En-Abl an All-Comer Ongoing Registry with a Novel Abluminal Coated Sirolimus-Eluting Stent, Presentation of Two-Year Clinical Data in Patients with Complex Lesions

Background: The aim of this registry is to evaluate the clinical performance the Abluminus DES (Envision Scientific), Novel Abluminal coated sirolimus eluting stent coated on stent and parts of balloon in a large real world patient.

Methods: Between January 2012 and April 2018, 2,500 patients were enrolled consecutively in this prospective, multi-center, real world, all-comers on-going registry employing the Abluminus DES in patients with significant stenosis in coronary vessels. Primary endpoint is Major Adverse Cardiac Event (MACE), which encompassed cardiac death, target vessel myocardial infarction (TV-MI) and target lesion/vessel revascularization (TLR/TVR) at 1 year follow-up. Also, stent thrombosis (ST) was recorded at 1 year follow-up.

In this all-comers setting, 2,359 (94.4%) and 1,908 (76.3%) patients completed 1 year and 2-years follow-up respectively and follow-up of remaining patient is ongoing. At 1-year follow-up, MACE were reported in 2.3%, comprising 0.6% cases of cardiac death, 0.4% cases of TV-MI and 1.4% cases of TLR/TVR. Event of stent thrombosis was reported in 0.6% patients at the end of 1-year follow-up. A MACE rate of 2.9% was observed within the 2 year for the overall cohort. The low MACE rate was also confirmed for the subgroups at the 1-year follow-up: diabetics (3.0%), acute myocardial infarction (2.3%), small vessels (3.2%) and long lesions (3.0%).

Conclusion: In conclusion, this multi-center, real world and all-comers registry indicated that the Abluminus DES appears to be safe and effective in treating coronary stenosis irrespective of patient complexity