CRYSSA 2012.
Methods | Randomized controlled trial. | |
Participants | 300 consecutive people undergoing isolated off‐pump CABG for stable coronary artery disease who received ≥ 1 SVG. | |
Interventions | Clopidogrel 75 mg plus aspirin 100 mg (n = 150; mean age (± SD) 59.4 ± 7.7 years; male sex 73.3%) for 12 months. Aspirin 100 mg (n = 150; mean age (± SD) 58.9 ± 8.3 years; male sex 75.3%) for 12 months. |
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Outcomes | Primary: response to platelet inhibition after off‐pump CABG. Secondary: graft occlusion at 12 months; major and minor bleeding (defined according to the CURE trial); and incidence of MACCEs (composite endpoint including cardiac deaths, any repeat revascularization (percutaneous coronary interventions or CABG), cerebrovascular accident and documented MI). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Patients ... were randomly assigned to aspirin alone or double antiplatelet treatment by a computer‐generated algorithm and antiplatelet therapy was initiated." |
Allocation concealment (selection bias) | Low risk | "Randomisation was fully blinded without taking account of clinical or demographic features." |
Blinding (performance bias and detection bias) All outcomes | High risk | "The CRYSSA trial is a prospective randomised controlled study." No placebo used. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The principal investigator (Dr Mannacio) provided additional data. |
Selective reporting (reporting bias) | Unclear risk | No protocol available. |
Other bias | Unclear risk | No data on funds. |