Prospective meta-analysis protocol on randomised trials of renin–angiotensin system inhibitors in patients with COVID-19: an initiative of the International Society of Hypertension

IntroductionWhether ACE inhibitors (ACEi) or angiotensin II receptor blocker (ARB) therapy should be continued, initiated or ceased in patients with COVID-19 is uncertain. Given the widespread use of ACEi/ARBs worldwide, guidance on the use of these drugs is urgently needed. This prospective meta-analysis aims to pool data from randomised controlled trials (RCTs) to assess the safety and efficacy of ACEi/ARB therapy in adults infected with SARS-CoV-2.Methods and analysisRCTs will be eligible if they compare patients with COVID-19 randomised to ACEi/ARB continuation or commencement versuss no ACEi/ARB therapy; study duration ≥14 days; recruitment completed between March 2020 and May 2021. The primary outcome will be all-cause mortality at ≤30 days. Secondary outcomes will include mechanical ventilation, admission to intensive care or cardiovascular events at short-term follow-up (≤30 days) and all-cause mortality at longer-term follow-up (>1 month). Prespecified subgroup analyses will assess the effect of sex; age; comorbidities; smoking status; ethnicity; country of origin on all-cause mortality. A search of ClinicalTrials.gov has been performed, which will be followed by a formal search of trial registers, preprint servers, MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials to identify RCTs that meet inclusion criteria. To date, a search of ClinicalTrials.gov identified 21 potentially eligible trials for this meta-analysis. We will request trial investigators/sponsors to contribute standardised grouped tabular outcome data.Ethics and disseminationEthics approval and informed consent will be the responsibility of the individual RCTs. Dissemination of results will occur by peer-reviewed publication. The results of our analysis can inform public health policy and clinical decision making regarding ACEi/ARB use in patients with COVID-19 on a global scale.

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Sulodexide versus Control and the Risk of Thrombotic and Hemorrhagic Events: Meta-Analysis of Randomized Trials

Seminars in Thrombosis and Hemostasis ◽

10.1055/s-0040-1716874 ◽

2020 ◽

Vol 46 (08) ◽

pp. 908-918

Author(s):

Behnood Bikdeli ◽

Saurav Chatterjee ◽

Ajay J. Kirtane ◽

Sahil A. Parikh ◽

Giuseppe M. Andreozzi ◽

...

Keyword(s):

Pulmonary Embolism ◽

Cardiovascular Mortality ◽

Dermatan Sulfate ◽

Meta Analysis ◽

Arterial Disease ◽

Controlled Trials ◽

Cochrane Central Register ◽

Bleeding Events ◽

Random Effects Models ◽

All Cause Mortality

AbstractThrombotic cardiovascular disease (myocardial infarction [MI], stroke, and venous thromboembolism [VTE]) remains a major cause of death and disability. Sulodexide is an oral glycosaminoglycan containing heparan sulfate and dermatan sulfate. We conducted a systematic review and meta-analysis to determine the cardiovascular efficacy, and safety of sulodexide versus control in randomized controlled trials (RCTs). We searched MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials for RCTs reporting cardiovascular outcomes in patients receiving sulodexide versus control (placebo or no treatment). Outcomes included all-cause mortality, cardiovascular mortality, MI, stroke, deep vein thrombosis (DVT), pulmonary embolism, and bleeding. We used inverse variance random-effects models with odds ratio (OR) as the effect measure. After screening 360 records, 6 RCTs including 7,596 patients (median follow-up duration: 11.6 months) were included. Patients were enrolled for history of MI, VTE, peripheral arterial disease, or cardiovascular risk factors plus nephropathy. Use of sulodexide compared with control was associated with reduced odds of all-cause mortality (OR 0.67, 95% confidence interval [CI] 0.52–0.85, p = 0.001), cardiovascular mortality (OR 0.44, 95% CI 0.22–0.89, p = 0.02), and MI (OR 0.70, 95% CI 0.51–0.96, p = 0.03), and nonsignificantly reduced odds of stroke (OR 0.78, 95% CI 0.45–1.35, p = 0.38). Sulodexide was associated with significantly reduced odds of VTE (OR 0.44, 95% CI 0.24–0.81, p = 0.008), including DVT (OR 0.41, 95% CI 0.26–0.65, p < 0.001), but not pulmonary embolism (OR 0.92, 95% CI 0.40–2.15, p = 0.86). Bleeding events were not significantly different in the two groups (OR 1.14, 95% CI 0.47–2.74, p = 0.48). In six RCTs across a variety of clinical indications, use of sulodexide compared with placebo or no treatment was associated with reduced odds of all-cause mortality, cardiovascular mortality, MI, and DVT, without a significant increase in bleeding. Additional studies with this agent are warranted.

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Febuxostat use and risks of CVD events, death from cardiac-cause and all-cause mortality: metaanalysis of randomized controlled trials

The Journal of Rheumatology ◽

10.3899/jrheum.200307 ◽

2020 ◽

pp. jrheum.200307

Author(s):

Hao Deng ◽

Bao Long Zhang ◽

Jin Dong Tong ◽

Xiu Hong Yang ◽

Hui Min Jin

Keyword(s):

Web Of Science ◽

Meta Analysis ◽

Relevant Literature ◽

Controlled Trials ◽

Cochrane Central Register ◽

Inclusion Criteria ◽

Randomized Controlled ◽

Central Register ◽

Increased Risk ◽

All Cause Mortality

Objective To assess whether febuxostat use increases the risk of developing cardiovascular events, death from cardiac-cause and all-cause mortalities. Methods The relevant literature was searched in several databases including the MEDLINE (PubMed, 1 Jan. 1966–29 Feb. 2020), Web of science, EMBASE (1 Jan. 1974–29 Feb. 2020), ClinicalTrials.gov and Cochrane Central Register for Controlled Trials. Manual searches for references cited in the original studies and relevant review articles were also performed. All studies included in this metanalysis were published in English. Results In the end, 20 studies that met our inclusion criteria were included in this meta-analysis. Use of febuxostat was found not to be associated with an increased risk of all-cause mortality (RR = 0.87, 95% CI 0.57–1.32, P =0.507). Also, there was no association between febuxostat use and mortalities arising from cardiovascular diseases (CVD) (RR = 0.84, 95% CI 0.49–1.45, P=0.528). The RR also revealed that febuxostat use was not associated with CVD events (RR = 0.98, 95% CI 0.83–1.16, P =0.827). Furthermore, the likelihood of occurrence of CVD events was found not to be dependent on febuxostat dose (RR = 1.04, 95% CI 0.84–1.30, P =0.723). Conclusion Febuxostat use is not associated with increased risks of all-cause mortality, death from CVD or CVD events. Accordingly, it is a safe drug for the treatment of gout. Systematic review registration: PROSPERO CRD42019131872

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Cinacalcet Treatment Significantly Improves All-Cause and Cardiovascular Survival in Dialysis Patients: Results from a Meta-Analysis

Kidney & Blood Pressure Research ◽

10.1159/000504139 ◽

2019 ◽

Vol 44 (6) ◽

pp. 1327-1338 ◽

Cited By ~ 1

Author(s):

Yuan Zu ◽

Xiangxue Lu ◽

Jinghong Song ◽

Ling Yu ◽

Han Li ◽

...

Keyword(s):

Cardiovascular Mortality ◽

Observational Studies ◽

Fixed Effects ◽

Meta Analysis ◽

Controlled Trials ◽

Cochrane Central Register ◽

Fixed Effects Model ◽

Long Term Effects ◽

Dialysis Patients ◽

All Cause Mortality

Objective: To assess the long-term effects including all-cause mortality, cardiovascular mortality, and fracture incidence, of cinacalcet on secondary hyperparathyroidism (SHPT) in patients on dialysis. Methods: PubMed, Embase, and the Cochrane Central Register of Controlled Trials were searched from their inception to October 2018. Randomized controlled trials (RCTs) and cohort design prospective observational studies assessing cinacalcet for the treatment of SHPT in dialysis patients were included. Data extraction was independently completed by 2 authors who determined the methodological quality of the studies and extracted data in duplicate. Study-specific risk estimates were tested by using a fixed effects model. Results: A total of 14 articles with 38,219 participants were included, of which 10 RCTs with 7,471 participants and 4 prospective observational studies with 30,748 participants fulfilled the eligibility criteria. Compared with no cinacalcet, cinacalcet administration reduced all-cause mortality (relative risk [RR] 0.91, 95% CI 0.89–0.94, p < 0.001) and cardiovascular mortality (RR 0.92, 95% CI 0.89–0.95, p < 0.001), but it did not significantly reduce the incidence of fractures (RR 0.93, 95% CI 0.87–1.00, p = 0.05). Conclusions: The results of this meta-analysis indicated that the treatment of SHPT with cinacalcet may in fact reduce all-cause mortality and cardiovascular mortality among patients receiving maintenance dialysis.

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Effects of tolvaptan add-on therapy in patients with acute heart failure: meta-analysis on randomised controlled trials

BMJ Open ◽

10.1136/bmjopen-2018-025537 ◽

2019 ◽

Vol 9 (4) ◽

pp. e025537 ◽

Cited By ~ 4

Author(s):

Guang Ma ◽

Xixi Ma ◽

Guoliang Wang ◽

Wei Teng ◽

Xuezhi Hui

Keyword(s):

Renal Function ◽

Body Weight ◽

Sodium Level ◽

Meta Analysis ◽

Mean Difference ◽

Controlled Trials ◽

Cochrane Central Register ◽

Short Term ◽

Worsening Renal Function ◽

All Cause Mortality

ObjectivesTreating acute decompensated heartfailure (ADHF) for improving congestion with diuretics may cause worsening renal function (WRF), but the clinical efficacy of tolvaptan add-on therapy on reducing WRF in ADHF patients is inconsistent. This analysis is to evaluate the effects of tolvaptan add-on therapy on reducing WRF in ADHF patients.MethodsMeta-analysis of randomised trials of tolvaptan add-on therapy on reducing WRF in ADHF patients. The MEDLINE, Embase and Cochrane Central Register of Controlled Trials databases were searched for relevant articles from their inception to 31 October, 2017. Two reviewers filtrated the documents on WRF, short-term all-cause mortality, body weight decreased, elevated sodium level for calculating pooled relatives risks, weighted mean difference and associated 95% CIs. We used fixed-effects or random-effects models according to I2statistics.AchievementsSeven random controlled trials with 937 patients were included for analysis. Compared with the control, tolvaptan add-on therapy did not improve incidence of worsening renal function (RR 0.78, 95% CI 0.48 to 1.26, p=0.31, I2=66%) and short-term all-cause mortality (RR 0.85, 95% CI 0.47 to 1.56, p=0.61, I2=0%). On subgroup analyses, there was a suggestion of possible effect modification by dose of tolvaptan, in which benefit was observed in low-dose (≤15 mg/day) group (RR 0.48, 95% CI 0.23 to 1.02, p=0.05, I2=54%), but not with high-dose (30 mg) group (RR 1.33, 95% CI 0.99 to 1.78, p=0.05, I2=0%). However, tolvaptan add-on therapy reduced body weight in 2 days (standardised mean difference −0.49, 95% CI −0.64 to −0.34, p<0.00001, I2=0%), increased sodium level (mean difference 1.56, 95% CI 0.04 to 3.07, p=0.04, I2=0%).ConclusionThe result suggests that comparing with the standard diuretic therapy, tolvaptan add-on therapy did not reduce the incidence of WRF and short-term mortality, however, it can decrease body weight and increase the sodium level in patients who are with ADHF. Further researches are still required for confirmation.

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Psychological interventions for coronary heart disease: Cochrane systematic review and meta-analysis

European Journal of Preventive Cardiology ◽

10.1177/2047487317739978 ◽

2017 ◽

Vol 25 (3) ◽

pp. 247-259 ◽

Cited By ~ 53

Author(s):

Suzanne H Richards ◽

Lindsey Anderson ◽

Caroline E Jenkinson ◽

Ben Whalley ◽

Karen Rees ◽

...

Keyword(s):

Myocardial Infarction ◽

Systematic Review ◽

Coronary Heart Disease ◽

Heart Disease ◽

Meta Analysis ◽

Psychological Interventions ◽

Controlled Trials ◽

Cochrane Central Register ◽

Considerable Uncertainty

Background Although psychological interventions are recommended for the management of coronary heart disease (CHD), there remains considerable uncertainty regarding their effectiveness. Design Systematic review and meta-analysis of randomised controlled trials (RCTs) of psychological interventions for CHD. Methods The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL and PsycINFO were searched to April 2016. Retrieved papers, systematic reviews and trial registries were hand-searched. We included RCTs with at least 6 months of follow-up, comparing the direct effects of psychological interventions to usual care for patients following myocardial infarction or revascularisation or with a diagnosis of angina pectoris or CHD defined by angiography. Two authors screened titles for inclusion, extracted data and assessed risk of bias. Studies were pooled using random effects meta-analysis and meta-regression was used to explore study-level predictors. Results Thirty-five studies with 10,703 participants (median follow-up 12 months) were included. Psychological interventions led to a reduction in cardiovascular mortality (rfcelative risk 0.79, 95% confidence interval [CI] 0.63 to 0.98), although no effects were observed for total mortality, myocardial infarction or revascularisation. Psychological interventions improved depressive symptoms (standardised mean difference [SMD] –0.27, 95% CI –0.39 to –0.15), anxiety (SMD –0.24, 95% CI –0.38 to –0.09) and stress (SMD –0.56, 95% CI –0.88 to –0.24) compared with controls. Conclusions We found that psychological intervention improved psychological symptoms and reduced cardiac mortality for people with CHD. However, there remains considerable uncertainty regarding the magnitude of these effects and the specific techniques most likely to benefit people with different presentations of CHD.

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Comparative Effectiveness of Endovascular Treatment Modalities for De Novo Femoropopliteal Lesions: A Network Meta-analysis of Randomized Controlled Trials

Journal of Endovascular Therapy ◽

10.1177/1526602819895996 ◽

2020 ◽

Vol 27 (1) ◽

pp. 42-59 ◽

Cited By ~ 3

Author(s):

Yang Zhou ◽

Zhihui Zhang ◽

Shaomang Lin ◽

Jianbin Xiao ◽

Wenjia Ai ◽

...

Keyword(s):

Effective Treatment ◽

De Novo ◽

Meta Analysis ◽

Controlled Trials ◽

Single Treatment ◽

Technical Success ◽

Binary Restenosis ◽

All Cause Mortality ◽

Better Than

Purpose: To report the results of a network meta-analysis of randomized controlled trials (RCTs) comparing multiple endovascular treatments for de novo femoropopliteal lesions. Materials and Methods: The MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials databases were systematically searched on June 1, 2019, for prospective RCTs comparing 14 treatments [ie, atherectomy, brachytherapy, cryoplasty, cutting balloons, drug-coated balloons, bare nitinol stents, drug-eluting stents (DES), covered stents (CS), and combinations] in the treatment of de novo femoropopliteal lesions. Outcomes were technical success; binary restenosis and target lesion revascularization (TLR) at 6, 12, and/or 24 months; and all-cause mortality at 12 months. Ultimately, 53 articles reporting on 45 studies (91 study arms; 5565 patients) were selected. For the technical success outcome, all types of stents, all balloons, and all atherectomy devices were aggregated in stent, balloon, and atherectomy technology groups, respectively. Results: In terms of technical success for aggregated treatment types, stent technology was the most effective treatment and was better than balloon and atherectomy technologies. In terms of binary restenosis, DES was the most effective single treatment at the 6- and 12-month follow-up and CS at the 24-month follow-up. Both DES and CS were better than the majority of other single treatments, including balloon angioplasty, cutting balloon, cryoplasty, directional atherectomy, and bare nitinol stent during all follow-up periods. In terms of TLR, DES was the second most effective single treatment and the most effective single treatment at the 6- and 12-month follow-up intervals; CS was the most effective single treatment at the 24-month follow-up. Both DES and CS were better than the majority of other single treatments. The 12-month all-cause mortality of both DES and CS were similar to other treatments, whereas cryoplasty seemed to be the least effective treatment with regard to binary restenosis and TLR. Conclusion: Both DES and CS had substantial advantages in terms of restenosis and TLR in femoropopliteal lesions and were similar to aggregate stent technology in terms of technical success. DES performed better within 12 months after operation and CS at ~24 months, but neither had much advantage in terms of mortality. In contrast, cryoplasty seemed to be a less effective treatment.

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Efficacy of tripterygium glycosides combined with ARB on diabetic nephropathy: a meta-analysis

Bioscience Reports ◽

10.1042/bsr20202391 ◽

2020 ◽

Vol 40 (11) ◽

Author(s):

Xue Wu ◽

Youye Huang ◽

Yao Zhang ◽

Chunling He ◽

Yongli Zhao ◽

...

Keyword(s):

Diabetic Nephropathy ◽

Meta Analysis ◽

Combined Treatment ◽

Mean Difference ◽

Biomedical Literature ◽

Controlled Trials ◽

Angiotensin Ii Receptor Blocker ◽

Cochrane Central Register ◽

Significant Difference ◽

Tripterygium Glycosides

Abstract The purpose of this meta-analysis was to evaluate the beneficial and adverse effects of tripterygium glycosides (TGs) combined with angiotensin II receptor blocker (ARB) on diabetic nephropathy (DN). We searched for randomized controlled trials (RCTs) in PubMed, Embase, Cochrane Central Register of Controlled Trials, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang Data, Chinese Biomedical Literature Database, China Science and Technology Journal Database up to June 2017. Weighted mean difference (WMD) and standardized mean difference (SMD) were used for continuous variables and all variables were expressed by 95% confidence interval (CI). Twenty-three studies with 1810 DN patients were included in this meta-analysis. TG combined with ARB statistically significantly improved 24-h urinary total protein (24-h UTP) (SMD = −1.46; 95% CI = −1.84 to −1.09; P<0.00001), urinary albumin excretion rate (UAER) (SMD = −6.9; 95% CI = −9.65 to −4.14, P<0.00001), serum creatinine (SCr) (WMD = −7.65.14; 95% CI = −12.99 to −2.31; P=0.005) and albumin (Alb) (WMD = 5.7; 95% CI = 4.44 to 6.96; P<0.00001) more than did ARB alone. TG combined with ARB statistically significantly affected the level of serum glutamic pyruvic transaminase (SGPT) (WMD = 1.08; 95% CI = 0.04 to 2.12, P=0.04) more than did ARB alone. Compared with ARB alone, TG combined with ARB showed no significant difference in improving blood urea nitrogen (BUN) and hemoglobin A1c (HbA1c). Minor side effects from the combined treatment were observed and mainly focused on the abnormal liver function. TG combined with ARB offers a novel concept in treating DN, more high-quality RCTs are needed for better understanding and applying the combined treatment in DN.

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Efficacy and Safety of Bevacizumab in the Treatment of Pterygium: An Updated Meta-Analysis of Randomized Controlled Trials

Journal of Ophthalmology ◽

10.1155/2018/4598173 ◽

2018 ◽

Vol 2018 ◽

pp. 1-9 ◽

Cited By ~ 2

Author(s):

Yi Sun ◽

Bowen Zhang ◽

Xiuhua Jia ◽

Shiqi Ling ◽

Juan Deng

Keyword(s):

Randomized Controlled Trials ◽

Meta Analysis ◽

Controlled Trials ◽

Cochrane Central Register ◽

Complication Rates ◽

Efficacy And Safety ◽

Conjunctival Autograft ◽

Randomized Controlled ◽

Significant Difference

Purpose. Studies investigating efficacy and safety of bevacizumab in pterygium have increased and reported controversial results. Thus, we updated this meta-analysis to clarify the issue. Methods. Studies were selected through search of the databases Embase, PubMed, Web of Science, and the Cochrane Central Register of Controlled Trials (CENTRAL) from their inception up until June 2017. The pooled risk ratio (RR) and 95% confidence interval (CI) were calculated for recurrence and complication rates by using random effects model. Results. 1045 eyes in 18 randomized controlled trials (RCTs) enrolled. Overall, the pooled estimate showed a statistically significant effect of bevacizumab on the reduction of recurrence (RR 0.74, 95% CI 0.56–0.97, P=0.03). Subgroup analyses presented significant results beneficial to bevacizumab (primary pterygium group, RR 0.53, 95% CI 0.33–0.83, P=0.006; conjunctival autograft group, RR 0.48, 95% CI 0.25–0.91, P=0.02; and follow-up longer than 12 months group, RR 0.36, 95% CI 0.13–0.99, P=0.05). No statistically significant difference was observed in complication rates. Conclusions. Application of bevacizumab showed a statistically significant decrease in recurrence rate following removal of primary pterygia, or in cases with conjunctival autograft, or with follow-up longer than 12 months, while complications were not increased.

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Evidence map of pancreatic surgery: protocol for a living systematic review and meta-analysis

BMJ Open ◽

10.1136/bmjopen-2019-032353 ◽

2019 ◽

Vol 9 (9) ◽

pp. e032353

Author(s):

Pascal Probst ◽

Felix J Hüttner ◽

Ömer Meydan ◽

Eva Kalkum ◽

Rüdiger Kretschmer ◽

...

Keyword(s):

Pancreatic Surgery ◽

Clinical Decision Making ◽

Meta Analysis ◽

Clinical Decision ◽

Outcome Data ◽

Primary Data ◽

Future Research ◽

Controlled Trials ◽

Cochrane Central Register ◽

Evidence Map

IntroductionPancreatic surgery is a large and complex field of research. Several evidence gaps exist for specific diseases or surgical procedures. An overview on existing knowledge is needed to plan and prioritise future research. The aim of this project is to create a systematic and living evidence map of pancreatic surgery.Methods and analysisA systematic literature search in MEDLINE (via PubMed), Web of Science and Cochrane Central Register of Controlled Trials will be performed searching for all randomised controlled trials (RCT) and systematic reviews (SR) on pancreatic surgery. RCT and SR will be grouped in research topics. Baseline and outcome data from RCT will be extracted, presented and effect sizes meta-analysed. Data from SR will be used to identify evidence gaps. A freely accessible web-based evidence map in the format of a mind map will be created. The evidence map and meta-analyses will be updated periodically.DisseminationAfter completion of the project, a permanently updated evidence map of pancreatic surgery will be available to patients, physicians, researchers and funding bodies viawww.evidencemap.surgery. Its use will allow clinical decision-making based on primary data and prioritisation of future research endeavours.PROSPERO registration numberCRD42019133444.

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

Journal of Endovascular Therapy ◽

10.1177/15266028211023505 ◽

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.

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