Incidence, timing, and correlates of stent thrombosis with the polymeric paclitaxel drug-eluting stent: a TAXUS II, IV, V, and VI meta-analysis of 3,445 patients followed for up to 3 years.
OBJECTIVE
This study sought to study stent thrombosis with the paclitaxel-eluting Taxus stent.


BACKGROUND
The incidence and timing of stent thrombosis after drug-eluting stent placement compared with bare-metal stent implantation remain unsettled, with consequent uncertainty about risk stratification and long-term recommendations for antiplatelet medications.


METHODS
This study used a patient-based meta-analysis using the 4 principal TAXUS randomized trials (3,445 patients) with a follow-up duration of > or =1 year.


RESULTS
Cumulative stent thrombosis occurred in 1.28% +/- 0.31% in the Taxus group and 0.76% +/- 0.23% in the bare-metal stent group at 3 years (hazard ratio 1.51 [95% confidence interval 0.73 to 3.14], p = 0.26). Hazard ratios (per 100 patients per 6 months) were similar between the Taxus stent group (0.59 [95% confidence interval 0.22 to 0.95]) and the bare-metal stent group (0.64 [95% confidence interval 0.26 to 1.02]) through 6 months during the prescribed clopidogrel period. However, from 6 months to 3 years there were more stent thromboses in the Taxus group (hazard ratio 0.19 [95% confidence interval 0.06 to 0.32] vs. 0.02 [95% confidence interval 0.00 to 0.07], p = 0.049). Of 8 patients with Taxus-related thrombosis after 6 months, 0 were taking clopidogrel and 2 were not taking aspirin consistently. No Taxus-related stent thrombosis occurred after 2 years (922 patients thus far followed up for 3 years). Independent correlates of stent thrombosis were nonuse of clopidogrel, male gender, smoking, and possibly use of multiple nonoverlapping stents.


CONCLUSIONS
Approximately 0.8% of Taxus patients have stent thrombosis in the first 6 months after stent implantation, similar to bare-metal stents. However, a modest increase in risk is present with Taxus stents beyond 6 months, possibly because of inadequate antiplatelet drug therapy.
Ellis
Stephen G
SG
Department of Cardiovascular Medicine, The Cleveland Clinic, Cleveland, Ohio 44195, USA. elliss@ccf.org
Colombo
Antonio
A
Grube
Eberhard
E
Popma
Jeffrey
J
Koglin
Joerg
J
Dawkins
Keith D
KD
Stone
Gregg W
GW
D000293:Adolescent; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000379:methods; D001807:Blood Vessel Prosthesis / Q000009:adverse effects; D006328:Cardiac Catheterization; D016001:Confidence Intervals; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000175:diagnosis / Q000401:mortality* / Q000628:therapy*; D004333:Drug Administration Routes; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000494:pharmacology*; D011336:Probability; D011474:Prosthesis Design; D011475:Prosthesis Failure; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D015607:Stents / Q000009:adverse effects*; D016019:Survival Analysis; D020946:Taxus; D013927:Thrombosis / Q000453:epidemiology / Q000209:etiology*; D013997:Time Factors
D017239:Paclitaxel