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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Incidence and Predictors of Drug-Eluting Stent Fracture in Human Coronary Artery

A Pathologic Analysis

Gaku Nakazawa, MD^_*, Aloke V. Finn, MD, Marc Vorpahl, MD^_*, Elena Ladich, MD^_*, Robert Kutys, MS^_*, Isidora Balazs, BS^_*, Frank D. Kolodgie, PhD^_* and Renu Virmani, MD^_*,_*

^_* CVPath Institute, Inc., Gaithersburg, Maryland
Emory University School of Medicine, Atlanta, Georgia

Manuscript received December 8, 2008; revised manuscript received April 23, 2009, accepted May 5, 2009.

^_* Reprint requests and correspondence: Dr. Renu Virmani, Medical Director, CVPath Institute, Inc., 19 Firstfield Road, Gaithersburg, Maryland 20878 (Email: rvirmani{at}cvpath.org).

Objectives: The aim of this study was to perform pathologic assessment on stent fracture.

Background: Clinically, stent fracture has been reported in 1% to 2% of patients after drug-eluting stent (DES) implantation.

Methods: High-contrast film-based radiographs of 177 consecutive lesions from the CVPath DES autopsy registry were reviewed. Stent fracture was graded as I (single-strut fracture), II (2 struts), III (2 struts with deformation), IV (with transection without gap), and V (with transection causing gap in stent segment). The incidence of adverse pathologic findings (thrombosis and restenosis) was assessed histologically.

Results: Stent fracture was documented in 51 lesions (29%; grade I = 10, II = 14, III = 12, IV = 6, and V = 9). Lesions with stent fracture had longer duration after implantation (172 days [interquartile range (IQR) 31 to 630 days] vs. 44 days [IQR 7 to 270 days], p = 0.004), a higher rate of Cypher (Cordis Corp., Miami Lakes, Florida) stent usage (63% vs. 36%, p = 0.001), longer stent length (30.0 mm [IQR 22.0 to 40.0 mm] vs. 20.0 mm [IQR 14.0 to 27.3 mm], p < 0.0001), and a higher rate of overlapping stents (45% vs. 22%, p = 0.003). Although fracture with grade I to IV did not have significant impact on the occurrence of adverse pathologic findings such as thrombosis and restenosis, 67% of the grade V fracture lesions were associated with adverse pathologic findings at fracture sites. Longer stent length, use of Cypher, and longer duration of implant were identified as independent risk factors of stent fracture by logistic regression analysis.

Conclusions: The incidence of stent fracture was 29% lesions at autopsy, which is much higher than clinically reported. A high rate of adverse pathologic findings was observed in lesions with grade V stent fracture, whereas fracture with grade I to IV did not have a significant impact on the pathological outcome.

Key Words: stent fracture • drug-eluting stent • pathology

Abbreviations and Acronyms   BMS = bare-metal stent(s)   DES = drug-eluting stent(s)   IVUS = intravascular ultrasound   LCx = left circumflex coronary artery   RCA = right coronary artery

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