The PROXIMAL Trial: Proximal Protection During Saphenous Vein Graft Intervention Using the Proxis Embolic Protection SystemA Randomized, Prospective, Multicenter Clinical Trial
Laura Mauri, MD, MSc, FACC*, ,*,
David Cox, MD, FACC ,
James Hermiller, MD, FACC ,
Joseph Massaro, PhD,
Joyce Wahr, MD||,
Sew Wah Tay, PhD||,
Michael Jonas, MD*,
Jeffrey J. Popma, MD, FACC*,
Jim Pavliska, BS||,
Dennis Wahr, MD, FACC|| and
Campbell Rogers, MD, FACC*
* Division of Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, Massachusetts
Harvard Clinical Research Institute, Boston, Massachusetts
Lehigh Valley Hospital, Allentown, Pennsylvania
St. Vincent’s Hopsital, Indianapolis, Indiana
|| Velocimed/St. Jude Medical, Maple Grove, Minnesota.
View larger version (41K):
[in this window]
[in a new window]
[Download PPT slide]
|
Figure 1 The Proxis Embolic Protection System
Proxis is tracked through the guide catheter and into the target vessel, proximal to the treatment area. The guidewire and interventional device are inserted through Proxis and may be staged proximal to the treatment area before balloon inflation. Balloon inflation suspends blood flow, ensuring stagnation of blood and liberated embolic material during treatment of the lesion. During protection, a static column of contrast verifies adequate sealing and highlights the treatment area to facilitate interventional device placement.
|
|
View larger version (23K):
[in this window]
[in a new window]
[Download PPT slide]
|
Figure 2 The PROXIMAL Trial
Randomization, actual treatment received, and associated major adverse cardiac event (MACE) rate in the PROXIMAL (Proximal Protection During Saphenous Vein Graft Intervention) trial. SVG = saphenous vein graft.
|
|
View larger version (19K):
[in this window]
[in a new window]
[Download PPT slide]
|
Figure 3 30-Day MACE Rates
Primary end point major adverse cardiac event (MACE) rates at 30 days according to intention to treat; (control = yellow bars, test = blue bars); device used (distal = yellow bars, Proxis = blue bars); and device used in lesions amenable to treatment with either proximal or distal protection (distal = yellow bars, Proxis = blue bars). The p values are those for noninferiority.
|
|
View larger version (20K):
[in this window]
[in a new window]
[Download PPT slide]
|
Figure 4 Periprocedural Myonecrosis by Intention-to-Treat Analysis Population
Cumulative frequency distribution curves of peak postprocedural creatine phosphokinase MB (CK-MB) isoenzyme for patients randomized to control (open circles) or test (stars). Each curve shows the percentage of patients whose CK-MB elevation (expressed as a multiple of institutional upper limit of normal) exceeds the value on the X-axis. The p value = 0.85 for difference.
|
|
View larger version (21K):
[in this window]
[in a new window]
[Download PPT slide]
|
Figure 5 Periprocedural Myonecrosis by Device Analysis Population
Cumulative frequency distribution curves of peak postprocedural creatine phosphokinase MB (CK-MB) for patients actually treated with distal protection (open circles) or proximal protection (stars). Each curve shows the percentage of patients whose CK-MB elevation (expressed as a multiple of institutional upper limit of normal) exceeds the value on the X-axis. The p value = 0.12 for difference.
|
|
View larger version (19K):
[in this window]
[in a new window]
[Download PPT slide]
|
Figure 6 Periprocedural Myonecrosis by Patients Eligible for Treatment With Either Device
Cumulative frequency distribution curves of peak postprocedural creatine phosphokinase MB (CK-MB) for patients eligible for treatment with either device and treated with distal protection (open circles) or proximal protection (stars). Each curve shows the percentage of patients whose CK-MB elevation (expressed as a multiple of institutional upper limit of normal) exceeds the value on the X-axis. The p value = 0.09 for difference.
|
|
|
