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A prospective randomized comparison between paclitaxel and sirolimus stents in the real world of interventional cardiology: the TAXi trial

OBJECTIVES: We conducted this trial to assess whether a sirolimus-eluting stent (SES) produces similar results to a paclitaxel-eluting stent (PES) when used in the real world of interventional cardiology. BACKGROUND: Several drug-eluting stents have been shown to exert a beneficial effect on restenosis when used in the treatment of coronary artery disease. Any potential superiority of one drug over the others, however, is still unknown. METHODS: To evaluate whether a PES or an SES is superior in daily practice, we randomized all patients suitable to receive a drug-eluting stent in our institution. Clinical follow-up was obtained after at least six months. RESULTS: A total of 202 patients were included in this trial. One hundred patients received a PES and 102 received an SES. Procedural success was 99% in both groups. Incidence of major adverse cardiac events at follow-up (mean 7 +/- 2 months) was 4% with the PES and 6% with the SES (p = 0.8). The need for target lesion revascularization was very low in both groups (1% with the PES and 3% with the SES). CONCLUSIONS: Our results confirm that the high success rate obtained with both stents in randomized trials can be replicated in routine clinical practice. In this small group of patients we were unable to show any advantage of one stent over the other.

Trial
Journal Ref. Goy J-J, Stauffer J-C, Siegenthaler M, Benoit A, Seydoux C: the TAXi trial. Journal of the American College of Cardiology 2005, 45:308-311.
Intervention Drug - Sirolimus and Paclitaxel Stents for Percutaneous Coronary Intervention (PCA)
Number of sites 1
Countries involved Switzerland
Sample size 202
Type of statistical analyses Intention-to-treat
Risk of bias Overall: Unclear details
Participant characteristics Age: 63-65 ± 10
Condition: coronary artery disease
Baseline severity: Requirement of PCI
Duration of trial April 2003 to January 2004
Primary outcome Major Adverse Cardiac Events (MACE) 6 months
Effect Measures
Events Intervention Total Events Control Total Risk Diff.
6 102 4 100 1.88 %
Follow up minimum duration of six months (mean 7 ± 2 months. Not significant p-values for MACE Death p = 1, non-Q-wave MI p = 0.6; Q-wave MI, TLR, CABG, Stent thrombosis p = 0.9
Show Score Ranges

Scores:

(shows median if more than one score was entered)

Elig. Recr. Setting Org. Int. Flex. Del. Flex. Adherence Follow-Up Prim. Out. Prim. An.
5 3 2 5 5 -1 5 5 5