TCT: OPEN II data show stents safe & effective at six months

The use of the STENTYS Self-Apposing® Stent, a paclitaxel-eluting stent (Taxol, Bristol-Myers Squibb), in certain patients with coronary bifurcation lesions has so far been safe and effective six months into a clinical trial, according to data presented Oct. 28 at the 2013 Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco. If longer-term follow-up confirms their findings, using this drug-eluting stent (DES) may also be less clinically complex than current DES.

The OPEN II trial is an ongoing nonrandomized, multicenter study taking place in Europe. The reason for the study is to test whether data from a previous feasibility trial for the same stent are reproducible over a longer-term follow-up period, lead researcher Christoph K. Naber, MD, PhD, of Contilia Heart and Vascular Center in Essen, Germany told Cardiovascular Business in an email. The STENTYS DES is not available for sale in the U.S.

In their study, Naber and colleagues enrolled 217 patients with bifurcation lesions and ischemia to receive the STENTYS DES. In the end, nine patients were excluded. Many of the enrolled patients had comorbidities, such as hypertension, hypercholesteremia and diabetes. More than 70 percent of the participants also had “true” lesions based on the Medina classification, Naber explained.

They assessed major adverse cardiac events (MACE) six months later as the study’s primary outcome.

Naber also said that MACE rates were similar or lower than those found at six- and nine-months follow-up in other similar studies, such as the British Bifurcation Coronary Study (BBC), the Nordic Bifurcation Study (NORDIC) and the combined BBC and NORDIC.

In addition, he explained, “typical bifurcation techniques such as proximal optimization, final kissing after accessing the side branch, etc., were not mandatory” with the STENTYS DES.

He added that if safety and efficacy are still confirmed at 12 months, using this stent could offer numerous clinical benefits.

The stent can be disconnected to support access to the side branch. In addition, once it is opened, it “will adapt and open to the side branch anatomy without being simultaneously malapposed in the main branch,” something that makes current DES require kissing, he explained.

The researchers are awaiting the results from the 12-month follow -p and plan to present them at a European conference next year.