P3574Distal left main trifurcation treatment with dedicated bifurcation stents: subgroup analysis from randomized clinical trials POLBOS I and POLBOS II

Abstract

Introduction: Left main (LM) trifurcations are encountered in about 10‐20% of LM cases and may require specific treatment strategies. Purpose: The aim of this retrospective analysis was to assess the effectiveness and safety of dedicated bifurcation BiOSS stents deployed in LM trifurcations in in patients with stable coronary artery disease (CAD) and NSTE‐ACS. Methods: BiOSS stents are a family of coronary dedicated bifurcation balloon expandable stents made of stainless steel. They are coated with a biodegradable polymer comprised of lactic and glycolic acids. The stent consists of two parts with different diameters connected with two struts. BiOSS Expert elutes paclitaxel and BiOSS LIM elutes sirolimus. We retrospectively analyzed data from BiOSS Expert Registry, international randomized clinical trial POLBOS I with BiOSS Expert, BiOSS LIM Registry and international randomized clinical trial POLBOS I with BiOSS LIM. Patients were enrolled between 2010 and 2013 in centers in Poland, Spain and Bulgaria with a final diagnosis of stable CAD or NSTE‐ACS who sign informed consent were enrolled. Patients with STEMI or Medina type 001 bifurcation lesions were excluded from the registry. An angiographic control was planned at 12 months. The primary end‐point was the rate of cardiac death, myocardial infarction (MI), and target lesion revascularization at 12 months. Results: The analyzed population counted of 345 patients, in whom 131 patients had BiOSS stent deployed in the distal LM. In this subgroup we identified 75 cases (72.8%) with distal LM bifurcation and 28 cases (27.2%) with distal LM trifurcation. Additionally, we differentiated three subgroups among trifurcations: treated with only BiOSS stent (group I: n=5, 17.9%), treated with 2 or 3 stent technique (group II: n=15, 53.6%) and pseudo‐trifurcations with high take off of diagonal or marginal branches (group III: n=8, 28.5%). The mean age of enrolled patients (82.1% males) was 66.8±9.77 years. Patients with trifurcation had more frequently hypertension (p<0.01) and underwent prior PCI (p<0.01) comparing with patients with bifurcations. All BiOSS stents were implanted successfully. The mean nominal stent parameters were as followed: 4.09±0.33mm x 3.44±0.38mm x 16.99±2.1mm. In 19 (67.9%) cases the second stent was implanted within the side branch, mainly in TAP technique. Proximal optimization technique was performed in 23 cases (82.1%). There were 64.3% of cases performed from radial access, and 21.4% ‐ using 7F guiding catheter. In 6 cases (21.4%) periprocedural MI was diagnosed. At 12 months there was no statistically significant differences between groups in MACE rates, 0, 13.3% (n=2), 12.5% (n=1), respectively. At ESC 2018 we will present data from the 5‐year follow‐up. Conclusions: Distal left main trifurcations are challenging lesions. Dedicated bifurcation BiOSS stents seem feasible devices with promising safety profile and mid‐term clinical effectiveness.