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<1>
Accession Number
2009440680
Authors
Morrow D.A. Scirica B.M. Fox K.A.A. Berman G. Strony J. Veltri E. Bonaca
M.P. Fish P. McCabe C.H. Braunwald E.
Institution
(Morrow, Scirica, Bonaca, Fish, McCabe, Braunwald) TIMI Study Group,
Cardiovascular Division, Department of Medicine, Boston, MA, United
States.
(Fox) Cardiovascular Research, University of Edinburgh, Edinburgh, United
Kingdom.
(Berman, Strony, Veltri) Schering-Plough Research Institute, Kenilworth,
NJ, United States.
Title
Evaluation of a novel antiplatelet agent for secondary prevention in
patients with a history of atherosclerotic disease: Design and rationale
for the Thrombin-Receptor Antagonist in Secondary Prevention of
Atherothrombotic Ischemic Events (TRA 2degreesP)-TIMI 50 trial.
Source
American Heart Journal. 158(3)(pp 335-341.e3), 2009. Date of Publication:
September 2009.
Publisher
Mosby Inc.
Abstract
Background: Thrombin potently activates platelets via interaction with the
protease-activated receptor 1. SCH 530348 is a novel antiplatelet agent
that selectively inhibits the cellular actions of thrombin via antagonism
of the protease-activated receptor 1. Because SCH 530348 does not
interfere with other pathways for hemostasis, it is possible that SCH
530348 reduces thrombosis with less increase in bleeding than do other
potent antiplatelet agents. Study design: TRA 2degreesP-TIMI 50 is a phase
III, randomized, double-blind, placebo-controlled, multinational clinical
trial designed to evaluate the efficacy and safety of SCH 530348 during
long-term treatment of patients with established atherosclerotic disease
receiving standard therapy (up to 27,000). Eligible patients with a
history of myocardial infarction, ischemic stroke, or peripheral arterial
disease are randomized 1:1 to SCH 530348 2.5 mg daily or matched placebo
until the end of study. Randomization is stratified by the qualifying
disease and planned use of a thienopyridine. The primary end point is the
composite of cardiovascular death, myocardial infarction, stroke, or
urgent coronary revascularization. The major secondary end point is the
composite of cardiovascular death, myocardial infarction, or stroke. The
evaluation of long-term safety includes bleeding defined by the GUSTO and
TIMI criteria. Recruitment began in September 2007. The trial will
continue until 2,279 primary end points and 1,400 secondary end points are
recorded with expected completion in 36 to 44 months from first
enrollment. Conclusions: TRA 2degreesP-TIMI 50 is evaluating whether a new
approach to platelet inhibition via interruption of thrombin-mediated
platelet activation reduces major cardiovascular events with a favorable
safety profile in patients with established atherosclerosis. copyright
2009.
<2>
Accession Number
2009440679
Authors
Pride Y.B. Wiviott S.D. Buros J.L. Zorkun C. Tariq M.U. Antman E.M.
Braunwald E. Gibson C.M.
Institution
(Pride) Department of Medicine, Beth Israel Deaconess Medical Center,
Boston, MA, United States.
(Wiviott, Antman, Braunwald) TIMI Study Group, Cardiovascular Division,
Brigham and Women's Hospital, Boston, MA, United States.
(Buros, Zorkun, Tariq, Gibson) Beth Israel Deaconess Medical Center,
Harvard Medical School, Boston, Boston, MA, United States.
Title
Effect of prasugrel versus clopidogrel on outcomes among patients with
acute coronary syndrome undergoing percutaneous coronary intervention
without stent implantation: A TRial to assess Improvement in Therapeutic
Outcomes by optimizing platelet inhibitioN with prasugrel
(TRITON)-Thrombolysis in Myocardial Infarction (TIMI) 38 Substudy.
Source
American Heart Journal. 158(3)(pp e21-e26), 2009. Date of Publication:
September 2009.
Publisher
Mosby Inc.
Abstract
Background: Prasugrel led to a significant reduction in ischemic
cardiovascular events among patients with acute coronary syndrome (ACS)
undergoing percutaneous coronary intervention (PCI) with stent
implantation compared to clopidogrel. Whether this benefit extends to
patients undergoing PCI without stent implantation is unknown. Methods: In
TRial to assess Improvement in Therapeutic Outcomes by optimizing platelet
inhibitioN with prasugrel (TRITON)-Thrombolysis in Myocardial Infarction
(TIMI) 38, patients (n = 13 608) undergoing PCI for ACS were randomized to
aspirin plus clopidogrel or prasugrel. This postrandomization analysis of
a prespecified subgroup was restricted to patients who underwent PCI
without stent implantation (n = 569). Results: Patients who underwent PCI
without stent implantation were older and had a higher incidence of
hypertension, diabetes, prior myocardial infarction (MI), prior coronary
artery bypass (CABG) surgery, and renal dysfunction than patients who
underwent stent implantation. In the group that did not undergo stent
implantation, baseline characteristics were similar between patients
receiving clopidogrel and prasugrel. The composite of cardiovascular
death, nonfatal MI, and nonfatal stroke occurred in 14.2% of patients
receiving prasugrel and 17.1% of patients receiving clopidogrel (HR 0.82,
P = .27). There were significant reductions favoring prasugrel in the
rates of urgent target vessel revascularization (TVR; HR 0.46, P = .040)
and any TVR (HR 0.40, P = .009) and a trend toward a reduction in the
incidence of nonfatal MI (HR 0.65, P = .11). CABG-related TIMI major
bleeding was more frequent among patients receiving prasugrel. There were
no significant interactions between treatment and PCI type. Conclusion:
Among ACS patients who underwent PCI without stent implantation, prasugrel
therapy tended to reduce clinical ischemic events and to increase bleeding
events to a similar magnitude as among patients who received stents.
copyright 2009.
<3>
Accession Number
2009436038
Title
The Thrombin Receptor Antagonist for Clinical Event Reduction in Acute
Coronary Syndrome (TRA*CER) trial: study design and rationale.
Source
American Heart Journal. 158(3)(pp 327-334.e4), 2009. Date of Publication:
September 2009.
Publisher
Mosby Inc.
Abstract
Background: The protease-activated receptor 1 (PAR-1), the main platelet
receptor for thrombin, represents a novel target for treatment of arterial
thrombosis, and SCH 530348 is an orally active, selective, competitive
PAR-1 antagonist. We designed TRA*CER to evaluate the efficacy and safety
of SCH 530348 compared with placebo in addition to standard of care in
patients with non-ST-segment elevation (NSTE) acute coronary syndromes
(ACS) and high-risk features. Trial design: TRA*CER is a prospective,
randomized, double-blind, multicenter, phase III trial with an original
estimated sample size of 10,000 subjects. Our primary objective is to
demonstrate that SCH 530348 in addition to standard of care will reduce
the incidence of the composite of cardiovascular death, myocardial
infarction (MI), stroke, recurrent ischemia with rehospitalization, and
urgent coronary revascularization compared with standard of care alone.
Our key secondary objective is to determine whether SCH 530348 will reduce
the composite of cardiovascular death, MI, or stroke compared with
standard of care alone. Secondary objectives related to safety are the
composite of moderate and severe GUSTO bleeding and clinically significant
TIMI bleeding. The trial will continue until a predetermined minimum
number of centrally adjudicated primary and key secondary end point events
have occurred and all subjects have participated in the study for at least
1 year. The TRA*CER trial is part of the large phase III SCH 530348
development program that includes a concomitant evaluation in secondary
prevention. Conclusion: TRA*CER will define efficacy and safety of the
novel platelet PAR-1 inhibitor SCH 530348 in the treatment of high-risk
patients with NSTE ACS in the setting of current treatment strategies.
copyright 2009 Mosby, Inc. All rights reserved.
<4>
Accession Number
2009435167
Authors
Gheorghiade M. Khan S. Blair J.E.A. Harinstein M.E. Krum H. Mukherjee R.
Pitt B.
Institution
(Gheorghiade, Khan, Blair, Harinstein) Department of Medicine, Center for
Cardiovascular Quality and Outcomes, Northwestern University, Chicago, IL,
United States.
(Krum) Monash University, Melbourne, Australia.
(Mukherjee) Pfizer Inc., New York, NY, United States.
(Pitt) Department of Medicine, Division of Cardiology, University of
Michigan, Ann Arbor, MI, United States.
Title
The effects of eplerenone on length of stay and total days of heart
failure hospitalization after myocardial infarction in patients with left
ventricular systolic dysfunction.
Source
American Heart Journal. 158(3)(pp 437-443), 2009. Date of Publication:
September 2009.
Publisher
Mosby Inc.
Abstract
Background: Heart failure (HF) with reduced left ventricular ejection
fraction (LVEF) after acute myocardial infarction (AMI) is associated with
increased readmission rates. This study evaluated the effects of
eplerenone, a selective aldosterone blocking agent, on the duration of
subsequent hospitalizations for HF in the Eplerenone Post-Acute Myocardial
Infarction Heart Failure Efficacy and Survival Study (EPHESUS). Methods:
The EPHESUS study included 6,632 patients post-AMI with LVEF [less-than or
equal to]40% and clinical HF or diabetes, receiving standard therapy,
randomized to either eplerenone 25 mg, titrated to 50 mg daily, or
placebo, with a mean follow-up of 16 months. Analyses of the length of
stay and total number of days of HF hospitalizations per patient were
conducted on a subgroup of 828 patients with subsequent HF
hospitalizations, overall and across 5 distinct geographic regions.
Results: Eplerenone was associated with a 1.6-day reduction in the mean
length of HF hospitalization (9.2 vs 10.8 days with placebo; P = .019) and
3.6-day reduction in the total days spent in the hospital for HF (13.3 vs
16.9 days with placebo; P = .0006). These benefits were observed in all
geographic regions. Conclusions: In patients post-AMI with reduced LVEF
and HF or diabetes, eplerenone added to standard therapy reduced the mean
length and total days of HF hospitalizations compared to placebo in all
regions. Given the high cost of hospital care for HF, these findings may
translate into an economic benefit to health care worldwide. copyright
2009 Mosby, Inc. All rights reserved.
<5>
Accession Number
2009460992
Authors
Kulik A. Ruel M.
Institution
(Kulik) Arizona Heart Institute, 2632 North 20th Street, Phoenix, AZ
85006, United States.
(Ruel) Department of Surgery, Cellular and Molecular Medicine, and
Epidemiology, University of Ottawa, University of Heart Institute, Ottawa,
ON, Canada.
Title
Statins and coronary artery bypass graft surgery: Preoperative and
postoperative efficacy and safety.
Source
Expert Opinion on Drug Safety. 8(5)(pp 559-571), 2009. Date of
Publication: September 2009.
Publisher
Informa Healthcare
Abstract
Background: In patients with native coronary artery disease, strong
evidence supports the use of statins to reduce the risk of recurrent
cardiovascular events and improve survival. However, for patients
undergoing coronary artery bypass graft surgery (CABG), statins appear to
be underutilized, and concerns have been raised regarding their
perioperative safety. Objective: The goal of this systematic review is to
evaluate the safety and efficacy of statin therapy before and after
coronary surgical revascularization. Methods: A systematic review was
performed to retrieve relevant articles from the Medline database
published between 1987 and January 2009. Results: Administered before
CABG, statins have been demonstrated to reduce perioperative mortality,
stroke and atrial fibrillation. Preoperative statin therapy also reduces
the systemic inflammatory response associated with cardiopulmonary bypass.
Following CABG, statins inhibit saphenous vein graft disease and the
progression of atherosclerosis in native coronary arteries. In addition,
postoperative statins reduce the recurrence of cardiovascular events and
improve all-cause mortality. High-intensity lipid reduction to achieve
low-density lipoprotein levels to 70 mg/dl may benefit post-CABG patients,
but this has yet to be evaluated prospectively. Adverse effects related to
perioperative statin therapy seem to be extremely rare, and little data
are available to support the practice of withholding statin therapy before
or after surgery. Conclusion: Numerous studies have demonstrated that
statins improve the outcomes of patients undergoing CABG. The benefits
seem to outweigh the risks associated with their use, both in the
preoperative and postoperative period. In the absence of
contraindications, essentially all CABG patients are candidates for
life-long statin therapy that ideally should be started before surgery.
The optimal postoperative statin regimen remains unknown and should be the
subject of future study. copyright 2009 Informa UK Ltd. All rights
reserved.
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