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Paclitaxel and sirolimus stents in the real world of interventional cardiology - TAXi
Description:
The goal of the trial was to evaluate treatment with a sirolimus-eluting stent (SES) compared with a paclitaxel-eluting stent (PES) when used in a real world setting among patients with stable or unstable angina.
Study Design
Study Design:
Patients Screened: 405
Patients Enrolled: 202
Mean Follow Up: Mean seven months
Mean Patient Age: Mean age 64 years
Female: 20
Patient Populations:
Selected to receive a drug-eluting stent
Exclusions:
Uncertainty in the ability to obtain follow-up information
Drug/Procedures Used:
Patients presenting to the center from April 2003 to January 2004 who were suitable to receive a drug-eluting stent were randomized to PES (n=100) or SES (n=102). Direct stenting was allowed only in low-risk lesions at the operator's discretion.
Concomitant Medications:
Aspirin 100 mg/day, pretreatment; heparin 70 U/kg at beginning of procedure; and clopidogrel 300 mg at end of procedure
Principal Findings:
The majority of patients presented with stable angina or silent ischemia (85%), with the remaining presenting with unstable angina (15%). Baseline clinical and angiographic characteristics were similar between the two treatment groups, with no difference in disease extent or lesion location. In-stent restenosis was present in 6% of the PES group and 3% of the SES group (p=0.5). The average number of stents received was 1.5 per patient in both groups. Postprocedure diameter stenosis was 5% and minimum lumen diameter was 2.9 mm.
There was no difference in in-hospital cardiac events by treatment group (n=3 in each group). There was no stent thrombosis in either group by 30 days, and one in the SES group by six months. Major adverse cardiac events (MACE) by six months occurred in 4% of the PES group and 6% of the DES group (p=0.8). MACE was defined as death, myocardial infarction (MI), target lesion revascularization, coronary artery bypass surgery, or stent thrombosis. There were three non-Q wave MIs in the PES group and one in the SES group (p=0.6).
Interpretation:
Among patients with stable or unstable angina in a real-world setting, treatment with an SES compared with a PES was not associated with a difference in postprocedural success or cardiac events at six months, although the sample size of the trial was small, limiting the ability to detect a potential difference in events.
When the study was designed, the event rate in both treatment groups was expected to be much higher than was observed (14% for PES and 6% for SES) and, therefore, the sample size planned for the trial was low. Based on the actual event rates observed, close to 3,000 patients would be needed to detect a difference in clinical events. The present study was, however, one of the first head-to-head comparisons of the two most widely used drug-eluting stents.
Additionally, the trial was designed to mimic a real-world setting, with need for a drug-eluting stent and patient consent as the only inclusion criteria. This differs from randomized trials, which often have criteria based upon lesion characteristics, presenting syndrome, and other clinical factors. The upcoming, much larger REALITY trial will compare the sirolimus versus paclitaxel drug-eluting stent in patients with de novo lesions.
References:
Goy JJ, Stauffer JC, Siegenthaler M, Benoît A, Seydoux C. A prospective randomized comparison between paclitaxel and sirolimus stents in the real world of interventional cardiology: the TAXi trial. J Am Coll Cardiol 2005;45:xxx.
Keywords: Paclitaxel, Myocardial Infarction, Angina, Stable, Thrombosis, Drug-Eluting Stents, Constriction, Pathologic, Sirolimus, Coronary Artery Bypass
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