Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents for primary percutaneous coronary revascularisation of acute myocardial infarction
Key result
Biodegradable polymer sirolimus-eluting stents reduced target lesion failure at 1 year compared to durable polymer everolimus-eluting stents in STEMI patients (3.4% vs 8.8%; RR 0.38; P=0.024).
Why the study?
Does a biodegradable polymer sirolimus-eluting stent reduce target lesion failure compared to a durable polymer everolimus-eluting stent in patients with acute STEMI?
Population
407 patients with acute ST-segment elevation myocardial infarction (STEMI) enrolled in the BIOSCIENCE trial
Comparison
Biodegradable polymer sirolimus-eluting stent vs Durable polymer everolimus-eluting stent (DP-EES)
Design
RCT, Randomisation was stratified according to the presence or absence of…
Follow-up
12 months
Authors
Discussion
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Implication
May favor BP-SES in selected patients; hypothesis-generating and requires larger trials before practice change.
Key Points
- This research aimed to evaluate the safety and efficacy of biodegradable polymer sirolimus-eluting stents compared to durable polymer everolimus-eluting stents in patients with acute STEMI.
- Single-blind, multicentre, randomized non-inferiority trial (NCT01443104).
- 407 STEMI patients randomly assigned to treatment with BP-SES or DP-EES.
- Primary endpoint was target lesion failure assessed within 12 months.
- Target lesion failure occurred in 3.4% of BP-SES patients vs. 8.8% of DP-EES patients (RR 0.38, 95% CI: 0.16-0.91, p=0.024).
- Cardiac death rates were 1.5% for BP-SES vs. 4.7% for DP-EES (RR 0.31, 95% CI: 0.08-1.14, p=0.062).
- No significant difference in the risk of definite stent thrombosis.
Study Design
Type
RCT (n=407)
Blinding
Single-blind
Randomization
Stratified according to the presence or absence of STEMI
Multicenter
Yes
Structured PICO
Does a biodegradable polymer sirolimus-eluting stent reduce target lesion failure compared to a durable polymer everolimus-eluting stent in patients with acute STEMI?
P
Population
407 patients with acute ST-segment elevation myocardial infarction (STEMI) followed for 1 year.
I
Intervention
Biodegradable polymer sirolimus-eluting stent (BP-SES)
C
Comparator
Durable polymer everolimus-eluting stent (DP-EES)
O
Outcome
Target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation within 12 monthscomposite
Main Result
Relative Risk: 0.38 (95% CI 0.16–0.91)
Absolute Event Rate: 3.4% vs 8.8%
p-value: p=0.024
In STEMI patients, an ultrathin strut biodegradable polymer sirolimus-eluting stent was associated with a significantly lower rate of target lesion failure at one year compared to a durable polymer everolimus-eluting stent.
Limitations
- Pre-specified subgroup analysis
- Findings require confirmation in a dedicated STEMI trial
- Pre-specified subgroup analysis requiring confirmation in a dedicated STEMI trial
Cite This Study
Pilgrim et al. (2016) conducted an RCT in Acute ST-segment elevation myocardial infarction (STEMI) (n=407). Biodegradable polymer sirolimus-eluting stent (BP-SES) vs. Durable polymer everolimus-eluting stent (DP-EES) was evaluated on Target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation within 12 months (RR 0.38, 95% CI 0.16-0.91, p=0.024). Biodegradable polymer sirolimus-eluting stents reduced target lesion failure at 1 year compared to durable polymer everolimus-eluting stents in STEMI patients (3.4% vs 8.8%; RR 0.38; P=0.024).