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CLINICAL STUDIES

Validation of the in vivo intravascular ultrasound measurement of in-stent neointimal hyperplasia volumes

^a Intravascular Ultrasound Imaging and Cardiac Catheterization Laboratories, Washington Hospital Center, Washington, DC, USA
^* University of Texas, San Antonio, Texas, USA

Manuscript received April 14, 1997; revised manuscript received May 14, 1998, accepted May 20, 1998.

Address for correspondence: Dr. Martin B. Leon, Washington Cardiology Center, 110 Irving Street NW, Suite 4B1, Washington, DC 20010

Objectives. This study was undertaken to validate the in vivo intravascular ultrasound (IVUS) measurement of in-stent neointimal hyperplasia (IH) volumes.

Background. Because stents reduce restenosis compared to balloon angioplasty, stent use has increased significantly. As a result, in-stent restenosis is now an important clinical problem. Serial IVUS studies have shown that in-stent restenosis is secondary to intimal hyperplasia. To evaluate strategies to reduce in-stent restenosis, accurate measurement of in-stent neointimal tissue is important.

Methods. Using a porcine coronary artery model of in-stent restenosis, single Palmaz–Schatz stents were implanted into 16 animals with a stent:artery ratio of 1.3:1. Intravascular ultrasound imaging was performed at 1 month, immediately prior to animal sacrifice. In vivo IVUS and ex vivo histomorphometric measurements included stent, lumen and IH areas; IH volumes were calculated with Simpson’s rule.

Results. Intravascular ultrasound measurements of IH (30.4 ± 11.0 mm³) volumes correlated strongly with histomorphometric measurements (26.7 ± 8.5 mm³, r = 0.965, p < 0.0001). The difference between the IVUS and the histomorphometric measurements of IVUS volume was 4.1 ± 2.7 mm³ or 15.8 ± 11% (standard error of the estimate = 0.7). Both histomophometry and IVUS showed that IH was concentric and uniformly distributed over the length of the stent. Intravascular ultrasound detected neointimal thickening of 0.2 mm in 5 of 16 stents.

Sample size calculations based on the IVUS measurement of IH volumes showed that 12 stented lesions/arm would be required to show a 50% reduction in IVUS-measured IH volume and 44 stented lesions/arm would be required to show a 25% reduction in IH volume.

Conclusions. In vivo IVUS measurement of IH volumes correlated strongly with ex vivo histomorphometry. Using volumetric IVUS end points, small sample sizes should be necessary to demonstrate effectiveness of strategies to reduce in-stent restenosis.

Abbreviations and Acronyms   CSA = cross-sectional area   DS = diameter stenosis   IH = intimal hyperplasia   IVUS = intravascular ultrasound   MLD = minimum lumen diameter   QCA = quantitative coronary angiography

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