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

Robert L. Wilensky, Jean Francois Tanguay, Shigenori Ito, Antonio L. Bartorelli, Jeffrey Moses, David O. Williams, Steven R. Bailey, Jack Martin, Theresa A. Bucher, Pam Gallant, Ann Greenberg, Jeffrey J. Popma, Neil J. Weissman, Gary S. Mintz, Aaron V. Kaplan, Martin B. Leon

Research output: Contribution to journalArticle

29 Citations (Scopus)

Abstract

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 (24.77%). 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.

Original languageEnglish (US)
Pages (from-to)1061-1070
Number of pages10
JournalAmerican Heart Journal
Volume139
Issue number6
DOIs
StatePublished - Jun 2000

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Tunica Intima
Hyperplasia
Blood Vessels
Heparin
Randomized Controlled Trials
Stents
Angioplasty
Safety
Dissection
Coronary Vessels
Myocardial Infarction
Incidence
Wounds and Injuries
Pharmaceutical Preparations
Genes

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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. / Wilensky, Robert L.; Tanguay, Jean Francois; Ito, Shigenori; Bartorelli, Antonio L.; Moses, Jeffrey; Williams, David O.; Bailey, Steven R.; Martin, Jack; Bucher, Theresa A.; Gallant, Pam; Greenberg, Ann; Popma, Jeffrey J.; Weissman, Neil J.; Mintz, Gary S.; Kaplan, Aaron V.; Leon, Martin B.

In: American Heart Journal, Vol. 139, No. 6, 06.2000, p. 1061-1070.

Research output: Contribution to journalArticle

Wilensky, RL, Tanguay, JF, Ito, S, Bartorelli, AL, Moses, J, Williams, DO, Bailey, SR, Martin, J, Bucher, TA, Gallant, P, Greenberg, A, Popma, JJ, Weissman, NJ, Mintz, GS, Kaplan, AV & Leon, MB 2000, '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', American Heart Journal, vol. 139, no. 6, pp. 1061-1070. https://doi.org/10.1067/mhj.2000.106614
Wilensky, Robert L. ; Tanguay, Jean Francois ; Ito, Shigenori ; Bartorelli, Antonio L. ; Moses, Jeffrey ; Williams, David O. ; Bailey, Steven R. ; Martin, Jack ; Bucher, Theresa A. ; Gallant, Pam ; Greenberg, Ann ; Popma, Jeffrey J. ; Weissman, Neil J. ; Mintz, Gary S. ; Kaplan, Aaron V. ; Leon, Martin B. / 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. In: American Heart Journal. 2000 ; Vol. 139, No. 6. pp. 1061-1070.
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abstract = "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 (24.77{\%}). 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.",
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T1 - Heparin infusion prior to stenting (HIPS) trial

T2 - Final results of a prospective, randomized, controlled trial evaluating the effects of local vascular delivery on intimal hyperplasia

AU - Wilensky, Robert L.

AU - Tanguay, Jean Francois

AU - Ito, Shigenori

AU - Bartorelli, Antonio L.

AU - Moses, Jeffrey

AU - Williams, David O.

AU - Bailey, Steven R.

AU - Martin, Jack

AU - Bucher, Theresa A.

AU - Gallant, Pam

AU - Greenberg, Ann

AU - Popma, Jeffrey J.

AU - Weissman, Neil J.

AU - Mintz, Gary S.

AU - Kaplan, Aaron V.

AU - Leon, Martin B.

PY - 2000/6

Y1 - 2000/6

N2 - 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 (24.77%). 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.

AB - 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 (24.77%). 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.

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