Twelve or 30 Months of Dual Antiplatelet Therapy after Drug-Eluting Stents
2014 · paper · Clinical trials
A randomized trial of 9,961 patients after drug-eluting stents, comparing continued thienopyridine with placebo from 12 to 30 months, all on aspirin. Continuing reduced stent thrombosis and major cardiovascular events but increased bleeding.
2 findings
Reference or label The Discussion cites "results from prior studies ... after 6 months, 10-13,23,24", and that range includes ref 13, the DAPT Study's own rationale-and-design paper.
- p. 7 Discussion, paragraph 2
thienopyridine discontinuation after 6 months, 10-13,23,24
- p. 9 Reference 13
Rationale and design of the dual antiplatelet therapy study
- p. 7 Discussion para 2
discontinuation after 6 months, 10-13,23,24
Only the authors can say what is right here.
Judge's note: The page 9 reference list gives ref 13 as "Mauri L, ... Rationale and design of the dual antiplatelet therapy study ... Am Heart J. 2010". Refs 10-12 are prior duration trials (Park, OPTIMIZE, ARCTIC-Interruption). The Introduction cites the comparable trials as 9-12, and elsewhere ref 13 is cited only for design and dosing. A design paper is not a prior study with results on discontinuation risk, so the range probably should read 10-12 or 9-12. Only the authors can confirm which.
Second check: another model agreed
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Reference or label The Table 1 row "Modified ACC/AHA lesion class B2 or C‡" carries a ‡ marker that matches no footnote. The only footnotes are *, **, *** and †.
- p. 15 Table 1, last row, and footnotes
Modified ACC/AHA lesion class B2 or C‡
Judge's note: The page 15 image confirms that no ‡ footnote is printed. The text about missing lesion class (6%) sits in the ** footnote instead.
Second check: another model agreed
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11 minor (typos and the like; most checked by the judge only)
Wording The Methods list the events that excluded subjects from randomization as "major adverse cardiovascular and cerebrovascular events, repeat revascularization, or moderate or severe bleeding". The Discussion lists "major adverse cardiovascular and cerebrovascular events, stent thrombosis or moderate or severe bleeding".
- p. 7 Discussion, limitations paragraph
who did not have major adverse cardiovascular and cerebrovascular events, stent thrombosis or moderate or severe bleeding in the first year were randomized
- p. 3 Methods, Study Procedures
major adverse cardiovascular and cerebrovascular events, repeat revascularization, or moderate or severe bleeding
Judge's note: I checked pages 3 and 7. Figure 1 (page 11) lists both stent thrombosis (108) and revascularization (1620) among the events that made subjects ineligible. So each text passage gives only part of the list, and each leaves out a different item. The criterion is described inconsistently, but the data are not affected.
Second check: another model agreed
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Wording In Table 2a's continued-thienopyridine arm, "ARC definite 15 (0.3%)" plus "ARC probable 5 (0.1%)" is 20, but the stent thrombosis total is "19 (0.4%)". In the placebo arm the parts add up (58+7=65).
- p. 16 Table 2a
ARC definite 15 (0.3%) ... ARC probable 5 (0.1%)
Only the authors can say what is right here.
Judge's note: The page 16 image confirms the values. A subject who had both a probable and a definite event could be counted once in the total and once in each subtype row. Figure 1 has a similar footnote ('Subjects may have >1 event'), but Table 2a gives no such explanation, so the authors should clarify.
Second check: another model agreed
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Typo Harold L. Dauerman's affiliation is tagged "University of Vermont (HD)", but other authors with a middle initial get three letters (e.g. DJK, DEK, DIS, DRH).
- p. 1 Affiliations
University of Vermont (HD)
Judge's note: I checked the page 1 image. The byline prints "Harold L. Dauerman, MD" and the affiliation tag is "(HD)". Other authors with a middle initial get all their initials. The tag is not ambiguous, so this is cosmetic.
Second check: none (judge only)
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Typo The byline gives "Laura Mauri, MD" but the correspondence footnote gives "Laura Mauri, MD, MSc".
- p. 1 Byline
Laura Mauri, MD
- p. 1 Address for correspondence
Laura Mauri, MD, MSc
Judge's note: The page 1 image shows both forms. Journals sometimes list degrees differently in the byline and the footnote, so either form could be legitimate. It is still a minor inconsistency within the document.
Second check: none (judge only)
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Typo There is a stray space before the comma in the affiliation "Paris , INSERM U-1148".
- p. 1 Affiliations
Paris , INSERM U-1148
Judge's note: The page 1 image shows the space before the comma, so it is printed and not an extraction artefact.
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Typo In "Second, while we did not quantify the net impact of ischemic and bleeding events; decision analysis suggests..." the 'while' clause is closed by a semicolon, which leaves a sentence fragment.
- p. 7 Discussion, limitations paragraph
Second, while we did not quantify the net impact of ischemic and bleeding events; decision analysis suggests
Judge's note: The page 7 image shows the wording as quoted. The fix is a comma, or dropping 'while'.
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Typo The Figure 2 legend writes "final 33 month visit" and the Figure 3 legend writes "final 33-month visit".
- p. 12 Figure 2 legend
start of final 33 month visit
- p. 13 Figure 3 legend
start of final 33-month
- p. 12
The numbers at risk at the start of final 33 month visit (i.e. 20 months post randomization)
Judge's note: Both legend images show the difference in hyphenation, which is cosmetic. The second reviewer note (20 vs 21 months) is judged under C010.
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Typo The Figure 2 and 3 legends expand MACCE as "major adverse cerebral and cardiovascular events", while the Figure 3 title and the Table 2a abbreviations use "major adverse cardiovascular and cerebrovascular events".
- p. 13 Figure 3 legend, abbreviations
MACCE, major adverse cerebral and cardiovascular events
- p. 12 Figure 2 legend, abbreviations
adverse cerebral and cardiovascular events
- p. 16 Table 2a abbreviations
MACCE, major adverse cardiovascular and cerebrovascular events
- p. 12 Figure 2 abbreviations
MACCE, major adverse cerebral and cardiovascular events
Judge's note: I checked the images of pages 12, 13 and 16. Both expansions name the same composite, so this is a cosmetic inconsistency.
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Typo The Figure 3 legend contains a stray word: "...stratified log-rank test. Error The number at risk is defined as...".
- p. 13 Figure 3 legend
Error The number at risk is defined as
- p. 13 Figure 3 legend
Error The number at risk is defined as the number of subjects
- p. 13 Figure 3 legend
Error The number at risk is defined
Judge's note: The page 13 image shows 'Error' printed in the legend. The otherwise identical Figure 2 legend on page 12 does not have it, so it is an editing remnant and not an extraction artefact.
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Typo Table 1 prints the unit as "BMI (Kg/m2 )" but the row above has "Weight (kg)". The correct symbol is lowercase 'kg'.
- p. 14 Table 1, BMI row
BMI (Kg/m2 )
Judge's note: The page 14 image shows both rows as quoted.
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Typo Table 2b caption: 'Only evaluable subjects were included in this analysis, e.g. subjects whose last contact date was ≥510 days post randomization or who experienced any adjudicated bleeding outcome...' – clause is a definition, so 'i.e.' appears intended.
- p. 17 Table 2b caption
Only evaluable subjects were included in this analysis, e.g. subjects whose last contact date was
Judge's note: Checked the upright image of p17. The clause after 'e.g.' reads as the complete definition of an evaluable subject, so 'i.e.' would be the usual form. This is a cosmetic wording point and does not affect any number.
Second check: none (judge only)