Comparison of the left main stem trials
| SYNTAX-LM | NOBLE | EXCEL | |
| Cohorts | LM subgroup cohort from ‘all comers’ with LM and/or three-vessel disease trial (n=705) | LM ≥50% stenosis or FFR ≤0.80 and <3 other non-complex lesions; including patients with ACS (n=1201) | LM ≥70% stenosis or ≥50% stenosis with ischaemia on invasive or non-invasive test; SYNTAX score <32; including patients with ACS (n=1905) |
| Recruitment | 2005–2007 | 2008–2015 | 2010–2014 |
| SYNTAX score | 31.5% low, 27.8% intermediate and 40.7% high | 51.8% low, 39.6% intermediate and 8.6% high | Local site: 60.5% low and 39.5% intermediate Core lab: 35.8% low, 40.0% intermediate and 24.2% high |
| Intracoronary diagnostics | Infrequent IVUS and FFR guidance | Recommended IVUS (75%) and FFR guidance | Recommended IVUS (77%) and FFR guidance (9.0%) |
| Stenting | PES 12.9% isolated LM | BES, 11% first-generation DES | EES (99.2%) |
| 54% isolated LM disease | 48.7% isolated LM disease | ||
| 87.7% bifurcation | 80.5% bifurcation | ||
| 35% two-stent strategy | Mean 2.4 stents | ||
| Mean length 49.1 mm | |||
| CABG | 2.6 grafts* 87.6% LIMA use* | 2.5 grafts 85.7% LIMA use | 2.6 grafts 98.8% LIMA use |
| Primary endpoints | All-cause death/MI/CVA/repeat revascularisation | All-cause death/non-procedural MI/CVA/repeat revascularisation | All-cause death/large MI/CVA |
| Follow-up | 5 years | Median 3 years with estimated 5 years | Median 3 years |
| Findings (PCI vs CABG) | Composite: 36.9% vs 31.0% (p=0.12) | Composite: 29% vs 19% (p=0.007) | Composite: 15.4% vs 14.7% (p=0.98) |
| All-cause death: 12.8% vs 14.6% (p=0.53) | All-cause death: 12% vs 9% (p=0.77) | All-cause death: 8.2% vs 5.9% (p=0.11) | |
| MI: 8.2% vs 4.8% (p=0.10) | Non-procedural MI: 7% vs 2% (p=0.004) | MI: 8.0% vs 8.3% (p=0.64) | |
| CVA: 1.5% vs 4.3% (p=0.03) | CVA: 5% vs 2% (p=0.07) | CVA: 2.3% vs 2.9% (p=0.37) | |
| Repeat revascularisation: 26.7% vs 15.5% (p>0.01) | Repeat revascularisation: 16% vs 10% (p=0.032) | ||
| Other: | Other: | Other: | |
| CV death: 8.6% vs 7.2% (p=0.46) | CV death: 3.0% vs3.0% (p=0.84) | CV death: 3.7% vs 3.4% (p=0.71) | |
| Periprocedural MI: 5.0% vs 7.0% (p=0.52) | Periprocedural MI: 3.8% vs 6.0% (p=0.03) | ||
| Non-procedural MI: 4.3% vs 2.7% (p=0.07) | |||
| ‘Confirmed’ ST/VGO: 5.1% vs 4.4% (p=0.70) | Definite ST/VGO: 3.0% vs 4.0% (p=0.22) | Definite ST/VGO: 0.7% vs 5.4% (p<0.001) | |
| Ischaemia-driven revascularisation: 12.6% vs 7.5%, (p<0.001) |
*Data not limited to the LM subgroup only.
ACS, acute coronary syndrome; BES, biolimus-eluting stent; CABG, coronary bypass grafting; CV, cardiovascular; CVA, cerebrovascular accident; DES, drug-eluting stents; EES, everolimus-eluting stent; EXCEL, Evaluation of Xience Versus CABG for Effectiveness of Left Main Revascularization; FFR, fractional flow reserve; IVUS, intravascular ultrasound; LIMA, left internal mammary artery; LM, left main stem; MI, myocardial infarction; NOBLE, Nordic-Baltic-British Left Main Revascularisation; PCI, percutaneous coronary intervention; PES, paclitaxel-eluting stent; ST, stent thrombosis; VGO, vein graft occlusion.