title: Local delivery of heparin post-PTCA: a multicenter randomized pilot study.
abstract: Bailout stenting for major dissection and threatened closure has high rates of ischemic complications. We performed a randomized trial of local heparin delivery using the infusion sleeve before bailout stenting for suboptimal angioplasty results. In phase I, 20 patients were randomized to local delivery with either 40- or 100-psi infusion pressure. In phase II, 37 patients were randomized to local delivery at 100 psi or standard therapy. Local delivery succeeded in all but one patient; overall there was no significant worsening of intimal dissection. One patient treated with 100-psi drug infusion suffered a perforation after stent placement. There were no significant differences in the composite endpoint of death, MI, CABG, urgent repeat angioplasty, and stent thrombosis at 30 days (21% vs. 0%; P = 0.18). At 6 months, the rates of myocardial infarction in phase II were 27% with local delivery vs. 10% with standard treatment (P = 0.4). Local heparin delivery in dissected vessels may be associated with increased complications and should be approached with caution.
authors.affiliation: Montreal Heart Institute, Montreal, Quebec, Canada.
authors.forename: J F
authors.initials: JF
authors.lastname: Tanguay
authors.forename: W J
authors.initials: WJ
authors.lastname: Cantor
authors.forename: M W
authors.initials: MW
authors.lastname: Krucoff
authors.forename: B
authors.initials: B
authors.lastname: Muhlestein
authors.forename: G W
authors.initials: GW
authors.lastname: Barsness
authors.forename: J P
authors.initials: JP
authors.lastname: Zidar
authors.forename: M H
authors.initials: MH
authors.lastname: Sketch
authors.forename: J E
authors.initials: JE
authors.lastname: Tcheng
authors.forename: H R
authors.initials: HR
authors.lastname: Phillips
authors.forename: R S
authors.initials: RS
authors.lastname: Stack
authors.forename: A V
authors.initials: AV
authors.lastname: Kaplan
authors.forename: E M
authors.initials: EM
authors.lastname: Ohman
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D017023:Coronary Angiography; D003328:Coronary Thrombosis / Q000000981:diagnostic imaging / Q000188:drug therapy*; D003331:Coronary Vessels / Q000187:drug effects*; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006493:Heparin / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007261:Infusions, Intra-Arterial / Q000295:instrumentation; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012307:Risk Factors; D015607:Stents
chemical_list: D006493:Heparin