Intervention in left main coronary artery disease
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Tarek Nafee, M.D. [2]
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Overview
Left main coronary artery stenosis is associated with poor patient outcomes secondary to ischemia of the large area of the myocardium which it supplies. Traditionally, CABG was indicated for left main disease. The SYNTAX trial demonstrated non-inferiority of PCI to CABG in a subgroup of patients with low to intermediate SYNTAX score. This clinical trial suggests a possible indication for a PCI option for the treatment of left main disease. Subsequently, the PRECOMBAT trial was conducted to compare the two interventions. In 2016, two large trials results were published (EXCEL trial and NOBLE trial) addressing the comparison of CABG and PCI in patients with left main disease in this particular subgroup of interest with low to intermediate SYNTAX scores.
Left Main Disease Trials
Synopsis
| Clinical Trial | Year | Sample Size (N) | Patient Population | Follow-up Period | Primary Endpoint | PCI Intervention | CABG Intervention | Post-procedural Anti-platelet Therapy Balanced Between Treatment arms? | Main Study Finding | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary graft artery used | On Pump or Off pump | Aspirin | P2Y12 inhibitors | ||||||||||
| 1 month | 12 months | 1 month | 12 months | ||||||||||
| SYNTAX | 2005 to 2007 | ~1800 patients | Stable angina, Unstable angina, Atypical chest pain, Candidates for PCI or CABG | 5 years | Death, MI, Stroke or repeat revascularization | 57% Plaxitaxel Stent, 24% BMS, 19% other DES | Not reported.
internal mammary artery preferred. |
15% off-pump procedure | |||||
| PRECOMBAT | 2004 to 2009 | ~600 patients | Stable angina, ACS, candidates for PCI or CABG | 5 years | Death, MI, Stroke, or target vessel revascularization | Sirolimus DES | 93.8% internal mammary artery | 63.8% off-pump procedure | ✓ | ✓ | ✘ | ✘ | |
| EXCEL | 2010 to 2014 | ~2000 patients | Stable angina, ACS, SYNTAX score <33, candidates for PCI or CABG | 3 years | Death, MI, or Stroke | Everolimus DES | 98.8% internal mammary artery | 29.4% off-pump procedure | ✓ | ✓ | ✘ | ✘ | |
| NOBLE | 2008 to 2015 | ~1200 patients | Stable angina, ACS, candidates for PCI or CABG | 5 years | Death, MI, Stroke, or revascularization | Biolimus DES | 94% internal mammary artery | 16% off-pump procedure | |||||
SYNTAX Trial
PRECOMBAT Trial
The PRECOMBAT trial was the first clinical trial primarily evaluating MTOR drug eluding stents to CABG in the treatment of left main disease.