Author + information
- Received August 16, 2004
- Revision received May 25, 2005
- Accepted May 31, 2005
- Published online September 20, 2005.
- Junya Ako, MD⁎,
- Yoshihiro Morino, MD⁎,
- Yasuhiro Honda, MD, FACC⁎,
- Ali Hassan, MD⁎,
- Shinjo Sonoda, MD, PhD⁎,
- Paul G. Yock, MD, FACC⁎,
- Martin B. Leon, MD, FACC†,
- Jeffrey W. Moses, MD, FACC†,
- Heidi N. Bonneau, RN, MS‡ and
- Peter J. Fitzgerald, MD, PhD, FACC⁎,⁎ ()
- ↵⁎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.
Objectives We sought to identify the frequency of incomplete stent apposition (ISA) in sirolimus-eluting stents (SES) and clarify its findings and clinical sequelae.
Background Late-acquired ISA has been reported in bare-metal stents (BMS) and brachytherapy and recently in drug-eluting stents. However, the characteristics of late ISA in SES have not been clarified.
Methods From the SIRIUS trial, a randomized, multicenter study comparing SES and BMS, serial qualitative intravascular ultrasound (IVUS; at stent implantation and eight-month follow-up) was available in 141 patients (BMS: n = 61; SES: n = 80). The IVUS images were reviewed for the presence of ISA.
Results Incomplete stent apposition at follow-up was observed in 19 patients (BMS: n = 6 [9.8%]; SES: n = 13 [16.3%]; p = NS). Among these, 12 had ISA after intervention and at follow-up (persistent ISA). Late-acquired ISA was seen in the remaining seven cases, all from the SES group (BMS: n = 0; SES: n = 7 [8.7%]; p < 0.05). In late-acquired ISA, there was an increase in external elastic membrane area (after intervention: 16.2 ± 2.7 m2; follow-up: 18.9 ± 3.6 mm2; p < 0.05). The location of stent-vessel wall separation was primarily at the stent edges in persistent ISA cases, whereas late-acquired ISA in SES occurred mostly in the mid portion of the stent. There were no negative clinical events reported for any ISA cases at 12-month clinical follow-up.
Conclusions Late ISA was observed in 8.7% of patients after SES implantation. There were no negative clinical events associated with this IVUS finding at 12-month clinical follow-up; however, careful long-term follow-up will be necessary.
Dr. Yock received a grant from and is a stock shareholder for Johnson & Johnson. Dr. Leon is a stock shareholder for Johnson & Johnson. Dr. Moses is a consultant and stock shareholder for Johnson & Johnson. Dr. Fitzgerald is a consultant for Johnson & Johnson.
- Received August 16, 2004.
- Revision received May 25, 2005.
- Accepted May 31, 2005.
- American College of Cardiology Foundation