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EACTS 2019: Leading cardiothoracic surgeon questions EXCEL trial’s conclusion (part 1)

Ngày 11/10/2019 09:30 | Lượt xem: 1514

Cardiothoracic surgeon David Taggart (Department of Cardiac Surgery, University of Oxford, John Radcliffe Hospital, Oxford, UK) told delegates attending the 2019 European Association for Cardio-Thoracic Surgery (EACTS) meeting (3–5 October, Lisbon, Portugal) that the definition of myocardial infarction used in EXCEL was incorrect, leading to the wrong conclusion that percutaneous coronary intervention (PCI) is non-inferior, at five years, to coronary artery bypass grafting (CABG) for the management of selected patients with left main disease. Taggart was an EXCEL trial investigator but withdrew his name as an author because of his view on the conclusion. 

The five-year outcomes of EXCEL were presented at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) meeting (25–29 September, San Francisco, USA) and were simultaneously published in the New England Journal of Medicine. They showed that PCI with a second-generation drug-eluting stent in selected patients (low or intermediate anatomical complexity) with left main disease was non-inferior to CABG in terms of the primary endpoint of death, stroke, or myocardial infarction at five years. The three-year results were previously presented at TCT and also showed no significant differences between PCI and CABG in the primary endpoint.

However, according to Taggart, the definition of myocardial infarction was changed “halfway through the trial” (“a disgrace”) from the “real” definition of myocardial infarction (30 days’ post procedure) to a biochemical periprocedural one. He stated: “If you look at outcomes at 30 days, the only thing that benefits PCI is myocardial infarction and this was after the change to a biochemical definition that favoured PCI and one that disadvantaged CABG. If you look at outcomes between 30 days and one year, there is no difference. If you look at outcomes between one year and five years, there is a very highly significant difference in the rate of death, myocardial infarction, and repeat revascularisation between PCI and CABG.”

The findings Taggart was referring to are—as reported in the New England Journal of Medicine—as follows:

• 30 days (myocardial infarction): 3.9% for PCI vs. 6.3% for CABG (hazard ratio [HR] 0.53)
• 30 days to one year (myocardial infarction): 1.7% vs. for PCI vs. 1.1% for CABG (HR 1.58)
• One year to five years (death, stroke, myocardial infarction, or ischaemia-driven revascularisation): 22.4% for PCI vs. 13.8% for CABG (HR 1.74)

Furthermore, Taggart told EACTS delegates that Mauro Gaudino (Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, USA) performed an analysis of the EXCEL data using the non-procedural myocardial infarction (“real myocardial infarction; the one that kills people”) and this showed that “CABG is the clear winner for death, myocardial infarction, and repeat revascularisation at five years”.

Gregg Stone

However, the principal investigator of EXCEL Gregg Stone Stone (Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, USA) told Cardiovascular News that Taggart’s assertion that the definition of myocardial infarction was changed midway through the trial is not true. He adds that the first and last versions of the protocol, which he says “anyone” can download from the NEJM, have “identical” definitions of periprocedural myocardial infarction. According to the document Stone sent to Cardiovascular News, both versions make reference to elevations in cardiac biomarkers being used to define periprocedural myocardial infarction.

To be continued

Source CardiovascularNews

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