Key result
The EXCEL 2 biodegradable polymer drug-eluting stent was noninferior to the EXCEL stent for in-stent late loss at 9 months (difference -0.03 mm; 95% CI -0.09 to 0.04; P<0.0001 for noninferiority).
Why the study?
Does a second-generation biodegradable polymer sirolimus-eluting stent improve in-stent late loss compared to a first-generation stent in patients undergoing PCI?
RCT (n=419)
randomized
Yes
Does a second-generation biodegradable polymer sirolimus-eluting stent improve in-stent late loss compared to a first-generation stent in patients undergoing PCI?
Mean Difference: -0.03 (95% CI -0.09–0.04)
Absolute Event Rate: 0.14% vs 0.16%
p-value: p=< .0001 for noninferiority
The second-generation EXCEL 2 biodegradable polymer sirolimus-eluting stent is noninferior to the first-generation EXCEL stent for 9-month angiographic in-stent late loss, with potentially lower 1-year target lesion failure.
Summary Aims We performed a multicenter, randomized controlled trial to determine the noninferiority of a novel biodegradable polymer drug‐eluting stent (BP‐DES), the EXCEL 2 stent, to the first‐generation BP‐DES, the EXCEL stent. Methods and Results Patients (n = 419) scheduled to undergo percutaneous coronary intervention (PCI) were randomized to receive either the EXCEL 2 stent (n = 208) or the EXCEL stent (n = 211) from 15 Chinese centers. At 9 months, primary endpoint in‐stent late loss (LL) difference was −0.03 mm (95% confidence interval: −0.09 mm to 0.04 mm) between the EXCEL 2 group (0.14 ± 0.26 mm) and the EXCEL group (0.16 ± 0.36 mm), demonstrating the noninferiority of EXCEL 2 to EXCEL in terms of in‐stent LL (P for noninferiority < .0001). Besides, target lesion failure (TLF) was statistically lower in EXCEL 2 group compared with EXCEL through 1 year (HR [95%CI] = 0.45 [0.20,0.98], Plog‐rank = .04). Definite/probable ST was observed in 0.0% vs 1.9% (P = .12) of EXCEL 2 vs EXCEL‐treated subjects. Conclusions The second‐generation BP‐DES (EXCEL 2) was noninferior to the first‐generation BP‐DES (EXCEL) for the primary endpoint of in‐stent LL at 9 months. Clinical Trial Registration—URL: http://www.clinicaltrials.gov . Unique identifier: NCT02057978.
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Xu et al. (2018) conducted an RCT in Scheduled to undergo percutaneous coronary intervention (PCI) (n=419). EXCEL 2 stent (second-generation biodegradable polymer sirolimus-eluting stent) vs. EXCEL stent (first-generation BP-DES) was evaluated on In-stent late loss (LL) at 9 months (MD -0.03, 95% CI -0.09 to 0.04, p=< .0001 for noninferiority). The EXCEL 2 biodegradable polymer drug-eluting stent was noninferior to the EXCEL stent for in-stent late loss at 9 months (difference -0.03 mm; 95% CI -0.09 to 0.04; P<0.0001 for noninferiority).
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