"Randomized clinical trials must be carefully designed and provide information as accurate as possible for important patient outcomes," Dr. Mario Gaudino of Weill Cornell Medicine, in New York City, told Reuters Health by email. "Cause-specific mortality may be conceptually appealing, but is open to adjudication errors and bias, as shown in my analysis - all-cause mortality is much more reliable and should be used."
Numerous clinical trials over the past three decades have compared PCI and CABG outcomes, but they have been underpowered to detect differences in mortality and all have used a composite of major adverse cardiac or cardiovascular events as their primary outcome.
The ongoing EXCEL trial, however, reported significantly higher all-cause mortality at five years after PCI, Dr. Gaudino and colleagues note in JAMA Internal Medicine.
The team evaluated the difference in all-cause and cause-specific mortality in their meta-analysis of 23 randomized clinical trials that compared PCI and CABG for the treatment of patients with coronary artery disease.
These trials included a total of 6,829 patients undergoing PCI and 6,791 patients undergoing CABG. Mean follow-up was 4.5 years, and the mean age of patients ranged from 60 to 71 years.
All-cause mortality was 17% higher with PCI than with CABG (95% confidence interval, 5% to 29%), cardiac mortality was 24% higher (95% CI, 5% to 45%) and noncardiac mortality was 19% higher (95% CI, 0% to 41%).
In subgroup analyses, the increased risks of all-cause mortality, cardiac mortality and noncardiac mortality associated with PCI did not differ significantly for studies including drug-eluting stents versus bare-metal stents or by anatomical extent of coronary disease.
The authors speculate that CABG offers additional protection against the evolution of lesions that were non-flow-limiting at the time of the procedure and that this accounts for some of the survival benefit.
"From the patients' perspective, death is death; it does not matter if you die of cardiac or noncardiac causes - this is what is important for patients, and this is what we must use in our trials," Dr. Gaudino said.
By Will Boggs MD
SOURCE: https://bit.ly/2Fst5TG JAMA Internal Medicine, online October 12, 2020.
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