Table 1.
Summary of Randomized Clinical Trials of PCI With DES Vs CABG for LMCA Disease
| LEMANS30,31 | Boudriot et al32 | SYNTAX-LM33, 34, 35 | PRECOMBAT36,38 | EXCEL39,40 | NOBLE41,42 | |
|---|---|---|---|---|---|---|
| Recruitment period | 2001-2004 | 2003-2009 | 2005-2007 | 2004-2009 | 2010-2014 | 2008-2015 |
| PCI/CABG, n/n | 52/53 | 100/101 | 357/348 | 300/300 | 948/957 | 592/592 |
| Follow-up, y | 10 | 1 | 5 10 (for mortality) |
10 | 5 | 5 |
| Diabetes, % | 18 | 36 | 25 | 32 | 29 | 15 |
| Bifurcation, % | 58 | 72 | 61 | 64 | 81 | 81 |
| SYNTAX score, mean | Not reported | 23 | 30 | 25 | 21 | 22 |
| Stent | BMS and DES (35%) | DP-SES | DP-PES | DP-SES | DP-EES | BP-BES and DP-SES (7.7%) |
| IVUS | Recommend | Infrequent | Infrequent | At discretion, 91% | Recommended, 77% | Recommended, 74% |
| FFR guidance | Not reported | Not reported | Infrequent | Not reported | Recommended, 9.0% | Recommended |
| LIMA, % | 72 | 99 | 97 | 94 | 99 | 96 |
| Off pump, % | 1.9 | 46 | Not reported | 64 | 29 | 16 |
| Primary trial endpoint | Change in LVEF | Cardiac death, MI, or TVR | Death, MI, stroke, or repeat revascularization 10-y all-cause death |
Death, MI, stroke, or TVR | Death, MI, or stroke | Death, nonprocedural MI, stroke, or repeat revascularization |
| Key finding | There was a trend toward higher LVEF at 10 y with PCI. | PCI was inferior to CABG at 1 y. | PCI was noninferior to CABG at 1 and 5 y in terms of death, MI, stroke, or repeat revascularization. No significant difference in 10-y all-cause death between PCI and CABG. | PCI was noninferior to CABG at 1, 5, and 10 y. | PCI was noninferior to CABG at 3 and 5 y. | PCI was inferior to CABG at 5 y. |
BMS = bare-metal stent; BP-BES = biodegradable polymer biolimus-eluting stent; CABG = coronary artery bypass grafting; DES = drug-eluting stent; DP-EES = durable polymer everolimus-eluting stent; DP-PES = durable polymer paclitaxel-eluting stent; DP-SES = durable-polymer sirolimus-eluting stent; EXCEL = Evaluation of Xience Everolimus Eluting Stent vs Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization; FFR = fractional flow reserve; IVUS = intravascular ultrasound; LEMANS = Left Main Stenting; LIMA = left internal mammary artery; LVEF = left ventricular ejection fraction; MI = myocardial infraction; NOBLE = Nordic-Baltic-British Left Main Revascularization; PCI = percutaneous coronary intervention; PRECOMBAT = Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease; SYNTAX = Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery; SYNTAX-LM = left main substudy of the SYNTAX (Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery); TVR = target vessel revascularization.