Key result
DynamX bioadaptor matches contemporary DES for 1-year TLF, reducing events beyond 6 months.
Why the study?
Adverse ischemic events continue to accrue beyond the first year after PCI with contemporary DES, and whether the DynamX sirolimus-eluting bioadaptor improves clinical outcomes compared with contemporary DES was uncertain.
Does the DynamX sirolimus-eluting bioadaptor improve clinical outcomes (target lesion failure) compared with contemporary drug-eluting stents following percutaneous coronary intervention?
Meta-Analysis (n=2,845)
Does the DynamX sirolimus-eluting bioadaptor improve clinical outcomes (target lesion failure) compared with contemporary drug-eluting stents following percutaneous coronary intervention?
The DynamX sirolimus-eluting bioadaptor demonstrates non-inferior 1-year performance compared to contemporary DES and significantly reduces target lesion failure beyond the 6-month uncaging period up to 4 years.
Answers are grounded in this paper and cite their sources.
Bioadaptors may improve late outcomes after PCI; extends randomized evidence for adaptive scaffolds beyond 1 year.
Introduction: Despite advances in contemporary drug-eluting stents (DES), adverse ischemic events continue to accrue beyond the first year after percutaneous coronary intervention (PCI). The DynamX sirolimus-eluting bioadaptor is designed to restore adaptive vessel function following polymer resorption, potentially improving long-term clinical outcomes. Research Question: Does the DynamX bioadaptor improve clinical outcomes compared with contemporary DES following PCI? Methods: We conducted a PROSPERO-registered systematic review and meta-analysis of randomized controlled trials comparing the DynamX bioadaptor with contemporary DES. MEDLINE, EMBASE, CENTRAL, and major cardiovascular conference proceedings were searched through June 2026. The primary outcome was target lesion failure (TLF), defined as cardiovascular death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization. Landmark analyses evaluated outcomes after the 6-month vessel-uncaging period. Results: Two randomized trials enrolling 2,845 patients were included. At 12 months, TLF rates were similar between the bioadaptor and DES groups (2.3% vs 2.8%; OR 0.82, 95% CI 0.51-1.31), confirming non-inferior short-term performance. During landmark follow-up beyond 6 months, the bioadaptor was associated with significantly lower TLF through 24 months (OR 0.47, 95% CI 0.26-0.85), representing a 53% relative reduction. In long-term follow-up of BIOADAPTOR-RCT, TLF at 4 years was 2.8% with the bioadaptor versus 7.8% with DES (OR 0.34, 95% CI 0.13-0.87; NNT=20). Cardiovascular mortality at 4 years was lower with the bioadaptor (0.5% vs 3.7%; p=0.020). No excess risk of device thrombosis was observed. Among patients undergoing LAD intervention, 4-year TLF was 2.7% versus 10.6% (p=0.021). Conclusion: The DynamX bioadaptor demonstrated non-inferior 12-month outcomes compared with contemporary DES and was associated with lower rates of target lesion failure during longer-term follow-up. The emergence of benefit after the 6-month uncaging period supports further investigation of vascular restoration strategies in PCI. Larger randomized studies with extended follow-up are needed to confirm these findings and define the role of bioadaptors in contemporary coronary intervention.
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Falodia et al. (2026) conducted a meta-analysis in Patients undergoing percutaneous coronary intervention (PCI) (n=2,845). DynamX sirolimus-eluting bioadaptor vs. Contemporary drug-eluting stents (DES) was evaluated on Target lesion failure (TLF), defined as cardiovascular death, target-vessel myocardial infarction, or ischemia-driven target lesion revascularization at 12 months (OR 0.82, 95% CI 0.51-1.31). The DynamX bioadaptor was noninferior to contemporary DES for 12-month target lesion failure and reduced TLF beyond 6 months through 24 months.
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