Table 2.
All-Cause Mortality in Randomized Trials Testing Clopidogrel Added to Aspirin
| #Deaths/#Randomized |
||||
|---|---|---|---|---|
| Short-Term Trials (14 d–3 mo) | Population | Combination | Aspirin Alone | OR (95% CI) |
| Clopidogrel and aspirin after surgery in CAD6 | CABG surgery | 0/124 | 1/125 | 0.33* (0.01–8.26) |
| Aspirin vs aspirin and clopidogrel in lower limb angioplasty7 | Leg atherosclerosis undergoing revascularization | 0/67 | 0/65 | 0.97* (0.02–50) |
| PROCLAIM8 | Metabolic syndrome | 0/89 | 0/92 | 1.03* (0.02–53) |
| COMMIT9 | Acute MI with ST changes | 1726/22 961 | 1845/22 891 | 0.93 (0.87–0.99) |
| All short-term trials | 1726/23 241 | 1846/23 173 | 0.93 (0.87–0.99)† | |
| #Deaths/#Randomized (Annualized Mortality Rate) |
Hazard Ratio (95% CI) |
|||
| Long-Term Trials (> 3 mo) | Population | Combination | Aspirin Alone | |
| SPS31 | Recent lacunar stroke | 113/1517 (2.1%/pt-yr) | 77/1503 (1.4%/pt-yr) | 1.49 (1.11–2.01) |
| CHARISMA10 | Vascular disease or risk factors | 371/7802 (2.0%/pt-yr) | 374/7801 (2.1%/pt-yr) | 0.99 (0.86–1.14) |
| CURE11 | Acute coronary syndromes | 359/6259 (7.6%/pt-yr) | 390/6303 (8.3%/pt-yr) | 0.92 (0.80–1.07)‡ |
| ACTIVE A12 | Atrial fibrillation unsuitable for warfarin | 825/3772 (6.4%/pt-yr) | 841/3782 (6.6%/pt-yr) | 0.98 (0.89–1.08) |
| CASCADE13 | Coronary artery bypass grafting | 0/56 (0%/pt-yr) | 1/57 (1.8%/pt-yr) | ⋯ |
| CREDO14 | Percutaneous coronary intervention | 18/1053 (≈1.7%/pt-yr) | 24/1063 (≈2.3%/pt-yr) | 0.75 (0.41–1.39) |
| REAL-LATE / ZEST-LATE15 | Drug-eluting stents >12 mo | 20/1357 (0.9%/pt-yr) | 13/1344 (0.6%/pt-yr) | 1.52 (0.75–3.50) |
| CASPAR16 | Lower extremity bypass | 24/425 (5.6%/pt-yr) | 17/426 (4.0%/pt-yr) | 1.44 (0.70–2.68) |
| All longer-term trials | 1730/22 241 | 1737/22 279 | 1.03 (0.91–1.16)§ | |
| Longer-term trials except SPS3 | ⋯ | 1617/20 724 | 1660/20 776 | 0.97 (0.91–1.04)¶ |
CAD indicates coronary artery disease; CABG, coronary artery bypass graft; MI, myocardial infarction.
*
Estimated by adding 0.5 to each cell.
†
I2 index, 0%; P=0.94 for heterogeneity.
‡
OR reported for mortality.
§
I2 index, 48%; P=0.07 for heterogeneity.
¶
I2 index, 0%; P=0.56 for heterogeneity.