MD Conference Express ACC 2012 - (Page 35)

Dr. Price suggested that physicians look at the study designs to see where their patients “fit” in terms of the type of MI (NSTEMI or STEMI), management strategy, pretreatment with clopidogrel, start of treatment before coronary angiography, potential need for CABG, and clinical characteristics (eg, advanced age, low body weight, previous stroke – each of which increases the risk of major bleeding). Table 1. Comparative Study Designs Testing the Safety and Efficacy of the P2Y12 Antagonists in ACS. CURE Study drug Comparator Size (n) Clinical Presentation Drug timing Pre-Tx with non-study drug? PCI performed Median Rx 1° Endpoint ARR Clopidogrel Placebo 12,562 NSTE-ACS TRITONTIMI 38 Prasugrel Clopidogrel 300 mg 13,608 NSTE-ACS 74% STEMI 26% After angiography (75%) No 99% 14.5 months CVD, MI, CVA 2.2% PLATO Ticagrelor Clopidogrel 300/600 mg 18,624 NSTE-ACS 60% STEMI 38% Presentation OASIS Clopidogrel 600/150 mg Clopidogrel 300/75 mg 25,807 NSTE-ACS 71% STEMI 29% Presentation in more recent data. An analysis from TRITON-TIMI 38 indicated no influence of PPIs on outcomes in patients who are treated with clopidogrel [O’Donoghue ML et al. Lancet 2009]. Likewise, recent analyses from PLATO showed no interaction of clopidogrel with PPI, with a consistent benefit of ticagrelor, regardless of PPI treatment [Goodman S et al. Circulation 2012]. The best clinical data that have evaluated the interaction of PPIs and clopidogrel are from the prospectively designed, randomized, double-blinded COGENT trial, in which prophylactic use of omeprazole reduced the rate of upper GI bleeding compared with placebo (HR, 0.13; 95% CI, 0.03 to 0.56; p=0.001) [Bhatt DL et al. N Engl J Med 2010]. There was no apparent CV interaction between clopidogrel and omeprazole (HR in patients who were randomized to omeprazole, 0.99; 95% CI, 0.68 to 1.44; p=0.96), but the study could not rule out a potentially clinically meaningful difference in CV events due to use of a PPI. To help provide insight on the issue, the ACC and AHA worked with the American College of Gastroenterology to develop an Expert Consensus Document on the use of PPIs and thienopyridines [Abraham NS et al. Circulation 2010]. The consensus document, recommends using a PPI to reduce GI bleeding among patients with a history of upper GI bleeding, stating that PPIs are appropriate in patients with multiple risk factors for GI bleeding who require antiplatelet therapy. The document also indicates that the routine use of a PPI is not recommended for patients who are at lower risk of upper GI bleeding. The risk of bleeding with prasugrel is higher than it is with clopidogrel. In particular, prasugrel should not be used in patients who have had a prior stroke or transient ischemic attack, and is not recommended for patients aged >75 years, except in high-risk situations. “This recommendation is derived from the data evaluating the net clinical benefit. [If ] patients have high ischemic risk, they will benefit overall from prasugrel because the ischemic benefit outweighs the risk of bleeding, and that was seen in elderly patients with diabetes or prior MI,” said Dr. Price. He also added that dose adjustment in lightweight patients should be considered. Concerns were initially raised about using ticagrelor for patients who had prior stroke as there was nearly a doubling of intracranial hemorrhage (ICH; HR, 1.87; 95% CI, 0.98 to 3.58; p=0.06) that was associated with ticagrelor compared with clopidogrel among all patients in the PLATO trial. However, further analysis showed that Presentation No 21% 9 months CVD, MI, CVA 2.1% Yes in 46% 65% 9.3 months V. Death, MI, CVA 1.9% No 38% 7 days Death, MI, CVA 0.6% Pre-Tx=pre-therapeutics; PCI=percutaneous coronary intervention; CVD=cardiovascular disease; MI=myocardial infarction; CVA=cerebrovascular accident; V. Death=vascular death; ARR=absolute risk reduction. Risk of Bleeding The risk of bleeding is the greatest safety concern with DAPT. “It’s been difficult, if not impossible, to disassociate a reduction in things like, stent thrombosis, from increases in bleeding,” said Deepak L. Bhatt MD, MPH, Brigham and Women’s Hospital, Boston, Massachusetts, USA. The potential for increased risk of bleeding must be an important factor in selecting an antiplatelet regimen. It is wise to factor gastrointestinal (GI) bleeding risk in particular, whether the patient is older, has a history of ulcers, has H. pylori, or is on an anticoagulant, corticosteroids, or an NSAID, advised Dr. Bhatt. Proton pump inhibitors (PPIs) have been used widely to reduce the risk of upper GI bleeding that is associated with clopidogrel, but studies have shown a pharmacodynamic interaction between PPIs and clopidogrel, potentially reducing its clinical effectiveness. However, the clinical significance of this interaction has not been substantiated Highlights from the American College of Cardiology 61st Annual Scientific Session 35 http://www.mdconferencexpress.com

Table of Contents for the Digital Edition of MD Conference Express ACC 2012

MD Conference Express ACC 2012
Table of Contents
Treatment of AMI in the Post-Herrick Era
The State of Hypertension Guidelines: 2012
ACRIN PA 4005: Coronary CTA in the ED Identifies Low-Risk Patients and Shortens Length of Stay
One-Year STAMPEDE Trial Results
TAVR Associated with Increased Late Mortality from Paravalvular Regurgitation
The CABG Surgery Off- or On- Pump- Revascularization Study (CORONARY)
The Moderate PE Treated with Thrombolysis Study (MOPETT)
Pacemaker Therapy In Patients With Neurally Mediated Syncope and Documented Asystole
Outcomes from the BRIDGE-ACS Trial
ROMICAT II: More Data Evaluating CT-First for Acute Chest Pain ED Triage
Elective PCI at Community Hospitals With Versus Without On-Site Surgery
Results from the TRA 2P-TIMI 50 Trial
The HOST-ASSURE Randomized Trial
New Monoclonal Antibody to PCSK9 Markedly Lowers LDL-C in Patients on Atorvastatin
Oral Rivaroxaban Alone for Symptomatic PE
Neutral Outcomes But Important Insights From FOCUS-CCTRN
Imaging
STEMI
Acute Coronary Syndrome
Antiplatelet Therapy
New Anti-Diabetes Agents Offer Promise in the Fight Against CVD
The New Hypertrophic Cardiomyopathy Practice Guidelines

MD Conference Express ACC 2012

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