Table 1.
Exclusion rates by subgroup, stratified by study eraa
| Variable | Contemporary Era (2006–2014), No. (%) | Prior Era (1985–2005b), No. (%) | P Value | ||
|---|---|---|---|---|---|
| Trials | Explicit Exclusion of KD, Trials | Trials | Explicit Exclusion of KD, Trials | ||
| Overall | 305 (100) | 139 (46) | 153 (100) | 86 (56) | 0.04 |
| Trial enrollment no. of patients | |||||
| 100–499 | 114 (37) | 56 (49) | 40 (26) | 15 (38) | 0.20 |
| 500–999 | 65 (21) | 29 (45) | 23 (15) | 14 (61) | 0.23 |
| ≥1000 | 126 (41) | 55 (44) | 90 (59) | 57 (63) | <0.01 |
| Sites | |||||
| Single center | 25 (8) | 13 (52) | 15 (10) | 3 (20) | 0.06 |
| Multicenter | 280 (92) | 126 (45) | 138 (90) | 83 (60) | 0.01 |
| Locationc | |||||
| United States/Canada | 32 (10) | 13 (41) | 64 (42) | 48 (75) | <0.01 |
| Europe | 123 (40) | 55 (45) | 77 (50) | 28 (36) | 0.76 |
| Asia/Australia/other | 21 (7) | 8 (38) | 12 (8) | 10 (83) | 0.03 |
| Therapeutic class | |||||
| Thrombolytic | 3 (1) | 1 (33) | 27 (18) | 9 (33) | >0.99 |
| PCI | 89 (29) | 26 (29) | 31 (20) | 11 (35) | 0.51 |
| Device (AICD/pacer) | 25 (8) | 4 (16) | 7 (5) | 3 (43) | 0.16 |
| RAAS inhibitor | 12 (4) | 10 (83) | 31 (20) | 29 (94) | 0.31 |
| β blocker | 3 (1) | 0 (0) | 13 (8) | 7 (54) | 0.21 |
| Antiplatelet agent | 46 (15) | 24 (52) | 14 (9) | 5 (36) | 0.37 |
| Anticoagulants | 31 (10) | 23 (74) | 12 (8) | 11 (92) | 0.41 |
| Statins | 8 (3) | 5 (63) | 7 (5) | 5 (71) | >0.99 |
| Non-RAAS modulation | 293 (96) | 129 (44) | 122 (80) | 57 (47) | 0.67 |
| Funding source | |||||
| Industry | 168 (55) | 86 (51) | 87 (57) | 54 (62) | 0.11 |
| Government (NIH/VA) | 27 (9) | 11 (41) | 31 (20) | 14 (45) | 0.80 |
| Combination | 58 (19) | 22 (38) | 17 (11) | 11 (65) | 0.06 |
| Not specified | 25 (8) | 13 (52) | 18 (12) | 7 (39) | 0.54 |
| Journal | |||||
| NEJM | 60 (20) | 30 (50) | 59 (39) | 38 (64) | 0.14 |
| JAMA | 39 (13) | 17 (44) | 12 (8) | 6 (50) | 0.75 |
| Lancet | 34 (11) | 10 (29) | 48 (31) | 23 (48) | 0.11 |
| Circulation | 33 (11) | 15 (46) | 12 (8) | 10 (83) | 0.04 |
| JACC | 57 (19) | 23 (40) | 11 (7) | 2 (18) | 0.19 |
| Am. Heart Journal | 17 (6) | 4 (24) | 6 (4) | 6 (100) | <0.01 |
| Euro. Heart Journal | 37 (12) | 24 (65) | 5 (3) | 1 (20) | 0.14 |
| Annals of IM | 2 (1) | 1 (50) | 0 | 0 | >0.99 |
| Diagnostic category | |||||
| AMI/ACS | 208 (68) | 92 (44) | 117 (76) | 58 (50) | 0.36 |
| CHF | 57 (19) | 29 (51) | 36 (24) | 28 (78) | 0.02 |
P values represent comparisons across groups. P value calculated using number of trials excluding KD not total trials. PCI, percutaneous coronary intervention; AICD, automated implantable cardioverter-defibrillator; NIH/VA, National Institute of Health/Veterans Affairs; NEJM, New England Journal of Medicine; JAMA, Journal of the American Medical Association; Am. Heart Journal, American Heart Journal; Euro. Heart Journal, European Heart Journal; Annals of IM, Annals of Internal Medicine; AMI, acute myocardial infarction; ACS, acute coronary syndromes; CHF, congestive heart failure.
Only comparable data were included.
Data from the 1985–2005 era were adopted from the study by Coca et al.5
United States/Canada versus Europe used in chi-squared analysis.