Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest among Patients with Atrial Fibrillation
2019 · paper · Clinical trials
A randomized trial of 2204 patients with atrial fibrillation, comparing catheter ablation with drug therapy. Death, disabling stroke, serious bleeding or cardiac arrest occurred in 8.0% versus 9.2%, not a significant difference; the authors note low event rates and treatment crossovers.
3 findings
Reference or label Reference 9 (Mont L et al, SARA study) is printed 'Eur Heart J. 2014;35:505-507'; the first page appears to be 501.
- p. 13
Mont L, Bisbal F, Hernandez-Madrid A, et al; SARA investigators. Catheter ablation vs anti
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: the Crossref record for doi:10.1093/eurheartj/eht457 gives pages 501-507. The page 13 image does show '2014;35:505-507'. A 3-page span for a full randomized trial report is also implausible.
Second check: another model agreed, code check
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Wording Discussion: '9.2% of catheter ablation patients declined their assigned procedure', but 9.2% is all 102 non-ablated patients, and only 84 of them refused (Figure 1: 14 physician discretion, 4 insurance issues).
- p. 8 Discussion, Treatment Assignment Sensitivity Analyses
9.2% of catheter ablation patients declined their assigned procedure
- p. 4 Figure 1
84 Patient or family refusal
- p. 4 Results, Treatments
102 patients did not re- ceive ablation due to patient or family refusal (82.4%) or phy- sician decision (13.7%)
Judge's note: Figure 1 on page 4 lists 84 patient or family refusal, 14 physician discretion and 4 insurance issues (sum 102). The Results text gives 82.4% refusal. In the page 8 Discussion, 9.2% equals 102/1108, so 'declined' wrongly covers the 18 patients who did not refuse.
Second check: another model agreed
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Wording Discussion: 'Pericardial effusion with tamponade, while infrequent, was the most common adverse event in catheter ablation patients', but Results say it was the most common serious adverse event (0.8%), and minor hematomas (2.3%) and pseudoaneurysms (1.1%) were more frequent.
- p. 10 Discussion, Adverse Events
Pericardial effusion with tamponade, while infrequent, was the most common adverse event in catheter ablation patients.
- p. 7 Results, Adverse Events
The most common serious adverse event in the catheter ablation group was cardiac tamponade (0.8%).
- p. 7 Results, Adverse Events
minor hematomas (2.3%) and pseudoaneurysms (1.1%)
- p. 10 Discussion, Adverse Events
was the most common adverse event in catheter ablation patients
Judge's note: Page 7 Results limit the claim to serious adverse events and give higher rates for minor hematomas and pseudoaneurysms. The page 10 Discussion drops 'serious'. Fix: 'most common serious adverse event'.
Second check: another model agreed
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9 minor (typos and the like; most checked by the judge only)
Wording The site list ('Listed in descending order of the number of randomized patients') ends with 'and Riccardo Cappato, IRCCS Istituto Clinico Humanitas, Milano, Italy.' with no patient count, after 126 counted entries that sum to 2204.
- p. 13 Clinical Site Principal Investigators and Institutions (end of list)
Riccardo Cappato, IRCCS Istituto Clinico Humanitas, Milano, Italy.
- p. 4 Results, Study Population
126 sites across 10 countries
Judge's note: I counted the entries on the page 12–13 images and text. There are 126 entries with counts, summing to 2204 (the total randomized), which matches '126 sites across 10 countries' on page 4. The 127th entry has no count. It is probably Cappato's current affiliation (he is listed as 'previously' PI at Policlinico San Donato (32) and is an author with a Humanitas affiliation). It breaks the list format and could be read as a 127th site, so this is minor.
Second check: another model agreed
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Wording Table 1 gives ablation-arm NYHA 'II/III (Most severe)' 376 (34.3), although footnote e defines a I–IV scale; Figure 4 gives '≥ Class II' as 34/378 in the ablation arm (drug arm 400 in both).
- p. 5 Table 1, Heart function severity (NYHA class)
II/III (Most severe)
- p. 6 Table 1 footnote e
On a scale of I to IV, with I indicating the least severe and IV, the most severe
- p. 9 Figure 4, Baseline NYHA class
34/378 (1396)
Only the authors can say what is right here.
Judge's note: Table 1 on page 5: I 153 (13.9), II/III 376 (34.3). Both percentages imply a denominator of about 1097. Figure 4 on page 9: 'No heart failure or class I' 719 and '≥ Class II' 378, which also sum to 1097. So the same population gives 376 in Table 1 and 378 in Figure 4, a difference of 2. Footnote e of the table and footnote c of the figure both define NYHA as I to IV, yet Table 1 labels II/III as 'Most severe'. The likely reading is that 2 class IV patients are left out of Table 1. The paper does not say so; asked as a query.
Second check: another model agreed
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Wording Table 1 'LVH 334 (38.7) 328 (42.1)': the percentages imply denominators of about 863 and 779, not the column n of 1108 and 1096, and no denominator is stated.
- p. 5 Table 1, Medical history, LVH row
LVH 334 (38.7) 328 (42.1)
Only the authors can say what is right here.
Judge's note: Checked on the page 5 image. Other rows in the same block use the full n (eg Heart failure 174/1108 = 15.7%). Only ejection fraction states a subset denominator (38/790). The LVH percentages must rest on an unstated subset, perhaps patients with an echocardiogram. Several other Table 1 rows also use unstated subsets (NYHA, rhythm control drugs), so this is an unstated-denominator query rather than a clear error.
Second check: another model agreed
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Wording Table 1 drug-arm AF types 'Persistent 518 (47.3), Paroxysmal 476 (43.5), Long-standing persistent 101 (9.2)' sum to 1095, not n = 1096; the percentages use 1095 without saying so.
- p. 6 Table 1 (continued), Type of AF at enrollment
Paroxysmal 470 (42.4) 476 (43.5)
Judge's note: Checked on the page 6 image. 518+476+101 = 1095. All three percentages match a denominator of 1095 (476/1095 = 43.47%), not 1096 (43.43%). So one drug-arm patient has no AF type recorded, and the table does not say so. Minor missing-data point.
Second check: another model agreed
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Wording Role of the Funder: 'The NIH ... had no role in the design of the study; collection, management, and interpretation of the data; preparation of the manuscript', yet NHLBI/NIH authors Rosenberg and Jeffries are credited with concept and design, data analysis/interpretation, statistical analysis and critical revision.
- p. 12 Role of the Funder/Sponsor
The NIH established an independent data and safety monitoring board to monitor safety but had no role in the design of the study
- p. 11 Author Affiliations / Author Contributions
Institutes of Health, Bethesda, Maryland (Rosenberg, Jeffries)
- p. 11 Author Contributions
Statistical analysis: Packer, Mark, Jeffries,
Only the authors can say what is right here.
Judge's note: Author Affiliations on page 11 list NHLBI, NIH, Bethesda (Rosenberg, Jeffries). Author Contributions: Rosenberg under Concept and design; Jeffries under Acquisition/analysis/interpretation and Statistical analysis; both under Critical revision. The page 12 funder statement denies any NIH role in these tasks. The authors may have contributed as individuals rather than for the funder, but the paper does not say so.
Second check: another model agreed
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Typo Author affiliations: 'Herz-und Diabeteszentru, Bad Oeynhausen, Germany (Noelker)' should read 'Diabeteszentrum' (the site list on page 12 has 'Herz-und Diabeteszentrum NRW').
- p. 11 Author Affiliations
Herz-und Diabeteszentru, Bad
- p. 11 Author Affiliations
Herz-und Diabeteszentru, Bad Oeynhausen, Germany (Noelker)
Judge's note: The truncated spelling is visible in the page 11 image, so it is not an extraction artefact.
Second check: none (judge only)
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Typo Site list: 'Cardioaniologisches Centrum Bethanien' is misspelled; it should be 'Cardioangiologisches'.
- p. 12 Clinical Site Principal Investigators list
Cardioaniologisches Centrum
Judge's note: Visible in the page 12 image; the 'g' is missing.
Second check: none (judge only)
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Typo Site list: 'Praxisklinik Herz and GefaBe, Dresden' has 'ß' set as 'B' (Gefäße), and 'und' is given as 'and'.
- p. 12 Clinical Site Principal Investigators list
Praxisklinik Herz and GefaBe
Judge's note: Visible in the page 12 image, so it is in the typeset text. The ß→B substitution is evident on the page. That the German name uses 'und' rests on general knowledge of the name.
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Typo Reference 24 reads 'Lan K, DeMets L. Discrete sequential boundaries for clinical trials'; the second author is normally cited as 'DeMets DL'.
- p. 14 Reference 24
Lan K, DeMets L. Discrete sequential
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: the author is David L. DeMets (usually cited as DeMets DL). The page 14 image shows 'DeMets L'.
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