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J Am Coll Cardiol, 2006; 48:193-202, doi:10.1016/j.jacc.2006.03.042 (Published online 4 May 2006).
© 2006 by the American College of Cardiology Foundation
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EXPEDITED REVIEW

Pathology of Drug-Eluting Stents in Humans

Delayed Healing and Late Thrombotic Risk

Michael Joner, MD*, Aloke V. Finn, MD{dagger}, Andrew Farb, MD§, Erik K. Mont, MD{ddagger}, Frank D. Kolodgie, PhD*, Elena Ladich, MD*, Robert Kutys, MS*, Kristi Skorija, BS*, Herman K. Gold, MD{dagger} and Renu Virmani, MD*,*

* CVPath, International Registry of Pathology, Gaithersburg, Maryland
{dagger} Cardiac Unit, Department of Internal Medicine, Massachusetts General Hospital, Boston, Massachusetts
{ddagger} Miami Dade County Medical Examiner Department, Heart Radiology, Miami, Florida; and the §Interventional Cardiology Devices Branch, U.S. Food and Drug Administration, Rockville, Maryland

Manuscript received January 26, 2006; revised manuscript received March 10, 2006, accepted March 16, 2006.

* Reprint requests and correspondence: Dr. Renu Virmani, CVPath, International Registry of Pathology, 19 Firstfield Road, Gaithersburg, Maryland 20878 (Email: rvirmani{at}cvpath.org).

OBJECTIVES: This study examined human drug-eluting stents (DES) to determine the long-term effects of these stents on coronary arterial healing and identified mechanisms underlying late stent thrombosis (LST).

BACKGROUND: Although DES reduce the need for repeat revascularization compared with bare-metal stents (BMS), data suggest the window of thrombotic risk for Cypher (Cordis Corp., Miami Lakes, Florida) and Taxus (Boston Scientific Corp., Natick, Massachusetts) DES extends far beyond that for BMS.

METHODS: From a registry of 40 autopsies of DES (68 stents), 23 DES cases of >30 days duration were compared with 25 matched autopsies of BMS implantation. Late stent thrombosis was defined as an acute thrombus within a stent >30 days old.

RESULTS: Of 23 patients with DES >30 days old, 14 had evidence of LST. Cypher and Taxus DES showed greater delayed healing characterized by persistent fibrin deposition (fibrin score 2.3 ± 1.1 vs. 0.9 ± 0.8, p = 0.0001) and poorer endothelialization (55.8 ± 26.5%) compared with BMS (89.8 ± 20.9, p = 0.0001). Moreover, DES with LST showed more delayed healing compared with patent DES. In 5 of 14 patients suffering LST, antiplatelet therapy had been withdrawn. Additional procedural and pathologic risk factors for LST were: 1) local hypersensitivity reaction; 2) ostial and/or bifurcation stenting; 3) malapposition/incomplete apposition; 4) restenosis; and 5) strut penetration into a necrotic core.

CONCLUSIONS: The Cypher and Taxus DES result in delayed arterial healing when compared with BMS of similar implant duration. The cause of DES LST is multifactorial with delayed healing in combination with other clinical and procedural risk factors playing a role.

Abbreviations and Acronyms
  BMS = bare-metal stents
  DES = drug-eluting stents
  FDA = Food and Drug Administration
  LST = late stent thrombosis




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