Long-term safety and efficacy of self-apposing Stentys drug-eluting stent in left main stem percutaneous coronary intervention: final results of multicentre LM-STENTYS registry.

Abstract

Background: Stentys drug-eluting stent (Stentys DES) was proposed to possess potential benefits over balloon-expandable platforms in large bifurcations, mainly distal left main stem (LMS). Several registries demonstrated favourable one-year clinical results of percutaneous coronary intervention (PCI) using Stentys DES for LMS disease. However, long-term follow- up data have been lacking hitherto.

Methods: The study enrolled 175 consecutive patients who underwent PCI with Stentys DES for unprotected LMS and categorized them into acute- and chronic coronary syndrome (ACS/CCS). The primary endpoint was major adverse cardiac and cerebral events (MACCE) composed of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and stroke assessed at five years. The secondary endpoints were stent thrombosis (ST), restenosis and target vessel revascularization (TVR).

Results: Clinical follow-up at five years was completed for 124 out of 175 patients (70.9%), encompassing 85 with ACS and 39 with CCS. At five years, MACCE occurred in 55 out of 124 patients (44.4%). Although, there was a higher rate of MACCE (53% vs 28.2%, p = 0.018), MI (27.1% vs 2.6%, p = 0.016) and TLR (20% vs 2.6%, p = 0.036) in ACS vs. CCS patients, the rates of cardiac deaths were similar (27.1% vs. 25.6%, p = 0.77, respectively).

Conclusions: Herein, favourable long-term outcome of LMS PCI with Stentys DES in the CCS setting are shown. In the ACS setting, worse one-year outcome persisted at five years and was partially related to high rate of acute/subacute ST that might be optimized by immediate loading with potent antiplatelet drugs.