title: Three-year outcomes associated with embolic protection in saphenous vein graft intervention: results in 49 325 senior patients in the Medicare-linked National Cardiovascular Data Registry CathPCI Registry.
abstract: BACKGROUND
  Information is limited on contemporary use and outcomes of embolic protection devices (EPDs) in saphenous vein graft interventions.
  
  
  RESULTS
  We formed a longitudinal cohort (2005-2009; n=49 325) by linking National Cardiovascular Data Registry CathPCI Registry to Medicare claims to examine the association between EPD use and both procedural and long-term outcomes among seniors (65+ years), adjusting for clinical factors using propensity and instrumental variable methodologies. Prespecified high-risk subgroups included acute coronary syndrome and de novo or graft body lesions. EPDs were used in 21.2% of saphenous vein grafts (median age, 75; 23% women) and were more common in acute coronary syndrome (versus non-acute coronary syndrome; 22% versus 19%), de novo (versus restenotic; 22% versus 14%), and graft body lesions (versus aortic and distal anastomosis; 24% versus 20% versus 8%, respectively). EPDs were associated with a slightly higher incidence of procedural complications, including no reflow (3.9% versus 2.8%; P<0.001), vessel dissection (1.3% versus 1.1%; P=0.05), perforation (0.7% versus 0.4%; P=0.001), and periprocedural myocardial infarction (2.8% versus 1.8%; P<0.001). By 3 years, death, myocardial infarction, and repeat revascularization occurred in 25%, 15%, and 30% of cases, respectively. EPD use was associated with a similar adjusted risk of death (propensity score-matched hazard ratio, 0.96; 95% confidence interval, 0.91-1.02), myocardial infarction (propensity score-matched hazard ratio, 1.00; 95% confidence interval, 0.93-1.09), and repeat revascularization (propensity score-matched hazard ratio, 1.02; 95% confidence interval, 0.96-1.08) in the overall cohort and high-risk subgroups.
  
  
  CONCLUSIONS
  In this contemporary cohort, EPDs were used more commonly among patients with high-risk clinical indications, yet there was no evidence of improved acute- or long-term outcomes. Further prospective studies are needed to support routine EPD use.
authors.affiliation: From the Duke Clinical Research Institute, Durham, NC (J.M.B., W.A.-H., D.D., S.V.R., K.J.A., E.D.P., P.S.D., M.H.S.); Sutter Pacific Heart Centers, San Francisco, CA (R.E.S.); Carolina Pacific Medical Center, San Francisco, CA (M.T.); Veterans Affairs North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas (E.S.B.); and Denver Veterans Affairs Medical Center, CO (J.C.M.). j.matthew.brennan@dm.duke.edu.
authors.forename: J Matthew
authors.initials: JM
authors.lastname: Brennan
authors.affiliation: From the Duke Clinical Research Institute, Durham, NC (J.M.B., W.A.-H., D.D., S.V.R., K.J.A., E.D.P., P.S.D., M.H.S.); Sutter Pacific Heart Centers, San Francisco, CA (R.E.S.); Carolina Pacific Medical Center, San Francisco, CA (M.T.); Veterans Affairs North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas (E.S.B.); and Denver Veterans Affairs Medical Center, CO (J.C.M.).
authors.forename: Wesam
authors.initials: W
authors.lastname: Al-Hejily
authors.affiliation: From the Duke Clinical Research Institute, Durham, NC (J.M.B., W.A.-H., D.D., S.V.R., K.J.A., E.D.P., P.S.D., M.H.S.); Sutter Pacific Heart Centers, San Francisco, CA (R.E.S.); Carolina Pacific Medical Center, San Francisco, CA (M.T.); Veterans Affairs North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas (E.S.B.); and Denver Veterans Affairs Medical Center, CO (J.C.M.).
authors.forename: David
authors.initials: D
authors.lastname: Dai
authors.affiliation: From the Duke Clinical Research Institute, Durham, NC (J.M.B., W.A.-H., D.D., S.V.R., K.J.A., E.D.P., P.S.D., M.H.S.); Sutter Pacific Heart Centers, San Francisco, CA (R.E.S.); Carolina Pacific Medical Center, San Francisco, CA (M.T.); Veterans Affairs North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas (E.S.B.); and Denver Veterans Affairs Medical Center, CO (J.C.M.).
authors.forename: Richard E
authors.initials: RE
authors.lastname: Shaw
authors.affiliation: From the Duke Clinical Research Institute, Durham, NC (J.M.B., W.A.-H., D.D., S.V.R., K.J.A., E.D.P., P.S.D., M.H.S.); Sutter Pacific Heart Centers, San Francisco, CA (R.E.S.); Carolina Pacific Medical Center, San Francisco, CA (M.T.); Veterans Affairs North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas (E.S.B.); and Denver Veterans Affairs Medical Center, CO (J.C.M.).
authors.forename: Marina
authors.initials: M
authors.lastname: Trilesskaya
authors.affiliation: From the Duke Clinical Research Institute, Durham, NC (J.M.B., W.A.-H., D.D., S.V.R., K.J.A., E.D.P., P.S.D., M.H.S.); Sutter Pacific Heart Centers, San Francisco, CA (R.E.S.); Carolina Pacific Medical Center, San Francisco, CA (M.T.); Veterans Affairs North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas (E.S.B.); and Denver Veterans Affairs Medical Center, CO (J.C.M.).
authors.forename: Sunil V
authors.initials: SV
authors.lastname: Rao
authors.affiliation: From the Duke Clinical Research Institute, Durham, NC (J.M.B., W.A.-H., D.D., S.V.R., K.J.A., E.D.P., P.S.D., M.H.S.); Sutter Pacific Heart Centers, San Francisco, CA (R.E.S.); Carolina Pacific Medical Center, San Francisco, CA (M.T.); Veterans Affairs North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas (E.S.B.); and Denver Veterans Affairs Medical Center, CO (J.C.M.).
authors.forename: Emmanouil S
authors.initials: ES
authors.lastname: Brilakis
authors.affiliation: From the Duke Clinical Research Institute, Durham, NC (J.M.B., W.A.-H., D.D., S.V.R., K.J.A., E.D.P., P.S.D., M.H.S.); Sutter Pacific Heart Centers, San Francisco, CA (R.E.S.); Carolina Pacific Medical Center, San Francisco, CA (M.T.); Veterans Affairs North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas (E.S.B.); and Denver Veterans Affairs Medical Center, CO (J.C.M.).
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Anstrom
authors.affiliation: From the Duke Clinical Research Institute, Durham, NC (J.M.B., W.A.-H., D.D., S.V.R., K.J.A., E.D.P., P.S.D., M.H.S.); Sutter Pacific Heart Centers, San Francisco, CA (R.E.S.); Carolina Pacific Medical Center, San Francisco, CA (M.T.); Veterans Affairs North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas (E.S.B.); and Denver Veterans Affairs Medical Center, CO (J.C.M.).
authors.forename: John C
authors.initials: JC
authors.lastname: Messenger
authors.affiliation: From the Duke Clinical Research Institute, Durham, NC (J.M.B., W.A.-H., D.D., S.V.R., K.J.A., E.D.P., P.S.D., M.H.S.); Sutter Pacific Heart Centers, San Francisco, CA (R.E.S.); Carolina Pacific Medical Center, San Francisco, CA (M.T.); Veterans Affairs North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas (E.S.B.); and Denver Veterans Affairs Medical Center, CO (J.C.M.).
authors.forename: Eric D
authors.initials: ED
authors.lastname: Peterson
authors.affiliation: From the Duke Clinical Research Institute, Durham, NC (J.M.B., W.A.-H., D.D., S.V.R., K.J.A., E.D.P., P.S.D., M.H.S.); Sutter Pacific Heart Centers, San Francisco, CA (R.E.S.); Carolina Pacific Medical Center, San Francisco, CA (M.T.); Veterans Affairs North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas (E.S.B.); and Denver Veterans Affairs Medical Center, CO (J.C.M.).
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Douglas
authors.affiliation: From the Duke Clinical Research Institute, Durham, NC (J.M.B., W.A.-H., D.D., S.V.R., K.J.A., E.D.P., P.S.D., M.H.S.); Sutter Pacific Heart Centers, San Francisco, CA (R.E.S.); Carolina Pacific Medical Center, San Francisco, CA (M.T.); Veterans Affairs North Texas Healthcare System and University of Texas Southwestern Medical Center, Dallas (E.S.B.); and Denver Veterans Affairs Medical Center, CO (J.C.M.).
authors.forename: Michael H
authors.initials: MH
authors.lastname: Sketch
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D057505:Embolic Protection Devices; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D006278:Medicare / Q000706:statistics & numerical data; D012042:Registries; D012501:Saphenous Vein / Q000601:surgery*; D016896:Treatment Outcome; D014481:United States; D058017:Vascular Grafting / Q000379:methods*
keywords: embolic protection devices