title: Femoral micropuncture or routine introducer study (FEMORIS).
abstract: OBJECTIVE
  The Micropuncture® 21-gauge needle may reduce complications related to vessel trauma from inadvertent venous or posterior arterial wall puncture.
  
  
  METHODS
  This was a single-center, multiple-user trial. Four hundred and two patients undergoing possible or definite percutaneous coronary intervention (PCI) were randomized 1:1 to an 18-gauge versus a 21-gauge needle. Patients and personnel pulling the sheaths and performing the follow-up were blinded. The primary end point was a composite of access bleeding. Events were tabulated following sheath removal, ≤ 24 h after the procedure and at the follow-up (at 1-2 weeks). End points were blindly adjudicated.
  
  
  RESULTS
  The event rate overall was 12.4% and did not differ significantly between groups, although the 21-gauge needle was found to reduce events by more than one third. An exploratory subgroup analysis of prespecified variables indicated that: patients who did not undergo PCI or elective procedures, female patients and those with a final sheath size of ≤ 6 Fr all had a significant or near-significant reduction of complications with Micropuncture.
  
  
  CONCLUSIONS
  Although no significant differences between the use of the 18- and 21-gauge needles were observed, there was a 50-75% reduction with Micropuncture in several subgroups. The study was terminated prematurely. Access site complications may be reduced by the use of the 21-gauge needle, particularly when the risk of bleeding is not high. Further multicenter data will be required to confirm these hypothesis-generating observations.
authors.affiliation: Division of Cardiology, Department of Internal Medicine, UCSF Fresno Medical Education Program, Fresno, Calif., USA.
authors.forename: John A
authors.initials: JA
authors.lastname: Ambrose
authors.forename: Joel
authors.initials: J
authors.lastname: Lardizabal
authors.forename: Mouatou
authors.initials: M
authors.lastname: Mouanoutoua
authors.forename: Cyrus F
authors.initials: CF
authors.lastname: Buhari
authors.forename: Ryan
authors.initials: R
authors.lastname: Berg
authors.forename: Bipin
authors.initials: B
authors.lastname: Joshi
authors.forename: Karim
authors.initials: K
authors.lastname: El-Sherief
authors.forename: Ralph
authors.initials: R
authors.lastname: Wessel
authors.forename: Manmeet
authors.initials: M
authors.lastname: Singh
authors.forename: Richard
authors.initials: R
authors.lastname: Kiel
mesh_terms: D000368:Aged; D003324:Coronary Artery Disease / Q000601:surgery*; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009339:Needles; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D011677:Punctures / Q000009:adverse effects / Q000295:instrumentation*; D016896:Treatment Outcome