Journal of interventional cardiology
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Current clinical guidelines recommend dual antiplatelet agents namely aspirin and clopidogrel for the treatment of patients suffering from acute coronary syndrome (ACS). But the efficacy of clopidogrel is variable as it is a pro-drug, which has to be metabolized to become an active drug thus exhibiting variable platelet inhibition, increases risk of bleeding, stent thrombosis, and ischemia. ⋯ Finally, a novel reversible and direct-acting oral adenosine diphosphate (ADP) receptor antagonist, ticagrelor was developed that showed consistent and increased P2Y12 inhibition with similar incidence of bleeding but greater reduction in cardiac events compared to clopidogrel. The focus of this article is to review ticagrelor as a new class of P2Y12 inhibitor.
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Coronary stent technology has rapidly evolved from a mechanical solution to abrupt vessel closure and elastic recoil following plain balloon angioplasty, to become a vector for local drug delivery and modification of coronary plaque pathophysiology. The advent of drug-eluting stents (DES) has significantly reduced restenosis, although there is increasing concern over the risk of late stent thrombosis, particularly following cessation of antiplatelet therapy. Here we consider the limitations of the current generation of DES, and review recent advances in platform, carrier, and pharmacological technology, and their place in future clinical practice.
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The use of a medical device outside of its approved label is commonly referred to as "off-label use." Off-label use arises when physicians see the opportunity to leverage an approved therapy for an unmet patient need. This practice typically occurs on a case by case basis without clear documentation of indication, frequency, or outcomes. Sponsors have a responsibility to consider formal indication expansion depending on the actual use, how well the therapy fits the unmet need, product iteration cycles, adoption speed, resource demands, and the clinical risk to benefit ratio. ⋯ This >7,000 patient registry documents both on-label and off-label use and key safety measures for the TAXUS stent. This real-world registry has successfully provided a data-driven approach to BSC's product development strategy, including the initiation of formal label expansion programs. For complex or combination products, more innovative ways of capturing risk to benefit data are needed to define off-label use and to maximize the potential therapeutic utility as supported by safety data.
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The efficacy with aspirin and clopidogrel treatment has been demonstrated in various clinical trials. Laboratory evaluation of platelet response in recent studies revealed that a distinctive response variability and nonresponsiveness/resistance in selected patients were associated with these antiplatelet agents. Moreover, some studies have correlated this nonresponsiveness/resistance phenomenon to the occurrence of thrombotic events. ⋯ Therefore, specific treatment recommendations for patients exhibiting high platelet reactivity or poor platelet inhibition during clopidogrel or aspirin therapy are not established. A higher aspirin dose and strict compliance to therapy may overcome the occurrence of "aspirin resistance" in selected patients. A higher clopidogrel dose may be considered in patients exhibiting clopidogrel nonresponsiveness.
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Neonates that present with hypoplastic left heart syndrome (HLHS) and intact atrial septum (IAS) pose a major management problem for the pediatric cardiac team. They are critically ill newborns with profound hypoxemia and acidosis that require immediate attention. Controversy exists as to the most appropriate management strategy. ⋯ Unfortunately to date, the results of attempted relief of aortic valve stenosis have been extremely poor. Finally, we as interventionalists need to continue to improve our skills to help in the complex management of these critically ill neonates and infants. Only through continued efforts of the entire cardiac team of intensivists, cardiologists, cardiothoracic surgeons, and interventionalists will our management strategy be defined to maximize the future outcome in this group of patients.