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Enrollment and Outcomes J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431

Enrollment and Outcomes

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Enrollment and Outcomes. J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431. Baseline Characteristics of the Patients*. J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431. - PowerPoint PPT Presentation

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Page 1: Enrollment and Outcomes

Enrollment and Outcomes

J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431

Page 2: Enrollment and Outcomes

Baseline Characteristics of the Patients*

J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431

Page 3: Enrollment and Outcomes

Levels of Lipids, Lipoproteins, Sterols, and C-Reactive Protein at Baseline and after 24 Months of Treatment, with Changes from Baseline* - Part I

J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431

Page 4: Enrollment and Outcomes

Levels of Lipids, Lipoproteins, Sterols, and C-Reactive Protein at Baseline and after 24 Months of Treatment, with Changes from Baseline* - Part II

J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431

Page 5: Enrollment and Outcomes

Effects of Simvastatin and Combined Therapy with Simvastatin plus Ezetimibe on Levels of Cholesterol and Triglycerides

J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431

Page 6: Enrollment and Outcomes

Measures of Intima–Media Thickness in Carotid and Femoral Arteries at Baseline and at 24 Months and Changes from Baseline*

J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431

Page 7: Enrollment and Outcomes

Mean (±SE) Intima–Media Thickness of theCarotid Artery during 24 Months of Therapy

J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431

Page 8: Enrollment and Outcomes

Carotid arterial segments. The common carotid (defined as the segment 1cm proximal to the dilatation), carotid bulb (between the dilatation and the flow divider) and the internal carotid (1cm distal from the flow divider) arterial segments. Carotids are scanned bilaterally

J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431Supplementary Appendix

Page 9: Enrollment and Outcomes

Femoral arterial segment. The common femoral (defined as the segment 1cm proximal to the dilatation)

arterial segment. Femorals are scanned bilaterally

J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431Supplementary Appendix

Page 10: Enrollment and Outcomes

B-mode ultrasound still image of the common carotid arterial wall segment and its standard settings as used in the

imaging trial proptocol. The arrow in the far wall indicates the carotid flow divider. The image is saved as a TIFF-file

J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431Supplementary Appendix

Page 11: Enrollment and Outcomes

M-mode images are created in the distal common carotid artery

J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431Supplementary Appendix

Page 12: Enrollment and Outcomes

The near and far walls are visualized in the 1/3 B-mode; the movement in time is depicted in the 2/3 M-mode image. The 1/3-2/3

image is saved as a TIFF-file of the same format as the Bmode image

J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431Supplementary Appendix

Page 13: Enrollment and Outcomes

Image analysis of a the region of interest of a B-mode image, using the eTrack program. The image analyst (or ‘reader’) indicates the

lumen-intima and media-adventitia interfaces with cross-hairs using an interactive cursor. The cross-hairs are splined

J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431Supplementary Appendix

Page 14: Enrollment and Outcomes

Control image as used for B-mode image analysis. The control image represents the ROI of the image. The splined (manual) tracings delineate the lumen-intima and the media adventitia interfaces. The light gray bar on the right side of the

control image indicates the videolines that could (homogeneous gray) and could not be (striping) evaluated by the image interpolation function of the image

analysis program. In this example, the striping is in the lumen and hence outside the region of interest of and of no influence on the IMT measurement

J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431Supplementary Appendix

Page 15: Enrollment and Outcomes

Image analysis of a the region of interest of an M-mode image, using the eTrack program. At least 2 heartbeats are required for a proper

tracing of the lumen and arterial wall stiffness parameters

J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431Supplementary Appendix

Page 16: Enrollment and Outcomes

Control image as used for M-mode image analysis. The (automatic) contour tracings delineate the peri-adventitial – adventitia interface and the intima-lumen interfaces of the near wall, and the lumen-intima and the media-advential interfaces of the far wall.

The lumen is measured between the leading edges of the interfaces of the intima-lumen of the near and the lumenintima of the far wall interfaces

J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431Supplementary Appendix

Page 17: Enrollment and Outcomes

Most common Treatment Related Treatment Emergent Adverse Events

J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431Supplementary Appendix

Page 18: Enrollment and Outcomes

Commonly Reported Treatment Emergent Adverse Events

J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431Supplementary Appendix

Page 19: Enrollment and Outcomes

Adverse event leading to withdrawal of consent

J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431Supplementary Appendix

Page 20: Enrollment and Outcomes

Additional secondary endpoints

J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431Supplementary Appendix

Page 21: Enrollment and Outcomes

Prespecified exploratory analyses

J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431Supplementary Appendix

Page 22: Enrollment and Outcomes

Treatment difference in change in cIMT in prespecified subgroupsBars represent (95% confidence interval)

J.J.P. Kastelein, et al. N Engl J Med 2008;358:1431Supplementary Appendix