Prevalence, predictors, and outcomes of premature discontinuation of thienopyridine
therapy after drug-eluting stent placement: results from the PREMIER registry.
08%, respectively which, were above the thienopyridine
hyporesponsiveness defined as inhibition of platelet aggregation (IPA) with 20mol/l ADP <20% based on previous work done by Brandt et al.
Both sNDAs are based on results from the 15,526-patient pivotal Phase 3 ATLAS ACS 2 TIMI 51 (Anti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine
therapy in Subjects with Acute Coronary Syndrome) clinical trial of XARELTO, which was presented at the American Heart Association s annual Scientific Sessions and published in the New England Journal of Medicine in November 2011.
Rivarox-aban maker Janssen Pharmaceuticals had proposed an indication to reduce the risk of thrombotic cardiovascular events in patients with ACS, based on the results of the ATLAS ACS 2 TIMI 51 (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Aspirin With/Without Thienopyridine
Therapy in Subjects With Acute Coronary Syndrome) trial.
The prevention of atherothrombotic events (cardiovascular death, myocardial infarction or stroke) after an Acute Coronary Syndrome in adult patients with elevated cardiac biomarkers when co-administered with acetylsalicylic acid (ASA) alone or with ASA plus a thienopyridine
(clopidogrel or ticlopidine)
Consequently, platelet function testing may identify patients in whom adjustment of thienopyridine
therapy is warranted to minimize the risk of both ischemic and bleeding complications.
In such patients, the risk of restenosis is higher, but when an acceptable or "stent-like" result occurs, thienopyridine
may not be required resulting in a reduction in risk of bleeding that may outweigh the increased risk of restenosis.
This drug is not a thienopyridine
like prasugrel and clopidogrel.
The filing is supported by data from the pivotal Phase 3 ATLAS ACS 2 TIMI 51 (Anti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine
therapy in Subjects with Acute Coronary Syndrome) trial, which was presented in November at the American Heart Association Scientific Sessions and published in the New England Journal of Medicine (10.
Clinical inclusion criteria for same day discharge included stable angina on presentation, asymptomatic patients with abnormal stress test, thienopyridine
use, lack of significant comorbidities, normal renal function and near normal left ventricular ejection fraction (LVEF).
Food and Drug Administration (FDA) approved a new thienopyridine
, prasugrel (Effient[TM]).
28] For patients with BMSs undergoing non-cardiac surgical procedures, 7 out of 40 (18%) developed myocardial infarction (MI); 5 out of the 7 had discontinued thienopyridine
therapy and 6 out of the 7 MIs were fatal.