Biodegradable Polymer Sirolimus-Eluting Stents Versus Durable Polymer Everolimus-Eluting Stents in Patients With STEMI - BIOSTEMI

Nov 02, 2023
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC; Kim A. Eagle, MD, MACC
Trial Sponsor:
Biotronik
Date Presented:
10/25/2023
Date Published:
10/25/2023
Date Updated:
11/02/2023
Original Posted Date:
10/15/2019
References

Contribution To Literature:

Highlighted text has been updated as of November 2, 2023.

The BIOSTEMI trial showed that biodegradable polymer sirolimus-eluting stents were superior at preventing target lesion failure.

Description:

The goal of the trial was to evaluate biodegradable polymer sirolimus-eluting stents compared with durable polymer everolimus-eluting stents among patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI).

Study Design

  • Randomized
  • Parallel
  • Bayesian design

Patients with STEMI undergoing primary PCI were randomized to a biodegradable polymer sirolimus-eluting stent (n = 649) vs. a durable polymer everolimus-eluting stent (n = 651).

The biodegradable polymer sirolimus-eluting stent has a strut thickness of 60 μm for stent diameters ≤3.0 mm and 80 μm for stent diameters >3.0 mm (Orsiro; Biotronik). The polymer is biodegradable poly-L-lactic acid that degrades over 12–24 months and releases sirolimus over 12–14 weeks. The durable polymer everolimus-eluting stent has a strut thickness of 81 μm (Xience Xpedition/Alpine; Abbott Vascular). The polymer is poly-n-butyl-methacrylate and vinylidine fluoride and hexafluoropropylene copolymer that releases everolimus.

  • Total number of enrollees: 1,300
  • Duration of follow-up: 2 years
  • Mean patient age: 62 years
  • Percentage female: 21%
  • Percentage with diabetes: 11%

Inclusion criteria:

  • Patients ≥18 years of age with STEMI undergoing primary PCI

Exclusion criteria:

  • Stent thrombosis
  • Mechanical complication of MI

Principal Findings:

The primary outcome, target lesion failure (composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization) at 1 year, occurred in 4% of the biodegradable polymer stents compared with 6% of the durable polymer stents (prespecified criterion for superiority met).

Secondary outcomes:

  • Cardiac death: 3% with biodegradable polymer stents vs. 6% with durable polymer stents
  • Any MI: 2% with biodegradable polymer stents vs. 2% with durable polymer stents
  • Definite or probable stent thrombosis: 2% with biodegradable polymer stents vs. 2% with durable polymer stents

Outcomes at 2 years:

  • Target lesion failure: 5.1% with biodegradable polymer stents vs. 8.1% with durable polymer stents (Bayesian credible interval 0.40-0.84)
  • Clinically indicated target lesion revascularization: 2.5% with biodegradable polymer stents vs. 5.1% with durable polymer stents (Bayesian credible interval 0.30-0.87)
  • Definite or probable stent thrombosis: 2.0% with biodegradable polymer stents vs. 2.3% with durable polymer stents

Outcomes at 5 years:

  • Target lesion failure: 7.7% with biodegradable polymer stents vs. 11.1% with durable polymer stents (Bayesian credible interval 0.47-0.98)
  • Clinically indicated target lesion revascularization: 3.1% with biodegradable polymer stents vs. 5.4% with durable polymer stents (Bayesian credible interval 0.32-0.96)
  • Definite stent thrombosis: 1.7% with biodegradable polymer stents vs. 2.6% with durable polymer stents

Interpretation:

Among patients with STEMI undergoing primary PCI, the ultra-thin biodegradable polymer sirolimus-eluting stent was superior to the durable polymer everolimus-eluting stent. The biodegradable polymer stent design was associated with less target lesion revascularization compared with the durable polymer stent.

The reduction in target lesion failure was sustained at 2 years and also 5 years with the biodegradable polymer sirolimus-eluting stent compared with the durable polymer everolimus-eluting stent. This was due to a significant reduction in the incidence of target lesion revascularization. Definite or probable stent thrombosis was similar between treatment groups.

The comparator stent in this trial has a proven track record, which makes it difficult for any experimental stent to show superiority with outcomes; therefore, these findings are impressive. It is unknown if the latest-generation durable polymer drug-eluting stent (i.e., Xience Sierra or Xience Skypoint) would have resulted in a different outcome.

References:

Iglesias JF, Roffi M, Losdat S, et al. Long-term outcomes with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in ST-segment elevation myocardial infarction: 5-year follow-up of the BIOSTEMI randomized superiority trial. Lancet 2023;Oct 25:[Epub ahead of print].

Presented by Dr. Juan F. Iglesias at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2023), San Francisco, CA, October 25, 2023.

Pilgrim T, Muller O, Heg D, et al. Biodegradable- Versus Durable-Polymer Drug-Eluting Stents for STEMI: Final 2-Year Outcomes of the BIOSTEMI Trial. JACC Cardiovasc Interv 2021;14:639-48.

Editorial Comment: Byrne RA, Coughlan JJ. Biodegradable- Versus Durable-Polymer DES in ST-Segment Elevation Myocardial Infarction: Time to Update Our a Priori Beliefs? JACC Cardiovasc Interv 2021;14:649-52.

Iglesias JF, Muller O, Heg D, et al. Biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (BIOSTEMI): a single-blind, prospective, randomised superiority trial. Lancet 2019;394:1243-53.

Editorial Comment: von Birgelen C, Buiten RA. Superiority of biodegradable polymer sirolimus-eluting stents in STEMI. Lancet 2019;394:1208-10.

Presented by Dr. Juan F. Iglesias at the European Society of Cardiology Congress, Paris, France, September 2, 2019.

Clinical Topics: Acute Coronary Syndromes, Invasive Cardiovascular Angiography and Intervention, Interventions and ACS

Keywords: Acute Coronary Syndrome, Percutaneous Coronary Intervention, TCT23, Transcatheter Cardiovascular Therapeutics


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