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CLINICAL RESEARCH

Two-Year Follow-Up of the Quantitative Angiographic and Volumetric Intravascular Ultrasound Analysis After Nonpolymeric Paclitaxel-Eluting Stent Implantation

Late "Catch-Up" Phenomenon From ASPECT Study

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^_*,_*

^_* Department of Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul
GangNeung, Korea
Cardiovascular Research Foundation, New York, New York
Washington Hospital Center, Washington, DC

Manuscript received April 14, 2006; revised manuscript received August 1, 2006, accepted August 7, 2006.

^_* 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. (Email: sjpark{at}amc.seoul.kr).

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 mm³ in placebo, 14 ± 11 mm³ in low-dose, and 10 ± 12 mm³ in 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 mm³ in high-dose vs. 4 ± 7 mm³ in low-dose patients, p = 0.074; and vs. 1 ± 13 mm³ in 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.

Abbreviations and Acronyms   BMS = bare-metal stents   DES = drug-eluting stents   IH = intimal hyperplasia   IVUS = intravascular ultrasound   MLA = minimum lumen area   MLD = minimal luminal diameter   QCA = quantitative coronary angiography

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