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Diabetes, Obesity & Metabolism Jul 2024To evaluate the efficacy and cardiovascular outcomes of combination pioglitazone with either a glucagon-like peptide-1 receptor agonist (GLP-1RA) or a sodium-glucose... (Meta-Analysis)
Meta-Analysis
Effect of combination pioglitazone with sodium-glucose cotransporter-2 inhibitors or glucagon-like peptide-1 receptor agonists on outcomes in type 2 diabetes: A systematic review, meta-analysis, and real-world study from an international federated database.
AIMS
To evaluate the efficacy and cardiovascular outcomes of combination pioglitazone with either a glucagon-like peptide-1 receptor agonist (GLP-1RA) or a sodium-glucose cotransporter-2 (SGLT2) inhibitor in individuals with type 2 diabetes (T2D) by conducting a systematic review, meta-analysis, and analysis of a large international real-world database.
METHODS
We searched MEDLINE, SCOPUS and Web of Science to identify relevant articles for inclusion (PROSPERO [CRD: 42023483126]). Nineteen studies assessing pioglitazone + SGLT2 inhibitors or GLP-1RAs versus controls were identified, 16 of which were randomized controlled trials. Risk of bias was assessed using Cochrane-endorsed tools and quality of evidence was assessed using GRADE. We additionally performed a retrospective cohort study of all individuals aged 18 years or over with T2D, using the TriNetX platform. We included propensity-score-matched individuals who were treated for at least 1 year with pioglitazone and a GLP-1RA or pioglitazone and an SGLT2 inhibitor, compared against GLP-1RA and SGLT2 inhibitor monotherapy. Outcomes were all-cause mortality, heart failure, chronic kidney disease and composite stroke and transient ischaemic attack.
RESULTS
The average follow-up in the included studies ranged from 24 to 52 weeks. Combination of pioglitazone with a GLP-1RA reduced glycated haemoglobin (HbA1c) and weight greater than in controls: mean differences -1% (95% confidence interval [CI] -1.27, -0.74) and -1.19 kg (95% CI -1.80, -0.58), respectively. There was no statistically significant difference in systolic blood pressure (SBP) or mortality between groups: mean difference - 1.56 mmHg (95% CI -4.48, 1.35; p = 0.30) and relative risk (RR) 0.29 (95% CI 0.07-1.15; p = 0.08), respectively. Combination of pioglitazone with SGLT2 inhibitors reduced HbA1c, weight and SBP to a greater extent than control treatment: mean differences -0.48% (95% CI -0.67, -0.28), -2.3 kg (95% CI -2.72, -1.88) and -2.4 mmHg (95% CI -4.1, -0.7; p = 0.01), respectively. There was no statistically significant difference in mortality between groups (RR 1.81, 95% CI 0.30-10.97; p = 0.52). The included trials demonstrated a reduction in risk of heart failure with combination treatment. Similarly, from the real-world database (n = 25 230 identified), pioglitazone and SGLT2 inhibitor combination therapy was associated with reduced risk of heart failure compared to monotherapy alone (hazard ratio 0.50, 95% CI 0.38-0.65; p < 0.001).
CONCLUSION
Both our systematic review/meta-analysis and the real-world dataset show that combination of pioglitazone with either GLP-1RAs or SGLT2 inhibitors is associated with increased weight loss and reduced risk of heart failure compared with monotherapy.
Topics: Diabetes Mellitus, Type 2; Humans; Pioglitazone; Sodium-Glucose Transporter 2 Inhibitors; Hypoglycemic Agents; Glucagon-Like Peptide-1 Receptor; Drug Therapy, Combination; Treatment Outcome; Female; Male; Middle Aged; Retrospective Studies; Databases, Factual; Glycated Hemoglobin; Cardiovascular Diseases; Glucagon-Like Peptide-1 Receptor Agonists
PubMed: 38558280
DOI: 10.1111/dom.15576 -
International Journal of Nursing Studies Jun 2024Although post-stroke delirium is a frequent complication in acute settings and has significant long-lasting implications for patients, the prevalence of post-stroke... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Although post-stroke delirium is a frequent complication in acute settings and has significant long-lasting implications for patients, the prevalence of post-stroke delirium diagnosed according to gold-standard criteria remains uncertain. This highlights the importance of updating the current evidence.
OBJECTIVE
This review aims to provide a precise estimation of the prevalence of delirium in acute post-stroke settings and to explore potential differences in the reported prevalence according to the characteristics of the study and stroke survivors.
DESIGN
Systematic review and meta-analysis.
SETTING AND PARTICIPANTS
Post-stroke survivors with delirium in acute settings.
DATA SOURCES
Five English and two Chinese language databases from inception to June 2023, and the reference lists of published reviews.
METHODS
Studies reporting the prevalence of post-stroke delirium according to the Diagnostic and Statistical Manual of Mental Disorders criteria with the description of assessment method in the absence of interventions for delirium were eligible. Two reviewers independently screened searched records and extracted data from eligible studies. A meta-analysis was conducted using a random-effects model to evaluate the prevalence of post-stroke delirium, and predefined subgroup analyses, sensitivity analyses, and mixed-effects meta-regression were conducted to explore the contribution of heterogeneity.
RESULTS
Twenty-nine eligible studies involving 8839 survivors were included. In acute settings, the overall weighted prevalence of post-stroke delirium was 25 % (95 % CI, 20-30; I, 95 %). Subgroup analyses revealed age-dependent variations in delirium prevalence, with rates of 20 %, 25 %, and 34 % for ages 60-64, 65-74, and 75-79, respectively. Delirium prevalence varied by assessment duration (7 days: 31 %, >7 days: 24 %, <7 days: 20 %). Initial screening significantly reduced reported prevalence to 15 %, compared with 30 % when no initial screening was conducted. Delirium prevalence was lower when nurses were involved in assessments (13 % vs. 29 %). No significant effects were detected for economic status, publication year, female percentage, onset-to-admission time, stroke type, and assessment frequency. Meta-regression analysis revealed that higher delirium prevalence was associated with increased survivors' age (β = 0.051; 95 % CI, -0.0002 to 0.103; P = 0.05; R = 13.36 %).
CONCLUSION
A high prevalence of post-stroke delirium was observed in acute settings. Nurses are required to integrate and coordinate the prevention, early detection, and management of delirium following stroke into their nursing practice, particularly for older stroke survivors. The findings necessitate the need for incorporating specialized training within nursing education to identify and manage the delirium effectively and accurately. This reinforces the pivotal role of nurses in the early detection and prevention of delirium within the acute stroke care continuum.
REGISTRATION
The protocol was registered on PROSPERO (CRD42022352097).
TWEETABLE ABSTRACT
Evidence suggests 25 % prevalence of post-stroke delirium in acute settings, with higher rates in older patients, emphasizing the need for prevention, early detection, and management in nursing practice.
Topics: Humans; Delirium; Prevalence; Stroke
PubMed: 38552472
DOI: 10.1016/j.ijnurstu.2024.104750 -
Journal of Clinical Medicine Mar 2024: The prevalence of neurological disorders is increasing worldwide. In recent decades, the conventional rehabilitation for people with neurological disorders has been... (Review)
Review
: The prevalence of neurological disorders is increasing worldwide. In recent decades, the conventional rehabilitation for people with neurological disorders has been often reinforced with the use of technological devices (robots and virtual reality). The aim of this systematic review was to identify the evidence on the economic cost of rehabilitation with robotic and virtual reality devices for people with neurological disorders through a review of the scientific publications over the last 15 years. : A systematic review was conducted on partial economic evaluations (cost description, cost analysis, description of costs and results) and complete (cost minimization, cost-effectiveness, cost utility and cost benefit) studies. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. The main data sources used were PubMed, Scopus and Web of Science (WOS). Studies published in English over the last 15 years were considered for inclusion in this review, regardless of the type of neurological disorder. The critical appraisal instrument from the Joanna Briggs Institute for economic evaluation and the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) were used to analyse the methodological quality of all the included papers. : A total of 15 studies were included in this review. Ten papers were focused on robotics and five on virtual reality. Most of the studies were focused on people who experienced a stroke. The robotic device most frequently used in the papers included was InMotion (Bionik Co., Watertown, MA, USA), and for those focused on virtual reality, all papers included used semi-immersive virtual reality systems, with commercial video game consoles (Nintendo Wii (Nintendo Co., Ltd., Kyoto, Japan) and Kinect (Microsoft Inc., Redmond, WA, USA)) being used the most. The included studies mainly presented cost minimization outcomes and a general description of costs per intervention, and there were disparities in terms of population, setting, device, protocol and the economic cost outcomes evaluated. Overall, the methodological quality of the included studies was of a moderate level. : There is controversy about using robotics in people with neurological disorders in a rehabilitation context in terms of cost minimization, cost-effectiveness, cost utility and cost benefits. Semi-immersive virtual reality devices could involve savings (mainly derived from the low prices of the systems analysed and transportation services if they are applied through telerehabilitation programmes) compared to in-clinic interventions.
PubMed: 38541755
DOI: 10.3390/jcm13061531 -
Journal of Integrative Neuroscience Mar 2024Single-nucleotide polymorphisms (SNPs) in the proprotein convertase subtilisin/kexin type 9 () gene are known to be associated with susceptibility to several... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Single-nucleotide polymorphisms (SNPs) in the proprotein convertase subtilisin/kexin type 9 () gene are known to be associated with susceptibility to several cerebrovascular diseases, including ischemic stroke (IS). The aims of this study was to evaluate associations between gene polymorphisms and the risk of IS. Based on previous reports linking PCSK9 SNPs to plasma lipid levels and to atherosclerosis, and to inconsistencies in the reported associations between the SNPs, plasma lipid levels and IS risk, we choose the rs505151, rs529787, and rs17111503 to performe the association analysis.
METHODS
Using multiple databases, all relevant case-control and cohort studies that matched our search criteria were collected. Quality assessment of included studies was performed using the Newcastle-Ottawa Scale. Demographic and genotype data were extracted from each study, and meta-analysis was performed using Stata/MP 17.0. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using fixed and random effects models.
RESULTS
A critical evaluation was conducted on ten case-control studies, involving a total of 2426 cases and 2424 controls. Pooled results from the allelic models indicated the rs505151 G allele (OR: 1.41, 95% CI: 1.06-1.87, = 0.019, I2 = 53.9%) and the rs17111503 A allele (OR: 1.38, 95% CI: 1.22-1.55, < 0.001, I2 = 43.5%) were significantly associated with IS. Study qualities ranged from moderate (n = 4) to good (n = 6). Begg's and Egger's tests results indicated there was no evidence of publication bias in the findings ( > 0.05).
CONCLUSIONS
This meta-analysis demonstrated that G allele variant of rs505151 and A allele variant of rs17111503 were associated with an increased risk of IS. Based on our findings, these SNPs could serve as potential targets for the diagnosis and treatment of IS. The integration of information on genetic polymorphism into IS risk prediction model may be beneficial in routine clinical practice.
Topics: Humans; Ischemic Stroke; Lipids; Polymorphism, Single Nucleotide; Proprotein Convertase 9
PubMed: 38538222
DOI: 10.31083/j.jin2303062 -
Journal of Neuroengineering and... Mar 2024The visual system and associated skills are of particular importance in stroke rehabilitation. The process of neuroplasticity involved in restoring cognitive function... (Meta-Analysis)
Meta-Analysis Review
The visual system and associated skills are of particular importance in stroke rehabilitation. The process of neuroplasticity involved in restoring cognitive function during this period is mainly based on anatomical and physiological mechanisms. However, there is little evidence-based knowledge about the effects of visual skills training that could be used to improve therapeutic outcomes in cognitive rehabilitation. A computerized systematic literature search was conducted in the PubMed, Medline, and Web of Science databases from 1 January 1960 to 11 Febuary 2024. 1,787 articles were identified, of which 24 articles were used for the calculation of weighted standardized mean differences (SMD) after screening and eligibility verification. The findings revealed moderate effects for global cognitive function (SMD = 0.62) and activities of daily living (SMD = 0.55) as well as small effects for executive function (SMD = 0.20) - all in favor of the intervention group. The analyses indicate that the results may not be entirely robust, and should therefore be treated with caution when applied in practice. Visual skills training shows positive effects in improving cognitive and executive functions, especially in combination with high cognitive load and in an early phase of rehabilitation. An improvement in activities of daily living can also be observed with this type of intervention. The high heterogeneity of the studies and different treatment conditions require the identification of a relationship between certain visual skills and executive functions in future research.
Topics: Humans; Executive Function; Activities of Daily Living; Stroke; Cognition; Stroke Rehabilitation
PubMed: 38532485
DOI: 10.1186/s12984-024-01338-5 -
Diabetes, Obesity & Metabolism Jun 2024To conduct an updated systematic review and meta-analysis to evaluate the efficacy of glucagon-like peptide-1 receptor agonists (GLP-1RAs) with regard to cardiac... (Meta-Analysis)
Meta-Analysis
The effect of glucagon-like peptide-1 receptor agonists on cardiac function and structure in patients with or without type 2 diabetes mellitus: An updated systematic review and meta-analysis.
AIMS
To conduct an updated systematic review and meta-analysis to evaluate the efficacy of glucagon-like peptide-1 receptor agonists (GLP-1RAs) with regard to cardiac function and structure in people with or without type 2 diabetes mellitus (T2DM).
MATERIALS AND METHODS
We conducted a systematic search using the PubMed, Embase and ClinicalTrials.gov online databases. The primary outcome of interest was changes in mitral inflow E-velocity to tissue Doppler e' velocity (E/e') ratio. Secondary outcomes included other indicators of cardiac reverse remodelling and functional capacity comprising changes in left ventricular mass (LVM), left ventricular global longitudinal strain, left ventricular end-diastolic volume, left ventricular end-systolic volume, left ventricular ejection fraction (LVEF), early to atrial mitral inflow velocity ratio, left atrial volume (LAV), N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels and 6-min walk test (6MWT) results.
RESULTS
A total of 15 trials involving 898 patients were included in this analysis. GLP-1RAs significantly improved E/e' ratio (mean difference [MD] = -0.73; 95% confidence interval [CI] -1.34, -0.13), LVM (MD = -3.86 g; 95% CI -7.60, -0.12), LAV (MD = -8.20 mL; 95% CI -12.37, -4.04), NT-proBNP level (standardized MD = -0.27; 95% CI -0.47, -0.06), and 6MWT result (MD = +22.31 m; 95% CI 1.64, 42.99). However, GLP-1RAs had no effect on LVEF (MD = +0.31%; 95% CI -1.02, 1.64).
CONCLUSIONS
In this systematic review and meta-analysis, GLP-1RAs were found to have a positive impact on left ventricle diastolic function, hypertrophy, and exercise capacity, but had no effect on systolic function.
Topics: Humans; Diabetes Mellitus, Type 2; Glucagon-Like Peptide-1 Receptor; Hypoglycemic Agents; Ventricular Function, Left; Ventricular Remodeling; Stroke Volume; Female; Male; Middle Aged; Heart; Natriuretic Peptide, Brain; Glucagon-Like Peptide-1 Receptor Agonists
PubMed: 38528818
DOI: 10.1111/dom.15557 -
Journal of Occupational Rehabilitation Mar 2024An increasing number of individuals with stroke are having difficulties in returning to work, having a significant impact on both individuals and society. The aims of...
PURPOSE
An increasing number of individuals with stroke are having difficulties in returning to work, having a significant impact on both individuals and society. The aims of this meta-analysis were to summarize the interventions to support the return to work (RTW) for individuals with stroke and to quantitatively evaluate the efficacy of each type of intervention.
METHODS
A systematic review and meta-analysis were conducted according to PRISMA guidelines. PubMed, Embase, Cochrane Library, CINAHL, and PsycINFO were searched until 26 June 2023, and the list of references of the initially included articles was also searched. Two researchers independently performed the search, screening, selection, and data extraction. The primary outcome was RTW rate (the RTW rate was defined as the proportion of individuals who returned to work in each group (intervention and control) at the endpoint). Pooled risk ratio (RR) was estimated using a random-effects model with 95% confidence intervals (CIs).
RESULTS
A total of 13 studies representing 4,282 individuals with stroke were included in our study. Results showed that physiological interventions could improve the RTW rate of individuals with stroke (RR: 1.19, 95% CI: 1.01 to 1.42, I = 72%). And receiving intravenous thrombolytic therapy was beneficial in promoting the RTW in individuals with stroke. Subgroup analysis and meta-regression analysis showed that the individuals' functional status during hospitalization was the only source of heterogeneity. Psychological interventions had little or no effect on the RTW rate of individuals with stroke (RR: 1.20, 95% CI: 0.58 to 2.51, I = 30%). Work-related interventions had little or no effect on the RTW rate of the individuals with stroke (RR:1.36,95%CI: 0.99 to 1.88, I = 73%). The subgroup analysis showed that country, age, and follow-up method were the sources of heterogeneity.
CONCLUSION
Physiological intervention promoted the RTW of individuals with stroke. But, the effect of psychological and work-related interventions in promoting the RTW of individuals with stroke was not significant. We anticipate that these findings may inform the design of future interventions. For future research, we recommend that more high-quality randomized controlled trials be conducted to further promote the RTW of individuals with stroke.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO Registration Number, CRD42023443668.
PubMed: 38512392
DOI: 10.1007/s10926-024-10178-y -
Health Technology Assessment... Mar 2024Artificial intelligence-derived software technologies have been developed that are intended to facilitate the review of computed tomography brain scans in patients with...
Software with artificial intelligence-derived algorithms for analysing CT brain scans in people with a suspected acute stroke: a systematic review and cost-effectiveness analysis.
BACKGROUND
Artificial intelligence-derived software technologies have been developed that are intended to facilitate the review of computed tomography brain scans in patients with suspected stroke.
OBJECTIVES
To evaluate the clinical and cost-effectiveness of using artificial intelligence-derived software to support review of computed tomography brain scans in acute stroke in the National Health Service setting.
METHODS
Twenty-five databases were searched to July 2021. The review process included measures to minimise error and bias. Results were summarised by research question, artificial intelligence-derived software technology and study type. The health economic analysis focused on the addition of artificial intelligence-derived software-assisted review of computed tomography angiography brain scans for guiding mechanical thrombectomy treatment decisions for people with an ischaemic stroke. The de novo model (developed in R Shiny, R Foundation for Statistical Computing, Vienna, Austria) consisted of a decision tree (short-term) and a state transition model (long-term) to calculate the mean expected costs and quality-adjusted life-years for people with ischaemic stroke and suspected large-vessel occlusion comparing artificial intelligence-derived software-assisted review to usual care.
RESULTS
A total of 22 studies (30 publications) were included in the review; 18/22 studies concerned artificial intelligence-derived software for the interpretation of computed tomography angiography to detect large-vessel occlusion. No study evaluated an artificial intelligence-derived software technology used as specified in the inclusion criteria for this assessment. For artificial intelligence-derived software technology alone, sensitivity and specificity estimates for proximal anterior circulation large-vessel occlusion were 95.4% (95% confidence interval 92.7% to 97.1%) and 79.4% (95% confidence interval 75.8% to 82.6%) for Rapid (iSchemaView, Menlo Park, CA, USA) computed tomography angiography, 91.2% (95% confidence interval 77.0% to 97.0%) and 85.0 (95% confidence interval 64.0% to 94.8%) for Viz LVO (Viz.ai, Inc., San Fransisco, VA, USA) large-vessel occlusion, 83.8% (95% confidence interval 77.3% to 88.7%) and 95.7% (95% confidence interval 91.0% to 98.0%) for Brainomix (Brainomix Ltd, Oxford, UK) e-computed tomography angiography and 98.1% (95% confidence interval 94.5% to 99.3%) and 98.2% (95% confidence interval 95.5% to 99.3%) for Avicenna CINA (Avicenna AI, La Ciotat, France) large-vessel occlusion, based on one study each. These studies were not considered appropriate to inform cost-effectiveness modelling but formed the basis by which the accuracy of artificial intelligence plus human reader could be elicited by expert opinion. Probabilistic analyses based on the expert elicitation to inform the sensitivity of the diagnostic pathway indicated that the addition of artificial intelligence to detect large-vessel occlusion is potentially more effective (quality-adjusted life-year gain of 0.003), more costly (increased costs of £8.61) and cost-effective for willingness-to-pay thresholds of £3380 per quality-adjusted life-year and higher.
LIMITATIONS AND CONCLUSIONS
The available evidence is not suitable to determine the clinical effectiveness of using artificial intelligence-derived software to support the review of computed tomography brain scans in acute stroke. The economic analyses did not provide evidence to prefer the artificial intelligence-derived software strategy over current clinical practice. However, results indicated that if the addition of artificial intelligence-derived software-assisted review for guiding mechanical thrombectomy treatment decisions increased the sensitivity of the diagnostic pathway (i.e. reduced the proportion of undetected large-vessel occlusions), this may be considered cost-effective.
FUTURE WORK
Large, preferably multicentre, studies are needed (for all artificial intelligence-derived software technologies) that evaluate these technologies as they would be implemented in clinical practice.
STUDY REGISTRATION
This study is registered as PROSPERO CRD42021269609.
FUNDING
This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR133836) and is published in full in ; Vol. 28, No. 11. See the NIHR Funding and Awards website for further award information.
Topics: Humans; Artificial Intelligence; Stroke; Cost-Effectiveness Analysis; Brain Ischemia; State Medicine; Algorithms; Software; Ischemic Stroke; Brain
PubMed: 38512017
DOI: 10.3310/RDPA1487 -
Annals of Vascular Surgery Jul 2024To assess the mortality and outcomes after thoracic endovascular aortic repair (TEVAR) in patients with type B aortic dissection (TBAD) in mainland China, and to compare... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
To assess the mortality and outcomes after thoracic endovascular aortic repair (TEVAR) in patients with type B aortic dissection (TBAD) in mainland China, and to compare these outcomes with data from Western countries, while analyzing the potential reasons for differences among different countries.
METHODS
An extensive literature search spanning from January 1999 to October 2023 was conducted using PubMed, Cochrane Library, and Embase databases for studies on endovascular treatment for TBAD. This systematic review and meta-analysis adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Data extraction and analysis followed the guidelines outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Primary outcomes were in-hospital mortality and mid-term (< 5 years) mortality.
RESULTS
Based on 25 publications (3,080 patients), pooled estimate for in-hospital mortality was 2.2% (95% confidence interval, 1.6%-2.9%). Major perioperative complications included stroke (2.4% [1.8%-3.3%]), spinal cord ischemia (1.4% [1.0%-2.2%]), retrograde type A aortic dissection (1.2% [0.8%-1.8%]), type I endoleak (5.6% [3.6%-8.6%]), visceral ischemia (1.0% [0.5%-2.1%]), and acute renal failure (2.8% [2.0%-3.8%]). Mid-term mortality was 5.1% (3.6%-7.3%), and secondary intervention rate was 4.9% (4.0%-6.0%) with 1.7% (1.0%-2.9%) conversion rate to open surgery. In subgroup analysis based on uncomplicated TBAD, in-hospital and mid-term mortality was 0.5% (0.2%-1.5%) and 0.6% (0.2-1.7%), respectively. Compared with data from Western countries, mainland Chinese patients had a lower mortality.
CONCLUSIONS
In mainland China, the outcomes of endovascular treatment for TBAD are comparable to those of Western countries. The large number of patients undergoing TEVAR in mainland China and its good performance support the use of TEVAR in uncomplicated TBAD.
Topics: Humans; Endovascular Procedures; Aortic Dissection; China; Hospital Mortality; Aortic Aneurysm, Thoracic; Blood Vessel Prosthesis Implantation; Treatment Outcome; Time Factors; Postoperative Complications; Risk Factors; Risk Assessment; Male; Female; Middle Aged; Aged; Endovascular Aneurysm Repair
PubMed: 38508445
DOI: 10.1016/j.avsg.2023.12.087 -
JAMA Cardiology May 2024Among patients undergoing percutaneous coronary intervention (PCI), it remains unclear whether the treatment efficacy of P2Y12 inhibitor monotherapy after a short course... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Among patients undergoing percutaneous coronary intervention (PCI), it remains unclear whether the treatment efficacy of P2Y12 inhibitor monotherapy after a short course of dual antiplatelet therapy (DAPT) depends on the type of P2Y12 inhibitor.
OBJECTIVE
To assess the risks and benefits of ticagrelor monotherapy or clopidogrel monotherapy compared with standard DAPT after PCI.
DATA SOURCES
MEDLINE, Embase, TCTMD, and the European Society of Cardiology website were searched from inception to September 10, 2023, without language restriction.
STUDY SELECTION
Included studies were randomized clinical trials comparing P2Y12 inhibitor monotherapy with DAPT on adjudicated end points in patients without indication to oral anticoagulation undergoing PCI.
DATA EXTRACTION AND SYNTHESIS
Patient-level data provided by each trial were synthesized into a pooled dataset and analyzed using a 1-step mixed-effects model. The study is reported following the Preferred Reporting Items for Systematic Review and Meta-Analyses of Individual Participant Data.
MAIN OUTCOMES AND MEASURES
The primary objective was to determine noninferiority of ticagrelor or clopidogrel monotherapy vs DAPT on the composite of death, myocardial infarction (MI), or stroke in the per-protocol analysis with a 1.15 margin for the hazard ratio (HR). Key secondary end points were major bleeding and net adverse clinical events (NACE), including the primary end point and major bleeding.
RESULTS
Analyses included 6 randomized trials including 25 960 patients undergoing PCI, of whom 24 394 patients (12 403 patients receiving DAPT; 8292 patients receiving ticagrelor monotherapy; 3654 patients receiving clopidogrel monotherapy; 45 patients receiving prasugrel monotherapy) were retained in the per-protocol analysis. Trials of ticagrelor monotherapy were conducted in Asia, Europe, and North America; trials of clopidogrel monotherapy were all conducted in Asia. Ticagrelor was noninferior to DAPT for the primary end point (HR, 0.89; 95% CI, 0.74-1.06; P for noninferiority = .004), but clopidogrel was not noninferior (HR, 1.37; 95% CI, 1.01-1.87; P for noninferiority > .99), with this finding driven by noncardiovascular death. The risk of major bleeding was lower with both ticagrelor (HR, 0.47; 95% CI, 0.36-0.62; P < .001) and clopidogrel monotherapy (HR, 0.49; 95% CI, 0.30-0.81; P = .006; P for interaction = 0.88). NACE were lower with ticagrelor (HR, 0.74; 95% CI, 0.64-0.86, P < .001) but not with clopidogrel monotherapy (HR, 1.00; 95% CI, 0.78-1.28; P = .99; P for interaction = .04).
CONCLUSIONS AND RELEVANCE
This systematic review and meta-analysis found that ticagrelor monotherapy was noninferior to DAPT for all-cause death, MI, or stroke and superior for major bleeding and NACE. Clopidogrel monotherapy was similarly associated with reduced bleeding but was not noninferior to DAPT for all-cause death, MI, or stroke, largely because of risk observed in 1 trial that exclusively included East Asian patients and a hazard that was driven by an excess of noncardiovascular death.
Topics: Ticagrelor; Percutaneous Coronary Intervention; Humans; Clopidogrel; Platelet Aggregation Inhibitors; Dual Anti-Platelet Therapy; Purinergic P2Y Receptor Antagonists; Hemorrhage
PubMed: 38506796
DOI: 10.1001/jamacardio.2024.0133