Objective:
Peripheral arterial disease is a powerful predictor of the loss of limb and even loss of life. Endovascular treatment (ET) and hybrid procedures are gradually replacing open procedures. The purpose of this study is to evaluate the management outcome of transatlantic intersociety consensus (TASC) C and D aortoiliac (AI) and femoropopliteal (FP) disease by various methods.
Materials and Methods:
Prospective observational study was done at Army Hospital (Research and Referral) Delhi Cantt from June 2015 to January 2017. Patients with TASC C and D AI and FP lesions were included. Patients were treated with either open, endovascular or hybrid technique and followed at 1, 3, and 6 months.
Results:
A total of 110 (36 AI and 74 FP) patients were included. 96.3% were smokers. Seventeen were TASC C and 93 were TASC D lesions. Fourteen out of 17 TASC C lesions could be managed by endovascular, two by hybrid and only one required open reconstruction. Whereas 58 out of 93 TASC D lesions needed to be opened, 15 were endovascular, and the rest 20 cases were managed by hybrid procedures. One had an iliac artery rupture managed with bypass graft. We have seven mortalities two within 30 days and five from 30 days to 1-year primary and secondary patency for ET was 72.4% and 80%, for open surgery was 76.2% and 93% and for hybrid procedure was 60% and 77.7%.
Conclusions:
Hybrid therapy simplifies and allows the one-step treatment with complex peripheral multifocal steno-obstructive vascular disease with high technical success rate and excellent long-term patency in few patients.
Background:
We designed this randomised, open-label, parallel group, multi-centre study to investigate the efficacy and safety of glycopyrronium/formoterol, a long-acting muscarinic antagonist/long-acting β2-agonist fixed dose combination, delivered through a dry powder inhaler (DPI) in patients with chronic obstructive pulmonary disease (COPD).
Material and Methods:
We randomised (1:1) patients with moderate to severe COPD (N = 356) to receive glycopyrronium 25 µg/formoterol 12 µg via DPI twice daily (GF-DPI) or glycopyrronium 50 µg monotherapy via DPI once daily (G-DPI). The primary study endpoint was the mean change from the baseline in pre-dose trough-forced expiratory volume in one second (FEV
1
) at 12 weeks.
Results:
At week 12, the mean increase from the baseline in pre-dose trough FEV
1
was higher in the GF-DPI group (120 ml) than in the G-DPI (60 ml) group. The mean difference (MD) between treatment groups was 0.06 L (95% CI: 0.00–0.12 L,
P
< 0.0001 for non-inferiority). At week 12, the mean pre-dose forced vital capacity (FVC), 1 hour post-dose FEV
1
, and post-dose FVC increased significantly from the baseline only in the GF-DPI group (p < 0.0001). The reduction in the COPD assessment test score was greater in the GF-DPI group (p = 0.0379). The average daily number of puffs of rescue medication and the reduction in mean modified Medical Research Council scale, COPD, and Asthma Sleep Impact Scale score at week 12 were similar between groups (p > 0.05). Overall, 35 adverse events and two serious adverse events unrelated to study drugs were reported. Both groups had similar results for overall drug safety.
Conclusion:
The results demonstrate efficacy and safety of GF-DPI in Indian patients with moderate to severe COPD. Treatment with GF-DPI significantly improved the lung function and quality of life and was well tolerated.
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