Key result
Paclitaxel-coated balloons reduce 9-month in-lesion late lumen loss by ~0.21 mm vs uncoated balloons in small vessels.
Why the study?
The performance of the XIENCE V everolimus-eluting stent in small coronary arteries had not been investigated.
RCT (n=216)
Single-blind (outcome assessors/core laboratory blinded)
Block randomization via interactive web response system (IWRS)
Yes
May inform device choice in small vessel disease; leaves open whether clinical outcomes improve in prospective trials.
OBJECTIVES: To evaluate the safety and efficacy of the XIENCE V everolimus-eluting stent compared to the TAXUS paclitaxel-eluting stent in small vessels. BACKGROUND: The XIENCE V everolimus-eluting stent (EES) has been shown to improve angiographic and clinical outcomes after percutaneous myocardial revascularization, but its performance in small coronary arteries has not been investigated. METHODS: In this pooled analysis, we studied a cohort of 541 patients with small coronary vessels (reference diameter <2.765 mm) by using patient and lesion level data from the SPIRIT II and SPIRIT III studies. TAXUS Express (73% of lesions) and TAXUS Liberté (27% of lesions) paclitaxel-eluting stents (PES) were used as controls in SPIRIT II. In SPIRIT III, Taxus Express(2) PES was the control. RESULTS: Mean angiographic in-stent and in-segment late loss was significantly less in the EES group compared with the PES group, (0.15 +/- 0.37 mm vs. 0.30 +/- 0.44 mm; P = 0.011 for in-stent; 0.10 +/- 0.38 mm vs. 0.21 +/- 0.34 mm; P = 0.034 for in-segment). EES also resulted in a significant reduction in composite major adverse cardiac events at 1 year (19/366 [5.2%] vs. 17/159 [10.7%]; P = 0.037), due to fewer non-Q-wave myocardial infarctions and target lesion revascularizations. At 1 year, the rate of non-Q-wave myocardial infarction was significantly lower in the EES group compared with that of the PES group (6/366 [1.6%] vs. 8/159 [5.0%]; P = 0.037). CONCLUSIONS: In patients with small vessel coronary arteries, the XIENCE V EES was superior to the TAXUS PES.
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Bartorelli et al. (2010) conducted an RCT in Coronary small vessel disease (n=216). Paclitaxel-coated balloon (Revita) vs. Uncoated balloon was evaluated on In-lesion late lumen loss (LLL) at 9 months (p=<0.001). The paclitaxel-coated balloon significantly reduced 9-month in-lesion late lumen loss compared with an uncoated balloon in patients with coronary small vessel disease (0.15 mm vs 0.36 mm, p < 0.001).
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