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Efficacy and Safety of PCSK9 Inhibition With Evolocumab in Reducing Cardiovascular Events in Patients With Metabolic Syndrome Receiving Statin Therapy: Secondary Analysis From the FOURIER Randomized Clinical Trial.
Deedwania, P, Murphy, SA, Scheen, A, Badariene, J, Pineda, AL, Honarpour, N, Keech, AC, Sever, PS, Pedersen, TR, Sabatine, MS, et al
JAMA cardiology. 2021;(2):139-147
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Abstract
IMPORTANCE The PCSK9 inhibitor evolocumab reduced low-density lipoprotein cholesterol and cardiovascular events in the FOURIER randomized clinical trial. Patients with metabolic syndrome (MetS) are at increased cardiovascular risk. OBJECTIVE To investigate outcomes with evolocumab in patients with and without MetS. DESIGN, SETTING, AND PARTICIPANTS The FOURIER trial randomized patients worldwide with stable atherosclerotic cardiovascular disease receiving statin to evolocumab vs placebo with follow-up for a median of 2.2 years. Data were collected February 2013 to November 2016. For this prespecified analysis, patients with the requisite data were stratified based on the National Cholesterol Education Program Adult Treatment Panel III MetS criteria; in secondary analyses, patients were further substratified by diabetes at baseline. Analysis was intention to treat. Analysis began March 2018 and ended April 2020. INTERVENTIONS Patients were randomized to evolocumab or placebo. MAIN OUTCOMES AND MEASURES The primary end point was cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary end point was cardiovascular death, myocardial infarction, or stroke. RESULTS Of 27 342 patients (mean [SD] age, 63 [9] years; 20 623 men [75.4%]) included in this analysis, 16 361 (59.8%) with baseline MetS were, when compared with patients without MetS, at higher risk of cardiovascular events (adjusted hazard ratio [95% CI], 1.31 [1.18-1.46]; P < .001 for the primary and 1.38 [1.20-1.57]; P < .001 for the key secondary end point). Evolocumab reduced low-density lipoprotein cholesterol similarly in patients with MetS (median [interquartile range], 92 [79-109] mg/dL vs 30 [19-48] mg/dL; P < .001) and without MetS (median [interquartile range], 92 [81-108] mg/dL vs 29 [18-44] mg/dl; P < .001). For the primary end point, the hazard ratios (95% CI) with evolocumab vs placebo were 0.83 (0.76-0.91) and 0.89 (0.79-1.01) in patients with and without MetS (P for interaction = .39). For the key secondary end point, the corresponding hazard ratios (95% CIs) were 0.76 (0.68-0.86) and 0.86 (0.74-1.01) (P for interaction = .23), respectively. Evolocumab did not increase the risk of new-onset diabetes or other major safety outcomes including worsening glycemic control, compared with placebo in patients with MetS. CONCLUSIONS AND RELEVANCE Patients with atherosclerotic cardiovascular disease and MetS have substantial residual risk of cardiovascular events despite statin therapy. Evolocumab significantly reduced low-density lipoprotein cholesterol and cardiovascular risk in patients with MetS without increasing new-onset diabetes, worsening glycemic control, or other major safety events. These data suggest the addition of evolocumab to statin therapy in patients with atherosclerotic cardiovascular disease and MetS is safe and efficacious to reduce residual cardiovascular risk. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01764633.
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Dietary Soy Consumption and Cardiovascular Mortality among Chinese People with Type 2 Diabetes.
Wang, X, Lv, J, Yu, C, Li, L, Hu, Y, Qin, LQ, Dong, JY
Nutrients. 2021;(8)
Abstract
Randomized controlled trials showed that soy intervention significantly improved blood lipids in people with diabetes. We sought to prospectively examine the association of soy consumption with the risk of cardiovascular death among individuals with diabetes. A total of 26,139 participants with a history of diabetes were selected from the Chinese Kadoorie Biobank study. Soy food consumption was assessed by a food frequency questionnaire. Causes of death were coded by the 10th International Classification of Diseases. The Cox proportional hazard regression was used to compute the hazard ratios. During a median follow-up of 7.8 years, a total of 1626 deaths from cardiovascular disease (CVD) were recorded. Compared with individuals who never consumed soy foods, the multivariable-adjusted risks (95% confidence intervals) of CVD mortality were 0.92 (0.78, 1.09), 0.89 (0.75, 1.05), and 0.77 (0.62, 0.96) for those who consumed soy foods monthly, 1-3 days/week, and ≥4 days/week, respectively. For cause-specific cardiovascular mortality, significant inverse associations were observed for coronary heart disease and acute myocardial infarction. Higher soy food consumption was associated with a lower risk of cardiovascular death, especially death from coronary heart disease and acute myocardial infarction, in Chinese adults with diabetes.
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Effects of the PCSK9 antibody alirocumab on coronary atherosclerosis in patients with acute myocardial infarction: a serial, multivessel, intravascular ultrasound, near-infrared spectroscopy and optical coherence tomography imaging study-Rationale and design of the PACMAN-AMI trial.
Zanchin, C, Koskinas, KC, Ueki, Y, Losdat, S, Häner, JD, Bär, S, Otsuka, T, Inderkum, A, Jensen, MRJ, Lonborg, J, et al
American heart journal. 2021;:33-44
Abstract
BACKGROUND The risk for cardiovascular adverse events after acute myocardial infarction (AMI) remains high despite potent medical treatment including low-density lipoprotein cholesterol (LDL-C) lowering with statins. Proprotein convertase subtilisin/kexin type 9 (PCSK9) antibodies substantially reduce LDL-C when added to statin. Alirocumab, a monoclonal antibody to PCSK9, reduces major adverse cardiovascular events after AMI. The effects of alirocumab on coronary atherosclerosis including plaque burden, plaque composition and fibrous cap thickness in patients presenting with AMI remains unknown. AIMS To determine the effect of LDL-C lowering with alirocumab on top of high-intensity statin therapy on intravascular ultrasound (IVUS)-derived percent atheroma volume (PAV), near-infrared spectroscopy (NIRS)-derived maximum lipid core burden index within 4 mm (maxLCBI4 mm) and optical coherence tomography (OCT)-derived fibrous cap thickness (FCT) in patients with AMI. METHODS In this multicenter, double-blind, placebo-controlled trial, 300 patients with AMI (ST-elevation or non-ST-elevation myocardial infarction) were randomly assigned to receive either biweekly subcutaneous alirocumab (150 mg) or placebo beginning <24 hours after the acute event as add-on therapy to rosuvastatin 20 mg. Patients undergo serial IVUS, NIRS and OCT in the two non-infarct related arteries at baseline (at the time of treatment of the culprit lesion) and at 52 weeks. The primary endpoint, change in IVUS-derived PAV, and the powered secondary endpoints, change in NIRS-derived maxLCBI4 mm, and OCT-derived minimal FCT, will be assessed 52 weeks post randomization. SUMMARY The PACMAN-AMI trial will determine the effect of alirocumab on top of high-intensity statin therapy on high-risk coronary plaque characteristics as assessed by serial, multimodality intracoronary imaging in patients presenting with AMI. CLINICAL TRIAL REGISTRATION NCT03067844.
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Effects of quercetin supplementation on inflammatory factors and quality of life in post-myocardial infarction patients: A double blind, placebo-controlled, randomized clinical trial.
Dehghani, F, Sezavar Seyedi Jandaghi, SH, Janani, L, Sarebanhassanabadi, M, Emamat, H, Vafa, M
Phytotherapy research : PTR. 2021;(4):2085-2098
Abstract
Myocardial infarction (MI) is one of the leading causes of death in the world. Epidemiological studies have shown that dietary flavonoids are inversely related to cardiovascular morbidity and mortality. The study aimed to determine whether quercetin supplementation can improve inflammatory factors, total antioxidant capacity (TAC) and quality of life (QOL) in patients following MI. This randomized double-blind, placebo-controlled trial was conducted on 88 post-MI patients. Participants were randomly assigned into quercetin (n = 44) and placebo groups (n = 44) receiving 500 mg/day quercetin or placebo tablets for 8 weeks. Quercetin supplementation significantly increased serum TAC compared to placebo (Difference: 0.24 (0.01) mmol/L and 0.00 (0.00) mmol/L respectively; p < .001). TNF-α levels significantly decreased in the quercetin group (p = .009); this was not, however, significant compared to the placebo group. As for QOL dimensions, quercetin significantly lowered the scores of insecurity (Difference: -0.66 (12.5) and 0.00 (5.55) respectively; p < .001). No significant changes in IL-6, hs-CRP, blood pressure and other QOL dimensions were observed between the two groups. Quercetin supplementation (500 mg/day) in post-MI patients for 8 weeks significantly elevated TAC and improved the insecurity dimension of QOL, but failed to show any significant effect on inflammatory factors, blood pressure and other QOL dimensions.
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Myocardial protective effect of intracoronary administration of nicorandil and alprostadil via targeted perfusion microcatheter in patients undergoing elective percutaneous coronary intervention: A randomized controlled trial.
Zhang, W, Dai, J, Zheng, X, Xu, K, Yang, X, Shen, L, Wang, X, Hao, Z, Qiu, X, Jiang, L, et al
Medicine. 2021;(15):e25551
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BACKGROUND The aim of the study was to evaluate the efficacy of nicorandil and alprostadil on myocardial protection in patients undergoing elective percutaneous coronary intervention (PCI). METHODS In this prospective, single-blinded, randomized controlled study, 90 consecutive patients scheduled for elective PCI for de novo coronary lesions were assigned to the nicorandil, alprostadil, and nitroglycerin groups in a 1:1:1 ratio. Drugs were administered intracoronary via a targeted perfusion microcatheter. The primary endpoint was the thrombolysis in myocardial infarction (TIMI) myocardial perfusion frame count (TMPFC). Additionally, the corrected TIMI frame count (cTFC), TIMI myocardial perfusion grade (TMPG), and incidence of periprocedural myocardial injury (PMI) were assessed. RESULTS Both nicorandil and alprostadil were significantly effective in reducing TMPFC (114.6 ± 33.7 vs 93.4 ± 30.9, P = .016; 114.3 ± 34.3 vs 94.7 ± 33.3, P = .029, respectively). Similar findings were observed in the improvement of cTFC (20.3 ± 10.5 vs 13.5 ± 5.0, P = .003; 20.2 ± 7.4 vs 15.2 ± 5.2, P = .003, respectively) and percentage of TMPG 3 (100% vs 82.8%, P = .052; 83.3% vs 96.7%, P = .196, respectively); whereas, nitroglycerin produced a limited effect on TMPFC (114.4 ± 30.9 vs 112.1 ± 31.9, P = .739), cTFC (19.4 ± 7.2 vs 19.3 ± 7.2, P = .936), and percentage of TMPG 3 (86.7% vs 86.7%, P = 1.000). No significant difference was found in the incidence of PMI (16.7% vs 16.0% vs 27.6%, P = .537), though it was comparatively lower in the nicorandil and alprostadil groups. Furthermore, the intracoronary administration of nicorandil and alprostadil had a mild effect on blood pressure and heart rate. CONCLUSIONS The intracoronary administration of nicorandil and alprostadil via a targeted perfusion microcatheter was more effective in improving myocardial perfusion in patients undergoing elective PCI than nitroglycerin.
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Impact of administration of nicorandil prior to percutaneous coronary intervention in treatment of acute myocardial infarction: A protocol for systematic review and meta-analysis.
Li, W, Zhang, G
Medicine. 2021;(17):e25565
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BACKGROUND In order to provide new evidence-based medical evidence for clinical treatment, we undertook a systematic review and meta-analysis to assess the efficacy and safety of nicorandil prior to percutaneous coronary intervention in acute myocardial infarction (AMI) patients. METHODS This systematic review and meta-analysis will be performed according to Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. Two reviewers independently will search randomized controlled trials or observational studies about the treatment of nicorandil on AMI patients. Retrieved databases include Web of Science, ClinicalTrials.gov, Pubmed, Embase, and Cochrane Library. And retrieval time is limited from inception to June 2021. Key words are nicorandil, myocardial infarction, or similar expansion words without publication limitation. Biomechanical studies, in vitro studies, review articles, techniques, case reports, letters to the editor, and editorials are excluded. RESULTS The results of our review will be reported strictly following the PRISMA criteria and the review will add to the existing literature by showing compelling evidence and improved guidance in clinic settings. OSF REGISTRATION NUMBER 10.17605/OSF.IO/UEPKB.
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Double or Triple Antithrombotic Treatment in Atrial Fibrillation Patients with Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention.
Benetou, DR, Varlamos, C, Mpahara, A, Alexopoulos, D
American journal of cardiovascular drugs : drugs, devices, and other interventions. 2021;(1):11-20
Abstract
Patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) have traditionally received triple antithrombotic therapy (TAT) consisting of aspirin and a P2Y12 inhibitor plus an oral anticoagulant (OAC) to reduce atherothrombotic events, even though this strategy is associated with a high risk of severe bleeding. Recent trials have indicated that dual antithrombotic therapy (DAT), consisting of a P2Y12 inhibitor plus an OAC, may be superior to TAT in terms of bleeding risk; however, the trade-off regarding ischemic complications may be questionable. Patients who have had a myocardial infarction (MI) before undergoing PCI warrant special consideration because of the accompanying high ischemic risk, including stent thrombosis, which might be exacerbated by an aspirin-free strategy such as DAT. In particular, in the acute phase of ST-segment elevation MI (STEMI), the highly prothrombotic milieu may necessitate initial TAT, though durations may vary, making a tailored antithrombotic regimen for this high-risk subset of patients a fairly challenging and difficult scenario for clinicians. Since patients with MI, especially STEMI, are underrepresented in randomized trials, data regarding the optimal antithrombotic treatment in such patients are sparse. This review aims to analyze the outcomes of different antithrombotic regimens in patients with MI and AF undergoing PCI, define the role of DAT versus TAT regarding safety and efficacy outcomes, and address controversial issues and future perspectives.
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Specialized oral nutritional supplement (ONS) improves handgrip strength in hospitalized, malnourished older patients with cardiovascular and pulmonary disease: A randomized clinical trial.
Matheson, EM, Nelson, JL, Baggs, GE, Luo, M, Deutz, NE
Clinical nutrition (Edinburgh, Scotland). 2021;(3):844-849
Abstract
BACKGROUND & AIMS Oral Nutritional Supplements (ONS) are used to treat malnutrition and improve clinical outcomes in malnourished patients. Poor handgrip strength (HGS) is associated with an increased risk of mortality, disability and other adverse health consequences. This analysis examined the effect of a specialized ONS on HGS and its relationship to nutritional status in hospitalized, older adults with malnutrition who were participants in the NOURISH trial. METHODS We enrolled older (≥65years), malnourished (Subjective Global Assessment [SGA] class B/C) adults hospitalized for cardiovascular and pulmonary events: congestive heart failure, acute myocardial infarction, pneumonia and/or chronic obstructive pulmonary disease exacerbation in a double-blind, randomized, placebo-controlled trial (NOURISH study). During hospitalization and until 90 days after discharge, participants received standard-of-care plus a high protein and beta-hydroxy-beta-methylbutyrate containing ONS (S-ONS; n = 328) or a placebo supplement (n = 324), aimed at 2 servings/day. HGS was evaluated by dynamometer at baseline, hospital discharge, day (d) 30, d60, and d90 post-discharge. RESULTS Post hoc, repeated measures analysis of data at discharge, d30, d60, and d90 showed significantly higher HGS in the S-ONS vs. the placebo group in the evaluable group (Least Squares Means ± Standard Error: (23.25 ± 0.25 vs. 22.63 ± 0.25, p = 0.043). At d90, there was a significant positive association between HGS and nutritional status (SGA) improvements in the entire cohort: 49% of participants with increased HGS from discharge had improved nutritional status versus 31% with unchanged or decreased HGS (p = 0.003). HGS and the scores on the Katz index of independence in activities of daily living (ADL) were positively associated at all visits including all ITT subjects (Pearson's r range: 0.24 to 0.34, all p < 0.0001). CONCLUSIONS S-ONS provided during hospitalization and up to 90 days post-discharge improves HGS in malnourished older adults following cardiovascular and pulmonary events and may contribute to improvement in patients' overall recovery. CLINICAL TRIAL REGISTRATION www.ClinicalTrials.gov NCT01626742.
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One year of omega 3 polyunsaturated fatty acid supplementation does not reduce circulating prothrombotic microvesicles in elderly subjects after suffering a myocardial infarction.
Chiva-Blanch, G, Bratseth, V, Laake, K, Arnesen, H, Solheim, S, Schmidt, EB, Badimon, L, Seljeflot, I
Clinical nutrition (Edinburgh, Scotland). 2021;(12):5674-5677
Abstract
BACKGROUND & AIMS Circulating microvesicles (cMV) are both effectors and biomarkers of cardiovascular disease (CVD), and the effects of omega 3 polyunsaturated fatty acids (n3 PUFA) in MV shedding are not yet well known. Therefore, we aimed to investigate the effects of long-term n3 PUFA supplementation on cMV release from cells of the vascular compartment in elderly subjects at very high risk of CVD. METHODS We included 156 elderly patients 2-8 weeks after suffering an acute myocardial infarction from the OMEMI cohort. Subjects were randomly allocated to receive 930 mg EPA + 660 mg DHA (n3 PUFA intervention) or corn oil (56% linoleic acid, 32% oleic acid, 10% palmitic acid) used as placebo daily for two years. At inclusion and after one-year follow-up, prothrombotic [annexin V (AV)+] cMV derived from blood and vascular cells were phenotyped by flow cytometry. RESULTS No differences were observed in the levels of cMV between the randomized groups at inclusion in the study. After one-year follow-up, total AV+, platelet-derived CD61+/AV+, and endothelial-derived CD31+/AV+ and CD31+/CD42b-/AV+ cMV increased significantly in both groups. In the n3 PUFA supplemented group, platelet-derived CD62P+/AV+, CD42b+/AV+ and CD31+/CD42b+/AV+; leukocyte-derived CD62L+/AV+, CD45+/AV+, and CD11b+/AV+, as well as endothelial derived CD146+/AV+, CD62E+/AV+, and CD309+/AV+ cMV also increased significantly. No significant differences were however, observed in the changes of cMV levels between groups. CONCLUSION In elderly Norwegians who have suffered a recent acute myocardial infarction and treated as per guidelines, long-term supplementation with 1.8 g/day n3 PUFA does not modulate prothrombotic MV release from blood and vascular cells. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT01841944.
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The Prognostic Significance of Body Mass Index and Metabolic Parameter Variabilities in Predialysis CKD: A Nationwide Observational Cohort Study.
Park, S, Cho, S, Lee, S, Kim, Y, Park, S, Kim, YC, Han, SS, Lee, H, Lee, JP, Joo, KW, et al
Journal of the American Society of Nephrology : JASN. 2021;(10):2595-2612
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BACKGROUND The association between variabilities in body mass index (BMI) or metabolic parameters and prognosis of patients with CKD has rarely been studied. METHODS In this retrospective observational study on the basis of South Korea's national health screening database, we identified individuals who received ≥3 health screenings, including those with persistent predialysis CKD (eGFR <60 ml/min per 1.73 m2 or dipstick albuminuria ≥1). The study exposure was variability in BMI or metabolic parameters until baseline assessment, calculated as the variation independent of the mean and stratified into quartiles (with Q4 the highest quartile and Q1 the lowest). We used Cox regression adjusted for various clinical characteristics to analyze risks of all-cause mortality and incident myocardial infarction, stroke, and KRT. RESULTS The study included 84,636 patients with predialysis CKD. Comparing Q4 versus Q1, higher BMI variability was significantly associated with higher risks of all-cause mortality (hazard ratio [HR], 1.66; 95% confidence interval [95% CI], 1.53 to 1.81), P [for trend] <0.001), KRT (HR, 1.20; 95% CI, 1.09 to 1.33; P<0.001), myocardial infarction (HR, 1.19; 95% CI, 1.05 to 1.36, P=0.003), and stroke (HR, 1.19; 95% CI, 1.07 to 1.33, P=0.01). The results were similar in the subgroups divided according to positive or negative trends in BMI during the exposure assessment period. Variabilities in certain metabolic syndrome components (e.g., fasting blood glucose) also were significantly associated with prognosis of patients with predialysis CKD. Those with a higher number of metabolic syndrome components with high variability had a worse prognosis. CONCLUSIONS Higher variabilities in BMI and certain metabolic syndrome components are significantly associated with a worse prognosis in patients with predialysis CKD.