This finding was confirmed after carrying forward the last valid observation (124.7 ± 63.4 vs. 88.4 ± 63.1 m, P < 0.01). Major cardiovascular events occurred in 32.0% and 3.9% of patients in Group A and Group B, respectively (P < 0.001). Five patients in Group A died vs. none in Group B (P = 0.02). No serious unexpected adverse reactions occurred in patients receiving iloprost. CONCLUSIONS: Iloprost, added to standard therapy, significantly increases exercise capacity in patients with PAD at severe stage IIb. The percentage of patients who died or experienced major cardiovascular events was significantly lower in patients receiving iloprost. Future studies should focus on the effects of this therapy on clinical outcome.

Correlation between elastosonography and nailfold microvascular alterations in systemic sclerosis patients.

AIM: Vascular damage and fibrotic process represent the pathophysiological hallmarks of systemic sclerosis (SSc). Peripheral microangiopathy can be early detected by nailfold videocapillaroscopy (NVC), whereas recent studies suggest that ultrasound real time elastosonography (US-RTE) can be a useful tool to evaluate the reduction of skin elasticity. The aim of our study was to investigate possible correlations between NVC microvascular alterations and finger tissue stiffness evaluated with US-RTE in SSc subjects. METHODS: 20 subjects (16 women and 4 men) who met the ACR criteria for SSc were recruited. All subjects underwent complete clinical examination, NVC and US-RTE evaluation. US-RTE was carried out on both the hands, at the level of the palmar surface of the distal phalanx of the fingers. RESULTS: 10 subjects showed limited disease subset (LSS) and 10 showed diffuse disease subset (DSS). Eight patients had 'Early/Active' NVC pattern and 12 had 'Late' NVC pattern. DSS subjects showed highest skin stiffness values when compared to both LSS (p = 0.03) and healthy subjects (p = 0.002). Multiple regression analysis shows an independent association between Late NVC pattern and skin stiffness (R2 = 0.24, p = 0.027). CONCLUSION: This study demonstrates, for the first time, a strong relationship between microvascular alterations and skin stiffness, evaluated with US-RTE, in SSc patients.

Prediction risk chart for scleroderma digital ulcers: a composite predictive model based on capillaroscopic, demographic and clinico-serological parameters.

BACKGROUND: Digital ulcers (DU) affect 50% of systemic sclerosis (SSc) patients, representing a challenging clinical problem. Despite a high negative predictive value, capillaroscopic scores proposed to select patients at risk for DU show an inadequate positive predictive value, especially in patients without previous DU. AIM OF THIS STUDY: To increase the predictive value for DU development of capillaroscopy, through a predictive risk chart taking into account capillaroscopic, demographic, and clinico-serological parameters. PATIENTS AND METHODS: Two hundred and nineteen unselected SSc patients from 8 Italian Rheumatology Centers were consecutively enrolled during a 6-month period. Demographic, clinical, serological and instrumental data and capillaroscopy skin ulcers risk index (CSURI) were collected. RESULTS: A multivariate logistic regression analysis showed a significant positive association between DU appearance and male gender, DU history, altered CSURI, and ESR. A prediction risk chart of the development of DU within 6 months were built on the basis of the above parameters. According to the risk level, four risk classes were identified: low (≤19.3%); medium (>19.3%, ≤58.6%); high (>58.6%, ≤89.2%), and very high risk (>89.2%). CONCLUSIONS: The systematic evaluation of the above parameters can be helpful to identify patients at risk to develop DU optimizing preventive vasoactive therapy.