Mortality Rates After Paclitaxel-Coated Device Use in Patients With Occlusive Femoropopliteal Disease: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials

2021 ◽  
pp. 152660282110235
Author(s):  
Krystal Dinh ◽  
Alexandra M. Limmer ◽  
Andy Z. L. Chen ◽  
Shannon D. Thomas ◽  
Andrew Holden ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Occlusive Disease ◽  
Control Group ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Increased Risk ◽  
All Cause Mortality

Purpose: A late increased mortality risk has been reported in a summary level meta-analysis of patients with femoropopliteal artery occlusive disease treated with paclitaxel-coated angioplasty balloons and stents. However, at the longer follow up timepoints that analysis was limited by small trial numbers and few participants. The aim of this study was to report an updated summary level risk of all-cause mortality after treatment with paclitaxel-coated devices in that same patient group. Materials and Methods: We performed a systematic review and meta-analysis of randomized controlled trials to investigate the mortality outcomes associated with paclitaxel-coated devices used to treat patients with occlusive disease of femoropopliteal arteries (last search date December 10, 2020). The single primary endpoint was all-cause mortality. Results: We identified 34 randomized controlled trials (7654 patients; 84% intermittent claudication). There were 622 deaths among 4147 (15.0%) subjects in the paclitaxel device group and 475 deaths among 3507 (13.5%) subjects in the noncoated control group [relative risk ratio (RR) 1.07, 95% confidence interval (CI) 0.96 to 1.20, p=0.20, I2=0%). All-cause mortality was similar between groups at 12 months (34 studies, 7654 patients; RR 0.99, 95% CI 0.81 to 1.22, p=0.94, I2=0%), 24 months (20 studies, 3799 patients; RR 1.16, 95% CI 0.87 to 1.55, p=0.31, I2=0%), and 60 months (9 studies, 2288 patients; RR 1.19, 95% CI 0.98 to 1.45, p=0.08, I2=0%). Conclusion: This updated meta-analysis with included additional trials and larger patient numbers shows no evidence of increased risk of all-cause mortality in patients treated with paclitaxel-coated devices, compared with uncoated devices for femoropopliteal disease at all time points to 60 months. There is therefore no justification to limit their use, or alter regulatory body follow-up recommendations in this patient population. Systematic Review Registration: CRD42020216140.

Mortality After Paclitaxel-Coated Device Use in Patients With Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 27 (2) ◽  
pp. 175-185 ◽  
Author(s):  
Krystal Dinh ◽  
Miguel Lemos Gomes ◽  
Shannon D. Thomas ◽  
Sharath C.V. Paravastu ◽  
Andrew Holden ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Mortality Data ◽  
Control Group ◽  
Controlled Trials ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
All Cause Mortality ◽  
Device Use

Purpose: To report the risk of all-cause mortality after treatment with paclitaxel-coated devices vs uncoated controls in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: A search of the PubMed, Embase, Cochrane, CINAHL, DARE, and PROSPERO databases was made on 5 November 2019 to identify randomized controlled trials (RCT) using intention-to-treat analysis to compare a paclitaxel-coated device to an uncoated device in PAD patients having clinical follow-up of at least 6 months. Half of the study population had to have CLTI or extractable data on the CLTI subgroup if <50%. The search identified 11 trials having 1450 patients randomized to a paclitaxel-coated device (n=866) or an uncoated control (n=584). There were 1367 (94.3%) patients with CLTI (range 10–429). The single endpoint was all-cause mortality, which was analyzed by pooling the mortality data in a DerSimonian and Laird random effects model. Summary statistics are expressed as relative risk ratios (RR) with a 95% confidence interval (CI). Results: The mean follow-up was 25.6 months (range 6–60); 10 of 11 studies reported a minimum 12-month follow-up. There were 161 (18.6%) deaths among 866 subjects in the paclitaxel device group and 116 deaths among 584 (19.9%) subjects in the non-coated control group (RR 0.93, 95% CI 0.78 to 1.12, p=0.45). Conclusion: There was no observed difference in short- to midterm mortality among a pooled patient population of predominately CLTI patients treated with paclitaxel-coated balloons or stents compared with uncoated controls.

scholarly journals The efficacy and safety of antimuscarinics for the prevention or treatment of catheter-related bladder discomfort: a systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Zhongbao Zhou ◽  
Yuanshan Cui ◽  
Xiaoyi Zhang ◽  
Youyi Lu ◽  
Zhipeng Chen ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Postoperative Nausea And Vomiting ◽  
Control Group ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Facial Flushing ◽  
Blurred Vision ◽  
Randomized Controlled

Abstract Objectives This meta-analysis aimed to evaluate the efficacy and safety of antimuscarinics for the prevention or treatment of catheter related bladder discomfort (CRBD). Methods The MEDLINE, EMBASE, and Cochrane Controlled Trials Register (from 1987 to July 2021) were used to search randomized controlled trials. The PRISMA checklists were followed. RevMan5.4.0 was used for statistical analysis. Results Eleven studies involving 1165 patients were involved in the analysis. The study reported that the incidence of CRBD observed in the antimuscarinics group was significantly lower than that of the control group at 0-, 1-, 2-, and 6-h after drug therapy (P = 0.001, P < 0.0001, P = 0.0005, and P = 0.001, respectively). For side effects, there were not statistical differences between the antimuscarinics group and the control group, mainly including dry mouth (risk ratio (RR) = 1.31, 95% confidence interval (CI) = 0.95 to 1.80, P = 0.09), postoperative nausea and vomiting (RR = 1.02, 95% CI = 0.55 to 1.90, P = 0.87), facial flushing (RR = 1.06, 95% CI = 0.43 to 2.61, P = 0.90), and blurred vision (RR = 0.95, 95% CI = 0.35 to 2.58, P = 0.91). Besides, rescue analgesics were required less in the antimuscarinics group than in the control group (RR = 0.51, 95% CI = 0.32 to 0.80, P = 0.003). Conclusions Compared with the control group, the antimuscarinics group had a significant improvement on CRBD, the patients were well tolerated and the use rate of rescue analgesics was low.

scholarly journals Mediterranean Diet Increases Endothelial Function in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 150 (5) ◽  
pp. 1151-1159 ◽  
Author(s):  
Oliver M Shannon ◽  
Inês Mendes ◽  
Christina Köchl ◽  
Mohsen Mazidi ◽  
Ammar W Ashor ◽  
...  
Keyword(s):  
Systematic Review ◽  
Health Status ◽  
Endothelial Function ◽  
Randomized Controlled Trials ◽  
Study Design ◽  
Meta Analysis ◽  
Control Group ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Study Duration

ABSTRACT Background The endothelium plays a key role in the maintenance of vascular health and represents a potential physiological target for dietary and other lifestyle interventions designed to reduce the risk of cardiovascular diseases (CVD) including stroke or coronary heart disease. Objective To conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) investigating the effects of the Mediterranean dietary pattern (MedDiet) on endothelial function. Methods Medline, Embase, and Scopus databases were searched from inception until January 2019 for studies that met the following criteria: 1) RCTs including adult participants, 2) interventions promoting the MedDiet, 3) inclusion of a control group, and 4) measurements of endothelial function. A random-effects meta-analysis was conducted. Metaregression and subgroup analyses were performed to identify whether effects were modified by health status (i.e., healthy participants versus participants with existing comorbidities), type of intervention (i.e., MedDiet alone or with a cointervention), study duration, study design (i.e., parallel or crossover), BMI, and age of participants. Results Fourteen articles reporting data for 1930 participants were included in the meta-analysis. Study duration ranged from 4 wk to 2.3 y. We observed a beneficial effect of the MedDiet on endothelial function [standardized mean difference (SMD): 0.35; 95% CI: 0.17, 0.53; P &lt;0.001; I2 = 73.68%]. MedDiet interventions improved flow-mediated dilation (FMD)—the reference method for noninvasive, clinical measurement of endothelial function—by 1.66% (absolute change; 95% CI: 1.15, 2.17; P &lt;0.001; I2 = 0%). Effects of the MedDiet on endothelial function were not modified by health status, type of intervention, study duration, study design, BMI, or age of participants (P &gt;0.05). Conclusions MedDiet interventions improve endothelial function in adults, suggesting that the protective effects of the MedDiet are evident at early stages of the atherosclerotic process with important implications for the early prevention of CVD. This study has the PROSPERO registration number: CRD42018106188.

scholarly journals The Efficacy and Tolerability of Ubrogepant for Acute Migraine: A Systematic Review and Meta-Analysis

2020 ◽  
Author(s):  
Yun Diao ◽  
Hang Yang ◽  
Yang Chun Zhou ◽  
Biao Du
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Acute Attack ◽  
Cochrane Library ◽  
Control Group ◽  
Controlled Trials ◽  
Acute Migraine ◽  
High Quality ◽  
Randomized Controlled

Abstract Objective: The aim of this review was to evaluate the efficacy and tolerability of ubrogepant in patients with acute migraine. Methods: We systematically searched PubMed, Embase, MEDLINE, Cochrane Library, and clinicaltrials.gov from inception to JULY, 2019. Randomized controlled trials of the efficacy and/or tolerability of ubrogepant for migraine were included. Meta-analysis was conducted by RevMan 5.3 software. Results: A total of 4 RCTs involving 4 163 patients were included. The meta-analysis showed that:compared to the control group, the percentage of participants with PF, the percentage of participants with PR, the percentage of participants with SPF, the percentage of participants with SPR,the absence of phonophobia in sound，the absence of phonophobia in light and the absence of nausea (RR=1.31,95%CI:1.18~1.45，P<0.00001, RR=1.63,95%CI:1.46~1.82，P<0.00001, RR=1.22,95%CI:1.15~1.29，P<0.00001, RR=1.32,95%CI:1.22~1.42，P<0.00001, RR=1.16,95%CI:1.05~1.27，P=0.002), all the differences were statistically significant. Conclusions: For adult patients with acute migraine, ubrogepant could effectively abort the acute attack. High-quality, adequately powered RCTs are needed to fully evaluate the efficacy and tolerability of ubrogepant for acute migraine.

scholarly journals Steroid therapy for COVID-19: A systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Author(s):  
Tarun Krishna Boppana ◽  
Saurabh Mittal ◽  
Karan Madan ◽  
Anant Mohan ◽  
Vijay Hadda ◽  
...  
Keyword(s):  
Systematic Review ◽  
Mechanical Ventilation ◽  
Randomized Controlled Trials ◽  
Steroid Therapy ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Treatment Modalities ◽  
Control Group ◽  
Controlled Trials ◽  
Randomized Controlled

There is an urgent need for effective treatment modalities for coronavirus disease 2019 (COVID-19). Data for the use of steroids in COVID-19 is emerging. We conducted this systematic review and meta-analysis to estimate the effectiveness of steroid administration in mortality reduction due to COVID-19 compared to the control group. A systematic search of the Pubmed and Embase databases was performed to extract randomized controlled trials (RCTs) regarding the use of steroid therapy for COVID-19. An overall and subgroup (based upon the type of steroid) pooled mortality analysis was performed, and odds ratios were reported. Cochrane risk of bias assessment tool was used to assess the risk of bias. Heterogeneity was assessed using the I2 statistic. Six RCTs, including 7707 patients, were selected for review. Three trials reported 28-day mortality, and two trials reported 21-day mortality, and one trial reported in-hospital mortality. There were 730 deaths among 2837 participants in the steroid group while 1342 deaths among 4870 patients randomized to the control group (Odds ratio 0.76, 95% confidence interval 0.58-1.00, p=0.05). The effect was significant in patients on oxygen or mechanical ventilation. There was no difference in the various preparations and doses of the steroids. There was heterogeneity among the trials as the I2 value was 53%, with a p-value of 0.06. There was no indication of increased serious adverse events. This meta-analysis of RCTs demonstrated that the use of systemic corticosteroids is associated with a reduction in all-cause mortality in patients with COVID-19 on oxygen or mechanical ventilation.

scholarly journals Effects of the Small-Sided Soccer Games on Blood Pressure in Untrained Hypertensive Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Healthcare ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 345
Author(s):  
Filipe Manuel Clemente ◽  
Rodrigo Ramirez-Campillo ◽  
Hugo Sarmento
Keyword(s):  
Systematic Review ◽  
Blood Pressure ◽  
Randomized Controlled Trials ◽  
Diastolic Blood Pressure ◽  
Meta Analysis ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Trials ◽  
Control Groups ◽  
Randomized Controlled

This systematic review with meta-analysis was conducted to assess the effects of small-sided games (SSGs)-based programs on the systolic and diastolic blood pressure of untrained hypertensive adults. The data sources utilized were Web of Science, Scopus, SPORTDiscus, and PubMed. The eligibility criteria were: (i) randomized controlled trials including a control group and an intervention group exclusively using soccer SSGs; (ii) intervention and control groups including an untrained hypertensive adult population; (iii) articles written in English; and (iv) only full-text and original articles. The database search initially identified 241 titles. From those, five articles were eligible for the systematic review and meta-analysis. The included randomized controlled studies involved five individual experimental groups and 88 participants, and 68 participants in the five control groups. The results showed a large and beneficial effect of SSG on systolic (ES = 1.69; 95% CI = 0.71 to 2.66; p = 0.001; I2 = 85.2%; Egger’s test p = 0.101) and diastolic blood pressure (ES = 2.25; 95% CI = 1.44 to 3.06; p < 0.001; I2 = 74.8%; Egger’s test p = 0.118) when compared to the control groups. The findings of the current systematic review and meta-analysis revealed consistent beneficial effects of recreational soccer SSGs on untrained men and women from the hypertensive population, although high levels of heterogeneity.

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