Dr. Yunus Çalapkulu

Name of the Study: Percutaneous coronary intervention with a bioadaptor compared to a contemporary drug eluting stent- one year primary outcomes (INFINITY-SWEDEHEART)

Published in Congress: ESC Congress 2024

Link: https://www.sciencedirect.com/science/article/pii/S0002870324001820

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Background:

Today, modern stent methods continue to be used with significant improvements, while still forming a rigid cage within the coronary artery lumen. Furthermore, the annual incidence of target lesion failure (TLF) after the first year is 2%-4%, and half of the patients continue to experience angina after 5 years. The DynamX bioadapter has helical threads that unlock and detach after in vivo degradation of the bioabsorbable polymer coating. It also has a thin (71 µm) cobalt-chromium platform that releases sirolimus. This stent allows normal physiologic function and motion of the vessel and, together with adaptive remodeling, may reduce the need for reintervention and reduce angina following percutaneous coronary intervention (PCI).

Objective:

The INFINITY-SWEDEHEART study compared the efficacy of the DynamX bioadapter with a contemporary drug-eluting stent (DES) in the treatment of coronary artery disease requiring PCI.

Methods:

In this single-blind, multicenter study, patients undergoing PCI for chronic or acute coronary syndromes were randomized 1:1 to undergo PCI with the DynamX sirolimus-eluting bioadapter (n = 1,201) or the Resolute Onyx stent (n = 1,198). Total follow-up was 12 months. The primary outcome of the study was TLF, a composite of cardiovascular death, target vessel myocardial infarction (TV-MI), or ischemia-induced target lesion revascularization (ID-TLR).

Results:

In the INFINITY-SWEDEHEART study, the median age at randomization was 68 years, with 2,399 patients, 76% male and 24% female. The composite endpoint of TLF at 12 months occurred in 2.4% in the DynamX bioadapter group and 2.8% in the Resolute Onyx DES group (95% confidence interval [CI] -1.94% to 1.11%, p < 0.001 for non-inferiority).

Secondary outcomes for DynamX bioadapter vs. Resolute Onyx at 1 year were 0.6% vs. 0.5% for cardiovascular death, 1.3% vs. 1.5% for TV-MI, 1.3% vs. 2.1% for ID-TLR, and 3.0% vs. 3.5% for target vessel failure (TVF), a composite of cardiovascular death, TV-MI, or target vessel revascularization.

Conclusion:

The INFINITY-SWEDEHEART study demonstrated that the DynamX bioadapter resulted in fewer target lesions and vascular insufficiencies compared to Resolute Onyx DES in patients undergoing PCI for chronic or acute coronary syndromes.

Interpretations:

These findings suggest that the DynamX bioadapter has a promising role for PCI across a broader range of coronary artery disease presentations. Further studies are needed to understand both long-term outcomes and efficacy when compared with other stent platforms such as everolimus-eluting durable polymer DES and biodegradable polymer DES (such as Orsiro) and in more complex anatomic lesions.