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EXCEL: PCI ‘acceptable revascularization modality’ for left main CAD at 5 years
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SAN FRANCISCO — Final 5-year data from the EXCEL trial demonstrate similar rates of death, stroke or MI with PCI or CABG for treatment of patients with left main CAD, according to late-breaking data presented at TCT 2019.
At 5 years, the primary composite outcome occurred in 22% of patients with left main CAD of low or intermediate anatomical complexity assigned PCI with cobalt-chromium everolimus-eluting stents (Xience, Abbott Vascular) compared with 19.2% of patients assigned CABG (difference, 2.8 percentage points; 95% CI, -0.9 to 6.5; P = .13), Gregg W. Stone, MD, director of academic affairs at Mount Sinai Heart and professor of medicine and population health science and policy at Icahn School of Medicine at Mount Sinai, reported here.
In interpreting the results, Stone said it is important to note differences in outcomes between PCI and CABG over time. The relative risk for PCI vs. CABG for the primary outcome varied between 0 and 30 days (HR = 0.61; 95% CI, 0.42-0.88), 30 days to 1 year (HR = 1.07; 95% CI, 0.68-1.7) and 1 year to 5 years (HR = 1.61; 95% CI, 1.23-2.12), he said. In further analyses, the early benefit of PCI gradually diminished over time with increased postprocedural risk among the patients who were assigned PCI. Restricted mean survival time analysis demonstrated risk for death, stroke or MI at 5 years was similar with PCI and CABG (OR = 1.19; 95% CI, 0.95-1.5), Stone said.
“The early benefits of PCI due to reduced periprocedural risk were attenuated by the greater number of events occurring during follow-up with CABG, such that at 5 years the cumulative mean time free from adverse events was similar with both treatments,” Stone said during a press conference.
At the end of 5-year follow-up, event-free survival time was 5.2 days longer (95% CI, –46.1 to 56.5) after PCI compared with CABG, he said.
In other 5-year results, the secondary composite of death, stroke, MI or ischemia-driven revascularization occurred in 31.3% of patients assigned PCI vs. 24.9% assigned CABG at 5 years (OR = 1.39; 95% CI, 1.13-1.71). Death from any cause at 5 years was higher with PCI (13% vs. 9.9%; OR = 1.38; 95% CI, 1.03-1.85), while definite CV death was similar in both groups (5% vs. 4.5%; OR = 1.13; 95% CI, 0.73-1.74). Eighteen of the 30 excess deaths in the PCI arm were adjudicated as non-CV deaths, five as definite CV deaths and seven as undetermined cause. Five-year rates of stroke (2.9% vs. 3.7%; OR = 0.78; 95% CI, 0.46-1.31) and MI (10.6% vs. 9.1%; OR = 1.14; 95% CI, 0.84-1.55) were not different.
“PCI may thus be considered an acceptable revascularization modality for selected patients with left main CAD, a decision which should be made after heart team discussion, taking into account each patient’s individual risk factors and preferences,” Stone said.
These findings build on 3-year data from EXCEL, previously reported by Healio at TCT 2016, which demonstrated PCI was noninferior to CABG in this patient population.
The EXCEL investigators randomly assigned 1,905 patients with left main CAD with a SYNTAX score 32 (mean, 20.6) to undergo a strategy of PCI (n = 948) or CABG (n = 957). Patients were enrolled from September 2010 to March 2014 at 126 sites in 17 countries. At baseline, the mean age was 66 years, 77% were men and 29% had diabetes. Eighty percent of patients had distal left main bifurcation disease. Adherence to guideline-directed medical therapy was high.
Stone reported 5-year follow-up data on 93.2% of the PCI group and 90.1% of the CABG group.
The final 5-year results were simultaneously published in The New England Journal of Medicine.
References:
Stone GW, et al. Late-Breaking Trials 3. Presented at: TCT Scientific Symposium; Sept. 25-29, 2019; San Francisco.
Stone GW, et al. N Engl J Med. 2019;doi:10.1056/NEJMoa1909406.
Disclosures: The EXCEL study was supported by Abbott Vascular. Stone reports no relevant financial disclosures.
Perspective
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Dharam J. Kumbhani, MD, SM
There was enthusiasm in the intervention community with the early results showing that at 2 to 3 years you were doing as well with PCI as CABG. You kind of still see that with the 5-year results; if you look at the entire time horizon, the two strategies are similar, but the fact that once you landmark it at 1 year, and certainly at 2 years where the lines seem to cross, does dampen my enthusiasm a bit for use in all patients with left main disease. EXCEL looked at true hard endpoints: death, MI and stroke. Many other trials have been criticized when they have compared PCI and CABG because they included revascularization as an endpoint, and that’s stacked against PCI. At the end of the day, these results will help us with shared decision making with our patients. Dr. Stone mentioned that there will not be longer-term follow-up beyond 5 years. If a 65-year-old male comes in, he’s not necessarily only looking at a 5-year horizon; he’s looking at a long-term horizon. You can speculate that maybe the lines will continue to diverge or maybe they will cross again. Unfortunately, we won’t know that with this trial.
Perspective
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Ashish Pershad, MD
One important message is that 25% of the patients thought by their enrolling sites to have intermediate SYNTAX scores actually had complex advanced coronary disease. In the past, that has been a zone where PCI has traditionally underperformed compared with surgery.
Even after those patients were reclassified by the core lab, at 5 years, the outcomes between surgery and PCI were comparable for the three most worrisome outcomes: death, stroke and MI. Even patients who had surgery start accruing target lesion revascularizations by 5 years due to restenosis occurring in vein grafts and new MIs occurring in new lesions. We were not unaware of this phenomenon, but until now we did not have data to support it.
Simplistic left main disease is no longer going to be outside the domain of treatment by interventional cardiologists. These data reinforce the two-way recommendation that currently exists in the community. There is now a very compelling case for consideration of PCI in patients with left main disease, and for engaging in patient-centered decision making.
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