BIOSTEMI

Biodegradable polymer sirolimus-eluting stent Orsiro® versus Durable Polymer everolimus-eluting stent Xience in patients with ST-segment Elevation Myocardial Infarction (STEMI) at 24 months

BIOSTEMI trial: Continued superiority in STEMI at 2 years°

Dr. Juan F. Iglesias, Geneva University Hospitals, Geneva, Switzerland presents the BIOSTEMI 2-year results

Conclusions

• At 24 months, Orsiro is superior to Xience in STEMI patients with respect to the primary endpoint of Target Lesion Failure (TLF) (5.1% vs. 8.1%, Rate Ratio (95% BCI**): 0.58 (0.40-0.84), Posterior Probability of Superiority: 99.8%)
• The difference in TLF rates remained statistically significant after the exclusion of historical information from the BIOSCIENCE trial (Rate Ratio (95% BCI**): 0.62 (0.40-0.96), Posterior Probability of Superiority: 98.5%)
• Clinically-indicated Target Lesion Revascularization (TLR) rate was significantly lower in Orsiro compared to Xience (2.5% vs. 5.1%, Rate Ratio (95% BCI**): 0.52 (0.30-0.87), Posterior Probability of Superiority: 99.3%)
• The significant difference at 24-m favoring the Orsiro vs. Xience DES might have clinically relevant implications for routine clinical practice.

Study Design

Investigator-initiated, prospective, multicentre, assessor-blinded, randomized (1:1), controlled, superiority trial comparing Orsiro and Xience in STEMI patients undergoing primary PCI.

Endpoints

Primary Endpoint
Target Lesion Failure (TLF) at 12 months follow-up defined
as the composite of:
• Cardiac Death,
• Target Vessel-Myocardial Reinfarction
• Clinically-indicated Target Lesion Revascularization (TLR)
Selected Secondary Endpoints
Individual components of the primary endpoint, All cause death, Target Vessel Revascularization (TVR), Target Vessel Failure (TVF), Definite Stent Thrombosis (Def ST), Definite or Probable Stent Thrombosis (Def/Prob ST)

Flowchart
Patient charcteristics1​​​​​​​ Orsiro n = 649 Xience n = 651
Age, years‡ 62.2 ± 11.8 63.2 ± 11.8
Male 79% 73%
Active Smoker 46% 39%
Diabetes Mellitus  11% 13%
BMI [kg/m2]‡ 26.9 ± 4.3 26.8 ± 4.3
Previous MI 4% 4%
Previous PCI 5% 5%
Previous CABG 0.3% 1%

 

Angiographic and procedural characteristics1 Orsiro n = 816¤ Xience n = 806¤
Number of lesions/patient‡ 1.26 ± 0.57 1.24 ± 0.52
Total Occlusion 49% 55%
Thrombus Aspiration 30% 31%
Baseline TIMI flow    
0 or 1 55% 59%
2 13% 14%
3 31% 27%
Cardiogenic shock 3% 3%
Small vessel (minimum stent diameter ≤3.0 mm) 36% 40%

Bifurcation treatment
(including left main coronary artery)

 12% 14%
Long Lesions (total stent length ≥20 mm) 71% 71%

Primary Endpoint – TLF at 24 months2

Orsiro is superior to Xience with respect to TLF at 24 months in STEMI patients. The effect was robust and maintained after the exclusion of historical information from the BIOSCIENCE trial.

Selected Secondary Endpoints at 24 months2

 

BIOSTEMI with

historical data from BIOSCIENCE

 BIOSTEMI only
 

Orsiro 

n = 649

Xience

n = 651

 Rate Ratio
(95% BCI**)		 Bayesian Posterior
Probability of Superiority		 Rate Ratio
(95% BCI**)		 Bayesian Posterior
Probability of Superiority
Cardiac Death 2.9% 3.2% 0.77 (0.44–1.35) 82.3% 0.91 (0.49–1.69) 61.4%
TV-MI 1.5% 2.0% 0.67 (0.33–1.34) 87.5% 0.77 (0.33–1.75) 73.1%
Clinically-indicated TLR 2.5% 5.1% 0.52 (0.30–0.87) 99.3% 0.48 (0.26–0.86) 99.3%
TVF 6.0% 9.4% 0.61 (0.43–0.86) 99.8% 0.63 (0.42–0.94) 98.8%
Clnically-indicated TVR 3.1% 6.1% 0.56 (0.35–0.87) 99.5% 0.50 (0.29–0.84) 99.6%
Def ST 1.4% 1.8% 0.73 (0.30–1.69) 77.1% 0.76 (0.31–1.77) 73.9%
Def/Prob ST 2.0% 2.3% 0.72 (0.38–1.44) 83.7% 0.87 (0.41–1.84) 64.2%

 

Subgroup Analysis – TLF at 24 months2

Principal investigators

Dr. J.F. Iglesias, Geneva University Hospital, Geneva, Switzerland
Dr. O. Muller, Lausanne University Hospital, Lausanne, Switzerland
Dr. T. Pilgrim, Bern University Hospital, Bern, Switzerland

* Xience is a trademark of Abbott Cardiovascular Systems Inc.

** Bayesian Credible Interval

‡ Data shown as mean ± SD

¤ Number of lesions

° vs. Xience at 24-months in the BIOSTEMI trial, with respect to TLF, based on combined data set of BIOSTEMI and BIOSCIENCE STEMI groups.

TLF - Target Lesion Failure

1. Iglesias 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, September, 2019; 2. Pilgrim et al. Biodegradable – versus durable-polymer drug-eluting stents for STEMI. Final 2-year outcomes of the BIOSTEMI trial. J Am Coll Cardiol. Cardiovasc Interven. 2021, doi: 10.1016/j.jcin.2020.12.011.

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Orsiro is a trademark or registered trademark of the BIOTRONIK Group of Companies.


Clinical data conducted with Orsiro, Orsiro Mission’s predecessor device can be used to illustrate Orsiro Mission clinical outcomes.

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