| Heparin infusion prior to stenting (HIPS) trial: final results of a prospective, randomized, controlled trial evaluating the effects of local vascular delivery on intimal hyperplasia. | |
| | |
MedLine Citation:
|
PMID: 10827388 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
BACKGROUND: Local delivery of pharmacologic agents or genes at the site of angioplasty is a promising approach to reduce restenosis. However, there are unresolved questions concerning the safety and feasibility of local vascular delivery in clinical practice as well as the efficacy of delivered drug. To this end, the safety, feasibility, and efficacy of local delivery of heparin were evaluated in the Heparin Infusion Prior to Stenting (HIPS) trial. METHODS AND RESULTS: A total of 179 patients were enrolled in this multicenter, randomized, prospective, core laboratory-evaluated trial. Patients were randomly assigned to 5000 U heparin either administered to the coronary artery lumen or infused into the arterial wall immediately after angioplasty and before stent placement. End points included procedural events and clinical, angiographic, and intravascular ultrasound events at 6 months. Patient groups were evenly matched. There was no difference in the incidence of arterial injury, defined as an increase in arterial dissection, acute closure, or decrease in Thrombolysis In Myocardial Infarction grade blood flow in the group receiving local delivery. At follow-up there was no difference in the major adverse event rate between intraluminal (22.7%) and local groups (24.7%). There was no difference between intraluminal and local therapy in the angiographic in-stent restenosis rate (12.5%, 12.7%) or the in-stent volumetric analysis by intravascular ultrasound (IVUS) (37.19 +/- 20. 86 mm(3) vs 43.79 +/- 25.52 mm(3)). CONCLUSIONS: Local delivery of 5000 U heparin into the arterial wall before stent implantation is safe and feasible. There was not a favorable effect of locally delivered heparin on clinical, angiographic, or IVUS end points of restenosis. The use of IVUS to measure volume of intimal hyperplasia in a multicenter, core laboratory-controlled trial is feasible. |
| | |
Authors:
|
R L Wilensky; J F Tanguay; S Ito; A L Bartorelli; J Moses; D O Williams; S R Bailey; J Martin; T A Bucher; P Gallant; A Greenberg; J J Popma; N J Weissman; G S Mintz; A V Kaplan; M B Leon |
Related Documents
:
|
11272368 - Effects of a positron-emitting vanadium-48 nitinol stent on experimental restenosis in ... 9483768 - The use of intravascular ultrasound for intraoperative assessment during semiclosed thr... 17049638 - In-stent restenosis in idiopathic isolated ostial left main coronary artery stenosis. 15619278 - Percutaneous coronary intervention with drug-eluting stent implantation vs. minimally i... 11128468 - Contralateral internal jugular vein interposition for salvage of a functioning arteriov... 899998 - Surgical management of intermittent claudication. |
Publication Detail:
|
Type: Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial |
Journal Detail:
|
Title: American heart journal Volume: 139 ISSN: 0002-8703 ISO Abbreviation: Am. Heart J. Publication Date: 2000 Jun |
Date Detail:
|
Created Date: 2000-07-13 Completed Date: 2000-07-13 Revised Date: 2006-11-15 |
Medline Journal Info:
|
Nlm Unique ID: 0370465 Medline TA: Am Heart J Country: UNITED STATES |
Other Details:
|
Languages: eng Pagination: 1061-70 Citation Subset: AIM; IM |
Affiliation:
|
University of Pennsylvania Medical Center, Philadelphia 19104, USA. ewilensk@mail.med.upenn.edu |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Blood Flow Velocity
/
drug effects Blood Vessel Prosthesis Implantation* Coronary Angiography Coronary Vessels / drug effects, pathology, ultrasonography Drug Evaluation Endosonography Feasibility Studies Female Fibrinolytic Agents / administration & dosage* Heparin / administration & dosage* Humans Hyperplasia / prevention & control Infusions, Intra-Arterial Male Middle Aged Myocardial Infarction / diagnosis, physiopathology, therapy* Preoperative Care Prospective Studies Recurrence / prevention & control Safety Stents* Thrombolytic Therapy Treatment Outcome Tunica Intima / drug effects, pathology*, ultrasonography |
| Chemical | |
Reg. No./Substance:
|
0/Fibrinolytic Agents; 9005-49-6/Heparin |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Early results and medium-term follow-up of stent implantation for mild residual or recurrent aortic ...
Next Document: Sensitivity and specificity of transesophageal echocardiography for determination of aortic valve mo...