Outcome of left main stent implantation: a randomized comparison between ultra-thin strut (Suprafex Cruz) and thin strut (SYNERGY) stent, a post-hoc sub-analysis of the Multivessel TALENT trial

Background Left main (LM) disease is a life-threatening pathology. Current guidelines, supported by meta-analyses of large randomized trials, endorse PCI for LM disease as an alternative to CABG in patients with lower anatomic complexity when PCI can achieve equivalent revascularization to CABG. However, in contemporary PCI, comparative outcome data for patients requiring LM stent implantation between newer-generation ultra-thin-strut and thin-strut drug-eluting stents are scarce. Purpose To evaluate 1-year clinical outcomes of patients, undergoing PCI for de novo three-vessel disease (3VD), that nevertheless underwent LM stent implantation and to compare ultra-thin-strut Supraflex Cruz™(60μm) and thin-strut SYNERGY™(74-81μm) in the Multivessel TALENT trial (NCT04390672). Methods This is a post-hoc sub-analysis of the Multivessel TALENT trial, a multicentre randomized trial (in 54 European sites) that randomized and treated 1533 patients with de novo 3VD with protocolar exclusion of LM disease. Patients were randomized 1:1 to Supraflex Cruz or SYNERGY and treated with contemporary PCI practice, including corelab-analysed angiography-derived FFR, post-PCI intravascular imaging-guided optimization, and 1-month DAPT followed by prasugrel monotherapy. The treatment of LM stenosis (n=20) or both ostial LAD and LCX stenoses (n=3) were exclusion criteria and protocol deviation, but single ostial LAD or LCX lesion treatment with extension of stent in LM (n=90) was allowed by protocol. The primary outcome in this sub-analysis was 1-year patient-oriented composite endpoint (POCE): composite of all-cause death, any MI, any stroke, and any revascularization. The patients with stent implantation to LM were compared with those without LM stent. The comparison between study stents (Supraflex Cruz and SYNERGY) was also performed within each group. Results Among 1533 patients that underwent PCI, 126 (8.2%) received stent(s) in LM. Compared with those without LM stenting, the LM stent group had significantly higher SYNTAX scores, larger total number of stents, and longer total stent length. Of 126 LM stent cases, LM bifurcations were present in 107 cases(10 true[Medina 1,1,1; 1,0,1; 0,1,1] and 97 non-true[Medina 1,1,0; 1,0,0; 0,1,0; 0,0,1]). For treatment of LM bifurcations, 1-stent and 2-stent strategies were used in 93 and 27 cases. The 1-year POCE was numerically higher with LM stenting but not statistically significant (17.7% vs 14.4%,HR 1.26, 95%CI 0.81-1.95, P=0.309). All-cause mortality tended to be higher in LM stent group (5.7% vs 2.7%,HR 2.09, 95%CI 0.93-4.67, P=0.074). However, 1-year POCE was comparable between ultra-thin Supraflex Cruz and thin SYNERGY (LM subset: 17.9% vs 17.4%, HR 1.08, 95%CI 0.46-2.49; non-LM subset: 14.8% vs 13.9%, HR 1.07, 95%CI 0.81-1.41; P for interaction=0.978). Conclusions In this underpowered post-hoc analysis, outcomes after LM stenting were comparable between ultra-thin Supraflex Cruz and thin SYNERGY.