A randomized comparison of novel bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent in patients with acute coronary syndromes: The CENTURY II high risk ACS substudy
Key result
Bioresorbable polymer sirolimus-eluting stents resulted in similar rates of target lesion failure at 24 months compared to permanent polymer everolimus-eluting stents (6.3% vs 6.5%; P=0.95).
Why the study?
Does a bioresorbable polymer sirolimus-eluting stent improve clinical outcomes compared to a permanent polymer everolimus-eluting stent in patients with high-risk acute coronary syndromes?
Population
264 patients with high risk acute coronary syndromes enrolled in the CENTURY II trial
Comparison
Percutaneous coronary intervention using a… vs Permanent polymer everolimus-eluting stent
Design
RCT, randomized, single blind
Follow-up
24 months
Authors
Discussion
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Implication
Supports either stent choice in high-risk ACS without outcome differences; confirms comparable performance of bioresorbable versus permanent polymer platforms.
Key Points
- The study aims to compare clinical outcomes using bioresorbable polymer sirolimus-eluting stents and durable polymer everolimus-eluting stents in patients with high risk acute coronary syndromes.
- Prospective, multicenter, randomized, single-blind controlled trial.
- 264 high-risk ACS patients analyzed from the CENTURY II trial.
- Primary endpoint: target lesion failure at 9 months post-stent implantation.
- At 24 months, target lesion failure occurred in 6.3% of BP-SES and 6.5% of PP-EES (P=0.95).
- Target vessel failure was 6.3% for BP-SES and 9.4% for PP-EES (P=0.36).
- No significant differences were observed in cardiac death, myocardial infarction, or stent thrombosis rates.
Study Design
Type
RCT (n=264)
Blinding
Single-blind
Randomization
randomized
Multicenter
Yes
Structured PICO
Does a bioresorbable polymer sirolimus-eluting stent improve clinical outcomes compared to a permanent polymer everolimus-eluting stent in patients with high-risk acute coronary syndromes?
P
Population
264 patients with high-risk acute coronary syndromes (STEMI and NSTEMI) enrolled in the CENTURY II trial, evaluated at 24 months.
I
Intervention
Percutaneous coronary intervention using a sirolimus-eluting stent with bioresorbable polymer (BP-SES)
C
Comparator
Permanent polymer everolimus-eluting stent (PP-EES)
O
Outcome
Target lesion failure (TLF) at 24 monthscomposite
Main Result
Absolute Event Rate: 6.3% vs 6.5%
p-value: p=0.95
Bioresorbable polymer sirolimus-eluting stents provide similar 24-month safety and efficacy outcomes compared to durable polymer everolimus-eluting stents in patients with high-risk acute coronary syndromes.
Limitations
- Hypothesis-generating finding that needs to be confirmed in larger trials with longer follow-up
- Subgroup analysis is hypothesis-generating
- Needs to be confirmed in larger trials with longer follow-up
Cite This Study
Díaz et al. (2016) conducted an RCT in High risk acute coronary syndromes (STEMI and NSTEMI) (n=264). Bioresorbable polymer sirolimus-eluting stent (BP-SES) vs. Permanent polymer everolimus-eluting stent (PP-EES) was evaluated on Target lesion failure (TLF) at 24 months (p=0.95). Bioresorbable polymer sirolimus-eluting stents resulted in similar rates of target lesion failure at 24 months compared to permanent polymer everolimus-eluting stents (6.3% vs 6.5%; P=0.95).