Introduction
Methods
Electronic Databases
Search Terms/Phrases and Mode of Search
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Cangrelor, clopidogrel and percutaneous coronary intervention/PCI
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Cangrelor, clopidogrel and diabetes mellitus
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Newer antiplatelets and percutaneous coronary intervention/PCI
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Cangrelor, clopidogrel and coronary angioplasty
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Cangrelor and diabetes mellitus
Inclusion and Exclusion Criteria
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Randomized controlled trials comparing cangrelor versus clopidogrel in patients undergoing PCI
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Trials which also included patients with T2DM
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Trials whereby efficacy and bleeding outcomes were reported
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Trials that reported outcomes at 48 h after PCI
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Observational studies (retrospective and prospective studies, reports, case studies)
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Meta-analyses and literature reviews as well as systematic reviews
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Studies that did not include participants with T2DM for extraction
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Studies that did not report the expected efficacy and bleeding events
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Repeated studies
Data Extraction and Quality Assessment
Statistical Analysis
Compliance with Ethics Guidelines
Results
Search Outcomes
General Properties of the Trials
Trials | Time period of patients’ enrollment | No. of T2DM participants assigned to cangrelor (n) | No. of T2DM participants assigned to clopidogrel (n) | Total no. of T2DM participants per trial (n) |
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CHAMPION PCI [4] | 2006–2009 | 1334 | 1331 | 2665 |
CHAMPION PHOENIX [5] | 2010–2012 | 330 | 359 | 689 |
CHAMPION PLATFORM [6] | 2006–2009 | 815 | 862 | 1677 |
Outcomes Reported in Each Trial
Trials | Type of participants | Outcomes reported | Follow-up time period |
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CHAMPION PCI [4] | T2DM patients with and without STEMI | Primary end point: composite of death, MI, and revascularization; MI, ischemia-driven revascularization, death from any cause, stent thrombosis, stroke, access site bleeding requiring radiological or surgical intervention, hematoma at puncture site ≤ 5 cm or > 5 cm, intracranial hemorrhage, intraocular hemorrhage, bleeding requiring surgery, retroperitoneal hemorrhage, ecchymosis, epistaxis, oozing at puncture site, thrombocytopenia, any blood transfusion, any platelet transfusion, ACUITY-defined minor and major bleeding, GUSTO mild, moderate, and severe bleeding, TIMI-defined major and minor bleeding | 48 h after PCI |
CHAMPION PHOENIX [5] | T2DM patients with stable coronary artery disease or acute coronary syndrome | Primary end point: composite of death, MI, ischemia-driven revascularization, or stent thrombosis; MI, stent thrombosis, ischemia-driven revascularization, death from any cause, non-CABG-related bleeding, GUSTO-defined mild, moderate, and severe bleeding, TIMI-defined minor and major bleeding, ACUITY-defined major bleeding, any blood transfusion | 48 h after PCI |
CHAMPION PLATFORM [6] | T2DM patients without STEMI or T2DM patients with unstable angina | Primary end point: composite of death, MI, and revascularization; MI, ischemia-driven revascularization, death from any cause, stent thrombosis, access site bleeding requiring radiological or surgical intervention, hematoma at puncture site: ≤ 5 cm or > 5 cm, intracranial hemorrhage, intraocular hemorrhage, bleeding requiring surgery, retroperitoneal hemorrhage, ecchymosis, epistaxis, oozing at puncture site, thrombocytopenia, any blood transfusion, any platelet transfusion, ACUITY-defined minor and major bleeding, GUSTO mild, moderate, and severe bleeding, TIMI-defined major and minor bleeding | 48 h after PCI |
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Primary end points including composites of death, myocardial infarction (MI), ischemia-driven revascularization, and/or stent thrombosis
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MI
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Death of any cause
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Ischemia-driven revascularization
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Stent thrombosis
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Access site bleeding requiring radiological or surgical intervention
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Hematoma at puncture site ≤ 5 cm or > 5 cm
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Intracranial hemorrhage
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Intraocular hemorrhage
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Bleeding requiring surgery
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Retroperitoneal hemorrhage
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Ecchymosis
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Epistaxis
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Oozing at puncture site
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Thrombocytopenia
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Any blood transfusion
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ACUITY (acute catheterization and urgent intervention triage strategy)-defined minor and major bleeding [9]
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GUSTO (global use of strategies to open occluded arteries) mild, moderate and severe bleeding [9]
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TIMI (thrombolysis in myocardial infarction)-defined major and minor bleeding [9]
Baseline Features of the Participants
Trials | Age (years) | Male (%) | Family history of CAD (%) | Smoking history (%) | Stable angina (%) |
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CA/CL | CA/CL | CA/CL | CA/CL | CA/CL | |
CHAMPION PCI [4] | 62.0/62.0 | 73.9/72.2 | 45.9/46.5 | 28.5/29.1 | 15.1/15.0 |
CHAMPION PHOENIX [5] | 64.0/64.0 | 72.5/71.9 | – | 25.4/25.7 | 69.4/63.4 |
CHAMPION PLATFORM [6] | 63.0/63.0 | 71.9/70.4 | 36.4/35.9 | 31.9/30.3 | 5.20/5.30 |
Results of This Analysis
Outcomes which were assessed | OR [95% CI] | P value | I2 value (%) |
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Primary end point | 0.94 [0.75–1.16] | 0.55 | 0 |
Myocardial infarction | 0.96 [0.76–1.20] | 0.71 | 0 |
Death of any cause | 0.70 [0.25–1.96] | 0.49 | 0 |
Ischemia-driven revascularization | 0.66 [0.32–1.36] | 0.26 | 0 |
Stent thrombosis | 0.45 [0.17–1.17] | 0.10 | 0 |
Assess site bleeding requiring radiological or surgical intervention | 0.68 [0.19–2.43] | 0.56 | 0 |
Hematoma at puncture site ≤ 5 cm | 1.21 [0.86–1.71] | 0.28 | 0 |
Hematoma at puncture site > 5 cm | 1.26 [0.95–1.68] | 0.11 | 22 |
Intracranial hemorrhage | 1.72 [0.23–13.06] | 0.60 | 0 |
Intraocular hemorrhage | 3.00 [0.12–73.60] | 0.50 | – |
Bleeding requiring surgery | 1.03 [0.14–7.30] | 0.98 | 0 |
Retroperitoneal hemorrhage | 1.52 [0.43–5.39] | 0.52 | 0 |
Ecchymosis | 1.32 [1.00–1.75] | 0.05 | 0 |
Epistaxis | 0.46 [0.16–1.33] | 0.15 | 0 |
Thrombocytopenia | 1.02 [0.21–5.05] | 0.98 | 0 |
Any blood transfusion | 1.22 [0.68–2.18] | 0.51 | 0 |
ACUITY-defined major bleeding | 1.43 [1.05–1.94] | 0.02 | 0 |
ACUITY-defined minor bleeding | 1.23 [1.04–1.46] | 0.02 | 0 |
GUSTO-defined mild bleeding | 1.28 [1.09–1.50] | 0.003 | 9 |
GUSTO-defined moderate bleeding | 1.36 [0.70–2.67] | 0.37 | 0 |
GUSTO-defined severe bleeding | 1.21 [0.41–3.59] | 0.74 | 0 |
TIMI-defined major bleeding | 1.02 [0.38–2.74] | 0.96 | 0 |
TIMI-defined minor bleeding | 1.39 [0.70–2.79] | 0.35 | 0 |