Left Main Coronary Artery Angioplasty Would Be Non-Inferior to Surgery

Courtesy of Dr. Carlos Fava.

Left main coronary artery (LMCA) lesions have always been defined as high-risk, with surgery as treatment of choice. Drug-eluting stents (DES) have slowly changed that, but their use still lacks strong supporting evidence.

The Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) study randomized patients with severe LMCA lesions to undergo angioplasty or surgical myocardial revascularization. The second-generation everolimus-eluting stent XIENCE was the chosen DES.

The trial enrolled 1905 patients with low or intermediate anatomical complexity according to the Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score (<32), who were randomized to undergo angioplasty (n = 948) or surgical myocardial revascularization (n = 957).

The study was designed to determine whether angioplasty was inferior to surgical myocardial revascularization in the treatment of patients with LMCA lesions. The primary endpoint was a composite of death, stroke, or infarction at 3 years, and secondary endpoints included a composite of death, stroke, or infarction at 30 days, and a composite of death, stroke, infarction, or ischemia-driven revascularization at 3 years.

Baseline characteristics were well balanced between the groups.

The angioplasty group received 2.4 stents/patient with a mean total stent length of 49.1 mm. The surgical myocardial revascularization group received 2.6 grafts/patient; an internal thoracic artery graft was used in 98.8% of the patients.

At 30 days, the primary endpoint was:

Angioplasty: 15.4%

Surgical myocardial revascularization: 14.7%

(Difference, 0.7 percentage points; p = 0.002 for noninferiority; p = 0.98 for superiority).

At 30 days, the secondary endpoint was:

Angioplasty: 4.9%

Surgical myocardial revascularization: 7.9%

(p > 0.001 for noninferiority; p = 0.008 for superiority).

At 3 years, it was:

Angioplasty: 23.1%

Surgical myocardial revascularization: 19.1%

(p = 0.01 for noninferiority; p = 0.10 for superiority).

Major peri-procedural events at 30 days were more frequent in patients who underwent surgical myocardial revascularization. The rate of ischemia-driven revascularization was higher in patients who underwent angioplasty (12.6% vs. 7.5%; p ≤ 0.001).

Conclusion

In patients with left main coronary artery lesions and low or intermediate SYNTAX score, angioplasty with an everolimus-eluting stent was noninferior to surgical myocardial revascularization as regards the composite endpoint of death, stroke, or infarction at 3 years.

Editorial

This is a full-scale study with second-generation DES showing that angioplasty is similar to surgical myocardial revascularization at 3 years and superior at 30 days in patients with LMCA lesions and low or intermediate SYNTAX score.

The weak point of stents is still a higher rate of ischemia-driven revascularization compared to surgical myocardial revascularization, but this does not change the outcome at 3 years.

A longer-term follow-up is necessary for better assessment of these data.

Courtesy of Dr. Carlos Fava. Buenos Aires Favaloro Foundation, Argentina.

Original title: Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease

Reference: Stone G., et al. NEJM 2016 on line before print.

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