Novel Stent Helps Treat Bifurcation Lesions in FIM Registry

PARIS, France—A novel, biodegradable-polymer, sirolimus-eluting stent designed to treat bifurcation lesions demonstrates positive angiographic and clinical results in a first-in-man registry experience, according to registry results presented Wednesday, May 22 at EuroPCR 2013.

The BiOSS LIM stent (Balton, Warsaw, Poland) is a 316L stainless steel device covered with a biodegradable polymer (polylactide and polyglycolide) and sirolimus. The device consists of 2 parts, with the proximal section larger in diameter than the distal section. The stent construction is meant to protect the carina from being crushed or damaged.

For the BiOSS LIM registry, researchers led by Robert J. Gil, MD, PhD, of Central Clinic Hospital (Warsaw, Poland), enrolled 60 patients with coronary bifurcations, over 70% of which were true bifurcations with side branch involvement. The majority (78.3%) had stable ischemic disease, while less than one-fourth (21.7%) had unstable angina/NSTEMI. In just under half (46.7%), the target lesion was located in the left main coronary artery.

Implantation success was achieved in all patients, while an additional stent in the side branch was required in 13.3% of patients.

The overall cohort showed positive post-stenting results on angiographic analysis (table 1).

Table 1. Angiographic Analysis: Entire Cohort

Equally good results were achieved in the left main cohort (table 2).

Table 2. Angiographic Analysis: Left Main Cohort

In the left main cohort, late lumen loss was 0.35 mm in the main vessel, 0.25 mm in the main branch, and 0.12 mm in the side branch. Corresponding late loss values were 0.26 mm, 0.22 mm, and 0.09 mm, respectively, in the non-left main group. Dr. Gil noted that the late loss results were similar to historical results with the Cypher stent (Cordis, Miami Lakes, FL).

In terms of clinical outcomes, TLR was 6.4% at 1 year. There was 1 death after respiratory failure due to flu infection, and 4 periprocedural MIs due to asymptomatic troponin I increase. There were no strokes, no stent thrombosis, and 1 TVR (2.1%). There were 2 PCIs performed in other vessels.

“BiOSS LIM enables a simple and fast bifurcation treatment option with a single stent,” Dr. Gil concluded. “It is user-friendly with a highly successful implantation rate.” He added that based on the registry data, one should expect “excellent clinical results in this severely diseased population, including patients with left main stenosis.”

Dr. Gil stressed that with regard to dedicated stents for specific lesions, “We should take into consideration the duration of the procedure and the amount of contrast media. I believe that with these dedicated bifurcation stents, we are able to shorten the procedure and the contrast media.” He added that the BioSS Lim stent comes in specific sizes for left main lesions. “I believe we’ll be able to prove at least for this subset of [bifurcation] patients that this is an ideal stent.”

The device is available in 3 lengths: 15, 18, and 23 mm.

Study Details

The average age was 66 years, with women comprising less than one-third (28.3%) of the study population. The target lesion was the LAD in 45.0% of cases, LCx in 6.7%, and RCA in 1.7%. Just over half of the bifurcation lesions (52%) were Medina classification 1.1.1, while 21% were 0.1.1, and 16% were 1.1.0.

Less than half of subjects (43.3%) received main vessel predilatation, while 20.0% received side branch predilatation and 11.7% had both branches predilatated. Side branch postdilatation was used in 58.3%. Mean fluoroscopy time was 18.04 minutes and mean contrast volume was 166 mL. Vascular access was radial in the majority of patients (76.3%) and femoral in 23.7%.

 

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Source:
Gil RJ. First-in-man study of dedicated bifurcation sirolimus-eluting stent BiOSS LIM – complete 6-month clinical results. Presented at: EuroPCR; May 22, 2013; Paris, France. 

Disclosure:

• Dr. Gil reports serving as a consultant for Balton.
  

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