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Circulation: Cardiovascular Interventions. 2008;1:111-118
Published online before print September 3, 2008, doi: 10.1161/CIRCINTERVENTIONS.108.784660
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Original Articles

Impact of In-Stent Minimal Lumen Area at 9 Months Poststent Implantation on 3-Year Target Lesion Revascularization–Free Survival

A Serial Intravascular Ultrasound Analysis From the TAXUS IV, V, and VI Trials

Hiroshi Doi, MD, PhD; Akiko Maehara, MD; Gary S. Mintz, MD; Neil J. Weissman, MD; Alan Yu, MS; Hong Wang, MS; Lazar Mandinov, MD; Jeffrey J. Popma, MD; Stephen G. Ellis, MD; Eberhard Grube, MD; Keith D. Dawkins, MD and Gregg W. Stone, MD

From the Cardiovascular Research Foundation, New York, NY (H.D., A.M., G.S.M., G.W.S.); Columbia University Medical Center, New York, NY (H.D., A.M., G.S.M., G.W.S.); Washington Hospital Center, Washington, DC (N.W.W.); Boston Scientific Corporation, Natick, Mass (A.Y., H.W., L.M., K.D.D.); St Elizabeth Medical Center, Boston, Mass (J.J.P); Cleveland Clinic, Cleveland, Ohio (S.G.E.); and Heart Center Siegburg, Siegburg, Germany (E.G.).

Correspondence to Gary S. Mintz, MD, 611 Pennsylvania Ave, SE #386, Washington, DC 20003. E-mail gsm18439{at}aol.com

Received April 6, 2008; accepted August 13, 2008.

Background— Intravascular ultrasound (IVUS) is used to assess intermediate lesions in native coronary arteries; minimum lumen area (MLA) <4.0 mm2 is accepted as a cutoff for a significant stenosis. We evaluated the IVUS in-stent MLA at 9-month follow-up that best predicted subsequent target lesion revascularization (TLR)–free survival in patients from the TAXUS IV, V, and VI studies.

Methods and Results— In the combined TAXUS IV, V, and VI randomized trials, 9-month IVUS was available in 635 patients (331 treated with paclitaxel-eluting stents [PES] and 304 treated with bare-metal stents [BMS]) who did not require TLR in the first 9 months postintervention and who were followed for 3 years. The in-stent MLA that best predicted 3-year TLR-free survival was determined. At 9-months follow-up, IVUS-measured in-stent MLA was 5.7±2.3 mm2 in the PES group and 4.8±2.3 mm2 in the BMS group. Between 9 months and 3 years, TLR was required in 4.9% of patients who were treated with PES and 6.7% of patients who were treated with BMS. Multivariate analysis identified MLA at 9 months as a significant predictor of late TLR (hazard ratio, 0.63 [0.43–0.93]; P=0.02). The ability of MLA to predict late TLR was further assessed using receiver operating characteristic analysis. MLA was found to be an acceptable discriminator for both PES (c=0.7448) and BMS (c=0.7329). Finally, the optimal thresholds of MLA that best predicted subsequent TLR-free survival were determined to be 4.2 mm2 for PES and 4.0 mm2 for BMS.

Conclusion— In the combined IVUS analysis of TAXUS IV, V, and VI, patients who did not require TLR within the first 9 months had a high subsequent TLR-free survival rate whether treated with PES or BMS. MLA measured by IVUS at 9 months predicted subsequent TLR with a cutoff similar to intermediate, de novo lesions in native coronary arteries.

Key Words: intravascular ultrasound • restenosis • stents


 

CLINICAL PERSPECTIVE


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Impact of In-Stent Minimal Lumen Area at 9 Months Poststent Implantation on 3-Year Target Lesion Revascularization–Free Survival: A Serial Intravascular Ultrasound Analysis From the TAXUS IV, V, and VI Trials
Hiroshi Doi, Akiko Maehara, Gary S. Mintz, Neil J. Weissman, Alan Yu, Hong Wang, Lazar Mandinov, Jeffrey J. Popma, Stephen G. Ellis, Eberhard Grube, Keith D. Dawkins, and Gregg W. Stone
Circ Cardiovasc Interv 2008 1: 111-118. [Abstract] [Full Text] [PDF]



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Circ Cardiovasc IntervHome page
T. A. Bass and P. Capranzano
Managing Patients With Intermediate In-Stent Restenotic Lesions: Is It "Prime Time" for Intravascular Ultrasound Imaging?
Circ Cardiovasc Interv, October 1, 2008; 1(2): 90 - 92.
[Full Text] [PDF]