Gao 2010.
Methods | Randomized controlled trial. | |
Participants | 249 people undergoing primary isolated CABG, with or without cardiopulmonary bypass who received ≥ 1 SVG. | |
Interventions | Aspirin 100 mg plus clopidogrel 75 mg (n = 124; mean age (± SD) 57.9 ± 8.25 years, female sex 17.7%) for 3 months. Aspirin 100 mg (n = 125; mean age (± SD) 59.8 ± 7.92 years, female sex 16.2%) for 3 months. |
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Outcomes | Primary: MSCT angiography. Secondary: MACEs, defined as: cardiogenic death; MI (hospital visit for MI reported by participant or hospital admission for MI reported by cardiologist); and need for revascularization (repeat operation or angioplasty reported by participant or cardiologist) through 3 months after CABG. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Patients with successful CABG surgery were randomly assigned to 2 groups." |
Allocation concealment (selection bias) | Unclear risk | "Patients with successful CABG surgery were randomly assigned to 2 groups." |
Blinding (performance bias and detection bias) All outcomes | High risk | "The current trials were carried out in a single center without placebo control ... In addition to the MSCTA [multislice computed tomography angiography] observers, the investigator and patients were not blinded to the randomized allocation." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Two‐hundred forty‐nine cardiac surgery candidates were randomized to group A [aspirin alone] (n=125) or group AC [aspirin plus clopidogrel] (n=124). Of the 249 participants, 1 (0.4%) (from group A) died at 6 weeks after CABG surgery. Of the remaining 248 patients, 239 (96.4%) completed a 3‐month follow‐up, and 224 (90.3%) underwent MSCTA. Deaths, numbers and reasons for loss to follow‐up, and numbers contributing to analyses are shown in Figure 1." |
Selective reporting (reporting bias) | Unclear risk | Mostly reported as per protocol, but major bleeding not reported. |
Other bias | Low risk | "This study was supported by the Key Project in the National Science & Technology Pillar Program during the 11th 5‐Year Plan Period (2006BAI01A09)." |