Percutaneous coronary intervention with ridaforolimus-eluting stents in long lesions: the BIONICS 38 mm prospective trial

Background: The ridaforolimus-eluting stent (RES) system is a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus. The aim of this trial was to assess the performance of a 38 mm RES in long coronary lesions.

Methods: A prospective, multicenter, single-arm, open-label clinical trial. Clinical follow-up was performed at 30 days, 6 months, and 1 year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameters of ≥2.75 mm to ≤4.25 mm. The primary endpoint was combined efficacy (final in-stent residual diameter stenosis <30%) without 30-day major adverse cardiovascular events (MACE) (composite of cardiac death, any myocardial infarction), or ischemia-driven target lesion revascularization.

Results: A total of 50 patients were enrolled in the study. Fourteen (28%) had acute coronary syndromes; 17 (34%) had diabetes. The mean lesion length was 32.4 mm ± 8.3, reference vessel diameter 2.88 mm ± 0.45, minimal lumen diameter 0.80 mm ± 0.41, and percent diameter stenosis 72.6% ± 13.2. The primary endpoint was achieved in 88% (44/50) of the patients (95% confidence interval: 75.7-95.5%). Thirty-day and 1-year MACE rates were 6% and 8%, respectively. Target lesion failure after 1 year occurred in three patients (6%). Forty-seven lesions (94%) were treated successfully, with final in-stent diameter stenosis of < 30% [95% confidence interval: (84-99%).

Conclusion: Percutaneous coronary intervention (PCI) of long lesions with a 38 mm RES achieved satisfactory results, and support the safety and efficacy of PCI with RES in patients with long lesions.

 

Comments:

This study seems to demonstrate promising results for the use of the ridaforolimus-eluting stent (RES) in treating long coronary lesions. The primary endpoint, which aimed for efficacy without major adverse cardiovascular events (MACE) at 30 days, was achieved in a significant percentage of patients, suggesting positive outcomes for this intervention

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The trial's inclusion of patients with acute coronary syndromes and diabetes offers insights into the performance of the RES system in more complex cases. Additionally, the low rates of MACE at 30 days (6%) and 1 year (8%) suggest a favorable safety profile for the procedure.

The successful treatment of a high percentage (94%) of lesions with minimal residual stenosis is another positive indicator of the efficacy of the 38 mm RES in addressing long lesions.

Overall, the study's findings support the safety and effectiveness of using the ridaforolimus-eluting stent in percutaneous coronary intervention (PCI) for patients with long coronary lesions. It could potentially offer a reliable option for this particular subset of patients, showcasing satisfactory outcomes.

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