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Pravastatin Reduces the Risk of Atherothrombotic Stroke when Administered within Six Months of an Initial Stroke Event.
Hosomi, N, Nagai, Y, Kitagawa, K, Nakagawa, Y, Aoki, S, Nezu, T, Kagimura, T, Maruyama, H, Origasa, H, Minematsu, K, et al
Journal of atherosclerosis and thrombosis. 2018;(3):262-268
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Abstract
AIMS: The J-STARS study examined whether pravastatin (10 mg/day) reduces recurrence of stroke in non-cardioembolic ischemic stroke patients who were enrolled within 1 month to 3 years after initial stroke events (ClinicalTrials.gov, NCT00221104). The main results showed that the frequency of atherothrombotic stroke was low in pravastatin-treated patients, although no effect of pravastatin was found for the other stroke subtypes. We evaluated differences of early (within 6 months) or late (after 6 months) pravastatin treatment benefits on the incidence of stroke or transient ischemic attack (TIA), as well as atherothrombotic stroke and the other subtypes. METHODS Subjects in the J-STARS study were classified into two cohorts, depending on whether they enrolled early (1 to 6 months) or late (6 months to 3 years) following initial stroke events. RESULTS A total of 1578 patients (491 female, 66.2±8.5 years) were randomly assigned to either the pravastatin group (n=793; n=426 in the early cohort, n=367 in the late cohort) or the control group (n=785; n=417 in the early cohort, n=368 in the late cohort). During the follow-up of 4.9± 1.4 years, the rate of atherothrombotic stroke was lower in the pravastatin group compared to controls in the early cohort (0.24 vs. 0.88%/year, p=0.01) but not in the late cohort (0.17 vs. 0.39%/year, p=0.29). However, this difference of pravastatin effect on atherothrombotic stroke was not significantly interacted by the early or late cohort (p=0.59). The incidence rates of other stroke subtype were not different in between pravastatin and control groups despite the timing of entry. CONCLUSIONS Pravastatin is likely to reduce atherothrombotic stroke in patients enrolled within 6 months after stroke onset. However, the clinical efficacy for prevention of recurrent stroke was not conclusive with earlier statin treatment.
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Effect of a combined education and eHealth programme on the control of oral anticoagulation patients (PORTALS study): a parallel cohort design in Dutch primary care.
Talboom-Kamp, EPWA, Verdijk, NA, Kasteleyn, MJ, Harmans, LM, Talboom, IJSH, Numans, ME, Chavannes, NH
BMJ open. 2017;(9):e017909
Abstract
OBJECTIVES To analyse the effect on therapeutic control and self-management skills of the implementation of self-management programmes, including eHealth by e-learning versus group training. SETTING Primary Care Thrombosis Service Center. PARTICIPANTS Of the 247 oral anticoagulation therapy (OAT) patients, 63 started self-management by e-learning, 74 self-management by group training and 110 received usual care. INTERVENTION AND METHODS Parallel cohort design with two randomised self-management groups (e-learning and group training) and a group receiving usual care. The effect of implementation of self-management on time in therapeutic range (TTR) was analysed with multilevel linear regression modelling. Usage of a supporting eHealth platform and the impact on self-efficacy (Generalised Self-Efficacy Scale (GSES)) and education level were analysed with linear regression analysis. After intervention, TTR was measured in three time periods of 6 months. MAIN OUTCOME MEASURES (1) TTR, severe complications,(2) usage of an eHealth platform,(3) GSES, education level. RESULTS Analysis showed no significant differences in TTR between the three time periods (p=0.520), the three groups (p=0.460) or the groups over time (p=0.263). Comparison of e-learning and group training showed no significant differences in TTR between the time periods (p=0.614), the groups (p=0.460) or the groups over time (p=0.263). No association was found between GSES and TTR (p=0.717) or education level and TTR (p=0.107). No significant difference was found between the self-management groups in usage of the platform (0-6 months p=0.571; 6-12 months p=0.866; 12-18 months p=0.260). The percentage of complications was low in all groups (3.2%; 1.4%; 0%). CONCLUSIONS No differences were found between OAT patients trained by e-learning or by a group course regarding therapeutic control (TTR) and usage of a supporting eHealth platform. The TTR was similar in self-management and regular care patients. With adequate e-learning or group training, self-management seems safe and reliable for a selected proportion of motivated vitamin K antagonist patients. TRIAL REGISTRATION NUMBER NTR3947.
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Fire Simulation and Cardiovascular Health in Firefighters.
Hunter, AL, Shah, AS, Langrish, JP, Raftis, JB, Lucking, AJ, Brittan, M, Venkatasubramanian, S, Stables, CL, Stelzle, D, Marshall, J, et al
Circulation. 2017;(14):1284-1295
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BACKGROUND Rates of myocardial infarction in firefighters are increased during fire suppression duties, and are likely to reflect a combination of factors including extreme physical exertion and heat exposure. We assessed the effects of simulated fire suppression on measures of cardiovascular health in healthy firefighters. METHODS In an open-label randomized crossover study, 19 healthy firefighters (age, 41±7 years; 16 males) performed a standardized training exercise in a fire simulation facility or light duties for 20 minutes. After each exposure, ex vivo thrombus formation, fibrinolysis, platelet activation, and forearm blood flow in response to intra-arterial infusions of endothelial-dependent and -independent vasodilators were measured. RESULTS After fire simulation training, core temperature increased (1.0±0.1°C) and weight reduced (0.46±0.14 kg, P<0.001 for both). In comparison with control, exposure to fire simulation increased thrombus formation under low-shear (73±14%) and high-shear (66±14%) conditions (P<0.001 for both) and increased platelet-monocyte binding (7±10%, P=0.03). There was a dose-dependent increase in forearm blood flow with all vasodilators (P<0.001), which was attenuated by fire simulation in response to acetylcholine (P=0.01) and sodium nitroprusside (P=0.004). This was associated with a rise in fibrinolytic capacity, asymptomatic myocardial ischemia, and an increase in plasma cardiac troponin I concentrations (1.4 [0.8-2.5] versus 3.0 [1.7-6.4] ng/L, P=0.010). CONCLUSIONS Exposure to extreme heat and physical exertion during fire suppression activates platelets, increases thrombus formation, impairs vascular function, and promotes myocardial ischemia and injury in healthy firefighters. Our findings provide pathogenic mechanisms to explain the association between fire suppression activity and acute myocardial infarction in firefighters. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01812317.
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Outcome After Myocardial Infarction Treated With Resolute Integrity and Promus Element Stents: Insights From the DUTCH PEERS (TWENTE II) Randomized Trial.
van Houwelingen, KG, Lam, MK, Löwik, MM, Danse, PW, Tjon Joe Gin, RM, Jessurun, GA, Anthonio, RL, Sen, H, Linssen, GCM, IJzerman, MJ, et al
Revista espanola de cardiologia (English ed.). 2016;(12):1152-1159
Abstract
INTRODUCTION AND OBJECTIVES In acute myocardial infarction (MI), novel highly deliverable drug-eluting stents (DES) may be particularly valuable as their flexible stent designs might reduce device-induced traumas to culprit lesions. The aim of the study was to assess the safety and efficacy of percutaneous coronary interventions with 2 novel durable polymer-coated DES in patients with acute MI. METHODS The prospective, randomized DUTCH PEERS (TWENTE II) multicenter trial compares Resolute Integrity and Promus Element stents in 1811 all-comer patients, of whom 817 (45.1%) were treated for ST-segment elevation MI or non-ST-segment elevation MI and the 2-year outcome is available in 99.9%. The primary clinical endpoint is target vessel failure (TVF), a composite of cardiac death, target vessel related MI, or target vessel revascularization. RESULTS Of all 817 patients treated for acute MI, 421 (51.5%) were treated with Resolute Integrity and 396 (48.5%) with Promus Element stents. At the 2-year follow-up, the rates of TVF (7.4% vs 6.1%; P = .45), target lesion revascularization (3.1% vs 2.8%; P = .79), and definite stent thrombosis (1.0% vs 0.5%; P = .69) were low for both stent groups. Consistent with these findings in all patients with acute MI, outcomes for the 2 DES were favorable and similar in both, with 370 patients with ST-segment elevation MI (TVF, 5.1% vs 4.9%; P = .81) and 447 patients with non-ST-segment elevation MI (TVF, 9.0% vs 7.5%; P = .56). CONCLUSIONS Resolute Integrity and Promus Element stents were both safe and efficacious in treating patients with acute MI. The present 2-year follow-up data underline the safety of using these devices in this particular clinical setting.
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Effectiveness of homocysteine lowering vitamins in prevention of thrombotic tendency at high altitude area: A randomized field trial.
Kotwal, J, Kotwal, A, Bhalla, S, Singh, PK, Nair, V
Thrombosis research. 2015;(4):758-62
Abstract
INTRODUCTION A higher risk of thrombosis has been reported on prolonged stay at high altitude (HAA). Lowering of homocysteine (Hcy) has been found to reduce the risk of venous thrombosis. A randomized field trial was conducted with primary question whether Hcy lowering agents have any effect on the incidence of thrombosis at HAA amongst Indian soldiers as compared to existing interventions. METHODS All units freshly inducted to HAA were randomized into intervention (Vit B12 1000 microgram/day, B6 3mg/day & folic acid 5mg/day) and control arms, with a sample size of 12,000 person-years in each arm. RESULTS At the end of one year stay at HAA, Folate and B 12 levels decreased significantly in control arm. The levels of Hcy, fibrinogen and plasminogen activator inhibitor (PAI 1) were lower and nitric oxide higher in intervention arm as compared to control arm (p<0.05). At the end of 2years, 5 thrombotic episodes occurred in the intervention arm and 17 in control arm with RR of 0.29 (95% CI 0.11-0.80), attributable fraction % (AFe) 70.59%, Population attributable risk percent 54.55% and Protective Fraction 240%. CONCLUSION Intervention with B12 and folic acid is effective in reducing Hcy, PAI 1, fibrinogen levels and increasing NO levels at 1yr as compared to control arm and reducing the incidence of thrombosis at 2years of stay at HAA. Thus, vitamin B 12, B6 and folic acid intervention is safe and effective method of reducing morbidity and mortality caused by HAA induced coagulopathy.
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Predictors and clinical implications of stent thrombosis in patients with ST-segment elevation myocardial infarction: Insights from the EXAMINATION trial.
Brugaletta, S, Sabate, M, Martin-Yuste, V, Masotti, M, Shiratori, Y, Alvarez-Contreras, L, Cequier, A, Iñiguez, A, Serra, A, Hernandez-Antolin, R, et al
International journal of cardiology. 2013;(3):2632-6
Abstract
BACKGROUND Few data are available about safety of second generation drug eluting stents in an all-comer ST elevation myocardial infarction (STEMI) population. We sought to investigate the predictors and clinical implications of 1-year stent thrombosis (ST) in patients with STEMI, included in the EXAMINATION trial. METHODS AND RESULTS The EXAMINATION trial is an all-comer prospective, randomized 1:1 controlled trial, testing everolimus-eluting stent (EES) vs. cobalt chromium bare metal stent (BMS) in STEMI patients. It included 1498 patients, randomized to EES (n = 751) or BMS (n = 747). At 1 year, definite/probable stent thrombosis, defined according to ARC criteria, occurred in 26 patients (1.73%), including 18 definite and 8 probable events. The incidence of ST was lower in patients treated with EES than in those treated with BMS (HR 0.16, 95% CI 0.03-0.29, p = 0.017). Patients with ST have higher 1-year rates of cardiac death (30.8% vs. 2.5%, p<0.001), myocardial infarction (30.8% vs. 0.5%, p<0.001) and target vessel revascularization (65.4% vs. 4.2%, p<0.001) compared with those without. Independent predictors of 1-year definite/probable ST were BMS implantation at the index procedure (HR 3.41, 95% CI 1.35-8.60), ST segment resolution of at least 70% in the EKG post-PCI (HR 0.30, 95% CI 0.13-0.70) and Killip class on admission (HR 2.57, 95% CI 1.70-3.90). CONCLUSIONS ST had low frequency in the first year after implantation of EES/BMS in STEMI patients, but it is associated with adverse events. BMS implantation, lack of ST-segment resolution and high Killip class on admission were independent predictors of 1-year ST.
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Clot resolution after 3 weeks of anticoagulant treatment for pulmonary embolism: comparison of computed tomography and perfusion scintigraphy.
van Es, J, Douma, RA, Kamphuisen, PW, Gerdes, VE, Verhamme, P, Wells, PS, Bounameaux, H, Lensing, AW, Büller, HR
Journal of thrombosis and haemostasis : JTH. 2013;(4):679-85
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INTRODUCTION Little is known about the natural history of clot resolution in the initial weeks of anticoagulant therapy in patients with acute pulmonary embolism (PE). Clot resolution of acute PE was assessed with either computed tomography pulmonary angiography scan (CT-scan) or perfusion scintigraphy scan (Q-scan) after 3 weeks of treatment. METHODS This was a predefined safety analysis of the Einstein PE study, including PE patients, randomized to either enoxaparin with vitamin K antagonist (VKA) or rivaroxaban. A similar scan as at baseline was repeated after 3 weeks. The percentage of vascular obstruction (PVO) was calculated on the basis of a weighted semiquantitative estimation of obstruction. Clot resolution was assessed blindly by calculating the relative change after 3 weeks. RESULTS PE was diagnosed in 264 patients with CT-scan and in 83 with Q-scan. Baseline characteristics were similar. At baseline, the mean PVO assessed with CT-scan (PVO-CT) and the mean PVO assessed with Q-scan (PVO-Q) were both 21% (standard deviation [SD] 13%) (P = 0.9). The mean relative decrease in PVO was 71% (SD 33%) for PVO-CT, and 62% (SD 36%) for PVO-Q (P = 0.02); complete resolution was observed in 44% (116/264; 95% confidence interval [CI] 38-50%) and 31% (26/83; 95% CI 22-42%) with CT-scan and Q-scan, respectively (P = 0.04). No difference in clot resolution between enoxaparin/VKA and rivaroxaban was found. CONCLUSION In patients with acute PE, only 3 weeks of anticoagulant treatment leads to complete clot resolution in a considerable proportion of patients, and normalization is more often observed with CT-scan than with Q-scan.
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Effect of 200μG/day of vitamin K1 on the variability of anticoagulation control in patients on warfarin: a randomized controlled trial.
Majeed, H, Rodger, M, Forgie, M, Carrier, M, Taljaard, M, Scarvelis, D, Gonsalves, C, Rodriguez, RA, Wells, PS
Thrombosis research. 2013;(3):329-35
Abstract
BACKGROUND Controversy exists whether low-dose vitamin K supplementation can improve anticoagulation control in patients with unstable anticoagulation under warfarin. In a single- centre randomized, double-blind, placebo-controlled study, we evaluated the effectiveness of 200 μg/day of vitamin K1 in patients with unstable control under warfarin. METHODS Effectiveness of Vitamin K1 supplementation was primarily assessed by the percentage (%) of Time-in-Therapeutic-Range (TTR) and secondarily by the standard deviation (SD) of the patient's INR values; the proportion of out-of-range INRs; and the number of dose changes on warfarin. Their change scores were obtained by subtracting the mean value in the 6 months pre-randomization from the mean value in the 6 months post-randomization. Multivariable linear-regressions identified factors associated with anticoagulation instability. RESULTS Fifty out of 54 patients were analyzed (intervention: n=26; placebo: n=24). Most indications (87%) for anticoagulation were venous thromboembolism (VTE). The intervention was associated with a greater reduction in the change scores for the SD of INRs between the pre and post-randomization periods compared with placebo. The mean change score was -0.259±0.307 with the intervention and -0.046±0.345 with placebo (p=0.026). There was no effect on the change scores of the (%) TTR (p=0.98), the number of INRs out-of-range (p=0.58) and the number of dose changes (p=0.604). Factors independently associated with increased variability in the SD of INRs were increased alcoholic drinks/week (p=0.017), dosing errors (p=0.0009) and missed INR appointments (p=0.035). CONCLUSION Vitamin K1 supplementation reduces the SD of INRs as an indicator of the variability in anticoagulation control in patients treated with warfarin for VTE.
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The effects of angiotensin receptor blockers vs. calcium channel blockers on the acute exercise-induced inflammatory and thrombotic response.
Liakos, CI, Vyssoulis, GP, Michaelides, AP, Chatzistamatiou, EI, Theodosiades, G, Toutouza, MG, Markou, MI, Synetos, AG, Kallikazaros, IE, Stefanadis, CI
Hypertension research : official journal of the Japanese Society of Hypertension. 2012;(12):1193-200
Abstract
Arterial hypertension is an established risk factor for acute coronary syndromes, and physical exertion may trigger the onset of such an event. The mechanisms involved include the rupture of a small, inflamed, coronary plaque and the activation of thrombogenic factors. Blood pressure (BP)-lowering treatment has been associated with beneficial effects on subclinical inflammation and thrombosis at rest and during exercise. This prospective study sought to compare the effect of different antihypertensive drugs on the inflammatory and thrombotic response during exercise. A total of 60 never-treated hypertensive patients were randomized to an angiotensin receptor blocker (ARB)- or non-dihydropyridine calcium channel blocker (CCB)-based regimen. Patients with inflammatory or coronary artery disease were excluded. Six months after pharmaceutical BP normalization, the patients underwent a maximal treadmill exercise testing. High-sensitivity C-reactive protein (hsCRP), serum amyloid A (SAA), white blood cells (WBC), tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), total fibrinogen (TF) and von Willebrand factor (vWF) levels, as well as plasminogen activator inhibitor-1 (PAI-1) activity were measured in blood samples taken while the patients were at rest and during peak exercise. All of these biomarkers increased with exercise, except PAI-1, which decreased (P<0.05 for the difference between resting and peak exercise for all biomarkers). The ARB group had less marked (P<0.05) exercise-induced changes than the CCB group in hsCRP (5.8% vs. 7.7%), SAA (4.2% vs. 7.2%), WBC (46.8% vs. 52.6%), TNF-α (16.3% vs. 24.3%), TF (9.5% vs. 16.9%) and PAI-1 (-9.5% vs. -12.3%) but a similar (P=NS) change in IL-6 (39.4% vs. 38.6%) and vWF (29.2% vs. 28.6%). In conclusion, ARBs are most likely more effective than CCBs at suppressing the exercise-induced acute phase response. Potential protection against exercise-related coronary events remains to be elucidated.
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The effect of consuming meat enriched in walnut paste on platelet aggregation and thrombogenesis varies in volunteers with different apolipoprotein A4 genotype.
Canales, A, Benedi, J, Bastida, S, Corella, D, Guillen, M, Librelotto, J, Nus, M, Sánchez-Muniz, FJ
Nutricion hospitalaria. 2010;(5):746-54
Abstract
BACKGROUND AND AIM Low-fat meat (LM) has been considered adequate under a cardiovascular disease point of view. Meat enriched in walnut paste (WM) consumption produces beneficial antithrombogenic effects but with striking inter-individual variability that may be related to gene polymorphism. Variants in the APOA4 gene (APOA4) polymorphism are known to affect the cardiovascular risk. This study aimed to compare the effects of consumption of WM and LM on platelet aggregation, production of thromboxane A2 (TXA2) and prostacyclin I2 (PGI2), and the TXA2/PGI2 ratio in 22 volunteers with different APOA4 polymorphism. SUBJECTS AND METHODS Six volunteers carried the Gln allele (APOA4-2) while 16 were homozygous for the His allele (APOA4-1). Platelet aggregation, TXA2 (measured as TXB2), PGI2 (measured as 6-keto-PGF1α), and the thrombogenic ratio (TXB2/6-keto-PGF1α) were determined at baseline and at weeks 3 and 5 for the WM and LM dietary periods. RESULTS Platelet aggregation decreased significantly (P<0.05) more in APOA4-1 than in APOA4-2 volunteers at 3-wk WM period, while TXB2 levels dropped more in APOA4-2 than in APOA4-1 volunteers at 5-wk WM period. TXB2 levels and the TXB2/6-keto-PGF1α ratio decreased significantly more (P<0.05) after 5 wk treatment in APOA4-2 than in APOA4-1 carriers on the WM diet than on the LM counterpart. However, 6-keto-PGF1α levels increased more (P<0.05) in APOA4-1 than in APOA4-2 volunteers after the 5-wk WM period than after the 5-wk LM diet. CONCLUSIONS Present results suggest that consumption of WM with respect to LM decrease the thrombogenic risk more in Gln carriers than in His/His.