title: Immediate removal of femoral-sheath following protamine administration in patients undergoing intracoronary paclitaxel-eluting-stent implantation.
abstract: BACKGROUND
  Immediate sheath-removal using post-procedural reversal of heparin with protamine reduces groin complications, shortens bed rest and hospital stay after percutaneous coronary intervention (PCI) with bare-metal stents. No data are available with newer and possibly more thrombogenic paclitaxel-eluting stents (PES).
  
  
  OBJECTIVE
  We assessed the safety and efficacy of post-procedural protamine administration after successful coronary PES implantation in elective PCI and in patients with acute coronary syndromes (ACS).
  
  
  METHODS
  A consecutive series of 291 patients received 0.5 mg of protamine per 100 units of heparin whenever the post-procedural ACT was > 180 seconds, followed by immediate removal of the sheath (protamine group). Outcomes were compared to a historic control group comprising 291 consecutive patients, who also underwent PCI with PES, but without reversal of anticoagulation by protamine (non protamine group). The incidence of post-procedural vascular complications and bleeding complications, as well as hospital stay, were compared; as were the incidence of major cardiac events at 24 h, 30 days and 6 months.
  
  
  RESULTS
  The post-procedural bleeding complications were significantly higher in the non-protamine group. Vascular complications were also more frequent in patients who were not treated with protamine. Hospitalisation length was significantly lower in the protamine group than in the non-protamine group (13.6 +/- 7 h versus 20.41 +/- 3.9 h; p < 0.001). The protamine-group patients also had a significantly reduced bed rest (10.3 h +/- 5.6 h versus 18 h +/- 3.5 h; p < 0.001). During hospitalisation, after PES implantation, no deaths or acute stent thrombosis were observed in either group. The overall incidence of thrombosis and major adverse cardiac events at follow-up were similar in the two groups.
  
  
  CONCLUSIONS
  Immediate heparin neutralisation by protamine after successful PES implantation appears to be safe and feasible, also in patients with ACS. Use of protamine and early sheath removal after PCI confers early deambulation and may significantly limit healthcare cost, reduce vascular complications, bedrest, delayed discharge and patient discomfort.
authors: Unitá Operativa di Emodinamica e Cardiologia Invasiva, Istituto Clinico Humanitas, Rozzano, Milano, Italy. marco_luciano.rossi@humanitas.it
authors: Marco L
authors: ML
authors: Rossi
authors: Dennis
authors: D
authors: Zavalloni
authors: Melania
authors: M
authors: Scatturin
authors: Gabriele L
authors: GL
authors: Gasparini
authors: Veronica
authors: V
authors: Lisignoli
authors: Patrizia
authors: P
authors: Presbitero
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D003331:Coronary Vessels / Q000187:drug effects / Q000502:physiology; D004333:Drug Administration Routes; D005260:Female; D005268:Femoral Vein / Q000502:physiology; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011479:Protamines / Q000008:administration & dosage*; D015607:Stents; D013997:Time Factors
chemical_list: D011479:Protamines; D017239:Paclitaxel