title: VIPER-2: a prospective, randomized single-center comparison of 2 different closure devices with a hemostatic wound dressing for closure of femoral artery access sites.
abstract: OBJECTIVE
  To report the outcome of a prospective randomized safety and performance trial of 2 access site closure devices versus a wound dressing.
  
  
  METHODS
  Between October 2005 and July 2006, 852 consecutive patients (605 men; mean age 67 years) undergoing diagnostic or interventional catheterization procedures thru a 5- or 6-F femoral sheath were randomized to one of the 3 closure methods: a collagen plug device (Angio-Seal), a clip (StarClose), or a wound dressing (D-Stat Dry). The efficacy of the devices was assessed, as well as the complications occurring at the puncture site during the hospital stay. The primary endpoint of the study was the cumulative incidence of access site pseudoaneurysm, major access site bleeding requiring transfusion, access site vascular surgery, or death from all causes.
  
  
  RESULTS
  There were no significant differences in baseline characteristics between the 3 treatment groups. The primary endpoint was reached in 20 (7.1%) of 281 patients treated with D-Stat Dry and in 11 (1.9%) of 571 patients treated with the mechanical closure devices (p<0.0001). There was no significant difference among the mechanical closure devices concerning the incidence of the primary endpoint (Angio-Seal 1.1% versus StarClose 2.8%; p = 0.13).
  
  
  CONCLUSIONS
  The collagen plug device had the lowest rates of major and minor access site-related complications after removal of 5- or 6-F femoral sheaths. The difference between the mechanical closure devices concerning the incidence of the primary endpoint did not reach statistical significance. The wound dressing showed significantly higher major and minor complication rates.
authors.affiliation: Abteilung Angiologie, Herz-Zentrum Bad Krozingen, Südring 15, Bad Krozingen, Germany. aljoscha.rastan@herzzentrum.de
authors.forename: Aljoscha
authors.initials: A
authors.lastname: Rastan
authors.forename: Sebastian
authors.initials: S
authors.lastname: Sixt
authors.forename: Uwe
authors.initials: U
authors.lastname: Schwarzwälder
authors.forename: Thomas
authors.initials: T
authors.lastname: Schwarz
authors.forename: Ulrich
authors.initials: U
authors.lastname: Frank
authors.forename: Karlheinz
authors.initials: K
authors.lastname: Bürgelin
authors.forename: Volker
authors.initials: V
authors.lastname: Pochert
authors.forename: Elias
authors.initials: E
authors.lastname: Noory
authors.forename: Pietro
authors.initials: P
authors.lastname: Amantea
authors.forename: Daniel
authors.initials: D
authors.lastname: Gremmelmaier
authors.forename: Christian
authors.initials: C
authors.lastname: Müller
authors.forename: Heinz-Joachim
authors.initials: HJ
authors.lastname: Büttner
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D001458:Bandages; D016009:Chi-Square Distribution; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006801:Humans; D016015:Logistic Models; D008297:Male; D011183:Postoperative Complications / Q000209:etiology / Q000517:prevention & control; D011446:Prospective Studies; D016896:Treatment Outcome