HOST-IDEA sub-analysis uncovers differences in ultrathin stent platforms

Orsiro DES

Results of a stent-level analysis from the HOST-IDEA study, which compared two ultrathin strut drug-eluting stents (DESs) Orsiro (Biotronik) and Coroflex ISAR (B Braun), have shown differences in efficacy between the two devices.

Presented by Hyo-Soo Kim (Seoul National University College of Medicine, Seoul, South Korea) at EuroPCR 2023 (16–19 May, Paris, France) on behalf of the HOST-IDEA investigators, the findings of the analysis were also published in Circulation.

HOST-IDEA is a large scale, multicentre, all-comers randomised controlled trial that demonstrated the non-inferiority of three- to six-month versus 12-month dual antiplatelet therapy (DAPT) after implantation of ultrathin strut DES. The study enrolled 2,173 patients in 37 South Korean centres who were treated either with Coroflex ISAR DES (n=559) or Orsiro DES (n=1,449).

In the presented post-hoc analysis out of a propensity score-matched population, results showed that at 12 months, the target lesion failure (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%, (hazard ratio [HR] 3.21, 95% confidence interval [CI] 1.28–8.05, p=0.01).

The difference in TLF was mainly driven by the difference in clinically-driven target lesion revascularisation (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.

Kim also shared additional findings from the post-hoc analysis of the clinical performance of the two devices following either three- or 12-month DAPT duration post-percutaneous coronary intervention (PCI). Results have shown that the Orsiro DES performed better for both DAPT duration scenarios providing especially at three months 1.5% TLF versus 3% 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 Kim. “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 optimising 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 programme, which has now more than 71,000 patients enrolled,” commented Stuart Perks, vice president marketing vascular intervention at Biotronik. “The HOST-IDEA study outcomes continue to show that not all DESs perform equally, especially in the ultrathin strut DES arena, where no class effect can be assumed for clinical performance.”


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