Despite advances in drug-eluting stents, device-related events continue to increase beyond the first year after angioplasty. In this context, the DynamX system emerged as a sirolimus-eluting coronary bioadaptor designed to overcome one of the main limitations of conventional stents: the loss of physiological vessel function.
Unlike a traditional stent, which maintains a permanently rigid structure, DynamX features a helical architecture initially connected by a bioabsorbable polymer. After approximately 6 months, this polymer is resorbed and the metallic struts are partially released, allowing recovery of a certain degree of pulsatility, conformability, and adaptive vascular remodeling while maintaining luminal support. The BIOADAPTOR-RCT compared this device against a contemporary zotarolimus-eluting drug-eluting stent (Resolute Onyx DES).
The primary endpoint was Target Lesion Failure (TLF), while secondary endpoints included Target Vessel Failure (TVF), cardiovascular death, target vessel myocardial infarction, and repeat revascularization.
A total of 445 patients from 34 international centers were randomized 1:1 to the DynamX bioadaptor (223 patients) or Resolute Onyx DES (222 patients). Mean age was 67 years, 22% were women, and approximately one-third presented with acute coronary syndrome. Complex lesions were present in about 22% of cases, and 4-year clinical follow-up reached 98%.
At 4 years, the bioadaptor demonstrated a significant reduction in TLF compared with conventional DES (2.8% vs 7.8%; p=0.020). Lower cardiovascular mortality was also observed (0.5% vs 3.7%; p=0.020), along with lower rates of target vessel myocardial infarction (0.9% vs 1.8%) and clinically driven revascularization (1.4% vs 2.8%). The benefit became evident mainly after 6 months, coinciding with the time when the device acquires its dynamic behavior.
In subgroup analysis, lesions in the left anterior descending artery showed a particularly marked benefit, with TLF rates of 2.7% with the bioadaptor versus 10.6% with DES (p=0.021). Likewise, target vessel failure was significantly lower with DynamX (3.3% vs 8.2%; p=0.025).
Conclusion: The DynamX bioadaptor reduced cardiovascular events and improved long-term PCI durability at 4 years
The 4-year follow-up of the BIOADAPTOR-RCT showed that the DynamX coronary bioadaptor was associated with a significant reduction in cardiovascular and device-related events compared with a contemporary DES. These findings suggest that partially restoring vascular physiology may improve the long-term durability of coronary angioplasty.
Original Title: BIOADAPTOR RCT Outcomes at 4-Year Follow Up: Randomized Controlled Trial of Sirolimus-Eluting Bioadaptor Versus Zotarolimus-Eluting Drug-Eluting Stent.
Reference: Presentado por Futoshi Yamanaka en EuroPCR 2026.
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