News | Stents Drug Eluting | July 12, 2023

Late-Breaking Study Data: BIOTRONIK’s Orsiro DES Outperforms Other Ultrathin Strut Drug-Eluting Stent

A subgroup analysis of the HOST-IDEA randomized controlled trial showed efficacy differences of Ultrathin Strut DES

A subgroup analysis of the HOST-IDEA randomized controlled trial showed efficacy differences of Ultrathin Strut DES

July 12, 2023 — In a late breaking trial session during EuroPCR 2023 in Paris, on behalf of the HOST-IDEA study investigators, Dr. Hyo-Soo Kim presented the results of a stent level analysis comparing two ultrathin strut drug-eluting stents (DES): Orsiro and Coroflex ISAR. The post-hoc comparison revealed significant differences in efficacy. 

HOST-IDEA is a large scale, multicenter, all-comers randomized controlled trial that demonstrated the non-inferiority of 3- to 6-month versus 12-month dual antiplatelet therapy (DAPT) after implantation of ultrathin strut DES. 2,173 patients in 37 South Korean centers were enrolled and treated either with Coroflex ISAR DES (n=559) or Orsiro DES (n=1,449). The study outcomes were published in Circulation1.   

  • At 12 months, the target lesion failure3 (TLF) rate was significantly lower for the Orsiro DES (n=559) as compared to the Coroflex ISAR DES (n=559): 1.1% vs. 3.4%, HR 3.21 (95% CI 1.28 – 8.05), p=0.01.  
  • The significant difference in TLF was mainly driven by the significant difference in clinically-driven target lesion revascularization (CD-TLR): 0.5% for the Orsiro DES and 2.6% for the Coroflex ISAR DES, p=0.01.  
  • There were significant differences regarding the target vessel failure and net adverse clinical event rates.  

Dr. Kim also shared additional findings from the post-hoc analysis of the clinical performance of the two devices following either 3- or 12-month DAPT duration post percutaneous coronary intervention. Results have shown that the Orsiro DES performed better for both DAPT duration scenarios providing especially at three months 1.5% TLF versus 3.0% in the case of the Coroflex ISAR DES. 

"Our post-hoc analysis showed that Orsiro biodegradable polymer sirolimus-eluting stent was associated with significantly better clinical outcomes than the Coroflex ISAR polymer-free sirolimus-eluting stent, mainly due to a lower rate of CD-TLR," concluded Dr. Hyo-Soo. Kim, Interventional Cardiologist at Seoul National University Hospital, South Korea. "The current results indicate that third-generation DES with ultrathin struts are not all the same – probably due to the differences in release kinetics and sirolimus dosage. The results are important to guide future directions of the development of DES." 

"When optimizing the care path for patients, short-DAPT duration is a critical concern for clinicians. BIOTRONIK continues to build solid evidence in the Orsiro DES family range clinical program, which has now more than 71,000 patients enrolled4," commented Stuart Perks, Vice President Marketing Vascular Intervention at BIOTRONIK. "The HOST-IDEA study outcomes continue to show that not all DES perform equally, especially in the ultrathin strut DES arena, where no class effect can be assumed for clinical performance."  

For more information: www.orsiro.com 

References:

1 Han J.K.et al. Comparison of 3- to 6-Month Versus 12-Month Dual Antiplatelet Therapy After Coronary Intervention Using the Contemporary Drug-Eluting Stents With Ultrathin Struts: The HOST-IDEA Randomized Clinical Trial, Circulation, 2023. 

3 Target lesion failure is a combined endpoint of cardiac death, target vessel related myocardial infarction, and clinically driven target lesion revascularization. 

4 BIOTRONIK data on file 

Related content:

American College of Cardiology Announces “ACC.23 Together with WCC” Program Highlights

ACC 2023 Late-breaking Clinical Trials Announced

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