Table 1.
Trial and Baseline Patient Characteristics, and Interventions
| Patients Randomised Post Elective CABG | Patients Randomized with ACS or symptomatic CAD - CABG Subgroup | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Clopidogrel 300 then 75 mg/d vs placebo | Clopidogrel 75 mg/d | Clopidogrel 75 mg/d vs placebo | Clopidogrel 75 mg/d | Clopidogrel 75 mg/d | Clopidogrel 300 then 75 mg/d vs placeboa | Clopidogrel 300 then 75 mg/d vs placebo | Ticagrelor 180 then 90 mg bid vs Clopidogrel 300 then 75 mg/d | Prasugrel 60 then 10 mg/d vs Clopidogrel 300 then 75 mg/d | |
| ASA Dose (mg/d) | 325 then 81 | 100 | 162 | 100 | 300 | 325 | 75-325 | 75-100 | 75-162 |
| Trial | Sun et al. [16] | Gao et al. [15] | CASCADE [21] | CRYSSA [22] | Gasparovic [23] | CREDO [18] | CURE [19] | PLATO [17] | TRITON- TIMI 38 [11] |
| n = CABG/total patients | n = 100/100 | n = 249/249 | n = 113/113 | n = 300/300 | n = 224/224 | n = 83/2116 | n = 2072/12562 | n = 1261 (1899)/18624 | n = 346 (485)/13608 |
| Trial Characteristics | |||||||||
| No. of Centres | 1 | 1 | 2 | 1 | 1 | 99 | 428 | 862 | 707 |
| Enrolment period | Nov 2006 – Feb 2008 | Dec 2007 – Dec 2008 | May 2006 – Jul 2008 | Dec 2006 – Oct 2009 | Jun 2010 – Feb 2013 | Jun 1999 – Apr 2001 | Dec 1998 – Sep 2000 | Oct 2006 – Jul 2008 | Nov 2004 – Jan 2007 |
| Treatment/Follow Up Post Randomization | 30 (all)/49 (median) d | 3 months (all) | 12 months (all) | 12 months (all) | 6 months (all) | 12 months (all) | 9 months (mean) | 224 days [7.5 months] (median) | 14.5 months (median) |
| Median Time to CABG Post Randomization | (Randomized At Time of CABG) | n/r (index CABG instead of PCI) | 25.5 days (IQR 12–70.5) | ~20 days | 100 days [50] | ||||
| Treatment/Follow Up Post CABG | 30 (all)/49 (median) d | 3 months (all) | 12 months (all) | 12 months (all) | 12 months (all) | ~12 months (all) | ~8 months (mean) | ~200 days [6.7 months] (median) | ~11.2 months (median) |
| Funding | Public/ Industry | Public | Public/Industry | n/r | n/r | Industry | Industry | Industry | Industry |
| Patients | n = 99 | n = 224 | n = 113 | n = 300 | n = 219 | n = 83 | n = 2072 | n = 1261 | n = 346 |
| Mean Age (years) | 65 | 59 | 67 | 59 | 65 | 61 | 64 | 64 | 61 |
| % Male | 90 | 83 | 89 | 74 | 75 | 74 | 70 | 79 | 77 |
| BMI | 31 | 26 | 28 | 26 | 29 | 29 | 27 | n/r (28b) | |
| Diabetes | 35 % | 40 % | 29 % | 0 % (excl) | 38 % | 22 % | 27 % | 32 % | 28 % |
| Hypertension | 70 % | 59 % | 50 % | 46 % | 96 % | 75 % | 61 % | 68 % | 64 % |
| Smoker | 59.6 % (current/ former) | 55.8 % (history of) | 13.2 % | n/r | 36 % | 33 % (within 1 year) | 64.5 % (current /former) | 31.2 % | n/r (38 %b) |
| COPD | n/r | n/r | 8.1 % | ||||||
| Dyslipidemia | 76 % | 38 % | 88 % | 56 % | 96 % | 71 % | n/r | 54 % | n/r (56 %b) |
| Prev MI | 39 % | 47 % | n/r | 36 % | n/r | 37 % | 36 % | 20 % | n/r (18 %b) |
| Prev stroke/TIA | 5.1 % | 4.9 % | n/r | n/r | n/r | n/r | 3.9 % | 3.9 %/3.1 % | 7.8 % |
| Periph Vasc Dz | 5.1 % | n/r | n/r | n/r | n/r | 6.2 % | 9.7 % | 7.6 % | 7.0 % |
| Chronic Renal Disease | excl Cr >130 μM | n/r | n/r | excl Cr >177 μM | n/r | n/r | n/r | 4.8 % | n/r (11 % CrCl < 60 mL/minb) |
| Mean LVEF | n/r | 60 % | 54 % | 54 % | 53 % | ||||
| CHF | 0 % (excl) | 20.3 % | n/r | n/r | 7.3 % | 4.1 % | 10.7 % | ||
| Severe LV dysfunction | 38 %(Gr 3 LV) | 0 % (excl) | n/r | n/r | n/r | n/r | Excluded | 3.9 % (EF ≤ 30 %) | |
| 1 % (Gr 4 LV) | |||||||||
| Previous PCI | n/r | 13 % | 16 % | n/r | 17 % | 7.4 % | 10 % | n/r | |
| Previous CABG | n/r | 0 % (excl) | 0 % (excl) | n/r | n/r | 8.5 % | 4.6 % | 1.5 % | 2.9 % |
| 3VD | 54 % | n/r | 77 % | n/r | |||||
| LM | 24.2 % | n/r | 48 % | n/r | |||||
| ST depression | 54.2 % | ||||||||
| ST elevation | 2.7 % | 33.0 % (persistent) | |||||||
| Abnormal ECG | 95.2 % | ||||||||
| Diagnosis: UA | 73.9 % | 64.1 % (UA/NSTEMI) | |||||||
| Diagnosis: MI | 26.1 % (all NSTEMI) | 35.9 % (STEMI) | |||||||
| Abnormal ECG/enzymes | 97.7 % | ||||||||
| CABG | |||||||||
| % Off-pump CABG | 0 % | 58.0 % | 3.6 % | 100 % | 0 % | ||||
| % arterial conduits | 100 % | 100 % | 100 % | 100 % | 93 % | ||||
| Grafts or adiseased vessels | 4.0 | 3.1 | 3.5 ± 0.7 | 3.2 ± 0.6 | n/r | 1–2 (31 %) | a1 (14.4 %) | ||
| 3–4 (60 %) | a2 (61.5 %) | ||||||||
| ≥5 (8 %) | a3 (20.5 %) | ||||||||
| Median (IQR) days to CABG (all) | 25.5 (12–70.5) | ~20 | 100(36) | ||||||
| CABG pre-d/c | 49 % | 57 % | 4.3 % | ||||||
| Median (IQR) days to CABG pre-d/c | 13 (8–21) vs 12 (8–19) | ||||||||
| CABG post-d/c | 51 % | 43 % | 95.7 % | ||||||
| Median (IQR) days to CABG post d/c | 67.5 (38–141) vs 73 (36–129) | ||||||||
| Days off study drug before CABG | 17 (9–33) | ≤2d (30.1 %) 3-5d (43.8 %) >5 (26.1 %) | ≤2d (25.1 %) 3-5d (29.0 %) >5 (45.4 %) | ||||||
| Restarted treatment post CABG | 76.1 % (66 never discontinued + 1451 resumed/1928; 78 data unavailable) | 66.4 % | 61.8 % (214/346); additional 21/173 prasugrel and 16/173 clopidogrel patients resumed open label clopidogrel | ||||||
| Days off study drug after CABG | 10 (6–25) | <7d (35.9 %) | n/r | ||||||
| 7–14(16.8 %) | |||||||||
| >14d (10.0 %) | |||||||||
aIn CREDO, both groups receive clopidogrel 75 mg/day for 28 days before control group changed to placebo from day 29 through 12 months
bProportion of all 13,608 randomized patients when data not provided for CABG subgroup in TRITON-TIMI 38
Abbreviations: ACS acute coronary syndrome, ASA acetylsalicylic acid (aspirin), BMI body mass index, CABG coronary artery bypass grafting, CAD coronary artery disease, CHF congestive heart failure, COPD chronic obstructive pulmonary disease, d/c (hospital) discharge, DM diabetes mellitus, Dx diagnosis, Dz disease, ECG electrocardiogram, EF ejection fraction, excl excluded, incl included, IQR inter-quartile range, LM left main artery disease, LV left ventricle, mg milligram, MI myocardial infarction, mM millimolar, n number of patients, no. number, n/r not reported, PCI percutaneous coronary intervention, periph peripheral, prev previous, pts patients, Rx treatment, sd standard deviation, TIA transient ischemic attack, vasc vascular, 3VD triple vessel disease, UA unstable angina, vasc vascular