Key result
Paclitaxel-eluting stents show no difference versus sirolimus-eluting stents for mid-term angiographic in-stent restenosis.
Why the study?
Does paclitaxel-eluting stent compared to sirolimus-eluting stent reduce angiographic-based binary in-stent restenosis in patients with de novo native coronary stenosis?
Cohort (n=1,287)
No
Does paclitaxel-eluting stent compared to sirolimus-eluting stent reduce angiographic-based binary in-stent restenosis in patients with de novo native coronary stenosis?
Odds Ratio: 1.15 (95% CI 0.68–1.93)
Absolute Event Rate: 11.7% vs 10.3%
p-value: p=0.605
In a real-world Japanese cohort, mid-term angiographic outcomes of paclitaxel-eluting stents were comparable to sirolimus-eluting stents for de novo coronary lesions, including in diabetic patients.
Comparable restenosis rates in this cohort; leaves open whether stent choice affects outcomes in randomized trials.
OBJECTIVE: We sought to perform a propensity score-matched lesion-based comparison of mid-term angiographic outcomes of sirolimus- (SES, Cypher Bx Velocity) and paclitaxel- (PES, TAXUS Liberté, the 2nd-generation TAXUS) eluting stents to treat de novo coronary stenosis and, particularly, in patients with diabetes mellitus (DM) in a daily practice environment. METHODS: The present study was a non-randomized, retrospective, lesion-based, single center study that included 1,287 de novo native coronary stenosis cases after successful SES or PES placement between February 2007 and April 2011. The primary endpoint was angiographic-based binary in-stent restenosis (% diameter stenosis >50 at secondary angiogram) within 550 days of placement. A propensity score-matched analysis was used to adjust the baselines. RESULTS: Among 360 baseline-adjusted angiographic lesions followed up in each arm, the incidence of the primary endpoint in the PES group (11.7%, follow-up period: 350±76 days) was not significantly different from that in the SES group (10.3%, p=0.645, 354±81 days, p=0.912). PES was not associated with the primary endpoint by logistic regression analysis (odds ratio: 1.15, 95% confidence interval: 0.68-1.93, p=0.605). In the DM specific sub-analysis, the primary endpoint in the PES group (19.6%) was not significantly different from that in the SES group (12.8%, p=0.105) in 148 baseline-adjusted lesions in each arm. CONCLUSION: The mid-term angiographic outcomes after TAXUS Liberté placement for all-comer de novo native coronary stenosis and in patients with DM were not significantly different from those of SES in a Japanese daily practice environment.
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Suzuki et al. (2014) conducted a cohort in De novo native coronary stenosis (n=1,287). TAXUS Liberté (paclitaxel-eluting stent) vs. Cypher Bx Velocity (sirolimus-eluting stent) was evaluated on Angiographic-based binary in-stent restenosis (% diameter stenosis >50 at secondary angiogram) within 550 days (OR 1.15, 95% CI 0.68-1.93, p=0.605). TAXUS Liberté paclitaxel-eluting stents did not significantly differ from Cypher sirolimus-eluting stents in the incidence of mid-term angiographic binary in-stent restenosis (11.7% vs 10.3%, OR 1.15).
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