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Copyright ©The Author(s) 2017.
World J Cardiol. Jul 26, 2017; 9(7): 583-593
Published online Jul 26, 2017. doi: 10.4330/wjc.v9.i7.583
Table 1 Results of clinical trials initially designed for patients with coronary artery disease, with subgroup analysis in peripheral arterial disease
Clinical trialNo. of patientsPatient populationDrugs studiedPrimary end pointOutcomes
PEGASUS TIMI-54 subgroup analysis[40] (2016)1143CAD and concomitant PADTicagrelor 90 mg BID + aspirin vs Ticagrelor 60 mg BID + aspirin vs Placebo + aspirinCardiovascular death, MI and stroke Acute limb ischemia and peripheral revascularization for ischemia15.2% in ticagrelor (pooled group) and 19.3% in placebo. ARR 4.1% in ticagrelor (pooled group) 60 mg dose more beneficial (ARR of 5.2%) 0.46% in ticagrelor (pooled group) and 0.71% in placebo (HR 0.65; 95%CI: 0.44-0.95; P = 0.026)
PLATO-subgroup analysis[32] (2015)1144CAD and concomitant PADTicagrelor vs clopidogrelCardiovascular death, MI and stroke18% in ticagrelor group and 20.6% in clopidogrel group (HR: 0.85; 95%CI: 0.64–1.11; P =0.99)
TRA 2P-TIMI 50[35] (2012)26449Previous history of MI or ischemic stroke within the previous 2 wk-12 mo or PADVorapaxar vs placeboCardiovascular death, MI, and stroke9.3% in vorapaxar group and 10.5% in placebo (P < 0.001) Subgroup analysis in PAD patients showed no difference between groups for the primary endpoint Rate of intracranial hemorrhage (1% vorapaxar vs 0.5% placebo; P < 0.001)
CHARISMA[38] (2006)15603Patients with either clinically documented vascular disease or risk factors for atherothrombotic diseaseAspirin plus clopidogrel vs aspirin monotherapyMI, stroke or cardiovascular death6.8% in clopidogrel plus aspirin group and 7.3% in aspirin group (P = 0.22) Subgroup analysis in PAD patients: no benefit was derived from dual antiplatelet therapy
CAPRIE[15] (1996)19185Recent MI, recent ischemic stroke or symptomatic PADAspirin vs clopidogrelMI, stroke and vascular deathRRR of 8.7% clopidogrel group (P = 0.043; 95%CI: 0.3-16.5) Subgroup analysis in PAD patients: 23.8% RRR in clopidogrel over aspirin (P = 0.0028; 95%CI: 8.9-36.2)