RevElution: Drug-filled stent signals favorable early healing profile

WASHINGTON — In the RevElution study, a polymer-free drug-filled stent met the primary endpoint of in-stent late lumen loss at 9 months compared with a drug-eluting stent, and was also linked with positive clinical outcomes, researchers reported at TCT 2016.

The RevElution study enrolled 101 patients with de novo lesions (diameter 2.25-3.5 mm; length 27 mm) at various sites in three countries. Patients were divided into two cohorts to measure outcomes at 9 and 24 months.

OCT data were reported from two cohorts of patients who were scheduled to undergo OCT at 1 and 9 months or 3 and 9 months. In both groups, the drug-filled stent (Medtronic) was associated with an early healing profile with the median strut coverage of 91.4% at 1 months, 95.6% at 3 months and 99.1% at 9 months. The drug-filled stent was linked with a low rate of malapposed struts at 1 month (0.3%), which decreased to 0% at 9 months. Non-Q-wave MI occurred in one patient, and the 9-month target lesion failure rate was 2.1%.

The primary endpoint was in-stent late lumen loss at 9 months in the 9-month cohort (n = 50) compared with a historical cohort that received a zotarolimus-eluting stent (ZES; Resolute, Medtronic). According to data presented at TCT 2016, in-stent late lumen loss was 0.26 mm with the drug-filled stent vs. 0.36 mm with the ZES (P for noninferiority < .001).

“In the first 50-patient cohort, the polymer-free drug-filled stent was safe and effective with late lumen loss noninferior to historical control[s],” Stephen Worthley, MBBS, PhD, of Royal Adelaide Hospital in Australia, said during a presentation.

The drug-filled stent features a novel tri-layer wire design. The innermost layer is removed and becomes a lumen continuously coated with sirolimus, which is eluted from the inside of the stent through multiple laser-drilled holes on the abluminal side of the stent. The polymer-free design allows for controlled and sustained drug elution directly into the arterial wall, according to a company press release.

“To date, polymer-free stents have failed to be able to sustain release of antiproliferative agents over a 3- to 4-month period that's required to suppress the restenotic process," Worthley said during a press conference here. "Therefore, a technology that could both avoid a polymer and, yet, allow a sustained release of antiproliferative agent up to 3 to 4 months would be a very attractive platform.”

Results of the RevElution trial show that drug-filled stenting could potentially allow shorter duration of dual antiplatelet therapy due to the ability to avoid polymer-associated adverse vascular response, according to the researchers.

“This novel polymer-free drug-eluting stent with these abluminal halts is safe and effective ... and forms a premise of a potential role for this in limiting [DAPT], but that would be dependent upon further randomized controlled trials,” Worthley said.

The drug-filled stent is available for investigational use only and is not currently approved for use outside of clinical studies. – by Dave Quaile

References:

Worthley S, et al. First Report Investigations 2. Presented at: TCT Scientific Symposium; Oct. 29-Nov. 2, 2016; Washington, D.C.

Worthley SG, et al. J Am Coll Cardiol Interv. 2016;doi:10.1016/j.jacc.2016.10.020.

Disclosure: Worthley reports receiving consultant fees and honoraria from Medtronic and St. Jude Medical.