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CLINICAL STUDY

Long-term vessel response to a self-expanding coronary stent: a serial volumetric intravascular ultrasound analysis from the ASSURE trial

Yoshiki Kobayashi, MD^*, Yasuhiro Honda, MD^*, Leonard G. Christie, MD, FACC, Paul S. Teirstein, MD, FACC, Steven R. Bailey, MD, FACC, Charles L. Brown, III, MD, FACC^||, Ray V. Matthews, MD, FACC^¶, Anthony C. De Franco, MD, FACC^#, Robert S. Schwartz, MD, FACC^**, Sheldon Goldberg, MD, FACC, Jeffrey J. Popma, MD, FACC, Paul G. Yock, MD, FACC^* and Peter J. Fitzgerald, MD, PhD, FACC^*

^* Center for Research in Cardiovascular Interventions, Stanford University Medical Center, Stanford, California, USA
Cardiovascular Associates, Eugene, Oregon, USA
Scripps Clinic, La Jolla, California, USA
University of Texas Health Science Center, San Antonio, Texas, USA
^|| Piedmont Hospital, Atlanta, Georgia, USA
^¶ Los Angeles Cardiology Associates, Los Angeles, California, USA
^# Moses Cone Memorial Hospital, Greensboro, North Carolina, USA
^** Mayo Clinic, Rochester, Minnesota, USA
Cooper Hospital, Boston, Massachusetts, USA
Massachusetts General Hospital, Boston, Massachusetts, USA

Manuscript received January 19, 2000; revised manuscript received December 8, 2000, accepted December 27, 2000.

Reprint requests and correspondence: Dr. Peter J. Fitzgerald, Center for Research in Cardiovascular Interventions, Stanford University Medical Center, 300 Pasteur Drive, Room H3554, Stanford, California 94305-5637

OBJECTIVES

We sought to investigate the in vivo mechanical properties of a new self-expanding coronary stent (RADIUS) and, particularly, the subsequent vessel response over time.

BACKGROUND

Preclinical studies have suggested that self-expanding stents may produce less vessel wall injury at initial deployment, leading to larger follow-up lumens than with balloon-expandable stents. However, the influence of the chronic stimulus from self-expanding stents on the vessel wall remains unknown.

METHODS

Sixty-two patients were randomly assigned to either the RADIUS self-expanding stent group (n = 32) or the Palmaz-Schatz balloon-expandable stent group (n = 30). Intravascular ultrasound was performed after stent deployment and at six-month follow-up.

RESULTS

At follow-up, the RADIUS stents had increased 23.6% in overall volume, while the Palmaz-Schatz stents had remained unchanged. Due to the greater mean neointimal area (3.0 ± 1.7 mm² vs. 1.9 ± 1.2 mm², p = 0.02) in the RADIUS group, no significant difference in net late lumen loss was observed between the two groups. On the other hand, analysis at the peristent margins demonstrated that mean late loss was significantly smaller in the RADIUS group than it was in the Palmaz-Schatz group (0.1 ± 2.1 mm² vs. 1.9 ± 2.4 mm², p = 0.02).

CONCLUSIONS

Serial volumetric IVUS revealed that the RADIUS stents continued to enlarge during the follow-up period. In this stent implantation protocol, this expansion was accompanied by a greater amount of neointima than the Palmaz-Schatz stents, resulting in similar late lumen loss in both configurations. In the peristent margins, however, late lumen loss was minimized with the RADIUS stents.

Abbreviations and Acronyms   ASSURE = A Stent vs. Stent Ultrasound Remodeling Evaluation   IVUS = intravascular ultrasound   SCORES = Stent COmparative REStenosis trial

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