Circulation, Volume 146, Issue Suppl_1, Page A14100-A14100, November 8, 2022. Background:Treatment with various sodium-glucose cotransporter 2 inhibitors (SGLT-2Is) has decreased cardiovascular events in patients with heart failure (HF). Therefore, we conducted a network meta-analysis to investigate which SGLT-2Is are more effective in patients with HF.Methods:PubMed, Web of Science, Scopus, and Embase, were systematically searched from inception to February 2022. We included randomized controlled trials (RCTs) that investigated the use of SGLT-2Is vs. placebo in HF patients. The main outcomes were all-cause, cardiovascular mortality, serious adverse events, and hospitalizations due to HF. The random-effects method model and inverse variance statistics were used to calculate the odds ratio (OR) with a 95% confidence interval (CI).Results:Our study included 12 RCTs with a total number of 69,024 patients (37,923 in the SGLT2 inhibitors group and 31,101 in the placebo group). Five RCTs used empagliflozin, 4 used dapagliflozin, 1 used canagliflozin, 1 used ertugliflozin, and 1 used sotagliflozin. Our analysis showed that empagliflozin has a statistically significant lowest odds for both cardiovascular mortality and serious adverse effects (OR: 0.80 with 95% CI [0.67-0.96]) and (OR: 0.84 with 95% CI [0.76-0.93]), respectively compared to other SGLT-2Is. All SGLT-2Is have been associated with the same lower odds without preferences for one over the others regarding all-cause mortality. Furthermore, the hospitalization rate due to HF showed a statistically significant decrease with all the SGLT-2Is except for canagliflozin, which showed insignificant results with (OR: 0.63 with 95% CI [0.39-1.01]).Conclusion:No differences between the SGLT-2Is included in this analysis were observed in terms of all-cause mortality. Empagliflozin had the lowest odds of cardiovascular mortality and serious adverse effects. Canagliflozin was the only SGLT-2Is that showed no significant results in odds of hospitalization for HF.
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Abstract 10566: Hypothermia as an Adjunctive Therapy to Percutaneous Intervention in St-Elevation Myocardial Infarction: A Systematic Review and Meta-Analysis of Randomized Control Trials
Circulation, Volume 146, Issue Suppl_1, Page A10566-A10566, November 8, 2022. Introduction:In the setting of acute ST-elevation myocardial infarction (STEMI), several randomized control trials (RCTs) suggested a potential benefit with the use of Therapeutic hypothermia (TH). However, results from previous studies are contradictory.Method:We performed a comprehensive literature search for studies that evaluated the efficacy and safety of adjunctive TH compared to the standard percutaneous coronary intervention (PCI) in awake patients with STEMI. The primary outcome was the infarct size (IS) and microvascular obstruction (MVO) assessed by cardiac imaging at the end of follow-up. The secondary outcomes were major adverse cardiovascular events (MACE), procedure-related complications, and door to balloon time. Relative risk (RR) or the mean difference (MD) and corresponding 95% confidence intervals (CIs) were calculated using the random-effects model.Results:A total of 10 RCTs, including 706 patients (mean age: 58±9.6 years, 364 patients managed with adjunctive TH vs. 342 with standard PCI), were included. As compared to standard PCI, TH was not associated with a statistically significant improvement in the IS (MD: -0.87 %, 95%CI: -2.97, 1.23; P = 0.42) or in the MVO (MD: 0.11 %, 95%CI: -0.06, 0.27; P = 0.21). MACE and its individual components were comparable between the two groups. However, the TH approach was associated with an increased risk of infection and prolonged door to balloon time. Furthermore, there was a trend in the TH group toward an increased incidence of stent thrombosis and paroxysmal atrial fibrillation.Conclusions:According to our meta-analysis of published RCTs, the benefit of TH in STEMI patients is modest, with a marginal safety profile and potential for care delays. Larger-scale RCTs are needed to further clarify our results.
Abstract 11279: Reporting of Diversity and Inclusion in Clinical Trials of Exercise Therapy for Peripheral Vascular Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Circulation, Volume 146, Issue Suppl_1, Page A11279-A11279, November 8, 2022. Introduction:Exercise therapy serves as a cornerstone of treatment for all patients with peripheral arterial disease (PAD); however, data suggest that women and minority groups with PAD suffer from disparate outcomes.Hypothesis:Randomized controlled trials (RCTs) of exercise therapy for PAD will demonstrate high rates of reporting and recruitment of women and minority groups.Methods:Databases were queried for RCTs that assessed the role of exercise therapy for PAD (Figure 1).Results:Only 2/47 (4%) of studies reported details of racial and ethnic subgroups (Figure 2). A meta-analysis of participation among non-white participants showed high heterogeneity (pooled effect 32%, I2 74%, p
Abstract 15645: Posterior Mediastinal Hematoma as a Rare Complication of Anti-Coagulation Use – A Case Report and Literature Review
Circulation, Volume 146, Issue Suppl_1, Page A15645-A15645, November 8, 2022. Introduction:Posterior mediastinal hematoma (PMH) is a rare complication of anti-coagulation (AC) use. We present a complex case of a patient with a sub-massive pulmonary embolism (PE) whose care was complicated by PMH causing airway obstruction following thrombectomy.Case:A 60-year-old male with a history of prostate cancer in remission presented after a syncopal event. On admission, he was afebrile, mildly tachycardic (100bpm), normotensive (135/91), with no oxygen requirement. Laboratory data showed high sensitivity troponin 244 ng/L and BNP 82 pg/ml. CTPA revealed a saddle PE with right heart strain (PESI score 100). He was initiated on anticoagulation and underwent successful mechanical thrombectomy using a Penumbra aspiration catheter. He had acute respiratory failure later that evening, necessitating intubation. Repeat CTPA showed increased clot burden and new onset PMH (Figure 1). Of note, his AC was continued due to clot burden. A repeat thrombectomy was performed using the FlowTriever System Device (Inari Medical, Irvine, CA). Despite this intervention, he continued to struggle with extubation, and a new stridor was noted. Bronchoscopy revealed external compression of proximal trachea correlating with the PMH location. He was deemed too high risk for evacuation of the PMH. Therefore, he underwent tracheostomy to bypass the area of compression. This subsequently allowed for successful extubation.Discussion:While thrombectomy can cause iatrogenic bleeding, no bleeding was seen on the post-procedure angiogram in our patient. Thus, these findings are attributed to PMH. PMH has been reported 6 times in literature (table 1), one associated with PE. Management options include hematoma evacuation or holding AC and performing serial follow up imaging. Our patient did not undergo evacuation of hematoma, and a tracheostomy was used instead to bypass the obstruction. This highlights the need to individualize management of these complex patients.
Abstract 13046: Bleeding Complications During Cardiac Electronic Device Implantation With Novel Oral Anticoagulants versus Vitamin K Antagonist : A Systematic Review and Meta-Analysis
Circulation, Volume 146, Issue Suppl_1, Page A13046-A13046, November 8, 2022. Introduction:Pocket hematoma is a feared complication of cardiac implantable electronic device (CIED) placement. About half the patients undergoing the procedure are on anticoagulation with consequent increased frequency of device-pocket hematoma. The risk of hematoma is variable based on the type of anticoagulation therapy. The purpose of this study was to compare the risk of device-hematoma in patients oninterruptednovel oral anticoagulants (NOAC) versusuninterruptedvitamin K antagonists (VKA) during the peri-operative period.Methods:We performed a meta-analysis using electronic literature search to retrieve studies with CIED surgery on uninterrupted VKA versus interrupted NOAC (range 12-96 hours). Primary outcome of interest was pocket-hematoma. Outcomes were pooled under random-effects meta-analyses and reported as risk ratios (RRs) and 95% CIs. 5 studies with low heterogeneity (I2=14%), 4 observational and 1post-hocanalysis of a randomized trial, were included. 1002 patients NOAC group=376 and VKA group=626 were followed for 4-6 weeks.Results:Baseline characteristics were similar, mean age 71 years and 71% male across both groups. There was no significant difference in endpoints: pocket hematoma (major and minor) {RR 0.74 (0.43-1.29), P=0.29}; major hematoma {RR 0.53 (0.24-1.19), P=0.13}; hematomas with new implants {RR 0.82 (0.46-1.48), P=0.51}; hematomas with generator changes {RR 1.90 (0.84-4.31), P=0.12}; hematomas with device-upgrade {RR 0.41 (0.15-1.07), P=0.07}; major bleed {RR 0.18 (0.03-1.09), P=0.06}; pericardial effusion {RR 1.01 (0.13-8.19), P=0.67}(Fig 1). One study reported peri-implantation infection (n=4/311 NOAC, n=2/467 VKA). One patient out of all 5 studies had systemic thromboembolism in each group (1/837 NOAC, 1/1000 VKA).Conclusion:Interrupted NOAC use is not associated with a higher risk of pocket hematoma compared to uninterrupted VKA after CIED placement.
Abstract 11962: Cardiopulmonary Exercise Testing Predicts Mortality in Cardiac Amyloidosis: A Systematic Review and Meta-Analysis
Circulation, Volume 146, Issue Suppl_1, Page A11962-A11962, November 8, 2022. Introduction:The cardiopulmonary exercise testing (CPET) has been proved to be a good tool in prognostic stratification of HFrEF and HFpEF, but its value in cardiac amyloidosis (CA) is uncertain. With the increasing knowledge and clinical suspicion toward CA, the growing prevalence of the disease, and the current availability of disease-modifying drugs, prognostic stratification is becoming fundamental to optimise the cost-effectiveness of treatment, patient follow-up and management.Hypothesis:We investigate the association of VO2max and VE/VCO2 slope with prognosis in patients with CA.Methods:We performed a systematic review following the PRISMA guidelines. Electronic databases (MEDLINE, Biomed Central, and Cochrane Library) were searched for clinical trials performing CPET for prognostication in transthyretin and light-chain CA patients. Studies reporting Hazard Ratio (HR) for mortality and VO2 max or VE/VCO2 slope (1-unit increase) were further selected for quantitative analysis. After logarithmic transformation, HRs were pooled using a random-effect model.Results:Five studies were selected for qualitative analysis and 3 for the quantitative analysis. A total of 233 patients were included in the meta-analysis, 127 (55%) with transthyretin and 106 (45%) with light-chain CA. Mean VO2 max in each trial was consistently depressed, ranging from a mean of 14.5 ± 4.5 mL/kg/min to 15.2 ± 10 mL/kg/min. On the other side, the VE/VCO2 slope ranged from a mean of 30 ± 3.0% to 41.3 ± 9.7%. Our pooled analysis shows that VO2 max (pooled HR 0.89, 95%CI 0.84-0.94) and VE/VCO2 slope (pooled HR 1.04, 95%CI 1.01-1.07) are significantly associated with the risk of death in CA patients, with no significant statistical heterogeneity for both analyses.Conclusions:CPET is a valuable tool for prognostic stratification in CA, identifying patients at increased risk of death. Large prospective clinical trials are needed to confirm this exploratory finding.
Abstract 14258: Left Bundle Branch Pacing for Cardiac Resynchronization Therapy in Heart Failure: A Systematic Review and Meta-Analysis
Circulation, Volume 146, Issue Suppl_1, Page A14258-A14258, November 8, 2022. Introduction:: Cardiac resynchronization therapy (CRT) using a biventricular pacemaker (BVP) reduced mortality and rehospitalizations in patients with symptomatic heart failure (HF) with a left ventricular ejection fraction (LVEF) of less than 35% and concomitant left bundle branch block. However, 10-30% of BVP patients fail to show a clinical or echocardiographic response. Recently left bundle branch pacing (LBBP) has been studied as a more physiological alternative to BVP. The aim of this study is to summarize the available evidence on LBBP.Hypothesis:LBBP is an effective and feasible alternative option for CRT.Methods:Unrestricted searches of the PubMed, EMBASE, and Cochrane databases from inception till June 1, 2022, for studies examining the role of LBBP for CRT in HF patients. Data were analyzed using Revman 5.3 software. Mean Difference (MD), Odds Ratio (OR), and 95% Confidence interval (CI) were calculated using the random-effects model.Results:A total of 8 observational studies (3 single-armed, and 5 comparative studies) examined 756 HF patients who underwent CRT (551 LBBP vs 205 BVP). LBBP was successful in 87% of patients. Compared to baseline, LBBP was associated with a reduction in QRS duration (MD -53.5, 95%CI -69.77, -37.24), an increase in LVEF (MD 17%, 95%CI 13.38, 20.6), and a reduction in NYHA class (MD -1.4, 95%CI -1.56, -1.05). Compared to BVP, LBBP was associated with a significant reduction in QRS duration (MD -22.68, 95%CI -31, -14.35), improvement in LVEF (MD 7.58, 95%CI 5.21, 9.95), and a decrease in NYHA class (MD -0.55, 95% CI -0.73, -0.37) during a mean follow-up of 9.2 months. The super response rate, which is defined as an increase in LVEF of more than 20% or LVEF at or above 50% after CRT, was higher in LBBP compared to BVP (OR 2.98, 95%CI 1.65, 5.32).Conclusions:LBBP is a feasible and effective alternative for CRT. LBBP was associated with better electrical ventricular synchrony than BVP which was also translated into better echocardiographic and clinical outcomes in the short term. Our findings need to be further validated in larger randomized controlled trials with a long-term follow-up.
Abstract 12626: A Systematic Review and Meta-analysis of Factors Associated With Long-Term Mortality in Adults After Coronary Artery Bypass Graft Surgery
Circulation, Volume 146, Issue Suppl_1, Page A12626-A12626, November 8, 2022. Background:With an ageing and increasingly multi-morbid population, the use of coronary artery bypass grafting (CABG) is expected to increase. As short-term CABG mortality rates have decreased, estimating long-term outcomes for patients with specific risk factors has become more relevant. Previous single observational studies have identified risk factors for adverse long-term outcomes, such as older age and diabetes.Purpose:Understanding the pre-operative characteristics that affect late mortality post-CABG can lead to effective risk stratification and enhancement of secondary prevention programmes, thereby aiming to improve long-term prognosis after the procedure.Methods:MEDLINE, Embase, Google Scholar, and Cochrane electronic databases were searched to identify all relevant articles evaluating associations between pre-operative risk factors and long-term mortality (≥5 years ) post-CABG. Studies with
Abstract 12471: Ventricular Tachycardia Ablation vs Antiarrhythmic Drug Efficacy and Safety: A Meta-Analysis and Systematic Review of Randomized Studies
Circulation, Volume 146, Issue Suppl_1, Page A12471-A12471, November 8, 2022. Introduction:Ventricular tachycardia (VT) poses a significant risk in patients with ischemic cardiomyopathy. Antiarrhythmic drugs (AAD) and catheter ablation are the 2 strategies employed to reduce the risk of future VT episodes. It is not established if one strategy is superior to the other.Hypothesis:Recently, randomized trials have been published comparing the efficacy and safety of both strategies for VT management. Unfortunately, most of these trials included a relatively small number of patients and had different outcomes or composite of outcomes limiting their utility.Methods:We performed a meta-analysis of randomized clinical trials comparing these treatment modalities for VT management. Criteria for appropriate studies were the inclusion of outcome data for both ablation and AAD arms, history of documented VT or ICD therapy before enrollments, and use of ICD to reliably monitor the incidence. Due to recent advances in substrate-based VT ablation and changes in ICD algorithms we limited our search for studies published in last 10 years. We identified four studies that met our inclusion and exclusion criteria.Results:Our included studies randomized 609 patients, 303 in ablation, and 310 in AAD groups. All-cause mortality data were available for all included studies. The cumulative odds ratio (OR) for all-cause mortality for VT ablation compared to AADs was 0.88, 95% confidence interval [0.56-1.39], p-value 0.58. Cumulative OR for cardiac death was 0.81 [95% CI 0.47-1.38], p-value 0.44, OR for ICD shocks was 0.82[0.57-1.18], p-value 0.29 and the OR for heart failure or cardiac rehospitalization was 0.82 [95% CI 0.53-1.25] p-value 0.35. Treatment-related complications were reported in only two studies with cumulative OR 0.31 [95% CI 0.19-0.51] p
Abstract 11273: Comparison of Outcome Between Type 2 versus Type 1 Myocardial Infarction: A Systematic Review and Meta-Analysis
Circulation, Volume 146, Issue Suppl_1, Page A11273-A11273, November 8, 2022. Introduction:Unlike type 1 myocardial infarction (T1MI) which is caused by plaque rupture and erosion, type 2 myocardial infarction (T2MI) is due to the mismatch between supply-demand of oxygen. To date, there were limited studies available and consequently, the outcomes of patients with T1MI compared to T2MI remained inconclusive.Hypothesis:We aimed to compare the outcomes of T1MI and T2MI patients in terms of mortality and adverse cardiovascular outcomes.Methods:We performed a systematic literature search of databases for relevant articles from inception until March 20, 2022.Results:340,802 patients had T1MI while the remaining 52,855 patients had T2MI. Mean age was similar between both groups (T1MI: 69.4 years, T2MI: 71.8 years) while proportion of female was found to be more higher in T2MI (61% vs 38%). Our analysis revealed that patients with T1MI had a significantly lower odds of all-cause mortality (OR 0.44, 95%CI 0.34 to 0.56, p
Abstract 12596: Comparison of the Efficacy and Safety of Direct Oral Anticoagulants With Vitamin K Antagonists in Patients With Thrombotic Antiphospholipid Syndrome: Systematic Review and Meta-analysis of Randomized Clinical Trials
Circulation, Volume 146, Issue Suppl_1, Page A12596-A12596, November 8, 2022. Introduction:The efficacy and safety of direct oral anticoagulants (DOACs) as treatment alternatives for patients with thrombotic antiphospholipid syndrome (APS) remain controversial.Methods:We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) that compared the efficacy and safety of DOACs with vitamin-K antagonists (VKAs) in patients with thrombotic APS. We searched PubMed, EMBASE and Cochrane Central Register of Controlled Trials through April 9, 2022. Main efficacy outcomes were a composite of arterial thrombotic events, and a composite of venous thromboembolic events (VTE). The main safety outcome was major bleeding according to the International Society on Thrombosis and Hemostasis (ISTH) criteria. A random effects model with inverse variance was used for the primary analysis. Risk of bias was assessed using the Cochrane Collaboration criteria.Results:Our search retrieved 253 studies. Four RCTs involving 474 patients were included (Figure). All four RCTs were open-label but had proper random sequence generation and adequate allocation concealment. The DOACs used were rivaroxaban (3 trials) and apixaban (1 trial). The mean percent time in therapeutic range in the warfarin arm among the four studies was 60%. Overall, use of DOACs compared with VKAs was associated with increased odds of composite of arterial thrombotic events (OR 5.64, 95% confidence interval [CI] 1.96-16.27,p=0.001, I2= 0%). The odds of subsequent VTE events (OR 1.19, 95% CI 0.31-4.53,p=0.80, I2= 0%), or major bleeding (OR 1.02, 95% CI 0.42-2.47,p=0.97, I2= 0%) were not significantly different between the two groups.Conclusions:Patients with thrombotic APS randomized to DOACs compared to VKAs appear to have increased risk for arterial thrombosis. No significant differences were observed between patients randomized to DOACs vs VKAs in the risk of subsequent VTE or major bleeding.
Abstract 13056: Evaluation of Stable Angina by Coronary Computed Tomographic Angiography versus Standard of Care: A Systematic Review and Meta-Analysis
Circulation, Volume 146, Issue Suppl_1, Page A13056-A13056, November 8, 2022. Introduction:There has been growing evidence comparing Coronary Computed Tomography Angiography (CCTA) versus the standard of care(SOC) in patients with suspected stable coronary artery disease (CAD). We aimed to perform a systematic review and meta-analysis to compare CCTA versus SOC in patients with stable CAD.Methods:We searched multiple databases for randomized controlled trials (RCTs) comparing CCTA with SOC with various functional testing approaches for the evaluation of stable CAD. We used a random-effects model to calculate risk ratios (RRs) with 95% confidence intervals (CIs). Outcomes included all-cause mortality, myocardial infarction (MI), hospitalization for unstable angina (UA), invasive angiography, revascularization, percutaneous coronary intervention (PCI), and coronary artery bypass grafting (CABG).Results:We identified 6 RCTs with a total of 19,881 patients with stable CAD, of which 9,995 underwent CCTA and 9,886 underwent UC. There were no significant differences between CCTA and SOC in terms of all-cause mortality (RR: 0.91; 95% CI: 0.70-1.19; p=0.64), MI (RR: 0.78; 95% CI: 0.58-1.05; p=0.70), hospitalizations for UA (RR: 1.20; 95% CI: 0.95-1.51;p=0.64), invasive angiography (RR: 0.11; 95% CI: 0.32-1.61; p
Abstract 11832: Impact of Social Determinants of Health on Sacubitril-Valsartan Accessibility: A Single Center Retrospective Review
Circulation, Volume 146, Issue Suppl_1, Page A11832-A11832, November 8, 2022. Introduction:Angiotensin receptor-neprilysin inhibitors (ARNI) like sacubitril-valsartan reduce morbidity and mortality in heart failure with reduced ejection fraction (HFrEF). However, its higher cost relative to other guideline-directed medical therapy(GDMT) may ultimately limit access for patients, especially those impacted by social determinants of health (SDOH).Methods:A retrospective review of all patients at Allegheny General Hospital with HFrEF taking sacubitril-valsartan between January 1, 2016 and January 1, 2022 was conducted. Logistic regression was used to study the impact of various SDOH (Income, Employment, Transportation, Insurance) on medication adherence.Results:Out of 201 patients who met the inclusion criteria, ARNI was discontinued in 47 (23.4%) patients. Common reasons for discontinuation included cost/insurance coverage in 10 patients (21.3%), hypotension in 18 patients (38.3%), hyperkalemia (4.3%) and worsening renal function (10.6%). Lower income (OR:0.75 [95% CI 0.58 to 0.98] p = 0.03) and greater distance from clinic (OR:1.25 [95% CI 1.03 to 1.51] p = 0.02) was associated with higher odds of discontinuing ARNI. Discontinuation was observed more frequently in retired patients (55.3% vs 43.5%) compared to those actively employed. Compared to those with Medicare, Medicaid or no insurance, ARNI was continued more frequently in patients with private insurance.Conclusions:Patients with HFrEF live longer when treated with appropriate GDMT. However, given costs associated with novel agents, clinicians must acknowledge that SDOH substantially impact a patient’s ability to fill such expensive prescriptions regularly.
Abstract 14167: Safety Profile of Leadless Pacemaker in Comparison to Conventional Transvenous Pacemaker: A Systemic Review and Meta-Analysis
Circulation, Volume 146, Issue Suppl_1, Page A14167-A14167, November 8, 2022. Introduction:Recently, there has been a dramatic surge of interest in leadless pacemakers (LP). Although benefits of LP versus transvenous pacemakers (TVP) have been reported in small institutional and some registry-based studies, the systematic comparison and pooling of data remain limited. Therefore, we sought to meta-analyze the safety and benefit of leadless pacemakers over conventional transvenous pacemaker systems.Method:We followed PRISMA guidelines to conduct the study. The study protocol has been registered in the PROSPERO (CRD42022325376). Databases were searched for published literature from inception to April 12, 2022. Comparative studies on TVP with LP reporting device-related, cardiac, vascular, thoracic complications, and infection were included. Studies were analyzed using RevMan 5.4.1 with odds ratios (OR) to assess overall complications, device dislodgement, reintervention, and other complications. The I-squared (I2) test was used to assess the heterogeneity.ResultTotal 879 studies were imported from databases. After the removal of 265 duplicates, 614 papers were screened for eligibility. Among 41 papers screened for full text, 17 meet the inclusion criteria. There were 50% lower odds of overall complications in the LP group (OR 0.50, 95% CI 0.32 to 0.78; n = 20825). Similarly, 73% lower odds of device dislodgment (OR 0.27, 95% CI 0.14 to 0.50; n = 6897), 46% lower odds of re-intervention (OR 0.54, 95% CI 0.45 to 0.64; n= 17009), 87% lower odds of pneumothorax (OR 0.13, 95% CI 0.03 to 0.57; n = 4261), however 2.08 higher odds of pericardial effusion (OR 2.08, 95% CI 1.04 to 4.16; n = 4842) observed in LP group.ConclusionMeta-analysis of observational studies suggests that LP demonstrates a more favorable complication profile than TVP, although with higher rates of pericardial effusion. However, patient selection was not uniform between studies, and inferences remain limited.
Abstract 11873: Association Between Perioperative Hyponatremia and Survival After Left Ventricular Assist Device Implantation: A Systematic Review and Meta-Analysis
Circulation, Volume 146, Issue Suppl_1, Page A11873-A11873, November 8, 2022. Background:Hyponatremia, defined as a serum sodium (Na) level
Abstract 12549: What is the Efficacy of New Therapies in Black Patients With Heart Failure and a Reduced Ejection Fraction? A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Circulation, Volume 146, Issue Suppl_1, Page A12549-A12549, November 8, 2022. Introduction:Evaluating the efficacy of newer medical therapies in black patients with heart failure with reduced ejection fraction (HFrEF) remains an important and unanswered question. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) in HFrEF to compare outcomes in black versus non-black patients with a specific focus on new therapies, namely ARNIs and SGLT2 inhibitors.Methods:Medline, Embase and Cochrane CENTRAL were searched from inception until May 2022. Pairs of reviewers independently identified RCTs that 1) compared either an SGLT2 inhibitor or an ARNI to placebo/standard of care in HFrEF patients and 2) reported outcomes stratified by race. Outcomes were pooled using the Generic Inverse Variance or Mantel-Haenszel models, and risk of bias was assessed using the Cochrane tool.Results:Four RCTs (n=17,797; 6.6% black) were identified, all of which were published in the past decade. In the placebo/control arm, black patients had a higher rate of heart failure hospitalization or cardiovascular death compared to non-black/white patients (OR: 1.52, 95% CI: 1.26, 1.84; absolute difference: 81, [95% CI: 43, 124] more events per 1,000 patients). In two RCTs, there was a trend towards a greater reduction in the composite of cardiovascular death or heart failure hospitalization with SGLT2 inhibitors in black patients (n=483; RR: 0.61, 95% CI: 0.45, 0.83) compared to white patients (n=6,445; RR: 0.84, 95% CI: 0.75, 0.95; p-interaction=0.06). In two RCTs, treatment with an ARNI was associated with reductions in the composite of cardiovascular death or heart failure hospitalization in both black patients (n=744; HR: 0.67, 95% CI: 0.40, 1.11) and non-black/white patients (n=6,109; HR: 0.80, 95% CI: 0.72, 0.89; p-interaction= p=0.49).Conclusions:Black patients are poorly represented in contemporary heart failure trials, and have worse outcomes compared with non-black patients. Newer therapies such as ARNIs and SGLT2 inhibitors are efficacious in black patients. SGLT2 inhibitors may afford greater risk reduction in black compared to non-black patients.