Author + information
- Received April 14, 2006
- Revision received August 1, 2006
- Accepted August 7, 2006
- Published online December 19, 2006.
- Duk-Woo Park, MD⁎,
- Myeong-Ki Hong, MD⁎,
- Gary S. Mintz, MD, FACC‡,
- Cheol Whan Lee, MD⁎,
- Jong-Min Song, MD⁎,
- Ki-Hoon Han, MD⁎,
- Duk-Hyun Kang, MD⁎,
- Sang-Sig Cheong, MD†,
- Jae-Kwan Song, MD, FACC⁎,
- Jae-Joong Kim, MD⁎,
- Neil J. Weissman, MD, FACC§,
- Seong-Wook Park, MD, FACC⁎ and
- Seung-Jung Park, MD, FACC⁎,⁎ ()
- ↵⁎Reprint requests and correspondence:
Dr. Seung-Jung Park, Departments of Medicine, University of Ulsan College of Medicine, Cardiac Center, Asan Medical Center, 388-1 Poongnap-dong, Songpa-gu, Seoul 138-736, Korea.
Objectives This study used serial angiographic and intravascular ultrasound (IVUS) analysis to evaluate the long-term efficacy of a nonpolymeric, paclitaxel-eluting stent coating on intimal hyperplasia (IH) 2 years after implantation.
Background Long-term efficacy of patients treated with nonpolymeric paclitaxel-eluting stents beyond 1 year has not been well determined.
Methods Patients were randomized to placebo or 1 of 2 doses of paclitaxel (low dose, 1.28 μg/mm2; high dose, 3.10 μg/mm2). Complete after-procedure, 6-month, and 2-year angiographic and IVUS data were available in 53 patients (17, 17, and 19 patients, respectively).
Results Baseline characteristics were similar among the 3 groups. Although 6-month minimal luminal diameter (MLD) was significantly smaller in placebo compared with paclitaxel-eluting stent patients (1.9 ± 0.6 mm in placebo, 2.5 ± 0.6 mm in low-dose, and 2.6 ± 0.5 mm in high-dose patients, p = 0.004), the MLDs at 2 years were similar (2.3 ± 0.6 mm, 2.3 ± 0.7 mm, and 2.0 ± 0.8 mm, respectively, p = 0.4). Despite a stepwise reduction in IH accumulation at 6 months (23 ± 18 mm3in placebo, 14 ± 11 mm3in low-dose, and 10 ± 12 mm3in high-dose, p =0.017), the increase of IH volume from 6 months to 2 years was significantly greater in the high-dose patients (13 ± 14 mm3in high-dose vs. 4 ± 7 mm3in low-dose patients, p =0.074; and vs. 1 ± 13 mm3in placebo, p =0.019). Late target lesion revascularization (beyond 1 year) was performed in 2 high-dose patients.
Conclusions Despite the suppression of IH after non-polymeric paclitaxel-eluting stents compared with bare-metal stents at 6 months, a “late catch-up” IH growth was found in the high-dose patients at 2-year follow-up.
This study was partly supported by Cardiovascular Research Foundation, Seoul, Korea, and Cook Cardiology; and by grants from the Korean Society of Circulation and the Korea Health 21 R&D Project, Ministry of Health & Welfare, Korea (0412-CR02-0704-0001).
- Received April 14, 2006.
- Revision received August 1, 2006.
- Accepted August 7, 2006.
- American College of Cardiology Foundation