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Fractional Flow Reserve versus Angiography for Guiding Percutaneous Coronary Intervention

2009 · paper · Clinical trials

A randomized trial of 1005 patients with multivessel coronary disease, comparing stenting guided by angiography alone with stenting guided also by fractional flow reserve measurements. At one year, death, heart attack or repeat revascularization occurred in 13.2% with flow-reserve guidance versus 18.3%.

0 findings

None that passed a second check.

7 minor (typos and the like; most checked by the judge only)
Wording The Discussion says "63.0% of all lesions that were measured had an FFR of 0.80 or less", but Table 2 gives 874/1387 (63.0). The denominator 1387 includes 58 totally occluded lesions that footnote ¶ says "were not measured for FFR" and were assigned a default value of 0.50.
  • p. 6 Discussion, first column/second column
    63.0% of all lesions that were measured had an FFR of 0.80 or less
  • p. 8 Table 2 and footnote ¶
    874/1387 (63.0)

Judge's note: Table 2 (p8) gives 1329/1414 lesions successfully measured. Footnote ¶ says 85 lesions were not measured: 58 total occlusions with a default FFR of 0.50, and 27 others. The 63.0% figure uses 1387 = 1329 + 58, so the Discussion's phrase 'lesions that were measured' does not describe that denominator. This is minor wording; the number matches the table.

Second check: another model agreed

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Wording The Discussion says FFR "consistently reduced the incidence of all types of adverse events by approximately 30%", but the relative risk for death in Table 3 is 0.58 (0.26–1.32), a point-estimate reduction of about 42%.
  • p. 6 Discussion, end of right column
    sistently reduced the incidence of all types of ad-verse events by approximately 30%
  • p. 9 Table 3, relative risks
    0.58 (0.26–1.32)
  • p. 6 Discussion, para 2
    routine measurement of FFR con-sistently reduced the incidence of all types of ad-verse events by approximately 30%

Judge's note: Table 3 (p9) relative risks are: composite 0.72, death 0.58, MI 0.66, repeat revascularization 0.68, death or MI 0.66. Every point estimate except death fits 'approximately 30%'. The death estimate (about 42%) sits outside that summary. This is a loose summary rather than an error.

Second check: another model agreed

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Wording Table 1, Hypertension: "327 (65.9) 312 (61.3) 0.10". The counts and the P value do not correspond under the declared chi-square test (footnote †).
  • p. 6 Table 1, Hypertension row
    327 (65.9) 312 (61.3) 0.10

Only the authors can say what is right here.

Judge's note: On the image, the row reads 327 (65.9) vs 312 (61.3), P 0.10. A Pearson 2x2 chi-square on 327/496 vs 312/509 gives z≈1.52 (chi-square ≈2.33), two-sided P≈0.13; a continuity correction would make P larger. Hypercholesterolemia (≈0.70 vs printed 0.62) and previous MI (≈0.88 vs 0.84) also differ slightly. Table 1 has no note on missing data or on a different denominator. The authors should say how these P values were computed.

Second check: another model agreed

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Typo First-page affiliations print "Rigshopitalet, Copenhagen (T.E.)"; the Appendix prints the same institution as "Rigshospitalet, Copenhagen".
  • p. 1 Affiliations footnote, first page
    Rigshopitalet, Copenhagen (T.E.)
  • p. 11 Appendix, Denmark
    Rigshospitalet, Copenhagen

Judge's note: Checked both page images. The affiliation footnote on p1 reads 'Rigshopitalet' and the Appendix on p11 reads 'Rigshospitalet'. The paper spells the same institution two ways, and the first-page form is missing an 's'.

Second check: none (judge only)

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Typo Two Table 3 row labels read "and repeat vascularization — no. (%)‡" and "Repeat vascularization — no. (%)"; the text calls this end point "repeat revascularization".
  • p. 9 Table 3, row labels
    and repeat vascularization — no. (%)
  • p. 9 Table 3, row label
    Repeat vascularization — no. (%)
  • p. 5 Results, Secondary End Points
    required repeat revascularization (P=0.08)
  • p. 9 Table 3 row labels
    and repeat vascularization — no. (%)‡

Judge's note: The Table 3 image (p9) shows 'vascularization' in both the composite row and the component row. The Results on p5 and the rest of the paper use 'repeat revascularization'.

Second check: none (judge only)

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Typo Appendix: "Clinical Events Committee — E. Eeckhout, M. El Gamal, E. Barbato, M. Kern; J. Hodgson; Data Analysis Committee". The semicolon after M. Kern should be a comma.
  • p. 10 Appendix, Clinical Events Committee
    M. Kern; J. Hodgson; Data Analysis Committee

Judge's note: The p10 image shows the semicolon. Elsewhere in the list, commas separate members within a committee and semicolons separate committees.

Second check: none (judge only)

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Typo The Appendix prints "Helsinborgs Lasarett, Helsingborg". The hospital name lacks the 'g' that appears in the city name in the same entry.
  • p. 11 Appendix, Sweden
    Helsinborgs Lasarett, Helsingborg
  • p. 11
    Helsinborgs Lasarett, Helsingborg: F. Schersten

Judge's note: The p11 image shows 'Helsinborgs Lasarett' in italic, followed by the city 'Helsingborg'. The two spellings are inconsistent within one entry.

Second check: none (judge only)

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