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J Am Coll Cardiol, 2005; 45:941-946, doi:10.1016/j.jacc.2004.11.064
© 2005 by the American College of Cardiology Foundation
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What is the risk of stent thrombosis associated with the use of paclitaxel-eluting stents for percutaneous coronary intervention?

A meta-analysis

Anthony A. Bavry, MD, MPH*, Dharam J. Kumbhani, MD, SM{dagger}, Thomas J. Helton, DO* and Deepak L. Bhatt, MD*,*

* Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio
{dagger} Department of Cardiac Surgery, Veterans Administration Boston Healthcare System, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts

Manuscript received August 3, 2004; revised manuscript received November 11, 2004, accepted November 29, 2004.

* Reprint requests and correspondence: Dr. Deepak L. Bhatt, Interventional Cardiology and Cardiovascular Fellowships, Cleveland Clinic Foundation, Department of Cardiovascular Medicine, 9500 Euclid Avenue, Desk F25, Cleveland, Ohio 44195 (Email: bhattd{at}ccf.org).

OBJECTIVES: This study investigated the risk of stent thrombosis associated with the use of paclitaxel-eluting stents (PES) compared to bare-metal stents (BMS).

BACKGROUND: Clinical experience with coronary drug-eluting stents (DES) is relatively limited. There is concern that DES used for percutaneous coronary intervention may result in subsequent thrombosis.

METHODS: We conducted a meta-analysis on eight trials (total of 13 study arms) in 3,817 patients with coronary artery disease who were randomized to either PES or BMS.

RESULTS: As compared with BMS, PES do not increase the hazard for thrombosis up to 12 months (risk ratio [RR] = 1.06, 95% confidence interval [CI] 0.55 to 2.04, p = 0.86]). There was no evidence of heterogeneity among the studies (chi-square value for Q-statistic = 5.90 [10 degrees of freedom], p = 0.82). Similar results were obtained when the analysis was restricted to trials with a polymeric stent platform (Treatment of de novo coronary disease using a single pAclitaXel elUting Stent [TAXUS]-I, -II, -IV, and -VI) (RR = 1.01, 95% CI 0.40 to 2.53, p = 0.99), trials with longer lesions (TAXUS-IV and -VI) (RR = 0.62, 95% CI 0.2 to 1.91, p = 0.41), and trials that used a higher dose of paclitaxel (ASian Paclitaxel-Eluting Stent Clinical trial [ASPECT], European evaLUaTion of paclitaxel Eluting Stents [ELUTES], and DELIVER-I) (RR = 1.87, 95% CI 0.52 to 6.81, p = 0.34).

CONCLUSIONS: Current evidence suggests that standard dose PES do not increase the hazard of stent thrombosis compared to BMS.

Abbreviations and Acronyms
  BMS = bare-metal stents
  CI = confidence interval
  DES = drug-eluting stents
  PCI = percutaneous coronary intervention
  PES = paclitaxel-eluting stents
  RR = risk ratio




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