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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 ,
Thomas J. Helton, DO* and
Deepak L. Bhatt, MD*,*
* Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio
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.
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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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