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September 28, 2019

Five-Year Results Presented From EXCEL Study

September 28, 2019— The Cardiovascular Research Foundation (CRF) announced that 5-year results from the EXCEL study were presented by Gregg W. Stone, MD, at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium, which is sponsored by CRF and held September 25–29 in San Francisco, California. The study was published simultaneously by Dr. Stone et al online in The New England Journal of Medicine.

The large-scale randomized study evaluated revascularization with percutaneous coronary intervention (PCI) versus coronary artery bypass graft surgery (CABG) to treat patients with left main coronary artery disease (LMCAD). Revascularization with either PCI or CABG has been shown to prolong survival in patients with left main disease compared with medical therapy alone. The 3-year EXCEL data, which were presented by Dr. Stone at TCT 2016, found no significant difference in the composite rate of death, stroke, or myocardial infarction (MI) between the two treatments, with a reduction in 30-day major adverse events with PCI.

As summarized in the CRF announcement, the EXCEL study recruited 2,905 patients with LMCAD at 126 sites in 17 countries between September 2010 and March 2014. Eligible patients (n = 1,905) with LMCAD and site-assessed low or intermediate coronary artery disease complexity (SYNTAX score ≤ 32) were randomized to revascularization with fluoropolymer-based cobalt-chromium everolimus-eluting stents (EES; n = 948) or CABG (n = 957). The EXCEL trial was funded by Abbott Vascular and used the company’s Xience Prime EES, Xience V EES, Xience Xpedition EES, or Xience Pro EES (used only outside the United States) to compare PCI and CABG.

For the 5-year analysis presented at TCT 2019, the primary outcome was the composite of death, stroke, or MI. Long-term additional secondary outcomes included their components at 5 years, as well as therapy failure (definite stent thrombosis or symptomatic graft stenosis or occlusion), all revascularizations, and all cerebrovascular events (stroke or transient ischemic attack).

In the CRF announcement, Dr. Stone concluded, “In patients with left main coronary artery disease and low or intermediate coronary disease complexity, we found no significant difference between PCI and CABG with respect to the composite rate of death, stroke, or MI at 5 years. Ten-year or longer follow-up is required to characterize the very late safety profile of PCI and CABG as both stents and bypass grafts progressively fail over time.”

Dr. Stone reported the following at TCT 2019:

  • 5-year follow-up was achieved in 93.2% of patients who received PCI and 90.1% of patients who received CABG.
  • The 5-year primary composite of death, stroke, or MI occurred in 22% of patients in the PCI group and 19.2% of patients in the CABG group (difference 2.8%; 95% confidence interval [CI], −0.9% to 6.5%; P = .13).
  • The relative risk of PCI versus CABG for the primary outcome varied between 0 to 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).
  • The early benefit of PCI gradually diminished over time with increased postprocedural risk among patients randomized to PCI.
  • The 5-year secondary composite of death, stroke, MI, or ischemia-driven revascularization occurred in 31.3% of patients in the PCI group and 24.9% of patients in the CABG group (difference 6.5%; 95% CI, 2.4–10.6).
  • All-cause death occurred in 13% of patients in the PCI group and 9.9% of patients in the CABG group (difference 3.1%; 95% CI, 0.2–6.1).
  • Of the 30 excess deaths in the PCI arm, 18 were adjudicated as noncardiovascular deaths, five as definite cardiovascular deaths, and seven as undetermined cause.
  • The 5-year rates of stroke and MI were not significantly different after PCI and CABG.
  • Ischemia-driven revascularization within 5 years was performed more frequently after PCI than CABG.
  • The 5-year rates of all cerebrovascular events and definite stent thrombosis or symptomatic graft stenosis or occlusion were less frequent with PCI than CABG.

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September 28, 2019

Three-Year COAPT Data Support Abbott's MitraClip TMVR Device

September 28, 2019

Three-Year COAPT Data Support Abbott's MitraClip TMVR Device