Gasparovic 2014.
Methods | Randomized controlled trial. | |
Participants | Adults scheduled to elective primary CABG. On postoperative day 4, people underwent an aggregometry‐based assessment of their on‐aspirin platelet reactivity. People found to be aspirin‐resistant were randomised into either the control or intervention group. | |
Interventions | Clopidogrel 75 mg plus aspirin 300 mg (n = 112; mean age (± SD) 65 ± 8 years; male sex 83%) for 6 months. Aspirin 300 mg (n = 110; mean age (± SD) 65 ± 9 years; male sex 82%) for 6 months. |
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Outcomes | Primary: MACCEs at 6 months (composite outcome including all‐cause mortality, non‐fatal MI, cerebrovascular accident and cardiovascular rehospitalization). Secondary: bleeding events components (Bleeding Academic Research Consortium definitions) and individual MACCE components (BARC type 3, 4 and 5 bleeding events as major bleeding, BARC type 1 and 2 as minor bleeding). | |
Notes | Prospective randomised study that selectively implemented DAPT after CABG in people with aggregometry‐documented aspirin resistance. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization software used for participant allocation into the control or intervention arms. |
Allocation concealment (selection bias) | Low risk | Randomization software used for participant allocation into the control or intervention arms. |
Blinding (performance bias and detection bias) All outcomes | High risk | Prospective randomised study. Single centre without placebo control. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 6‐month follow‐up completed in 107 (97%) participants in aspirin monotherapy group and 112 (98%) in DAPT group. |
Selective reporting (reporting bias) | Low risk | Reported as per protocol. |
Other bias | Unclear risk | No data on funds. |