Are Paclitaxel-Eluting Stents Better in Unprotected Left Main Coronary Artery Disease? Three-Year Clinical and Intravascular Imaging Results From a Randomized Study

Medicina ◽  
2011 ◽  
Vol 47 (10) ◽  
pp. 77 ◽  
Author(s):  
Inga Narbute ◽  
Sanda Jegere ◽  
Indulis Kumsars ◽  
Iveta Mintale ◽  
Ilja Zakke ◽  
...  
Keyword(s):  
Randomized Study ◽  
Syntax Score ◽  
Left Main ◽  
Cardiac Events ◽  
Left Main Disease ◽  
Cutting Balloon ◽  
Imaging Results ◽  
Unprotected Left Main Disease

Background and Objective. Recent publications have demonstrated superior outcomes in unprotected left main patients after paclitaxel-eluting stent (PES) implantation. Long-term data in these patients are limited. The aim of this study was to evaluate if intravascular ultrasound (IVUS)-guided PES implantation is superior to bare metal stent (BMS) implantation in unprotected left main disease after lesion pretreatment with cutting balloon during long-term follow-up. Material and Methods. Unprotected left main patients were randomized to BMS (n=50) or PES implantation (n=53). All interventions were IVUS-guided and cutting balloon pretreatment before stenting was performed in all patients. All patients were scheduled for 6-month and 3-year follow-up. Subgroups of patients who underwend IVUS and OCT imaging at 3-year follow-up were analyzed. The primary endpoint was the major adverse cardiac events (MACEs) defined as death, Q-wave myocardial infarction, or target lesion revascularization. Results. Baseline characteristics were similar in both the groups with a mean SYNTAX score of 31.4±14.5 in BMS and 32.6±11.7 in PES patients (P=0.718). At 3 years, MACEs occurred in 18 patients (36.0%) in the BMS and 7 patients (13.2%) in the PES group (P=0.011). By IVUS, percent neointimal volume obstruction at 3 years was reduced from 18.1%±8.7% with BMSs to 10.0%±5.4% with PESs (P<0.001). The total number of uncovered stent struts per OCT image and IVUS image was 0.4±0.8 and 1.2±1.5, respectively (P<0.001). Conclusions. The current study demonstrated that IVUS-guided PES implantation was superior to BMS implantation after cutting balloon pretreatment in unprotected left main disease at 3 years. If compared with IVUS, OCT was more precise in the assessment of stent endothelization.

278Clinical outcomes of state-of-the-art percutaneous coronary revascularization in patients with three-vessel disease: 3-year follow-up of the SYNTAX II study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
P W J C Serruys ◽  
S Walsh ◽  
M Sabate ◽  
J Davies ◽  
M Lesiak ◽  
...  
Keyword(s):  
De Novo ◽  
State Of The Art ◽  
Syntax Score ◽  
Left Main ◽  
Left Main Disease ◽  
Vessel Disease ◽  
Syntax Score Ii ◽  
State Of Art

Abstract Background The clinical implication of state-of-art PCI at long term follow-up in patients with three vessel disease is undetermined. Purpose The purpose of the study was to investigate whether the favourable outcomes of state-of-the-art PCI in the SYNTAX-II trial, demonstrated up to 2 years, are maintained at 3-year follow-up. Methods The SYNTAX-II study was a multicentre, single arm study that investigated the impact of a state-of-art PCI strategy on clinical outcomes in patients with de novo three vessel coronary artery disease, without left main disease. State-of-art PCI includes: heart team decision-making utilizing the SYNTAX score II, hybrid iFR-FFR decision-making strategy, intravascular ultrasound guided stent implantation, contemporary chronic total occlusion revascularization techniques and guideline-directed medical therapy. The primary endpoint is major adverse cardiac and cerebrovascular events (MACCE – a composite of all-cause death, any stroke, myocardial infarction, or revascularization) at 3 years. Clinical outcomes in SYNTAX-II were compared to the predefined PCI (SYNTAX-I PCI) and coronary artery bypass graft (SYNTAX-I CABG) cohorts from the landmark SYNTAX Trial (SYNTAX-I), selected on the basis of equipoise for long-term (4-year) mortality utilising the SYNTAX Score II. Results Between February 2014 and November 2015, 454 patients out of 708 screened patients were enrolled in SYNTAX-II. In SYNTAX-I, 643 (58.8%) patients with 3VD without left main disease had an equipoise recommendation for CABG or PCI based on the SYNTAX Score II and were used as the comparator. At 2 years, MACCE rate in SYNTAX-II was significantly lower compared to SYNTAX-I PCI (13.2% vs. 21.9%, p=0.001). Furthermore, similar two-year outcomes for MACCE were evident between SYNTAX II-PCI and SYNTAX-I CABG (13.2 vs. 15.1%, p=0.42). Three-year results will be presented at ESC2019. Conclusions Three-year results of his study may offer an attractive option of revascularization strategy in predefined patients with de novo 3VD (SYNTAX Score II inclusion) even if the patients have moderate to severe anatomical complexity (anatomic SYNTAX score >22). Acknowledgement/Funding European Cardiovascular Research Institute (ECRI) with unrestricted research grants from Volcano and Boston Scientific

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