title: Effectiveness of Arterial Closure Devices for Preventing Complications With Percutaneous Coronary Intervention: An Instrumental Variable Analysis.
abstract: BACKGROUND
  Bleeding is associated with poor outcomes after percutaneous coronary intervention (PCI). Although arterial closure devices (ACDs) are widely used in clinical practice, whether they are effective in reducing bleeding complications during transfemoral PCI is uncertain. The objective of this study was to evaluate the effectiveness of ACDs for the prevention of vascular access site complications in patients undergoing transfemoral PCI using an instrumental variable approach.
  
  
  RESULTS
  We performed a retrospective analysis of the CathPCI Registry from 2009 to 2013 at 1470 sites across the United States. Variation in the proportion of ACDs used by each individual physician operator was used as an instrumental variable to address potential confounding. A 2-stage instrumental variable analysis was used as the primary approach. The main outcome measure was vascular access site complications, and nonaccess site bleeding was used as a falsification end point (negative control) to evaluate for potential confounding. A total of 1 053 155 ACDs were used during 2 056 585 PCIs during the study period. The vascular access site complication rate was 1.5%. In the instrumental variable analysis, the use of ACDs was associated with a 0.40% absolute risk reduction in vascular access site complications (95% confidence interval, 0.31-0.42; number needed to treat=250). Absolute differences in nonaccess site bleeding were negligible (risk difference, 0.04%; 95% confidence interval, 0.01-0.07), suggesting acceptable control of confounding in the comparison.
  
  
  CONCLUSIONS
  ACDs are associated with a modest reduction in major bleeding after PCI. The number needed to treat with ACDs to prevent 1 major bleeding event is high.
authors.affiliation: From the Division of Cardiology, Department of Medicine, Christiana Care Health System, Newark, DE (N.J.W.); Division of Cardiology, Department of Medicine, Massachusetts General Hospital, Boston (E.A.S.); Division of Cardiology, Department of Medicine, Brigham and Women's Hospital, Boston, MA (L.M.); Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.T.R., D.D.); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, CA (P.S.-C.); Division of Cardiology, Department of Medicine, University of Washington, Seattle (J.M.M.); Division of Cardiology, Department of Medicine, Lahey Clinic, Burlington, MA (F.S.R.); Division of Cardiology, Department of Medicine, University of Michigan, Ann Arbor (H.S.G.); and Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y.).
authors.forename: Neil J
authors.initials: NJ
authors.lastname: Wimmer
authors.affiliation: From the Division of Cardiology, Department of Medicine, Christiana Care Health System, Newark, DE (N.J.W.); Division of Cardiology, Department of Medicine, Massachusetts General Hospital, Boston (E.A.S.); Division of Cardiology, Department of Medicine, Brigham and Women's Hospital, Boston, MA (L.M.); Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.T.R., D.D.); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, CA (P.S.-C.); Division of Cardiology, Department of Medicine, University of Washington, Seattle (J.M.M.); Division of Cardiology, Department of Medicine, Lahey Clinic, Burlington, MA (F.S.R.); Division of Cardiology, Department of Medicine, University of Michigan, Ann Arbor (H.S.G.); and Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y.).
authors.forename: Eric A
authors.initials: EA
authors.lastname: Secemsky
authors.affiliation: From the Division of Cardiology, Department of Medicine, Christiana Care Health System, Newark, DE (N.J.W.); Division of Cardiology, Department of Medicine, Massachusetts General Hospital, Boston (E.A.S.); Division of Cardiology, Department of Medicine, Brigham and Women's Hospital, Boston, MA (L.M.); Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.T.R., D.D.); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, CA (P.S.-C.); Division of Cardiology, Department of Medicine, University of Washington, Seattle (J.M.M.); Division of Cardiology, Department of Medicine, Lahey Clinic, Burlington, MA (F.S.R.); Division of Cardiology, Department of Medicine, University of Michigan, Ann Arbor (H.S.G.); and Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y.).
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
authors.affiliation: From the Division of Cardiology, Department of Medicine, Christiana Care Health System, Newark, DE (N.J.W.); Division of Cardiology, Department of Medicine, Massachusetts General Hospital, Boston (E.A.S.); Division of Cardiology, Department of Medicine, Brigham and Women's Hospital, Boston, MA (L.M.); Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.T.R., D.D.); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, CA (P.S.-C.); Division of Cardiology, Department of Medicine, University of Washington, Seattle (J.M.M.); Division of Cardiology, Department of Medicine, Lahey Clinic, Burlington, MA (F.S.R.); Division of Cardiology, Department of Medicine, University of Michigan, Ann Arbor (H.S.G.); and Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y.).
authors.forename: Matthew T
authors.initials: MT
authors.lastname: Roe
authors.affiliation: From the Division of Cardiology, Department of Medicine, Christiana Care Health System, Newark, DE (N.J.W.); Division of Cardiology, Department of Medicine, Massachusetts General Hospital, Boston (E.A.S.); Division of Cardiology, Department of Medicine, Brigham and Women's Hospital, Boston, MA (L.M.); Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.T.R., D.D.); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, CA (P.S.-C.); Division of Cardiology, Department of Medicine, University of Washington, Seattle (J.M.M.); Division of Cardiology, Department of Medicine, Lahey Clinic, Burlington, MA (F.S.R.); Division of Cardiology, Department of Medicine, University of Michigan, Ann Arbor (H.S.G.); and Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y.).
authors.forename: Paramita
authors.initials: P
authors.lastname: Saha-Chaudhuri
authors.affiliation: From the Division of Cardiology, Department of Medicine, Christiana Care Health System, Newark, DE (N.J.W.); Division of Cardiology, Department of Medicine, Massachusetts General Hospital, Boston (E.A.S.); Division of Cardiology, Department of Medicine, Brigham and Women's Hospital, Boston, MA (L.M.); Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.T.R., D.D.); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, CA (P.S.-C.); Division of Cardiology, Department of Medicine, University of Washington, Seattle (J.M.M.); Division of Cardiology, Department of Medicine, Lahey Clinic, Burlington, MA (F.S.R.); Division of Cardiology, Department of Medicine, University of Michigan, Ann Arbor (H.S.G.); and Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y.).
authors.forename: David
authors.initials: D
authors.lastname: Dai
authors.affiliation: From the Division of Cardiology, Department of Medicine, Christiana Care Health System, Newark, DE (N.J.W.); Division of Cardiology, Department of Medicine, Massachusetts General Hospital, Boston (E.A.S.); Division of Cardiology, Department of Medicine, Brigham and Women's Hospital, Boston, MA (L.M.); Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.T.R., D.D.); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, CA (P.S.-C.); Division of Cardiology, Department of Medicine, University of Washington, Seattle (J.M.M.); Division of Cardiology, Department of Medicine, Lahey Clinic, Burlington, MA (F.S.R.); Division of Cardiology, Department of Medicine, University of Michigan, Ann Arbor (H.S.G.); and Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y.).
authors.forename: James M
authors.initials: JM
authors.lastname: McCabe
authors.affiliation: From the Division of Cardiology, Department of Medicine, Christiana Care Health System, Newark, DE (N.J.W.); Division of Cardiology, Department of Medicine, Massachusetts General Hospital, Boston (E.A.S.); Division of Cardiology, Department of Medicine, Brigham and Women's Hospital, Boston, MA (L.M.); Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.T.R., D.D.); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, CA (P.S.-C.); Division of Cardiology, Department of Medicine, University of Washington, Seattle (J.M.M.); Division of Cardiology, Department of Medicine, Lahey Clinic, Burlington, MA (F.S.R.); Division of Cardiology, Department of Medicine, University of Michigan, Ann Arbor (H.S.G.); and Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y.).
authors.forename: Frederic S
authors.initials: FS
authors.lastname: Resnic
authors.affiliation: From the Division of Cardiology, Department of Medicine, Christiana Care Health System, Newark, DE (N.J.W.); Division of Cardiology, Department of Medicine, Massachusetts General Hospital, Boston (E.A.S.); Division of Cardiology, Department of Medicine, Brigham and Women's Hospital, Boston, MA (L.M.); Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.T.R., D.D.); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, CA (P.S.-C.); Division of Cardiology, Department of Medicine, University of Washington, Seattle (J.M.M.); Division of Cardiology, Department of Medicine, Lahey Clinic, Burlington, MA (F.S.R.); Division of Cardiology, Department of Medicine, University of Michigan, Ann Arbor (H.S.G.); and Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y.).
authors.forename: Hitinder S
authors.initials: HS
authors.lastname: Gurm
authors.affiliation: From the Division of Cardiology, Department of Medicine, Christiana Care Health System, Newark, DE (N.J.W.); Division of Cardiology, Department of Medicine, Massachusetts General Hospital, Boston (E.A.S.); Division of Cardiology, Department of Medicine, Brigham and Women's Hospital, Boston, MA (L.M.); Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.T.R., D.D.); Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, CA (P.S.-C.); Division of Cardiology, Department of Medicine, University of Washington, Seattle (J.M.M.); Division of Cardiology, Department of Medicine, Lahey Clinic, Burlington, MA (F.S.R.); Division of Cardiology, Department of Medicine, University of Michigan, Ann Arbor (H.S.G.); and Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y.). ryeh@bidmc.harvard.edu.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Yeh
mesh_terms: D000368:Aged; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects*; D011677:Punctures; D012042:Registries; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D065506:Vascular Closure Devices
keywords: bleeding; complications; femoral artery; percutaneous coronary intervention; vascular closure devices