EuroPCR 2026 | Are bioresorbable stents making a comeback? Five-year results of FUTURE-II with Firesorb

The first bioresorbable coronary scaffolds generated great expectations because of their potential to restore vascular physiology after device resorption. However, early studies such as ABSORB III demonstrated a higher incidence of late scaffold thrombosis and device-related adverse events, significantly limiting their clinical adoption. Proposed mechanisms included thick struts, heterogeneous degradation, and local flow disturbances.

In this context, Firesorb emerged as a new-generation sirolimus-eluting bioresorbable scaffold designed with thinner struts (100–125 μm), lower drug load, and an architecture intended to optimize the local hemodynamic profile.

The FUTURE-II study was a prospective, multicenter, randomized trial comparing Firesorb BRS versus a contemporary everolimus-eluting cobalt-chromium stent (CoCr-EES). The primary endpoint was in-segment late lumen loss at 1 year. Secondary endpoints included Target Lesion Failure (TLF), Patient-Oriented Cardiovascular Events (PoCE), and definite or probable device thrombosis.

A total of 433 patients from 28 centers in China were randomized 1:1 to Firesorb-BRS (215 patients) or CoCr-EES (218 patients). Mean age was approximately 57 years, 73% presented with unstable angina, and about 26–30% were diabetic. Non-complex coronary lesions were included, with vessel diameters between 2.5 and 4.0 mm and lesion length ≤25 mm. Clinical follow-up at 5 years reached 96.3%.

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The primary non-inferiority endpoint was achieved, with similar in-segment late lumen loss between both devices at 1 year (0.17 ± 0.27 mm with Firesorb vs 0.18 ± 0.37 mm with CoCr-EES; p<0.0001 for non-inferiority). At 5 years, rates of target lesion failure were comparable between groups (5.2% with Firesorb vs 5.5% with CoCr-EES; p=0.85). No significant differences were observed in cardiac death (0.5% vs 0.9%), target vessel myocardial infarction (0.5% vs 0.9%), or ischemia-driven target lesion revascularization (3.3% vs 5.1%).

One of the most relevant findings of the study was the absence of definite or probable device thrombosis during the 5-year follow-up in both groups, particularly noteworthy for Firesorb considering the historical concerns associated with first-generation bioresorbable scaffolds.

Conclusion: Firesorb showed outcomes comparable to DES without increased late thrombosis at 5 years

The 5-year follow-up of the FUTURE-II trial demonstrated that the thin-strut Firesorb bioresorbable scaffold achieved clinical outcomes comparable to contemporary DES in non-complex coronary lesions, without signals of increased late device thrombosis.

Original Title: Five-year outcomes of thinner-strut Firesorb bioresorbable scaffold in the FUTURE-II trial.

Reference: Presented by Lei Song at EuroPCR 2026.