Dabigatran versus Warfarin in Patients with Atrial Fibrillation
2009 · paper · Clinical trials
A randomized noninferiority trial of two dabigatran doses versus warfarin in 18,113 patients with atrial fibrillation. The 110 mg dose matched warfarin for stroke prevention with less major bleeding; the 150 mg dose lowered stroke and embolism with similar major bleeding.
3 findings
Substance Figure 2 Region rows print South America "1,134" and South Asia "1,134"; the seven regions sum to 18,291, more than the 18,113 patients in all.
- p. 11 Figure 2, Region rows, Patients total no.
1,134
- p. 11 Figure 2, All patients
18,113
- p. 11 Figure 2, Region rows
South Asia 1,134 (also South America 1,134)
- p. 11 Figure 2, Region rows (Patients, total no.)
South America 1,134
Only the authors can say what is right here.
Judge's note: In the page 11 image every other subgroup set sums to 18,113 or less (e.g., sex 11,514+6,598 = 18,112). The region counts sum to 18,291, an excess of 178. The South America square is drawn much smaller than the 1,072-patient 'Other' square, although the legend says square size is proportional to subgroup size. This suggests the South America count is wrong (a likely value is 956). Only the authors can supply the correct figure.
Second check: another model agreed
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Reference or label Table 1 footnote § ('Long-term therapy with a vitamin K antagonist (VKA) denotes...') has no § marker in the table; the row reads "Long-term VKA therapy" with no symbol.
- p. 5 Table 1, row 'Long-term VKA therapy' and footnote §
Long-term VKA therapy
Judge's note: In the page 5 image, *, † and ‡ all appear in the table (title, CHADS2 score, Statin). The 'Long-term VKA therapy' row has no § mark, so footnote § is not linked to any row.
Second check: another model agreed
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Wording Discussion: "the rate of this complication with both doses of dabigatran was less than one third the rate with warfarin", yet Table 3 gives intracranial bleeding of 0.30 vs 0.74 %/yr (RR 0.40) for 150 mg.
- p. 10 Discussion, paragraph 3
was less than one third the rate with warfarin
- p. 8 Table 3, Intracranial bleeding
0.40 (0.27–0.60)
- p. 10 Discussion, para 3
with both doses of dabigatran was less than one third the rate with warfarin
- p. 10 Discussion
less than one third the rate with warfarin
Only the authors can say what is right here.
Judge's note: Page 10: the antecedent of 'this complication' is 'intracranial hemorrhage, especially hemorrhagic stroke' and 'warfarin doubles the risk of intracranial hemorrhage'. Table 3 (page 8, upright) gives intracranial bleeding RR 0.31 for 110 mg and 0.40 for 150 mg, and 0.40 is above one third. The claim holds for hemorrhagic stroke (RR 0.31 and 0.26 in the Results), so the sentence holds only if 'this complication' means hemorrhagic stroke. The wording is ambiguous or overstated for the 150-mg dose.
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6 minor (typos and the like; most checked by the judge only)
Reference or label "The rate of major bleeding with warfarin was higher in our study than in some previous trials.11,13,14" cites ref 13, 'Effect of clopidogrel added to aspirin in patients with atrial fibrillation'.
- p. 10 Discussion, paragraph 3
in our study than in some previous trials.11,13,14
- p. 13 Reference 13
Effect of clopidogrel added to aspirin in patients with atrial fibrillation
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: that ACTIVE A (ref 13) had no warfarin arm, which its title (clopidogrel added to aspirin) implies. The Discussion also cites ref 13 for 'more effective than aspirin alone'. It is unclear how ref 13 supports a statement about warfarin bleeding rates, unless it is cited for the bleeding definition. The authors should confirm.
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Typo Table 1, warfarin, persistent AF: "1930/6021 (32.0)"; 1930/6021 = 32.05%, which rounds to 32.1.
- p. 5 Table 1, Type of atrial fibrillation, Persistent, Warfarin
1930/6021 (32.0)
Judge's note: Checked on the page 5 image. 1930/6021 = 32.0545%, which is just above the 32.05 tie, so it rounds to 32.1. The same column rounds elsewhere (2036/6021 = 33.815 is printed 33.8). As printed, the warfarin AF-type percentages add to 99.9 (32.0+33.8+34.1) although the counts add exactly to 6021. This is a rounding slip of 0.1 point.
Second check: none (judge only)
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Typo Table 1, dabigatran 110 mg, permanent AF: "2132/6011 (35.4)"; 2132/6011 = 35.47%, which rounds to 35.5.
- p. 5 Table 1, Type of atrial fibrillation, Permanent, Dabigatran 110 mg
2132/6011 (35.4)
Judge's note: Checked on the page 5 image. 2132/6011 = 35.468%, which rounds to 35.5. Truncation is unlikely because the same column rounds elsewhere: 1929/6011 = 32.09 is printed 32.1. The counts 1950+1929+2132 = 6011 are exact, but the printed percentages add to 99.9.
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Typo Reference 16 first author printed "Deiner HC"; the byline and appendix spell the coauthor 'Diener' (Hans-Christoph Diener; H.C. Diener).
- p. 13 Reference 16
Deiner HC
- p. 13 Reference 16
Deiner HC, Executive Steering Com-mittee
- p. 13 Reference 16
Deiner HC, Executive Steering Com-
Judge's note: The page 13 image shows 'Deiner HC'. The byline (line 14) and appendix (line 1591) spell it Diener.
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Typo Reference 16 prints "SPORTIFF III and V Investigators" but later in the same entry "SPORTIF III and V studies".
- p. 13 Reference 16
SPORTIFF III and V Investi-gators
- p. 13 Reference 16
mittee of the SPORTIFF III and V Investi-gators
Judge's note: The page 13 image shows the double F in the first instance and a single F later in the same reference. The first is a misspelling.
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Typo Reference 2 title: "Management of Patients with Arial Fibrillation" should read 'Atrial'.
- p. 13 Reference 2
Patients with Arial Fibrilla-tion
- p. 13 Reference 2
agement of Patients with Arial Fibrilla-tion
- p. 13 Reference 2
agement of Patients with Arial Fibrilla-
- p. 13
Management of Patients with Arial Fibrilla-
Judge's note: The page 13 image shows 'Arial Fibrilla-tion' in ref 2, which is a misspelling of Atrial.
Second check: none (judge only)