EXCEL: 5-year outcomes from a randomized trial of PCI vs. CABG in patients with left main coronary artery disease

Reported from the TCT Congress 2019 in San Francisco - USA

The methodology

In 2016 the main report of the EXCEL trial (NCT01205776)¹ was presented in the NEJM.
The actual report is an extension of the follow-up up to 5 years². The authors randomly assigned 1905 patients with left main coronary artery disease of low or intermediate SYNTAX score to undergo either PCI with cobalt-chromium everolimus-eluting stents (EES) (948 patients) or CABG (957 patients). The primary outcome was a composite of death, stroke, or myocardial infarction.

The previous report of 2016¹

At three years, the authors found, a primary endpoint event had occurred in 15.4% of the patients in the PCI group and 14.7% of the patients in the CABG group (P=0.02 for noninferiority; hazard ratio, 1.00; 95% confidence interval, 0.79 to 1.26; P=0.98 for superiority). Therefore, they concluded that in patients with left main coronary artery disease and low or intermediate SYNTAX scores by site assessment, PCI with EES was noninferior to CABG with respect to the rate of the composite endpoint of death, stroke, or myocardial infarction at three years.

What were the results?

At five years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (95%CI, -0.9 to 6.5; P = 0.13).

Death from any cause occurred more frequently in the PCI group than in the CABG group. However, in the PCI and CABG groups, the incidences of definite cardiovascular death and myocardial infarction were not significantly different. Ischemia-driven revascularization was more frequent after PCI than after CABG.

My take on this study

• The 3-year primary outcomes are confirmed at 5-years.
• PCI showed to have better outcomes in the acute, and after 36 months, there is an inversion of the curves showing better outcomes in the CABG group.
  • However, the increased risk was not statistically significant in the primary endpoint, and the differences were driven by an increase in non-cardiac deaths such as infections and malignancy.
• CABG was associated with a reduced risk of ID-TLR when compared to PCI.
• The lack of very long-term follow-up is a limitation, and it will be interesting to extend the follow-up up to 10-years as in the SYNTAXES trial.³

#CardioPoll

You can find the results of our pre Late-Breaking Trial Cardio Poll related to the EXCEL trial.

EXCEL: Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL). Funded by Abbott Vascular.

References

1. Stone GW, Sabik JF, Serruys PW, Simonton CA, Genereux P, Puskas J, Kandzari DE, Morice MC, Lembo N, Brown WM, 3rd, Taggart DP, Banning A, Merkely B, Horkay F, Boonstra PW, van Boven AJ, Ungi I, Bogats G, Mansour S, Noiseux N, Sabate M, Pomar J, Hickey M, Gershlick A, Buszman P, Bochenek A, Schampaert E, Page P, Dressler O, Kosmidou I, Mehran R, Pocock SJ, Kappetein AP and Investigators ET. Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease. N Engl J Med. 2016;375:2223-2235.
2. Stone GW, Kappetein AP, Sabik JF, Pocock SJ, Morice MC, Puskas J, Kandzari DE, Karmpaliotis D, Brown WM, 3rd, Lembo NJ, Banning A, Merkely B, Horkay F, Boonstra PW, van Boven AJ, Ungi I, Bogats G, Mansour S, Noiseux N, Sabate M, Pomar J, Hickey M, Gershlick A, Buszman PE, Bochenek A, Schampaert E, Page P, Modolo R, Gregson J, Simonton CA, Mehran R, Kosmidou I, Genereux P, Crowley A, Dressler O, Serruys PW and Investigators ET. Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease. N Engl J Med. 2019.
3. Thuijs D, Kappetein AP, Serruys PW, Mohr FW, Morice MC, Mack MJ, Holmes DR, Jr., Curzen N, Davierwala P, Noack T, Milojevic M, Dawkins KD, da Costa BR, Juni P, Head SJ and Investigators SES. Percutaneous coronary intervention versus coronary artery bypass grafting in patients with three-vessel or left main coronary artery disease: 10-year follow-up of the multicentre randomised controlled SYNTAX trial. Lancet. 2019.