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COMMIT/CCS-2 ( C l O pidogrel & M etoprolol in M yocardial I nfarction T rial)

COMMIT/CCS-2 ( C l O pidogrel & M etoprolol in M yocardial I nfarction T rial). Designed, conducted, analysed and interpreted independently by COMMIT/CCS-2 collaboration Sources of funding (US$ 3M): SanofiAventis/BMS AstraZeneca British Heart Foundation UK Medical Research Council.

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COMMIT/CCS-2 ( C l O pidogrel & M etoprolol in M yocardial I nfarction T rial)

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  1. COMMIT/CCS-2(ClOpidogrel & Metoprolol in MyocardialInfarction Trial) • Designed, conducted, analysed and interpreted independently by COMMIT/CCS-2 collaboration • Sources of funding (US$ 3M): • SanofiAventis/BMS • AstraZeneca • British Heart Foundation • UK Medical Research Council

  2. COMMIT: 45,852 patients from 1250 centres in China Heilongjiang (53) Jilin (50) Xinjiang (7) Liaoning (92) Beijing (48) Nei Mongol(38) Tianjin (21) Hebei (115) Ningxia (8) Qinghai (4) Shandong (148) Shanxi (58) Gansu (25) Henan (121) Jiangsu (63) Shaanxi (43) Shanghai (16) Anhui (28) Sichuan (49) Hubei (54) Zhejiang (12) Chongqing (11) Jiangxi (20) Fujian (22) Hunan (37) Guizhou (11) Guangdong (49) Yunnan (12) Guangxi (30) Hainan (7)

  3. COMMIT: Study design • TREATMENT: Clopidogrel 75 mg daily vs placebo • (aspirin 162mg daily in both groups) • INCLUSION: Suspected acute MI (ST change orLBBB) within 24 h of symptom onset • EXCLUSION: Primary PCI or high-risk of bleeding • 1 OUTCOMES: Death & death, re-MI or stroke up to 4 weeks in hospital (or prior discharge) • Mean treatment and follow-up: 16 days

  4. COMMIT: Baseline characteristics • Characteristic Clopidogrel Placebo (n=22,960) (n=22,891) • Age 70+ y 26.0% 26.0% • Female 27.7% 27.9% • Time delay <6 h 33.8% 33.7% • STEMI/LBBB 93.1% 93.1% • Killip class II/III 24.1% 24.0% • Fibrinolytic: • All patients 49.7% 49.8% • STEMI <12h 67.8% 67.7%

  5. COMMIT: Concomitant therapy • Therapy Clopidogrel Placebo (n=22,958) (n=22,891) • Anticoagulants 74.1% 75.0% • ACE inhibitors 68.2% 68.3% • Anti-arrhythmics 22.4% 22.2% • Nitrates 94.1% 94.3% • Diuretics 23.3% 23.3% • Calcium antagonists 11.8% 11.8%

  6. COMMIT: Effects of CLOPIDOGREL on Death, Re-MI or Stroke Placebo + ASA: 2311 events (10.1%) Clopidogrel + ASA: 2125 events (9.3%) 9% (SE3) relative risk reduction (2P=0.002) Event (%) Days since randomisation (up to 28 days)

  7. COMMIT: Effect of CLOPIDOGREL on Death in hospital Placebo + ASA: 1846 deaths (8.1%) Clopidogrel +ASA: 1728 deaths (7.5%) 7% (SE3) relative risk reduction (2P=0.03) Dead (%) Days since randomisation (up to 28 days)

  8. COMMIT: Effects of CLOPIDOGREL on Reinfarction Outcome Clopidogrel Placebo Odds ratio & 95% CI after Re-MI (22,958) (22,891) Clopid. better Placebo better Died 209 (0.9%) 223 (1.0%) Survived 273 (1.2%) 330 (1.4%) 13% SE 6 ALL COMBINED 482 (2.1%) 553 (2.4%) (2P = 0.02) 0.4 0.6 0.8 1.0 1.2 1.4 1.6

  9. COMMIT: Effects of CLOPIDOGREL on any Stroke Types Clopidogrel Placebo Odds ratio & 95% CI (22,958) (22,891) Clopid. better Placebo better Ischaemic 162 (0.7%) 192 (0.8%) Haemorrhagic 55 (0.2%) 55 (0.2%) 14% SE 9 ALL COMBINED 216 (0.9%) 249 (1.1%) (2P > 0.1; NS) 0.4 0.6 0.8 1.0 1.2 1.4 1.6

  10. COMMIT: Major bleed in hospital • Type Clopidogrel Placebo (n=22,958) (n=22,891) • Cerebral • Fatal 39 40 • Non-fatal 16 15 • Non-cerebral • Fatal 36 37 • Non-fatal 46 36 • Any major bleed 134 124 • (0.58%) (0.54%)

  11. COMMIT: Effects of CLOPIDOGREL on Death,Re-MI or Stroke by day of event Day of event Clopidogrel Placebo Odds ratio & 95% CI (22,958) (22,891) Clopid. better Placebo better 0 463 (2.0%) 523 (2.3%) 1 486 (2.1%) 527 (2.3%) 2-3 449 (2.0%) 451 (2.0%) 4-7 432 (1.9%) 463 (2.0%) 8-28 295 (1.3%) 347 (1.5%) 9% SE 3 ALL 2125 (9.3%) 2311 (10.1%) (2P = 0.002) 0.4 0.6 0.8 1.0 1.2 1.4 1.6

  12. COMMIT: Effects of CLOPIDOGREL on Death,Re-MI or Stroke by sex and age Baseline Clopidogrel Placebo Odds ratio & 95% CI features (22,958) (22,891) Clopid. better Placebo better Sex Male 1276 (7.7%) 1416 (8.6%) Female 849 (13.3%) 895 (14.0%) Age (years) <60 487 (5.1%) 513 (5.4%) 60-69 747 (10.2%) 835 (11.2%) 70+ 891 (14.9%) 963 (16.2%) 9% SE 3 ALL 2125 (9.3%) 2311 (10.1%) (2P = 0.002) 0.4 0.6 0.8 1.0 1.2 1.4 1.6

  13. COMMIT: Effects of CLOPIDOGREL on Death,Re-MI or Stroke by delay & fibrinolytic Baseline Clopidogrel Placebo Odds ratio & 95% CI features (22,958) (22,891) Clopid. better Placebo better Hour to entry 0-6 776 (9.3%) 904 (10.9%) 7-12 672 (9.7%) 735 (10.7%) 13-24 666 (8.8%) 666 (8.7%) Lytic given Yes 1005 (8.8%) 1123 (9.9%) No 1120 (9.7%) 1188 (10.3%) 9% SE 3 ALL 2125 (9.3%) 2311 (10.1%) (2P = 0.002) 0.4 0.6 0.8 1.0 1.2 1.4 1.6

  14. From ISIS-2 to COMMIT: Effects of aspirin and clopidogrel on Death, Re-MI or Stroke • ISIS-2: Placebo 14% • ASA 10% • COMMIT: ASA 10% • ASA + Clop. 9% • ASA + Clopidogrel vs nil: ~50 per 1000 treated ~40 per 1000 ~10 per 1000

  15. COMMIT: Conclusions •  Adding 75 mg daily CLOPIDOGREL to aspirin in acute MI prevents ~10 major vascular events per 1000 treated •  No excess of cerebral, fatal or transfused bleeds (even with fibrinolytic therapy and in older people) • Each million MI patients treated for ~2 weeks would avoid 5000 deaths and 5000 non-fatal events • Slides available on: www.commit-ccs2.org

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