Published Online: March 30, 2014. doi:10.1001/jama.2014.3316.
Study concept and design: Abdel-Wahab, Frerker, Tölg, Richardt.
Acquisition, analysis, or interpretation of data: Abdel-Wahab, Mehilli, Frerker, Neumann, Kurz, Tölg, Zachow, Guerra, Massberg, Schäfer, El-Mawardy, Richardt.
Drafting of the manuscript: Abdel-Wahab, Guerra, Schäfer, Richardt.
Critical revision of the manuscript for important intellectual content: Abdel-Wahab, Mehilli, Frerker, Neumann, Kurz, Tölg, Zachow, Guerra, Massberg, Schäfer, El-Mawardy, Richardt.
Statistical analysis: Abdel-Wahab, Frerker, Guerra.
Obtained funding: Abdel-Wahab, Neumann, Richardt.
Administrative, technical, or material support: Abdel-Wahab, Mehilli, Kurz, Tölg, Zachow, Schäfer, El-Mawardy,
Study supervision: Abdel-Wahab, Neumann, Kurz, Tölg, Guerra, Massberg, Schäfer, El-Mawardy.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Abdel-Wahab reports that he has received institutional grant support from Medtronic and personal fees from Edwards Lifesciences and Boston Scientific. Dr Mehilli reports that she has served on the advisory board of Abbott Vascular and Terumo and has received lecture fees from Abbott Vascular, Terumo, Lilly/Daiichi Sankyo, and Biotronik. Dr Neumann reports receiving institutional research grants and speaker honoraria from Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Schäfer reports that he has received support for serving as a proctor for Medtronic and Edwards Lifesciences. Dr Richardt reports receiving an institutional research grant from Medtronic and lecture fees from Boston Scientific. No other authors reported disclosures.
Funding/Support: This trial was sponsored by the Heart Center, Segeberger Kliniken GmbH, Bad Segeberg, Germany.
Role of the Sponsor: The sponsor had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Data management and analysis was carried out by an independent data coordinating center, with oversight from a steering committee.
Additional Contributions: We thank Derek R. Robinson, DPhil, Senior Lecturer of Statistics, University of Sussex, Brighton, England, and Mrs Susanne Sachse, Zentrum für Klinische Studien, Bad Segeberg, Germany, for serving as the main trial coordinator. Dr Robinson has been compensated for his contribution and Mrs Sachse is an employee at the data coordinating center.