Author + information
- Published online August 12, 2019.
Reddy VY, Neuzil P, de Potter T, van der Heyden J, Tromp SC, Rensing B, Jiresova E, Dujka L, Lekesova V
Permanent Percutaneous Carotid Artery Filter to Prevent Stroke in Atrial Fibrillation Patients: The CAPTURE Trial
J Am Coll Cardiol 2019;74:829–39.
The initial online publication of the CAPTURE Trial was published without final adjudication of all events and without the approval of the Data and Safety Monitoring Board or the Clinical Events Committee (DSMB/CEC), which was unbeknownst to JACC or its Editors. This final version, along with the erratum, has received DSMB/CEC approval.
Listed here are the changes that occurred between initial online publication and the final version. This list compiles all changes made following the approval of the revised manuscript by Prof. Lickfett (DSMB/CEC Chairman) and JACC.
The following changes were made in the main text.
1. In the abstract, first sentence of the Results section, “4 centers” was changed to “3 centers”:
At 3 centers, 25 patients were enrolled: age 71 ± 9 years, CHA2DS2-VASc = 4.4 ± 1.0, prior embolism in 48%.
2. In the abstract, the text starting from the fourth sentence of the Results section until its end read as follows in the online version:
After 6 months mean follow-up, in situ thrombus was not observed. The filter captured emboli in 4 patients (1 bilateral, 4 unilateral), none developed symptoms. In all patients, the thrombi dissolved with subcutaneous heparin. In 1 patient, 2 minor strokes involving non-CCA territory strokes occurred.
This has been corrected to the following in the final version:
After 6 months mean follow-up, asymptomatic thrombi were detected in 4 patients (1 bilateral, 4 unilateral) adjudicated as captured (n = 3), unclassified (n = 2) or in situ (n = 0). In all patients, the thrombi dissolved with subcutaneous heparin. In 1 patient, 2 device/procedure-unrelated minor strokes occurred.
3. In the final sentence of the Introduction “ongoing” was inserted before “first-in-human”:
Herein, we report the results from an ongoing first-in-human clinical trial of the feasibility and safety of the CCA filter, evaluated in AF patients unsuitable for OAC.
4. In the Methods, in the first sentence of the Trial Design subsection, “4-center” was replaced with “multicenter”:
The CAPTURE (Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients) (NCT03571789) clinical trial is a first-in-human, multicenter, nonrandomized feasibility study of the CCA filter.
5. In the Methods, the following sentence was added after the last sentence of the Endpoints subsection:
Thrombi on the filter adjudicated by the CEC as “definitely” or “probably” device-related were counted toward the endpoint, while those adjudicated as “unrelated” or “possibly” device-related were not.
6. In the Results, the following sentence was added before the last sentence of the second paragraph of the Other Outcomes Assessment subsection:
Due to the coincident nature of this fall and thrombus, the fall was classified by the CEC as “possibly device-related,” although no causal relationship between the 2 was demonstrated.
7. In the Results, in the first sentence of the third paragraph of the Other Outcomes Assessment subsection, “(1 bilateral, 4 unilateral)” was inserted after “filter”:
There were 6 occurrences of thrombi on the CCA filter (1 bilateral, 4 unilateral) that were identified by ultrasound imaging in 4 patients during the study (Figure 5).
8. In the Results, in the second sentence of the third paragraph of the Other Outcomes Assessment subsection the phrase “the CEC adjudicated 3 thrombi as captured, and undetermined in 2” was added after “thrombi”:
All thrombi were reported by the sites as most probably captured, and not in situ thrombi; the CEC adjudicated 3 thrombi as captured, and undetermined in 2. The thrombi varied in thickness between 0.15 and 2.0 mm, and in length between about 2.0 and 10 mm.
9. In the Discussion, the online version of the first sentence of the sixth paragraph read:
The appearance of the thrombi in all cases was “string like” and mobile, resembling the appearance of captured thrombi in ovine studies (10).
In the print version, the sentence reads:
The appearance of the thrombi in all cases was elongated and mobile, resembling the string-like appearance of captured thrombi in ovine studies in 5 of 6 cases (Yodfat et al., unpublished data).
The following changes were made in the online appendix.
1. The following sentence was added at the end of the Site/Investigators subsection:
(There was a 4th center, Middelheim Cardiovascular Center in Antwerp, Belgium, that received IRB approval and screened patients, but did not treat or attempt to treat any patients.)
2. A subsection titled Timing of CEC Adjudication of Events was added, which reads:Timing of CEC Adjudication of Events
At the timing of the initial submission of the manuscript (April 2019), the CEC had formally adjudicated 12 clinical events. For an additional 19 events that had not been adjudicated by the CEC, the data in the submitted manuscript was classified as reported by the individual sites. After the manuscript was accepted, CEC adjudication for these remaining 19 events was completed. Of these latter events, the material changes (between site-reported and CEC-adjudicated events) were:
• Related to thrombi on filters: All thrombi were reported by sites as captured emboli; the CEC could not determine the etiology of one bilateral thrombus and one unilateral thrombus (the remaining 3 thrombi were CEC-adjudicated as captured thrombi).
• A fall with traumatic brain injury and coincidental finding of a thrombus on the filter two days later was reported by the site as “device unrelated.” The CEC adjudicated the fall as “possibly device related” due to the coincidence of the thrombus, although there were no stroke symptoms and no causal relationship between the thrombus and the fall identified.
• A major bleeding event (intracranial bleeding) was reported by the site as a Major Adverse Event. The CEC downgraded this to a Serious Adverse Event (because the bleeding event resulted from the aforementioned fall).
3. “Major Bleeding” was downgraded from MAE to SAE in Supplemental Table 3.
4. In the online version, the last sentence of Footnote 3 to Supplemental Table 3 read:
All cases adjudicated by the CEC until the date of submission of the present paper as most probably captured thrombus
In the final version, this sentence has been replaced by the following:
CEC adjudicated these thrombi as captured in 3 instances (all unilateral thrombi), and could not determine the etiology in 2 instances (1 bilateral and 1 unilateral); none were adjudicated as in situ thrombus formation
The authors apologize for these errors.
The final version of the article has been corrected to reflect these changes.
- 2019 The Authors