Peristent remodeling and neointimal suppression 2 years after polymer-based, paclitaxel-eluting stent implantation : Insights from serial intravascular ultrasound analysis in the TAXUS II study

• Published in: Circulation (New York, N.Y.) N.Y.), 2005-12, Vol.112 (25), p.3876-3883
• Main Authors: AOKI, Jiro, COLOMBO, Antonio, DUDEK, Dariusz, BANNING, Adrian P, DRZEWIECKI, Janusz, ZMUDKA, Krzysztof, SCHIELE, Francois, RUSSELL, Mary E, KOGLIN, Joerg, SERRUYS, Patrick W
• Format: Article
• Language: English
• Subjects: Aged; Antineoplastic Agents, Phytogenic - administration & dosage; Biological and medical sciences; Blood and lymphatic vessels; Cardiology. Vascular system; Cardiovascular system; Cell Proliferation - drug effects; Diseases of the cardiovascular system; Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous; Dose-Response Relationship, Drug; Double-Blind Method; Female; Follow-Up Studies; Graft Occlusion, Vascular - prevention & control; Humans; Investigative techniques, diagnostic techniques (general aspects); Male; Medical sciences; Middle Aged; Paclitaxel - administration & dosage; Polymers; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Stents - adverse effects; Taxus; Tunica Intima - diagnostic imaging; Tunica Intima - drug effects; Tunica Intima - pathology; Ultrasonic investigative techniques; Ultrasonography, Interventional
• ISSN: 0009-7322; 1524-4539
• DOI: 10.1161/CIRCULATIONAHA.105.558601

The purpose of this study was to evaluate long-term vascular responses as long as 2 years after implantation of polymer-based, paclitaxel-eluting stents in contrast to uncoated stents. TAXUS II is a randomized, double-blind trial comparing slow-release (SR) and moderate-release (MR) TAXUS stents with bare-metal control stents (BMSs). One hundred sixty-one event-free patients (SR, 43; MR, 41; and BMS, 77) underwent serial intravascular ultrasound (IVUS) analysis after the procedure and at 6 months and 2 years. At 2 years, neointimal responses continued to be significantly suppressed in the SR and MR groups when compared with the BMS group (BMS, 1.49+/-1.12 mm2; SR, 0.94+/-0.76 mm2 [P=0.004]; and MR, 1.06+/-0.90 mm2 [P=0.02]). Between 6 months and 2 years, the BMS group showed compaction of the neointima (Delta, -0.22+/-1.05 mm2 [P=0.08]). In contrast, both the SR and MR groups exhibited an increase (Delta SR, 0.30+/-0.76 mm2 (P=0.01); MR, 0.41+/-0.94 mm2 [P=0.009]). Between 6 months and 2 years, the initial increase in plaque outside the stent regressed in the BMS and SR groups to levels comparable to those after the procedure, whereas expansive remodeling partially regressed in the MR group (Delta between after the procedure and 2 years BMS, -0.34+/-1.28 mm2 [P=0.05]; SR, -0.02+/-1.40 mm2 [P=0.93]; MR, 0.32+/-1.56 mm2 [P=0.27]). The 2-year follow-up demonstrates that neointimal suppression was dose independent and that this effect was still sustained at 2 years. However, the increase in area outside the stent seen at 6 months regressed to different extents in a dose-dependent manner at 2 years.