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Impact of Post-Intervention Minimal Stent Area on 9-Month Follow-Up Patency of Paclitaxel-Eluting Stents

An Integrated Intravascular Ultrasound Analysis From the TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent Trials

Hiroshi Doi, MD, PhD^_*, Akiko Maehara, MD^_*,_*, Gary S. Mintz, 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, Neil J. Weissman, MD^¶, Mark A. Turco, MD^#, John A. Ormiston, MBChB^_**, Gregg W. Stone, MD^_*

^_* Cardiovascular Research Foundation and Columbia University Medical Center, New York, New York
Boston Scientific Corporation, Natick, Massachusetts
St. Elizabeth Medical Center, Boston, Massachusetts
Cleveland Clinic, Cleveland, Ohio
^|| Heart Center Siegburg, Siegburg, Germany
^¶ Washington Hospital Center, Washington, DC
^# Washington Adventist Hospital, Tacoma Park, Maryland
^_** Auckland City Hospital, Auckland, New Zealand

^_* Reprint requests and correspondence: Dr. Akiko Maehara, Cardiovascular Research Foundation, 111 East 59th Street, 12th floor, New York, New York 10022 (Email: amaehara{at}crf.org).

Objectives: We investigated the predictive value of the intravascular ultrasound (IVUS) measured post-intervention minimum stent area (MSA) on 9-month follow-up paclitaxel-eluting stent (PES) patency compared with bare-metal stents (BMS).

Background: Stent underexpansion is a strong predictor for restenosis after sirolimus-eluting stent implantation, but the implication of underexpansion in PES is still unknown.

Methods: From the combined TAXUS IV, V, and VI and TAXUS ATLAS Workhorse, Long Lesion, and Direct Stent trials, 1,580 patients (PES 1,098, BMS 482) in IVUS substudies were analyzed. The MSA that best predicted angiographic in-stent restenosis (ISR) (% diameter stenosis 50%) was determined.

Results: The post-intervention IVUS MSA was similar in PES and BMS (6.6 ± 2.5 mm² vs. 6.7 ± 2.3 mm², p = 0.92). At 9-month follow-up, ISR was lower in the PES group versus the BMS group (10% vs. 31%, p < 0.0001). Using multivariable logistic regression analysis, post-intervention IVUS MSA was the independent predictor of subsequent ISR in both the PES and BMS groups (p = 0.0002 for PES and p = 0.0002 for BMS). The ability of the post-intervention IVUS MSA to predict ISR was further assessed using receiver operating characteristic analysis. The post-intervention IVUS MSA was found to be a faithful discriminator between patients with and without ISR in both PES (c = 0.6382) and BMS (c = 0.6373). Finally, the optimal thresholds of post-intervention IVUS MSA that best predicted stent patency at 9 months were 5.7 mm² for PES and 6.4 mm² for BMS.

Conclusions: Post-intervention MSA measured by IVUS can predict 9-month follow-up stent patency after both PES and BMS implantation. (Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stents to Treat De Novo Coronary Lesions; NCT00301522) (Direct Stenting of TAXUS Liberté-SR Stent for the Treatment of Patients With de Novo Coronary Artery Lesions; NCT00371423) (A Study of the TAXUS Liberté Stent for the Treatment of Long De Novo Coronary Artery Lesions; NCT00371475) (A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels; NCT00371748)

Key Words: intravascular ultrasound • in-stent restenosis • paclitaxel-eluting stent • stent expansion

Abbreviations and Acronyms   BMS = bare-metal stent(s)   DES = drug-eluting stent(s)   ISR = in-stent restenosis   IVUS = intravascular ultrasound   MLA = minimal lumen area   MSA = minimum stent area   PES = paclitaxel-eluting stent(s)   ROC = receiver-operator characteristic   SES = sirolimus-eluting stent(s)   TLR = target lesion revascularization

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