Unique identifier NCT00976092 (www.clinicaltrials.gov).
Primary percutaneous coronary intervention (PCI) is the preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI). Effective and safe adjunct antithrombotic therapy is a major determinant for short-and long-term outcomes after primary PCI. Two separate studies have shown significant benefits vs conventional therapy for 2 recently approved drugs. In the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, bivalirudin after pretreatment with clopidogrel resulted in improved net clinical outcome compared with heparin plus glycoprotein IIb/IIIa inhibitors. However, during the first 24 hours after PCI, there was an increase in stent thrombosis rates with bivalirudin. In the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel-Thrombolysis In Myocardial Infarction (TRITON-TIMI) 38 trial, prasugrel was superior to clopidogrel in patients with acute coronary syndrome with and without ST-segment elevation. The synergic actions of prasugrel and bivalirudin may maximize the benefit of antithrombotic therapy for STEMI patients undergoing primary PCI. However, no specifically designed studies have so far compared the combination of prasugrel plus bivalirudin with that of clopidogrel plus unfractionated heparin in these patients. The Bavarian Reperfusion Alternatives Evaluation (BRAVE) 4 study is a randomized, open-label, multicenter trial aimed to test the hypothesis that a strategy based on prasugrel plus bivalirudin is superior to a strategy based on clopidogrel plus unfractionated heparin in terms of net clinical outcome in STEMI patients with planned primary PCI. 270 Clin. Cardiol. 37, 5, 270-276 (2014) Introduction Primary percutaneous coronary intervention (PCI) with stent implantation is the preferred reperfusion strategy for patients presenting with acute ST-segment elevation myocardial infarction (STEMI). 1 Adjunct antithrombotic pharmacotherapy is critical for the safe and efficacious performance of PCI. The introduction of dual antiplatelet therapy with acetylsalicylic acid (ASA) and the thienopyridine ticlopidine resulted in a drastic reduction in periprocedural stent thrombosis rates and bleeding complications compared with a regimen with heparin and warfarin derivatives. 2 -4 However, the use of ticlopidine in primary PCI is limited by its delayed onset of action and adverse side effects. Glycoprotein (GP) IIb/IIIa inhibitors are characterized by a faster and more potent antiplatelet effect compared with the thienopyridine ticlopidine and were soon included in the armamentarium of adjunct antithrombotic treatment. Since the Evaluation of Platelet IIb/IIIa Inhibitor for Stenting (EPISTENT) trial in 1998, 5 the peri-interventional administration of the GP IIb/IIIa inhibitor abciximab became an integral part of PCI, particularly in patients presenting with acute coronary syndrome (ACS). In several clinical trials of STEMI patients, abciximab in addition to ASA and tic...
ZusammenfassungWährend in den 1970er-Jahren noch körperliche Aktivität als supportive Therapie in der Onkologie kritisiert und abgelehnt wurde, gewannen bewegungstherapeutische Interventionen seit den 1990er-Jahren immer mehr an Bedeutung [3, 9]. Nachdem die Wirksamkeit rehabilitativer Bewegungsprogramme in der Nachsorge wie auch während der Akuttherapie in zahlreichen Studien bestätigt wurde, zeigten erste prähabilitative, bewegungstherapeutische Interventionen positive Einflüsse auf den postoperativen Genesungsprozess. Dabei werden Bewegungsprogramme im Zeitraum zwischen der Krebsdiagnose und der operativen Therapie durchgeführt [15].Dieses Potenzial zeigt sich auch bei der prähabilitativen Bewegungstherapie eines Mammakarzinoms. Körperliche Aktivität ist während einer neoadjuvanten Chemotherapie unter moderater bis intensiver Belastungsintensität machbar und sicher. Zudem können sowohl Wundheilungsstörungen und Bewegungsmangelsymptome reduziert, die körperliche Leistungsfähigkeit und die psychische Verfassung verbessert sowie eine bewegungsspezifische Gesundheitskompetenz erlangt werden. Die Anzahl der Krankenhaustage verringern sich, und die Kosten für die Krankenkasse können gesenkt werden [16].Trotz der Relevanz dieses neuen Forschungsfeldes werden prähabilitative Interventionen bei einem Mammakarzinom hauptsächlich durch einzelne wissenschaftliche Projekte durchgeführt. Es bedarf weiterer randomisierter, kontrollierter Studien, um die Wirksamkeit der prähabilitativen Sport- und Bewegungstherapie zu prüfen und deren Stellenwert für eine Mammakarzinomerkrankung aufzuzeigen.
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