Yedidya I, Netzer A, Vaduganathan M, et al. Clopidogrel tapering as a strategy to attenuate platelet rebound phenomenon in patients with bare-metal stents. Journal of Thrombosis and Thrombolysis 2012;33:16-21
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/22081256
Full text article: https://link.springer.com/article/10.1007%2Fs11239-011-0652-z
| Methods | Study design: Open-label randomized controlled study with a parallel-design
Number of groups: Two groups |
| Participants | Number of participants: 20 randomized, 20 completed
· Intervention deprescribing group: 10 randomized, 10 completed · Control group: 10 randomized, 10 completed Age, tapering group: 65.9 ± 5.0 Age, abrupt cessation group: 63.2 ± 7.6 Sex: 5 females, 15 males Inclusion criteria: · Patients with coronary artery disease · Underwent percutaneous coronary intervention with bare metal stent placement · Stent surgery was at Rabin Medical Center (Petah-Tikva, Israel) · Treated with clopidogrel 75 mg daily and aspirin 100 mg for 3 months after the intervention and were scheduled to discontinue clopidogrel treatment after 3 months Exclusion criteria: · Required repeat intervention · Specific contraindication to using aspirin or clopidogrel · Concurrent treatment with warfarin · Severe bleeding diathesis · Myocardial infarction (ST-elevated myocardial infarction or non-ST-elevated myocardial infarction) · Thrombocytopenia (\100 9 103 cells/mm3) · Anemia (hemoglobin less than 10 grams/dl) · Renal insufficiency (creatinine[2.5 mg/dl) · History of major comorbid illness that would prevent participation in the full duration of the study Country: Israel Setting: Community |
| Interventions | Medicine: Clopidogrel after 3 months insertion of a bare metal stent
Comparator and withdrawal schedule: Participants were randomized to: 1. Tapering group: a pre-specified tapering regimen over four weeks with clopidogrel 75 mg every other day 2. Abrupt cessation group: immediate discontinuation of clopidogrel “Both groups continued to receive daily treatment of 100 mg aspirin throughout the study period, and afterwards.” |
| Outcomes | Hematological end-points (surrogate end-points) e.g. platelet aggregation
Clinical events (bleeding or Ischemic) |
| Dates | Dates: Not described
Duration: 24 months |
| Funding sources | “Funding: There are no sources of financial support for this research.” |
| Notes | The authors stated: “There are no potential sources of conflict for this research.” |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | Unclear risk | Randomization is stated to have occurred, but not described. |
| Allocation concealment (selection bias) | High risk | The study does not appear to have been blinded or concealed. |
| Blinding of participants and personnel (performance bias) | High risk | The study does not appear to have been concealed. |
| Blinding of outcome assessment (detection bias) | High risk | The study does not appear to have been concealed. |
| Incomplete outcome data (attrition bias) | Low risk | The authors did not report on drop-outs. It appears that this may have been as there were no withdrawals. |
| Selective reporting (reporting bias) | Unclear risk | There was a pre-specified protocolthough it is unclear how closely the researchers adhered to this. All stated outcomes were reported, but it is unclear what the actual pre-specified end-points were.The stated objective was “Accordingly, we aimed to assess the effect of a pre-specified clopidogrel tapering strategy on platelet reactivity in this population.” While this was reported, clinical events were also reported. |
| Other bias | Low risk | No conflicts reported. Other concurrent medications may have had an effect on platelet functions e.g. SSRIs. |
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