Key result
The everolimus-eluting stent yielded significantly less 6-month in-stent late loss than the paclitaxel-eluting stent across high-risk subgroups, including diabetics (0.15 vs 0.39 mm; P=0.006).
Why the study?
Does an everolimus-eluting stent reduce in-stent late loss at six months compared to a paclitaxel-eluting stent in patients with de novo native coronary artery lesions, including high-risk subgroups?
RCT (n=300)
randomised
Does an everolimus-eluting stent reduce in-stent late loss at six months compared to a paclitaxel-eluting stent in patients with de novo native coronary artery lesions, including high-risk subgroups?
Everolimus-eluting stents provide superior angiographic outcomes with reduced late loss compared to paclitaxel-eluting stents across various high-risk lesion and patient subgroups at 6 months.
Supports everolimus-eluting stent selection in high-risk subgroups including diabetics; extends angiographic superiority data to these populations.
AIMS: Restenosis is higher among certain subpopulations when subjected to percutaneous coronary interventions even when using drug-eluting stents. The randomised SPIRIT II trial demonstrated the superiority of the XIENCE V Everolimus Eluting Coronary Stent System over the TAXUS Paclitaxel-Eluting Stent System in terms of in-stent late loss at six months among 300 patients treated for de novo native coronary artery lesions. METHODS AND RESULTS: In this post-hoc analysis of SPIRIT II we focused on six-month angiographic outcomes of diabetic patients (n=69), left anterior descending arteries (n=149), long lesions >20 mm (n=43), small vessels <3.0 mm (n=209) and type B2 and C lesions (n=233). In-stent late loss was consistently less among all subgroups when treated by everolimus-eluting stents compared to paclitaxel-eluting stents: diabetics 0.15+/-0.26 mm versus 0.39+/-0.34 mm, p=0.006; LAD 0.12+/-0.23 mm versus 0.44+/-0.37 mm, p<0.001; long lesions 0.13+/-0.26 mm versus 0.43+/-0.46 mm, p=0.070; small vessels 0.17+/-0.28 mm versus 0.37+/-0.39 mm, p<0.001; B2/C lesions 0.12+/-0.31 mm versus 0.36+/-0.36 mm, p<0.001. CONCLUSION: The everolimus-eluting stent remained superior in terms of in-stent late loss in a variety of higher risk populations for restenosis compared to the paclitaxel-eluting stent. These analyses were consistent with the in-stent late loss results of the overall SPIRIT II trial population.
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Khattab et al. (2008) conducted an RCT in de novo native coronary artery lesions (n=300). XIENCE V Everolimus Eluting Coronary Stent System vs. TAXUS Paclitaxel-Eluting Stent System was evaluated on in-stent late loss at six months. The everolimus-eluting stent yielded significantly less 6-month in-stent late loss than the paclitaxel-eluting stent across high-risk subgroups, including diabetics (0.15 vs 0.39 mm; P=0.006).
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