Author: "Lewis, Basil S." / Topic: acute coronary syndrome - Searchworks@Jio Institute Digital Library Search Results

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1. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation.

Author: Collet JP, Thiele H, Barbato E, Barthélémy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Jüni P, Lambrinou E, Lewis BS, Mehilli J, Meliga E, Merkely B, Mueller C, Roffi M, Rutten FH, Sibbing D, and Siontis GCM
Subjects: Arrhythmias, Cardiac, Humans, Platelet Aggregation Inhibitors, Acute Coronary Syndrome diagnosis, Acute Coronary Syndrome therapy, Non-ST Elevated Myocardial Infarction diagnosis, Non-ST Elevated Myocardial Infarction therapy
Published: 2021
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2. Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial.

Author: Windecker S, Lopes RD, Massaro T, Jones-Burton C, Granger CB, Aronson R, Heizer G, Goodman SG, Darius H, Jones WS, Aschermann M, Brieger D, Cura F, Engstrøm T, Fridrich V, Halvorsen S, Huber K, Kang HJ, Leiva-Pons JL, Lewis BS, Malaga G, Meneveau N, Merkely B, Milicic D, Morais J, Potpara TS, Raev D, Sabaté M, de Waha-Thiele S, Welsh RC, Xavier D, Mehran R, and Alexander JH
Subjects: Acute Coronary Syndrome complications, Acute Coronary Syndrome surgery, Aged, Anticoagulants adverse effects, Atrial Fibrillation complications, Combined Modality Therapy, Disease Management, Drug Therapy, Combination, Elective Surgical Procedures, Female, Fibrinolytic Agents adverse effects, Hemorrhage chemically induced, Hemorrhage epidemiology, Hospitalization, Humans, Male, Middle Aged, Platelet Aggregation Inhibitors adverse effects, Proportional Hazards Models, Prospective Studies, Purinergic P2Y Receptor Antagonists adverse effects, Purinergic P2Y Receptor Antagonists therapeutic use, Treatment Outcome, Vitamin K antagonists & inhibitors, Acute Coronary Syndrome drug therapy, Anticoagulants therapeutic use, Aspirin therapeutic use, Atrial Fibrillation drug therapy, Cardiovascular Agents therapeutic use, Fibrinolytic Agents therapeutic use, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors therapeutic use, Pyrazoles therapeutic use, Pyridones therapeutic use
Abstract: Background: The safety and efficacy of antithrombotic regimens may differ between patients with atrial fibrillation who have acute coronary syndromes (ACS), treated medically or with percutaneous coronary intervention (PCI), and those undergoing elective PCI., Methods: Using a 2×2 factorial design, we compared apixaban with vitamin K antagonists and aspirin with placebo in patients with atrial fibrillation who had ACS or were undergoing PCI and were receiving a P2Y 12 inhibitor. We explored bleeding, death and hospitalization, as well as death and ischemic events, by antithrombotic strategy in 3 prespecified subgroups: patients with ACS treated medically, patients with ACS treated with PCI, and those undergoing elective PCI., Results: Of 4614 patients enrolled, 1097 (23.9%) had ACS treated medically, 1714 (37.3%) had ACS treated with PCI, and 1784 (38.8%) had elective PCI. Apixaban compared with vitamin K antagonist reduced International Society on Thrombosis and Haemostasis major or clinically relevant nonmajor bleeding in patients with ACS treated medically (hazard ratio [HR], 0.44 [95% CI, 0.28-0.68]), patients with ACS treated with PCI (HR, 0.68 [95% CI, 0.52-0.89]), and patients undergoing elective PCI (HR, 0.82 [95% CI, 0.64-1.04]; P interaction =0.052) and reduced death or hospitalization in the ACS treated medically (HR, 0.71 [95% CI, 0.54-0.92]), ACS treated with PCI (HR, 0.88 [95% CI, 0.74-1.06]), and elective PCI (HR, 0.87 [95% CI, 0.72-1.04]; P interaction =0.345) groups. Compared with vitamin K antagonists, apixaban resulted in a similar effect on death and ischemic events in the ACS treated medically, ACS treated with PCI, and elective PCI groups ( P interaction =0.356). Aspirin had a higher rate of bleeding than did placebo in patients with ACS treated medically (HR, 1.49 [95% CI, 0.98-2.26]), those with ACS treated with PCI (HR, 2.02 [95% CI, 1.53-2.67]), and those undergoing elective PCI (HR, 1.91 [95% CI, 1.48-2.47]; P interaction =0.479). For the same comparison, there was no difference in outcomes among the 3 groups for the composite of death or hospitalization ( P interaction =0.787) and death and ischemic events ( P interaction =0.710)., Conclusions: An antithrombotic regimen consisting of apixaban and a P2Y 12 inhibitor without aspirin provides superior safety and similar efficacy in patients with atrial fibrillation who have ACS, whether managed medically or with PCI, and those undergoing elective PCI compared with regimens that include vitamin K antagonists, aspirin, or both., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02415400.
Published: 2019
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3. Impact of Diabetes Mellitus and Chronic Kidney Disease on Cardiovascular Outcomes and Platelet P2Y 12 Receptor Antagonist Effects in Patients With Acute Coronary Syndromes: Insights From the PLATO Trial.

Author: Franchi F, James SK, Ghukasyan Lakic T, Budaj AJ, Cornel JH, Katus HA, Keltai M, Kontny F, Lewis BS, Storey RF, Himmelmann A, Wallentin L, and Angiolillo DJ
Subjects: Acute Coronary Syndrome epidemiology, Aged, Comorbidity, Dose-Response Relationship, Drug, Electrocardiography, Female, Follow-Up Studies, Humans, Male, Middle Aged, Platelet Aggregation Inhibitors administration & dosage, Prognosis, Purinergic P2Y Receptor Antagonists administration & dosage, Retrospective Studies, Risk Factors, Survival Rate trends, United States epidemiology, Acute Coronary Syndrome drug therapy, Clopidogrel administration & dosage, Diabetes Mellitus epidemiology, Renal Insufficiency, Chronic epidemiology, Ticagrelor administration & dosage
Abstract: Background There are limited data on how the combination of diabetes mellitus ( DM ) and chronic kidney disease ( CKD ) affects cardiovascular outcomes as well as response to different P2Y 12 receptor antagonists, which represented the aim of the present investigation. Methods and Results In this post hoc analysis of the PLATO (Platelet Inhibition and Patient Outcomes) trial, which randomized acute coronary syndrome patients to ticagrelor versus clopidogrel, patients (n=15 108) with available DM and CKD status were classified into 4 groups: DM +/ CKD + (n=1058), DM +/ CKD - (n=2748), DM -/ CKD + (n=2160), and DM -/ CKD - (n=9142). The primary efficacy end point was a composite of cardiovascular death, myocardial infarction, or stroke at 12 months. The primary safety end point was PLATO major bleeding. DM +/ CKD + patients had a higher incidence of the primary end point compared with DM -/ CKD - patients (23.3% versus 7.1%; adjusted hazard ratio 2.22; 95% CI 1.88-2.63; P<0.001). Patients with DM +/ CKD - and DM -/ CKD + had an intermediate risk profile. The same trend was shown for the individual components of the primary end point and for major bleeding. Compared with clopidogrel, ticagrelor reduced the incidence of the primary end point consistently across subgroups ( P-interaction=0.264), but with an increased absolute risk reduction in DM +/ CKD +. The effects on major bleeding were also consistent across subgroups ( P-interaction=0.288). Conclusions In acute coronary syndrome patients, a gradient of risk was observed according to the presence or absence of DM and CKD , with patients having both risk factors at the highest risk. Although the ischemic benefit of ticagrelor over clopidogrel was consistent in all subgroups, the absolute risk reduction was greatest in patients with both DM and CKD . Clinical Trial Registration URL : http://www.clinicatrials.gov . Unique identifier: NCT 00391872.
Published: 2019
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4. On-treatment analysis of the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT).

Author: Blazing MA, Giugliano RP, de Lemos JA, Cannon CP, Tonkin A, Ballantyne CM, Lewis BS, Musliner TA, Tershakovec AM, Lokhnygina Y, White JA, Reist C, McCagg A, and Braunwald E
Subjects: Aged, Anticholesteremic Agents administration & dosage, Anticholesteremic Agents adverse effects, Dose-Response Relationship, Drug, Drug Monitoring methods, Drug Synergism, Drug Therapy, Combination methods, Drug Therapy, Combination statistics & numerical data, Female, Humans, Male, Middle Aged, Treatment Outcome, Acute Coronary Syndrome blood, Acute Coronary Syndrome diagnosis, Acute Coronary Syndrome drug therapy, Cholesterol, LDL blood, Ezetimibe administration & dosage, Ezetimibe adverse effects, Simvastatin administration & dosage, Simvastatin adverse effects
Abstract: Background: We aimed to determine the efficacy and safety of adding ezetimibe (Ez) to simvastatin (S) in a post-acute coronary syndrome (ACS) population in a prespecified on-treatment analysis., Methods: We evaluated 17,706 post-ACS patients from the IMPROVE-IT trial who had low-density lipoprotein cholesterol values between 50 and 125 mg/dL and who received Ez 10 mg/d with S 40 mg/d (Ez/S) or placebo with simvastatin 40 mg/d (P/S). The primary composite end point was cardiovascular death, myocardial infarction, unstable angina, coronary revascularization ≥30 days postrandomization, or stroke. The on-treatment analysis included patients who received study drug for the duration of the trial or experienced a primary end point or noncardiovascular death within 30 days of drug discontinuation., Results: Mean low-density lipoprotein cholesterol values at 1 year were 71 mg/dL for P/S and 54 mg/dL for Ez/S (absolute difference -17 mg/dL = -24%; P < .001). The 7-year Kaplan-Meier estimate of the primary end point occurred in 32.4% in the P/S arm and 29.8% in the Ez/S arm (absolute difference 2.6%; HR adj 0.92 [95% CI 0.87-0.98]; P = .01). The absolute treatment effect favoring Ez/S was 30% greater than in the intention-to-treat analysis of IMPROVE-IT., Conclusions: This analysis provides additional support for the efficacy and safety of adding Ez to S in this high-risk, post-ACS population., (Copyright Â© 2016 Elsevier Inc. All rights reserved.)
Published: 2016
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5. Apixaban Plus Mono Versus Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights From the APPRAISE-2 Trial.

Author: Hess CN, James S, Lopes RD, Wojdyla DM, Neely ML, Liaw D, Hagstrom E, Bhatt DL, Husted S, Goodman SG, Lewis BS, Verheugt FWA, De Caterina R, Ogawa H, Wallentin L, and Alexander JH
Subjects: Aged, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Male, Middle Aged, Acute Coronary Syndrome diagnosis, Acute Coronary Syndrome drug therapy, Factor Xa Inhibitors administration & dosage, Platelet Aggregation Inhibitors administration & dosage, Purinergic P2Y Receptor Antagonists administration & dosage, Pyrazoles administration & dosage, Pyridones administration & dosage
Abstract: Background: Bleeding limits anticoagulant treatment in patients with acute coronary syndromes (ACS)., Objectives: We investigated whether background concomitant antiplatelet therapy influences the effects of apixaban after ACS., Methods: This study examined high-risk ACS patients who were treated with aspirin or aspirin plus clopidogrel and who were randomized to apixaban 5 mg twice daily or placebo. In a post-hoc analysis, we assessed whether the effect of apixaban on efficacy and safety outcomes varied by the concomitant antiplatelet regimen by using simple Cox modeling and marginal structural models with propensity scores and antiplatelet therapy as a time-dependent covariate., Results: At baseline, of 7,364 patients, 16.3% (n = 1,202) were on aspirin alone, and 79.0% (n = 5,814) were on aspirin plus clopidogrel. A total of 19.2% (n = 1,415) switched antiplatelet therapy during follow-up. No differential effect of apixaban versus placebo was observed for the composite endpoint of cardiovascular death, myocardial infarction, and ischemic stroke in patients taking aspirin (12.21 per 100 patient-years vs. 13.21 per 100 patient-years; adjusted hazard ratio [HR]: 0.91; 95% confidence interval [CI]: 0.62 to 1.32) or aspirin plus clopidogrel (13.22 vs. 14.24; adjusted HR: 0.95; 95% CI: 0.78 to 1.14; p(interaction)= 0.84). Compared with placebo, apixaban increased Thrombolysis In Myocardial Infarction major bleeding in patients taking aspirin (1.48 vs. 0.25; adjusted HR: 6.62; 95% CI: 0.75 to 51.73) and in patients taking aspirin plus clopidogrel (2.58 vs. 1.02; adjusted HR: 2.44; 95% CI: 1.34 to 4.45; p(interaction)= 0.41). Similar results were obtained with marginal structural models and in patients treated with and without percutaneous coronary intervention., Conclusions: Post-ACS treatment with apixaban versus placebo showed no efficacy, but it increased bleeding regardless of concomitant therapy with aspirin alone or aspirin plus clopidogrel. (Apixaban for Prevention of Acute Ischemic Events 2 [APPRAISE-2]; NCT00831441)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
Published: 2015
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6. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes.

Author: Cannon CP, Blazing MA, Giugliano RP, McCagg A, White JA, Theroux P, Darius H, Lewis BS, Ophuis TO, Jukema JW, De Ferrari GM, Ruzyllo W, De Lucca P, Im K, Bohula EA, Reist C, Wiviott SD, Tershakovec AM, Musliner TA, Braunwald E, and Califf RM
Subjects: Aged, Anticholesteremic Agents adverse effects, Azetidines adverse effects, Cardiovascular Diseases epidemiology, Cardiovascular Diseases mortality, Cardiovascular Diseases prevention & control, Double-Blind Method, Drug Therapy, Combination, Ezetimibe, Female, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors adverse effects, Kaplan-Meier Estimate, Male, Middle Aged, Triglycerides blood, Acute Coronary Syndrome drug therapy, Anticholesteremic Agents therapeutic use, Azetidines therapeutic use, Cholesterol, LDL blood, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Simvastatin therapeutic use
Abstract: Background: Statin therapy reduces low-density lipoprotein (LDL) cholesterol levels and the risk of cardiovascular events, but whether the addition of ezetimibe, a nonstatin drug that reduces intestinal cholesterol absorption, can reduce the rate of cardiovascular events further is not known., Methods: We conducted a double-blind, randomized trial involving 18,144 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days and had LDL cholesterol levels of 50 to 100 mg per deciliter (1.3 to 2.6 mmol per liter) if they were receiving lipid-lowering therapy or 50 to 125 mg per deciliter (1.3 to 3.2 mmol per liter) if they were not receiving lipid-lowering therapy. The combination of simvastatin (40 mg) and ezetimibe (10 mg) (simvastatin-ezetimibe) was compared with simvastatin (40 mg) and placebo (simvastatin monotherapy). The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, unstable angina requiring rehospitalization, coronary revascularization (≥30 days after randomization), or nonfatal stroke. The median follow-up was 6 years., Results: The median time-weighted average LDL cholesterol level during the study was 53.7 mg per deciliter (1.4 mmol per liter) in the simvastatin-ezetimibe group, as compared with 69.5 mg per deciliter (1.8 mmol per liter) in the simvastatin-monotherapy group (P<0.001). The Kaplan-Meier event rate for the primary end point at 7 years was 32.7% in the simvastatin-ezetimibe group, as compared with 34.7% in the simvastatin-monotherapy group (absolute risk difference, 2.0 percentage points; hazard ratio, 0.936; 95% confidence interval, 0.89 to 0.99; P=0.016). Rates of prespecified muscle, gallbladder, and hepatic adverse effects and cancer were similar in the two groups., Conclusions: When added to statin therapy, ezetimibe resulted in incremental lowering of LDL cholesterol levels and improved cardiovascular outcomes. Moreover, lowering LDL cholesterol to levels below previous targets provided additional benefit. (Funded by Merck; IMPROVE-IT ClinicalTrials.gov number, NCT00202878.).
Published: 2015
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7. Extent of coronary artery disease and outcomes after ticagrelor administration in patients with an acute coronary syndrome: Insights from the PLATelet inhibition and patient Outcomes (PLATO) trial.

Author: Kotsia A, Brilakis ES, Held C, Cannon C, Steg GP, Meier B, Cools F, Claeys MJ, Cornel JH, Aylward P, Lewis BS, Weaver D, Brandrup-Wognsen G, Stevens SR, Himmelmann A, Wallentin L, and James SK
Subjects: Acute Coronary Syndrome epidemiology, Adenosine therapeutic use, Aged, Electrocardiography, Female, Follow-Up Studies, Global Health, Humans, Incidence, Male, Middle Aged, Purinergic P2Y Receptor Antagonists therapeutic use, Retrospective Studies, Risk Factors, Survival Rate trends, Ticagrelor, Treatment Outcome, Acute Coronary Syndrome drug therapy, Adenosine analogs & derivatives, Platelet Aggregation Inhibitors therapeutic use
Abstract: Background: Extensive coronary artery disease (CAD) is associated with higher risk. In this substudy of the PLATO trial, we examined the effects of randomized treatment on outcome events and safety in relation to the extent of CAD., Methods: Patients were classified according to presence of extensive CAD (defined as 3-vessel disease, left main disease, or prior coronary artery bypass graft surgery). The trial's primary and secondary end points were compared using Cox proportional hazards regression., Results: Among 15,388 study patients for whom the extent of CAD was known, 4,646 (30%) had extensive CAD. Patients with extensive CAD had more high-risk characteristics and experienced more clinical events during follow-up. They were less likely to undergo percutaneous coronary intervention (58% vs 79%, P < .001) but more likely to undergo coronary artery bypass graft surgery (16% vs 2%, P < .001). Ticagrelor, compared with clopidogrel, reduced the composite of cardiovascular death, myocardial infarction, and stroke in patients with extensive CAD (14.9% vs 17.6%, hazard ratio [HR] 0.85 [0.73-0.98]) similar to its reduction in those without extensive CAD (6.8% vs 8.0%, HR 0.85 [0.74-0.98], Pinteraction = .99). Major bleeding was similar with ticagrelor vs clopidogrel among patients with (25.7% vs 25.5%, HR 1.02 [0.90-1.15]) and without (7.3% vs 6.4%, HR 1.14 [0.98-1.33], Pinteraction = .24) extensive CAD., Conclusions: Patients with extensive CAD have higher rates of recurrent cardiovascular events and bleeding. Ticagrelor reduced ischemic events to a similar extent both in patients with and without extensive CAD, with bleeding rates similar to clopidogrel., (Published by Mosby, Inc.)
Published: 2014
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8. Response to letter regarding article, "Stent thrombosis with ticagrelor versus clopidogrel in patients with acute coronary syndromes: an analysis from the prospective, randomized PLATO trial".

Author: Steg PG, Harrington RA, Emanuelsson H, Katus HA, Mahaffey KW, Meier B, Storey RF, Wojdyla DM, Lewis BS, Maurer G, Wallentin L, and James SK
Subjects: Female, Humans, Male, Acute Coronary Syndrome drug therapy, Adenosine analogs & derivatives, Coronary Thrombosis drug therapy, Internationality, Stents adverse effects, Ticlopidine analogs & derivatives
Published: 2014
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9. Age, treatment, and outcomes in high-risk non-ST-segment elevation acute coronary syndrome patients: insights from the EARLY ACS trial.

Author: Lopes RD, White JA, Tricoci P, White HD, Armstrong PW, Braunwald E, Giugliano RP, Harrington RA, Lewis BS, Brogan GX Jr, Gibson CM, Califf RM, and Newby LK
Subjects: Acute Coronary Syndrome metabolism, Age Factors, Aged, Aged, 80 and over, Female, Follow-Up Studies, Humans, Male, Middle Aged, Myocardial Infarction diagnosis, Myocardial Infarction metabolism, Myocardial Infarction therapy, Platelet Aggregation Inhibitors pharmacology, Platelet Glycoprotein GPIIb-IIIa Complex metabolism, Risk Factors, Treatment Outcome, Acute Coronary Syndrome diagnosis, Acute Coronary Syndrome therapy, Percutaneous Coronary Intervention trends, Platelet Aggregation Inhibitors therapeutic use, Platelet Glycoprotein GPIIb-IIIa Complex antagonists & inhibitors
Abstract: Background: Elderly patients with acute coronary syndromes (ACS) are at high risk for death and recurrent thrombotic events. We evaluated the efficacy and safety of intensive treatment with glycoprotein IIb/IIIa inhibitors in an elderly population, and the relationships between age, timing of administration, and clinical outcomes., Methods: We used data from high-risk non-ST-segment elevation ACS patients randomized to early eptifibatide vs. delayed provisional use at percutaneous coronary intervention. In multivariable models, we included age×treatment interaction terms to assess whether treatment effect varied by age after adjusting for confounders., Results: Of 9406 patients, 13.9% were aged <55 years; 27.6%, 55-64 years; 33.2%, 65-74 years; and 25.3%, ≥ 75 years. For each 10-year age increase, the adjusted odds ratio (OR) (95% confidence interval [CI]) for 96-hour death, myocardial infarction (MI), recurrent ischemia requiring urgent revascularization, or thrombotic bailout was 1.13 (1.04-1.23) and for 30-day death or MI was 1.13 (1.04-1.22). Increasing age was also associated with greater 1-year mortality (adjusted hazard ratio per 10 years: 1.44, 95% CI 1.30-1.60). There was no interaction between age and treatment (p interaction=0.99, 0.54, and 0.87, respectively). Increasing age was associated with more non-coronary artery bypass grafting-related TIMI major bleeding (adjusted OR and 95% CI per 10 years: 1.54 [1.24-1.92]), GUSTO moderate/severe bleeding (1.52 [1.33-1.75]), and transfusion (1.25 [1.07-1.45]). The amount by which TIMI major bleeding was increased with early vs. delayed provisional eptifibatide use was significantly greater with increasing age (p interaction=0.02), but the age×treatment interactions were not significant for GUSTO moderate/severe bleeding or transfusion (p interaction=0.33 and 0.54, respectively)., Conclusion: Increasing age was associated with greater risk for ischemic events and more bleeding. Despite higher baseline ischemic risk in older patients, there was no preferential benefit of early vs. delayed provisional eptifibatide use for ischemic outcomes as age increased, but the incremental bleeding risk was amplified., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)
Published: 2013
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10. Stent thrombosis with ticagrelor versus clopidogrel in patients with acute coronary syndromes: an analysis from the prospective, randomized PLATO trial.

Author: Steg PG, Harrington RA, Emanuelsson H, Katus HA, Mahaffey KW, Meier B, Storey RF, Wojdyla DM, Lewis BS, Maurer G, Wallentin L, and James SK
Subjects: Acute Coronary Syndrome epidemiology, Acute Coronary Syndrome surgery, Adenosine therapeutic use, Aged, Clopidogrel, Coronary Thrombosis epidemiology, Double-Blind Method, Female, Follow-Up Studies, Heart Diseases drug therapy, Heart Diseases epidemiology, Humans, Male, Middle Aged, Platelet Aggregation Inhibitors therapeutic use, Prospective Studies, Purinergic P2Y Receptor Antagonists therapeutic use, Risk Factors, Ticagrelor, Ticlopidine therapeutic use, Treatment Outcome, Acute Coronary Syndrome drug therapy, Adenosine analogs & derivatives, Coronary Thrombosis drug therapy, Internationality, Stents adverse effects, Ticlopidine analogs & derivatives
Abstract: Background: We aimed to describe the effects of ticagrelor versus clopidogrel on stent thrombosis in the Platelet Inhibition and Patient Outcomes (PLATO) trial., Methods and Results: Of 18 624 patients hospitalized for acute coronary syndromes, 11 289 (61%) had at least 1 intracoronary stent. Ticagrelor reduced stent thrombosis compared with clopidogrel across all definitions: definite, 1.37% (n=71) versus 1.93% (n=105; hazard ratio [HR], 0.67; 95% confidence interval [CI], 0.50-0.90; P=0.0091); definite or probable, 2.21% (n=118) versus 2.87% (n=157; HR, 0.75; 95% CI, 0.59-0.95; P=0.017); and definite, probable, and possible, 2.94% (n=154) versus 3.77 (n=201; HR, 0.77; 95% CI, 0.62-0.95). The reduction in definite stent thrombosis was consistent regardless of acute coronary syndrome type, presence of diabetes mellitus, stent type (drug-eluting or bare metal stent), CYP2C19 genetic status, loading dose of aspirin, dose of clopidogrel before randomization, and use of glycoprotein IIb/IIIa inhibitors at randomization. The reduction in stent thrombosis with ticagrelor was numerically greater for late (>30 days; HR, 0.48; 95% CI, 0.24-0.96) and subacute (4 hours-30 days; HR, 0.60; 95% CI, 0.39-0.93) compared with acute (<24 hours; HR, 0.94; 95% CI, 0.43-2.05) stent thrombosis or for patients compliant to therapy (ie, taking blinded study treatment ≥80% of the time) compared with less compliant patients. Randomization to ticagrelor was a strong independent inverse predictor of definite stent thrombosis (HR, 0.65; 95% CI, 0.48-0.88)., Conclusion: Ticagrelor compared with clopidogrel reduces the incidence of stent thrombosis in patients with acute coronary syndromes, with consistent benefit across a broad range of patient, stent, and treatment characteristics.
Published: 2013
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11. Duration of eptifibatide infusion after percutaneous coronary intervention and outcomes among high-risk patients with non-ST-segment elevation acute coronary syndrome: insights from EARLY ACS.

Author: Hess CN, Schulte PJ, Newby LK, Steg PG, Dalby AJ, Schweiger MJ, Lewis BS, Armstrong PW, Califf RM, van de Werf F, and Harrington RA
Subjects: Acute Coronary Syndrome mortality, Eptifibatide, Female, Hemorrhage chemically induced, Humans, Infusions, Intravenous, Male, Middle Aged, Myocardial Infarction mortality, Myocardial Ischemia mortality, Peptides adverse effects, Percutaneous Coronary Intervention mortality, Platelet Aggregation Inhibitors adverse effects, Recurrence, Risk Factors, Treatment Outcome, Acute Coronary Syndrome therapy, Peptides administration & dosage, Percutaneous Coronary Intervention methods, Platelet Aggregation Inhibitors administration & dosage
Abstract: Background and Objectives: Eptifibatide is indicated during percutaneous coronary intervention (PCI) with continuation for 18-24 hours post procedure but is associated with bleeding. We examined the efficacy and safety of shorter post-PCI eptifibatide infusions in high-risk non-ST-segment elevation acute coronary syndrome (NSTE ACS) patients., Methods: EARLY ACS patients treated with PCI and eptifibatide were grouped by post-procedure infusion duration: <10, 10-13, 13-17, and 17-25 (per protocol) hours. Adjusted estimated event rates for 96-hour death/myocardial infarction (MI)/recurrent ischaemia requiring urgent revascularization (RIUR), 30-day death/MI, post-PCI packed red blood cell (PRBC) transfusion, and GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries) moderate/severe bleeding were obtained using inverse-propensity weighting to account for informative censoring of infusions., Results: Among 3271 eptifibatide-treated PCI patients, there were 66 96-hour death/MI/RIUR events, 94 30-day death/MI events, 127 PRBC transfusions, and 115 GUSTO moderate/severe bleeds. Compared with per protocol, patients receiving post-PCI infusions <10 hours had similar adjusted estimated rates of 96-hour death/MI/RIUR (absolute difference 0.021 higher; 0.040 vs. 0.019, 95% CI -0.023 to 0.064; p=0.35) and 30-day death/MI (0.020 higher; 0.046 vs. 0.026, 95% CI -0.021 to 0.062; p=0.34). There were also no differences in ischaemic outcomes between infusions of 10-17 hours and per-protocol infusions. Adjusted estimated rates of PRBC transfusion were higher for the <10-hour infusion group compared with per protocol (0.048 higher; 0.079 vs. 0.031, 95% CI 0.005 to 0.091, p=0.03) but were similar for other groups. Adjusted GUSTO moderate/severe bleeding rates were similar to per-protocol rates for all groups., Conclusions: In high-risk NSTE ACS patients, post-PCI eptifibatide infusions <18 hours were not associated with worse ischaemic outcomes. Shorter eptifibatide infusions in this population may be feasible.
Published: 2013
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12. Effect of ticagrelor on the outcomes of patients with prior coronary artery bypass graft surgery: insights from the PLATelet inhibition and patient outcomes (PLATO) trial.

Author: Brilakis ES, Held C, Meier B, Cools F, Claeys MJ, Cornel JH, Aylward P, Lewis BS, Weaver D, Brandrup-Wognsen G, Stevens SR, Himmelmann A, Wallentin L, and James SK
Subjects: Acute Coronary Syndrome mortality, Acute Coronary Syndrome surgery, Adenosine adverse effects, Adenosine therapeutic use, Aged, Female, Hemorrhage epidemiology, Humans, Male, Middle Aged, Myocardial Infarction epidemiology, Platelet Aggregation Inhibitors adverse effects, Proportional Hazards Models, Risk Factors, Stroke epidemiology, Survival Analysis, Ticagrelor, Treatment Outcome, Acute Coronary Syndrome drug therapy, Adenosine analogs & derivatives, Coronary Artery Bypass methods, Hemorrhage chemically induced, Myocardial Infarction etiology, Platelet Aggregation Inhibitors therapeutic use, Purinergic P2Y Receptor Antagonists therapeutic use, Stroke etiology
Abstract: Background: Patients with prior coronary artery bypass graft surgery (CABG) who present with an acute coronary syndrome have a high risk for recurrent events. Whether intensive antiplatelet therapy with ticagrelor might be beneficial compared with clopidogrel is unknown. In this substudy of the PLATO trial, we studied the effects of randomized treatment dependent on history of CABG., Methods: Patients participating in PLATO were classified according to whether they had undergone prior CABG. The trial's primary and secondary end points were compared using Cox proportional hazards regression., Results: Of the 18,613 study patients, 1,133 (6.1%) had prior CABG. Prior-CABG patients had more high-risk characteristics at study entry and a 2-fold increase in clinical events during follow-up, but less major bleeding. The primary end point (composite of cardiovascular death, myocardial infarction, and stroke) was reduced to a similar extent by ticagrelor among patients with (19.6% vs 21.4%; adjusted hazard ratio [HR], 0.91 [0.67, 1.24]) and without (9.2% vs 11.0%; adjusted HR, 0.86 [0.77, 0.96]; P(interaction) = .73) prior CABG. Major bleeding was similar with ticagrelor versus clopidogrel among patients with (8.1% vs 8.7%; adjusted HR, 0.89 [0.55, 1.47]) and without (11.8% vs 11.4%; HR, 1.08 [0.98, 1.20]; P(interaction) = .46) prior CABG., Conclusions: Prior-CABG patients presenting with acute coronary syndrome are a high-risk cohort for death and recurrent cardiovascular events but have a lower risk for major bleeding. Similar to the results in no-prior-CABG patients, ticagrelor was associated with a reduction in ischemic events without an increase in major bleeding., (© 2013.)
Published: 2013
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13. Radial versus femoral access, bleeding and ischemic events in patients with non-ST-segment elevation acute coronary syndrome managed with an invasive strategy.

Author: Klutstein MW, Westerhout CM, Armstrong PW, Giugliano RP, Lewis BS, Gibson CM, Lutchmedial S, Widimsky P, Steg PG, Dalby A, Zeymer U, Van de Werf F, Harrington RA, Newby LK, and Rao SV
Subjects: Aged, Cardiac Catheterization adverse effects, Eptifibatide, Erythrocyte Transfusion, Female, Femur abnormalities, Humans, Male, Middle Aged, Peptides therapeutic use, Pierre Robin Syndrome, Platelet Aggregation Inhibitors therapeutic use, Propensity Score, Radial Artery, Acute Coronary Syndrome therapy, Cardiac Catheterization methods, Hemorrhage epidemiology
Abstract: Background: Bleeding is a major limitation of antithrombotic therapy among invasively managed non-ST-segment elevation acute coronary syndromes (NSTE-ACS) patients; therefore, we examined the use of radial access and its association with outcomes among NSTE-ACS patients., Methods: Clinical characteristics and geographic variation in radial access were examined, as well as its association with bleeding, red blood cell transfusion and ischemic outcomes (96-hour death/myocardial infarction/recurrent ischemic/thrombotic bailout; 30-day death/myocardial infarction; 1-year death) in the EARLY versus delayed, provisional eptifibatide in acute coronary syndromes trial., Results: Of 9126 patients, 13.5% underwent radial-access catheterization. Female sex, age, weight, and prior revascularization were inversely associated with radial access, and its use varied widely by country (2%-97%). There were fewer GUSTO severe/moderate bleeds and red blood cell transfusions in the radial access group; however, it was attenuated after adjustment (odds ratio 0.73, 95% confidence intervals [CI] [0.50-1.06], P = .094 and 1.00 [0.71-1.40] P = .991). Ischemic outcomes did not differ by access site., Conclusions: In this post hoc analysis of a large clinical trial, there was significant international variation in use of radial access for NSTE-ACS patients undergoing invasive management, and it was preferentially used in those at lower risk for bleeding. Radial approach was not associated with a significant reduction in either bleeding or ischemic outcomes. Further study is needed to determine whether wider application of radial approach to acute coronary syndrome patients at high risk for bleeding improves overall outcomes., (Copyright © 2013 Mosby, Inc. All rights reserved.)
Published: 2013
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14. Thrombin-receptor antagonist vorapaxar in acute coronary syndromes.

Author: Tricoci P, Huang Z, Held C, Moliterno DJ, Armstrong PW, Van de Werf F, White HD, Aylward PE, Wallentin L, Chen E, Lokhnygina Y, Pei J, Leonardi S, Rorick TL, Kilian AM, Jennings LH, Ambrosio G, Bode C, Cequier A, Cornel JH, Diaz R, Erkan A, Huber K, Hudson MP, Jiang L, Jukema JW, Lewis BS, Lincoff AM, Montalescot G, Nicolau JC, Ogawa H, Pfisterer M, Prieto JC, Ruzyllo W, Sinnaeve PR, Storey RF, Valgimigli M, Whellan DJ, Widimsky P, Strony J, Harrington RA, and Mahaffey KW
Subjects: Acute Coronary Syndrome therapy, Aged, Angioplasty, Cardiovascular Diseases mortality, Cardiovascular Diseases prevention & control, Combined Modality Therapy, Coronary Artery Bypass, Double-Blind Method, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Intracranial Hemorrhages chemically induced, Kaplan-Meier Estimate, Lactones adverse effects, Male, Middle Aged, Platelet Aggregation Inhibitors adverse effects, Pyridines adverse effects, Acute Coronary Syndrome drug therapy, Hemorrhage chemically induced, Lactones therapeutic use, Platelet Aggregation Inhibitors therapeutic use, Pyridines therapeutic use, Receptor, PAR-1 antagonists & inhibitors
Abstract: Background: Vorapaxar is a new oral protease-activated-receptor 1 (PAR-1) antagonist that inhibits thrombin-induced platelet activation., Methods: In this multinational, double-blind, randomized trial, we compared vorapaxar with placebo in 12,944 patients who had acute coronary syndromes without ST-segment elevation. The primary end point was a composite of death from cardiovascular causes, myocardial infarction, stroke, recurrent ischemia with rehospitalization, or urgent coronary revascularization., Results: Follow-up in the trial was terminated early after a safety review. After a median follow-up of 502 days (interquartile range, 349 to 667), the primary end point occurred in 1031 of 6473 patients receiving vorapaxar versus 1102 of 6471 patients receiving placebo (Kaplan-Meier 2-year rate, 18.5% vs. 19.9%; hazard ratio, 0.92; 95% confidence interval [CI], 0.85 to 1.01; P=0.07). A composite of death from cardiovascular causes, myocardial infarction, or stroke occurred in 822 patients in the vorapaxar group versus 910 in the placebo group (14.7% and 16.4%, respectively; hazard ratio, 0.89; 95% CI, 0.81 to 0.98; P=0.02). Rates of moderate and severe bleeding were 7.2% in the vorapaxar group and 5.2% in the placebo group (hazard ratio, 1.35; 95% CI, 1.16 to 1.58; P<0.001). Intracranial hemorrhage rates were 1.1% and 0.2%, respectively (hazard ratio, 3.39; 95% CI, 1.78 to 6.45; P<0.001). Rates of nonhemorrhagic adverse events were similar in the two groups., Conclusions: In patients with acute coronary syndromes, the addition of vorapaxar to standard therapy did not significantly reduce the primary composite end point but significantly increased the risk of major bleeding, including intracranial hemorrhage. (Funded by Merck; TRACER ClinicalTrials.gov number, NCT00527943.).
Published: 2012
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15. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial.

Author: Jolly SS, Yusuf S, Cairns J, Niemelä K, Xavier D, Widimsky P, Budaj A, Niemelä M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, and Mehta SR
Subjects: Acute Coronary Syndrome diagnostic imaging, Aged, Angioplasty, Balloon, Coronary adverse effects, Catheterization, Peripheral adverse effects, Coronary Angiography adverse effects, Coronary Artery Bypass, Female, Hemorrhage etiology, Humans, Male, Middle Aged, Myocardial Reperfusion, Stents, Acute Coronary Syndrome therapy, Angioplasty, Balloon, Coronary methods, Catheterization, Peripheral methods, Coronary Angiography methods, Femoral Artery, Radial Artery
Abstract: Background: Small trials have suggested that radial access for percutaneous coronary intervention (PCI) reduces vascular complications and bleeding compared with femoral access. We aimed to assess whether radial access was superior to femoral access in patients with acute coronary syndromes (ACS) who were undergoing coronary angiography with possible intervention., Methods: The RadIal Vs femorAL access for coronary intervention (RIVAL) trial was a randomised, parallel group, multicentre trial. Patients with ACS were randomly assigned (1:1) by a 24 h computerised central automated voice response system to radial or femoral artery access. The primary outcome was a composite of death, myocardial infarction, stroke, or non-coronary artery bypass graft (non-CABG)-related major bleeding at 30 days. Key secondary outcomes were death, myocardial infarction, or stroke; and non-CABG-related major bleeding at 30 days. A masked central committee adjudicated the primary outcome, components of the primary outcome, and stent thrombosis. All other outcomes were as reported by the investigators. Patients and investigators were not masked to treatment allocation. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, NCT01014273., Findings: Between June 6, 2006, and Nov 3, 2010, 7021 patients were enrolled from 158 hospitals in 32 countries. 3507 patients were randomly assigned to radial access and 3514 to femoral access. The primary outcome occurred in 128 (3·7%) of 3507 patients in the radial access group compared with 139 (4·0%) of 3514 in the femoral access group (hazard ratio [HR] 0·92, 95% CI 0·72-1·17; p=0·50). Of the six prespecified subgroups, there was a significant interaction for the primary outcome with benefit for radial access in highest tertile volume radial centres (HR 0·49, 95% CI 0·28-0·87; p=0·015) and in patients with ST-segment elevation myocardial infarction (0·60, 0·38-0·94; p=0·026). The rate of death, myocardial infarction, or stroke at 30 days was 112 (3·2%) of 3507 patients in the radial group compared with 114 (3·2%) of 3514 in the femoral group (HR 0·98, 95% CI 0·76-1·28; p=0·90). The rate of non-CABG-related major bleeding at 30 days was 24 (0·7%) of 3507 patients in the radial group compared with 33 (0·9%) of 3514 patients in the femoral group (HR 0·73, 95% CI 0·43-1·23; p=0·23). At 30 days, 42 of 3507 patients in the radial group had large haematoma compared with 106 of 3514 in the femoral group (HR 0·40, 95% CI 0·28-0·57; p<0·0001). Pseudoaneurysm needing closure occurred in seven of 3507 patients in the radial group compared with 23 of 3514 in the femoral group (HR 0·30, 95% CI 0·13-0·71; p=0·006)., Interpretation: Radial and femoral approaches are both safe and effective for PCI. However, the lower rate of local vascular complications may be a reason to use the radial approach., Funding: Sanofi-Aventis, Population Health Research Institute, and Canadian Network for Trials Internationally (CANNeCTIN), an initiative of the Canadian Institutes of Health Research., (Copyright © 2011 Elsevier Ltd. All rights reserved.)
Published: 2011
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16. Design and rationale of the radial versus femoral access for coronary intervention (RIVAL) trial: a randomized comparison of radial versus femoral access for coronary angiography or intervention in patients with acute coronary syndromes.

Author: Jolly SS, Niemelä K, Xavier D, Widimsky P, Budaj A, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Cairns J, Chrolavicius S, Yusuf S, and Mehta SR
Subjects: Coronary Angiography methods, Humans, Acute Coronary Syndrome therapy, Angioplasty, Balloon, Coronary methods, Femoral Artery, Radial Artery
Abstract: Background: Major bleeding in acute coronary syndromes (ACS) is associated with an increased risk of subsequent mortality and recurrent ischemic events. Observational data and small randomized trials suggest that radial instead of femoral access for coronary angiography/intervention results in fewer bleeding complications, with preserved and possibly improved efficacy. Radial access versus femoral access has yet to be formally evaluated in a randomized trial adequately powered for the comparison of clinically important outcomes., Objectives: The aim of this study is to evaluate the efficacy and safety of radial versus femoral access for coronary angiography/intervention in patients with ACS managed with an invasive strategy., Design: This was a multicenter international randomized trial with blinded assessment of outcomes. 7021 patients with ACS (with or without ST elevation) have been randomized to either radial or femoral access for coronary angiography/intervention. The primary outcome is the composite of death, myocardial infarction, stroke, or non-coronary artery bypass graft-related major bleeding up to day 30. The key secondary outcomes are (1) death, myocardial infarction, or stroke up to day 30 and (2) non-coronary artery bypass graft-related major bleeding up to day 30. Percutaneous coronary intervention (PCI) success rates will also be compared between the two access sites., Conclusions: The RIVAL trial will help define the optimal access site for coronary angiography/intervention in patients with ACS., (Copyright © 2011 Mosby, Inc. All rights reserved.)
Published: 2011
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17. Ticagrelor versus clopidogrel in acute coronary syndromes in relation to renal function: results from the Platelet Inhibition and Patient Outcomes (PLATO) trial.

Author: James S, Budaj A, Aylward P, Buck KK, Cannon CP, Cornel JH, Harrington RA, Horrow J, Katus H, Keltai M, Lewis BS, Parikh K, Storey RF, Szummer K, Wojdyla D, and Wallentin L
Subjects: Acute Coronary Syndrome physiopathology, Adenosine adverse effects, Adenosine therapeutic use, Aged, Cardiovascular Diseases epidemiology, Cardiovascular Diseases physiopathology, Chronic Disease, Clopidogrel, Female, Hemorrhage epidemiology, Hemorrhage physiopathology, Humans, Kaplan-Meier Estimate, Kidney Diseases complications, Male, Middle Aged, Outcome Assessment, Health Care, Platelet Aggregation Inhibitors adverse effects, Receptors, Purinergic P2Y12, Risk Factors, Ticagrelor, Ticlopidine adverse effects, Ticlopidine therapeutic use, Treatment Outcome, Acute Coronary Syndrome drug therapy, Adenosine analogs & derivatives, Kidney Diseases physiopathology, Platelet Aggregation Inhibitors therapeutic use, Purinergic P2 Receptor Antagonists, Ticlopidine analogs & derivatives
Abstract: Background: Reduced renal function is associated with a poorer prognosis and increased bleeding risk in patients with acute coronary syndromes and may therefore alter the risk-benefit ratio with antiplatelet therapies. In the Platelet Inhibition and Patient Outcomes (PLATO) trial, ticagrelor compared with clopidogrel reduced the primary composite end point of cardiovascular death, myocardial infarction, and stroke at 12 months but with similar major bleeding rates., Methods and Results: Central laboratory serum creatinine levels were available in 15 202 (81.9%) acute coronary syndrome patients at baseline, and creatinine clearance, estimated by the Cockcroft Gault equation, was calculated. In patients with chronic kidney disease (creatinine clearance <60 mL/min; n=3237), ticagrelor versus clopidogrel significantly reduced the primary end point to 17.3% from 22.0% (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.65 to 0.90) with an absolute risk reduction greater than that of patients with normal renal function (n=11 965): 7.9% versus 8.9% (HR, 0.90; 95% CI, 0.79 to 1.02). In patients with chronic kidney disease, ticagrelor reduced total mortality (10.0% versus 14.0%; HR, 0.72; 95% CI, 0.58 to 0.89). Major bleeding rates, fatal bleedings, and non-coronary bypass-related major bleedings were not significantly different between the 2 randomized groups (15.1% versus 14.3%; HR, 1.07; 95% CI, 0.88 to 1.30; 0.34% versus 0.77%; HR, 0.48; 95% CI, 0.15 to 1.54; and 8.5% versus 7.3%; HR, 1.28; 95% CI, 0.97 to 1.68). The interactions between creatinine clearance and randomized treatment on any of the outcome variables were nonsignificant., Conclusions: In acute coronary syndrome patients with chronic kidney disease, ticagrelor compared with clopidogrel significantly reduces ischemic end points and mortality without a significant increase in major bleeding but with numerically more non-procedure-related bleeding., Clinical Trial Registration: URL:http://www.clinicatrials.gov. Unique identifier: NCT00391872.
Published: 2010
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18. Comparison of ticagrelor with clopidogrel in patients with a planned invasive strategy for acute coronary syndromes (PLATO): a randomised double-blind study.

Author: Cannon CP, Harrington RA, James S, Ardissino D, Becker RC, Emanuelsson H, Husted S, Katus H, Keltai M, Khurmi NS, Kontny F, Lewis BS, Steg PG, Storey RF, Wojdyla D, and Wallentin L
Subjects: Acute Coronary Syndrome physiopathology, Adenosine therapeutic use, Aged, Aged, 80 and over, Angioplasty, Balloon, Coronary, Clopidogrel, Double-Blind Method, Electrocardiography, Female, Humans, Male, Middle Aged, Purinergic P2 Receptor Antagonists, Receptors, Purinergic P2Y12, Ticagrelor, Ticlopidine therapeutic use, Acute Coronary Syndrome drug therapy, Adenosine analogs & derivatives, Platelet Aggregation Inhibitors therapeutic use, Ticlopidine analogs & derivatives
Abstract: Background: Variation in and irreversibility of platelet inhibition with clopidogrel has led to controversy about its optimum dose and timing of administration in patients with acute coronary syndromes. We compared ticagrelor, a more potent reversible P2Y12 inhibitor with clopidogrel in such patients., Methods: At randomisation, an invasive strategy was planned for 13 408 (72.0%) of 18 624 patients hospitalised for acute coronary syndromes (with or without ST elevation). In a double-blind, double-dummy study, patients were randomly assigned in a one-to-one ratio to ticagrelor and placebo (180 mg loading dose followed by 90 mg twice a day), or to clopidogrel and placebo (300-600 mg loading dose or continuation with maintenance dose followed by 75 mg per day) for 6-12 months. All patients were given aspirin. The primary composite endpoint was cardiovascular death, myocardial infarction, or stroke. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00391872., Findings: 6732 patients were assigned to ticagrelor and 6676 to clopidogrel. The primary composite endpoint occurred in fewer patients in the ticagrelor group than in the clopidogrel group (569 [event rate at 360 days 9.0%] vs 668 [10.7%], hazard ratio 0.84, 95% CI 0.75-0.94; p=0.0025). There was no difference between clopidogrel and ticagrelor groups in the rates of total major bleeding (691 [11.6%] vs 689 [11.5%], 0.99 [0.89-1.10]; p=0.8803) or severe bleeding, as defined according to the Global Use of Strategies To Open occluded coronary arteries, (198 [3.2%] vs 185 [2.9%], 0.91 [0.74-1.12]; p=0.3785)., Interpretation: Ticagrelor seems to be a better option than clopidogrel for patients with acute coronary syndromes for whom an early invasive strategy is planned., (Copyright 2010 Elsevier Ltd. All rights reserved.)
Published: 2010
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19. Apixaban, an oral, direct, selective factor Xa inhibitor, in combination with antiplatelet therapy after acute coronary syndrome: results of the Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) trial.

Author: Alexander JH, Becker RC, Bhatt DL, Cools F, Crea F, Dellborg M, Fox KA, Goodman SG, Harrington RA, Huber K, Husted S, Lewis BS, Lopez-Sendon J, Mohan P, Montalescot G, Ruda M, Ruzyllo W, Verheugt F, and Wallentin L
Subjects: Acute Coronary Syndrome complications, Adolescent, Adult, Aged, Aged, 80 and over, Aspirin therapeutic use, Clopidogrel, Dose-Response Relationship, Drug, Double-Blind Method, Drug Therapy, Combination, Factor Xa Inhibitors, Female, Hemorrhage chemically induced, Humans, Male, Middle Aged, Myocardial Ischemia prevention & control, Pyrazoles toxicity, Pyridones toxicity, Ticlopidine analogs & derivatives, Ticlopidine therapeutic use, Young Adult, Acute Coronary Syndrome drug therapy, Platelet Aggregation Inhibitors therapeutic use, Pyrazoles administration & dosage, Pyridones administration & dosage
Abstract: Background: After an acute coronary syndrome, patients remain at risk of recurrent events. Apixaban, an oral direct factor Xa inhibitor, is a novel anticoagulant that may reduce these events but also poses a risk of bleeding., Methods and Results: Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) was a phase 2, double-blind, placebo-controlled, dose-ranging study. Patients (n=1715) with recent ST-elevation or non-ST-elevation acute coronary syndrome were randomized to 6 months of placebo (n=611) or 1 of 4 doses of apixaban: 2.5 mg twice daily (n=317), 10 mg once daily (n=318), 10 mg twice daily (n=248), or 20 mg once daily (n=221). Nearly all patients received aspirin; 76% received clopidogrel. The primary outcome was International Society of Thrombosis and Hemostasis major or clinically relevant nonmajor bleeding. A secondary outcome was cardiovascular death, myocardial infarction, severe recurrent ischemia, or ischemic stroke. At the recommendation of the Data Monitoring Committee, the 2 higher-dose apixaban arms were discontinued because of excess total bleeding. Compared with placebo, apixaban 2.5 mg twice daily (hazard ratio, 1.78; 95% confidence interval, 0.91 to 3.48; P=0.09) and 10 mg once daily (hazard ratio, 2.45; 95% confidence interval, 1.31 to 4.61; P=0.005) resulted in a dose-dependent increase in major or clinically relevant nonmajor bleeding. Apixaban 2.5 mg twice daily (hazard ratio, 0.73; 95% confidence interval, 0.44 to 1.19; P=0.21) and 10 mg once daily (hazard ratio, 0.61; 95% confidence interval, 0.35 to 1.04; P=0.07) resulted in lower rates of ischemic events compared with placebo. The increase in bleeding was more pronounced and the reduction in ischemic events was less evident in patients taking aspirin plus clopidogrel than in those taking aspirin alone., Conclusions: We observed a dose-related increase in bleeding and a trend toward a reduction in ischemic events with the addition of apixaban to antiplatelet therapy in patients with recent acute coronary syndrome. The safety and efficacy of apixaban may vary depending on background antiplatelet therapy. Further testing of apixaban in patients at risk of recurrent ischemic events is warranted.
Published: 2009
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20. Early versus delayed, provisional eptifibatide in acute coronary syndromes.

Author: Giugliano RP, White JA, Bode C, Armstrong PW, Montalescot G, Lewis BS, van 't Hof A, Berdan LG, Lee KL, Strony JT, Hildemann S, Veltri E, Van de Werf F, Braunwald E, Harrington RA, Califf RM, and Newby LK
Subjects: Acute Coronary Syndrome mortality, Acute Coronary Syndrome therapy, Aged, Angina Pectoris therapy, Angioplasty, Balloon, Coronary, Combined Modality Therapy, Coronary Artery Bypass, Drug Administration Schedule, Drug Therapy, Combination, Electrocardiography, Eptifibatide, Female, Hemorrhage chemically induced, Humans, Infusions, Intravenous, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction epidemiology, Myocardial Infarction therapy, Odds Ratio, Peptides adverse effects, Platelet Aggregation Inhibitors adverse effects, Thrombosis epidemiology, Thrombosis prevention & control, Treatment Failure, Acute Coronary Syndrome drug therapy, Coronary Angiography, Peptides administration & dosage, Platelet Aggregation Inhibitors administration & dosage, Platelet Glycoprotein GPIIb-IIIa Complex antagonists & inhibitors
Abstract: Background: Glycoprotein IIb/IIIa inhibitors are indicated in patients with acute coronary syndromes who are undergoing an invasive procedure. The optimal timing of the initiation of such therapy is unknown., Methods: We compared a strategy of early, routine administration of eptifibatide with delayed, provisional administration in 9492 patients who had acute coronary syndromes without ST-segment elevation and who were assigned to an invasive strategy. Patients were randomly assigned to receive either early eptifibatide (two boluses, each containing 180 microg per kilogram of body weight, administered 10 minutes apart, and a standard infusion > or = 12 hours before angiography) or a matching placebo infusion with provisional use of eptifibatide after angiography (delayed eptifibatide). The primary efficacy end point was a composite of death, myocardial infarction, recurrent ischemia requiring urgent revascularization, or the occurrence of a thrombotic complication during percutaneous coronary intervention that required bolus therapy opposite to the initial study-group assignment ("thrombotic bailout") at 96 hours. The key secondary end point was a composite of death or myocardial infarction within the first 30 days. Key safety end points were bleeding and the need for transfusion within the first 120 hours after randomization., Results: The primary end point occurred in 9.3% of patients in the early-eptifibatide group and in 10.0% in the delayed-eptifibatide group (odds ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P=0.23). At 30 days, the rate of death or myocardial infarction was 11.2% in the early-eptifibatide group, as compared with 12.3% in the delayed-eptifibatide group (odds ratio, 0.89; 95% CI, 0.79 to 1.01; P=0.08). Patients in the early-eptifibatide group had significantly higher rates of bleeding and red-cell transfusion. There was no significant difference between the two groups in rates of severe bleeding or nonhemorrhagic serious adverse events., Conclusions: In patients who had acute coronary syndromes without ST-segment elevation, the use of eptifibatide 12 hours or more before angiography was not superior to the provisional use of eptifibatide after angiography. The early use of eptifibatide was associated with an increased risk of non-life-threatening bleeding and need for transfusion. (ClinicalTrials.gov number, NCT00089895.), (2009 Massachusetts Medical Society)
Published: 2009
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21. Perceived disability and lifestyle modification following hospitalization for non-ST elevation versus ST elevation acute coronary syndromes: the patients' point of view.

Author: Yuval R, Halon DA, and Lewis BS
Subjects: Activities of Daily Living psychology, Acute Coronary Syndrome diagnosis, Acute Coronary Syndrome prevention & control, Adaptation, Psychological, Adult, Aged, Aged, 80 and over, Angina, Unstable diagnosis, Angina, Unstable prevention & control, Angina, Unstable psychology, Employment psychology, Female, Humans, Male, Middle Aged, Multivariate Analysis, Myocardial Infarction diagnosis, Myocardial Infarction prevention & control, Nursing Methodology Research, Quality of Life psychology, Risk Reduction Behavior, Self Care methods, Self Care psychology, Self Efficacy, Surveys and Questionnaires, Acute Coronary Syndrome psychology, Attitude to Health, Disabled Persons psychology, Hospitalization, Life Style, Myocardial Infarction psychology
Abstract: Background and Aims: Medical personnel generally believe that non-ST elevation (NSTE) acute coronary syndromes (ACS) are less damaging than ST elevation myocardial infarction (STEMI), in keeping with the lower morbidity and mortality attributed to these subgroups in randomized clinical trials. We examined whether this concept translates into a difference from the patients' point of view regarding lifestyle modification and return to work following hospitalization for ACS., Methods: A structured anonymous self-completed questionnaire was mailed and returned by 160 consecutive patients (age 64+/-11 years; 125 (78%) men) 3-12 months after hospitalization for ACS. In 49 patients, the diagnosis was unstable angina pectoris (UAP), in 34 non-ST elevation myocardial infarction (NSTEMI) and in 73, ST elevation myocardial infarction (STEMI). The questionnaire addressed issues relating to demographic data, medical history, occupation, employment and income before the acute event, changes following hospitalization for ACS and questions relating to current perceived health status and return to work., Results: Most (98/159, 62%) patients saw themselves as "heart patients" after hospitalization for ACS. Quality of life was perceived to have decreased in 70 (44%), self-image in 85 (53%), self-confidence in 78 (49%) and sexual function in 75 (48%), with no differences according to ACS type. Anxiety was reported by 85 (54%) patients and anxiety level (1.47+/-1.25 on the Brief Symptom Inventory scale) was high. Only 38 (49%) of 77 patients who were working prior to the acute event returned to full- or part-time gainful employment. By multivariate analysis, return to work was associated with 3 variables: younger age (p=0.015), shorter duration of hospitalization (p=0.036) and higher income bracket prior to the acute event (p=0.0001), with no relation to gender, in-hospitalization revascularization strategy, rehabilitation program or to underlying cardiac diagnosis (UAP, NSTEMI or STEMI)., Conclusions: Hospitalization for ACS had a major negative impact on patient lifestyle and return to work, irrespective of the underlying cardiac diagnosis. The experience of hospitalization for an acute heart condition was uniformly traumatic with in many instances a prolonged adverse effect on patient function.
Published: 2007
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22. Impact of 64-slice cardiac computed tomographic angiography on clinical decision-making in emergency department patients with chest pain of possible myocardial ischemic origin.

Author: Rubinshtein R, Halon DA, Gaspar T, Jaffe R, Goldstein J, Karkabi B, Flugelman MY, Kogan A, Shapira R, Peled N, and Lewis BS
Subjects: Contrast Media, Coronary Artery Disease diagnostic imaging, Coronary Stenosis diagnostic imaging, Emergency Service, Hospital, Female, Hospitalization statistics & numerical data, Humans, Iohexol analogs & derivatives, Male, Middle Aged, Acute Coronary Syndrome diagnosis, Chest Pain etiology, Coronary Angiography methods, Decision Making, Tomography, X-Ray Computed methods
Abstract: To examine the impact of contrast enhanced multidetector computed tomography (MDCT) on clinical decision-making in patients who present to the emergency department (ED) with chest pain of possible ischemic origin, we studied 58 consecutive patients (age 56 +/- 10 years, 36% female) with chest pain, intermediate risk, and no ischemic electrocardiographic changes or increased biomarker measurements. After standard ED patient assessment including cardiology consultation, a diagnosis of acute coronary syndrome was made in 41 patients (71%), hospitalization was recommended in 47 (81%), and 32 (55%) were scheduled for an early invasive strategy. Patients underwent 64-slice contrast agent-enhanced MDCT with image reconstruction in multiple formats using retrospective electrocardiographic gating, which revealed normal (no or trivial atheroma) coronary vasculature in 15 patients, nonobstructive atheroma in 20 patients, and obstructive coronary disease (> or =1 luminal narrowing of > or =50%) in 23 patients. After MDCT, the diagnosis of acute coronary syndrome was revised in 18 of 41 patients (44%; 16 normal MDCT/widely patent stents, 2 alternative diagnoses), planned hospitalization canceled in 21 of 47 patients (45%; 13 normal MDCT/patent stent, 8 minor branch vessel disease), and planned early invasive strategy altered in 25 of 58 patients (43%; unnecessary in 20 of 32, advisable in 5 of 26 others). Effect of MDCT on clinical decisions was greater in the 36 patients without known preceding coronary disease. In 32 patients discharged from the ED (11 after initial triage, 21 patients after MDCT), there were no major adverse cardiac events (e.g., death, myocardial infarction, unplanned revascularization) during a 12-month follow-up period. In conclusion, contrast agent-enhanced 64-slice cardiac MDCT was a valuable diagnostic tool in the ED triage of patients with chest pain of possible ischemic origin and decreased the need for hospitalization by almost half in this patient cohort.
Published: 2007
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23. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: The Task Force for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC)

Author: Collet, Jean-Philippe, Thiele, Holger, Barbato, Emanuele, Barthélémy, Olivier, Bauersachs, Johann, Bhatt, Deepak L, Dendale, Paul, Dorobantu, Maria, Edvardsen, Thor, Folliguet, Thierry, Gale, Chris P, Gilard, Martine, Jobs, Alexander, Jüni, Peter, Lambrinou, Ekaterini, Lewis, Basil S, Mehilli, Julinda, Meliga, Emanuele, Merkely, Béla, and Mueller, Christian
Subjects: ACUTE coronary syndrome, CARDIAC patients, MYOCARDIAL infarction diagnosis, HEART disease diagnosis, ELECTROCARDIOGRAPHY, CORONARY angiography
Abstract: The article discusses the 2020 guidelines presented by the European Society of Cardiology (ESC) for acute coronary syndrome (ACS) management in patients without persistent ST-segment elevation. Topics explored include the clinical characteristics and diagnosis of myocardial infarction, the administration of electrocardiogram to assess patients with suspected ACS, and the patients which may not be considered for invasive coronary angiography.
Published: 2021
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24. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC)

Author: Roffi, Marco, Patrono, Carlo, Collet, Jean-Philippe, Mueller, Christian, Valgimigli, Marco, Andreotti, Felicita, Bax, Jeroen J, Borger, Michael A, Brotons, Carlos, Chew, Derek P, Gencer, Baris, Hasenfuss, Gerd, Kjeldsen, Keld, Lancellotti, Patrizio, Landmesser, Ulf, Mehilli, Julinda, Mukherjee, Debabrata, Storey, Robert F, Windecker, Stephan, Patrono, Marco, Baumgartner, Helmut, Gaemperli, Oliver, Achenbach, Stephan, Agewall, Stefan, Badimon, Lina, Baigent, Colin, Bueno, Héctor, Bugiardini, Raffaele, Carerj, Scipione, Casselman, Filip, Cuisset, Thomas, Erol, Çetin, Fitzsimons, Donna, Halle, Martin, Hamm, Christian, Hildick-Smith, David, Huber, Kurt, Iliodromitis, Efstathios, James, Stefan, Lewis, Basil S, Lip, Gregory y H, Piepoli, Massimo F, Richter, Dimitrios, Rosemann, Thomas, Sechtem, Udo, Steg, Ph Gabriel, Vrints, Christian, Luis Zamorano, Jose, Nutrition, obésité et risque thrombotique (NORT), Institut National de la Recherche Agronomique (INRA)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Aix Marseille Université (AMU)-Institut National de la Recherche Agronomique (INRA)-Institut National de la Santé et de la Recherche Médicale (INSERM), Roffi, Marco, Patrono, Carlo, Collet, Jean-Philippe, Mueller, Christian, Valgimigli, Marco, Andreotti, Felicita, Bax, Jeroen J, Borger, Michael A, Brotons, Carlo, Chew, Derek P, Gencer, Bari, Hasenfuss, Gerd, Kjeldsen, Keld, Lancellotti, Patrizio, Landmesser, Ulf, Mehilli, Julinda, Mukherjee, Debabrata, Storey, Robert F, Windecker, Stephan, Baumgartner, Helmut, Gaemperli, Oliver, Achenbach, Stephan, Agewall, Stefan, Badimon, Lina, Baigent, Colin, Bueno, Héctor, Bugiardini, Raffaele, Carerj, Scipione, Casselman, Filip, Cuisset, Thoma, Erol, Çetin, Fitzsimons, Donna, Halle, Martin, Hamm, Christian, Hildick-Smith, David, Huber, Kurt, Iliodromitis, Efstathio, James, Stefan, Lewis, Basil S, Lip, Gregory Y H, Piepoli, Massimo F, Richter, Dimitrio, Rosemann, Thoma, Sechtem, Udo, Steg, Ph Gabriel, Vrints, Christian, Luis Zamorano, Jose, ACS - Amsterdam Cardiovascular Sciences, APH - Amsterdam Public Health, and Cardiology
Subjects: High-sensitivity troponin, Ticagrelor, Chest pain unit, medicine.medical_treatment, Atherothrombosis, Myocardial ischaemia, Recommendations, MESH: Risk Assessment, Early invasive strategy, Electrocardiography, Acute cardiac care, Acute coronary syndromes, Angioplasty, Anticoagulation, Apixaban, Aspirin, Beta-blockers, Bivalirudin, Bypass surgery, Cangrelor, Clopidogrel, Dabigatran, Diabetes, Enoxaparin, European society of cardiology, Fondaparinux, Glycoprotein IIb/IIIa inhibitors, Guidelines, Heparin, Nitrates, Non-ST-elevation myocardial infarction, Platelet inhibition, Prasugrel, Revascularization, Rhythm monitoring, Rivaroxaban, Statin, Stent, Unstable angina, Vorapaxar, Cardiology and Cardiovascular Medicine, ST segment, Myocardial infarction, 610 Medicine & health, ComputingMilieux_MISCELLANEOUS, MESH: Platelet Glycoprotein GPIIb-IIIa Complex, Platelet aggregation inhibitor, MESH: Percutaneous Coronary Intervention, MESH: Hemorrhage, medicine.medical_specialty, Acute coronary syndrome, Cardiotonic Agents, MESH: Algorithms, Hemorrhage, Platelet Glycoprotein GPIIb-IIIa Complex, MESH: Anticoagulants, Risk Assessment, Percutaneous Coronary Intervention, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Humans, Acute Coronary Syndrome, Physical Examination, Management of acute coronary syndrome, MESH: Humans, MESH: Cardiotonic Agents, Recommendation, medicine.disease, MESH: Acute Coronary Syndrome, Long-Term Care, MESH: Coronary Angiography, MESH: Non-ST Elevated Myocardial Infarction, Purinergic P2Y Receptor Antagonists, Human medicine, Biomarkers, Guideline, Diabete, Nitrate, Coronary Angiography, MESH: Angina Pectoris, MESH: Long-Term Care, Non-ST Elevated Myocardial Infarction, reproductive and urinary physiology, Atherothrombosi, MESH: Platelet Aggregation Inhibitors, embryonic structures, Cardiology, MESH: Purinergic P2Y Receptor Antagonists, biological phenomena, cell phenomena, and immunity, Algorithms, medicine.drug, Settore BIO/14 - FARMACOLOGIA, Glycoprotein IIb/IIIa inhibitor, European Society of Cardiology, Angina Pectoris, Diagnosis, Differential, MESH: Physical Examination, MESH: Diagnosis, Differential, Internal medicine, medicine, Beta-blocker, urogenital system, business.industry, Percutaneous coronary intervention, Anticoagulants, MESH: Electrocardiography, MESH: Biomarkers, business, Platelet Aggregation Inhibitors
Abstract: ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation : The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC).
Published: 2015

25. Ezetimibe added to statin therapy after acute coronary syndromes

Author: Cannon, Christopher P., Blazing, Michael A., Giugliano, Robert P., Mccagg, Amy, White, Jennifer A., Theroux, Pierre, Darius, Harald, Lewis, Basil S., Ophuis, Ton Oude, Jukema, J. Wouter, De Ferrari, Gaetano M., Ruzyllo, Witold, De Lucca, Paul, Kyungah, Im, Bohula, Erin A., Reist, Craig, Wiviott, Stephen D., Tershakovec, Andrew M., Musliner, Thomas A., Braunwald, Eugene, Califf, Musliner T, Robert M., Tershakovec, A, Gurfinkel, E, Aylward, P, Tonkin, A, Maurer, G, Van de Werf, F, Nicolau, Jc, Theroux, P, Genest, J, Armstrong, P, Corbalan, R, Isaza, D, Spinar, J, Grande, P, Voitk, J, Kesaniemi, A, Bassand, Jp, Farnier, M, Darius, H, Keltai, M, Mathur, A, Mittal, S, Reddy, K, Lewis, B, De Ferrari GM, Ophuis, To, Jukema, J, White, H, Pedersen, T, Britto, F, Ruzyllo, W, Carrageta, M, Duris, T, Dalby, A, Seung, Kb, Lopez-Sendon, J, Dellborg, M, Mach, F, Guneri, S, Parkhomenko, A, Brady, A, Cannon, C, Blazing, M, Ballantyne, C, de Lemos, J, Kleiman, N, Mcguire, Dk, Centeno, E, Casalins, M, Cartasegna, L, Beltrano, Mc, Guerrero, R, Fanuele, M, Berra, F, Egido, J, Colombo, H, Dellatorre, M, Terns, P, Blumberg, E, Reges, P, Azize, G, Ramos, H, Fernandez, R, Carlessi, C, Milesi, R, Schmuck, R, Duronto, E, Procopio, G, Carlevaro, O, Maffeo, H, Beloscar, J, Viso, M, Hominal, M, Castoldi, M, Bluguermann, J, Mauro, D, Macin, S, Cocco, N, Ruiz, N, Ricart, J, Lozada, A, Nani, S, Turri, D, Fernandez, H, Caruso, O, Zarandon, R, Bono, J, Arias, V, Allall, O, Marino, J, Cusimano, S, Schygiel, P, Buzetti, C, Penaloza, N, Berli, M, Worthley, S, Roach, A, Chew, D, Wright, T, Leitch, J, Hicks, E, Rankin, J, Venn-Edmonds, C, Lehman, R, Morrison, H, Shaw, J, Mak, V, Hii, C, Smith, K, Cross, D, Lilwall, L, Nelson, G, Loxton, A, Horowitz, J, Rose, J, Steinwender, C, Leisch, F, Kammler, J, Brussee, H, Zweiker, R, Niederl, E, Weihs, W, Giorgio, G, Lang, I, Drexel, H, Zanolin, D, Hoppe, U, Atzenhofer-Baumgartner, K, Pichler, M, Hainzer, D, Eber, B, Pichler, F, Foeger, B, Wechselberger, T, Mayr, H, Hofer, J, Stockenhuber, F, Warlits, B, Huber, K, Egger, F, Weidinger, F, Ziegler, B, Jirak, P, Metzler, B, Pachinger, O, Wanitschek, M, Auer, J, Grabscheit, G, Podczeck-Schweighofer, A, Priesnitz, T, Frank, H, El Allaf, D, Marechal, P, Roosen, J, Joly, E, Lefebvre, P, Arend, C, Sinnaeve, P, De Velder, L, Hellemans, S, Vanhauwaert, B, Van Dorpe, A, Heyse, A, Vantomme, C, Striekwold, H, Van Den Broeck, D, Lancellotti, P, Schoors, D, Lemoine, I, Taeymans, Y, De Wolf, L, Brike, C, Vercauteren, S, Tahon, S, Vervoort, G, Mestdagh, I, Pirenne, B, Cardinal, F, Lips, S, Dujardin, K, Debrouwer, K, Dhooghe, G, Holvoet, G, van de Borne, P, Renard, M, De Clippel, M, Lesseliers, H, Van Miert, N, Saraiva, J, Vicente, C, Rossi, P, Dos Santos LB, Duda, N, Tognon, Ap, Serrano, C, Gomes, Fl, Manenti, Er, Silveira, Ds, Maia, L, Mouco, Om, Paiva, M, Antonangelo, A, de Souza, J, Lino, Ea, Leães, P, Blacher, Mg, Kormann, A, Ultramari, Ft, Dutra, O, Mendelski, Am, Morgado, S, Ardito, W, Greque, G, Ardito, Rv, Pimentel Filho, P, Zucchetti, C, Alves, A, Seabra, Am, Mattos, M, Miranda, Lf, Silva, D, Uehara, Rm, Marin Neto, J, Schmidt, A, Braga, J, Rodrigues, A, Abrantes, J, Pinheiro, L, Bodanese, L, Magedanz, Éh, Piegas, L, Dos Santos ES, Wainstein, M, Ribeiro, J, Stein, R, Marino, R, Machado, Vm, Moraes Junior, J, Guimarães, S, da Costa FA, Ferraz, Rf, Albuquerque, D, Rocha, Rm, de Carvalho Moreira, R, Dohmann, H, Costantini, C, Tarastchuk, Jc, Coelho, O, Cirillo, W, Sousa, A, Almeira, As, Stefanini, E, Silva, F, Teixeira, M, da Cunha, C, Précoma, D, Facchi, Tl, Rupka, D, Thiessen, S, Warnica, J, Smith, B, Della Siega, A, Klinke, P, Nelson, S, Dion, D, Gilbert, N, Hui, W, Kvill, L, Sussex, B, Luther, A, Dupuis, R, Ouimet, F, Pandey, A, Clarus, S, Senaratne, M, Ferdinandis, H, Mukherjee, A, Bozek, B, Vizel, S, Markov, G, Zimmermann, R, Stephens, W, Tremblay, B, Wong, G, Uchida, N, Brossoit, R, Peck, C, Van Kieu, C, Forgione, M, Bata, I, Cossett, J, Kostuk, W, Arnold, M, Bone, C, Grondin, F, Bilodeau, N, Gosselin, G, David, M, Giannoccaro, J, Beresford, P, Polasek, P, Roberts, P, Doucet, M, Beaudry, M, Cheung, S, Cleveland, T, Bhargava, R, Mccallum, A, Ma, P, Morrissette, J, Cleveland, D, Chadwyn, D, Nigro, F, Weeks, A, Cryderman, C, Leader, R, Houde, G, Rousseau, S, Pearce, M, Radyk, M, Lonn, E, Magi, A, Lefkowitz, C, Sandrin, F, Coffin, N, Lubelsky, B, Coldwell, J, Habot, J, Mcpherson, C, De Larochelliere, R, Roy, M, Haichin, R, Barber, C, Bhesania, T, Kitagawa, H, To, T, Donnelly, B, Tymchak, W, Harris, L, Kouz, S, Huynh, T, St Jacques, B, Lamy, A, Rizzo, A, Stein, J, Childs, C, Wong, B, Poirier, R, Gupta, M, Dela Cruz, C, Constance, C, Gauthier, M, Ervin, F, Ouellette, M, Kokis, A, Lemay, C, Kwok, K, Leung, C, Lee, D, Nesmith, J, Renton, J, Syan, G, Turek, M, Hogan, D, Griffin, P, Lipson, A, Winestock, J, Abramson, B, Fogel, A, Gagne, C, Bergeron, J, Clarke, A, Slipp, S, Darcel, I, Carling-Chambers, L, Kannampuzha, P, Pallie, S, Krekorian, S, Vertes, G, Roth, S, Lai, K, Heath, J, Perez, L, Arriagada, G, Castro, P, Villa, F, Rodríguez, M, Ramos, G, Baraona, F, Núñez, A, García, M, Jofre, C, Silva, P, Lamich, R, Yovaniniz, P, Escobar, E, Dussaubat, A, Segura, E, Ramirez, M, Lapostol, C, Palma, A, Encina, L, Zapata, M, Baeza, N, Varela, P, Pérez, L, Jaramillo, C, Ruiz, S, Sanchez, G, Perdomo, I, Manzur, F, Cohen, Le, Velasquez, J, Arana, C, Alvarez, Y, Triana, M, Balaguera, J, de Salazar, D, Rendon, N, Botero, R, Ruiz, A, Saaibi, J, Medina, J, Jaramillo, M, Calderón, Mj, Delgado, J, Bohorquez, R, Medina, Mf, Herrera, M, Rosales, D, Mendoza, F, Martinez, S, Ternera, A, Castro, R, Baiz, A, Martinez, M, Orozco, A, Suarez, M, Fonseca, Y, Beltran, R, Cepeda, M, Jaramillo, N, Valenzuela, C, Gutierrez, M, Sanchez, A, Vitovec, J, Hlinomaz, O, Poloczek, M, Mayer, O, Veselka, J, Vejvoda, J, Soucek, M, Spac, J, Novobilsky, K, Srp, V, Francek, L, Branny, M, Sknouril, L, Motovska, Z, Rohac, F, Stankova, A, Fiala, T, Holub, M, Zeman, K, Pohludkova, L, Pospisilova, E, Tuma, P, Cihalik, C, Oral, I, Podpera, I, Stepanovova, R, Uricar, M, Solar, M, Pelouch, R, Porzer, M, Grussmannova, K, Stipal, R, Reichert, P, 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Sharma, T., Orosz, S., Shah, R., Petrino, M., Hughes, M., Hershey, J., Hudock, D., Hui, P., Von Bakonyi, A., Arnold, A., Kappel, D., Pennock, G., Cloud, B., Tucker, K., Harp, L., Hoover, C., Eisenhauer, M., Roth, J., Young, C., Thai, H., Escalante, A., Bautista, J., Gazmuri, R., Nyland, J., Cubeddu, L., DeFranco, A., Dias, D., Fielding, M., Reeves, R., Hermany, P., Meissner-Dengler, S., Evans, M., Flores, E., Tannenbaum, A., McGarr, K., Moran, J., Stout, E., Allred, S., Henderson, D., Crandall, L., Strote, J., Voyles, W., Robeson, D., Bedoya, R., Omar, B., Pettyjohn, F., Revere, C., Coy, K., Margolis, J., Sotolongo, C., Scheffel, M., Munir, A., Shirwany, A., Douglas, L., Girala, R., Humphreys, R., Agarwal, J., Bankowski, D., Watson, R., Bishop, B., Klementowicz, P., Blais, D., Cohen, B., Lobur, E., Dimenna, J., Dempsey, K., Izzo, M., Bondi, L., Carell, E., Eaton, C., Saltiel, F., Grewal, G., Connolly, T., Little, T., Wiegman, P., Gips, S., Held, J., Paraschos, A., Quesada, R., Goudreau, E., Sears, M., Istfan, P., Holt, S., McClung, J., Nguyen, N., Quintana, O., Gottlieb, D., Knutson, T., Barringhaus, K., Lester, F., Sullivan, P., Rodriguez-Ospina, L., Cannon, Cp, Blazing, Ma, Giugliano, Rp, Mccagg, A, White, Ja, Theroux, P, Darius, H, Lewis, B, Ophuis, To, Jukema, Jw, De Ferrari, Gm, Ruzyllo, W, De Lucca, P, Im, K, Bohula, Ea, Reist, C, Wiviott, Sd, Tershakovec, Am, Musliner, Ta, Braunwald, E, Califf, Rm, for the IMPROVE-IT, Investigator, Cianflone, D, Cardiovascular Division (SZG), Brigham and Women's Hospital [Boston], College of Information Science and Engineering, Ritsumeikan University, Montreal Heart Institute (MONTREAL HEART INSTITUTE), Laboratoire des Micro-algues toxiques, Institut Louis Malardé [Papeete] (ILM), Institut de Recherche pour le Développement (IRD)-Institut de Recherche pour le Développement (IRD), Interuniversity Cardiology Institute Netherlands, Institute of Cardiology (WARSAW - Cardiology), Institute of Cardiology, Merck Sharp & Dohme Corp., Merck & Co. Inc, DIPARTIMENTO DI MEDICINA SPECIALISTICA, DIAGNOSTICA E SPERIMENTALE, Facolta' di MEDICINA e CHIRURGIA, AREA MIN. 06 - Scienze mediche, Cannon, C.P., Blazing, M.A., Giugliano, R.P., Mccagg, A., White, J.A., Lewis, B.S., Jukema, J.W., De Lucca, P., Im, K., Bohula, E.A., Reist, C., Wiviott, S.D., Tershakovec, A.M., Musliner, T.A., Braunwald, E., Califf, R.M., for the IMPROVE-IT Investigators [.., C. Rapezzi, ], Other departments, Cannon, Christopher P, Blazing, Michael A., Giugliano, Robert P., Mccagg, Amy, White, Jennifer A., Theroux, Pierre, Darius, Harald, Lewis, Basil S., Ophuis, Ton Oude, Jukema, J. Wouter, De Ferrari, Gaetano M., Ruzyllo, Witold, De Lucca, Paul, Kyungah, Im, Bohula, Erin A., Reist, Craig, Wiviott, Stephen D., Tershakovec, Andrew M., Musliner, Thomas A., Braunwald, Eugene, and Califf, Robert M.
Subjects: Male, Simvastatin, acute coronary syndrome, aged, anticholesteremic agents, azetidines, cardiovascular diseases, cholesterol, ldl, double-blind method, drug therapy, combination, ezetimibe, female, humans, hydroxymethylglutaryl-coa reductase inhibitors, kaplan-meier estimate, male, middle aged, simvastatin, triglycerides, medicine (all, [SDV]Life Sciences [q-bio], Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Bococizumab, Triglyceride, chemistry.chemical_compound, 0302 clinical medicine, Azetidine, Cardiovascular Disease, Anticholesteremic Agent, Acute Coronary Syndrome, Aged, Anticholesteremic Agents, Azetidines, Cardiovascular Diseases, Cholesterol, LDL, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Middle Aged, Triglycerides, 030212 general & internal medicine, Medicine (all), Research Support, Non-U.S. Gov't, Hazard ratio, General Medicine, Acute Coronary Syndrome, Aged, Anticholesteremic Agents, Azetidines, Cardiovascular Diseases, Ezetimibe, Female, Humans, Male, Middle Aged, 3. Good health, Multicenter Study, Editorial, Cholesterol, Randomized Controlled Trial, Combination, Ezetimibe, lipids (amino acids, peptides, and proteins), Human, medicine.drug, medicine.medical_specialty, Acute Coronary Syndroms, Urology, Acute Coronary Syndrome/drug therapy, Anticholesteremic Agents/adverse effects, Anticholesteremic Agents/therapeutic use, Azetidines/adverse effects, Azetidines/therapeutic use, Cardiovascular Diseases/epidemiology, Cardiovascular Diseases/mortality, Cardiovascular Diseases/prevention & control, Cholesterol, LDL/blood, Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects, Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use, Simvastatin/therapeutic use, Triglycerides/blood, NO, LDL, 03 medical and health sciences, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Drug Therapy, Internal medicine, Journal Article, medicine, Comparative Study, Alirocumab, business.industry, PCSK9, ta3121, Lomitapide, DOENÇAS CARDIOVASCULARES, Endocrinology, chemistry, Statin Therapy, Hydroxymethylglutaryl-CoA Reductase Inhibitor, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: BACKGROUND: Statin therapy reduces low-density lipoprotein (LDL) cholesterol levels and the risk of cardiovascular events, but whether the addition of ezetimibe, a nonstatin drug that reduces intestinal cholesterol absorption, can reduce the rate of cardiovascular events further is not known.METHODS: We conducted a double-blind, randomized trial involving 18,144 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days and had LDL cholesterol levels of 50 to 100 mg per deciliter (1.3 to 2.6 mmol per liter) if they were receiving lipid-lowering therapy or 50 to 125 mg per deciliter (1.3 to 3.2 mmol per liter) if they were not receiving lipid-lowering therapy. The combination of simvastatin (40 mg) and ezetimibe (10 mg) (simvastatin-ezetimibe) was compared with simvastatin (40 mg) and placebo (simvastatin monotherapy). The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, unstable angina requiring rehospitalization, coronary revascularization (≥30 days after randomization), or nonfatal stroke. The median follow-up was 6 years.RESULTS: The median time-weighted average LDL cholesterol level during the study was 53.7 mg per deciliter (1.4 mmol per liter) in the simvastatin-ezetimibe group, as compared with 69.5 mg per deciliter (1.8 mmol per liter) in the simvastatin-monotherapy group (PCONCLUSIONS: When added to statin therapy, ezetimibe resulted in incremental lowering of LDL cholesterol levels and improved cardiovascular outcomes. Moreover, lowering LDL cholesterol to levels below previous targets provided additional benefit. (Funded by Merck; IMPROVE-IT ClinicalTrials.gov number, NCT00202878.).
Published: 2015

26. Plaque Morphology as Predictor of Late Plaque Events in Patients With Asymptomatic Type 2 Diabetes: A Long-Term Observational Study.

Author: Halon, David A., Lavi, Idit, Barnett-Griness, Ofra, Rubinshtein, Ronen, Zafrir, Barak, Azencot, Mali, and Lewis, Basil S.
Abstract: The authors used coronary computed tomography angiography (CTA) to determine plaque characteristics predicting individual late plaque events precipitating acute coronary syndromes (ACS) in a cohort of asymptomatic type 2 diabetic patients. In patients with coronary artery disease, CTA plaque characteristics may predict mid-term patient events. Asymptomatic patients with diabetes 55 to 74 years of age with no history of coronary artery disease (N = 630) underwent baseline 64-slice CTA and detailed plaque level analysis. All subsequent clinical events were recorded and adjudicated. In patients who developed ACS, culprit plaque was identified at invasive angiography and its precursor located on the baseline CTA. Plaque characteristics predicting an ACS-associated culprit plaque event were analyzed by time to event accounting for inpatient clustering of plaques and competing events. Among 2,242 plaques in 499 subjects, 24 ACS culprit plaques were identified in 24 subjects during median follow-up of 9.2 years (interquartile range: 8.4 to 9.8 years). Plaque volume (upper vs. lower quartile hazard ratio [HR]: 6.9; 95% confidence interval [CI]: 1.6 to 30.8; p = 0.011), percentage of low-density plaque content <50 Hounsfield units (HR: 14.2; 95% CI: 1.9 to 108; p = 0.010), and mild plaque calcification (HR vs. all other plaques 3.3 [95% CI: 1.5 to 7.3]; p = 0.004) predicted plaque events univariately and after adjustment by clinical risk score. A culprit plaque event occurred in 13 of 376 (3.5%) high-risk plaques (HRP) (plaques with ≥2 risk predictors) versus 11 of 1,866 (0.6%) in non-HRPs (p < 0.0001), at 12 of 343 (3.5%) stenotic sites (≥50%) versus 12 of 1,899 (0.6%) nonstenotic sites (p < 0.0001) and in 7 of 131 (5.3%) HRP with stenosis (p < 0.0001 vs. all others). In 130 (20.6%) subjects, no coronary plaque was present on baseline CTA. In asymptomatic patients with type 2 diabetes, CTA plaque volume, percent low-density plaque content, and mild calcification predicted late plaque events. The additional presence of luminal stenosis increased the probability of an acute event. [ABSTRACT FROM AUTHOR]
Published: 2019
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27. Effect of Reconstituted Human Apolipoprotein A-I on Recurrent Ischemic Events in Survivors of Acute MI.

Author: Povsic, Thomas J., Korjian, Serge, Bahit, M. Cecilia, Chi, Gerald, Duffy, Danielle, Alexander, John H., Vinereanu, Dragos, Tricoci, Pierluigi, Mears, Sojaita Jenny, Deckelbaum, Lawrence I., Bonaca, Marc, Ridker, Paul M., Goodman, Shaun G., Cornel, Jan H., Lewis, Basil S., Parkhomenko, Alexander, Lopes, Renato D., Aylward, Philip, Lincoff, A. Michael, and Heise, Mark
Subjects: *APOLIPOPROTEIN A, *MYOCARDIAL infarction, *ACUTE coronary syndrome
Abstract: The AEGIS-II trial hypothesized that CSL112, an intravenous formulation of human apoA-I, would lower the risk of plaque disruption, decreasing the risk of recurrent events such as myocardial infarction (MI) among high-risk patients with MI. This exploratory analysis evaluates the effect of CSL112 therapy on the incidence of cardiovascular (CV) death and recurrent MI. The AEGIS-II trial was an international, multicenter, randomized, double-blind, placebo-controlled trial that randomized 18,219 high-risk acute MI patients to 4 weekly infusions of apoA-I (6 g CSL112) or placebo. The incidence of the composite of CV death and type 1 MI was 11% to 16% lower in the CSL112 group over the study period (HR: 0.84; 95% CI: 0.7-1.0; P = 0.056 at day 90; HR: 0.86; 95% CI: 0.74-0.99; P = 0.048 at day 180; and HR: 0.89; 95% CI: 0.79-1.01; P = 0.07 at day 365). Similarly, the incidence of CV death or any MI was numerically lower in CSL112-treated patients throughout the follow-up period (HR: 0.92; 95% CI: 0.80-1.05 at day 90, HR: 0.89; 95% CI: 0.79-0.996 at day 180, HR: 0.91; 95% CI: 0.83-1.01 at day 365). The effect of CSL112 treatment on MI was predominantly observed for type 1 MI and type 4b (MI due to stent thrombosis). Although CSL112 did not significantly reduce the occurrence of the primary study endpoints, patients treated with CSL112 infusions had numerically lower rates of CV death and MI, type-1 MI, and stent thrombosis–related MI compared with placebo. These findings could suggest a role of apoA-I in reducing subsequent plaque disruption events via enhanced cholesterol efflux. Further prospective data would be needed to confirm these observations. [Display omitted] [ABSTRACT FROM AUTHOR]
Published: 2024
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27 results on '"Lewis, Basil S."'

1. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation.

2. Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial.

3. Impact of Diabetes Mellitus and Chronic Kidney Disease on Cardiovascular Outcomes and Platelet P2Y 12 Receptor Antagonist Effects in Patients With Acute Coronary Syndromes: Insights From the PLATO Trial.

4. On-treatment analysis of the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT).

5. Apixaban Plus Mono Versus Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights From the APPRAISE-2 Trial.

6. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes.

7. Extent of coronary artery disease and outcomes after ticagrelor administration in patients with an acute coronary syndrome: Insights from the PLATelet inhibition and patient Outcomes (PLATO) trial.

8. Response to letter regarding article, "Stent thrombosis with ticagrelor versus clopidogrel in patients with acute coronary syndromes: an analysis from the prospective, randomized PLATO trial".

9. Age, treatment, and outcomes in high-risk non-ST-segment elevation acute coronary syndrome patients: insights from the EARLY ACS trial.

10. Stent thrombosis with ticagrelor versus clopidogrel in patients with acute coronary syndromes: an analysis from the prospective, randomized PLATO trial.

11. Duration of eptifibatide infusion after percutaneous coronary intervention and outcomes among high-risk patients with non-ST-segment elevation acute coronary syndrome: insights from EARLY ACS.

12. Effect of ticagrelor on the outcomes of patients with prior coronary artery bypass graft surgery: insights from the PLATelet inhibition and patient outcomes (PLATO) trial.

13. Radial versus femoral access, bleeding and ischemic events in patients with non-ST-segment elevation acute coronary syndrome managed with an invasive strategy.

14. Thrombin-receptor antagonist vorapaxar in acute coronary syndromes.

15. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial.

16. Design and rationale of the radial versus femoral access for coronary intervention (RIVAL) trial: a randomized comparison of radial versus femoral access for coronary angiography or intervention in patients with acute coronary syndromes.

17. Ticagrelor versus clopidogrel in acute coronary syndromes in relation to renal function: results from the Platelet Inhibition and Patient Outcomes (PLATO) trial.

18. Comparison of ticagrelor with clopidogrel in patients with a planned invasive strategy for acute coronary syndromes (PLATO): a randomised double-blind study.

19. Apixaban, an oral, direct, selective factor Xa inhibitor, in combination with antiplatelet therapy after acute coronary syndrome: results of the Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) trial.

20. Early versus delayed, provisional eptifibatide in acute coronary syndromes.

21. Perceived disability and lifestyle modification following hospitalization for non-ST elevation versus ST elevation acute coronary syndromes: the patients' point of view.

22. Impact of 64-slice cardiac computed tomographic angiography on clinical decision-making in emergency department patients with chest pain of possible myocardial ischemic origin.

24. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC)

25. Ezetimibe added to statin therapy after acute coronary syndromes

26. Plaque Morphology as Predictor of Late Plaque Events in Patients With Asymptomatic Type 2 Diabetes: A Long-Term Observational Study.

27. Effect of Reconstituted Human Apolipoprotein A-I on Recurrent Ischemic Events in Survivors of Acute MI.

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