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

Worthley, Stephen G; Abizaid, Alexandre; Kirtane, Ajay J; Simon, Daniel I; Windecker, Stephan; Brar, Sandeep; Meredith, Ian T; Shetty, Sharad; Sinhal, Ajay; Almonacid, Alexandra Popma; Chamié, Daniel; Maehara, Akiko; Stone, Gregg W (2017). First-in-Human Evaluation of a Novel Polymer-Free Drug-Filled Stent: Angiographic, IVUS, OCT, and Clinical Outcomes From the RevElution Study. JACC. Cardiovascular Interventions, 10(2), pp. 147-156. Elsevier 10.1016/j.jcin.2016.10.020

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OBJECTIVES

This study sought to assess the safety and effectiveness of the drug-filled stent (DFS) (Medtronic, Santa Rosa, California) in the treatment of patients with coronary artery disease.

BACKGROUND

Polymer-free drug-eluting stents have the potential to improve clinical outcomes and facilitate shorter durations of dual antiplatelet therapy. The polymer-free DFS is made from a trilayered continuous wire with an outer cobalt chromium layer, a middle tantalum layer, and an inner lumen coated with sirolimus. Small laser-drilled holes on the abluminal stent surface control drug elution.

METHODS

The RevElution trial enrolled 100 patients with de novo coronary lesions 2.25 to 3.50 mm in diameter and length ≤27 mm in 2 cohorts of 50 patients for angiographic, intravascular ultrasound, and clinical assessment at 9 or 24 months, with optical coherence tomography performed in a subset of 30 patients at each time period. The primary endpoint was angiographic in-stent late lumen loss at 9 months compared with Resolute zotarolimus-eluting stent (Medtronic) historical control data.

RESULTS

Fifty patients with 56 lesions were treated with DFS in the 9-month cohort. In-stent late lumen loss was 0.26 ± 0.28 mm for DFS and 0.36 ± 0.52 mm for Resolute (pnoninferiority <0.001). The binary angiographic restenosis rate was 0%. Median stent strut coverage by optical coherence tomography was 91.4%, 95.6%, and 99.1% at 1, 3, and 9 months, respectively. One non-Q-wave myocardial infarction occurred, with a 9-month target lesion failure rate of 2.1%. No stent thrombosis occurred.

CONCLUSIONS

At 9 months, the polymer-free DFS was safe and effective with high rates of early strut coverage and noninferior late lumen loss compared to Resolute. (Medtronic RevElution Trial [RevElution]; NCT02480348).

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