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1.
Artigo em Inglês | MEDLINE | ID: mdl-36183395

RESUMO

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has increasingly been utilized in patients with bicuspid aortic valve (BAV) related aortic stenosis (AS) with insufficient large-scale data on its safety. METHODS: The Nationwide Inpatient Sample and Nationwide Readmission Database (2011-2018) were queried to identify patients undergoing TAVI for BAV versus trileaflet aortic valve (TAV) associated AS. The in-hospital, 30- and 180-day odds of outcomes were assessed using a propensity-matched analysis (PSM) to calculate adjusted odds ratios (aOR) with its 95% confidence interval (CI). RESULTS: A total of 216,723 TAVI (TAV: 214,050 and BAV: 2,673) crude and 5,347 matched population (TAV: 2,674 and BAV: 2,673) was included in the final analysis. At index admission, the adjusted odds of in-hospital mortality (aOR: 1.57, 95% CI: 0.67-3.66), stroke (aOR: 0.77, 95% CI: 0.38-1.57), cardiac tamponade (aOR: 0.75, 95% CI: 0.17-3.36), vascular complications (aOR: 0.33, 95% CI: 0.09-1.22), cardiogenic shock (aOR: 1.77, 95% CI: 0.93-3.38), paravalvular leak (aOR: 0.55, 95% CI: 0.26-1.14), need for mechanical circulatory support device, and permanent pacemaker implantation (PPM) (aOR: 1.02, 95% CI: 0.69-1.52) were not significantly different between TAVI for BAV versus TAV. At 30- and 180-day follow-up duration, the risk of stroke and major postprocedural complications remained similar, except that TAVI in BAV had a higher incidence of PPM implantation compared with TAV. The yearly trend showed an increase in the utilization of TAVI for both TAV and BAV and a steady decline in the overall annual rate of in-hospital complications. CONCLUSION: TAVI utilization in patients with BAV has increased over the recent years. The relative odds of in-hospital mortality, and all other major complications, were similar between patients undergoing TAVI for BAV- and TAV-related AS.

2.
Hypertension ; : 101161HYPERTENSIONAHA12219882, 2022 Sep 16.
Artigo em Inglês | MEDLINE | ID: mdl-36111537

RESUMO

BACKGROUND: Hypertension control has worsened nationally, and treatment intensification is important for control. National trends for appropriate blood pressure intensification for older adults are unknown. We determine the proportion of ambulatory visits where older adults with hypertension were appropriately intensified on antihypertensives from 2008 to 2018. METHODS: Data from National Ambulatory Medical Care Survey were used. National Ambulatory Medical Care Survey is a nationally representative sample of ambulatory visits. Adults 60 years or older were included. Appropriate antihypertensive intensification was defined as addition of an antihypertensive for a blood pressure reading above target. We examined appropriate intensification by blood pressure targets set by the American College of Cardiology-American Heart Association, the European Society of Cardiology, and the American College of Physicians-American Academy of Family Physicians guidelines for older adults. Further, we defined an additional all-inclusive criterion meeting all 3 guidelines. RESULTS: From 2008 to 2018, appropriate intensification by American College of Cardiology/American Heart Association occurred at 11.1% (95% CI, 9.8%-12.5%) of visits, decreasing from 13.6% (95% CI, 15.6%-28.7%) of visits in 2008 to 2009 to 10.4% (95% CI, 10.9%-26.4%) in 2015 to 2018. Appropriate intensification by European Society of Cardiology occurred at 14.2% (12.1%-16.6%) of visits over 2008 to 2018, decreasing from 16.9% (95% CI, 13.5%-21.0%) in 2008 to 2009 to 12.5% (95% CI, 7.4%-20.3%) from 2015 to 2018. Appropriate intensification by American Academy of Family Physicians/American College of Physicians occurred at 18.9% (16.2%-22.0%) of visits over 2008 to 2018, decreasing from 24.7% (95% CI, 20.2%-29.0%) in 2008 to 2009 to 14.9% (95% CI, 9.0%-23.7%) from 2015 to 2018. By all-inclusive criteria, intensification trended toward worsening with time: odds ratio: 0.93 ([95% CI, 0.87-1.00]; P=0.07). CONCLUSIONS: Appropriate treatment intensification for older adults with hypertension in the United States was suboptimal over the past decade.

3.
Glob Heart ; 17(1): 54, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36051328

RESUMO

Background: Dysglycemia is a major and increasingly prevalent cardiometabolic risk factor worldwide, but is often undiagnosed even in high-risk patients. We evaluated the impact of protocolized screening for dysglycemia on the prevalence of prediabetes and diabetes among patients presenting with ST-segment elevation myocardial infarction (STEMI) in North India. Methods: We conducted a prospective NORIN STEMI registry-based study of patients presenting with STEMI to two government-funded tertiary care medical centers in New Delhi, India, from January to November 2019. Hemoglobin A1c (HbA1c) was collected at presentation as part of the study protocol, irrespective of baseline glycemic status. Results: Among 3,523 participants (median age 55 years), 855 (24%) had known diabetes. In this group, baseline treatment with statins, sodium-glucose cotransporter 2 inhibitors, or glucagon-like peptide-1 receptor agonists was observed in 14%, <1%, and 1% of patients, respectively. For patients without known diabetes, protocolized inpatient screening identified 737 (28%) to have prediabetes (HbA1c 5.7-6.4%) and 339 (13%) to have newly detected diabetes (HbA1c ≥ 6.5%). Patients with prediabetes (49%), newly detected diabetes (53%), and established diabetes (48%) experienced higher rates of post-MI LV dysfunction as compared to euglycemic patients (42%). In-hospital mortality (5.6% for prediabetes, 5.1% for newly detected diabetes, 10.3% for established diabetes, 4.3% for euglycemia) and 30-day mortality (8.1%, 7.6%, 14.4%, 6.6%) were higher in patients with dysglycemia. Compared with euglycemia, prediabetes (adjusted odds ratio (aOR) 1.44 [1.12-1.85]), newly detected diabetes (aOR 1.57 [1.13-2.18]), and established diabetes (aOR 1.51 [1.19-1.94]) were independently associated with higher odds of composite 30-day all-cause mortality or readmission. Conclusions: Among patients presenting with STEMI in North India, protocolized HbA1c screening doubled the proportion of patients with known dysglycemia. Dysglycemia was associated with worse clinical outcomes at 30 days, and use of established pharmacotherapeutic risk-reduction strategies among patients with known diabetes was rare, highlighting missed opportunities for screening and management of dysglycemia among high-risk patients in North India.


Assuntos
Diabetes Mellitus , Infarto do Miocárdio , Estado Pré-Diabético , Infarto do Miocárdio com Supradesnível do Segmento ST , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/epidemiologia , Hemoglobina A Glicada/análise , Humanos , Pessoa de Meia-Idade , Estado Pré-Diabético/diagnóstico , Estado Pré-Diabético/epidemiologia , Estado Pré-Diabético/terapia , Estudos Prospectivos , Sistema de Registros , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/epidemiologia , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia
4.
J Clin Lipidol ; 2022 Aug 23.
Artigo em Inglês | MEDLINE | ID: mdl-36153281

RESUMO

Elevated red blood cell distribution width (RDW) is associated with increased risk for major adverse cardiovascular events (MACE) and death in patients with cardiovascular disease. The ODYSSEY OUTCOMES trial compared alirocumab with placebo in 18,924 patients with recent acute coronary syndrome (ACS) and elevated atherogenic lipoproteins despite optimized statin treatment. This post hoc analysis determined whether RDW independently predicts risk of MACE and death in patients after recent ACS, whether RDW influences MACE reduction with alirocumab, and whether alirocumab treatment affects RDW. Associations of baseline RDW with risk of MACE and death were analyzed in the placebo group in adjusted proportional hazards models. Interactions of RDW and treatment on the risk of MACE and death were evaluated. An increasing quartile of RDW was associated with characteristics that predicted risk of MACE and death including age, hypertension, diabetes, atherosclerotic conditions and events, revascularizations, low-density lipoprotein cholesterol, and high-sensitivity C-reactive protein. After adjusting for baseline characteristics associated with the risk of MACE or death, baseline RDW remained independently associated with the risk of MACE and death in the placebo group (hazard ratios [95% confidence intervals] 1.08 [1.02-1.15] and 1.13 [1.03-1.24] per 1% increase of RDW, respectively, both p <0.001). There was no interaction of RDW and treatment on MACE or death, nor did alirocumab affect RDW. RDW was associated with an increased risk of MACE and death, independent of established risk factors.

5.
Lancet ; 2022 Sep 16.
Artigo em Inglês | MEDLINE | ID: mdl-36130612

RESUMO

BACKGROUND: The SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) trial showed the safety but not efficacy of the Symplicity system (Medtronic, Santa Rosa, CA, USA) at 6 months follow-up in patients with treatment-resistant hypertension. This final report presents the 36-month follow-up results. METHODS: SYMPLICITY HTN-3 was a single-blind, multicentre, sham-controlled, randomised clinical trial, done in 88 centres in the USA. Adults aged 18-80 years, with treatment-resistant hypertension on stable, maximally tolerated doses of three or more drugs including a diuretic, who had a seated office systolic blood pressure of 160 mm Hg or more and 24 h ambulatory systolic blood pressure of 135 mm Hg or more were randomly assigned (2:1) to receive renal artery denervation using the single electrode (Flex) catheter or a sham control. The original primary endpoint was the change in office systolic blood pressure from baseline to 6 months for the renal artery denervation group compared with the sham control group. Patients were unmasked after the primary endpoint assessment at 6 months, at which point eligible patients in the sham control group who met the inclusion criteria (office blood pressure ≥160 mm Hg, 24 h ambulatory systolic blood pressure ≥135 mm Hg, and still prescribed three or more antihypertensive medications) could cross over to receive renal artery denervation. Changes in blood pressure up to 36 months were analysed in patients in the original renal artery denervation group and sham control group, including those who underwent renal artery denervation after 6 months (crossover group) and those who did not (non-crossover group). For comparisons between the renal artery denervation and sham control groups, follow-up blood pressure values were imputed for patients in the crossover group using their most recent pre-crossover masked blood pressure value. We report long-term blood pressure changes in renal artery denervation and sham control groups, and investigate blood pressure control in both groups using time in therapeutic blood pressure range analysis. The primary safety endpoint was the incidence of all-cause mortality, end stage renal disease, significant embolic event, renal artery perforation or dissection requiring intervention, vascular complications, hospitalisation for hypertensive crisis unrelated to non-adherence to medications, or new renal artery stenosis of more than 70% within 6 months. The trial is registered with ClinicalTrials.gov, NCT01418261. FINDINGS: From Sep 29, 2011, to May 6, 2013, 1442 patients were screened, of whom 535 (37%; 210 [39%] women and 325 [61%] men; mean age 57·9 years [SD 10·7]) were randomly assigned: 364 (68%) patients received renal artery denervation (mean age 57·9 years [10·4]) and 171 (32%) received the sham control (mean age 56·2 years [11·2]). 36-month follow-up data were available for 219 patients (original renal artery denervation group), 63 patients (crossover group), and 33 patients (non-crossover group). At 36 months, the change in office systolic blood pressure was -26·4 mm Hg (SD 25·9) in the renal artery denervation group and -5·7 mm Hg (24·4) in the sham control group (adjusted treatment difference -22·1 mm Hg [95% CI -27·2 to -17·0]; p≤0·0001). The change in 24 h ambulatory systolic blood pressure at 36 months was -15·6 mm Hg (SD 20·8) in the renal artery denervation group and -0·3 mm Hg (15·1) in the sham control group (adjusted treatment difference -16·5 mm Hg [95% CI -20·5 to -12·5]; p≤0·0001). Without imputation, the renal artery denervation group spent a significantly longer time in therapeutic blood pressure range (ie, better blood pressure control) than patients in the sham control group (18% [SD 25·0] for the renal artery denervation group vs 9% [SD 18·8] for the sham control group; p≤0·0001) despite a similar medication burden, with consistent and significant results with imputation. Rates of adverse events were similar across treatment groups, with no evidence of late-emerging complications from renal artery denervation. The rate of the composite safety endpoint to 48 months, including all-cause death, new-onset end-stage renal disease, significant embolic event resulting in end-organ damage, vascular complication, renal artery re-intervention, and hypertensive emergency was 15% (54 of 352 patients) for the renal artery denervation group, 14% (13 of 96 patients) for the crossover group, and 14% (10 of 69 patients) for the non-crossover group. INTERPRETATION: This final report of the SYMPLICITY HTN-3 trial adds to the totality of evidence supporting the safety of renal artery denervation to 36 months after the procedure. From 12 months to 36 months after the procedure, patients who were originally randomly assigned to receive renal artery denervation had larger reductions in blood pressure and better blood pressure control compared with patients who received sham control. FUNDING: Medtronic.

6.
J Card Fail ; 2022 Sep 18.
Artigo em Inglês | MEDLINE | ID: mdl-36130688

RESUMO

OBJECTIVES: To investigate risk factors and outcomes of cardiogenic shock complicating acute myocardial infarction (AMI-CS) in young AMI patients. BACKGROUND: AMI-CS is associated with high morbidity and mortality. Data regarding AMI-CS in younger individuals are limited. METHODS AND RESULTS: Consecutive type 1 AMI patients aged 18-50 years admitted to two large tertiary care academic centers were included and CS adjudicated by physician review of electronic medical records using the Society for Cardiovascular Angiography and Interventions (SCAI) CS classification system. Outcomes included all-cause mortality (ACM), cardiovascular mortality (CVM) and 1-year hospitalization for heart failure (HHF). In addition to using the full population, matching was also used to define a comparator group in the non-CS cohort. Among 2097 patients (mean age 44 ± 5.1 years, 74% white, 19% female), AMI-CS was present in 148 (7%). Independent risk factors of AMI-CS included STEMI, left main disease, out of hospital cardiac arrest, female sex, peripheral vascular disease and diabetes. Over median follow-up of 11.2 years, young AMI-CS patients had a significantly higher risk of ACM (adjusted HR 2.84, 95% CI 1.68-4.81, p<0.001), CVM (adjusted HR 4.01, 95% CI 2.17-7.71, p<0.001), and 1-year HHF (adjusted HR 5.99, 95% CI 2.04-17.61, p=0.001) compared with matched non-AMI-CS patients. Over the course of the study, there was an increase in the incidence of AMI-CS among young MI patients as well as rising mortality for both AMI-CS and non-AMI-CS patients. CONCLUSIONS: 7% of young AMI patients developed AMI-CS, which was associated with a significantly elevated risk of mortality and HHF. BRIEF LAY SUMMARY: The epidemiology, characteristics and outcomes of young acute myocardial infarction (AMI) patients who develop cardiogenic shock (AMI-CS) is unknown. In this detailed analysis of 2097 patients in the YOUNG-MI registry, AMI patients under the age of 50 years had a 7% incidence of AMI-CS, a condition that was associated with poor short- and long-term outcomes in this population. ST-elevation myocardial infarction, left main disease, cardiac arrest, female sex, peripheral vascular disease and diabetes were all associated with risk of developing AMI-CS. The incidence of AMI-CS has been increasing despite advances in medical and surgical therapies.

7.
J Am Heart Assoc ; 11(18): e026075, 2022 Sep 20.
Artigo em Inglês | MEDLINE | ID: mdl-36102276

RESUMO

Background The emergence of PCSK9i (proprotein convertase subtilisin kexin type 9 inhibitor) and icosapent ethyl (IPE) has expanded the role of lipid-lowering therapies beyond statins. Despite recommendations by clinical practice guidelines, their national eligibility and use rates remain unclear. Methods and Results In the National Health and Nutrition Examination Survey data from 2017 to 2020, we assessed eligibility and the use of statins, PCSK9i, and IPE among US adults according to American College of Cardiology/American Heart Association guideline recommendations. Eligibility for PCSK9i and IPE were determined in the following 2 scenarios: (1) assuming existing lipid-lowering therapy as the maximum tolerated before assessing eligibility for novel therapies and (2) assessing eligibility after assuming initiation and maximal escalation of preexisting lipid-lowering therapies and accounting for expected lipid improvements. Of 2729 sampled individuals, representing 149.3 million adults, 1376 had indications for statins, representing 65.8 million or 44.0% (95% CI, 40.9%-47.2%) of adults. Current statin use was 45% of those eligible and was low across demographic groups. A total of 9.7 and 11.6 million adults would benefit from PCSK9i and IPE, respectively, based on lipid profiles and existing therapies. Assuming maximal escalation of statins and addition of ezetimibe, 4.1% (95% CI, 2.8%-5.4%) of adults or 6.1 million would benefit from PCSK9i and 6.8% (95% CI, 5.4%-8.3%) or 10.2 million from IPE. Conclusions Six and 10 million individuals have clinical profiles whereby PCSK9i and IPE, respectively, would be expected to improve cardiovascular outcomes even after maximum escalation of statins and ezetimibe use, but remain undertreated with lipid-lowering therapies. Optimal use of lipid-targeted agents that include these novel agents is needed to improve population health outcomes.


Assuntos
Inibidores de Hidroximetilglutaril-CoA Redutases , Adulto , Ezetimiba/uso terapêutico , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Inquéritos Nutricionais , Pró-Proteína Convertases , Subtilisinas , Estados Unidos/epidemiologia
8.
Clin Cardiol ; 2022 Sep 19.
Artigo em Inglês | MEDLINE | ID: mdl-36124341

RESUMO

BACKGROUND: Chronic kidney disease (CKD) is a known risk factor of atherosclerotic cardiovascular disease (ASCVD). Per the 2018 American Heart Association/American College of Cardiology cholesterol guidelines, high-risk ASCVD patients with CKD and low-density lipoprotein cholesterol (LDL-C) levels ≥ $\ge $ 70 mg/dL should take a high-intensity statin with ezetimibe and/or a proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i). OBJECTIVE/METHODS: We examined the changes in use of lipid lowering therapies (LLT) over two years in 3304 patients with ASCVD and CKD in the Getting to an imprOved Understanding of Low-Density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD) observational cohort study. RESULTS: Of those with eGFR <60 ml/min/1.73 m2 , 21.6% (171/791) had intensification of LLT while 10.4% (82/791) had de-escalation of LLT. Notably, 61.6% (487/791) had no change in LLT regimen over 2 years. Statin use was 83.2% (785/944) at baseline and 80.1% (634/791) at 2 years. Statin/ezetimibe use increased from 2.9% (27/944) to 4.9% (39/791). Statin discontinuation at 2 years was greater with lower eGFR levels across all cohorts. CONCLUSION: Despite the recommendations of multiscociety guidelines, statin use, while high, is not ubiquitous and rates of high-intensity statin and ezetimibe use remain low in patients with CKD. There remains a significant opportunity to optimize LLT and achieve atheroprotective cholesterol levels in the CKD population.

9.
Ann Rheum Dis ; 2022 Sep 22.
Artigo em Inglês | MEDLINE | ID: mdl-36137735

RESUMO

OBJECTIVES: Evaluate risk of major adverse cardiovascular events (MACE) with tofacitinib versus tumour necrosis factor inhibitors (TNFi) in patients with rheumatoid arthritis (RA) with or without a history of atherosclerotic cardiovascular disease (ASCVD) in ORAL Surveillance. METHODS: Patients with RA aged ≥50 years with ≥1 additional CV risk factor received tofacitinib 5 mg or 10 mg two times per day or TNFi. Hazard rations (HRs) were evaluated for the overall population and by history of ASCVD (exploratory analysis). RESULTS: Risk of MACE, myocardial infarction and sudden cardiac death were increased with tofacitinib versus TNFi in ORAL Surveillance. In patients with history of ASCVD (14.7%; 640/4362), MACE incidence was higher with tofacitinib 5 mg two times per day (8.3%; 17/204) and 10 mg two times per day (7.7%; 17/222) versus TNFi (4.2%; 9/214). HR (combined tofacitinib doses vs TNFi) was 1.98 (95% confidence interval (CI) 0.95 to 4.14; interaction p values: 0.196 (for HR)/0.059 (for incidence rate difference)). In patients without history of ASCVD, MACE HRs for tofacitinib 5 mg two times per day (2.4%; 30/1251) and 10 mg two times per day (2.8%; 34/1234) versus TNFi (2.3%; 28/1237) were, respectively, 1.03 (0.62 to 1.73) and 1.25 (0.76 to 2.07). CONCLUSIONS: This post hoc analysis observed higher MACE risk with tofacitinib versus TNFi in patients with RA and history of ASCVD. Among patients without history of ASCVD, all with prevalent CV risk factors, MACE risk did not appear different with tofacitinib 5 mg two times per day versus TNFi. Due to the exploratory nature of this analysis and low statistical power, we cannot exclude differential MACE risk for tofacitinib 5 mg two times per day versus TNFi among patients without history of ASCVD, but any absolute risk excess is likely low. TRIAL REGISTRATION NUMBER: NCT02092467.

10.
Artigo em Inglês | MEDLINE | ID: mdl-36008352

RESUMO

BACKGROUND AND OBJECTIVES: Contrast-associated AKI may result in higher morbidity and mortality. Intravenous fluid administration remains the mainstay for prevention. There is a lack of consensus on the optimal administration strategy. We studied the association of periprocedure fluid administration with contrast-associated AKI, defined as an increase in serum creatinine of at least 25% or 0.5 mg/dl from baseline at 3-5 days after angiography, and 90-day need for dialysis, death, or a 50% increase in serum creatinine. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We conducted a secondary analysis of 4671 PRESERVE participants who underwent angiographic procedures. Although fluid type was randomized, strategy of administration was at the discretion of the clinician. We divided the study cohort into quartiles by total fluid volume. We performed multivariable logistic regression, adjusting for clinically important covariates. We tested for the interaction between fluid volume and duration of fluid administration, categorized as <6 or ≥6 hours. RESULTS: The mean (SD) age was 70 (8) years, 94% of participants were male, and median (interquartile range) eGFR was 60 (41-60) ml/min per 1.73 m2. The range of fluid administered was 89-882 ml in quartile 1 and 1258-2790 ml in quartile 4. Compared with the highest quartile (quartile 4) of fluid volume, we found a significantly higher risk of the primary outcome in quartile 1 (adjusted odds ratio, 1.58; 95% confidence interval, 1.06 to 2.38) but not in quartiles 2 and 3 compared with quartile 4. There was no difference in the incidence of contrast-associated AKI across the quartiles. The interaction between volume and duration was not significant for any of the outcomes. CONCLUSIONS: We found that administration of a total volume of 1000 ml, starting at least 1 hour before contrast injection and continuing postcontrast for a total of 6 hours, is associated with a similar risk of adverse outcomes as larger volumes of intravenous fluids administered for periods >6 hours. Mean fluid volumes <964 ml may be associated with a higher risk for the primary outcome, although residual confounding cannot be excluded.

11.
Artigo em Inglês | MEDLINE | ID: mdl-35953437

RESUMO

AIMS: Cigarette smoking is among the most well-established risk factors for adverse cardiovascular outcomes. We sought to determine whether icosapent ethyl (IPE), a highly purified form of eicosapentaenoic acid with anti-atherothrombotic properties, may reduce the excessive risk of cardiovascular disease (CVD) attributable to smoking. METHODS AND RESULTS: REDUCE-IT was a multinational, double-blind trial that randomized 8179 statin-treated patients with elevated triglycerides and CV risk to IPE or placebo, with a median follow-up period of 4.9 years. IPE reduced the primary composite endpoint (CV death, nonfatal myocardial infarction [MI], nonfatal stroke, coronary revascularization, or hospitalization for unstable angina) by 25% (P<0.0001). In the current analyses, the effect of IPE was evaluated in REDUCE-IT using post hoc analyses based upon smoking history. Groups were classified as current smokers (n = 1241), former smokers (n = 3672) and never smokers (n = 3264). Compared with placebo, IPE use in combined current and former smokers (n = 4913) was associated with significant reductions in time to the primary composite endpoint (hazard ratio, 0.77 [95% CI, 0.68-0.87]; P<0.0001) and in total events (rate ratio, 0.71 [95% CI, 0.61-0.82]; P<0.0001). These benefits remained significant when subdivided into current and former smokers (P = 0.04, P = 0.005), with reductions in the key secondary composite endpoint (P<0.0001) and in the individual components of CV death or nonfatal MI (P = 0.04, P = 0.01) and fatal or nonfatal MI (P = 0.009, P = 0.01), respectively. Benefits were consistent and significant in nonsmokers as well. Overall, there were similar estimated rates of first occurrences of primary CVD endpoints in current smokers (23.8%) and former smokers (23.0%) assigned to IPE compared with never smokers on placebo (25.7%). CONCLUSION: In REDUCE-IT, IPE treatment was associated with reduced risk of CV events in current and former smokers to levels observed in never smokers. While smoking cessation should always be recommended, these data raise the possibility that IPE treatment may attenuate CV hazards attributable to smoking.

12.
ESC Heart Fail ; 2022 Aug 10.
Artigo em Inglês | MEDLINE | ID: mdl-35950269

RESUMO

AIMS: To describe clinical characteristics and outcomes for those with STEMI and reduced left ventricular ejection fraction (LVEF) in low-income and middle-income countries (LMICs). METHODS AND RESULTS: Adults presenting with STEMI to two government-owned tertiary care centres in Delhi, India were prospectively enrolled in the North India ST-elevation myocardial infarction (NORIN-STEMI) registry. LVEF was evaluated at presentation and clinical characteristics were compared across LVEF categories. Overall, 3597 patients were included, of whom 468 (13%) had LVEF >50%, 1482 (41%) had mildly reduced LVEF (40-49%), 1357 (38%) had moderately reduced LVEF (30-39%), and 290 (8%) had severely reduced LVEF (<30%). Presentation delay >24 h, prior MI, and hyperlipidaemia were associated with decreasing LVEF category. Although most patients with reduced LVEF were discharged on appropriate guideline-directed therapies, adherence at 1 year was low (ACE inhibitor/ARB 91% to 41%, beta blocker 98% to 78%, aldosterone receptor antagonist 69% to 6%). After multivariable adjustment, a Cox regression model showed moderately reduced LVEF (HR 1.77, 95% CI 1.20, 2.60) and severely reduced LVEF (HR 3.63, 95% CI 2.41, 5.48) were associated with increased risk of all-cause mortality compared with LVEF ≥50%. CONCLUSIONS: On presentation for STEMI, almost 90% of NORIN-STEMI participants had at least mildly reduced LVEF and almost half had LVEF <40%. Patients with LVEF <40% had significantly higher risk of mortality at 1 year, and adherence to guideline-directed therapies at 1 year was poor. Systematic initiatives to improve access to timely revascularization and guideline-directed therapies are essential in advancing STEMI care in LMICs.

13.
Circulation ; 2022 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-36030390

RESUMO

BACKGROUND: Oral factor XIa (FXIa) inhibitors may modulate coagulation to prevent thromboembolic events without significantly increasing bleeding. We explored the pharmacodynamics, safety, and efficacy of the oral FXIa inhibitor asundexian for secondary prevention after acute myocardial infarction (MI). METHODS: We randomized 1601 patients with recent acute MI to oral asundexian 10, 20, or 50 mg or placebo once daily for 6-2 months in a double-blind, placebo-controlled, phase 2, dose-ranging trial. Patients were randomized within 5 days of their qualifying MI and received dual antiplatelet therapy with aspirin plus a P2Y12 inhibitor. The effect of asundexian on factor XIa inhibition was assessed at 4 weeks. The prespecified main safety outcome was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding comparing all pooled asundexian doses with placebo. The prespecified efficacy outcome was a composite of cardiovascular death, MI, stroke, or stent thrombosis comparing pooled asundexian 20 and 50 mg doses with placebo. RESULTS: The median age was 68 years, 23% were women, 51% had ST-elevation MI, 80% were treated with aspirin plus ticagrelor or prasugrel, and 99% underwent percutaneous coronary intervention before randomization. Asundexian caused dose-related inhibition of FXIa activity with 50 mg resulting in >90% inhibition. Over a median follow-up of 368 days, the main safety outcome occurred in 30 (7.6%), 32 (8.1%), 42 (10.5%), and 36 (9.0%) patients receiving asundexian 10, 20, 50 mg, and placebo (pooled asundexian vs. placebo: HR 0.98, 90% CI 0.71-1.35). The efficacy outcome occurred in 27 (6.8%), 24 (6.0%), 22 (5.5%), and 22 (5.5%) patients assigned asundexian 10, 20, 50 mg, and placebo (pooled asundexian 20 and 50 mg vs. placebo: HR 1.05, 90% CI 0.69-1.61). CONCLUSIONS: In patients with recent acute MI, 3 doses of asundexian, when added to aspirin plus a P2Y12 inhibitor, resulted in dose-dependent, near-complete inhibition of FXIa activity without a significant increase in bleeding and a low rate of ischemic events. These data support the investigation of asundexian at a dose of 50 mg daily in an adequately powered clinical trial of patients following acute MI.

14.
JAMA Cardiol ; 2022 Aug 31.
Artigo em Inglês | MEDLINE | ID: mdl-36044233

RESUMO

Importance: Despite advances in cardiac care, patients remain at a high risk of death and the development of heart failure (HF) following myocardial infarction (MI). These risks are highest in patients with reduced ejection fraction (EF) or signs of HF immediately after MI. Drugs to mitigate these risks have been identified through the systematic evaluation of therapies with proven efficacy in patients with HF and reduced EF (HFrEF). Observations: Although landmark studies in patients with HFrEF consistently exclude patients with recent MI, dedicated post-MI trials of these drugs have led to multiple therapies with proven benefit in these patients. However, not all therapies with proven efficacy in patients with chronic HF have been shown to provide benefit in the post-MI population, as recently evidenced by the discrepant results between chronic HF and post-MI trials of sacubitril-valsartan. Similarly, multiple trials of early and aggressive use of therapies effective in chronic heart failure immediately post-MI failed to demonstrate benefit or were associated with harm, emphasizing the vulnerability of the post-MI population. Conclusions and Relevance: Trials of patients at high risk of HF following MI have emphasized the differences between the post-MI and HFrEF populations and the necessity for dedicated trials in the post-MI population. This review summarizes trials studying the use of these therapies for at-risk patients following MI from therapies used in patients with HFrEF and exploring new potential therapies for this high-risk population.

16.
Artigo em Inglês | MEDLINE | ID: mdl-36036856

RESUMO

Low dose enteric-coated aspirin (EC-ASA) is routinely used for secondary cardiovascular event prevention. However, absorption of EC tablets is poor, which can result in subtherapeutic antiplatelet effects. Phospholipid-aspirin liquid filled capsules (PL-ASA) are a novel FDA-approved immediate-release formulation designed to reduce gastrointestinal (GI) injury by limiting direct contact with the stomach lining. We compared the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of PL-ASA versus EC-ASA at a low dose. This randomized, open-label, crossover study assessed PK and PD following a single 81-mg dose of PL-ASA versus EC-ASA under fasting conditions in 36 volunteers without cardiovascular disease between 18 and 75 years of age. Volunteers were randomly assigned 1:1 to either PL-ASA then EC-ASA or vice versa with a minimum 14-day washout. Assessments included PK parameters for acetylsalicylic acid and salicylic acid, platelet aggregation in response to arachidonic acid (AA), and serum thromboxane B2 (TxB2) assessments over 24 h. PL-ASA was rapidly absorbed. PL-ASA reached Tmax 3 h earlier (1.01 vs. 4.00 h, p < 0.0001), with almost double the Cmax (720 vs. 368 ng/mL, p < 0.0001) and overall 44% higher exposure of acetylsalicylic acid (AUC0-t: 601 vs. 416 h*ng/mL, p = 0.0013) compared with EC-ASA. Within 1 h of dosing, PL-ASA achieved significantly lower residual platelet aggregation, which persisted for the full 24 h (median AA-LTA was 47% with PL-ASA vs. 80.5% with EC-ASA; p = 0.0022 at hour-24). Treatment with PL-ASA also resulted in significantly lower serum TxB2 concentrations at each time point compared with EC-ASA (all p-values < 0.05). PL-ASA resulted in faster and more complete aspirin absorption paralleled by more prompt and potent platelet inhibition compared with EC-ASA after a single 81 mg dose. PL-ASA represents an attractive novel aspirin formulation for the secondary prevention of cardiovascular events.Clinical Trial Registration ClinicalTrials.gov identifier: NCT04811625.

17.
JAMA Netw Open ; 5(8): e2227746, 2022 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-35984655

RESUMO

Importance: The Bypass Versus Angioplasty for Severe Ischemia of the Leg randomized controlled trial showed comparable outcomes between endovascular revascularization (ER) and surgical revascularization (SR) for patients with critical limb ischemia (CLI). However, several observational studies showed mixed results. Most of these studies were conducted before advanced endovascular technologies were available. Objective: To compare ER and SR treatment strategies for 6-month outcomes among patients with CLI. Design, Setting, and Participants: This retrospective, population-based cohort study used the Nationwide Readmissions Database to identify 66 277 patients with CLI who underwent ER or SR from January 1, 2016, to December 31, 2018. Data analyses were conducted from January 1, 2022, to February 8, 2022. A propensity score with 1:1 matching was applied. Patients with CLI who underwent ER or SR were identified, and those with missing information on the length of stay and/or younger than 18 years were excluded. Exposures: Endovascular or surgical revascularization. Main Outcomes and Measures: The primary outcome was a major amputation at 6 months. Significant secondary outcomes were in-hospital and 6-month mortality and an in-hospital safety composite of acute kidney injury, major bleeding, and vascular complication. Subgroup analysis was conducted for major amputation in high-volume centers. Results: A total of 66 277 patients were identified between 2016 and 2018 who underwent ER or SR for CLI. The Nationwide Readmissions Database does not provide racial and ethnic categories. The mean (SD) age of the cohort was 69.3 (12) years, and 62.5% of patients were male. A total of 54 546 patients (82.3%) underwent ER and 11 731 (17.7%) underwent SR. After propensity score matching, 11 106 matched pairs were found. Endovascular revascularization was associated with an 18% higher risk of major amputation compared with SR (997 of 10 090 [9.9%] vs 869 of 10 318 [8.4%]; hazard ratio, 1.18; 95% CI, 1.08-1.29; P = .001). However, no difference was observed in major amputation risk when both procedures were performed in high-volume centers. Endovascular revascularization and SR had similar mortality rates (517 of 11 106 [4.7%] vs 490 of 11 106 [4.4%]; hazard ratio, 1.06; 95% CI, 0.93-1.20; P = .39). However, the ER group had a 17% lower risk of in-hospital safety outcomes compared with the SR group (2584 of 11 106 [23.3%] vs 2979 of 11 106 [26.8%]; odds ratio, 0.83; 95% CI, 0.78-0.88; P < .001). Conclusions and Relevance: The results of this study suggest that ER was safer, without any difference in mortality, but ER was associated with an increased risk of major amputation compared with SR. However, the risk of major amputation was similar when both procedures were performed at high-volume centers.


Assuntos
Isquemia Crônica Crítica de Membro , Procedimentos Endovasculares , Idoso , Idoso de 80 Anos ou mais , Isquemia Crônica Crítica de Membro/cirurgia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
18.
JAMA ; 328(8): 737-745, 2022 08 23.
Artigo em Inglês | MEDLINE | ID: mdl-35997731

RESUMO

Importance: High lipid concentrations are a modifiable risk factor for cardiovascular disease. Little is known about how population-level lipid concentrations, as well as trends in lipid control, have changed over the past decade among US adults. Objective: To determine whether lipid concentrations and rates of lipid control changed among US adults and whether these trends differed by sex and race and ethnicity, from 2007 to 2018. Design, Setting, and Participants: Serial cross-sectional analysis of 33 040 US adults aged 20 years or older, weighted to be nationally representative, from the National Health and Nutrition Examination Surveys (2007-2008 to 2017-2018). Main Outcomes and Measures: Lipid concentrations among US adults and rates of lipid control among adults receiving statin therapy. Lipid control was defined as a total cholesterol concentration of 200 mg/dL or less. Results: The mean age of the study population was 47.4 years, and 51.4% were women; of the 33 040 participants, 12.0% were non-Hispanic Black; 10.3%, Mexican American; 6.4%, other Hispanic American; 62.7%, non-Hispanic White; and 8.5%, other race and ethnicities (including non-Hispanic Asian. Among all US adults, age-adjusted total cholesterol improved significantly in the overall population from 197 mg/dL in 2007-2008 to 189 mg/dL in 2017-2018 (difference, -8.6 mg/dL [95% CI, -12.2 to -4.9 mg/dL]; P for trend <.001), with similar patterns for men and women. Black, Mexican American, other Hispanic, and White adults experienced significant improvements in total cholesterol, but no significant change was observed for Asian adults. Among adults receiving statin therapy, age-adjusted lipid control rates did not significantly change from 78.5% in 2007-2008 to 79.5% in 2017-2018 (difference, 1.1% [95% CI, -3.7% to 5.8%]; P for trend = .27), and these patterns were similar for men and women. Across all racial and ethnic groups, only Mexican Americans experienced a significant improvement in age-adjusted lipid control (P for trend = .008). In 2015-2018, age-adjusted rates of lipid control were significantly lower for women than for men (OR, 0.54 [95% CI, 0.40 to 0.72]). In addition, when compared with White adults, rates of lipid control while taking statins were significantly lower among Black adults (OR, 0.66 [95% CI, 0.47 to 0.94]) and other Hispanic adults (OR, 0.59 [95% CI, 0.37 to 0.95]); no significant differences were observed for other racial and ethnic groups. Conclusions and Relevance: In this serial cross-sectional study, lipid concentrations improved in the US adult population from 2007-2008 through 2017-2018. These patterns were observed across all racial and ethnic subgroups, with the exception of non-Hispanic Asian adults.


Assuntos
Inibidores de Hidroximetilglutaril-CoA Redutases , Hiperlipidemias , Lipídeos , Colesterol/sangue , Estudos Transversais , Feminino , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Hiperlipidemias/sangue , Hiperlipidemias/tratamento farmacológico , Hiperlipidemias/epidemiologia , Hiperlipidemias/etnologia , Lipídeos/sangue , Masculino , Pessoa de Meia-Idade , Estados Unidos/epidemiologia
19.
Eur Heart J ; 43(33): 3164-3178, 2022 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-36044988

RESUMO

AIMS: The effect of the COVID-19 pandemic on care and outcomes across non-COVID-19 cardiovascular (CV) diseases is unknown. A systematic review and meta-analysis was performed to quantify the effect and investigate for variation by CV disease, geographic region, country income classification and the time course of the pandemic. METHODS AND RESULTS: From January 2019 to December 2021, Medline and Embase databases were searched for observational studies comparing a pandemic and pre-pandemic period with relation to CV disease hospitalisations, diagnostic and interventional procedures, outpatient consultations, and mortality. Observational data were synthesised by incidence rate ratios (IRR) and risk ratios (RR) for binary outcomes and weighted mean differences for continuous outcomes with 95% confidence intervals. The study was registered with PROSPERO (CRD42021265930). A total of 158 studies, covering 49 countries and 6 continents, were used for quantitative synthesis. Most studies (80%) reported information for high-income countries (HICs). Across all CV disease and geographies there were fewer hospitalisations, diagnostic and interventional procedures, and outpatient consultations during the pandemic. By meta-regression, in low-middle income countries (LMICs) compared to HICs the decline in ST-segment elevation myocardial infarction (STEMI) hospitalisations (RR 0.79, 95% confidence interval [CI] 0.66-0.94) and revascularisation (RR 0.73, 95% CI 0.62-0.87) was more severe. In LMICs, but not HICs, in-hospital mortality increased for STEMI (RR 1.22, 95% CI 1.10-1.37) and heart failure (RR 1.08, 95% CI 1.04-1.12). The magnitude of decline in hospitalisations for CV diseases did not differ between the first and second wave. CONCLUSIONS: There was substantial global collateral CV damage during the COVID-19 pandemic with disparity in severity by country income classification.


Assuntos
COVID-19 , Doenças Cardiovasculares , Infarto do Miocárdio com Supradesnível do Segmento ST , COVID-19/epidemiologia , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/terapia , Mortalidade Hospitalar , Hospitalização , Humanos , Pandemias
20.
N Engl J Med ; 387(11): 967-977, 2022 09 15.
Artigo em Inglês | MEDLINE | ID: mdl-36018037

RESUMO

BACKGROUND: A polypill that includes key medications associated with improved outcomes (aspirin, angiotensin-converting-enzyme [ACE] inhibitor, and statin) has been proposed as a simple approach to the secondary prevention of cardiovascular death and complications after myocardial infarction. METHODS: In this phase 3, randomized, controlled clinical trial, we assigned patients with myocardial infarction within the previous 6 months to a polypill-based strategy or usual care. The polypill treatment consisted of aspirin (100 mg), ramipril (2.5, 5, or 10 mg), and atorvastatin (20 or 40 mg). The primary composite outcome was cardiovascular death, nonfatal type 1 myocardial infarction, nonfatal ischemic stroke, or urgent revascularization. The key secondary end point was a composite of cardiovascular death, nonfatal type 1 myocardial infarction, or nonfatal ischemic stroke. RESULTS: A total of 2499 patients underwent randomization and were followed for a median of 36 months. A primary-outcome event occurred in 118 of 1237 patients (9.5%) in the polypill group and in 156 of 1229 (12.7%) in the usual-care group (hazard ratio, 0.76; 95% confidence interval [CI], 0.60 to 0.96; P = 0.02). A key secondary-outcome event occurred in 101 patients (8.2%) in the polypill group and in 144 (11.7%) in the usual-care group (hazard ratio, 0.70; 95% CI, 0.54 to 0.90; P = 0.005). The results were consistent across prespecified subgroups. Medication adherence as reported by the patients was higher in the polypill group than in the usual-care group. Adverse events were similar between groups. CONCLUSIONS: Treatment with a polypill containing aspirin, ramipril, and atorvastatin within 6 months after myocardial infarction resulted in a significantly lower risk of major adverse cardiovascular events than usual care. (Funded by the European Union Horizon 2020; SECURE ClinicalTrials.gov number, NCT02596126; EudraCT number, 2015-002868-17.).


Assuntos
Inibidores da Enzima Conversora de Angiotensina , Doenças Cardiovasculares , Inibidores de Hidroximetilglutaril-CoA Redutases , Inibidores da Agregação Plaquetária , Inibidores da Enzima Conversora de Angiotensina/efeitos adversos , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Aspirina/efeitos adversos , Aspirina/uso terapêutico , Atorvastatina/efeitos adversos , Atorvastatina/uso terapêutico , Doenças Cardiovasculares/etiologia , Doenças Cardiovasculares/mortalidade , Doenças Cardiovasculares/prevenção & controle , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , AVC Isquêmico/prevenção & controle , Infarto do Miocárdio/complicações , Infarto do Miocárdio/prevenção & controle , Infarto do Miocárdio/terapia , Inibidores da Agregação Plaquetária/efeitos adversos , Inibidores da Agregação Plaquetária/uso terapêutico , Ramipril/efeitos adversos , Ramipril/uso terapêutico , Prevenção Secundária/métodos
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