Risultati per: Infezione da Helicobacter pylori: review

Circulation, Volume 150, Issue Suppl_1, Page A4124370-A4124370, November 12, 2024. Background:Dual antiplatelet therapy (DAPT) is well established as standard of care following percutaneous coronary intervention (PCI). Recent trials have shown a potential benefit in the reduction of hemorrhagic events with a shorter course of DAPT. However, the optimal duration of DAPT following PCI remains unclear.Question:Is 1 month of DAPT followed by P2Y12 inhibitor monotherapy superior to the standard 12-month DAPT regimen in terms of cardiovascular outcomes in patients post-PCI?Methods:Medline, PubMed, and Cochrane Central Register of Controlled Trials databases were searched for randomized clinical trials (RCTs) comparing 1-month vs. 12-months of DAPT followed by P2Y12 inhibitor monotherapy post-PCI. The outcomes of interest were cardiovascular death, myocardial infarction, and major bleeding. We used R version 4.1.2 (The R Foundation, 2021) to pool the data using a random-effects model. Heterogeneity was assessed with I2.Results:We included three RCTs reporting data from 22,413 patients, of whom 11,180 (49.8%) were treated with 1-month of DAPT, followed by P2Y12 inhibitor monotherapy. Follow-up ranged from 12 months to 24 months. The incidence of all-cause death (RR 1.20; 95% CI 0.95-1.51; p=0.12) and myocardial infarction (RR 0.86; 95% CI 0.71-1.05; p=0.14) were not significantly different between the groups. However, major bleeding (RR 0.51; 95% CI 0.26-0.99; p=0.048) was significantly reduced with a short course of DAPT followed by P2Y12 inhibitor monotherapy, as compared with standard 12 months of DAPT.Conclusion:Following PCI, a transition from DAPT to P2Y12 inhibitor monotherapy at 1-month is associated with a significant reduction in major bleeding as compared with standard DAPT for 12-months, with no significant change in the incidence of all-cause mortality or myocardial infarction.

Circulation, Volume 150, Issue Suppl_1, Page A4143312-A4143312, November 12, 2024. Background:Heart failure (HF) in adults have benefitted significantly from addition of angiotensin receptor-neprilysin inhibitor (ARNI). However, limited data exist on the efficacy and safety of ARNI in adults with congenital heart disease (ACHD) related HF.Methods:We conducted a comprehensive search of 3 major databases- PubMed, Scopus, and Embase, and collected articles published the use of ARNI for HF in ACHD patients who were already receiving angiotensin-converting enzyme inhibitors (ACEi)/angiotensin receptor blockers (ARB), beta-blockers, and mineralocorticoid antagonists. We excluded articles on acute decompensated HF and HF with preserved ejection fraction. The primary outcome was the change in NYHA functional class (FC). Additionally, we evaluated the safety and tolerability of ARNI by studying adverse effects such as hypotension, elevated serum creatinine (Cr), and potassium (K+). A pooled effect size was calculated based on mean differences (MD) or log odds ratio (LogOR).Results:Our meta-analysis included 14 studies with a total of 305 patients, aged 25 to 84 (median 42 years) (Table). Among 305 ACHD patients, 70% had systemic RV, 27% had systemic LV, and 3% were Fontan patients with unknown ventricular morphology. When ARNI replaced ACEIs/ARBs and was added to remaining therapies, the pooled analysis indicated that ARNI significantly improved NYHA FC (LogOR: 0.67, 95% confidence interval (CI) 0.15-1.19, p=0.01) (Figure 1A). However, there was no significant change in ventricular function (logOR: 0.37, 95% CI 0.45-0.42, p=0.38). Notably, ARNI use led to a significant decrease in systolic blood pressure (MD=0.49, 95% CI -0.70 to -0.29, p=0.00) (Figure 1B), and elevated Cr levels (MD = 0.30, 95% CI 0.10-0.45, p=0.00) (Figure 1C). No significant change in K+level (MD=0.0, 95% CI -0.61 to 0.61; p=0.99) (Figure 1D). Eighteen patients (6%) discontinued ARNI due to side effects.Conclusion:Our meta-analysis found that ARNI replacement for ACEIs/ARBs improved NYHA FC in most ACHD HF patients across a heterogeneous group of ACHD HF patients consisting of single ventricle, systemic- RV and LV. However, there was no significant change in ventricular function or natriuretic peptide levels. Hypotension and increased serum Cr are more frequent with ARNI use, warranting close monitoring. Future research is needed to assess composite outcomes, including hospitalizations and mortality in ACHD HF patients after adding ARNI to conventional therapy.

Circulation, Volume 150, Issue Suppl_1, Page A4144488-A4144488, November 12, 2024. Background:Oral anticoagulants (OAC) including Vitamin K antagonists such as warfarin and direct oral anticoagulants like Apixaban, Rivaroxaban, and Edoxaban, have long been the standard treatment for stroke prevention in patients with atrial fibrillation (AF). However, they increase the risk of bleeding, making them unsuitable for certain patient populations, particularly those with a personal history of bleeding, elderly individuals prone to falls or those with high-risk occupation with safety hazards. In cases of non-valvular AF, where thrombi typically form in the left atrial appendage, mechanical left atrial appendage closure (LAAC) has come out as an alternative for selected patients. Numerous studies have shown that LAAC is comparable to OAC in preventing strokes while significantly reducing major bleeding events. This meta-analysis aims to compare the 4–5-year outcomes of these two treatment strategies in non-valvular AF.Methods:4 studies (3 randomized controlled trials and 1 observational study) comparing the 4–5-year outcomes of LAAC versus OAC in patients with AF were included in this meta-analysis. These studies were identified after a thorough search of PUBMED, COCHRANE, and MEDLINE databases from inception till May 2024. The outcomes of interest were MACE (composite of stroke, embolism, and death), ischemic stroke, major bleeding episodes, cardiovascular (CV) deaths, and all-cause death. The results were reported as Risk Ratio (RR) with 95% confidence intervals (CI), using a random effects model.Results:6,012 patients were identified from the 4 studies. After a median follow-up of 4–5 years, LAAC was associated with a clinically significant reduction in MACE (RR: 0.76, 95% CI: 0.61-0.94, p=0.01), all-cause mortality (RR: 0.77, 95% CI: 0.62-0.96, p=0.02), and CV mortality (RR: 0.64, 95% CI: 0.45-0.90, p=0.01). Additionally, a significant reduction in major bleeding episodes (RR: 0.63, 95% CI: 0.44-0.91, p=0.01) was also noted between the two treatment strategies favoring LAAC treatment group. There was no significant difference in the incidence of ischemic stroke (RR: 1.07, 95% CI: 0.62-1.85, p=0.80) between the two groups.Conclusion:Over a median follow-up of 4-5 years, LAAC was found to be as effective as OAC in preventing ischemic strokes, while also showing lower incidence of MACE, all-cause, CV mortality and major bleeding episodes. More RCTs are needed to further assess the long-term outcomes between the two strategies.

Circulation, Volume 150, Issue Suppl_1, Page A4145254-A4145254, November 12, 2024. Background:The efficacy of semaglutide, a glucagon-like peptide-1 receptor agonist, has been studied in patients with type 2 diabetes mellitus (T2DM) who also have advanced chronic kidney disease (CKD) and/or established cardiovascular disease. These conditions pose a high cardiovascular risk. However, the impact of semaglutide on safety outcomes and the incidence of adverse effects in this population remains unclear.Hypothesis:The use of semaglutide is associated with a higher incidence of gastrointestinal adverse events and specific safety concerns such as severe hypoglycemia and retinopathy.Aims:This study aimed to evaluate the impact of semaglutide on safety outcomes in high-risk cardiovascular patients with T2DM.Methods:PubMed, Embase, and Cochrane Central databases were systematically searched in May 2024 for randomized controlled trials (RCTs) that compared semaglutide (oral and subcutaneous) to placebo in adult patients with T2DM with CKD and/or established cardiovascular disease and reported the safety outcomes of (1) gastrointestinal disorder; (2) acute pancreatitis; (2) severe hypoglycemia; (3) retinopathy; (4) acute kidney failure and (5) malignant neoplasm. A systematic review and meta-analysis of the findings were performed using RStudio version 2024.04.0. Heterogeneity was examined with the Cochran Q test and I2 statistics.Results:We included 3 RCTs in the final analysis, with a total of 10.013 participants, of whom 5.006 (49.99%) were on semaglutide. Semaglutide was associated with a significant increase in the incidence of gastrointestinal disorders compared with placebo (OR 2.00; 95% CI 1.07-3.77; p= 0.031; figure 1A). Severe hypoglycemia (OR 1.10; 95% CI 0.92-1.31; p=0.31; figure 1B), acute kidney failure (OR 0.93; 95% CI 0.78-1.10; p= 0.402), acute pancreatitis (OR 0.92; 95% CI 0.49-1.71; p= 0.792), retinopathy (OR 1.17; 95% CI 0.91, 1.50; p=0.225) and malignant neoplasm (OR 1.02; 95% CI 0.85-1.24; p=0.809) were not significantly different between groups.Conclusion:In high cardiovascular risk T2DM patients, semaglutide was associated with a higher incidence of gastrointestinal disorders as compared with placebo.

Circulation, Volume 150, Issue Suppl_1, Page A4139964-A4139964, November 12, 2024. Background:Transthyretin amyloid cardiomyopathy (ATTR-CM) is estimated to occur in 120,000 US adults and remains underdiagnosed. However, awareness of ATTR-CM has improved following the introduction of new diagnostic tools and disease-modifying treatments. Hence, patients (pts) enrolled in contemporary clinical trials could be at an earlier stage of the disease than pts in past clinical studies.Aim:To assess temporal trends in the baseline risk of pts with ATTR-CM enrolled in clinical trials.Methods:Embase, MEDLINE, CENTRAL, and conference websites were searched on November 23, 2023, for peer-reviewed articles and abstracts. Randomized and single-arm clinical trials examining treatments for ATTR-CM were included, and baseline characteristics and outcomes in pts treated with placebo (PBO) were compared across studies.Results:We reviewed 39 publications derived from 4 randomized and 4 single-arm trials. Studies enrolled pts between 2008 and 2021, although 1 study (INOCARD, 2022) did not report years of enrollment. Several baseline characteristics were comparable across studies, including sex, age, race/ethnicity, genotype, and troponin I level. NYHA class at baseline varied with year of enrollment, with fewer NYHA class III pts in recent trials (Figure). Recent trials also showed a trend toward lower NT-proBNP levels (medians ranging from 1911-3178 pg/mL) and higher eGFR levels (means ranging from 54.7-69.0 mL/min/1.73 m2). In PBO groups, all-cause mortality (ACM) rates at 12 months dropped from 9% in ATTR-ACT (enrolled 2013-2015) to 6.9% in ATTRibute-CM (enrolled 2019-2020) and 5.6% in APOLLO-B (enrolled 2019-2021); ACM rates at 30 months dropped from 42.9% in ATTR-ACT to 25.7% in ATTRibute-CM.Conclusions:This systematic review found that disease-modifying treatments and diagnostic advances have led to earlier diagnosis of pts with ATTR-CM. Recent clinical trials appear to have enrolled pts with a better prognosis. Comparisons of results across these trials are limited and should acknowledge the potential impact of variability in baseline risks among trial populations.

Circulation, Volume 150, Issue Suppl_1, Page A4138850-A4138850, November 12, 2024. Introduction:Mitral regurgitation is the second most common valvular heart disease, it has a high prevelance in older patients, transcatheter mitral valve edge-to-edge repair has been introduced as an alternative treatment to mitral valve surgery especially in the elderly, MitraClip is used as a standard treatment for transcatheter mitral valve edge-to-edge repair (M-TEER). PASCAL has recently been used with minimal evidence comparing both of them.Aim:We aimed to compare the outcomes of both device systems on mitral regurgitation residuals and clinical outcomes.Methods:PubMed, Scopus, WOS, and Cochrane were retrieved from inception until May 2024 for relevant clinical studies that compared PASCAL to MitraClip approaches in M-TEER procedure and reported the primary outcome of interest, which was the grade of MR at follow-up. Other reported outcomes were technical success, Death from any cause, and reintervention, Dichotomous data were analyzed using OR and 95% CI with a fixed-effect model.Results:Seven studies were included with a total of 1834 patients. MR ≤ 2 at discharge was less with MitraClip (RR, 0.67, 95%CI [0.45 to 1]), and MR ≤ 2 at follow-up was less with MitraClip (RR, 0.84, 95% CI [0.64 to 1.1]), MR ≤ 1 at follow up was significantly less with MitraClip (RR 0.69, [0.56 to 0.85]). However, there were no significant differences in technical success, Death from any cause, or reintervention between the two systems used.Conclusion:MitraClip and PASCAL are similar in procedural success, with better outcomes for PASCAL regarding Mitral regurgitation grades after the procedure. The guide to proceed with MitraClip or PASCAL should be guided by mitral valve anatomy, the etiology of MR, and device-specific features. Also, Large-volume RCTs are warranted to validate the current findings.

Circulation, Volume 150, Issue Suppl_1, Page A4144767-A4144767, November 12, 2024. Background:The efficacy of beta-blockers (BB) in patients with heart failure and reduced ejection fraction (EF) is well established. In fact, current guidelines widely recommend BB use after myocardial infarction (MI). However, the effects of long-term BB therapy in patients with acute myocardial infarction (AMI) and preserved EF remains uncertain.Hypothesis:The use of BB after AMI improves long-term outcomes in patients with preserved EF.Aims:To compare the long-term effects of BB with non-BB post AMI in patients with preserved EF.Methods:PubMed, Embase, and Cochrane Library were systematically searched from inception to May 2024 to identify studies comparing BB with no BB use after AMI in patients with preserved EF ( >50%), with a minimum follow-up of 1 year. We pooled hazard ratios (HR) with 95% confidence intervals (CI) to preserve time-to-event data in the pooled analysis. Statistical analyses were performed using R software version 4.3.1.Results:We included two randomized controlled trials and eight cohorts comprising 25,357 patients, of whom 47% received BB and 52% were men. Mean age of patients ranged from 58 to 66.2 years. Follow-up ranged from 1 to 5.2 years. There were no significant differences between groups in all-cause mortality (HR 0.86; 95% CI 0.68-1.08; p=0.20; Figure 1A), myocardial infarction (HR 1.02; 95% CI 0.84-1.24; p=0.86; Figure 1B), or hospitalization for heart failure (HR 1.06; 95% CI 0.78-1.43; p=0.71; Figure 1C). However, when performed a leave-one-out sensitivity analysis in all-cause mortality we saw significant results favoring the use of BB after omitting each study.Conclusion:In this meta-analysis, there were no significant differences in all-cause mortality, myocardial infarction, or hospitalization for heart failure when comparing long-term use of BB with no BB use after AMI in patients with preserved EF. Further trials are needed to clarify the role of BB in this setting.

Circulation, Volume 150, Issue Suppl_1, Page A4139378-A4139378, November 12, 2024. Introduction:The potential benefits and risks of paclitaxel-coated balloon (PCB) angioplasty over uncoated balloon (UB) angioplasty in the management of coronary in-stent restenosis (ISR) is not well established.Hypothesis/Aims:This study aims to determine whether PCB angioplasty is superior to UB angioplasty in patients with coronary ISR in terms of target lesion revascularization (TLR), myocardial infarction (MI), and all-cause mortality rates.Methods:PubMed, Embase and Cochrane Central databases were systematically searched for randomized clinical trials (RCT) comparing PCB with UB angioplasty in patients with coronary ISR. Statistical analyses were performed using Review Manager version 5.4.1. Risk Ratios (RR) with 95% confidence intervals (CI) for dichotomous endpoints were computed with the use of a Mantel-Haenszel random effects model.Results:A total of 1,407 patients from 7 randomized clinical trials were included. Follow-up periods in the included studies ranged from 6 months to 1 year. PCB angioplasty significantly reduced TLR (RR 0.28; 95% CI 0.16-0.48; p

Circulation, Volume 150, Issue Suppl_1, Page A4139425-A4139425, November 12, 2024. Introduction:Although prior reports suggest that percutaneous coronary intervention (PCI) of non-infarct-related artery (NIRA) in patients with acute myocardial infarction (AMI) and multivessel disease improves clinical outcomes, the optimal timing for NIRA-PCI remains debated.Research Questions:When is the preferred timing to perform NIRA-PCI after infarct-related-artery (IRA)- PCI?Aims:We aimed to compare the clinical outcomes based on PCI strategies classified by the timing of NIRA-PCI in AMI patients with multivessel disease.Methods:We performed a systematic review and network meta-analysis of randomized controlled trials (RCTs) evaluating clinical outcomes to compare PCI strategies for multivessel disease in AMI patients until September 2023. The primary outcome measure was all-cause death, while the secondary outcomes included myocardial infarction, stroke, coronary revascularization, and bleeding.Results:We included 22 RCTs (N=13,093) comparing the IRA only-PCI and NIRA-PCI strategies. Immediate NIRA-PCI strategy was defined as performing NIRA-PCI after IRA-PCI without delay. Staged NIRA-PCI strategies were categorized into three groups based on the protocol-defined or treated timing for NIRA-PCI from the IRA-PCI: within one week (Staged_Within1W), one week to one month (Staged_1Wto1M), and after one month (Staged_After1M). Compared with IRA-only PCI, Staged_Within1W had significantly lower risks for all-cause death, myocardial infarction, and coronary revascularization. The immediate PCI strategy relative to IRA-only PCI favored for myocardial infarction and coronary revascularization; however, there was no significant difference for all-cause death. Although Staged_1Wto1M or Staged_After1M showed trends similar to Staged_Within1W, all outcome measures had no significant difference. The risk for bleeding or stroke was comparable among the four strategies.Conclusions:This meta-analysis demonstrated a consistent benefit of the NIRA-PCI strategies relative to IRA-only PCI strategy in patients with AMI and multivessel disease. Among the NIRA-PCI strategies, NIRA-PCI within one week appeared the most preferred strategy in patients with AMI and multivessel disease.

Circulation, Volume 150, Issue Suppl_1, Page A4142197-A4142197, November 12, 2024. Introduction:Few randomized clinical trials (RCTs) have evaluated the safety and efficacy of abbreviated Ticagrelor-based dual antiplatelet therapy (DAPT) in acute coronary syndrome (ACS); however, these RCTs were underpowered to detect differences in hard clinical outcomes.Research Question:What effect does abbreviated Ticagrelor-based DAPT have on risk of ischemic and bleeding events in ACS?Methods:A systematic search of MEDLINE, Cochrane, and Scopus databases was performed through 05/2024, for trials that compared abbreviated (≤ 3-months) versus standard 12-months Ticagrelor-based DAPT in ACS. The primary endpoint was all-cause mortality. Endpoints were measured at 12-months after DAPT initiation. Data were pooled using random-effects model. Heterogeneity was assessed via Chi-squared and Higgin’s I2test. RevMan 5.0 (Cochrane Collaboration, Oxford, United Kingdom) was utilized to perform statistical analysis.Results:Five trials were included in this analysis with 21,407 patients assessed. ULTIMATE-DAPT, T-PASS, and GLOBAL LEADERS-ACS assessed 1-month DAPT duration while TICO and TWILIGHT-ACS assessed 3-months DAPT duration. The average age was 62.7 years and 22.7% were women. Hypertension (61.7%), dyslipidemia (49.9%), diabetes (27.8%), and chronic kidney disease (12.7%) were the most common comorbidities. ACS presentations included NSTEMI (40.1%), unstable angina (35.2%), and STEMI (31.5%). Abbreviated Ticagrelor-based DAPT was associated with lower risk of all-cause mortality (RR 0.78; 95% CI 0.62-0.98, I2=0%) compared with standard duration DAPT. There was no differences between groups in cardiovascular death (RR 0.65; 95% CI 0.41-1.03, I2=0%), myocardial infarction (RR 1.04; 95% CI 0.85-1.27, I2=0%), stent thrombosis (RR 0.97; 95% CI 0.64-1.45, I2=0%), or ischemic stroke (RR 0.90; 95% CI 0.62-1.30, I2=0%). Abbreviated DAPT duration was associated with lower risk of major bleeding (RR 0.50; 95% CI 0.38-0.66, I2=46%).Conclusion:Our analysis includes the totality of randomized data evaluating the merits of abbreviated Ticagrelor-based DAPT after ACS. The salient study finding was the observed reduced risk of all-cause mortality with abbreviated DAPT approach, which was driven by reduced bleeding risk.

Circulation, Volume 150, Issue Suppl_1, Page A4134589-A4134589, November 12, 2024. Background:Risk stratification for embolism in cardiac myxomas remains poorly explored.Goals:By this meta-analysis we studied the risk factors assicated with embolism among patients with cardiac myxoma.Methods:A comprehensive search was conducted across PubMed, Embase, Cochrane Library, and Google Scholar from their inception until January 2024. Statistical analyses were performed using Cochrane’s RevMan 5.4 software. For each risk factor, the pooled odds ratio or mean difference was calculated along with the corresponding 95% confidence interval.Results:We included 18 studies in our analysis with a total population of 2601 out of which 525 patients (20.1%) had at least one episode of embolism. The pooled analyses showed that hypertension (p = 0.001), New York Heart Association I/II (p = 0.03), irregular tumor surface (p

Circulation, Volume 150, Issue Suppl_1, Page A4144752-A4144752, November 12, 2024. Background:Adults with congenital heart disease (ACHD) are lifelong at high risk for premature cardiovascular events and life-threatening complications, suggestive of early or accelerated cardiovascular disease. Endothelial and microvascular dysfunction as well as arterial stiffness play a key role in the emergence and progression of cardiovascular complications. As vascular dysfunction may precede the occurrence of adverse events, early identification of endothelial damage markers in ACHD is crucial.Aim:This is the first systematic review and meta-analysis of studies investigating the endothelial and microvascular function in ACHD patients versus healthy controls.Methods:We systematically searched four major electronic databases (PubMed, CENTRAL, Scopus, Web of Science), ClinicalTrials.gov and grey literature. We included studies evaluating endothelial and microvascular function with any semi- or non-invasive method in adult patients with and without ACHD. Studies exploring arterial stiffness indices were also investigated.Results:In total, 31 studies (1118 ACHD patients, 794 controls) were included in this systematic review. Branchial arterial endothelium-dependent (assessed via flow-mediated dilatation, FMD) and -independent vasodilation (assessed via nitroglycerine-mediated dilatation, NMD) were impaired in ACHD patients versus controls (mean difference [MD] -2.5, 95% confidence intervals [CI] -3.7; -1.3 and MD -3.9, 95%CI -6.8; -1.0, respectively). Microvascular dysfunction was also evident; significantly lower reactive hyperemia index and peripheral arterial tonometry (PAT) ratio were found in ACHD patients compared with controls (MD −0.26, 95%CI −0.48; −0.04 and MD −0.26, 95%CI −0.5; −0.4, respectively). Regarding arterial stiffness, pooled analysis revealed non-significant differences in pulse wave velocity between the study groups (standardized MD 0.2, 95%CI -0.2; 0.6). However, augmentation index was significantly higher in ACHD (standardized MD 1.6, 95%CI 0.8; 2.4).Conclusions:ACHD patients have impaired endothelial and microvascular function and increased arterial stiffness, factors that may be responsible for the increased adverse cardiovascular events in this population.

Circulation, Volume 150, Issue Suppl_1, Page A4114970-A4114970, November 12, 2024. Background:Pulsed field ablation (PFA) and high-power short-duration radiofrequency ablation (HPSD) are emerging techniques for treating atrial fibrillation (AF), offering promising results compared to cryoballoon ablation (CBA). This network meta-analysis aims to evaluates the efficacy and safety of PFA, HPSD, and CBA.Method:PubMed, Embase, Cochrane Central Register of Controlled Trials, and EBSCO Information Services were systematically searched for relevant studies until April 2024. The primary outcome is freedom from atrial arrhythmia. A random-effects model was used for data synthesis, and P-scores were employed for outcome ranking. Point estimation (odd ratios) was calculated for comparisons.Results:Fifteen studies were included in our network meta-analysis, involving 5,093 atrial fibrillation patients: 812 (16%), 2,659 (52%), and 1,622 (32%) patients underwent PFA, CBA, and HPSD, respectively. PFA demonstrated the highest efficacy (P-scores 99.3%). Point estimation between PFA and HPSD, and PFA and CBA, were 1.394 (95% CI: 1.047-1.858) and 1.479 (95% CI: 1.134–1.929), respectively. PFA had higher complications compared to HPSD (OR=4.44, 95% CI: 1.405-14.031) and CBA (OR=2.581, 95% CI: 0.992–6.720). HPSD had the shortest fluoroscopic time (P-scores 100%), while CBA had the longest (P-scores 0%). PFA had the shortest procedural time compared to CBA and HPSD with P-scores of 100% 50% and 0%, respectively.Conclusion:PFA showed higher efficacy but higher complication risk than HPSD and CBA. HPSD and CBA demonstrated similar efficacy and safety.

Circulation, Volume 150, Issue Suppl_1, Page A4135791-A4135791, November 12, 2024. Background:While non-vitamin K antagonist oral anticoagulants (NOACs) are more effective than single antiplatelets (mostly low-dose aspirin) at reducing stroke risk in patients with atrial fibrillation (AF), differences in bleeding risk between NOACs and single-dose antiplatelets across various populations remain unclear.Aim:We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing bleeding outcomes of NOACs versus single antiplatelet therapy.Methods:We searched MEDLINE, EMBASE, and CENTRAL to June 2024 for RCTs that compared NOAC (therapeutic doses used for stroke prevention in AF patients) versus single antiplatelet therapy for a treatment duration of ≥3 months. For the meta-analyses, we used fixed-effects models and reported results as summary risk ratios (RRs). We used Risk of Bias 2 and GRADE to assess the quality and certainty of the evidence.Results:Eight RCTs with 26,194 participants were included. Mean follow-up time was 18 (±13) months. NOACs included in the studies were apixaban (4 studies), rivaroxaban (2 studies), and dabigatran (2 studies). All studies used low-dose aspirin as the comparator. When compared to aspirin, NOACs had a higher risk of major bleeding (326/13107 [2.5%] vs. 239/13087 [1.8%] events; RR 1.36 95% CI 1.15-1.60, I2=52%, 8 trials; high certainty) (Figure A), gastrointestinal bleeding (104/8803 [1.2%] vs. 74/8788 [0.8%] events; RR 1.39; 95%CI, 1.04-1.87; I2=0%; 5 trials; high certainty), and clinically relevant non-major bleeding (318/10397 [3.1%] vs. 230/10395 [2.2%] events; RR 1.38; 95%CI, 1.17-1.63; I2=16%; 5 trials; high certainty). There was no difference in the risk of intracranial hemorrhage (88/13107 [0.7%] vs. 84/13087 [0.6%] events; RR 1.04, 95%CI 0.78-1.41; I2=48%; 9 trials; high certainty) (Figure B) nor fatal bleeding (22/12412 [0.2%] vs. 28/12392 [0.2%] events; RR 0.78; 95%CI, 0.45-1.36; I2=8%; 6 trials; high certainty).Conclusion:When compared to aspirin, NOACs are associated with an increased risk of major bleeding and clinically relevant non-major bleeding, but not intracranial hemorrhage. These data are important to inform patients about the risks of antithrombotic treatment.

Circulation, Volume 150, Issue Suppl_1, Page A4137467-A4137467, November 12, 2024. 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

Circulation, Volume 150, Issue Suppl_1, Page A4138662-A4138662, November 12, 2024. Background:While mineralocorticoid antagonists (MRA) reduce mortality in patients developing heart failure post myocardial infarction (MI), it is unclear whether they are beneficial in an unselected post-MI population.Aims:Using a systematic review and meta-analysis, we aim to determine the effect of MRA treatment versus no MRA treatment on all-cause mortality in unselected post-MI patients from randomized data, simultaneously with the presentation of the largest randomized controlled trial on the topic, the CLEAR SYNERGY trial.Methods/Approach:We completed a systematic review of all randomized controlled trials comparing MRA treatment to no MRA treatment in post-MI patients. We will perform our primary analysis using fixed effects with the Peto odds ratio method and use random effects as a sensitivity analysis. The primary outcome will be all-cause mortality, and secondary outcomes will include cardiovascular mortality, new or worsening heart failure, recurrent myocardial infarction and stroke.Results/Data:Our systematic review of Pubmed, Embase, and CENTRAL from inception until April 30, 2024, yielded 456 records. A total of 11,199 participants from 11 randomized clinical trials will be included in addition to the late-breaking CLEAR SYNERGY trial. The CLEAR SYNERGY trial is a 2 x 2 factorial randomized controlled trial of low-dose colchicine 0.5mg daily versus placebo and spironolactone 25mg daily versus placebo in 7,062 post-MI patients who were within 72h of the index percutaneous coronary intervention. The results of the spironolactone factorial will be presented in the fall of 2024 with an expected median follow-up of 3.5 years. As the investigators of the CLEAR SYNERGY trial, we will combine our data with the other 11 trials for a total of 12 trials and 18,261 participants.Conclusions:CLEAR SYNERGY is the largest randomized controlled trial with the longest follow-up of spironolactone in the post-MI population. Our meta-analysis will provide updated effect estimates of post-MI MRA treatment, leveraging the late-breaking CLEAR SYNERGY data to reflect the totality of the evidence.