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Initial Invasive or Conservative Strategy for Stable Coronary Disease

New England Journal of Medicine, 2020 · paper · Clinical trials

A randomized trial of 5179 patients with stable coronary disease and moderate or severe ischemia, comparing an initial invasive strategy with medical therapy alone. Over a median 3.2 years, it found no evidence the invasive strategy reduced ischemic events or death; results depended on how heart attack was defined.

5 findings

Substance In Table 1, the Hispanic or Latino Total cell prints "4815 (15.8)". 4815 is the denominator (2402+2413), and the numerator 763 (372+391) is missing, so the cell reads as if 4815 patients were Hispanic.
  • p. 22 Table 1, Hispanic or Latino row, Total column
    4815 (15.8)

Judge's note: The upright page 22 image confirms the cell. Every other cell in the block uses no./total no. (%). 763/4815 = 15.85%, which matches the printed 15.8. The intended cell is '763/4815 (15.8)'.

Second check: another model agreed

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Reference or label Page 5: "We also estimated the difference in restricted mean event-free time over 5 years.18,19" cites refs 18 (Keeley, primary angioplasty vs thrombolysis in acute MI) and 19 (Fox, routine vs selective invasive strategy in NSTE-ACS). These are clinical ACS meta-analyses, not sources for the restricted-mean method.
  • p. 5 Statistical Analysis, paragraph 2
    We also estimated the difference in restricted mean event-free time over 5 years.18,19
  • p. 16 References 18 and 19
    Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy
  • p. 8 Discussion, limitations
    The findings do not apply to patients with acute coronary syndromes,18,19
  • p. 5 Statistical Analysis
    restricted mean event-free time over 5 years.18,19

Judge's note: The page 5 image shows superscript 18,19 on the restricted-mean sentence. The page 16 reference list shows refs 18 and 19 as the ACS/MI clinical meta-analyses. The same 18,19 are cited on page 8 for 'acute coronary syndromes', where they fit. A search of the text found no methodological reference for restricted mean survival time. The Methods citation appears to point at the wrong entries.

Second check: another model agreed

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Reference or label G.B.J. Mancini's affiliation reads "Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver, Canada". The '(G.G.)' tag marks Gosselin's institution, which has been merged into Mancini's entry.
  • p. 9 Author list, G.B.J. Mancini
    Montreal Heart Institute Research Center, Montreal (G.G.), and the University of
  • p. 12 Affiliations list
    Montreal Heart Institute Research Center, Montreal (G.G.), and the University of

Judge's note: The page 9 image shows this text. In the text layer, G. Gosselin is listed separately with 'Montreal Heart Institute Research Center, Montreal'. The initials tag points to the affiliation footnote of the original journal version, so Mancini's own entry should be the University of British Columbia.

Second check: another model agreed

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Reference or label The affiliation "Cleerly the Cardiovascular Research Foundation, New York" fuses two organisations and is assigned to J.K. Min, Z.A. Ali and G.W. Stone.
  • p. 9 Author list, J.K. Min
    Cleerly the Cardiovascular Research Foundation, New York
  • p. 10 Author list, Z.A. Ali
    Cleerly the Cardiovascular Research Foundation, New York
  • p. 11 Author list, G.W. Stone
    Cleerly the Cardiovascular Research Foundation, New York

Only the authors can say what is right here.

Judge's note: The page 9 image shows the fused string, and the text layer repeats it for Ali (p10) and Stone (p11). The disclosures name Cleerly separately as a company in which Dr. Min holds equity, so Cleerly and the Cardiovascular Research Foundation are separate entities. The string looks like an affiliation-tag conversion error. Only the authors can say which institution belongs to which author.

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Wording In Figure 1, "3339 Were excluded" is broken down as 1350 + 1218 + 434 = 3002, leaving 337 excluded patients with no listed reason and no 'other' category.
  • p. 17 Figure 1, exclusion box
    3339 Were excluded

Only the authors can say what is right here.

Judge's note: The page 17 image confirms the box contents. The total matches 8518 − 5179. A text search found no 'other reasons' category in the figure, the legend or the text. Overlapping reasons would push the sum above the total, not below it. Either a category is missing or a count is misprinted; only the authors can say which.

Second check: another model agreed

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10 minor (typos and the like; most checked by the judge only)
Wording Page 5: "83 mg per deciliter (2.2 mmol per liter)". With the standard LDL factor, 83 mg/dL converts to 2.15 mmol/L, which rounds to 2.1, not 2.2. The companion value "64 mg per deciliter (1.7 mmol per liter)" converts consistently.
  • p. 5 Results, Baseline Characteristics paragraph
    83 mg per deciliter (2.2 mmol per liter)

Only the authors can say what is right here.

Judge's note: Rests on outside knowledge: the LDL cholesterol conversion factor of 38.67 mg/dL per mmol/L. The page 5 image confirms the printed values. 83/38.67 = 2.146, which sits close to the 2.15 rounding boundary. The paper may have taken the median in mmol/L directly from source data, so only the authors can say. Treated as a query, not a definite error.

Second check: another model agreed

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Typo Page 2: "treated with guide-line-based medical therapy" has a stray hyphen; it should read "guideline-based".
  • p. 2 first paragraph
    guide-line-based medical therapy

Judge's note: The page 2 crop shows 'guide-line-based' in the middle of a line, so it is not a line-break hyphen. Cosmetic.

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Typo The Results subheading on page 5 is misspelled: "BASEUNE CHARACTERISTICS AND MEDICAL THERAPY" should read "BASELINE".
  • p. 5 Results subsection heading
    BASEUNE CHARACTERISTICS AND MEDICAL THERAPY

Judge's note: The page 5 image shows 'BASEUNE' as printed.

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Typo Page 6: "4.8% in the invasive-strategy group and 2.9% the conservative-strategy group" is missing 'in' before 'the conservative-strategy group'.
  • p. 6 Secondary Outcomes, paragraph 1
    2.9% the conservative-strategy group

Judge's note: The page 6 image shows the missing word.

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Typo Dr. Goodman's disclosure reads "Bristol Myers Sqiubb–Pfizer"; it should be 'Squibb'.
  • p. 14 Disclosures, Dr. Goodman
    Bristol Myers Sqiubb–Pfizer

Judge's note: The page 14 image shows 'Sqiubb'. The same company is spelled 'Squibb' elsewhere in the disclosures.

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Typo Dr. White's disclosure reads "Medical, Acetelion, and Genentech"; the company name is presumably 'Actelion'.
  • p. 14 Disclosures, Dr. White
    Medical, Acetelion, and Genentech
  • p. 14 Disclosures, Dr. White
    Acetelion

Only the authors can say what is right here.

Judge's note: Rests on outside knowledge: the pharmaceutical company is spelled Actelion. The page 14 image shows 'Acetelion'.

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Typo The Acknowledgments print "Clinical and Translational Science Awards (11UL1 TR001445 and UL1 TR002243)" with a stray '11' before the first award number.
  • p. 14 Acknowledgments
    11UL1 TR001445

Judge's note: The page 14 image shows '11UL1 TR001445' in the same font as the surrounding text. The second award is printed 'UL1 TR002243', so the prefix is inconsistent.

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Typo Dr. Ferguson's disclosure, "Dr. Ferguson, fees for serving as founder and chief medical officer of RFPi", lacks the verb 'receiving' used in every other entry.
  • p. 15 Disclosures, Dr. Ferguson
    Dr. Ferguson, fees for serving as founder and chief medical officer of RFPi

Judge's note: The page 15 image shows the text as quoted. Cosmetic.

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Typo The disclosures spell the company "Heart-Flow" for Dr. Berman but "HeartFlow" for Dr. Mark and Dr. Stone.
  • p. 15 Disclosures, Dr. Berman
    Heart-Flow
  • p. 15 Disclosures, Dr. Mark
    HeartFlow, Merck

Judge's note: The page 15 image shows 'Heart-Flow' at the start of a line, within a single line. It is probably a line-break hyphen left over from the original typesetting. A cosmetic inconsistency only.

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Typo Table 2, death from any cause, at 6 mo: the estimated difference is printed as "0.4 (−0 to 0.8)". A lower bound of "−0" is a formatting oddity; it should be written as 0, or to more decimals (e.g. −0.0x).
  • p. 24 Table 2, death from any cause, at 6 mo
    0.4 (−0 to 0.8)

Judge's note: I checked the upright page image of PDF page 24. The Table 2 row for death from any cause at 6 months reads "0.4 (−0 to 0.8)", and the minus sign is visible. This is most likely a small negative lower bound rounded to the table's one decimal place. Elsewhere the table prints zero bounds without a sign: "−2.2 (−4.4 to 0)" and "0.7 (0 to 1.3)". The data themselves are not in question, so this is a cosmetic inconsistency only.

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