f最新突破性临床研究结果clarityccs研究解读.ppt

强化抗血小板治疗新证据解读 目的:本试验旨在研究急性ST段抬高心梗患者在溶栓和其他标准治疗的基础上加用氯吡格雷是否对血管造影结果和临床预后产生益处 CLopidogrel as Adjunctive ReperfusIon TherapY (CLARITY) – TIMI 28 Trial Results 研究的组织和病例入组 研究设计1 Inclusion/Exclusion Criteria1 Inclusion criteria Age 18?75 years STEMI within 12 hours Planned treatment with fibrinolytic Major exclusion criteria Clopidogrel within 7 days Planned clopidogrel or GPIIb/IIIa before angiography Contraindications to thrombolysis (stroke, ICH, brain tumor) Cardiogenic shock Intention of angiography within 48 hours CABG, creatinine 2.5 mg/dL, hepatic insufficiency, ? platelets ?67 kg and 4000 U bolus UFH; 67 kg and 5000 U bolus 1.1 mg/kg subcutaneous of enoxaparin Study Endpoints1 Primary endpoint: Composite of occluded infarct related artery (TFG 0/1) on pre-discharge angiogram, or death or MI before angiography Death or MI by hospital discharge (maximum 8 days) if no angiography performed Secondary endpoints: Angiographic (TFG 0/1) Clinical (death, recurrent MI or recurrent ischemia) Clinical events* at 30 days Safety endpoints: Primary: TIMI major bleeding Secondary: TIMI minor bleeding, ICH TIMI Flow Grade Definitions1 TIMI flow grade describes epicardial blood flow: Grade 0: complete occlusion Grade 1: penetration of obstruction with no distal perfusion Grade 2: perfusion of artery with delayed flow Grade 3: full perfusion with normal flow TIMI Myocardial Perfusion Grade Definitions1 TIMI Myocardial Perfusion Grade (TMPG) or ‘blush score’ describes blood flow in the microvasculature: Grade 0: no dye enters Grade 1: dye slowly enters but fails to exit Grade 2: delayed entry and exit of dye Grade 3: normal entry and exit of dye Relationship Between Angiographic Outcomes and Long-term Mortality1 Baseline Characteristics1 Clopidogrel Placebo Characteristic (n=1752) (n=1739) Age (years) 57.7 57.2 Male gender (%) 79.9 80.7 Hypertension (%) 42.8 43.9 Hyperlipidemia (%) 32.2 33.0 Current smoker (%) 50.7 49.9 Diabetes mellitus (%) 16.5 16.4 Prior MI (%) 9.1 9.1 P