Paclitaxel coating reduces in-stent intimal hyperplasia in human coronary arteries

A serial volumetric intravascular ultrasound analysis from the Asian Paclitaxel-Eluting Stent Clinical Trial (ASPECT)

Myeongki Hong, Gary S. Mintz, Cheol Whan Lee, Jong Min Song, Ki Hoon Han, Duk Hyun Kang, Jae Kwan Song, Jae Joong Kim, Neil J. Weissman, Neal E. Fearnot, Seong Wook Park, Seung Jung Park

Research output: Contribution to journalArticle

174 Citations (Scopus)

Abstract

Background - The aim of this study was to use serial volumetric intravascular ultrasound (IVUS) to evaluate the effect of a paclitaxel coating on in-stent intimal hyperplasia (IH). Methods and Results - Patients were randomized to placebo (bare metal stents) or 1 of 2 doses of paclitaxel (low dose: 1.28 μg/mm2; high dose: 3.10 μg/mm2). Complete post-stent implantation and follow-up IVUS were available in 81 patients, including 25 control patients and in 28 receiving a low-dose and 28 receiving a high dose. Volumetric analysis of the stented segment and of both reference segments was performed. Baseline stent measurements and both reference measurements were similar among the groups. With increasing doses, there was a stepwise reduction in IH accumulation within the stented segment (31±22 mm3 in control, 18±15 mm3 in low dose, and 13±14 mm3 in high dose, P<0.001). Post hoc analysis showed less IH accumulation when low- and high-dose patients were compared with control (P=0.009 and P<0.001, respectively), but not when low-dose patients were compared with high-dose patients (P=0.2). Focal late malapposition was seen in 1 high-dose patient. With increasing doses, there was no significant change in the reference segments. Conclusions - Paclitaxel-coated stents are effective in reducing in-stent neointimal tissue proliferation in humans. They are not associated with edge restenosis or significant late malapposition.

Original languageEnglish
Pages (from-to)517-520
Number of pages4
JournalCirculation
Volume107
Issue number4
DOIs
Publication statusPublished - 2003 Feb 4

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Tunica Intima
Paclitaxel
Hyperplasia
Stents
Coronary Vessels
Clinical Trials
Metals
Placebos

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Hong, Myeongki ; Mintz, Gary S. ; Lee, Cheol Whan ; Song, Jong Min ; Han, Ki Hoon ; Kang, Duk Hyun ; Song, Jae Kwan ; Kim, Jae Joong ; Weissman, Neil J. ; Fearnot, Neal E. ; Park, Seong Wook ; Park, Seung Jung. / Paclitaxel coating reduces in-stent intimal hyperplasia in human coronary arteries : A serial volumetric intravascular ultrasound analysis from the Asian Paclitaxel-Eluting Stent Clinical Trial (ASPECT). In: Circulation. 2003 ; Vol. 107, No. 4. pp. 517-520.
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abstract = "Background - The aim of this study was to use serial volumetric intravascular ultrasound (IVUS) to evaluate the effect of a paclitaxel coating on in-stent intimal hyperplasia (IH). Methods and Results - Patients were randomized to placebo (bare metal stents) or 1 of 2 doses of paclitaxel (low dose: 1.28 μg/mm2; high dose: 3.10 μg/mm2). Complete post-stent implantation and follow-up IVUS were available in 81 patients, including 25 control patients and in 28 receiving a low-dose and 28 receiving a high dose. Volumetric analysis of the stented segment and of both reference segments was performed. Baseline stent measurements and both reference measurements were similar among the groups. With increasing doses, there was a stepwise reduction in IH accumulation within the stented segment (31±22 mm3 in control, 18±15 mm3 in low dose, and 13±14 mm3 in high dose, P<0.001). Post hoc analysis showed less IH accumulation when low- and high-dose patients were compared with control (P=0.009 and P<0.001, respectively), but not when low-dose patients were compared with high-dose patients (P=0.2). Focal late malapposition was seen in 1 high-dose patient. With increasing doses, there was no significant change in the reference segments. Conclusions - Paclitaxel-coated stents are effective in reducing in-stent neointimal tissue proliferation in humans. They are not associated with edge restenosis or significant late malapposition.",
author = "Myeongki Hong and Mintz, {Gary S.} and Lee, {Cheol Whan} and Song, {Jong Min} and Han, {Ki Hoon} and Kang, {Duk Hyun} and Song, {Jae Kwan} and Kim, {Jae Joong} and Weissman, {Neil J.} and Fearnot, {Neal E.} and Park, {Seong Wook} and Park, {Seung Jung}",
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Paclitaxel coating reduces in-stent intimal hyperplasia in human coronary arteries : A serial volumetric intravascular ultrasound analysis from the Asian Paclitaxel-Eluting Stent Clinical Trial (ASPECT). / Hong, Myeongki; Mintz, Gary S.; Lee, Cheol Whan; Song, Jong Min; Han, Ki Hoon; Kang, Duk Hyun; Song, Jae Kwan; Kim, Jae Joong; Weissman, Neil J.; Fearnot, Neal E.; Park, Seong Wook; Park, Seung Jung.

In: Circulation, Vol. 107, No. 4, 04.02.2003, p. 517-520.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Paclitaxel coating reduces in-stent intimal hyperplasia in human coronary arteries

T2 - A serial volumetric intravascular ultrasound analysis from the Asian Paclitaxel-Eluting Stent Clinical Trial (ASPECT)

AU - Hong, Myeongki

AU - Mintz, Gary S.

AU - Lee, Cheol Whan

AU - Song, Jong Min

AU - Han, Ki Hoon

AU - Kang, Duk Hyun

AU - Song, Jae Kwan

AU - Kim, Jae Joong

AU - Weissman, Neil J.

AU - Fearnot, Neal E.

AU - Park, Seong Wook

AU - Park, Seung Jung

PY - 2003/2/4

Y1 - 2003/2/4

N2 - Background - The aim of this study was to use serial volumetric intravascular ultrasound (IVUS) to evaluate the effect of a paclitaxel coating on in-stent intimal hyperplasia (IH). Methods and Results - Patients were randomized to placebo (bare metal stents) or 1 of 2 doses of paclitaxel (low dose: 1.28 μg/mm2; high dose: 3.10 μg/mm2). Complete post-stent implantation and follow-up IVUS were available in 81 patients, including 25 control patients and in 28 receiving a low-dose and 28 receiving a high dose. Volumetric analysis of the stented segment and of both reference segments was performed. Baseline stent measurements and both reference measurements were similar among the groups. With increasing doses, there was a stepwise reduction in IH accumulation within the stented segment (31±22 mm3 in control, 18±15 mm3 in low dose, and 13±14 mm3 in high dose, P<0.001). Post hoc analysis showed less IH accumulation when low- and high-dose patients were compared with control (P=0.009 and P<0.001, respectively), but not when low-dose patients were compared with high-dose patients (P=0.2). Focal late malapposition was seen in 1 high-dose patient. With increasing doses, there was no significant change in the reference segments. Conclusions - Paclitaxel-coated stents are effective in reducing in-stent neointimal tissue proliferation in humans. They are not associated with edge restenosis or significant late malapposition.

AB - Background - The aim of this study was to use serial volumetric intravascular ultrasound (IVUS) to evaluate the effect of a paclitaxel coating on in-stent intimal hyperplasia (IH). Methods and Results - Patients were randomized to placebo (bare metal stents) or 1 of 2 doses of paclitaxel (low dose: 1.28 μg/mm2; high dose: 3.10 μg/mm2). Complete post-stent implantation and follow-up IVUS were available in 81 patients, including 25 control patients and in 28 receiving a low-dose and 28 receiving a high dose. Volumetric analysis of the stented segment and of both reference segments was performed. Baseline stent measurements and both reference measurements were similar among the groups. With increasing doses, there was a stepwise reduction in IH accumulation within the stented segment (31±22 mm3 in control, 18±15 mm3 in low dose, and 13±14 mm3 in high dose, P<0.001). Post hoc analysis showed less IH accumulation when low- and high-dose patients were compared with control (P=0.009 and P<0.001, respectively), but not when low-dose patients were compared with high-dose patients (P=0.2). Focal late malapposition was seen in 1 high-dose patient. With increasing doses, there was no significant change in the reference segments. Conclusions - Paclitaxel-coated stents are effective in reducing in-stent neointimal tissue proliferation in humans. They are not associated with edge restenosis or significant late malapposition.

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