CURE CURE PCI

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     1  Keith A A Fox Royal Infirmary & University of Edinburgh CURE and PCI-CURE
     2  Total outcomes: admission to 6 months Largest multinational registry covering the full spectrum of ACS ESC 2001
     3  Randomized, double-blind trial: clopidogrel vs placebo in patients with ACS All patients receive ASA (75-325 mg) International trial (28 countries), 12,562 patients Central randomization Primary outcome: -CV death, MI, strokes Study Design
     4  CURE Study 3 months > double-blind treatment < 12 months Aspirin 75-325mg Clopidogrel 75mg o.d. (~6,250 patients) Placebo 1 tab o.d. (~6,250 patients) Aspirin 75-325mg Day 1 6 m. Visit 9 m. Visit 12 m. or Final Visit 300mg loading dose 3 m. Visit 1 m. Visit Patients with Acute Coronary Syndrome (UA or MI Without ST elevation) R loading dose
     5  CV Death: Excludes clear non-CV deaths MI: Two of three standard criteria: (Chest Pain, ECG, enzyme changes) Stroke: Neurological deficit ? 24 hrs (CT/MRI) Outcome Definitions Refractory Ischemia: Inhosp*: recurrent ischemia on max med Rx + ECG changes + intervention ? 1 day After discharge: Rehosp for UA with ECG changes Severe Ischemia*: Changes similar to RFA, but no intervention Recurrent Angina*: All other ischemic CP in hospital
     6  Cumulative Hazard Rates for CV Death/MI/Stroke 6303 6259 P = 0.00005
     7  Cumulative Hazard Rates for CV Death/MI/Stroke up to 30 Days P=0.003 Clopidogrel Placebo Cumulative Hazard Rates Days of Follow-up 0 10 20 30 6303 6259 6097 6093 5994 6027 5954 5981 No. Plac No. Clop
     8  Very Early Events *p<0.05 **<0.01 *** <0.002
     9  Events During Initial Hospitalization
     10  CURE: Who Benefits and When? Similar benefits across all major treatment groups On or off lipid lowering treatment, beta-blockers, heparin, ACE inhibitors Irrespective of revascularization or not RR 0.81 with and RR 0.78 without, both significant Higher and lower risk groups show similar risk reduction Curves separate early and remain separated Primary outcome at 24hrs: 143 vs 93 clopidogrel (RR 0.65 CI 0.50 – 0.85)
     11  Life Threatening Bleed
     12  Bleeds With CABG
     13  CURE: Magnitude of Benefit Primary Outcome: MI, stroke or CV death: 11.4% placebo, 9.2%** clopidogrel (22 per 1000 absolute difference) (Non-CV death 0.7 vs 0.7%) Treating 1000 patients for 9 months: prevents 28 vascular events with 6 individuals requiring transfusion TIMI bleeding criteria: 68 clopidogrel,73 placebo RR 0.94 (CI 0.68-1.30) GUSTO criteria: 78 clopidogrel, 70 placebo RR 1.11 (CI 0.81-1.55)
     14  Study Design Randomize PCI PLACEBO + ASA CLOPIDOGREL + ASA 30 d. post PCI End of follow-up: 12 months Open-label thienopyridine Pretreatment Pretreatment N=2,658 patients undergoing PCI N = 1345 N = 1313 CURE PCI-CURE Open-label thienopyridine
     15  Baseline Characteristics 43.2% 42.4% ST depression 12.0% 13.0% Prior CABG 13.4% 13.8% Prior PCI 27.3% 26.0% Previous MI 19.0% 19.0% Diabetes 30.3% 30.1% Sex (%F) 61.6 61.4 Age (yrs) Clopidogrel n=1254 Placebo n=1272
     16  0.0 0.05 0.10 0.15 0 40 100 200 300 400 10 100 200 300 400 A B Days following PCI Cumulative Hazard Rate P=0.002 Clopidogrel Placebo A=median time to PCI B=30 days after PCI Overall Results: CV Death or MI Lancet 2001: 358:527-33
     17  Events Before PCI Lancet 2001: 358:527-33
     18  Major Outcomes: From PCI to 30 days Lancet 2001: 358:527-33 *Primary endpoint
     19  Other Outcomes Mehta SR et. al. Lancet 2001: 358:527-33
     20  Major Outcomes: Long Term Treatment Lancet 2001: 358:527-33
     21  Clinical Suspicion of ACS: Physical examination, ECG Blood samples No persistent STelevation Aspirin b-blocker “heparin” clopidogrel