Composite Of Major Adverse Cardiovascular Events Research Articles

A-23 | Gender Disparities in Cardiovascular Outcomes of Percutaneous Coronary Intervention for Chronic Total Occlusions

Several studies have demonstrated the utility of percutaneous coronary intervention (PCI) in improving cardiovascular outcomes in patients with chronic total occlusions (CTOs). However, the differences in clinical outcomes based on gender have not been well elucidated. This meta-analysis aims to evaluate the differences in cardiovascular outcomes of CTO PCI based on gender. A literature search was conducted for studies reporting on clinical endpoints after CTO PCI based on gender. The primary endpoint was all-cause mortality. Secondary endpoints included procedural success, recurrent acute myocardial infarction (AMI), and composite major adverse cardiovascular events (MACE). The search included the following databases: Ovid MEDLINE, EMBASE, Web of Science, and Google Scholar. The search was not restricted to time or publication status. A total of 14 studies with 15,129 patients with CTO PCIs (2804 females, 12325 males) met inclusion criteria. Mean follow-up was 48 months. Female gender was associated with a trend toward higher risk of all-cause mortality and MACE and lower procedural success; however, this was not statistically significant (OR 1.2, 95% CI 0.98-1.48; p=0.08; OR 1.26, 95% CI 0.99-1.59; p=0.06; OR 1.12, 95% CI 0.98-1.27; p=0.08). There was no significant difference in the risk of recurrent AMI on long-term follow-up post-PCI in females compared to males (OR 1.07, 95% CI 0.82-1.40; p=0.61). Female patients who undergo CTO PCI have similar procedural success without increased risk of long-term all-cause mortality, MACE, or recurrent AMI compared to male patients.

Cardiovascular Safety in Type 2 Diabetes With Sulfonylureas as Second-Line Drugs: A Nation-Wide Population-Based Comparative Safety Study.

To assess the real-world cardiovascular (CV) safety for sulfonylureas (SU), in comparison with dipeptidylpeptidase-4 inhibitors (DPP4i) and thiazolidinediones (TZD), through development of robust methodology for causal inference in a whole nation study. A cohort study was performed including people with type 2 diabetes diagnosed in Scotland before 31 December 2017, who failed to reach HbA1c 48 mmol/mol despite metformin monotherapy and initiated second-line pharmacotherapy (SU/DPP4i/TZD) on or after 1 January 2010. The primary outcome was composite major adverse cardiovascular events (MACE), including hospitalization for myocardial infarction, ischemic stroke, heart failure, and CV death. Secondary outcomes were each individual end point and all-cause death. Multivariable Cox proportional hazards regression and an instrumental variable (IV) approach were used to control confounding in a similar way to the randomization process in a randomized control trial. Comparing SU to non-SU (DPP4i/TZD), the hazard ratio (HR) for MACE was 1.00 (95% CI: 0.91-1.09) from the multivariable Cox regression and 1.02 (0.91-1.13) and 1.03 (0.91-1.16) using two different IVs. For all-cause death, the HR from Cox regression and the two IV analyses was 1.03 (0.94-1.13), 1.04 (0.93-1.17), and 1.03 (0.90-1.17). Our findings contribute to the understanding that second-line SU for glucose lowering are unlikely to increase CV risk or all-cause mortality. Given their potent efficacy, microvascular benefits, cost effectiveness, and widespread use, this study supports that SU should remain a part of the global diabetes treatment portfolio.

Randomized Trial of Targeted Transendocardial Mesenchymal Precursor Cell Therapy in Patients With Heart Failure

BackgroundMesenchymal precursor cells (MPCs) are allogeneic, immunoselected cells with anti-inflammatory properties that could improve outcomes in heart failure with reduced ejection fraction (HFrEF). ObjectivesThis study assessed the efficacy and safety of MPCs in patients with high-risk HFrEF. MethodsThis randomized, double-blind, multicenter study evaluated a single transendocardial administration procedure of MPCs or sham-control in 565 intention-to-treat patients with HFrEF on guideline-directed therapies. The primary endpoint was time-to-recurrent events caused by decompensated HFrEF or successfully resuscitated symptomatic ventricular arrhythmias. Hierarchical secondary endpoints included components of the primary endpoint, time-to-first terminal cardiac events, and all-cause death. Separate and composite major adverse cardiovascular events analyses were performed for myocardial infarction or stroke or cardiovascular death. Baseline and 12-month echocardiography was performed. Baseline plasma high-sensitivity C-reactive protein levels were evaluated for disease severity. ResultsThe primary endpoint was similar between treatment groups (HR: 1.17; 95% CI: 0.81-1.69; P = 0.41) as were terminal cardiac events and secondary endpoints. Compared with control subjects, MPCs increased left ventricular ejection fraction from baseline to 12 months, especially in patients with inflammation. MPCs decreased the risk of myocardial infarction or stroke by 58% (HR: 0.42; 95% CI: 0.23-0.76) and the risk of 3-point major adverse cardiovascular events by 28% (HR: 0.72; 95% CI: 0.51-1.03) in the analysis population (n = 537), and by 75% (HR: 0.25; 95% CI: 0.09-0.66) and 38% (HR: 0.62; 95% CI: 0.39-1.00), respectively, in patients with inflammation (baseline high-sensitivity C-reactive protein ≥2 mg/L). ConclusionsThe primary and secondary endpoints of the trial were negative. Positive signals in prespecified, and post hoc exploratory analyses suggest MPCs may improve outcomes, especially in patients with inflammation.

Risk Factors Control After an Acute Coronary Syndrome and Association with Major Adverse Cardiovascular Events: A Single Center Experience in Latin-America.

An important challenge in the secondary prevention of cardiovascular diseases is the optimization of risk factors (RFs) after hospital discharge. These have been shown to be insufficiently controlled in clinical practice. To evaluate whether secondary prevention goals were met at our institution at 12 months after an acute coronary syndrome (ACS) index event, as well as analyzing if achieving these goals was associated with a lower incidence of major adverse cardiovascular events (MACE). Retrospective cohort of patients with a former diagnosis of ACS over a period of 4 years. To evaluate the proportion of patients who met RF control goals at 12 months after the index event, we used two sets of preestablished goals: stringent and lenient. During follow-up we evaluated the occurrence of MACE, defined by the following: ACS, coronary revascularization, stroke, hospitalization because of acute heart failure and cardiovascular death. We included 468 patients during the study period. The mean age of the patients was 60 ± 10.76 years, 20.5% were women, and mean follow-up was 41.8 ± 22.0 months. The proportion of patients that met all secondary prevention stringent and lenient goals accounted for 5.5% and 17.2%, respectively, and 8% did not achieve any target. Overall, 9.6% presented the composite of MACE during follow-up. The number of RFs in control at 12 months was associated with a lower rate of MACE, both with stringent and lenient goals. Achieving established goals for modifiable RFs can lower the incidence of MACE during long-term follow-up.

Abstract TMP25: Major Adverse Brain Events: Incidence Rates Of A Novel Composite Vascular Neurologic Outcome

Background: The classical 3-point composite outcome MACE (major adverse cardiovascular events) includes incident stroke, myocardial infarction, and cardiovascular death. Conventional use of MACE may fail to account for important neurological consequences of vascular risk factors. We sought to report incidence rates of a novel composite neurologic outcome called major adverse brain events (MABE), comprised of incident stroke, dementia, and impaired balance in individuals with the vascular risk factor of hypertension. Methods: We analyzed TriNetX, the Health and Retirement Study (HRS), and Atherosclerosis Risk in Communities (ARIC), three longitudinal, publicly available datasets. We ascertained MABE as well as MACE and MACABE (MABE & MACE) as comparators by applying distinct adjudication methodologies in each dataset. We also evaluated the effect of good vascular health (maintenance of systolic blood pressure <140mm Hg and moderate or high physical activity, GVH) on rates of MABE and MACE in HRS through odds ratios (OR) adjusted for age, sex, and race/ethnicity. Results: We included 10,496,366 hypertensive individuals aged ≥40 years in the TriNetX sample with up to 4 years of follow-up, 2,251 hypertensive individuals aged ≥60 years in HRS with 4 years of follow-up, and 1,409 hypertensive individuals in ARIC with a mean of 4.9 years of follow-up. The incidence of MABE was 10.5% in TriNetX (Figure 1), 35.9% in HRS, and 33.3% in ARIC, of MACE was 17.5%, 40.8% and 12.9%, and of MACABE was 21.2%, 56.3%, and 39.9%, respectively. MABE incidence was highest in older, female, and Black individuals. In HRS, the adjusted OR in those with GVH was 0.50 (95% CI 0.34-0.73) for MABE, 0.71 (95% CI 0.51-0.99) for MACE, and 0.59 (95% CI 0.43-0.82) for MACABE. Conclusions: These data suggest that MABE is common among patients with hypertension, even in administrative datasets which are expected to have lower event rates. MABE may be useful for interventions that target brain health.

Antithrombotic treatment after stroke due to intracerebral haemorrhage.

Antithrombotic treatment after stroke due to intracerebral haemorrhage.

Cardiovascular outcomes and mortality after incident ischaemic stroke in patients with a recent cancer history

Background: Up to 10% of patients with ischaemic stroke have comorbid cancer and stroke in these patients is thought to have a poor short-term prognosis. There is little known about the long-term cardiovascular morbidity and mortality outcomes after incident ischaemic stroke in patients with recent cancer history.Objective: To assess the risk of subsequent cardiovascular morbidity and mortality outcomes in patients with an incident ischaemic stroke and recent cancer history.Methods: Patients aged ≥18 years with an incident ischaemic stroke between 1998 and 2017, with any diagnosis of cancer within 12 months before the stroke event, and no prior history of serious vascular event were identified from UK Clinical Practice Research Datalink (CPRD GOLD) linked to Hospital Episode Statistics (HES) data. To minimize selection bias, these patients were propensity-score matched with patients with incident ischaemic stroke and no history of cancer. Propensity-score matching was done using covariates such as demographic data, vascular risk factors, comorbid conditions, and prescribed medication. Multivariable models (Competing risks and Cox regression) were used to determine the risk of subsequent major adverse cardiovascular event (MACE) outcomes and all-cause mortality.Results: Our cohort included 22,460 patients with a median age of 75 (IQR 64–83) years and a follow-up of 12.3 (IQR 7.2–16.7) years. Recent cancer was identified in 1,149 patients (5.1%) at the time of incident ischaemic stroke. The patients with recent cancer history had a lower risk of composite MACE (sub-distribution hazard ratio (SHR) 0.83 [95% CI: 0.75–0.92]) and recurrent stroke (SHR 0.85 95% CI:0.75–0.96]) and a higher risk of all-cause mortality (hazard ratio 1.67 [95% CI:1.47–1.91]). The risk of coronary heart disease, peripheral vascular disease, heart failure, and CVD-related death outcomes did not differ significantly between the groups.Conclusions: After incident ischaemic stroke, patients with recent cancer history have a lower risk of composite MACE and recurrent stroke outcomes but a higher risk of all-cause mortality when compared with patients without a prior history of cancer.

Abstract 11787: Impact of Estimated Plasma Volume Status on Clinical Outcomes in Lower Extremity Artery Disease Patients Who Underwent Endovascular Therapy

Introduction: Lower extremity artery disease (LEAD) is an arterial occlusive disease associated with high morbidity and mortality. Estimated plasma volume status (ePVS), a marker of plasma volume expansion and contraction, is gaining attention in the field of cardiovascular disease. However, it remains undetermined the impact of ePVS on clinical outcome in patients with LEAD. Methods: We calculated two ePVS using Kaplan-Hakim and Duarte formula in 288 LEAD patients who underwent first endovascular therapy and retrospectively followed during a median follow-up period of 617 days. The primary and secondary endpoints were composite events including all-cause death and major adverse limb events (Death/MALE) and major adverse cardiovascular events (MACE), respectively. Results: ePVS significantly increased with advancing Fontaine class. All patients were divided into two groups based on the median ePVS value. Kaplan-Meier analysis demonstrated high ePVS group had higher incidence of composite events and MACE compared to low ePVS group. A multivariate Cox proportional hazard analysis revealed that ePVS was an independent predictor of Death/MALE and MACE after adjustment for confounding risk factors. Prognostic ability for Death/MALE was significantly improved by addition of ePVS to the basic predictors. These results are consistent with each formula. Conclusions: ePVS was associated with severity of LEAD and clinical outcome, suggesting ePVS could be an additional risk factor for Death/MALE and MACE in LEAD patients who underwent endovascular therapy.

Association of Prior Intracerebral Hemorrhage With Major Adverse Cardiovascular Events

Patients with stroke due to nontraumatic (spontaneous) intracerebral hemorrhage (ICH) often harbor vascular risk factors and comorbidities, but it is unclear which major adverse cardiovascular events (MACEs) occur more frequently among patients with a prior ICH than the general population. To evaluate the risk of a MACE for patients with a prior ICH compared with the general population. This cohort study identified 8991 patients with a first ICH in the Danish Stroke Registry from January 1, 2005, to June 30, 2018, who were aged 45 years or older and survived more than 30 days after an ICH. Patients in this ICH cohort were matched 1:40 on age, sex, and ICH-onset date with a comparison cohort of 359 185 individuals from the general population without a prior ICH. Both cohorts were followed up for 6 months or more until December 31, 2018, for outcomes using registry data. Data were analyzed from October 1, 2021, to July 19, 2022. Intracerebral hemorrhage identified by a nationwide clinical database. The main outcomes were ICH, ischemic stroke, myocardial infarction, and a composite of MACEs. For each outcome, a case-control study nested within the cohorts was also performed, adjusting for time-varying exposures and potential confounders. Crude absolute event rates per 100 person-years, adjusted hazard ratios (aHRs) and 95% CIs and, in the nested case-control analyses, crude and adjusted odds ratios and 95% CIs were calculated. The ICH cohort (n = 8991; 4814 men [53.5%]; mean [SD] age, 70.7 [11.5] years) had higher event rates than the comparison cohort (n = 359 185; 192 256 men [53.5%]; mean [SD] age, 70.7 [11.5] years) for MACEs (4.16 [95% CI, 3.96-4.37] per 100 person-years vs 1.35 [95% CI, 1.33-1.36] per 100 person-years; aHR, 3.13 [95% CI, 2.97-3.30]), ischemic stroke (1.52 [95% CI, 1.40-1.65] per 100 person-years vs 0.56 [95% CI, 0.55-0.57] per 100 person-years; aHR, 2.64 [95% CI, 2.43-2.88]), and ICH (1.44 [95% CI, 1.32-1.56] per 100 person-years vs 0.06 [95% CI, 0.06-0.07] per 100 person-years; aHR, 23.49 [95% CI, 21.12-26.13]) but not myocardial infarction (0.52 [95% CI, 0.45-0.60] per 100 person-years vs 0.48 [95% CI, 0.47-0.49] per 100 person-years; aHR, 1.12 [95% CI, 0.97-1.29]). Nested case-control analyses returned risk estimates of similar magnitude as the cohort analyses. The findings of this cohort study suggest that Danish patients with a prior ICH had statistically significantly higher rates of MACEs than the general population, indicating a need for attention to optimal secondary prevention with blood pressure lowering and antithrombotic and statin therapies after an ICH in clinical research and practice.

Comparison between ticagrelor and clopidogrel in high bleeding risk patients with acute coronary syndrome

Abstract Background Potent antiplatelet agents such as ticagrelor are associated with a lower risk of ischemic events than clopidogrel in patients with acute coronary syndrome (ACS). However, it is uncertain whether the benefits of more intensive anti-ischemic therapy outweigh the risks of major bleeding in individuals who have a high bleeding risk (HBR). This study aimed to assess treatment outcomes following dual antiplatelet therapy (DAPT) using either ticagrelor or clopidogrel in ACS patients with HBR. Methods All HBR patients enrolled in the SWEDEHEART registry who were discharged with DAPT using ticagrelor or clopidogrel following ACS between 2010 and 2017 were included in this study. Bleeding risk was assessed using the 4-item PRECISE-DAPT score, which consists of age, prior bleeding, haemoglobin concentration and creatinine clearance. HBR was defined as a PRECISE-DAPT score ≥25. Inverse-probability of treatment weighting was used to adjust for baseline differences between the treatment groups. The main analysis consisted of a doubly robust estimation of causal effect using Cox proportional hazards models. Data on major bleeding, recurrent myocardial infarction (MI), ischemic stroke and all-cause mortality was obtained from national registries, with 365 days of follow-up. Additional outcomes include major adverse cardiovascular events (MACE), a composite of MI, ischemic stroke and all-cause mortality, and net adverse clinical events (NACE), a composite of MACE and major bleeding. Results Of all ACS patients, 36% (n=25,042) had a PRECISE-DAPT score ≥25. Approximately half of the study participants were treated with ticagrelor (n=11,848). Ticagrelor reduced the risk of MI (hazard ratio [HR], 0.82 [95% CI 0.74–0.91]), ischemic stroke (HR, 0.73 [95% CI 0.60–0.88]) and MACE (HR, 0.90 [95% CI 0.84–0.97]), while also increasing the risk of major bleeding compared to clopidogrel (HR, 1.30 [95% CI 1.16–1.47]). We found no significant differences in all-cause mortality (HR 1.02 [95% CI 0.92–1.12]) and NACE (HR 0.98 [95% CI 0.92–1.05]). Conclusions Ticagrelor was associated with a lower risk of recurrent ischemic events, but a higher risk of major bleeding compared to clopidogrel. There were no significant differences in all-cause mortality and NACE between the treatment groups. These results suggest that more potent antiplatelet agents might not be superior to clopidogrel in ACS patients with HBR. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): Stockholm county council

Long-term effects of phosphodiesterase-5 inhibitors on cardiovascular outcomes and death: a systematic review and meta-analysis of cohort studies

Abstract Background Phosphodiesterase type 5 inhibitors (PDE-5i), which are widely used for the treatment of erectile dysfunction, have been found to exhibit systemic vascular benefits by improving endothelial function possibly lowering the risk for cardiovascular events and death. Purpose We sought to evaluate the effects of PDE5i on long-term cardiovascular outcomes and mortality. Methods A comprehensive search of electronic databases was conducted up to February 28, 2022. Cohort studies comparing PDE5i treatment at any dose with placebo or no treatment and a minimum follow-up duration of 6 months were considered eligible. The outcomes of interest were: (1) major adverse cardiovascular events (MACE) and (2) all-cause mortality. Pooled risk ratios (RR) with 95% confidence intervals (CI) were calculated. Results Eight trials were included (1,152,106 subjects, 8.5% treated with PDE5i). All were males [median age 61.5 years (range 30–72.8)]. The median follow-up duration was 3.8 years (range 2.3–7.5) across the studies. PDE5i use was associated with significant reduction in the composite of MACE [RR 0.79, 95% confidence intervals (CI) 0.69–0.91] (Figure 1). In addition, the analysis of pooled data from 5 studies, after removal of a study with a relatively small sample size, demonstrated that the use of PDE5i was associated with a significantly lower risk of all-cause mortality (RR 0.70, 95% CI 0.53–0.91) (Figure 2). Focusing on patients with a history of coronary artery disease, PDE5i was also found to reduce the risk of all-cause mortality by 15% (RR 0.85, 95% CI 0.74–0.98). Conclusion The use of PDE5i in men with or without known coronary artery disease was associated with a lower risk of cardiovascular events and overall mortality. This information underlines that PDE5i could provide considerable clinical benefit beyond the treatment of ED and could instigate the conduction of further, large-scale randomized clinical trials. Funding Acknowledgement Type of funding sources: None.

The change in nutritional status is related to cardiovascular events in patients with pacemaker implantation: A 4-year follow-up study.

BackgroundThe aim of our study was to evaluate changes in nutritional status as measured by the prognostic nutritional index (PNI) and geriatric nutritional risk index (GNRI) scores, and their abilities to predict clinical prognosis in patients with pacemaker implantation (PMI).MethodsA total of 595 patients who underwent permanent PMI from January 2011 to December 2020 were included. PNI and GNRI scores were separately calculated at the beginning day of PMI operation and at the end of 12-month follow-up, and their net changes (Δ) were calculated by PNI or GNRI scores at follow-up minus the corresponding scores on admission. The cohort patients were divided into low risk of malnutritional status (ΔPNI or ΔGNRI scores ≥ 0) and high risk of malnutritional status (ΔPNI or ΔGNRI scores < 0) groups. Primary outcome measure was a composite major adverse cardiovascular event (MCE), defined as heart failure hospitalization (HFH), myocardial infarction (MI), stroke, or death from any cause, presented as hazard ratios (HR) with 95% confidence intervals (CI) calculated by MCE in the crude or multivariate-adjusted Cox Proportional Hazards models. Receiver operating characteristic (ROC) curve analysis was used to compare the differential ability to predict incident MCEs betweenΔPNI andΔGNRI scores.ResultsIn total, 16% of patients developed the MCE during the follow-up. The cumulative event rates determined by Kaplan–Meier analysis were significantly higher in the high risk of malnutritional patients compared to the low risk of malnutritional patients (P < 0.05). Adjusted multivariate analysis showed that decreased PNI scores (HR: 2.228, 95% CI: 1.482–3.350) and decreased GNRI scores (HR: 2.178, 95% CI: 1.439–3.295) were independently associated with favorable outcomes. ROC curve analysis revealed an area under curve (AUC) of 0.586 forΔPNI scores and AUC of 0.592 for ΔGNRI scores, but their predictive abilities were not statistically different.ConclusionEither positive change of PNI or GNRI scores were associated with reduced risk of MCEs in patients with PMI, and they have similar ability to predict clinical cardiometabolic risk. Additional enhancing nutritional status during follow-up may help to prevent unfavorable prognosis in clinical practices.

Use of Contrave, Naltrexone with Bupropion, Bupropion, or Naltrexone and Major Adverse Cardiovascular Events: A Systematic Literature Review.

Naltrexone/Bupropion extended release (ER; Contrave) is an extended-release, fixed-dose combination medication of naltrexone (8 mg) and bupropion (90 mg) for patients with obesity or overweight with at least one weight-related comorbidity. Obese and overweight patients with or without comorbidities are at increased cardiovascular (CV) risk. Due to the increased CV risk profile in this patient population, this systematic literature review was conducted to assess human studies reporting major adverse CV events (MACE) and other CV events. A priori eligibility criteria included clinical studies (randomized and observational) published from January 1, 2012, to September 30, 2021, with data comparing users of naltrexone/bupropion ER, naltrexone with bupropion, bupropion without naltrexone, or naltrexone without bupropion versus comparator groups (placebo or other treatments), and with sufficient information to determine the frequency of MACE or other CV adverse events by treatment group. Among 2539 English-language articles identified, 70 articles met the eligibility criteria: seven studies of naltrexone/bupropion ER or naltrexone with bupropion, 32 studies of bupropion, and 31 studies of naltrexone. No studies reported an increased risk of MACE among users of naltrexone/bupropion ER, naltrexone with bupropion, or bupropion or naltrexone individually compared with nonusers. One-half of the available studies (n = 35) reported no (zero) CV events and the other half (n = 35) reported that a non-zero frequency of CV events occurred. Four studies reported data on MACE, including three studies of bupropion and one study of naltrexone/bupropion ER. For composite MACE and its components, the difference in proportions between naltrexone/bupropion ER-, bupropion-, or naltrexone-treated patients compared with active comparators or placebo-treated patients did not exceed 2.5%. In conclusion, the available human evidence does not indicate an increased risk of CV events or MACE following use of naltrexone/bupropion ER, naltrexone with bupropion, or the individual components.

Dynamic changes in soluble suppression of tumorigenicity 2 levels predict major adverse cardiovascular events in patients with ST‑segment elevation myocardial infarction.

We aimed to investigate the role of sST2 in predicting MACEs in STEMI patients after primary percutaneous coronary intervention (pPCI). A total of 350 patients were enrolled in this study. The levels of sST2, N‑terminal pro-B‑type natriuretic peptide (NT‑proBNP), cardiac troponin I (TnI), and creatine kinase-MB (CK‑MB) were measured on admission as well as 24 hours and 5 days after pPCI. The end point was the incidence of MACEs. Compared with the values on admission, sST2 levels increased 24 hours post pPCI and decreased significantly at day 5 after the procedure in the whole cohort. The pattern of sST2 level changes between the 3 time points was similar in the MACE and MACE‑free groups. Notably, the change in the sST2 level from admission to 24 hours post pPCI (Δ1sST2) was significantly higher in the MACE group. After multivariable adjustment, Δ1sST2 was an independent risk factor for MACEs, with an area under the curve of 0.621 (95% CI, 0.547-0.695). Patients with a greater Δ1sST2 had a significantly higher incidence of composite MACEs, coronary revascularization, and cardiac rehospitalization. However, the change in sST2 levels from admission to 5 days post pPCI, as well as the dynamic changes in NT‑proBNP, TnI, and CK‑MB levels had no predictive value. The increase in plasma sST2 levels from admission to 24 hours post pPCI has a potential value for independently predicting the incidence of coronary revascularization and cardiac rehospitalization at 1 year in patients with STEMI.

Major adverse cardiovascular events following acute coronary syndrome in patients with bipolar disorder

BackgroundPersons with bipolar disorder (BD) have a higher cardiovascular mortality compared to the general population, partially explained by the increased burden of cardiovascular risk factors. Research regarding outcomes following acute coronary syndrome (ACS) in this population remains scarce. DesignThis Danish register-based study included patients diagnosed with BD and ACS in the period between January 1st, 1995, to December 31st, 2013. Study participants were matched 1:2 to patients without BD on sex, date of birth, time of ACS diagnosis and comorbidities. The primary outcome of interest was major adverse cardiovascular events (MACE) a composite of all-cause mortality, reinfarction or stroke. MACE and its individual components were compared between patients with and without BD. Results796 patients with BD were compared to 1592 patients without BD, both groups had a mean age of first ACS of 66.5 years. MACE was 38% increased (HR 1.38 95% CI 1.25–1.54), all-cause mortality was 71% increased (HR 1.71 95% CI 1.52–1.92), stroke was 94% increased (HR 1.94 95% CI 1.56–2.41) and reinfarction rates were 17% lower (HR 0.83 95% CI 0.69–1.00) in the BD population compared to the population without BD. We also found higher prevalences of heart failure (9.1% vs. 6.5%), valve disease (5.3% vs. 3.5%), anemia (8.7% vs. 5.8%), chronic obstructive pulmonary disease (13.4% vs. 9.3%) and stroke (11.8% vs. 7.8%) in the population with BD at baseline, all p-values <0.05. ConclusionBipolar disorder was associated with a higher risk of composite MACE, all-cause mortality, and stroke, after ACS compared to patients without BD.

The effect of vitamin D supplementation on cardiovascular risk in patients with prediabetes: A secondary analysis of the D2d study

AimsLow blood 25(OH)D level is associated with increased cardiovascular disease (CVD) risk. Additionally, individuals with prediabetes are at higher risk for CVD than individuals with normoglycemia. We investigated the effects of vitamin D supplementation on CVD outcomes in the vitamin D and type 2 diabetes (D2d) study, a large trial among adults with prediabetes. Methods2423 participants were randomized to 4000 IU/day of vitamin D3 or placebo and followed for median 3.0 years for new-onset diabetes. In pre-specified secondary analyses, we examined the effect of vitamin D supplementation on composite Major Adverse Cardiovascular Events (MACE); expanded MACE (MACE + revascularization); atherosclerotic CVD (ASCVD) risk score; and individual CVD risk factors (blood pressure, lipids, high-sensitivity C-reactive protein). Cox models compared hazard ratios (HR) between the two groups on MACE and expanded MACE. ResultsMean age was 60 years, 45 % were women, 13 % had history of CVD. Twenty-one participants assigned to vitamin D and 12 participants assigned to placebo met the MACE outcome (HR 1.81, 95%CI 0.89 to 3.69). There were 27 expanded MACE outcomes in each group (HR 1.02, 95%CI, 0.59 to 1.76). There were no significant differences between vitamin D and placebo in individual CVD risk factors, but change in ASCVD risk score favored the vitamin D group (−0.45 %, 95%CI -0.75 to −0.15). ConclusionsIn people with prediabetes not selected for vitamin D insufficiency and with intermediate CVD risk, vitamin D supplementation did not decrease MACE but had a small favorable effect on ASCVD risk score.Trial registration: D2d ClinicalTrials.gov number, NCT01942694, prospectively registered September 16, 2013.

A Randomized Controlled Trial Evaluating Outcome Impact of Cilostazol in Patients with Coronary Artery Disease or at a High Risk of Cardiovascular Disease.

Previous studies found that cilostazol has a favorable effect on glucose and lipid homeostasis, endothelial function, atherosclerosis, and vasculo-angiogenesis. However, it is poorly understood whether these effects can translate into better clinical outcomes. This study investigated the outcome effect of cilostazol in patients with coronary artery disease (CAD) or at a high risk of cardiovascular (CV) disease. We conducted a randomized, double-blind, placebo-controlled trial involving 266 patients who received cilostazol, 200 mg/day (n = 134) or placebo (n = 132). Pre-specified clinical endpoints including composite major adverse cardiovascular events (MACE) (CV death, non-fatal myocardial infarct, non-fatal stroke, hospitalization for heart failure, or unplanned coronary revascularization), the composite major coronary event (MCE) and major adverse CV and cerebrovascular event (MACCE), were prospectively assessed. The mean duration of follow-up was 2.9 years. Relative to placebo, cilostazol treatment had a borderline effect on risk reduction of MACE (hazard ratio [HR], 0.67; 95% confidence interval (CI), 0.34–1.33), whereas the beneficial effect in favor of cilostazol was significant in patients with diabetes mellitus or a history of percutaneous coronary intervention (p for interaction, 0.02 and 0.06, respectively). Use of cilostazol, significantly reduced the risk of MCE (HR, 0.38; 95% CI, 0.17–0.86) and MACCE (HR, 0.47; 95% CI, 0.23–0.96). A significantly lower risk of angina pectoris (HR, 0.38; 95% CI, 0.17–0.86) was also observed in the cilostazol group. After multi-variable adjustment, cilostazol treatment independently predicted a lower risk of MCE. In conclusion, these results suggest cilostazol may have beneficial effects in patients with CAD or at a high risk of CV disease.

No Paradoxical Effect of Smoking Status on Recurrent Cardiovascular Events in Patients Following Percutaneous Coronary Intervention: Thai PCI Registry.

Background“Smoker's paradox” is a controversial phenomenon that describes an unexpectedly favorable short-term outcome of smokers post-percutaneous coronary intervention (PCI). This study aimed to evaluate the effect of smoking status on recurrent major adverse cardiovascular events (MACEs) in patients who recently underwent PCI and to determine whether it was paradoxical.MethodsThis study utilized data from the nationwide Thai PCI registry, enrolling patients during 2018–2019. Our study factor was smoking status, classified as current smokers, ex-smokers, and nonsmokers. The outcome of interest was the time to occurrence of a composite of MACEs (i.e., all-cause death, myocardial infarction (MI), stroke, and unplanned revascularization) evaluated at about 1-year post-PCI. A propensity score (PS) model using inverse probability weighting with regression adjustment was used to estimate the effect of smoking on the occurrence of MACE.ResultsCurrent smokers, ex-smokers, and non-smokers accounted for 23, 32, and 45% of the 22,741 subjects, respectively. Smokers were younger, more frequently male, and had fewer traditional atherosclerotic risk factors. Current smokers presented more frequently with ST-elevation MIs (STEMIs) and cardiogenic shock (54 and 14.6%, respectively) than non-smokers. MACE rates were 1.9, 1.2, and 1.6 per 100 patients per month in the current smokers, ex-smokers, and non-smokers, respectively. After applying a PS, patients with a history of current smoking and ex-smoking developed the onset of recurrent MACEs significantly sooner than non-smokers, with a median time of 4.4 vs. 4.9 vs. 13.5 months (p < 0.001), respectively.Conclusions“Smoker's paradox” was not observed in our patient population. Current smokers and ex-smokers were prone to develop an earlier onset of a post-PCI MACEs than nonsmokers and need a smoke cessation program for further prevention.

Coronary Atherosclerosis, Cardiac Troponin, and Interleukin-6 in Patients With Chest Pain: The PROMISE Trial Results

BackgroundIncreased inflammation and myocardial injury can be observed in the absence of myocardial infarction or obstructive coronary artery disease (CAD). ObjectivesThe authors determined whether biomarkers of inflammation and myocardial injury—interleukin (IL)-6 and high-sensitivity cardiac troponin (hs-cTn)—were associated with the presence and extent of CAD and were independent predictors of major adverse cardiovascular events (MACEs) in stable chest pain. MethodsUsing participants from the PROMISE trial, the authors measured hs-cTn I and IL-6 concentrations and analyzed computed tomography angiography (CTA) images in the core laboratory for CAD characteristics: significant stenosis (≥70%), high-risk plaque (HRP), Coronary Artery Disease Reporting and Data System (CAD-RADS) categories, segment involvement score (SIS), and coronary artery calcium (CAC) score. The primary endpoint was a composite MACE (death, myocardial infarction, or unstable angina). ResultsThe authors included 1,796 participants (age 60.2 ± 8.0 years; 47.5% men, median follow-up 25 months). In multivariable linear regression adjusted for atherosclerotic cardiovascular disease (ASCVD) risk, hs-cTn was associated with HRP, stenosis, CAD-RADS, and SIS. IL-6 was only associated with stenosis and CAD-RADS. hs-cTn above median (1.5 ng/L) was associated with MACEs in univariable analysis (HR: 2.1 [95% CI: 1.3-3.6]; P = 0.006), but not in multivariable analysis adjusted for ASCVD and CAD. IL-6 above median (1.8 ng/L) was associated with MACEs in multivariable analysis adjusted for ASCVD and HRP (HR: 1.9 [95% CI: 1.1-3.3]; P = 0.03), CAC (HR: 1.9 [95% CI: 1.0-3.4]; P = 0.04), and SIS (HR: 1.8 [95% CI: 1.0-3.2]; P = 0.04), but not for stenosis or CAD-RADS. In participants with nonobstructive CAD (stenosis 1%-69%), the presence of both hs-cTn and IL-6 above median was strongly associated with MACEs (HR: 2.5-2.7 after adjustment for CAD characteristics). ConclusionsConcentrations of hs-cTn and IL-6 were associated with CAD characteristics and MACEs, indicating that myocardial injury and inflammation may each contribute to pathways in CAD pathophysiology. This association was most pronounced among participants with nonobstructive CAD representing an opportunity to tailor treatment in this at-risk group. (PROspective Multicenter Imaging Study for Evaluation of Chest Pain [PROMISE]; NCT01174550)

Abstract 63: The Impact Of Percutaneous Coronary Intervention On Transcatheter Aortic Valve Replacement Outcomes

Background: Many patients undergoing transcatheter aortic valve replacement (TAVR) for aortic stenosis also have significant coronary artery disease (CAD). Although the impact of planned percutaneous coronary intervention (PCI) before TAVR has been studied, a clear strategy for timing of PCI has yet to be determined. Additionally, the effects of emergent PCI for acute coronary syndrome (ACS) prior to TAVR have not been investigated. The purpose of this study is to evaluate the impact of both emergent and planned pre-TAVR PCI on outcomes, namely major adverse cardiovascular events (MACE). Methods: Retrospective analysis of electronic medical records from 2018-2020 at the University of Illinois at Chicago and affiliated Veterans Affairs identified all TAVR patients. Patients were placed into one of three groups: those who had TAVR within 6 months of urgent/emergent PCI for ACS, those who had TAVR within 6 months of planned PCI for stable ischemic heart disease (SIHD), and those who did not have PCI in that time period. Primary outcomes included composite MACE (all-cause mortality, MI, or CVA) at 6 and 12 months. Results: Of 152 patients, 78% (118) were male and 56% (85) were non-white. In the 6 months prior to TAVR, 5 patients underwent PCI for ACS, 49 underwent PCI for SIHD, and 98 did not have PCI. There were no differences in co-morbidities including DM, HTN, CHF, and CKD between the three groups. No significant difference in outcomes were identified at 6 months. At 12 months, 80% (4/5) of patients with PCI for ACS had MACE compared to 20.4% (10/49) in patients with PCI for SIHD, and 14.3% (14/98) in patients with no PCI (p=0.001). All-cause mortality at 12 months was 60% (3/5) for patients with PCI for ACS, 12.2% (6/49) for patients with PCI for SIHD, and 13.3% (13/98) for patients with no PCI (p=0.01). Conclusion: Our findings suggest that patients requiring PCI for ACS close to TAVR are at higher risk for poor outcomes compared to those with non-emergent PCI, or no PCI. Their 12 month mortality also exceeds expected mortality for patients who undergo PCI for ACS without TAVR. For this reason, these patients may require more careful follow up post-procedurally. It remains uncertain whether delay of TAVR for these patients improves outcomes.