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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Late Incomplete Stent Apposition After Sirolimus-Eluting Stent Implantation

A Serial Intravascular Ultrasound Analysis

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^_*,_*

^_* Center for Research in Cardiovascular Interventions, Stanford University Medical Center, Stanford, California
Lenox Hill Hospital, New York, New York
Highlands Consulting Inc., San Jose, California.

Manuscript received August 16, 2004; revised manuscript received May 25, 2005, accepted May 31, 2005.

^_* 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. (Email: ivus{at}crci.stanford.edu).

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.

Abbreviations and Acronyms   BMS = bare-metal stent   DES = drug-eluting stent   EEM = external elastic membrane   ISA = incomplete stent apposition   IVUS = intravascular ultrasound   SES = sirolimus-eluting stent   SIRIUS = Sirolimus-Eluting Stent in De Novo Coronary Lesions study

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