Background
The SPIRIT II and SPIRIT III clinical trials compared the XIENCE V (Abbott Vascular, Santa Clara, CA, USA) everolimus-eluting stent (EES) to the TAXUS Express 2 (Boston Scientific, Natick, MA, USA) paclitaxel-eluting stent (PES) and evaluated the safety and efficacy in patients with a maximum of two de novo native coronary artery lesions. These were multicenter, prospective, randomized, controlled trials conducted in Europe and the Asia-Pacific (SPIRIT II) and the US (SPIRIT III). A pooled analysis of the 3-year clinical follow-up data from these trials was performed to compare long-term outcomes of EES to PES.
Methods
In the SPIRIT II ( n =300) and SPIRIT III ( n =1002) trials, 1302 total patients were randomized to either EES or PES arm. Inclusion and exclusion criteria were comparable with similar baseline characteristics and event definitions. Patient-level pooled analysis was performed for 3-year clinical outcomes from these trials.
Methods
In the SPIRIT II ( n =300) and SPIRIT III ( n =1002) trials, 1302 total patients were randomized to either EES or PES arm. Inclusion and exclusion criteria were comparable with similar baseline characteristics and event definitions. Patient-level pooled analysis was performed for 3-year clinical outcomes from these trials.
Results
Table 1 provides 3-year cardiac adverse event rates from the SPIRIT II and III pooled analysis. In patients treated with EES compared to PES, significant reductions in major adverse cardiac events (MACE=cardiac death, MI, or TLR) ( P =.0004), target vessel failure (TVF=cardiac death, MI, or TVR) ( P =.01), MI ( P =.04), and TLR ( P =.02) rates were observed ( Table 1 ). Stent thrombosis (ARC definite or probable) and cardiac death rates were low in the EES group ( Table 1 ).
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