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Optimal Medical Therapy with or without PCI for Stable Coronary Disease

2007 · paper · Clinical trials

A randomized trial of 2287 patients with stable coronary artery disease, comparing stenting (PCI) plus intensive medical therapy with medical therapy alone. Over about 4.6 years, death and heart attack rates were similar: 19.0% with PCI versus 18.5% without.

2 findings

Substance Figure 3, CCS angina class "II or III 1371" contradicts Table 1 (409+425+261+221 = 1316); with 0 or I = 964 the subgroups total 2335 > 2287 randomized.
  • p. 11 Figure 3, CCS angina class, II or III row, No. of Patients
    1371
  • p. 6 Table 1, Angina (CCS class) II and III rows
    409 (36)
  • p. 11 Figure 3, CCS angina class rows
    0 or I 964 … II or III 1371
  • p. 6 Table 1, CCS class rows
    II 409 (36) 425 (37); III 261 (23) 221 (19)

Judge's note: Table 1 (p.6) gives class 0: 135/148, I: 340/341, II: 409/425, III: 261/221, missing 3/2, with complete totals of 1148 and 1137. The 0/I row in Figure 3 (964) matches Table 1, but II/III should be 1316. Missing data cannot make subgroups sum to more than N. 1371 is also the count printed for 'Myocardial infarction: No', which suggests it was carried over from that row.

Second check: another model agreed

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Substance Figure 2 numbers at risk at year 7: Panel C "127 / 134" and Panel D "120 / 134" exceed Panel B (overall survival) "38 / 44" and Panel A "30 / 35".
  • p. 10 Figure 2, Panel D, No. at Risk, year 7
    120
  • p. 10 Figure 2, Panel C, No. at Risk, year 7
    127
  • p. 10 Figure 2, Panel B, No. at Risk, year 7
    38

Only the authors can say what is right here.

Judge's note: Read on the page-10 image. A patient at risk for ACS or MI must be alive and under follow-up, so the C and D risk sets cannot exceed B's. Panel D matches Panel A exactly through year 6 (192/200), as expected when death removes patients from both risk sets. Its year-7 value of 120/134 against A's 30/35 is therefore inconsistent. Panel C's year 6 (236/246) and year 7 are also implausible against B (302/312, then 38/44).

Second check: another model agreed

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12 minor (typos and the like; most checked by the judge only)
Wording Results p.4: "PCI was attempted for 1688 lesions in 1077 patients, of whom 1006 (94%) received at least one stent"; 1006/1077 is 93.4%, which rounds to 93%.
  • p. 4 Results, Baseline Characteristics and Angiographic Data, para 2
    1077 patients, of whom 1006 (94%)

Only the authors can say what is right here.

Judge's note: Checked on the page-4 crop. The stated denominator is 1077. Figure 1 also gives 1006 receiving a stent, and in the next sentence 590+416=1006 with 59% and 41%, which match 1006. Nothing in the text supports a denominator that gives 94%. The difference is one percentage point. Only the authors can say whether the count or the percentage is the one to change.

Second check: another model agreed

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Wording Figure 3, Diabetes "No 1468" with Yes 766 (= Table 1 367+399) sums to 2234, 51 short of the 2285 with baseline data.
  • p. 11 Figure 3, Diabetes, No
    1468
  • p. 6 Table 1, History, Diabetes
    367 (32)
  • p. 11 Figure 3, Diabetes
    No 1468

Only the authors can say what is right here.

Judge's note: The Table 1 footnote says baseline data were missing for only one patient per group. Missing diabetes status is not reported. Several other Figure 3 splits also fall short of 2285 (EF 2254, MI 2247), so missing covariate data is a possible explanation, but the paper does not state it.

Second check: another model agreed

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Wording Adjusted treatment effect "(1.09; 95% CI, 0.90 to 1.33; P = 0.77)": which model term, scale and test does each number come from?
  • p. 7 Results, Subgroup Analyses
    (1.09; 95% CI, 0.90 to 1.33; P = 0.77)

Only the authors can say what is right here.

Judge's note: Page 7. The Methods (p.3–4) say the adjusted analysis used a Cox model with eight covariates. They say the unadjusted primary comparison used a stratified log-rank test, but they do not say how the P value for the adjusted HR was obtained. On a Wald test with the log-HR SE derived from the interval, ln(1.09)=0.086 and SE=(ln1.33−ln0.90)/3.92≈0.0996, giving z≈0.87 and two-sided P≈0.39. The printed 0.77 is not reached that way. This is raised as a question about which test produced each number, not as a statement that a value is wrong.

Second check: another model agreed

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Wording Discussion: "All secondary outcomes and individual components of the primary outcome showed no significant differences between the study groups", yet Table 3 ("Primary and Secondary Outcomes") lists revascularization with HR 0.60 (0.51–0.71), P<0.001.
  • p. 9 Discussion, first paragraph
    All secondary outcomes and individual com­ponents of the primary outcome showed no sig­nificant differences between the study groups
  • p. 9 Table 3, Revascularization row
    0.60 (0.51–0.71)
  • p. 7 Results, revascularization paragraph
    (hazard ratio, 0.60; 95% CI, 0.51 to 0.71; P<0.001)
  • p. 7 Results, Secondary Outcomes
    P<0.001

Only the authors can say what is right here.

Judge's note: The Methods (p.3) name as secondary outcomes the death/MI/stroke composite and hospitalization for unstable angina, both nonsignificant, so the sentence may mean only the prespecified clinical secondary outcomes. However, Table 3's title puts revascularization among the secondary outcomes. Freedom from angina (Table 2, footnote †) also differed significantly at 1 and 3 years. As worded, the sentence overstates.

Second check: another model agreed

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Wording Figure 3, "Single-vessel disease 700" vs Table 1 single-vessel 361+343 = 704, while multivessel 1581 matches Table 1 exactly.
  • p. 11 Figure 3, Extent of CAD, Single-vessel disease
    700
  • p. 7 Table 1 (continued), Vessels with disease, row 1
    361 (31)
  • p. 11 Figure 3, Extent of CAD
    Single-vessel disease 700

Only the authors can say what is right here.

Judge's note: Table 1 (continued, p.7) vessel counts are complete (361+446+341=1148; 343+439+355=1137). The 4-patient gap is small and unexplained, and only the authors can say which number is right.

Second check: another model agreed

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Wording Table 2, Angina-free, PCI 3 Yr: "602 (72)" with No. evaluated 820; 602/820 = 73.4%.
  • p. 8 Table 2, Angina-free, PCI 3 Yr
    602 (72)

Only the authors can say what is right here.

Judge's note: Checked on the page-8 image. 602 (72) fits neither rounding nor truncation against the stated 820. Other angina-free cells also deviate from the 'No. evaluated' row under rounding (595/1010=58.9 printed 58; 558/824=67.7 printed 67; 296/406=72.9 printed 72; 316/423=74.7 printed 74). This suggests the angina-free percentages use denominators that are not stated, but only the authors can confirm that.

Second check: another model agreed

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Wording Figure 3, Myocardial infarction "No 1371" with Yes 876 (= Table 1 437+439) sums to 2247, 38 short of 2285.
  • p. 11 Figure 3, Myocardial infarction
    No 1371

Only the authors can say what is right here.

Judge's note: Table 1 notes no missing MI history beyond the one patient per group. The same 1371 also appears in the CCS II/III row (see C008). It is unclear which row holds the intended value.

Second check: another model agreed

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Wording Appendix: affiliation "Mid America Heart Institute, Kansas City, MO (J.A.S.)" vs site list "Mid America Heart Institute, St. Louis — J. O'Keefe, P. Kennedy".
  • p. 12 Appendix, authors' affiliations
    Mid America Heart Institute, Kansas City, MO (J.A.S.)
  • p. 13 Appendix, U.S. Non-VA clinical sites
    America Heart Institute, St. Louis
  • p. 13 Appendix, U.S. non-VA clinical sites
    Mid America Heart Institute, St. Louis — J. O’Keefe, P. Kennedy

Only the authors can say what is right here.

Judge's note: Rests on outside knowledge: which city is correct for the institute. In the files, the two appendix entries (p.12 and p.13) give different cities for the same institution name.

Second check: another model agreed

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Typo Appendix affiliations: "(P.M.H)" and "(D.J.M)" lack the final period used for every other set of initials.
  • p. 12 Appendix, authors' affiliations
    West Haven, CT (P.M.H)
  • p. 12 Appendix, authors' affiliations
    Nashville (D.J.M)

Judge's note: Confirmed on the page-12 crops.

Second check: none (judge only)

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Typo Appendix name lists: "R. O'Rourke (study cochair) K. Teo" (comma missing), "P. Hartigan. W. Weintraub" and "A. Jacobs. C. Berger" (period instead of comma).
  • p. 12 Appendix, Writing Committee
    R. O’Rourke (study cochair) K. Teo
  • p. 12 Appendix, Writing Committee
    P. Hartigan. W. Weintraub
  • p. 13 Appendix, Boston Medical Center site
    A. Jacobs. C. Berger

Judge's note: All three are visible in the page images (p.12 Writing Committee; p.13 Boston Medical Center site).

Second check: none (judge only)

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Typo Halifax institution named "Queen Elizabeth Health Sciences Centre, Halifax" in the affiliations but "Queen Elizabeth II Health Care Center, Halifax" in the site list.
  • p. 12 Appendix, authors' affiliations
    Queen Elizabeth Health Sciences Centre, Halifax
  • p. 13 Appendix, Canada sites
    Queen Elizabeth II Health Care Center, Halifax

Judge's note: Both forms appear in the images (p.12 and p.13), attached to L.M.T./L. Title. This is a naming inconsistency, and either form may be acceptable.

Second check: none (judge only)

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Typo In the Appendix VA site list, the investigator at VA Medical Center, Lexington, KY is printed without an initial: "Center, Lexington, KY — Booth, M. Shockey". Elsewhere the paper gives this person as D. Booth.
  • p. 13 Appendix, VA sites
    Center, Lexington, KY — Booth, M. Shockey

Judge's note: I checked the crop image. The printed text reads "Lexington, KY — Booth, M. Shockey", so the missing initial is in the published page and is not an extraction artefact. Every other investigator in this list has at least one initial. Elsewhere the paper gives the name as "David C. Booth, M.D." in the author list and "D. Booth" in the committee list, so the fix is to print "D. Booth". This is a cosmetic omission.

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