Author + information
- Received November 4, 2003
- Revision received January 8, 2004
- Accepted January 27, 2004
- Published online June 2, 2004.
- 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
- ↵*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.
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 mm2for SES and 6.5 mm2for 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.
☆ Dr. Sonoda is supported by Fukuda Memorial Foundation for Medical Technologies, Tokyo, Japan and Japan North America Medical Exchange Foundation, Tokyo, Japan. Dr. Yock: grant, stock shareholder (Johnson and Johnson); Dr. Leon: stock shareholder (Johnson and Johnson); Dr. Moses: consultant, stock shareholder (Johnson and Johnson); Dr. Fitzgerald: consultant (Cordis, Johnson and Johnson).
- Received November 4, 2003.
- Revision received January 8, 2004.
- Accepted January 27, 2004.
- American College of Cardiology Foundation