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Endocrine Practice : Official Journal... Jan 2024To investigate the impact of testosterone replacement therapy (TRT) on cardiovascular outcomes in hypogonadal men. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To investigate the impact of testosterone replacement therapy (TRT) on cardiovascular outcomes in hypogonadal men.
METHODS
A meta-analysis of 26 randomized controlled trials involving 10 941 participants was conducted. Various clinical outcomes, including all-cause mortality, cardiovascular-related mortality, myocardial infarction, stroke, congestive heart failure, atrial fibrillation, pulmonary embolism, and venous thrombosis, were assessed.
RESULTS
No statistically significant differences were observed between the TRT group and the control group in terms of these clinical outcomes. Sensitivity analysis and publication bias assessment supported the robustness of the findings. Meta-regression analysis found no significant associations between clinical outcomes and potential covariates, including age, diabetes, hypertension, dyslipidemia, and smoking.
DISCUSSION
Previous research on TRT and cardiovascular events, with comparisons to studies like the Testosterone Trials and the studies conducted by Vigen et al, Finkle et al, Layton et al, and Wallis et al, is provided. The significance of the systematic review and meta-analysis approach is emphasized, particularly its exclusive focus on hypogonadal patients.
CONCLUSION
This study offers reassurance that TRT does not increase mortality risk or worsen cardiovascular outcomes in hypogonadal men. However, further research, especially long-term studies involving diverse populations, is essential to strengthen the evidence base and broaden the applicability of these findings.
Topics: Humans; Male; Hormone Replacement Therapy; Hypogonadism; Randomized Controlled Trials as Topic; Testosterone; Cardiovascular Diseases
PubMed: 37797887
DOI: 10.1016/j.eprac.2023.09.012 -
The Cochrane Database of Systematic... Sep 2023Concerns regarding the safety and availability of transfused donor blood have prompted research into a range of techniques to minimise allogeneic transfusion... (Review)
Review
BACKGROUND
Concerns regarding the safety and availability of transfused donor blood have prompted research into a range of techniques to minimise allogeneic transfusion requirements. Cell salvage (CS) describes the recovery of blood from the surgical field, either during or after surgery, for reinfusion back to the patient.
OBJECTIVES
To examine the effectiveness of CS in minimising perioperative allogeneic red blood cell transfusion and on other clinical outcomes in adults undergoing elective or non-urgent surgery.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, three other databases and two clinical trials registers for randomised controlled trials (RCTs) and systematic reviews from 2009 (date of previous search) to 19 January 2023, without restrictions on language or publication status.
SELECTION CRITERIA
We included RCTs assessing the use of CS compared to no CS in adults (participants aged 18 or over, or using the study's definition of adult) undergoing elective (non-urgent) surgery only.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
We included 106 RCTs, incorporating data from 14,528 participants, reported in studies conducted in 24 countries. Results were published between 1978 and 2021. We analysed all data according to a single comparison: CS versus no CS. We separated analyses by type of surgery. The certainty of the evidence varied from very low certainty to high certainty. Reasons for downgrading the certainty included imprecision (small sample sizes below the optimal information size required to detect a difference, and wide confidence intervals), inconsistency (high statistical heterogeneity), and risk of bias (high risk from domains including sequence generation, blinding, and baseline imbalances). Aggregate analysis (all surgeries combined: primary outcome only) Very low-certainty evidence means we are uncertain if there is a reduction in the risk of allogeneic transfusion with CS (risk ratio (RR) 0.65, 95% confidence interval (CI) 0.59 to 0.72; 82 RCTs, 12,520 participants). Cancer: 2 RCTs (79 participants) Very low-certainty evidence means we are uncertain whether there is a difference for mortality, blood loss, infection, or deep vein thrombosis (DVT). There were no analysable data reported for the remaining outcomes. Cardiovascular (vascular): 6 RCTs (384 participants) Very low- to low-certainty evidence means we are uncertain whether there is a difference for most outcomes. No data were reported for major adverse cardiovascular events (MACE). Cardiovascular (no bypass): 6 RCTs (372 participants) Moderate-certainty evidence suggests there is probably a reduction in risk of allogeneic transfusion with CS (RR 0.82, 95% CI 0.69 to 0.97; 3 RCTs, 169 participants). Very low- to low-certainty evidence means we are uncertain whether there is a difference for volume transfused, blood loss, mortality, re-operation for bleeding, infection, wound complication, myocardial infarction (MI), stroke, and hospital length of stay (LOS). There were no analysable data reported for thrombosis, DVT, pulmonary embolism (PE), and MACE. Cardiovascular (with bypass): 29 RCTs (2936 participants) Low-certainty evidence suggests there may be a reduction in the risk of allogeneic transfusion with CS, and suggests there may be no difference in risk of infection and hospital LOS. Very low- to moderate-certainty evidence means we are uncertain whether there is a reduction in volume transfused because of CS, or if there is any difference for mortality, blood loss, re-operation for bleeding, wound complication, thrombosis, DVT, PE, MACE, and MI, and probably no difference in risk of stroke. Obstetrics: 1 RCT (1356 participants) High-certainty evidence shows there is no difference between groups for mean volume of allogeneic blood transfused (mean difference (MD) -0.02 units, 95% CI -0.08 to 0.04; 1 RCT, 1349 participants). Low-certainty evidence suggests there may be no difference for risk of allogeneic transfusion. There were no analysable data reported for the remaining outcomes. Orthopaedic (hip only): 17 RCTs (2055 participants) Very low-certainty evidence means we are uncertain if CS reduces the risk of allogeneic transfusion, and the volume transfused, or if there is any difference between groups for mortality, blood loss, re-operation for bleeding, infection, wound complication, prosthetic joint infection (PJI), thrombosis, DVT, PE, stroke, and hospital LOS. There were no analysable data reported for MACE and MI. Orthopaedic (knee only): 26 RCTs (2568 participants) Very low- to low-certainty evidence means we are uncertain if CS reduces the risk of allogeneic transfusion, and the volume transfused, and whether there is a difference for blood loss, re-operation for bleeding, infection, wound complication, PJI, DVT, PE, MI, MACE, stroke, and hospital LOS. There were no analysable data reported for mortality and thrombosis. Orthopaedic (spine only): 6 RCTs (404 participants) Moderate-certainty evidence suggests there is probably a reduction in the need for allogeneic transfusion with CS (RR 0.44, 95% CI 0.31 to 0.63; 3 RCTs, 194 participants). Very low- to moderate-certainty evidence suggests there may be no difference for volume transfused, blood loss, infection, wound complication, and PE. There were no analysable data reported for mortality, re-operation for bleeding, PJI, thrombosis, DVT, MACE, MI, stroke, and hospital LOS. Orthopaedic (mixed): 14 RCTs (4374 participants) Very low- to low-certainty evidence means we are uncertain if there is a reduction in the need for allogeneic transfusion with CS, or if there is any difference between groups for volume transfused, mortality, blood loss, infection, wound complication, PJI, thrombosis, DVT, MI, and hospital LOS. There were no analysable data reported for re-operation for bleeding, MACE, and stroke.
AUTHORS' CONCLUSIONS
In some types of elective surgery, cell salvage may reduce the need for and volume of allogeneic transfusion, alongside evidence of no difference in adverse events, when compared to no cell salvage. Further research is required to establish why other surgeries show no benefit from CS, through further analysis of the current evidence. More large RCTs in under-reported specialities are needed to expand the evidence base for exploring the impact of CS.
Topics: Female; Pregnancy; Adult; Humans; Elective Surgical Procedures; Blood Transfusion; Stroke; Myocardial Infarction; Pulmonary Embolism; Arthritis, Infectious; Wound Infection; Hematopoietic Stem Cell Transplantation
PubMed: 37681564
DOI: 10.1002/14651858.CD001888.pub5 -
Circulation. Cardiovascular... Sep 2023Short-term (≤6 months) dual antiplatelet therapy (DAPT) and DAPT de-escalation become attractive for patients with acute coronary syndrome. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Short-term (≤6 months) dual antiplatelet therapy (DAPT) and DAPT de-escalation become attractive for patients with acute coronary syndrome.
METHODS
A systemic search identified randomized controlled trials that included patients with acute coronary syndrome treated using (1) standard DAPT (12 months) with clopidogrel, prasugrel (standard/low dose), or ticagrelor; (2) extended DAPT (≥18 months); (3) short-term DAPT (≤6 months) followed by P2Y inhibitor or aspirin; (4) 12-month DAPT with unguided de-escalation from potent P2Y inhibitors to low-dose potent P2Y inhibitor or clopidogrel at 1 month; and (5) guided selection DAPT with genotype or platelet function tests. The primary efficacy outcome (major adverse cardiovascular events) was a composite of cardiovascular death, myocardial infarction, or stroke. The primary safety outcome was major or minor bleeding.
RESULTS
This meta-analysis included 32 randomized controlled trials with 103 497 patients. While there were no differences in efficacy between short, unguided de-escalation and guided selection strategies, unguided de-escalation was associated with reduced risk of major adverse cardiovascular events compared with standard DAPT with clopidogrel or ticagrelor (hazard ratio [95% CI], 0.67 [0.49-0.93] and 0.68 [0.50-0.93]). Both short DAPT followed by P2Y inhibitor and unguided de-escalation were associated with reduced risks in safety compared with other strategies, including guided selection (hazard ratio [95% CI], 0.66 [0.47-0.93] and 0.48 [0.33-0.71]). Short DAPT followed by a P2Y inhibitor was associated with reduced risk of major bleeding and all-cause death compared with standard, extended DAPT (eg, versus DAPT with clopidogrel; hazard ratio [95% CI], 0.64 [0.42-0.97] and 0.60 [0.44-0.82]). By rankogram, unguided de-escalation strategy was the safest and most effective strategy in reducing major adverse cardiovascular events and major or minor bleeding while short DAPT followed by P2Y inhibitor was ranked the best for major bleeding and all-cause death.
CONCLUSIONS
In patients with acute coronary syndrome, unguided de-escalation was associated with the lowest risk of major adverse cardiovascular events and major or minor bleeding outcomes, while short DAPT followed by P2Y inhibitor was associated with the lowest risk of major bleeding and all-cause death.
Topics: Humans; Acute Coronary Syndrome; Platelet Aggregation Inhibitors; Network Meta-Analysis; Clopidogrel; Ticagrelor; Treatment Outcome
PubMed: 37609850
DOI: 10.1161/CIRCINTERVENTIONS.123.013242 -
The Cochrane Database of Systematic... Jul 2023At least 7000 major lower limb amputations (MLLAs) are performed in the UK each year, 80% of which are due to peripheral arterial disease (PAD). Intraoperative blood... (Review)
Review
BACKGROUND
At least 7000 major lower limb amputations (MLLAs) are performed in the UK each year, 80% of which are due to peripheral arterial disease (PAD). Intraoperative blood loss can have a deleterious effect on patient outcomes, and its replacement with transfused blood is not without risk. Tourniquets can be used in lower limb surgical procedures to provide a bloodless surgical field, minimise intraoperative blood loss, and reduce perioperative blood transfusion requirements. Although their safety has been demonstrated in certain orthopaedic operations, their use among people with PAD undergoing MLLA remains controversial. Many clinicians are concerned about tourniquets potentially compromising perfusion of the stump and thereby impacting wound healing through direct tissue injury, damage to the arterial supply of the wound, or both.
OBJECTIVES
To assess the safety and effectiveness of tourniquet use in people undergoing MLLA for complications of PAD, specifically with regard to intraoperative blood loss, change in haemoglobin levels, transfusion rates, wound healing, need for revision surgery, and postoperative complications including mortality.
SEARCH METHODS
We searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers from inception to 17 May 2022.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing tourniquet use to no tourniquet use among people with PAD undergoing MLLA.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Primary outcomes were intraoperative blood loss, fall in haemoglobin levels, and perioperative blood transfusion requirement. Secondary outcomes were primary wound-healing rates, stump revision rates, other postoperative complications defined as per Clavien-Dindo classification, and postoperative mortality at 30 days and at maximal follow-up. We used GRADE to assess the certainty of evidence for each outcome.
MAIN RESULTS
One RCT met our inclusion criteria, which was a prospective randomised blinded controlled trial conducted in Sheffield, UK in 2006. In total 64 participants undergoing transtibial amputation for non-reconstructable PAD were randomised to either tourniquet or no tourniquet to assess for intraoperative blood loss, fall in haemoglobin, transfusion requirement, wound healing, stump breakdown and revision. Ten participants were excluded postrandomisation (five from the tourniquet group and five from the no tourniquet group). The reported median volume of intraoperative blood loss was significantly less in the tourniquet group (255 mL (interquartile range (IQR) 150 to 572.5 mL))) compared to the control group (550 mL (IQR 255 to 1050 mL)) (P = 0.014). There was a significantly lower median drop in haemoglobin concentration in the tourniquet group (1.0 g/dL (IQR 0.6 to 2.4 g/dL)) compared to the control group (1.8 g/dL (IRQ 0 to 1.2 g/dL)) (P = 0.035). There was a significantly lower perioperative blood transfusion requirement in the tourniquet group (8 participants, 32%) compared to the control group (14 participants, 48%) (P = 0.047). There were no clear differences in wound breakdown, stump revision, primary wound healing at six weeks, postoperative complications (myocardial infarction, cardiac arrhythmias, pulmonary oedema), and death between groups. We assessed the one included study as at low risk of bias for sequence generation and blinding of outcome assessors; high risk of bias for incomplete outcome data and selective outcome reporting; and unclear risk of bias for allocation concealment, blinding of participants and personnel, and other sources of bias. We assessed the certainty of the evidence as low or very low due to risk of bias, small sample size, and the study being insufficiently powered for most outcomes.
AUTHORS' CONCLUSIONS
This review identified only one small historical RCT evaluating tourniquet use in MLLA. Tourniquets appeared to reduce intraoperative blood loss, drop in haemoglobin, and blood transfusion requirements following transtibial amputations for people with PAD. However, it is unclear whether tourniquets affect wound healing, stump revision rates, postoperative complications, or mortality. High-certainty evidence is required to inform clinical decision-making for the use of tourniquets in these patients.
Topics: Humans; Blood Loss, Surgical; Peripheral Arterial Disease; Amputation, Surgical; Postoperative Complications; Lower Extremity; Randomized Controlled Trials as Topic
PubMed: 37462258
DOI: 10.1002/14651858.CD015232.pub2 -
Anaesthesia Sep 2023Tranexamic acid is an antifibrinolytic drug that is widely used during surgery, but there are concerns about its thromboembolic effects. We aimed to investigate the... (Meta-Analysis)
Meta-Analysis Review
Tranexamic acid is an antifibrinolytic drug that is widely used during surgery, but there are concerns about its thromboembolic effects. We aimed to investigate the effect of prophylactic intravenous tranexamic acid on thromboembolic outcomes in patients undergoing non-cardiac surgery. The MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials were searched. Randomised controlled trials comparing intravenous tranexamic acid with placebo or no treatment in patients undergoing non-cardiac surgery were included. The primary outcome was a composite of peri-operative cardiovascular thromboembolic events, defined as any deep vein thrombosis, pulmonary embolism, myocardial ischaemia/infarction or cerebral ischaemia/infarction. A total of 191 randomised controlled trials (40,621 patients) were included in the review. The primary outcome occurred in 4.5% of patients receiving intravenous tranexamic acid compared with 4.9% of patients in the control group. Our analysis showed that there was no difference between groups for composite cardiovascular thromboembolic events (risk ratio 1.02, 95%CI 0.94-1.11, p = 0.65, I 0%, n = 37,512). This finding remained robust when sensitivity analysis was performed with continuity correction and in studies with a low risk of bias. However, in trial sequential analysis, our meta-analysis only achieved 64.6% of the required information size. There was no association between intravenous tranexamic acid and seizure rate or mortality rate within 30 days. Intravenous tranexamic acid was associated with a reduced blood transfusion rate compared with control (9.9% vs. 19.4%, risk ratio 0.46, 95%CI 0.41-0.51, p < 0.0001). It was encouraging to see the evidence that the administration of intravenous tranexamic in patients undergoing non-cardiac surgery was not associated with an increased risk of thromboembolic outcomes. However, our trial sequential analysis demonstrated that currently available evidence is not yet sufficient to reach a firm conclusion.
Topics: Humans; Tranexamic Acid; Antifibrinolytic Agents; Thromboembolism; Blood Transfusion; Myocardial Infarction; Blood Loss, Surgical
PubMed: 37314744
DOI: 10.1111/anae.16058 -
Chronic Obstructive Pulmonary Diseases... Jul 2023Previous studies have reported mixed associations between inhaled corticosteroids (ICSs) and cardiovascular disease (CVD) in people with chronic obstructive pulmonary...
BACKGROUND
Previous studies have reported mixed associations between inhaled corticosteroids (ICSs) and cardiovascular disease (CVD) in people with chronic obstructive pulmonary disease (COPD). Using updated literature, we investigated the association between ICS-containing medications and CVD in COPD patients, stratified by study-related factors.
METHODS
We searched MEDLINE and EMBASE for studies that reported effect estimates for the association between ICS-containing medications and the risk of CVD in COPD patients. CVD outcomes specifically included heart failure, myocardial infarction, and stroke-related events. We conducted a random-effects meta-analysis and a meta-regression to identify effect-modifying study-related factors.
RESULTS
Fifteen studies met inclusion criteria and investigated the association between ICS-containing medications and the risk of CVD. Pooled results from our meta-analysis showed a significant association between ICS-containing medication and reduced risk of CVD (hazard ratio 0.87, 95% confidence intervals 0.78 to 0.97). Study follow-up time, non-ICS comparator, and exclusion of patients with previous CVD modified the association between ICS use and risk of CVD.
CONCLUSIONS
Overall, we found an association between ICS-containing medications and reduced risk of CVD in COPD patients. Results from the meta-regression suggest that subgroups of COPD patients may benefit from ICS use more than others and further work is needed to determine this.
PubMed: 37289196
DOI: 10.15326/jcopdf.2022.0386 -
Current Problems in Cardiology Oct 2023Twelve CCI patients were studied with confirmed or suspected COVID-19 infection. The majority of these patients were males (83.3%) with a median age of 55 years from... (Review)
Review
Twelve CCI patients were studied with confirmed or suspected COVID-19 infection. The majority of these patients were males (83.3%) with a median age of 55 years from three geographical locations, constituting the Middle East (7), Spain (3), and the USA (1). In 6 patients, IgG/IgM was positive for COVID-19, 4 with high pretest probability and 2 with positive RT-PCR. Type 2 DM, hyperlipidemia, and smoking were the primary risk factors. Right-sided neurological impairments and verbal impairment were the most common symptoms. Our analysis found 8 (66%) synchronous occurrences. In 58.3% of cases, neuroimaging showed left Middle Cerebral Artery (MCA) infarct and 33.3% right. Carotid artery thrombosis (16.6%), tandem occlusion (8.3%), and carotid stenosis (1%) were also reported in imaging. Dual antiplatelet therapy (DAPT) and anticoagulants were conservative therapies (10). Two AMI patients had aspiration thrombectomy, while three AIS patients had intravenous thrombolysis/tissue plasminogen activator (IVT-tPA), 2 had mechanical thrombectomy (MT), and 1 had decompressive craniotomy. Five had COVID-19-positive chest X-rays, whereas 4 were normal. four of 8 STEMI and 3 NSTEMI/UA patients complained chest pain. LV, ICA, and pulmonary embolism were further complications (2). Upon discharge, 7 patients (70%) had residual deficits while 1 patient unfortunately died.
Topics: Female; Humans; Male; Middle Aged; Anticoagulants; COVID-19; Infarction, Middle Cerebral Artery; Stroke; Thrombectomy; Thrombolytic Therapy; Tissue Plasminogen Activator; Treatment Outcome; Case Reports as Topic
PubMed: 37209804
DOI: 10.1016/j.cpcardiol.2023.101814 -
BMJ Quality & Safety Nov 2023Diagnostic error (DE) is a common problem in clinical practice, particularly in the emergency department (ED) setting. Among ED patients presenting with cardiovascular...
Diagnostic error among vulnerable populations presenting to the emergency department with cardiovascular and cerebrovascular or neurological symptoms: a systematic review.
BACKGROUND
Diagnostic error (DE) is a common problem in clinical practice, particularly in the emergency department (ED) setting. Among ED patients presenting with cardiovascular or cerebrovascular/neurological symptoms, a delay in diagnosis or failure to hospitalise may be most impactful in terms of adverse outcomes. Minorities and other vulnerable populations may be at higher risk of DE. We aimed to systematically review studies reporting the frequency and causes of DE in under-resourced patients presenting to the ED with cardiovascular or cerebrovascular/neurological symptoms.
METHODS
We searched EBM Reviews, Embase, Medline, Scopus and Web of Science from 2000 through 14 August 2022. Data were abstracted by two independent reviewers using a standardised form. The risk of bias (ROB) was assessed using the Newcastle-Ottawa Scale, and the certainty of evidence was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation approach.
RESULTS
Of the 7342 studies screened, we included 20 studies evaluating 7436,737 patients. Most studies were conducted in the USA, and one study was multicountry. 11 studies evaluated DE in patients with cerebrovascular/neurological symptoms, 8 studies with cardiovascular symptoms and 1 study examined both types of symptoms. 13 studies investigated missed diagnoses and 7 studies explored delayed diagnoses. There was significant clinical and methodological variability, including heterogeneity of DE definitions and predictor variable definitions as well as methods of DE assessment, study design and reporting.Among the studies evaluating cardiovascular symptoms, black race was significantly associated with higher odds of DE in 4/6 studies evaluating missed acute myocardial infarction (AMI)/acute coronary syndrome (ACS) diagnosis compared with white race (OR from 1.18 (1.12-1.24) to 4.5 (1.8-11.8)). The association between other analysed factors (ethnicity, insurance and limited English proficiency) and DE in this domain varied from study to study and was inconclusive.Among the studies evaluating DE in patients with cerebrovascular/neurological symptoms, no consistent association was found indicating higher or lower odds of DE. Although some studies showed significant differences, these were not consistently in the same direction.The overall ROB was low for most included studies; however, the certainty of evidence was very low, mostly due to serious inconsistency in definitions and measurement approaches across studies.
CONCLUSIONS
This systematic review demonstrated consistent increased odds of missed AMI/ACS diagnosis among black patients presenting to the ED compared with white patients in most studies. No consistent associations between demographic groups and DE related to cerebrovascular/neurological diagnoses were identified. More standardised approaches to study design, measurement of DE and outcomes assessment are needed to understand this problem among vulnerable populations.
TRIAL REGISTRATION NUMBER
The study protocol was registered in the International Prospective Register of Systematic Reviews PROSPERO 2020 CRD42020178885 and is available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020178885.
Topics: Humans; Diagnostic Errors; Emergency Service, Hospital; Systematic Reviews as Topic; Vulnerable Populations
PubMed: 36972982
DOI: 10.1136/bmjqs-2022-015038 -
Minerva Cardiology and Angiology Oct 2023The association of coronary stent malapposition (SM) and adverse clinical outcomes after percutaneous coronary intervention (PCI) remains unclear. We aimed to perform a... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
The association of coronary stent malapposition (SM) and adverse clinical outcomes after percutaneous coronary intervention (PCI) remains unclear. We aimed to perform a systematic review and meta-analysis of randomized and observational studies to assess the association between acute and persistent SM detected using intravascular ultrasound (IVUS) or optical coherence tomography (OCT) and adverse cardiovascular outcomes.
EVIDENCE ACQUISITION
Available studies were identified through a systematic search of PubMed, reference lists of relevant articles, and Medline. Main efficacy outcomes of interest were: device-oriented composite endpoint (DoCE, including cardiac death, myocardial infarction [MI], target lesion revascularization [TLR], and stent thrombosis [ST]), major safety events (MSE, including cardiac death, MI and ST), TLR, and ST. A sensitivity analysis regarding the impact of major malapposition was also performed.
EVIDENCE SYNTHESIS
A total of 9 studies enrolling 6497 patients were included in the meta-analysis. After a mean follow-up of 24±14 months, overall acute and/or persistent malapposition was not significantly associated with the occurrence of all the outcomes of interest, including DoCE (risk ratio [RR] 1.00, 95% confidence interval [CI, 0.79-1.26], P=0.99), MSE (RR 1.42, 95%CI [0.81-2.50], P=0.22), TLR (RR 0.84, 95%CI [0.59-1.19], P=0.33), and ST (RR 1.16, 95%CI [0.48-2.85], P=0.74). In the sensitivity analysis, we found a significant increase of MSE in patients with major malapposition (RR 2.97, 95%CI [1.51-5.87], P=0.001).
CONCLUSIONS
Acute and persistent SM were not overall associated with adverse cardiovascular clinical outcomes at follow-up. However, major malapposition was associated with an increased risk of major safety events, including cardiac death, MI and ST. These findings should be taken into account during stent implantation and PCI optimization.
Topics: Humans; Coronary Artery Disease; Percutaneous Coronary Intervention; Drug-Eluting Stents; Treatment Outcome; Stents; Myocardial Infarction; Thrombosis; Death
PubMed: 36912166
DOI: 10.23736/S2724-5683.22.06185-3