Key result
The SYNERGY bioabsorbable polymer-coated stent was non-inferior to the PROMUS Element Plus stent for 9-month in-stent late loss (0.20 vs 0.17 mm; P<0.0008 for non-inferiority).
Why the study?
Does the SYNERGY bioabsorbable polymer-coated EES improve in-stent late loss at nine months compared to the PROMUS Element Plus permanent polymer-coated EES in patients with de novo native coronary artery lesions?
RCT (n=412)
1:1
Yes
Does the SYNERGY bioabsorbable polymer-coated EES improve in-stent late loss at nine months compared to the PROMUS Element Plus permanent polymer-coated EES in patients with de novo native coronary artery lesions?
Absolute Event Rate: 0.2% vs 0.17%
p-value: p=<0.0008 for non-inferiority
The SYNERGY bioabsorbable polymer-coated EES is non-inferior to the PROMUS Element Plus permanent polymer-coated EES regarding 9-month angiographic late loss in Chinese patients.
Noninferior late loss supports SYNERGY use as an alternative; extends RCT evidence for bioabsorbable polymer stents to Chinese patients.
AIMS: The EVOLVE China randomised study sought to evaluate the clinical safety and effectiveness of the SYNERGY bioabsorbable polymer-coated everolimus-eluting stent (EES) for the treatment of patients with coronary heart disease in China. METHODS AND RESULTS: Eligible patients with de novo native coronary artery lesions were randomised (1:1) to receive the SYNERGY or PROMUS Element Plus stent. The primary endpoint was in-stent late loss at nine months. Secondary endpoints included death, MI, revascularisation, and stent thrombosis up to 12 months. A total of 412 subjects were randomised (205 SYNERGY; 207 PROMUS Element Plus) at 14 sites in China from October 2013 to July 2014. SYNERGY was non-inferior to PROMUS Element Plus for the primary endpoint of nine-month in-stent late loss: SYNERGY 0.20±0.33 mm vs. PROMUS Element Plus 0.17±0.38 mm with an upper one-sided 97.5% confidence interval of the difference (0.10 mm), significantly less than the non-inferiority margin (0.15 mm; p<0.0008). Clinical adverse event rates were low and not significantly different between groups at nine and 12 months (all p>0.05). CONCLUSIONS: In the EVOLVE China trial, the SYNERGY bioabsorbable polymer-coated EES was noninferior to the PROMUS Element Plus permanent polymer-coated EES for the primary endpoint of late loss at nine months.
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Han et al. (2017) conducted an RCT in Coronary heart disease (n=412). SYNERGY bioabsorbable polymer-coated everolimus-eluting stent vs. PROMUS Element Plus permanent polymer-coated everolimus-eluting stent was evaluated on in-stent late loss at nine months (95% CI upper one-sided 97.5% CI 0.10, p=<0.0008 for non-inferiority). The SYNERGY bioabsorbable polymer-coated stent was non-inferior to the PROMUS Element Plus stent for 9-month in-stent late loss (0.20 vs 0.17 mm; P<0.0008 for non-inferiority).
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