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.

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.

scholarly journals Short-term Clinical Outcomes of Hip Arthroscopy Versus Physical Therapy in Patients With Femoroacetabular Impingement: A Systematic Review and Meta-analysis of Randomized Controlled Trials

2020 ◽  
Vol 8 (11) ◽  
pp. 232596712096849
Author(s):  
Maria T. Schwabe ◽  
John C. Clohisy ◽  
Abby L. Cheng ◽  
Cecilia Pascual-Garrido ◽  
Marcie Harris-Hayes ◽  
...  
Keyword(s):  
Systematic Review ◽  
Physical Therapy ◽  
Randomized Controlled Trials ◽  
Hip Arthroscopy ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Short Term ◽  
Intention To Treat ◽  
Randomized Controlled

Background: Both physical therapy (PT) and surgery are effective in treating femoroacetabular impingement (FAI), but their relative efficacy has not been well established until recently. Several randomized controlled trials (RCTs) comparing the early clinical outcomes of these treatments have been published, with contradictory results. Purpose/Hypothesis: The purpose of this study was to perform a meta-analysis of RCTs that compared early patient-reported outcomes (PROs) of hip arthroscopy versus PT in patients with symptomatic FAI. The hypothesis was that surgical treatment of FAI leads to better short-term outcomes than PT. Study Design: Systematic review; Level of evidence, 1. Methods: In March 2019, a systematic review was performed to identify RCTs comparing hip arthroscopy and PT in patients with symptomatic FAI. A total of 819 studies were found among 6 databases; of these, 3 RCTs met eligibility (Griffin et al, 2018; Mansell et al, 2018; and Palmer et al, 2019). All 3 RCTs reported international Hip Outcome Tool--33 (iHOT-33) scores, and 2 reported Hip Outcome Score (HOS)–Activities of Daily Living (ADL) and HOS-Sport results. In a random-effects meta-analysis, between-group differences in postintervention scores were assessed according to intention-to-treat and as-treated approaches. Quality was assessed with CONSORT, CERT, TiDieR, and the Cochrane Collaboration tool. Results: The 3 RCTs included 650 patients with FAI; the mean follow-up ranged from 8 to 24 months. All studies reported PRO improvement from baseline to follow-up for both PT and surgery. The quality of the Griffin and Palmer studies was good, with minimal bias. In the Mansell study, a 70% crossover rate from PT to surgery increased the risk of bias. The meta-analysis demonstrated improved iHOT-33 outcomes with surgery compared with PT for intention-to-treat (mean difference [MD], 11.3; P = .046) and as-treated (MD, 12.6; P = .007) analyses. The as-treated meta-analysis of HOS-ADL scores favored surgery (MD, 12.0; P < .001), whereas the intention-to-treat analysis demonstrated no significant difference between groups for HOS-ADL (MD, 3.9; P = .571). Conclusion: In patients with FAI, the combined results of 3 RCTs demonstrated superior short-term outcomes for surgery versus PT. However, PT did result in improved outcomes and did not appear to compromise the surgical outcomes of patients for whom therapy failed and who progressed to surgery.

scholarly journals Conservative oxygen therapy for critically ill patients: a meta-analysis of randomized controlled trials

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Xiao-Li Chen ◽  
Bei-Lei Zhang ◽  
Chang Meng ◽  
Hui-Bin Huang ◽  
Bin Du
Keyword(s):  
Sensitivity Analysis ◽  
Randomized Controlled Trials ◽  
Critically Ill Patients ◽  
Oxygen Therapy ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Icu Patients ◽  
Randomized Controlled

Abstract Objective Conservative oxygen strategy is recommended in acute illness while its benefit in ICU patients remains controversial. Therefore, we sought to conduct a systematic review and meta-analysis to examine such oxygen strategies’ effect and safety in ICU patients. Methods We searched PubMed, Embase, and the Cochrane database from inception to Feb 15, 2021. Randomized controlled trials (RCTs) that compared a conservative oxygen strategy to a conventional strategy in critically ill patients were included. Results were expressed as mean difference (MD) and risk ratio (RR) with a 95% confidence interval (CI). The primary outcome was the longest follow-up mortality. Heterogeneity, sensitivity analysis, and publication bias were also investigated to test the robustness of the primary outcome. Results We included seven trials with a total of 5265 patients. In general, the conventional group had significantly higher SpO2 or PaO2 than that in the conservative group. No statistically significant differences were found in the longest follow-up mortality (RR, 1.03; 95% CI, 0.97–1.10; I2=18%; P=0.34) between the two oxygen strategies when pooling studies enrolling subjects with various degrees of hypoxemia. Further sensitivity analysis showed that ICU patients with mild-to-moderate hypoxemia (PaO2/FiO2 >100 mmHg) had significantly lower mortality (RR, 1.24; 95% CI, 1.05–1.46; I2=0%; P=0.01) when receiving conservative oxygen therapy. These findings were also confirmed in other study periods. Additional, secondary outcomes of the duration of mechanical ventilation, the length of stay in the ICU and hospital, change in sequential organ failure assessment score, and adverse events were comparable between the two strategies. Conclusions Our findings indicate that conservative oxygen therapy strategy did not improve the prognosis of the overall ICU patients. The subgroup of ICU patients with mild to moderate hypoxemia might obtain prognosis benefit from such a strategy without affecting other critical clinical results.

scholarly journals Inverted internal limiting membrane flap technique versus internal limiting membrane peeling for large macular holes: A meta-analysis of randomized controlled trials

2021 ◽  
Author(s):  
Ji-Guo Yu ◽  
Jing Wang ◽  
Yi Xiang
Keyword(s):  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Internal Limiting Membrane ◽  
Controlled Trials ◽  
Ilm Peeling ◽  
Closure Rate ◽  
Flap Technique ◽  
Randomized Controlled ◽  
Macular Holes

Background: Vitrectomy with internal limiting membrane (ILM) peeling is an effective surgical procedure for the treatment of macular holes (MHs). However, there is a possibility of poor postoperative anatomical closure with conventional ILM peeling for MHs larger than 400 μm. Therefore, a novel inverted ILM flap technique was developed for such cases. Objectives: This meta-analysis study was performed to evaluate and compare the anatomical and visual outcomes of the inverted ILM flap technique and ILM peeling in large MHs. Methods: The Cochrane Library, PubMed, and Embase databases were searched to identify randomized controlled trials (RCTs). The trial eligibility and risk of bias were assessed according to Cochrane review methods. The primary outcome measures included MH closure rate and postoperative visual acuity (VA). Subgroup analysis of postoperative VA based on follow-up time was also conducted. Pooled odds ratios (ORs), weighted mean difference (WMD), and 95% confidence intervals (CIs) were calculated. Statistical analysis was performed using RevMan 5.3 software. Results: Five RCTs with a total of 155 eyes in the inverted ILM flap group and 161 eyes in the ILM peeling group were included in this meta-analysis. Statistical meta-analysis revealed that the overall MH closure rate in the inverted ILM flap group was significantly higher than that in the ILM peeling group (OR, 3.10; 95% CI, 1.25 to 7.66; P = 0.01). The postoperative VA was significantly better in the inverted ILM flap group than ILM peeling group (WMD, -0.14; 95% CI, -0.21 to -0.07; P = 0.0002). The subgroup meta-analysis indicated that the postoperative VA was significantly better in the inverted ILM flap group than ILM peeling group (WMD, -0.17; 95% CI, -0.26 to -0.08; P = 0.0004) at the 3-month follow-up. However, no significant difference was observed between the two groups at the 6-month follow-up (WMD, -0.09; 95% CI, -0.20 to 0.02; P = 0.10). Conclusions: Vitrectomy with inverted ILM flap technique showed a higher anatomical closure rate as well as visual gain—although only in the short-term as no difference in visual recovery was found at the 6-month follow-up—than did ILM peeling in large MHs. The inverted ILM flap technique should be considered as a preferred and routine procedure for the treatment of patients with MHs larger than 400 µm.

Long-term mortality and patency after drug-coated balloon angioplasty in the hemodialysis circuit: A systematic review and meta-analysis of randomized controlled trials

2022 ◽  
pp. 112972982110701
Author(s):  
Yunfeng Li ◽  
Zhenwei Shi ◽  
Yunyun Zhao ◽  
Zhanjiang Cao ◽  
Zhengli Tan
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Balloon Angioplasty ◽  
Meta Analysis ◽  
Primary Patency ◽  
Controlled Trials ◽  
Technical Success ◽  
Randomized Controlled ◽  
All Cause Mortality ◽  
Drug Coated Balloon

Purpose: To compare all-cause mortality and primary patency with drug-coated balloon angioplasty (DCBA) compared with plain balloon angioplasty (PBA) in people with hemodialysis-related stenosis. Materials and methods: PubMed, Embase, and Cochrane Library databases were searched from November 1966 to February 2021 to identify randomized controlled trials (RCTs) that assessed the use of DCBA versus PBA for stenosis in hemodialysis circuits. Data extracted from the articles were integrated to determine all-cause mortality, target lesion primary patency (TLPP), circuit access primary patency (CAPP), 30-day adverse events, and technical success for the two approaches. We performed meta-analysis on these results using a fixed-effects model to evaluate odds ratios (ORs) and 95% confidence intervals (CIs) where I2 < 50% in a test for heterogeneity, or a random-effect model if otherwise. Sensitivity and subgroup analyses were also performed. Results: Sixteen RCTs of 1672 individuals were included in our meta-analysis, of which 839 individuals received DCBA and 833 received PBA. The pooled outcome showed no statistical difference between DCBA and PBA in all-cause mortality at 6 months (OR = 1.29, 95% CI = 0.72–2.32, p = 0.39, I2 = 4%), 12 months (OR = 1.02, 95% CI = 0.68–1.53, p = 0.91, I2 = 0%), and 24 months (OR = 1.50, 95% CI = 0.87–2.57, p = 0.15, I2 = 0%), 30-day adverse events (OR = 1.09, 95% CI = 0.30–3.98, p = 0.90, I2 = 66%), and technical success (OR = 0.18, 95% CI = 0.02–1.92, p = 0.16, I2 = 65%). The DCBA had significantly better outcomes versus PBA in TLPP at 6 months (OR = 2.37, 95% CI = 1.84–3.04, p < 0.001, I2 = 44%) and 12 months (OR = 1.77, 95% CI = 1.22–2.56, p = 0.002, I2 = 56%), and CAPP at 6 months (OR = 2.07, 95% CI = 1.21–3.54, p = 0.008, I2 = 67%) and 12 months (OR = 1.66, 95% CI = 1.29–2.15, p < 0.001, I2 = 0%). Conclusion: In hemodialysis circuit stenosis, DCBA appears to have similar safety but greater efficacy than PBA.

scholarly journals Effects of Diet, Aerobic Exercise, or Both on Non-HDL-C in Adults: A Meta-Analysis of Randomized Controlled Trials

Cholesterol ◽  
2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
George A. Kelley ◽  
Kristi S. Kelley
Keyword(s):  
Aerobic Exercise ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Statistical Significance ◽  
Density Lipoprotein ◽  
Control Group ◽  
Controlled Trials ◽  
Mixed Effect ◽  
Randomized Controlled ◽  
Effect Model

Purpose. To use the meta-analytic approach to examine the effects of diet (D), aerobic exercise (E), or both (DE) on non-high-density lipoprotein cholesterol (non-HDL-C) in adults. Methods. Randomized controlled trials in adults ≥18 years of age were included. A mixed-effect model was used to combine effect size (ES) results within each subgroup and to compare subgroups (Qb). Heterogeneity was examined using the Q and I2 statistics, and 95% confidence intervals (CI) were also calculated. Statistical significance was set at P≤0.05, while a trend for statistical significance was set between P>0.05, and ≤0.10. Results. A statistically significant exercise minus control group decrease in non-HDL-C was found for DE (7 ESs, 389 participants, x¯=-11.1 mg/dL, 95%  CI=−21.7 to −0.6, P=0.04, Q=2.4, P=0.88, I2=0%), a trend for the D group (7 ESs, 402 participants, x¯=−8.5 mg/dL, 95%  CI=−18.6 to 1.6, P=0.10, Q=0.76, P=0.99, I2=0%), and no change for the E group (7 ESs, 387 participants, x¯=3.0 mg/dL, 95%   CI=−7.1 to 13.1, P=0.56, Q=0.78, P=0.99, I2=0%). Overall, no statistically significant between-group differences were found (Qb=4.1, P=0.12). Conclusions. Diet combined with aerobic exercise may reduce non-HDL-C among adults in some settings.

scholarly journals The Effect of Virtual Reality on Preoperative Anxiety: A Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 9 (10) ◽  
pp. 3151
Author(s):  
Chang-Hoon Koo ◽  
Jin-Woo Park ◽  
Jung-Hee Ryu ◽  
Sung-Hee Han
Keyword(s):  
Virtual Reality ◽  
Randomized Controlled Trials ◽  
Pediatric Patients ◽  
Meta Analysis ◽  
Random Effect Model ◽  
Preoperative Anxiety ◽  
Control Group ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Significant Difference

Virtual reality (VR), a technology that provides a stimulated sensory experience, has recently been implemented in various fields of medicine. Several studies have investigated the efficacy of VR on preoperative anxiety. The purpose of this meta-analysis was to validate whether VR could relieve preoperative anxiety in patients undergoing surgery. Electronic databases were searched to identify all randomized controlled trials (RCTs) investigating the effect of VR on preoperative anxiety. The primary outcome was defined as the preoperative anxiety scores. We estimated the effect size using the standard mean difference (SMD) with a 95% confidence interval (CI) using a random effect model. Ultimately, 10 RCTs, with a total of 813 patients, were included in the final analysis. Preoperative anxiety was significantly lower in the VR group than in the control group (SMD −0.64, 95% CI −1.08 to −0.20, p = 0.004). In a subgroup analysis, the preoperative anxiety scores were lower in the VR group than in the control group in pediatric patients (SMD −0.71, 95% CI −1.14 to −0.27, p = 0.002), whereas a significant difference was not observed between the two groups in adult patients (p = 0.226). The results of this meta-analysis indicated that VR could decrease preoperative anxiety, especially in pediatric patients.

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.

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