Clinical decision support systems to optimize adherence to anticoagulant guidelines in patients with atrial fibrillation: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Clinical decision support systems (CDSS) have been utilized as a low-cost intervention to improve healthcare process measures. Thus, we aim to estimate CDSS efficacy to optimize adherence to oral anticoagulant guidelines in eligible patients with atrial fibrillation (AF). METHODS: A systematic review and meta-analysis of randomized controlled trials (RCTs) retrieved from PubMed, WOS, SCOPUS, EMBASE, and CENTRAL through August 2023. We used RevMan V. 5.4 to pool dichotomous data using risk ratio (RR) with a 95% confidence interval (CI). PROSPERO ID: CRD42023471806. RESULTS: We included nine RCTs with a total of 25,573 patients. There was no significant difference, with the use of CDSS compared to routine care, in the number of patients prescribed anticoagulants (RR: 1.06, 95% CI [0.98, 1.14], P = 0.16), the number of patients prescribed antiplatelets (RR: 1.01 with 95% CI [0.97, 1.06], P = 0.59), all-cause mortality (RR: 1.19, 95% CI [0.31, 4.50], P = 0.80), major bleeding (RR: 0.84, 95% CI [0.21, 3.45], P = 0.81), and clinically relevant non-major bleeding (RR: 1.05, 95% CI [0.52, 2.16], P = 0.88). However, CDSS was significantly associated with reduced incidence of myocardial infarction (RR: 0.18, 95% CI [0.06, 0.54], P = 0.002) and cerebral or systemic embolic event (RR: 0.11, 95% CI [0.01, 0.83], P = 0.03). CONCLUSION: We report no significant difference with the use of CDSS compared to routine care in anticoagulant or antiplatelet prescription in eligible patients with AF. CDSS was associated with a reduced incidence of myocardial infarction and cerebral or systemic embolic events.

Intravascular imaging-guided versus angiography-guided percutaneous coronary intervention: a systematic review and bayesian network meta-analysis of randomized controlled trials.

BACKGROUND: Percutaneous coronary intervention (PCI) has become one of the most commonly performed interventional life-saving procedures worldwide. Intravascular Imaging (intravascular ultrasound (IVUS) and optical coherence tomography (OCT)) have initially evolved to guide PCI compared with angiography. However, this technology is not universally employed in all PCI procedures, and there is ongoing controversy regarding its additional benefits to patient outcomes. We aim to estimate the efficacy and safety of imaging modalities during PCI, allowing pre-, per, and post-intervention assessment of coronary vascularization. METHODS: A systematic review and Bayesian network meta-analysis of randomized controlled trials (RCTs), which were retrieved from PubMed, WOS, SCOPUS, EMBASE, and CENTRAL through September 2023. We used R, version 4.2.0. Effect sizes will be presented as odds ratios with accompanying 95% credible intervals. PROSPERO ID: CRD42024507821. RESULTS: Our study, encompassing 36 RCTs with a total of 17,572 patients, revelead that compared to conventional angiography, IVUS significantly reduced the risk of major adverse cardiovascular events (MACE) (OR: 0.71 [95% CrI: 0.56 to 0.87]) but not OCT (OR: 0.91 [95% CrI: 0.62 to 1.39]), IVUS and OCT significantly reduced the risk of cardiac death (OR: 0.50 [95% CrI: 0.33 to 0.76]) and (OR: 0.55 [95% CrI: 0.31 to 0.98]), respectively, IVUS significantly reduced the risk of target vessel-related revascularization (OR: 0.60 [95% CrI: 0.48 to 0.75]) but not OCT (OR: 0.86 [95% CrI: 0.60 to 1.19]), IVUS and OCT significantly reduced the risk of stent thrombosis (OR: 0.50 [95% CrI: 0.28 to 0.92]) and (OR: 0.48 [95% CrI: 0.22 to 0.98]), respectively, IVUS significantly reduced the risk of re-stenosis (OR: 0.65 [95% CrI: 0.46 to 0.88]) but not OCT (OR: 0.55 [95% CrI: 0.15 to 1.99]), neither IVUS (OR: 0.97 [95% CrI: 0.71 to 1.38]) nor OCT (OR: 0.75 [95% CrI: 0.49 to 1.22]) were associated with statistically significant reductions in all-cause mortality, neither IVUS (OR: 0.70 [95% CrI: 0.45 to 1.32]) nor OCT (OR: 0.81 [95% CrI: 0.47 to 1.59]) were associated with statistically significant reductions in target vessel failure, neither IVUS (OR: 0.88 [95% CrI: 0.43 to 2.44]) nor OCT (OR: 0.81 [95% CrI: 0.37 to 2.04]) were associated with statistically significant reductions in target lesion failure, and neither IVUS (OR: 0.82 [95% CrI: 0.60 to 1.06]) nor OCT (OR: 0.84 [95% CrI: 0.59 to 1.19]) were associated with statistically significant reductions in myocardial infarction. CONCLUSION: Intravascular imaging-guided, including IVUS and OCT, improved the postinterventional outcomes of PCI, notably suggesting their advantage over traditional angiography with no significant difference between IVUS and OCT.

Ultrasound-Guided Versus Palpation-Guided Techniques to Achieve Vascular Access in Children Undergoing Cardiac Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Pediatric heart surgery is a vital therapeutic option for congenital heart disease, which is one of the most prevalent causes of death in children. Arterial cannulation (AC) and central venous catheter (CVC) are required in pediatric cardiac surgery for continuous monitoring of the central venous pressure (CVP), replacement of fluid or blood products, close hemodynamic monitoring, and frequent sampling for arterial blood gases (ABG). A systematic review and meta-analysis synthesizing evidence from randomized controlled trials (RCTs) retrieved from PubMed, Embase Cochrane, Scopus, and WOS until February 2024. Risk ratio (RR) was used to report dichotomous outcomes, and mean difference (MD) was used to report continuous outcomes, both with a 95% confidence interval (CI) using the random-effects model. Thirteen RCTs with 1060 children were included. Regarding arterial cannulation, the ultrasound-guided technique (US) was associated with a statistically significant increase in successful cannulation [RR: 1.31 with 95% CI (1.10, 1.56), P < 0.0001], and first-attempt success [RR: 1.88 with 95% CI (1.35, 2.63), P < 0.0001]. However, US was not associated with any statistically significant difference in venous cannulation in both outcomes with [RR: 1.13 with 95% CI (0.98, 1.30), P = 0.10], [RR: 1.53 with 95% CI (0.86, 2.71), P = 0.15] respectively. Moreover, US was associated with a statistically significant decrease in the number of attempts either in arterial cannulation with [MD: - 0.73 with 95% CI (- 1.00, - 0.46), P < 0.0001] or in venous cannulation with [MD: - 1.34 with 95% CI (- 2.55, - 0.12), P = 0.03], and the time of attempted cannulation also either in arterial cannulation with [MD: - 2.27 with 95% CI (- 3.38, - 1.16), P < 0.0001] or in venous cannulation with [MD: - 4.13 with 95% CI (- 7.06, - 1.19), P < 0.0001]. US guidance improves successful cannulation rates and first-attempt success in arterial access and reduces the number of attempts and procedural time for arterial and venous access. It was also associated with a lower incidence of complications and procedure failure, particularly in arterial access. However, it was associated with a higher incidence of venous puncture.

The effect of clinical decision support systems on clinical outcomes in acute kidney injury: a systematic review and meta-analysis of randomized controlled trials.

OBJECTIVES: To determine whether clinical decision support systems (CDSS) for acute kidney injury (AKI) would enhance patient outcomes in terms of mortality, dialysis, and acute kidney damage progression. METHODS: The systematic review and meta-analysis included the relevant randomized controlled trials (RCTs) retrieved from PubMed, EMBASE, Web of Science, Cochrane, and SCOPUS databases until 21st January 2024. The meta-analysis was done using (RevMan 5.4.1). PROSPERO ID: CRD42024517399. RESULTS: Our meta-analysis included ten RCTs with 18,355 patients. There was no significant difference between CDSS and usual care in all-cause mortality (RR: 1.00 with 95% CI [0.93, 1.07], p = 0.91) and renal replacement therapy (RR: 1.11 with 95% CI [0.99, 1.24], p = 0.07). However, CDSS was significantly associated with a decreased incidence of hyperkalemia (RR: 0.27 with 95% CI [0.10, 0.73], p = 0.01) and increased eGFR change (MD: 1.97 with 95% CI [0.47, 3.48], p = 0.01). CONCLUSIONS: CDSS were not associated with clinical benefit in patients with AKI, with no effect on all-cause mortality or the need for renal replacement therapy. However, CDSS reduced the incidence of hyperkalemia and improved eGFR change in AKI patients.

Efficacy and safety of restrictive versus liberal blood transfusion strategies in acute myocardial infarction and anemia: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Blood transfusion strategies in patients with acute myocardial infarction (AMI) and anemia are yet to be conclusively identified. Thus, we aim to assess the efficacy and safety of restrictive versus liberal blood transfusion strategies for AMI and anemia. METHODS: A systematic review and meta-analysis of randomized controlled trials (RCTs) retrieved from PubMed, web of science, SCOPUS, EMBASE, and Cochrane Central Register of Controlled Trials were performed through November 2023. We used RevMan V. 5.4 to pool dichotomous data using risk ratio (RR) and continuous data using mean difference (MD) with a 95% confidence interval (CI). (PROSPERO): ID: CRD42023490692. RESULTS: We included four RCTs with 4.325 patients. There was no significant difference between both groups regarding MACE whether at 30 days (RR: 0.93 with 95% CI [0.57-1.51], P  = 0.76) or ≥ six months (RR: 1.17 with 95% CI [0.95-1.45], P  = 0.14), all-cause mortality at 30 days (RR: 1.16 with 95% CI [0.95-1.40], P  = 0.14) or ≥ six months (RR: 1.16 with 95% CI [0.88-1.53], P  = 0.28). However, the liberal strategy was significantly associated with increased hemoglobin level change (MD: -1.44 with 95% CI [-1.68 to -1.20], P  < 0.00001). However, the restrictive strategy was significantly associated with a lower incidence of acute lung injury (RR: 0.11 with 95% CI [0.02-0.60], P  = 0.01). CONCLUSION: There was no significant difference between the restrictive blood transfusion strategy and the liberal blood transfusion strategy regarding the clinical outcomes. However, restrictive blood transfusion strategy was significantly associated with a lower incidence of acute lung injury than liberal blood transfusion strategy.

Efficacy and safety of radiofrequency ablation versus cryoballoon ablation for persistent atrial fibrillation: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Persistent Atrial Fibrillation (PeAF) is a challenging case for rhythm control modalities. Catheter ablation is the mainstay in PeAF management; however, data regarding the comparative safety and efficacy of cryoballoon ablation (CBA) versus radiofrequency ablation (RFA) for PeAF is still limited. We aim to compare the safety and efficacy of CBA versus RFA for PeAF ablation. METHODS: We conducted a systematic review and meta-analysis synthesizing randomized controlled trials (RCTs), which were retrieved by systematically searching PubMed, EMBASE, Web of Science, SCOPUS, and Cochrane through October 2023. RevMan version 5.4 software was used to pool dichotomous data using risk ratio (RR) and continuous data using mean difference (MD) with a 95% confidence interval (CI). PROSPERO ID: CRD42023480314. RESULTS: Three RCTs with 400 patients were included. There was no significant difference between RFA and CBA regarding AF recurrence (RR: 0.77, 95% CI [0.50, 1.20], P = 0.25), atrial tachycardia or atrial flutter recurrence (RR: 0.54, 95% CI [0.11, 2.76], P = 0.46), and any arrhythmia recurrence (RR: 0.96, 95% CI [0.70, 1.31], P = 0.80). CBA was significantly associated with decreased total procedure duration (MD: - 45.34, 95% CI [- 62.68, - 28.00], P < 0.00001), with no significant difference in fluoroscopy duration (MD: 3.59, 95% CI [- 5.13, 12.31], P = 0.42). Safety parameters were similar in both groups, including the incidence of any complications, phrenic nerve palsy (RR: 2.91 with 95% CI [0.31, 27.54], P = 0.35), access site complications (RR: 0.33 with 95% CI [0.05, 2.03], P = 0.23), and pericardial effusion. CONCLUSIONS: In PeAF catheter ablation, CBA is comparable to RFA in terms of safety and efficacy. Also, CBA is associated with a shorter total procedure duration.

The efficacy and safety of new potassium binders on renin-angiotensin-aldosterone system inhibitor optimization in heart failure patients: a systematic review and meta-analysis.

Guideline-directed medical therapy (GDMT) has improved outcomes in patients with heart failure, including the use of renin-angiotensin-aldosterone system inhibitors, which can hinder the excretion of potassium, resulting in hyperkalaemia. New potassium binders (NPBs) can prevent this adverse effect; however, the efficacy and safety of NPB for this indication have not been fully established. We conducted a systematic review and meta-analysis synthesizing randomized controlled trials (RCTs), which were retrieved by systematically searching PubMed, Web of Science, Scopus, and Cochrane through 26 April 2023. The risk of bias assessment was conducted, following Cochrane's updated Risk of Bias 2 assessment tool. We used the fixed-effects model to pool dichotomous data using risk ratio (RR) and continuous data using mean difference (MD), with a 95% confidence interval (CI) (PROSPERO ID: CRD42023426113). We included six RCTs with a total of 1432 patients. NPB was significantly associated with successful mineralocorticoid receptor antagonist (MRA) optimization [RR: 1.13 with 95% CI (1.02-1.25), P = 0.02], decreased patients with MRA at less than the target dose [RR: 0.72 with 95% CI (0.57-0.90), P = 0.004], and decreased hyperkalaemic episodes [RR: 0.42 with 95% CI (0.24-0.72), P = 0.002]. However, there was no difference between NPB and placebo regarding angiotensin-converting enzyme inhibitor (ACEi)/angiotensin receptor blocker (ARB)/angiotensin receptor/neprilysin inhibitor (ANRi) optimization [RR: 1.02 with 95% CI (0.89-1.17), P = 0.76] and serum potassium change [MD: -0.31 with 95% CI (-0.61 to 0.00), P = 0.05], with an acceptable safety profile except for the increased incidence of hypokalaemia with NPB [RR: 1.57 with 95% CI (1.12-2.21), P = 0.009]. NPB has been shown to improve GDMT outcomes by enhancing MRA optimization and reducing hyperkalaemic episodes. However, there are limited data on the effects of NPB on ACEi/ARB/ANRi optimization. Future RCTs should investigate ACEi/ARB/ANRi optimization and conduct head-to-head comparisons of NPB (patiromer and sodium zirconium cyclosilicate).

Antithrombotic Strategies After Transcatheter Aortic Valve Replacement in Patients Without an Indication of Oral Anticoagulants: A Network Meta-Analysis of Randomized Controlled Trials.

Single-antiplatelet therapy (SAPT) has been a standard of care posttranscatheter aortic valve replacement with no clear evidence exist using direct oral anticoagulants (DOACs), vitamin K antagonists (VKA), or dual antiplatelet agents (DAPT); thus we aim to compare the safety and efficacy of the various antithrombotic strategies after transcatheter aortic valve replacement. We performed a network meta-analysis using a frequentist framework, pooling dichotomous outcomes using risk ratio (RR), and continuous data using mean difference, along with the corresponding 95% confidence interval (CI). Nine randomized controlled trials with 4193 patients were included, 567 patients were in the VKA group, 591 patients in the SAPT group, 1571 patients in the DAPT group, and 1464 patients in the DOACs group. Only DOAC showed a statistically significant higher risk of all-cause mortality [RR of 1.88 (95% CI: 1.07-3.28)] with no statistically significant difference between our arms in terms of mortality. For minor bleeding, DAPT had a significant higher risk with RR of 1.53 (95% CI: 1.04-2.25), while for major bleeding, DAPT and DOAC had a significant higher risk with RR of 2.36 (95% CI: 1.27-4.40) and 4.74 (95% CI: 2.05-10.92), respectively. There was no significant difference in terms of stroke and life-threatening bleeding. Moreover, only DOAC showed a significantly lower risk for valve thrombosis, when compared to other strategies [RR: 0.24 (95% CI: 0.13-0.46)]. Overall, SAPT had lower major bleeding events compared to other arms. There were no differences in the outcomes of stroke, myocardial infarction, or life-threatening bleeding outcomes. However, DOACs significantly reduced valve thrombosis compared to VKAs.

Intensive Blood Pressure Control After Endovascular Thrombectomy for Acute Ischemic Stroke: a Systematic Review and Meta-Analysis.

BACKGROUND AND PURPOSE: Optimal clinical outcome with successful recanalization from endovascular thrombectomy (EVT) requires optimal blood pressure (BP) management. We aimed to evaluate the efficacy and safety of the intensive BP target (< 140 mm Hg) versus the standard BP target (< 180 mm Hg) after EVT for acute ischemic stroke. METHODS: We conducted a systematic review and meta-analysis synthesizing evidence from randomized controlled trials (RCTs) obtained from PubMed, Embase Cochrane, Scopus, and WOS until September 7th, 2023. We used the fixed-effect model to report dichotomous outcomes using risk ratio (RR) and continuous outcomes using mean difference (MD), with a 95% confidence interval (CI). PROSPERO ID: CRD42023463206. RESULTS: We included four RCTs with 1559 patients. There was no difference between intensive BP and standard BP targets regarding the National Institutes of Health Stroke Scale (NIHSS) change after 24 h [MD: 0.44 with 95% CI (0.0, 0.87), P = 0.05]. However, the intensive BP target was significantly associated with a decreased risk of excellent neurological recovery (mRS ≤ 1) [RR: 0.87 with 95% CI (0.76, 0.99), P = 0.03], functional independence (mRS ≤ 2) [RR: 0.81 with 95% CI (0.73, 0.90), P = 0.0001] and independent ambulation (mRS ≤ 3) [RR: 0.85 with 95% CI (0.79, 0.92), P < 0.0001]. CONCLUSIONS: An intensive BP target after EVT is associated with worse neurological recovery and significantly decreased rates of functional independence and independent ambulation compared to the standard BP target. Therefore, the intensive BP target should be avoided after EVT for acute ischemic stroke.

Efficacy and safety of high-power short-duration ablation for atrial fibrillation: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: High-power short-duration (HPSD) ablation has emerged as an alternative to conventional standard-power long-duration (SPLD) ablation. We aim to assess the efficacy and safety of HPSD versus SPLD for atrial fibrillation (AF) ablation. METHODS: A systematic review and meta-analysis of randomized controlled trials (RCTs) retrieved from PubMed, WOS, SCOPUS, EMBASE, and CENTRAL were performed through August 2023. We used RevMan V. 5.4 to pool dichotomous data using risk ratio (RR) and continuous data using mean difference (MD) with a 95% confidence interval (CI). PROSPERO ID: CRD42023471797. RESULTS: We included six RCTs with a total of 694 patients. HPSD was significantly associated with a decreased total procedure time (MD: -22.88 with 95% CI [-36.13, -9.63], P = 0.0007), pulmonary vein isolation (PVI) time (MD: -19.73 with 95% CI [-23.93, -15.53], P < 0.00001), radiofrequency time (MD: -10.53 with 95% CI [-12.87, -8.19], P < 0.00001). However, there was no significant difference between HPSD and SPLD ablation with respect to the fluoroscopy time (MD: -0.69 with 95% CI [-2.00, 0.62], P = 0.30), the incidence of esophageal lesions (RR: 1.15 with 95% CI [0.43, 3.07], P = 0.77), and the incidence of first pass isolation (RR: 0.98 with 95% CI [0.88, 1.08], P = 0.65). CONCLUSION: HPSD ablation was significantly associated with decreased total procedure time, PVI time, and radiofrequency time compared with SPLD ablation. On the contrary, SPLD ablation was significantly associated with low maximum temperature.

Once-weekly Insulin Icodec Versus Once-daily Long-acting Insulin for Type II Diabetes: A Meta-analysis of Randomized Controlled Trials.

Background: Insulin icodec is a novel basal insulin analog with once-weekly subcutaneous administration. We aim to estimate the efficacy and safety of insulin icodec vs long-acting insulin (insulin glargine and degludec) in type II diabetic patients. Methods: We conducted a systematic review and meta-analysis synthesizing randomized controlled trials (RCTs), which were retrieved by systematically searching PubMed, Web of Science, SCOPUS, and Cochrane through May 29, 2023. We used RevMan V. 5.4 to pool dichotomous data using risk ratio (RR) and continuous data using mean difference (MD) with a 95% confidence interval (CI). Our primary outcome was glycated hemoglobin (HbA1C) change. Results: We included 7 RCTs with a total of 3183 patients. Insulin icodec was associated with significantly decreased HbA1C (MD: -0.15 with 95% CI [-0.24, -0.06], P = .002) and increased percentage of time with glucose in range (TIR) (MD: 4.06 with 95% CI [2.06, 6.06], P = .0001). However, insulin icodec was associated with increased body weight (MD: 0.57 with 95% CI [0.45, 0.70], P = .00001). Also, there was no difference regarding any serious adverse events (AEs) (RR: 0.96 with 95% CI [0.76, 1.20], P = .7) or AEs leading to withdrawal (RR: 1.54 with 95% CI [0.84, 2.82], P = .16). However, insulin icodec was associated with increased any AEs incidence (RR: 1.06 with 95% CI [1.01, 1.12], P = .02). Conclusion: Insulin icodec was associated with decreased HbA1C, increased TIR, with similar hypoglycemic and serious AEs. However, it was also associated with increased body weight and the incidence of any AEs.

The efficacy and safety of exercise regimens to mitigate chemotherapy cardiotoxicity: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Cardiotoxicity is one of the most common adverse events of the chemotherapy. Physical exercise was shown to be cardioprotective. We aim to estimate the efficacy and safety of exercise in cancer patients receiving cardiotoxic chemotherapy. METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs), which were retrieved by systematically searching PubMed, Web of Science, SCOPUS, Cochrane, Clinical Trials.gov, and MedRxiv through July 17th, 2023. We used RevMan V. 5.4 to pool dichotomous data using risk ratio (RR) and continuous data using mean difference (MD), with a 95% confidence interval (CI). PROSPERO ID: CRD42023460902. RESULTS: We included thirteen RCTs with a total of 952 patients. Exercise significantly increased VO2 peak (MD: 1.95 with 95% CI [0.59, 3.32], P = 0.005). However, there was no significant effect regarding left ventricular ejection fraction, global longitudinal strain, cardiac output, stroke volume, left ventricular end-diastolic volume, left ventricular end-systolic volume, E/A ratio, resting heart rate, peak heart rate, resting systolic blood pressure, and resting diastolic blood pressure. Also, there was no significant difference regarding any adverse events (AEs) (RR: 4.44 with 95% CI [0.47, 41.56], P = 0.19), AEs leading to withdrawal (RR: 2.87 with 95% CI [0.79, 10.43], P = 0.11), serious AEs (RR: 3.00 with 95% CI [0.14, 65.90], P = 0.49), or all-cause mortality (RR: 0.25 with 95% CI [0.03, 2.22], P = 0.21). CONCLUSION: Exercise is associated with increased VO2 peak in cancer patients receiving cardiotoxic chemotherapy. However, there was no significant difference between exercise and usual care regarding the echocardiographic and safety outcomes.

Comparative effectiveness of ultrathin vs. standard strut drug-eluting stents: insights from a large-scale meta-analysis with extended follow-up.

BACKGROUND: Newer generation ultrathin strut stents are associated with less incidence of target lesion failure (TLF) in patients undergoing percutaneous coronary intervention (PCI) in the short term. However, its long-term effect on different cardiovascular outcomes remains unknown. OBJECTIVES: We aim to identify the effects of newer-generation ultrathin-strut stents vs. standard thickness second-generation drug-eluting stents (DES) on long-term outcomes of revascularization in coronary artery disease. METHODS: We searched PubMed, Web of Science, Cochrane Library databases, and Scopus for randomized controlled trials (RCTs) and registries that compare newer-generation ultrathin-strut (< 70 mm) with thicker strut (> 70 mm) DES to evaluate cardioprotective effects over a period of up to 5 years. Primary outcome was TLF, a composite of cardiac death, target vessel myocardial infarction (TVMI) or target lesion revascularization (TLR). Secondary outcomes included the components of TLF, stent thrombosis (ST), and all-cause death were pooled as the standardized mean difference between the two groups from baseline to endpoint. RESULTS: We included 19 RCTs and two prospective registries (103,101 patients) in this analysis. The overall effect on the primary outcome was in favor of second-generation ultrathin struts stents in terms of TLF at ≥ 1 year, ≥ 2 years, and ≥ 3 years (P value = 0.01, 95% CI [0.75, 0.96]), P value = 0.003, 95% CI [0.77, 0.95]), P value = 0.007, 95% CI [0.76, 0.96]), respectively. However, there was no reported benefit in terms of TLF when we compared the two groups at ≥ 5 years (P value = 0.21), 95% CI [0.85, 1.04]). Some of the reported components of the primary and secondary outcomes, such as TLR, target vessel revascularization (TVR), and TVMI, showed the same pattern as the TLF outcome. CONCLUSION: Ultrathin-strut DES showed a beneficial effect over thicker strut stents for up to 3 years. However, at the 5-year follow-up, the ultrathin strut did not differ in terms of TLF, TLR, TVR, and TVMI compared with standard-thickness DES, with similar risks of patient-oriented composite endpoint (POCE), MI, ST, cardiac death, and all-cause mortality.

The Efficacy and Safety of Levosimendan in Patients with Advanced Heart Failure: An Updated Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: Intermittent ambulatory levosimendan administration has been shown in several small randomized controlled trials to benefit patients with advanced heart failure, preventing heart failure rehospitalization and mortality. We aim to investigate the totality of high-quality evidence regarding the efficacy and safety of intermittent levosimendan in advanced heart failure patients. METHODS: Up to September 2023, we systematically reviewed the randomized controlled trials indexed in PubMed, Embase Cochrane, SCOPUS, and Web of Science. We used mean difference (MD) to estimate the continuous outcomes, and risk ratio (RR) for the dichotomous outcomes with a 95% confidence interval (CI), using the random-effects model. Ultimately, a trial sequential analysis was employed to enhance the reliability of our findings and Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework for certainty leveling. RESULTS: Fifteen randomized controlled trials with 1181 patients were included. Intermittent levosimendan was significantly associated with an improved left ventricular ejection fraction compared with  placebo (MD 6.39 [95% CI 3.04-9.73], P = 0.002; I2 = 75, P = 0.0005), with cumulative z-score of change after ≤ 1 week passing the monitoring boundaries, favoring the levosimendan, but did not cross the required information size. Additionally, levosimendan reduced the all-cause mortality rate (RR 0.60 [95% CI 0.40-0.90], P = 0.01; I2 = 9, P = 0.36). However, we found no difference between levosimendan and placebo in all-cause rehospitalization rate (RR 0.75 [95% CI 0.46-1.22], P = 0.25; I2 = 70, P = 0.04), event-free survival rate (RR 0.97 [95% CI 0.72-1.30], P = 0.84; I2 = 63, P = 0.03), or any adverse event (RR 1 [95% CI 0.73-1.37], P = 1.00, I2 = 0%, P = 0.70). CONCLUSION: In patients with advanced heart failure, intermittent levosimendan significantly improved left ventricular ejection fraction, brain natriuretic peptide values, and all-cause mortality rate. Levosimendan use is not associated with a change in rehospitalization or event-free survival. REGISTRATION: PROSPERO identifier number (CRD42023487838).