Randomized Controlled Trials Research Articles

Abstract 4137306: Percutaneous Coronary Intervention Versus Optimal Medical Therapy for Vulnerable Atherosclerotic Coronary Plaques: A Pilot Meta-Analysis of Randomized Controlled Trials

Background: Vulnerable coronary plaques are identified as thin-capped fibroatheromas with substantial plaque and a lipid-enriched necrotic core. These plaques are often non-flow-limiting on assessment; however, they have been associated with future adverse clinical outcomes, such as unstable angina, myocardial infarction, and sudden cardiac death. Current guidelines do not recommend revascularization of such coronary plaques; however, percutaneous coronary intervention (PCI) can theoretically slow atherosclerotic progression and potentially reduce future adverse events. Methods: Major electronic databases were searched for randomized controlled trials (RCTs) that compared PCI to optimal medical therapy (OMT) for vulnerable coronary plaques. The outcomes were pooled using a random-effects model, and the results were expressed as risk ratios (RR) with corresponding 95% confidence intervals (CI). Results: 3 RCTs with 1811 patients (909: PCI and 902: OMT) were included. PCI demonstrated a statistically insignificant trend towards a decreased risk of all-cause mortality [RR: 0.40; 95% CI: 0.13, 1.27; p=0.12], cardiovascular mortality [RR: 0.17; 95% CI: 0.02, 1.38; p=0.10], myocardial infarction [RR: 0.78; 95% CI: 0.35, 1.72; p=0.53], target vessel-related myocardial infarction [RR: 0.68; 95% CI: 0.04, 11.27; p=0.79], ischemia-driven target vessel revascularization [RR: 0.22; 95% CI: 0.04, 1.22; p=0.08], and major adverse cardiovascular events [RR: 0.41; 95% CI: 0.14, 1.18; p=0.10] compared to OMT. Conclusion: This study concluded that PCI was comparable to OMT in patients with vulnerable atherosclerotic coronary plaques. Further large-scale RCTs with longer follow-up durations are required to confirm these findings.

Effects of Nicotinamide Mononucleotide on Glucose and Lipid Metabolism in Adults: A Systematic Review and Meta-analysis of Randomised Controlled Trials.

Supplementation of nicotinamide mononucleotides (NMN) has been claimed to improve metabolic function. We reviewed human randomised controlled trials (RCTs) of NMN to evaluate its effect on markers of glucose and lipid metabolism. Eight RCTs on NMN (dosage ranged 250-2000mg/d for a duration of 14days to 12weeks) involving a total of 342 middle-age/older adults (49% females, mainly non-diabetic) reporting at least one outcome on glucose control or lipid profile published in 2021-2023 were reviewed. The random-effects meta-analyses indicated no significant benefit of NMN on fasting glucose, fasting insulin, glycated hemoglobin, homeostatic model assessment for insulin resistance and lipid profile. Based on the small number of RCTs involving mainly relatively healthy adults, short-term supplementation of NMN of 250-2000mg/d did not show significantly positive impacts on glucose control and lipid profile.

Abstract 4132498: Hemodynamic and Clinical Outcomes with Balloon-Expandable Valves Versus Self-Expanding Valves in Patients with Small Aortic Annulus Undergoing Transcatheter Aortic Valve Implantation: A Meta-Analysis of Randomized Controlled Trials and Propensity Score Matched Studies

Background: Transcatheter aortic valve implantation (TAVI) is thought to be more effective than surgery for patients with small aortic annulus (SAA), however, the comparative efficacy of different transcatheter heart valves (THVs) remains uncertain. The objective of this meta-analysis was to compare the effects of balloon-expandable valves (BEVs) and self-expanding valves (SEVs) on hemodynamic parameters and clinical outcomes in patients with SAA who underwent TAVI. Methods: A thorough literature search was performed across PubMed/MEDLINE, Embase, and the Cochrane Library from their inception until May 2024 to identify eligible randomized controlled trials (RCTs) and propensity-score matched (PSM) studies. Clinical outcomes were evaluated using a random-effects model to pool risk ratios (RRs) with 95% confidence intervals (CIs). Results: The analysis included 8 studies; 2 RCTs and 6 PSM studies, with a total of 2,180 patients with SAA. BEVs were associated with a smaller indexed effective orifice area (MD: -0.18, 95% CI: -0.31 to -0.05) and a higher transvalvular mean pressure gradient (MD: 5.23, 95% CI 3.44 to 7.02) than SEVs. The risk for prosthesis-patient mismatch (PPM) (RR= 1.82, 95% CI: 1.27 to 2.60) and severe PPM (RR= 2.77, 95% CI: 1.93 to 3.98) was significantly higher for patients receiving BEVs than those receiving SEVs. However, no significant difference was observed between BEVs and SEVs regarding the risk of paravalvular leak (RR= 0.98, 95% CI: 0.57 to 1.69) and the permanent pacemaker implantation (RR= 0.78, 95% CI: 0.50 to 1.23). Although patients receiving BEVs showed a slightly lower risk of major bleeding events (RR= 0.69, 95% CI: 0.49 to 0.99), BEVs were associated with a significantly increased risk of 1-year cardiovascular mortality (RR= 1.61, 95% CI: 1.05 to 2.47) compared to those receiving SEVs. However, no significant differences were observed between BEVs and SEVs regarding 30-day all-cause mortality (RR= 1.19, 95% CI: 0.57 to 2.49), 1-year all-cause mortality (RR= 1.17, 95% CI: 0.89 to 1.53), stroke rates (RR= 0.83, 95% CI: 0.52 to 1.31) and any vascular complication (RR= 1.13, 95% CI: 0.72 to 1.75). Conclusion: In patients with SAA, SEVs showed reduced risks of PPM and severe PPM compared to BEVs, along with a larger indexed effective orifice area. Moreover, SEVs were associated with a lower risk of 1-year cardiovascular mortality.

Abstract 4144508: Efficacy and Safety of Intravenous Hydralazine vs Intravenous Labetalol in Management of Gestational Hypertension: A Meta-analysis of Randomized Controlled Trials

Background: Hypertension in pregnancy affects around 15% of all pregnant women and is one of the leading causes of maternal and fetal, mortality and morbidity. Hydralazine and labetalol are administered intravenously to control hypertension in pregnant women. However, data regarding their comparative efficacy and safety is limited. Considering the paucity of data, we conducted a systematic review and meta-analysis to pool all the studies published on this subject and provide robust evidence. Methods: We followed PRISMA guidelines for conducting this systematic review and meta-analysis. Two investigators searched PubMed/MEDLINE, Scopus, the Cochrane Library, and Google Scholar from inception until May 2024. The randomized controlled trials (RCTs) which compared the effects of intravenous labetalol versus hydralazine in pregnant women with hypertensive disorder of pregnancy were included in our pooled analysis. A random-effects model was used to calculate the weighted mean differences (MD) for continuous outcomes and odds ratio (OR) for the discrete outcomes along with the corresponding 95% confidence intervals (CIs). We considered a p-value of less than 0.05 statistically significant in all cases. Results: A total of 8 RCTs with total population of 1138 patients were pooled. The pooled analysis showed that the final systolic blood pressure (MD = -4.74, 95% CI: -12.09 to 2.62, p = 0.21) and diastolic pressure (MD = -0.86, 95% CI: -9.22 to 7.49, p = 0.84) remained comparable. The incidence of maternal hypotension (OR = 0.13, 95% CI: 0.06 to 0.29, p<0.001) was significantly lower with labetalol administration compared to hydralazine. However, we found no statistically significant difference between two groups for persistent hypertension (OR = 0.86, 95% CI: 0.37 to 1.97, p = 0.72), neonatal death (OR = 2.97, 95% CI: 0.58 to 15.25, p = 0.19), stillbirth (OR = 0.73, 95% CI: 0.25 to 2.17, p = 0.57), fetal arrhythmia (OR = 0.56, 95% CI: 0.30 to 1.07, p = 0.08), APGAR score < 7 at 5 min (OR = 2.44, 95% CI: 0.69 to 8.65, p = 0.17), cesarean section (OR = 0.97, 95% CI: 0.53 to 1.80, p = 0.93), and the number of mean doses required for successful blood pressure control (MD = -0.37, 95% CI: -1.07 to 0.34, p = 0.31). Conclusion: Intravenous labetalol and hydralazine have similar efficacy and safety profiles for blood pressure control in pregnant women. However, the risk of maternal hypotension is significantly lower with labetalol administration as compared to hydralazine.

Effects of repetitive transcranial magnetic stimulation combined with repetitive peripheral magnetic stimulation on upper limb motor function after stroke: a systematic review and meta-analysis

ObjectiveTo evaluate the effectiveness of repetitive transcranial magnetic stimulation (rTMS) combined with repetitive peripheral magnetic stimulation (rPMS) on upper limb motor dysfunction after stroke.MethodsWe systematically searched databases up to May 2024, including PubMed, Embase, Cochrane Library, Web of Science, CNKI, VIP, Wanfang, and CBM. Randomized controlled trials (RCTs) examining the application of rTMS combined rPMS on upper limb motor dysfunction after stroke were included based on predefined inclusion criteria. We used Cochrane Risk of Bias 2 tool to assess bias risk of the included RCTs. Meta-analysis was conducted using RevMan 5.4 and Stata 17.0 software.ResultsA total of 9 RCTs involving 483 participants were included in this study. Compared with the control groups that used either conventional therapy or rTMS alone, the experimental group that used rTMS combined rPMS showed significant improvements in stroke patients' upper limb motor function [MD = 3.65, 95% CI (2.75, 4.54), P < 0.05], ability of daily living [MD = 4.50, 95% CI (3.50, 5.50), P < 0.05], and spasticity [MD = –0.34, 95% CI (−0.48, −0.20), P < 0.05]. Meanwhile, in terms of neurophysiological indicators, significant differences were found both for motor evoked potential latency [MD = −1.77, 95% CI (−3.19, −0.35), P < 0.05] and motor evoked potential amplitude [MD = 0.25, 95% CI (0.01, 0.49), P < 0.05].ConclusionThis study provides low-level evidence that the therapy of LF-rTMS or HF-rTMS combined with rPMS can improve the upper limb motor function and daily living ability of stroke patients. However, given that the low quality of the evidence for the evaluation results, further evidence from high-quality studies is needed to substantiate this conclusion.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024539195, PROSPERO Platform [CRD42024539195].

Abstract 4120966: Outcomes Following Balloon Angioplasty with Drug Coated Versus Uncoated Balloons in Patients with Coronary In-Stent Restenosis: A Systematic Review and Meta-Analysis

Background <div> </div> <div>The development of in-stent restenosis (ISR) has emerged as a substantial barrier to interventional treatment for coronary heart disease. Drug-coated balloon (DCB) is an efficacious interventional technique for the management of ISR. This meta-analysis compares the efficacy of DCB in the treatment of ISR with that of an uncoated balloon (UCB).</div> <div> </div> <div>Methods</div> <div> </div> <div>We comprehensively searched literature on MEDLINE, Embase, Cochrane, and clinicaltrials.gov using MeSH terms and relevant keywords for “Balloon Angioplasty” and “in-stent Restenosis” from inception to June 1, 2024, followed by a meta-analysis of all randomized controlled trials (RCTs) to assess both strategies for treatment of ISR. Random effects model was used to aggregate the risk ratios (RR) for dichotomous and mean differences (MD) for continuous outcomes, with 95% confidence intervals (CI).</div> <div> </div> <div>Results</div> <div> </div> <div>The search strategy retrieved 2330 studies. Duplicates and irrelevant articles were removed and data from seven RCTs (1,408 patients) was extracted. The mean age ranged from 64 to 74 years. The mean clinical follow-up ranged from 1 to 10 years. DCB was found to be superior to UCB at latest follow up in terms of target lesion revascularization (TLR) (RR 0.34, 95% CI 0.19-0.58; p 0.0001; I2 79%), major adverse cardiovascular events (MACE) (RR 0.41, 95% CI 0.23-0.73; p 0.003; I2 84%), late lumen loss (LLL) (MD -0.46 mm, 95% CI -0.64- -0.28]; p <0.00001; I2 64%), and target vessel revascularization (TVR) (RR 0.45, 95% CI 0.29-0.70; p 0.0003; I2 67%). The two groups were comparable at latest follow up in terms of mortality (RR 0.87, 95% CI 0.65-1.16; p 0.35; I2 0%), cardiac death (RR 0.89, 95% CI 0.66-1.19; p 0.43; I2 0%), myocardial infarction (MI) (RR 0.70, 95% CI 0.39-1.24; p 0.22; I2 28%) and stent thrombosis (RR 0.22, 95% CI 0.04-1.10; p 0.06; I2 46%).</div> <div> </div> <div> </div> <div> </div> <div>Conclusion</div> <div> </div> <div>DCB showed promising results in the treatment of patients with coronary ISR. DCB outperformed UCB in significantly reducing TLR, MACE, LLL and TVR risks. The risk of mortality, cardiac death, MI, and stent thrombosis was similar between DCB and UCB.</div> <div> </div> <div> </div>

Abstract 4117397: SGLT2i And Cardio-Renal Outcomes In Type 2 Diabetes Mellitus: A Systematic Review And Meta Analysis.

Background: Diabetes Mellitus (DM) significantly impacts global health through cardiovascular and renal complications. SGLT2 inhibitors (SGLT2i) have emerged as beneficial for cardiovascular outcomes in Type 2 Diabetes Mellitus (T2DM). However, only few studies report outcomes related to renal function. Aim: This study aims to analyse the efficacy of SGLT2i on cardiorenal outcomes in adults with T2DM. Methods: A systematic review and meta-analysis, following PRISMA-2020 guidelines was conducted. We evaluated the efficacy of SGLT2i on cardiorenal outcomes in adults with T2DM. We included randomized controlled trials(RCT) and post hoc analyses that compared SGLT2i with placebo, focusing on cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke, heart failure hospitalizations, and renal outcomes such as the progression of albuminuria and the decline of eGFR. Dichotomous outcomes were calculated using relative risk (RR) with 95% confidence interval (CI). Results: We identified 2753 studies, registered in PubMed(=788), Embase(n=538), WoS(n=369), Scopus(n=908), and Cochrane(n=150). We included 11 studies 6 RCT and 7 Post Hoc Analysis, sample size of 50.653 patients. Meta-analysis showed that SGLT2i improve cardiovascular outcomes such as reduced cardiovascular mortality (RR 0.84 [95% CI 0.73–0.97] p=0.02), heart failure hospitalizations (RR 0.65 [95%CI 0.54–0.77]p<0.00001), and their composites outcomes. Furthermore, renal outcomes with SGLT2i significantly improve Urinary Albumin-to-Creatinine Ratio (RR1.10 [95%CI 1.03–1.18]p=0.004), Improvement of the decline of the eGFR (RR1.08 [95%CI 1.04–1.11] p<0.00001) and progression of albuminuria (RR 0.69[95%CI 0.66–0.72]p<0.00001). Slower Doubling of serum creatinine (RR 0.71 [95% CI 0.61–0.82] p<0.00001), end-stage kidney disease (RR 0.66 [95% CI 0.53–0.83] p=0.0003). Reduced Acute Kidney Injury (RR 0.72 [95% CI 0.58–0.89] p=0.002) and renal impairment (RR 0.57 [95% CI 0.34–0.95] p=0.03). Regarding death from renal causes, we identified a 46% relative reduction in the risk in SGLT2i group, although was not statistically significant (RR 0.54 [95% CI: 0.23, 1.27] p=0.16). The observed heterogeneity across studies calls for careful application of these results to individual patients. Conclusion: SGLT2i confers notable advantages in managing cardiorenal complications in T2DM, demonstrating a reduction in cardiovascular mortality and heart failure hospitalizations and offering a nephroprotective effect.

Abstract 4135270: Clinical and Procedural Outcomes after Transcatheter Aortic Valve Replacement vs Surgical Aortic Valve Replacement in Severe Aortic Stenosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Introduction: A growing body of evidence from randomized controlled trials (RCTs) has demonstrated the superiority of transcatheter aortic valve replacement (TAVR) over surgical aortic valve replacement (SAVR) irrespective of surgical risk in patients with severe aortic stenosis (SAS). Given the rise in TAVR procedures, analyzing trends in outcomes over time is critical to aid clinical decision-making. Hence, we pooled RCT data for a robust assessment of clinical and procedural outcomes in SAS patients undergoing TAVR and SAVR. Methods: PUBMED and SCOPUS were queried until April 2024. Trials were classified into high and low-risk groups based on surgical risk. The outcomes were analyzed at 30 days (short-term), 1 year (mid-term), and 5 years (long-term). Estimates were calculated as random effects risk ratios (RRs) with 95% confidence intervals (CI). Results: 10 RCTs with a total of 10,252 patients were included. There was no significant association between TAVR and SAVR in reducing all-cause mortality at 30 days (RR: 0.84 [0.64, 1.10]; Figure 1a). While TAVR was associated with a significantly lower all-cause mortality at 1 year (RR: 0.82 [0.68-0.97]; Figure 1b), it was linked with a significantly higher all-cause mortality at 5 years (RR: 1.14 [1.07-1.21]; Figure 1c). Myocardial infarction and stroke were similar in both groups up to 5 years. TAVR was associated with a lower risk of acute kidney injury for up to 1 year and atrial fibrillation for up to 5 years but a higher risk of new permanent pacemaker implantation and aortic valve re-intervention for up to 5 years. In low-risk patients, TAVR showed no significant differences from SAVR for all-cause mortality at 30 days and 5 years, but it was significant at 1 year. In high-surgical-risk patients, all-cause mortality was comparable between TAVR AND SAVR at 30 days and 1 year, with a higher rate observed with TAVR at 5 years. Conclusion: Compared with SAVR, TAVR was superior in reducing all-cause mortality at 1 year in low-risk patients and inferior in reducing all-cause mortality at 5 years in high-risk patients. A thorough evaluation of anatomical, clinical, and procedural factors is crucial to tailor the optimal intervention for each patient.

Abstract 4138221: Ezetimibe plus statin combination vs. double dose statin for patients with dyslipidemia and ASCVD risk: A Systematic Review and Meta-Analysis

Background: Dyslipidemia is a major risk factor for Atherosclerotic Cardiovascular Disease (ASCVD). Statin is a crucial intervention to fix dyslipidemia and reduce the ASCVD risk. Still, there are several regimens to achieve blood lipid level targets, including increasing the statin dose or adding ezetimibe to the statin used. However, the best option between the two regimens is still a matter of debate. Research Question: We aim to evaluate the efficacy and safety of Ezetimibe plus any type of statin versus a double dose of the same statin in patients with ASCVD risk. Methods: A systematic review and meta-analysis based on randomized controlled trials (RCTs) obtained from PubMed, Embase Cochrane, Scopus, and WOS till December 2023. We used the random-effects model to report dichotomous outcomes using odds ratio (OR) and continuous outcomes using mean difference (MD), with a 95% confidence interval (CI). Results: Forty-seven studies with a total of 18592 patients were included. Ezetimibe plus statin was associated with a decrease in low-density lipoprotein (LDL) levels [MD: -13.69 with 95% CI (-15.64, -11.74), P <0.01], and more patients achieving their targeted LDL levels [OR: 2.89 with 95% CI (2.40, 3.47), P <0.01]. However, there was no significant difference between the two groups regarding any adverse events [OR: 0.98 with 95% CI (0.89, 1.08), P =0.62], and the composite endpoint of cardiovascular death, major coronary events, or nonfatal stroke [OR: 0.72 with 95% CI (0.39, 1.32), P = 0.29], although there was a trend towards better results for patients with the combination regimen. Conclusion: Ezetimibe plus statin combination led to more reduced LDL levels and more patients achieving their goal levels than double dose statin, without a significant difference in the rate of any adverse events occurrence. More RCTs are mandatory to assess the effect of both regimens on major clinical events such as stroke, coronary events, and death.

Abstract 4119941: Identification of individuals who benefit from omega-3 fatty acid supplementation to prevent coronary heart disease: A machine-learning analysis of the VITAL

Backgrounds: Randomized controlled trials (RCTs) have demonstrated benefits of marine omega-3 polyunsaturated fatty acids (omega-3 FA) supplementation for the prevention of coronary heart disease (CHD). However, it has not been clear which individuals would benefit the most from the supplementation. We sought to predict the individual treatment effect of omega-3 FA supplementation on CHD prevention and to develop an omega-3 effect score to stratify individuals according to their expected benefit from the supplementation. Methods: Among the 25,871 randomized participants without history of CVD in the VITamin D and OmegA-3 TriaL (VITAL), we applied machine-learning (ML) approaches to predict individual treatment effect of omega-3 FA supplementation on 5-year CHD risk (a composite of myocardial infarction, coronary revascularization, and CHD death) using 11 covariates pre-specified in the VITAL trial protocol. A 10-fold cross-validation was used and held-out test dataset was used for the evaluation. An omega-3 effect score was developed such that each covariate contributed linearly, and utility of the score was further evaluated by transportability analysis using the National Health and Nutrition Examination Survey (NHANES) data as the target population. Results: Omega-3 FA intervention led to absolute 0.48% [SE: 0.20] reduction in CHD in the total population. ML algorithms effectively stratified participants by their expected benefit according to individual factors; decreased CHD risk was observed in those with quintile 1 and 2 of the expected benefit (absolute CHD risk reduction %: 1.30 % [0.55] and 1.32 % [0.51] in quintile 1 and 2, respectively). Race, diabetes, and fish intake most contributed to the omega-3 effect score. CHD incidence rates per 1000 person-year were 5.5 [0.44] if treated and 8.5 [0.55] if not treated (35.3% reduction) in individuals with the score ≥11 (upper 40th percentile), and 3.9% [0.31] if treated and 3.4% [0.55] if not treated (14.7% increase) in those with the score <11, respectively. The transportability of the utility of the score to baseline NHANES data was confirmed. Conclusion: In VITAL, ML approaches identified individuals who experienced greater CHD reduction from the omega-3 FA intervention, and an omega-3 effect score stratified the expected benefit. Although it warrants testing in a new RCT, the omega-3 effect score holds promise for guiding the indication of omega-3 FA supplementation in US primary prevention population.

Abstract 4138553: Sodium-Glucose Cotransporter-2 Inhibitors After Acute Myocardial Infarction: A Meta-analysis of Randomized Controlled Trials

Background: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) were initially developed to treat type 2 diabetes mellitus, but they have also shown benefits in mitigating cardiovascular risk. Given the increasing evidence of their efficacy in diverse disease states and their proposed mechanisms of action, it is plausible that SGLT2i could improve outcomes in patients with acute myocardial infarction (AMI) if administered early after presentation. However, the efficacy and safety of these therapies when used early in the course of acute coronary heart disease remain largely unexplored. Objective: The aim of this current study was to assess the benefit of early initiation of SGLT2i after AMI. Methods: We searched the Cochrane Central Registry of Controlled Trials, PubMed, Embase, Web of Science, and clinicalTrials.gov databases for all randomized controlled trials (RCTs) published up to May 2024 comparing SGLT2 inhibitors to placebo. The primary clinical endpoints included overall mortality, cardiovascular (CV) death, heart failure (HF) hospitalization, and adverse effects. Data were analyzed using a random-effects model to account for potential heterogeneity among the included studies. Significant heterogeneity was defined as an I-squared statistic ≥ 50%; a fixed-effects model was employed if heterogeneity was not significant. The odds ratio (OR) with a 95% confidence interval (CI) was calculated for each endpoint. Results: Four RCTs were included in the analysis, comprising 11,108 patients (SGLT2i, n = 5,561; placebo, n = 5,547) who enrolled with a mean age of 63±9 years and 77% males. SGLT2i were associated with a 28% reduction in risk of HF hospitalization (OR: 0.72 [95% CI, 0.59-0.88]; p = 0.001; I 2 = 0%). However, there was no significant reduction in overall mortality (OR: 1.01 [95% CI, 0.83-1.23]; p = 0.93; I 2 = 27%), CV mortality (OR: 1.04 [95% CI, 0.83-1.30]; p = 0.74; I 2 = 0%), and serious adverse effects (OR: 1.06 [95% CI, 0.87-1.28]; p = 0.59; I 2 = 62%). Conclusion: In patients with AMI, early initiation of SGLT2i was associated with a lower risk of HF hospitalization without increasing the incidence of serious adverse effects when compared to placebo. However, no significant difference was observed in overall mortality and CV deaths.

Abstract 4137870: Nasal Etripamil Spray efficacy for Acute Paroxysmal Supraventricular Tachycardia: A Systematic Review, Meta-Analysis and Trial Sequential Analysis.

Background: Acute paroxysmal supraventricular tachycardia (PSVT) is a common arrhythmia. Etripamil, a novel calcium channel blocker via nasal spray, has shown promise for PSVT management. This meta-analysis and trial sequential analysis (TSA) evaluates the efficacy and safety of nasal Etripamil for treating PSVT. Methods: We systematically searched Pubmed, Embase, and Cochrane databases for studies assessing the efficacy and safety of Etripamil for PSVT. The main outcome was conversion to sinus rhythm(CSR) within 15 minutes. Secondary outcomes included adverse events(AE). Meta-analysis was performed using random-effects models, and TSA was employed to assess the robustness of the evidence and required information size. Results: Three randomized controlled trials (RCTs) and two extensive trials involving 1,652 participants were analyzed. Nasal Etripamil significantly increased the CSR within 15 minutes compared to placebo (RR 1.87 95% CI; 1.39-2.52, p <0.001; Figure A). Outcome TSA suggested a low risk of type 1 error; therefore, this result may be conclusive (Figure B). For the AEs both a pairwise and single-arm meta-analysis of studies was performed with 1 AEs being statistically significant in the single-arm plot, Nasal Discomfort (22.11 95% CI; 16.02-29.70 events per 100 observations, p <0.01 Figure C). In the pairwise, the overall was statistically significant and it favored placebo (RR 3.93, 95% CI; 2.46-6.27, p <0.001 Figure D). Conclusion: Nasal Etripamil is effective and safe for the treatment of acute PSVT, offering a non-invasive alternative to traditional therapies. Larger-scale RCTs are warranted to confirm these findings and explore long-term outcomes.

Abstract 4137467: Intravascular ultrasound-guided versus angiography-guided percutaneous coronary intervention: A systematic review, meta-analysis, and meta-regression of randomized controlled trials

Background: Intravascular ultrasound (IVUS) guidance during percutaneous coronary intervention (PCI) allows better visualization of atherosclerotic plaques than angiography alone. We conducted a systematic review and meta-analysis to comprehensively synthesize the available evidence regarding the efficacy of IVUS-guidance compared to angiography-guided PCI. Moreover, we conducted a sensitivity analysis to determine the applicability of IVUS guidance in complex PCI. Methods: We conducted a comprehensive literature search of major bibliographic databases from inception until May 2024 to identify randomized controlled trials (RCTs) comparing IVUS-guided versus angiography-guided PCI. Risk ratios (RR) with their corresponding 95% confidence intervals (CI) were pooled using the random-effects model, with a p-value <0.05 considered statistically significant. We conducted meta-regression to determine the moderating of baseline covariates on pooled outcomes. Results: Sixteen RCTs were included with 10,993 patients undergoing PCI (IVUS-guided PCI: 5684 patients; angiography-guided PCI: 5157 patients). IVUS-guided PCI demonstrated a significantly lower risk of cardiac death [RR: 0.49; 95% CI: 0.35, 0.68], major adverse cardiovascular events [RR: 0.64; 95% CI: 0.51, 0.80], myocardial infarction [RR: 0.73; 95% CI: 0.59, 0.89], stent thrombosis [RR: 0.45; 95% CI: 0.27, 0.75], target lesion revascularization [RR: 0.60; 95% CI: 0.49, 0.74], and target vessel revascularization [RR: 0.56; 95% CI: 0.45, 0.70] than angiography-guided PCI. IVUS-guided PCI demonstrated a nonsignificant trend toward a reduced risk of all-cause mortality [RR: 0.79; 95% CI: 0.61, 1.04]. Meta-regression showed a nonsignificant moderating effect of the duration of follow-up, age of patients, baseline dyslipidemia, and hypertension status on pooled outcomes. A sensitivity analysis was conducted for patients undergoing complex PCI. The sensitivity analysis showed the superiority of IVUS-guided PCI compared to angiography-guided PCI by resulting in a significant improvement in the clinical outcomes. Conclusion: This meta-analysis concluded that IVUS-guided PCI resulted in a reduction in cardiac death, major adverse cardiovascular events, myocardial infarction, stent thrombosis, target lesion revascularization, and target vessel revascularization, compared to angiography-guided PCI. Moreover, we observed the superiority of IVUS guidance in complex PCI as well.

Effects of football training on cognitive performance in children and adolescents: a meta-analytic review

BackgroundThe cognitive development of children and adolescents is crucial for their academic success and overall well-being. Physical activity has been linked to improved cognitive performance, but the specific effects of football training on cognitive function in this population remain unclear. This meta-analytic review aimed to comprehensively evaluate the impact of football training on cognitive performance in children and adolescents.MethodsLiterature was searched through PubMed, PsycINFO, SPORTDiscus, Embase, and Web of Science. Eligible studies were randomized controlled trials (RCTs) or crossover designs assessing cognitive performance following football training interventions. Outcome measures included attention, inhibitory control, and working memory. Data synthesis and meta-analysis were performed to determine the overall effect sizes.ResultsTwelve studies were included in the meta-analysis, comprising 1,574 children and 94 adolescents. Football training demonstrated moderate, statistically significant effects on attention (Hedges’ g = −0.77, p = 0.01), inhibitory control (Hedges’ g = −0.67, p = 0.02), and working memory (Hedges’ g = −0.44, p = 0.03). The findings suggest that football training positively influences cognitive performance in children and adolescents.ConclusionFootball training holds promise for enhancing cognitive function in children and adolescents, particularly in attention, inhibitory control, and working memory. Theoretical frameworks emphasizing environmental enrichment, cardiovascular fitness, and cognitive component skills help elucidate the underlying mechanisms. Future research should explore how football training compares to other sports and assess whether integrative drills that combine cognitive elements with skill practice offer greater cognitive benefits than skill training alone. These insights support the inclusion of football in educational programs to foster cognitive development.

Abstract 4129965: Efficacy of Sodium Glucose Cotransporter 2 Inhibitors In Patients With Acute Myocardial Infarction: A Meta-Analysis of Randomized Controlled Trials

Background: Sodium-glucose cotransporter 2 (SGLT2) inhibitors improve cardiovascular outcomes in patients with or without type 2 diabetes and heart failure (HF). However, studies have shown conflicting evidence regarding their efficacy in patients following acute myocardial infarction (MI). We conducted a systematic review and meta-analysis to synthesize the available evidence regarding the effectiveness of SGLT2 inhibitors in MI. Methods: A systematic literature search was conducted using PubMed/MEDLINE, the Cochrane Library, and Embase databases to identify randomized controlled trials (RCTs) that compared clinical outcomes of SGLT2 inhibitors with placebo following MI. We conducted the statistical analysis using RevMan, version 5.4, and pooled risk ratios (RRs) along the corresponding 95% confidence interval (CI) for all outcomes. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. Results: Five RCTs reporting data for 11,211 patients were included in our study. Our pooled analysis showed that SGLT2 inhibitors significantly reduced the risk of hospitalizations for heart failure (HHF) (RR = 0.76, 95% CI: 0.61-0.88, p = 0.001; high certainty). In terms of absolute effects, this translated to 12 fewer HHF per 1,000 patients who received SGLT2 inhibitors compared with the placebo (absolute risk difference 12 (95% CI 17 to 5) fewer per 1000 patients) in patients with MI. However, the risk of all-cause mortality (RR = 1.05, 95% CI: 0.78-1.41, p = 0.76; high certainty), cardiovascular (CV) mortality (RR = 1.04, 95% CI = 0.84-1.29, p = 0.73; high certainty), and all-cause hospitalizations (RR = 1.06, 95% CI: 0.96-1.17, p = 0.25; high certainty) remained comparable across the two groups. Conclusion: SGLT2 inhibitors reduce HHF without affecting all-cause mortality, CV mortality, and all-cause hospitalizations. However, further evidence is required to reach a definitive conclusion.

Abstract 4124281: Dexmedetomidine for junctional ectopic tachycardia in patients undergoing tetralogy of Fallot repair: a meta-analysis of randomized controlled trials

Background: Junctional ectopic tachycardia (JET) occurs in 2 to 22% of patients after cardiac surgery for congenital heart diseases, including tetralogy of Fallot (TOF) repair. Dexmedetomidine emerged as a potential drug to prevent JET in these patients. This systematic review and meta-analysis aimed to evaluate the efficacy of dexmedetomidine in JET in patients undergoing TOF repair. Methods: We systematically searched PubMed, Embase, and Cochrane databases for randomized controlled trials (RCTs) analyzing the use of dexmedetomidine in patients undergoing TOF repair. We pooled risk ratios (RR) for binary outcomes, and mean differences (MD) for continuous outcomes with 95% confidence intervals (CI) with a random-effects model. We performed a trial sequential analysis (TSA) to assess the random risk of incidence of JET. We used R version 4.3.2 and TSA version 0.5.9.10 for statistical analyses. Results: Our meta-analysis included 5 RCTs comprising 546 patients, of whom 268 (49%) were randomized to dexmedetomidine. Compared with control, dexmedetomidine significantly reduced the incidence of JET (RR 0.46; 95% CI: 0.30 to 0.71; p<0.05; Figure A). However, there were no significant differences in mortality (RR 0.45; 95% CI: 0.12 to 1.71; p=0.24; Figure B) between groups. In addition, dexmedetomidine also reduced the length of intensive care unit (ICU) stay (MD -7.75 hours; 95% CI: -15.08 to -0.41; p<0.05; Figure C). There were no significant differences in ionotropic score (MD -0.97 ug.min/Kg; 95 % CI: -1.98 to 0.18; p=0.10; Figure D), and ventilation time (MD -2.29 hours; 95% CI: -8.39 to 2.41; p=0.27; Figure E). For the primary endpoint, TSA suggested a low risk of type 1 error; therefore, this result may be conclusive. Conclusion: In patients undergoing TOF repair surgery, dexmedetomidine significantly reduced the incidence of JET and the length of ICU stay.

Pondering the problem of peri-implant pathology.

Randomised control trials were identified via searches of PubMed, Embase, Web of Science and The Cochrane Library. Only randomised control trials involving adults with at least a single dental implant which had experienced peri-implant mucositis or peri-implantitis were considered. Within studies, one cohort must have been treated with a combination of mechanical debridement (MD) and non-surgical strategies, and the other solely by mechanical debridement. Outcomes were measured using periodontal indices such as bleeding on probing, and each group needed to comprise minimum five patients. Extracted information included the name of the lead author, size of patient groups, length of follow-up and the main results from the studies. The results indicated that in peri-implantitis the most effective treatment in reducing periodontal pocketing depths (PPDs) was photo biomodulation therapy and MD, while systemic antibiotics and MD were the most effective in improving clinical attachment loss and marginal bone loss. With regards to peri-implant mucositis; probiotics and MD yielded the best improvement in PPDs and plaque index, whereas systemic antibiotics with MD improved bleeding on probing the most. This analysis gives potentially useful data regarding specific treatment combinations for peri-implant disease. In light of this, it may help in guiding clinical decisions, but should be used in conjunction with recognised guidelines, and further high quality primary research is still required in the field.

Abstract 4136969: Empagliflozin's Role in Post-Myocardial Infarction Management: Insights from a Meta-Analysis

Background: Empagliflozin, a Sodium Glucose Cotransporter 2 (SGLT2) Inhibitor, is used to treat type 2 diabetes mellitus and heart failure. Its safety and efficacy in patients with Myocardial Infarction (MI) have been studied recently. Research Questions/Hypothesis: What is the role of Empagliflozin in post-myocardial infarction management by preventing cardiovascular deaths, reducing hospitalization due to heart failure, and minimizing adverse events? Goals/Aims: Role of Empagliflozin in post-myocardial infarction management by preventing cardiovascular deaths, reducing hospitalization due to heart failure, and minimizing adverse events Methods: A literature search was done on PubMed, Medline, Web of Science, Scopus, and Cochrane Central Register of Controlled Trials from inception until May 2024. All Randomized Control Trials (RCT) reporting the safety and efficacy of Empagliflozin in MI management were selected. Outcomes were pooled as Mean Difference (MD) or Risk Ratio (RR) with 95% Confidence Intervals (CI) in this meta-analysis using Revman 5.4. Results: Data from ten RCTs, with a combined sample size of 10,560 patients was pooled, and showed that Empagliflozin is superior to placebo in terms of Cardiovascular death (RR=0.75, 95% CI [0.64, 0.88],p < 0.0004) and hospitalization due to heart failure (RR=0.70, 95% CI [0.59, 0.82], p < 0.0001). However, the results were non-significant for both groups in terms of adverse events (RR=1.00, 95% CI [0.96, 1.03], p < 0.78). Conclusion: Empagliflozin significantly lowers the risk of cardiovascular events in patients with MI who are at a high risk of death due to cardiovascular causes.

Abstract 4145802: Association between Glucagon-like peptide-1 receptor agonists and risk of Arrhythmias or Heart Failure among patients with Type 2 Diabetes: A Meta-Analysis of 29 Randomized Controlled Trials.

Background: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have shown a reduction in major adverse cardiovascular events (MACE) among patients with type 2 diabetes mellitus (T2DM). However, their effect on reducing the risk of incidence of arrhythmias and heart failure has not been established, and there is very limited literature to date. Objective: We evaluated the effect of GLP-1 RAs on the incidence of arrhythmias and heart failure among patients with T2DM. Methods: We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) that enrolled patients with type 2 diabetes and compared GLP-1 RAs and control groups. PubMed and ClinicalTrials.gov were systematically searched from inspection till May 2024 without any language restrictions. Odds ratios (OR) and 95% confidence intervals (CI) were pooled using a random-effect model. Results: A total of 29 RCTs with 72,868 patients (35,631 in the GLP-1 RA group and 37,237 in the control group) were included in the analysis. Pooled analysis showed that there is no significant association between GLP-1 RAs and incidence of atrial fibrillation (OR, 0.94(95%CI: 0.75-1.18), P=0.60), atrial flutter (OR, 0.87(95%CI: 0.60-1.26), P=0.46), cardiac arrest (OR, 0.79(95%CI: 0.51-1.23), P=0.30), ventricular tachycardia (OR, 1.37(95%CI: 0.90-2.07), P=0.14), and ventricular fibrillation (OR, 0.91 (95%CI: 0.45-1.84), P=0.80) when compared with control group. However, GLP-RAs reduced the incidence of atrioventricular block complete (OR, 0.58 (95%CI: 0.35-0.97), P=0.04), and heart failure (OR, 0.795 (95%CI: 0.634-0.997), P=0.047). Conclusion: This study shows that GLP-1 RAs reduced the incidence of atrioventricular block complete and incidence of heart failure. However, no significant association has been observed for arrhythmias.

Efficacy and safety of multi-day antiemetic treatment for patients undergoing multi-day chemotherapy: a systematic review of Clinical Practice Guidelines for Antiemesis 2023 from Japan Society of Clinical Oncology.

A standardized multi-day antiemetic regimen for multi-day chemotherapy remains elusive. This systematic review evaluated the efficacy and safety of multi-day antiemetic regimens in patients undergoing multi-day intravenous chemotherapy. We conducted a comprehensive search of PubMed, Cochrane Library, and Ichushi-Web databases for relevant studies published from January 1990 to December 2020. We included studies comparing multi-day and single-day antiemetic regimens for preventing chemotherapy-induced nausea and vomiting. No studies directly comparing multi-day versus single-day antiemetic regimens were found. Despite expanding control group criteria beyond "single-day antiemetic therapy" limited high-quality studies and variations in cancer types, chemotherapy regimens, and antiemetic treatments precluded meta-analysis. Among the included studies, some randomized controlled trials (RCTs) focused on complete response and vomiting rates. Two studies comparing two- and three-drug combinations reported higher complete response and no-vomiting rates with the three-drug regimen. Limited RCTs explored "nausea control" and "cost," and assessing "adverse events" proved challenging due to inconsistent reporting. The research on multi-day antiemetic therapy is limited, necessitating further investigation. Nonetheless, our findings suggest that three-drug combination therapy, including aprepitant, may offer superior antiemetic efficacy compared to two-drug regimens. Multi-day antiemetic therapy is strongly recommended during multi-day intravenous administration of cytotoxic anticancer drugs.