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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Impact of final stent dimensions on long-term results following sirolimus-eluting stent implantation

Serial intravascular ultrasound analysis from the sirius trial

Shinjo Sonoda, MD^*, Yoshihiro Morino, MD^*, Junya Ako, MD^*, Mitsuyasu Terashima, MD^*, Ali H. M. Hassan, MD^*, Heidi N. Bonneau, RN, MS, Martin B. Leon, MD, FACC, Jeffrey W. Moses, MD, FACC, Paul G. Yock, MD, FACC^*, Yasuhiro Honda, MD^*, Richard E. Kuntz, MD, MSc, Peter J. Fitzgerald, MD, PhD, FACC^*,* for the SIRIUS Investigators

^* Center for Research in Cardiovascular Interventions, Stanford University Medical Center, Stanford, California, USA
Highlands Consulting Inc., San Jose, California, USA
Lenox Hill Hospital, New York, New York, USA
Brigham and Women's Hospital, Boston, Massachusetts, USA

Manuscript received November 4, 2003; revised manuscript received January 8, 2004, accepted January 27, 2004.

^* Reprint requests and correspondence: Dr. Peter J. Fitzgerald, Center for Research in Cardiovascular Interventions, Stanford University Medical Center, 300 Pasteur Drive, H3554, Stanford, California 94305-5637, USA.
ivus{at}crci.stanford.edu

OBJECTIVES: We assessed the predictive value of minimum stent area (MSA) for long-term patency of sirolimus-eluting stents (SES) implantation compared to bare metal stents (BMS).

BACKGROUND: Although MSA is a consistent predictor of in-stent restenosis, its predictive value in BMS is still limited because of biologic variability in the restenosis process.

METHODS: From the SIRolImUS (SIRIUS) trial, 122 cases (SES: 72; BMS: 50) with complete serial intravascular ultrasound (IVUS) (baseline and 8-month follow-up) were analyzed. Postprocedure MSA and follow-up minimum lumen area (MLA) were obtained. Based on previous physiologic studies, adequate stent patency at follow-up was defined as MLA >4 mm².

RESULTS: In both groups, a significant positive correlation was observed between baseline MSA and follow-up MLA (SES: p < 0.0001, BMS: p < 0.0001). However, SES showed higher correlation than BMS (0.8 vs. 0.65) with a higher regression coefficient (0.92 vs. 0.59). The sensitivity and specificity curves identified different optimal thresholds of MSA to predict adequate follow-up MLA: 5 mm² for SES and 6.5 mm² for BMS. The positive predictive values with these cutoff points were 90% and 56%, respectively.

CONCLUSIONS: In this SIRIUS IVUS substudy, SES reduced both biologic variability and restenosis, resulting in increased predictability of long-term stent patency with postprocedure MSA. In addition, SES had a considerably lower optimal MSA threshold compared to BMS.

Abbreviations and Acronyms   BMS = bare metal stents   IVUS = intravascular ultrasound   MLA = minimum lumen area   MSA = minimum stent area   SES = sirolimus-eluting stents

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