Local delivery of heparin post-PTCA: A multicenter randomized pilot study

Bailout stenting for major dissection and threatened closure has high rates of ischemic complications. We performed a randomized trial of local hepari n delivery using the infusion sleeve before bailout stenting for suboptimal angioplasty results. In phase 1, 20 patients were randomized to local deli very 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 de livery succeeded in all but one patient; overall there was no significant w orsening of intimal dissection. One patient treated with 100-psi drug infus ion suffered a perforation after stent placement. There were no significant differences in the composite endpoint of death, MI, CABG, urgent repeat an gioplasty, and stent thrombosis at 30 days (21% vs. 0%; P = 0.18). At 6 mon ths, the rates of myocardial infarction in phase II were 27% with local del ivery 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. (C) 2000 Wiley-Liss, Inc.