Author Contributions: Drs Nicholls and Nissen and Mr Hu had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Nicholls, Tuzcu, Sipahi, Schoenhagen, Desai, Nissen.
Acquisition of data: Tuzcu, Schoenhagen, Hu.
Analysis and interpretation of data: Nicholls, Tuzcu, Sipahi, Grasso, Schoenhagen, Hu, Wolski, Crowe, Desai, Hazen, Kapadia, Nissen.
Drafting of the manuscript: Nicholls, Tuzcu, Hu, Desai, Kapadia, Nissen.
Critical revision of the manuscript for important intellectual content: Nicholls, Tuzcu, Sipahi, Grasso, Schoenhagen, Wolski, Crowe, Desai, Hazen, Nissen.
Statistical analysis: Nicholls, Sipahi, Hu, Wolski, Nissen.
Obtained funding: Tuzcu, Nissen.
Administrative, technical, or material support: Tuzcu, Crowe, Nissen.
Study supervision: Nicholls, Tuzcu, Schoenhagen, Hazen, Kapadia, Nissen.
Financial Disclosures: Dr Nicholls reported receiving honoraria for lectures from Pfizer, AstraZeneca, and Merck Schering-Plough; consulting fees from AstraZeneca and Anthera Pharmaceuticals; and research support from LipidSciences. Dr Tuzcu reported receiving research support from Pfizer, AstraZeneca, and Sankyo Pharma; and honoraria for lectures from Pfizer and AstraZeneca. Dr Sipahi reported receiving an educational grant from Pfizer. Dr Hazen reported receiving research support and honoraria for lectures from Pfizer, Merck, and Sankyo. Dr Grasso reported owning stock in Pfizer. Dr Schoenhagen reported giving lectures for Takeda Pharmaceuticals but noted that all honoraria were directly paid to charity. Dr Desai reported receiving honoraria for lectures from Merck and Pfizer. Dr Kapadia reported receiving honoraria for lectures from Pfizer. Dr Nissen reported receiving research support from AstraZeneca, Eli Lilly, Pfizer, Takeda, Sankyo, and Sanofi-Aventis; and consulting for a number of pharmaceutical companies without financial compensation. Dr Nissen's honoraria, consulting fees, or other payments from any for-profit entity are paid directly to charity, so that neither income nor any tax deduction is received. No other authors reported financial disclosures.
Funding/Support: The REVERSAL and CAMELOT studies were sponsored by Pfizer; the ASTEROID study was sponsored by AstraZeneca; and the ACTIVATE study was sponsored by Sankyo Pharma. Dr Nicholls was supported by a Ralph Reader Overseas Research Fellowship from the National Heart Foundation of Australia.
Role of the Sponsor: The sponsors of REVERSAL, CAMELOT, ASTEROID, and ACTIVATE did not provide financial support for this pooled analysis.
Independent Statistical Analysis: The sponsors of the clinical trials were not involved in the current pooled analysis. An independent statistical analysis was conducted by Tingfei Hu, MS, and Kathy Wolski, MPH, both from the Department of Cardiovascular Medicine at the Cleveland Clinic. These statisticians received the trial databases from the sponsors, including raw data, and independently computed the intravascular ultrasound efficacy parameters and confirmed the lipid level outcomes and basic demographic variables. Mr Hu and Ms Wolski are employed by the Cleveland Clinic Cardiovascular Coordinating Center, which received compensation for conducting the source clinical trials, including reimbursement for statistical services.
Acknowledgment: We thank the technical expertise of the Intravascular Core Laboratory of the Cleveland Clinic and Amy Hsu, MS (Cleveland Clinic), for her statistical assistance. Ms Hsu was compensated for her work as part of her salary from the Cleveland Clinic.