Evaluation of four-year coronary artery response after sirolimus-eluting stent implantation using serial quantitative intravascular ultrasound and computer-assisted grayscale value analysis for plaque composition in event-free patients.

OBJECTIVES This study sought to evaluate the long-term arterial response after sirolimus-eluting stent implantation. BACKGROUND Sirolimus-eluting stents are effective in inhibiting neointimal hyperplasia without affecting plaque volume behind the stent struts at six months. METHODS Serial quantitative intravascular ultrasound and computer-assisted grayscale value analysis over four years were performed in 23 event-free patients treated with sirolimus-eluting stents. RESULTS In the first two years, the mean plaque volume (155.5 +/- 42.8 mm3 post-procedure and 156.8 +/- 57.7 mm3 at two years, p = 0.86) and plaque compositional change expressed as mean percent hypoechogenic tissue of the plaque behind the stent struts (78.9 +/- 8.6% post-procedure and 78.2 +/- 8.9% at two years, p = 0.67) did not significantly change. However, significant plaque shrinking (change in plaque volume = -18.4 mm3, p = 0.02) with an increase in plaque echogenicity (change in percent hypoechogenic tissue = -7.8%, p < 0.0001) was observed between two and four years. The mean neointimal volume increased over four years from 0 to 8.4 +/- 5.8 mm3 (p < 0.0001). However, no further statistically significant change occurred between two and four years (7.0 +/- 6.7 mm3 vs. 8.4 +/- 5.8 mm3, p = 0.25). CONCLUSIONS Between two and four years after sirolimus-eluting stent implantation, peri-stent tissue shrank with a concomitant increase in echogenicity. These intravascular ultrasound findings suggest that late chronic artery responses may evolve for up to four years after sirolimus-eluting stent implantation. In addition, the fact that the neointima does not significantly change from two to four years may suggest that the biological phenomenon of a delayed healing response has begun to subside.

[1]  P. Tsao,et al.  Stent-Based Delivery of Sirolimus Reduces Neointimal Formation in a Porcine Coronary Model , 2001, Circulation.

[2]  M Schartl,et al.  Use of Intravascular Ultrasound to Compare Effects of Different Strategies of Lipid-Lowering Therapy on Plaque Volume and Composition in Patients With Coronary Artery Disease , 2001, Circulation.

[3]  Ousa,et al.  A RANDOMIZED COMPARISON OF A SIROLIMUS-ELUTING STENT WITH A STANDARD STENT FOR CORONARY REVASCULARIZATION , 2002 .

[4]  O. Joakimsen,et al.  Echolucent Plaques Are Associated With High Risk of Ischemic Cerebrovascular Events in Carotid Stenosis: The Tromsø Study , 2001, Circulation.

[5]  Jeffrey W Moses,et al.  Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. , 2003, The New England journal of medicine.

[6]  P. Tsao,et al.  Long-term effects of polymer-based, slow-release, sirolimus-eluting stents in a porcine coronary model. , 2004, Cardiovascular research.

[7]  Tat-Jin Teo,et al.  Adjustment method for mechanical Boston scientific corporation 30 MHz intravascular ultrasound catheters connected to a Clearview® console , 2004, The International Journal of Cardiovascular Imaging.

[8]  Torben V. Schroeder,et al.  Ultrasonic Echolucent Carotid Plaques Predict Future Strokes , 2001, Circulation.

[9]  R. Virmani,et al.  Images in cardiovascular medicine. Vascular healing 4 years after the implantation of sirolimus-eluting stent in humans: a histopathological examination. , 2004, Circulation.

[10]  Patrick W Serruys,et al.  Unrestricted Utilization of Sirolimus-Eluting Stents Compared With Conventional Bare Stent Implantation in the “Real World”: The R apamycin-E luting S tent E valuated A t R otterdam C ardiology H ospital (RESEARCH) Registry , 2004, Circulation.

[11]  J. Moses,et al.  Sirolimus-eluting stents vs. standard stents in patients with stenosis in a native coronary artery , 2004 .

[12]  Giuseppe Musumeci,et al.  Localized Hypersensitivity and Late Coronary Thrombosis Secondary to a Sirolimus-Eluting Stent: Should We Be Cautious? , 2004, Circulation.

[13]  P. Serruys,et al.  Intravascular Ultrasound Findings in the Multicenter, Randomized, Double-Blind RAVEL (RAndomized study with the sirolimus-eluting VElocity balloon-expandable stent in the treatment of patients with de novo native coronary artery Lesions) Trial , 2002, Circulation.

[14]  K. Kanmatsuse,et al.  Variability in quantitative measurement of the same segment with two different intravascular ultrasound systems: In vivo and in vitro studies , 2004, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[15]  B. Tuch,et al.  A comparison of the sensitivity of pig and human peripheral blood mononuclear cells to the antiproliferative effects of traditional and newer immunosuppressive agents. , 1999, Transplant immunology.

[16]  P. Serruys,et al.  Chronic Arterial Responses to Polymer-Controlled Paclitaxel-Eluting Stents: Comparison With Bare Metal Stents by Serial Intravascular Ultrasound Analyses: Data From the Randomized TAXUS-II Trial , 2004, Circulation.

[17]  J. Roelandt,et al.  Images in Cardiovascular Medicine , 2000 .

[18]  Patrick W Serruys,et al.  Retrospective image‐based gating of intracoronary ultrasound images for improved quantitative analysis: The intelligate method , 2004, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[19]  P. Serruys,et al.  Maintenance of Long-Term Clinical Benefit With Sirolimus-Eluting Coronary Stents: Three-Year Results of the RAVEL Trial , 2005, Circulation.

[20]  Antonio Colombo,et al.  Mechanism of Late In-Stent Restenosis After Implantation of a Paclitaxel Derivate–Eluting Polymer Stent System in Humans , 2002, Circulation.

[21]  P. Serruys,et al.  Evaluation of coronary remodeling after sirolimus-eluting stent implantation by serial three-dimensional intravascular ultrasound. , 2003, The American journal of cardiology.

[22]  F Prati,et al.  Correlation between high frequency intravascular ultrasound and histomorphology in human coronary arteries , 2001, Heart.

[23]  R. Virmani,et al.  Pathology of acute and chronic coronary stenting in humans. , 1999, Circulation.

[24]  Jeffrey J. Popma,et al.  Lack of Neointimal Proliferation After Implantation of Sirolimus-Coated Stents in Human Coronary Arteries: A Quantitative Coronary Angiography and Three-Dimensional Intravascular Ultrasound Study , 2001, Circulation.

[25]  K. Seung,et al.  Visualization of coronary atherosclerotic plaques in patients using optical coherence tomography: comparison with intravascular ultrasound. , 2002, Journal of the American College of Cardiology.

[26]  P. Serruys,et al.  Characterizing Vulnerable Plaque Features With Intravascular Elastography , 2003, Circulation.

[27]  C von Birgelen,et al.  ECG-gated versus nongated three-dimensional intracoronary ultrasound analysis: implications for volumetric measurements. , 1998, Catheterization and cardiovascular diagnosis.

[28]  E. Tuzcu,et al.  Coronary Plaque Classification With Intravascular Ultrasound Radiofrequency Data Analysis , 2002, Circulation.

[29]  P. Dhawale,et al.  Intracoronary ultrasound-defined plaque composition: computer-aided plaque characterization and correlation with histologic samples obtained during directional coronary atherectomy. , 1995, American heart journal.

[30]  N. Bruining,et al.  Computer assisted three-dimensional plaque characterization in intracoronary ultrasound studies , 2003, Computers in Cardiology, 2003.