XIENCE: The New Direction in Left Main Stenting

In the past, patients with obstructive left main coronary artery disease (LMCAD) have usually been treated with coronary artery bypass grafting (CABG). These patients' high morbidity and mortality are due to the large amount of myocardium at risk. Now the EXCEL trial1 shows that, using XIENCE, percutaneous coronary intervention (PCI) is a suitable, and less invasive, option in patients with a SYNTAX score < 32.


Review Latest Data for Left Main Disease

The EXCEL trial demonstrates the safety of XIENCE revascularization for patients with left main disease who have a SYNTAX score of 32 or lower.  

“A major difference between PCI and CABG was the 30-day incidence of procedural myocardial infarction (MI). Large MIs, including ST-segment elevation MIs, were substantially more common with bypass surgery than with PCI. In part that's because graft failure, early on, was more common with bypass surgery than with PCI.”

— Gregg Stone, MD, at TCT referring to EXCEL trial

Experts' Point of View: Applying EXCEL Results to Clinical Practice

"It was a fairly complex [patient population]: 80% bifurcation, 25-30% heavily calcified. And at 3-year follow-up we had a 0.7% incidence of definite stent thrombosis."

Gregg Stone, MD, interviewed by C. Michael Gibson, MD

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XIENCE Demonstrates Extremely Low Definite Stent Thrombosis Rates

Because of recent improvements in PCI and surgical outcomes, and use of the SYNTAX scoring tool, the EXCEL trial was designed to re-examine safety in left main stenting. EXCEL randomized 1,905 patients with unprotected left main disease—and low or intermediate anatomical complexity, e.g., a SYNTAX score of 32 or lower— either to CABG or to PCI with XIENCE.1

The EXCEL trial results showed a significant difference in definite stent thrombosis or symptomatic graft occlusion.

XIENCE vs CABG: 87% Lower Rate of Definite ST or Symptomatic Graft Occlusion at 3 Years

XIENCE Non-Inferiority: Preferred or Acceptable* to CABG in Selected Left Main Patients 


XIENCE Non-Inferiority: Preferred or Acceptable* to CABG in Selected Left Main Patients

The 2 arms of the EXCEL trial showed no significant differences in the primary endpoint (death, stroke, and MI) at 3 years. Most of the patients (80.5%) had distal left main bifurcation or trifurcation disease.1

Primary Endpoint at 3 Years: Death, MI, Stroke (Intention to Treat) 

XIENCE Non-Inferiority: Preferred or Acceptable* to CABG in Selected Left Main Patients 

 

EXCEL revealed that PCI using everolimus-eluting stents (EES) was non-inferior to CABG. The authors concluded that PCI with EES is an acceptable or perhaps preferred* alternative to CABG in selected LMCAD patients. 

Authors' analysis of the screening registry suggests that about 62% of LMCAD patients might be eligible for PCI.*

Note: Placement of the stent in the left main coronary artery has the potential to compromise blood flow to the distal anatomy.

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References

* The CABG vs PCI treatment decision should be made after heart team discussion, taking into account each patient’s circumstances and preferences.

  1. Stone GW, et al. EXCEL Trial. N Engl J Med. 2016;375:2223-2235. doi: 10.1056/NEJMoa1610227.

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