New Generation of DES already being tested, so far safe

This study evaluated the safety and efficacy of the new drug eluting stents (Medtronic, Santa Rosa, California) to treat de novo coronary lesions.

These new polymer free drug filled stents have the potential to improve clinical outcomes and allow a shorter dual antiplatelet therapy. In addition, they have been made with three layers of continuous wire with an outer cobalt chromium layer, a middle tantalum layer, and an inner layer filled with sirolimus. Small laser-drilled holes on the abluminal stent surface control drug elution.

The RevElution study enrolled 100 patients with coronary de novo lesions 2.25 to 3.50 mm diameter and ≤27 length mm in 2 cohorts of 50 patients for angiographic, intravascular ultrasound (IVUS), and clinical follow up at 9 and 24 months. Also, in a subset of 30 patients, optical coherence tomography (OCT) was performed in the same time periods. 

Primary end point was late lumen loss at 9 months vs. historical data on the zotarolimus DES Resolute.

Fifty patients with 56 lesions were treated with the new drug filled device in the 9 month cohort. Late lumen loss was 0.26 ± 0.28 mm for the drug filled stent and 0.36 ± 0.52 mm for the Resolute (p for non-inferiority <0.001). Binary restenosis was 0%. Struts coverage by OCT was 91.4%, 95.6% and 99.1% at one month, 3 months and 9 months respectively.

Target vessel failure at 9 months was 2.1% and there was no in-stent thrombosis.

Conclusion

At 9 months, the polymer free drug filled stent was safe and effective with a high early strut coverage and non-inferior late lumen loss compared to the Resolute.

Original Title: First-in-Human Evaluation of a Novel Polymer-Free Drug-Filled Stent Angiographic, IVUS, OCT, and Clinical Outcomes from the RevElution Study.

Reference: Stephen G. Worthley et al. J Am Coll Cardiol Intv 2017;10:147–56.

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