Late-Breaking Data at EuroPCR: BIOTRONIK's Orsiro Demonstrates Unique Benefits in Small Vessels

A Subgroup Analysis of the BIO-RESORT RCT Three-Year Data Showed Significant Differences in Efficacy in Favor of Ultrathin Strut Orsiro

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BIOTRONIK

May 21, 2019, 11:06 ET

PARIS and BUELACH, Switzerland, May 21, 2019 /PRNewswire/ -- Focusing on patients with small vessels, three-year outcomes of the BIO-RESORT randomized controlled trial (RCT) showed a significantly lower target lesion revascularization (TLR) rate and thus better efficacy of the Orsiro^® drug-eluting stent¹ (DES) in comparison to the Resolute Integrity DES.² Prof. Clemens von Birgelen, Thoraxcentrum Twente, MST, Enschede, the Netherlands, presented the new subgroup data in a late-breaking clinical trials session at EuroPCR.³

BIO-RESORT three-year data shows significant differences in efficacy in favor of Orsiro.

In the large all-comers BIO-RESORT trial, 1,506 patients with small coronary vessels⁴ were treated with the Orsiro, Resolute Integrity or Synergy DES⁵. The three-year results presented at EuroPCR 2019 and published in the Journal of the American Medical Association⁶ show the rate of target lesion failure⁷ (TLF) in favor of Orsiro 7.0% (Orsiro vs. Resolute Integrity p= 0.08), for Resolute Integrity 10.0% and for Synergy 9.5% (Synergy vs. Resolute Integrity p=0.72).

In terms of cardiac death and myocardial infarction, the three stents showed similar results. However, patients treated with the ultrathin strut Orsiro experienced significantly fewer repeat target lesion revascularizations (TLR) than those treated with the thin strut Resolute Integrity (Orsiro 2.1% vs. Resolute Integrity 5.3%, p=0.009; Synergy 4.0%).

Divergence seemed more pronounced after the first year post index procedure, when dual antiplatelet therapy (DAPT) was stopped. This is supported in a TLR landmark analysis between one and three years, where the TLR rate with Orsiro was 1.0%, with Resolute Integrity 3.7% (p=0.006) and with Synergy 2.7%. Additionally, Orsiro showed a trend towards a lower rate of definite or probable stent thrombosis with a rate of 0.6% compared to 1.5% for Resolute Integrity (p=0.16) and 1.5% for Synergy.

"The results may be clinically relevant, as they suggest a relation between the use of ultrathin strut sirolimus-eluting stents and a lower repeat revascularization risk in all-comers patients with small target vessels," explained principal investigator Prof. Clemens von Birgelen. "Due to a greater relative impact of stent strut size on lumen obstruction, the substantially thinner struts of these new-generation drug-eluting stents may be particularly advantageous in small vessels."

In the large scale, multicenter BIO-RESORT trial, 42.9% of the full cohort of 3,514 patients undergoing percutaneous coronary intervention presented the need for small vessel treatment. While stenting of small coronary vessels is common, these patients are exposed to subsequent increased adverse cardiovascular event risks.

"The BIO-RESORT outcomes add to the growing body of evidence that demonstrate ultrathin strut Orsiro provides real clinical advantages over second-generation, thicker strut DES," commented Dr. Alexander Uhl, Senior Vice President Corporate Marketing at BIOTRONIK. "These favorable results, together with the significant differences in efficacy shown in the SCAAR data at this EuroPCR, and BIOFLOW-V underscore that Orsiro is a tool every interventionalist should have access to."

References

¹	Orsiro is a trademark or registered trademark of the BIOTRONIK Group of Companies.
²	Resolute, Integrity and Resolute Integrity are trademarks or registered trademarks of the Medtronic Group of Companies.
³	von Birgelen C, on behalf of BIO-RESORT investigators. Three-year clinical outcome following treatment with thin, very thin or ultrathin strut DES in small coronary vessels in BIO-RESORT. Presented at: EuroPCR, May 21, 2019; Paris, France.
⁴	Vessel diameter < 2.5 mm.
⁵	Synergy is a trademark or registered trademark of the Boston Scientific Group of Companies.
⁶	Buiten RA, Ploumen EH, Zocca P, et al. Outcome in patients treated with thin, very thin, or ultrathin strut drug-eluting stents in small coronary vessels: a secondary analysis of the randomized BIO-RESORT trial. JAMA Cardiology 2019.
⁷	Target lesion failure is a combined endpoint of cardiac death, target vessel related myocardial infarction, and clinically driven target lesion revascularization.

About BIOTRONIK
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.

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