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JIM 2020: Weigh up early and late events in EXCEL to determine treatment for left main disease

Ngày 17/02/2020 09:35 | Lượt xem: 1109

Gregg W Stone (Icahn School of Medicine, Mount Sinai, New York, USA) addressed the EXCEL controversy today at the Joint Interventional Meeting (JIM 2020; 13–15 February, Milan, Italy), stipulating that although percutaneous coronary intervention (PCI) has early advantages and coronary artery bypass graft (CABG) confers late advantages, in the long term there are no significant major differences in long-term survival, major adverse cardiovascular events (MACE: death, myocardial infarction[MI], or stroke), or quality of life between the two procedures.

He said that heart team discussions needed to weigh up the early advantages of PCI—it is less invasive, with fewer peri-procedural complications (such as, stroke, atrial fibrillation, bleeding, acute kidney injury), a lower 30-day MACE rate, and a more rapid recovery with better early quality of life and earlier angina relief—against the late advantages seen with CABG—it is more durable with fewer adverse events beyond 30 days, particularly MI and repeat revascularisation procedures—when deciding which to choose.

Looking at five-year mortality data from EXCEL—one of the main areas around which disagreement has arisen—Stone described mortality as an “underpowered exploratory endpoint” that was not specified for hypothesis testing, and said that the observed difference of 87% survival for PCI versus 90% for CABG, a difference of 3% over two years (0.6% per year) was “modest”.

Stone also addressed the use of periprocedural MI as an endpoint in EXCEL rather than the universal definition (UD) of MI, a further major point of contention. He explained that because the universal definition uses different criteria for MI in PCI and CABG, the same periprocedural definition of MI for both PCI and CABG was agreed upon before the trial in order to minimise ascertainment and other biases.

In his presentation, Stone described a subanalysis of EXCEL (CABG n=957; PCI n=948) that identified three distinct periods of relative risk for all cause death, stroke or MI: “In the first 30 days, there was a substantial 40% reduction in major events for PCI compared to CABG [hazard ratio (HR) 0.61, 95% confidence interval (CI) 0.42–0.88, p=0.008]. From one month to one year, there was no significant difference between the two groups [HR 1.07, 95% CI 0.68–1.7, p=0.76]. Between one year and five years, the curves clearly benefited CABG [HR is 1.61, 95% CI 1.23–2.12, p<0.001] [treatment time interaction p<0.001].”

He asked: “How do you judge the overall risk to the patient when you can have these three different periods of overall risk? If you are going to have an adverse event, would you rather have it later than early? That is one thing to take into account.”

Calculation of the mean survival time in EXCEL identified the time event burden of disease, which is more in CABG than PCI: “Early on, PCI patients are more likely to be disease free than CABG patients; that peaks at about 30 to 36 months, and thereafter the low mortality risk of CABG starts to provide a benefit. At the end of five years, the average PCI patient was free of death, stroke, or MI five days longer than the average CABG patient. The 95% confidence intervals are very wide, so obviously there is no difference between these two therapies.”

“There is not a lot of difference in death, stroke, or MI in terms of overall burden of disease between PCI and CABG, at least out to five years.”

He also said the presence of other factors such as distal main disease, diabetes, left ventricular ejection fraction, or low, intermediate SYNTAX score led to no difference in ratios for death, MI or stroke between PCI and CABG: “The bottom line is that there is no significant interaction for any subgroup.”

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