The OPEN II study and data from a series from the Amsterdam Medical Center, which were both presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference last week (27 October–1 November, San Francisco, USA), show that the Self-Apposing stent (Stentys) can be successfully used outside of its current indication of acute myocardial infarction.
According to a press release , OPEN II is a prospective, single-arm trial that enrolled 217 patients treated for chest pain due to a narrowing at a coronary artery bifurcation with the paclitaxel-eluting stent in 21 hospitals in six European countries. The primary endpoint of MACE (composite of cardiac death, myocardial infarction, emergent by-pass surgery and target lesion revascularisation) at six months was 10.1% for the whole study group, with a rate of 6.9% in patients with simple lesions. Study presenter and principal investigator Christoph K Naber (Contilia Heart and Vascular Center, Essen, Germany) said: “This large study in a highly complex group of patients with challenging lesions confirms that the Stentys stent can be used in routine practice, and leads to very good results compared to those published historically,”
Huangling Lu (Amsterdam Medical Center, Amsterdam, the Netherlands) also presented a series of 87 patients treated with the Self-Apposing stent at her institution. This series enrolled primarily patients with atypical anatomy: 53% had aneurysmatic or ectactic vessels, 31% had tapered vessels, 23% had large vessels and 10% had by-pass grafts. At 12 months, the MACE rate was 4.7%.