This Article Figures Only Full Text Full Text (PDF) View PROXIMAL Study organization View Cardiosource Slide Set All Versions of this Article: j.jacc.2007.06.039v1 50/15/1442    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in Web of Science Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Web of Science (7) Citing Articles via Google Scholar Google Scholar Articles by Mauri, L. Articles by Rogers, C. Search for Related Content PubMed Articles by Mauri, L. Articles by Rogers, C.

CLINICAL RESEARCH: CLINICAL TRIAL

The PROXIMAL Trial: Proximal Protection During Saphenous Vein Graft Intervention Using the Proxis Embolic Protection System

A 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.

Manuscript received May 8, 2007; revised manuscript received June 15, 2007, accepted June 25, 2007.

^_* Reprint requests and correspondence: Dr. Laura Mauri, Brigham and Women’s Hospital, 75 Francis Street, Boston, Massachusetts 02115. (Email: lmauri1{at}partners.org).

Objectives: To determine if outcomes could be further improved, we investigated an embolic protection device placed proximal to the target lesion that could provide protection before lesion instrumentation, allow the use of conventional guidewires, and permit embolic protection in anatomy unfavorable for distal devices.

Background: Embolic complications during stenting of degenerated saphenous vein coronary bypass grafts are reduced, but not eliminated, by distal protection.

Methods: A total of 594 patients undergoing stenting of 639 saphenous vein grafts were prospectively randomized, using a noninferiority design, to compare 2 treatment strategies: control (distal protection whenever possible) or test (proximal protection when possible, distal when not).

Results: The primary composite end point of death, myocardial infarction, or target vessel revascularization at 30 days by intention to treat analysis occurred in 10.0% of control and 9.2% of test patients; difference = –0.8% (95% confidence interval [CI] –5.5% to 4.0%); p for noninferiority = 0.0061. In device specific analysis, this composite end point occurred in 11.7% of distal protection patients and 7.1% of proximal protection patients (difference = –4.6% [95% CI –9.6% to 0.3%]; p for superiority = 0.10, p for noninferiority = 0.001). Finally, in the subset of patients with lesions amenable to treatment with either proximal or distal protection devices (n = 410), the primary composite end point occurred in 12.2% of distal protection patients and 7.4% of proximal protection patients; difference = –4.7% (95% CI –10.4% to 1.0%), p for superiority = 0.14, p for noninferiority = 0.001.

Conclusions: Using proximal embolic protection whenever possible during treatment of diseased saphenous vein grafts produced outcomes similar to those with distal embolic protection.

Abbreviations and Acronyms   MACE = major adverse cardiac event   MI = myocardial infarction   PCI = percutaneous coronary intervention   SVG = saphenous vein graft

This article has been cited by other articles:

				G. Heusch, P. Kleinbongard, D. Bose, B. Levkau, M. Haude, R. Schulz, and R. Erbel Coronary Microembolization: From Bedside to Bench and Back to Bedside Circulation, November 3, 2009; 120(18): 1822 - 1836. [Abstract] [Full Text] [PDF]

				J. D.E. Haeck, K. T. Koch, L. Bilodeau, R. J. Van der Schaaf, J. P.S. Henriques, M. M. Vis, J. Baan Jr, A. C. Van der Wal, J. J. Piek, J. G.P. Tijssen, et al. Randomized Comparison of Primary Percutaneous Coronary Intervention With Combined Proximal Embolic Protection and Thrombus Aspiration Versus Primary Percutaneous Coronary Intervention Alone in ST-Segment Elevation Myocardial Infarction: The PREPARE (PRoximal Embolic Protection in Acute myocardial infarction and Resolution of ST-Elevation) Study J. Am. Coll. Cardiol. Intv., October 1, 2009; 2(10): 934 - 943. [Abstract] [Full Text] [PDF]

				M. Srinivasan, C. Rihal, D. R. Holmes, and A. Prasad Adjunctive Thrombectomy and Distal Protection in Primary Percutaneous Coronary Intervention: Impact on Microvascular Perfusion and Outcomes Circulation, March 10, 2009; 119(9): 1311 - 1319. [Abstract] [Full Text] [PDF]

				P. G. Steg and G. Ducrocq Devices to protect against embolization during primary angioplasty for ST-segment elevation myocardial infarction: the good, the bad and the ugly Eur. Heart J., December 2, 2008; 29(24): 2953 - 2954. [Full Text] [PDF]

				S. R. Dixon, C. L. Grines, and W. W. O'Neill The year in interventional cardiology. J. Am. Coll. Cardiol., June 17, 2008; 51(24): 2355 - 2369. [Full Text] [PDF]

				E. R. Bates Aspirating and Filtering Atherothrombotic Debris During Percutaneous Coronary Intervention J. Am. Coll. Cardiol. Intv., June 1, 2008; 1(3): 265 - 267. [Full Text] [PDF]

				A. Coolong, D. S. Baim, R. E. Kuntz, A. J. O'Malley, S. Marulkar, D. E. Cutlip, J. J. Popma, and L. Mauri Saphenous Vein Graft Stenting and Major Adverse Cardiac Events: A Predictive Model Derived From a Pooled Analysis of 3958 Patients Circulation, February 12, 2008; 117(6): 790 - 797. [Abstract] [Full Text] [PDF]

				A. N. DeMaria, J. J. Bax, O. Ben-Yehuda, P. Clopton, G. K. Feld, G. S. Ginsburg, B. H. Greenberg, J. D. Knoke, W. Y.W. Lew, J. A.C. Lima, et al. Highlights of the year in JACC 2007. J. Am. Coll. Cardiol., January 29, 2008; 51(4): 490 - 512. [Full Text] [PDF]

				Proximal Protection for Saphenous Vein Graft Percutaneous Coronary Intervention Journal Watch Cardiology, December 12, 2007; 2007(1212): 7 - 7. [Full Text]