Results of a new randomized trial show no benefit in clinical outcomes of active surveillance using functional tests over usual care among high-risk patients with a history percutaneous coronary intervention (PCI).
At 2 years, there was no difference in a composite outcome of death from any cause, myocardial infarction (MI), or hospitalization for unstable angina between patients who underwent routine functional tests after 1 year and patients who received standard care in POST-PCI (Pragmatic Trial Comparing Symptom-Oriented versus Routine Stress Testing in High-Riskpatients Undergoing Percutaneous Coronary Intervention).
“Our trial does not support active surveillance with routine functional testing for follow-up strategy in high-risk patients undergoing PCI,” said first author Duk-Woo Park, MD, Division of Cardiology, Asan Medical Center, Faculty of Medicine at the University of Ulsan, Seoul, South Korea, said elcorazon.org | Medscape Cardiology.
The researchers say their results should be interpreted in the context of previous findings from the ISCHEMIA trial that showed no difference in death or ischemic events with an initial invasive approach versus an initial conservative approach in patients with stable disease. coronary artery disease and moderate to severe ischemia on stress tests.
“Both the ISCHEMIA and POST-PCI trials show the benefits of the ‘less is more’ concept (ie, if more invasive strategies or tests are performed less frequently, better patient outcomes will be achieved),” the authors write. Although the characteristics of the patients in these trials “were quite different, a more invasive therapeutic approach (in the ISCHEMIA trial) as well as a more aggressive follow-up approach (in the POST-PCI trial) did not provide additional treatment effect beyond of a conservative strategy based on guideline-directed medical therapy.
The results were presented on August 28 at the 2022 European Society of Cardiology (ESC) Congress and Posted online simultaneously in the New England Journal of Medicine.
Convincing New Evidence
in the accompanying editorial Jacqueline E. Tamis-Holland, MD, Icahn School of Medicine at Mount Sinai, Mount Sinai Morningside Hospital, N.Y., also agrees that this new result “builds on the findings” of the ISCHEMIA trial. “Taken together, these trials highlight the lack of benefit of routine stress testing in asymptomatic patients,” she writes.
Tamis-Holland notes that many of the deaths in this trial occurred before the 1-year stress test, possibly related to stent thrombosis, and therefore would not have been prevented by routine testing at 1 year. And, overall, event rates were “fairly low and probably reflect adherence to guideline recommendations” in the trial. For example, 99% of patients were receiving statins and 74% of procedures used intravascular imaging for PCI procedures, “a much higher usage rate than most centers in the United States,” she notes.
“The POST-PCI assay provides compelling new evidence for a future class III recommendation for routine surveillance testing after PCI,” Tamis-Holland concludes. “Until then, we should refrain from prescribing surveillance stress tests to our patients after PCI, in the absence of other clinical signs or symptoms suggestive of stent failure.”
Commenting on the results, B. Hadley Wilson, MD, executive vice president of the Sanger Heart & Vascular Institute/Atrium Health, clinical professor of medicine at the University of North Carolina School of Medicine, and vice president of the American College of Cardiology, said that for decades it was thought that patients who had high-risk PCI should be followed more closely for possible future events.
“And it actually turned out that there was no difference in the results between the groups,” he said. elcorazon.org | Medscape Cardiology.
“So I think it’s a good study, well conducted, good numbers, that answers the question that routine functional stress testing, even for high-risk PCI patients, is not effective, cost-effective, or beneficial on a yearly basis,” said. she said. “I think it will help frame care that patients are followed up with the best medical therapy and then, if symptoms return, they will be considered for further evaluation, either with stress testing or angiography.”
Current guidelines do not recommend the use of routine stress testing after revascularization, the authors write in their article. “However, surveillance using image-based stress testing may be considered in high-risk patients at 6 months after a revascularization procedure (class IIb recommendation), and routine image-based stress testing can be considered 1 year after PCI and more than 5 years after CABG (class IIb recommendation),” they note.
But in real-world clinical practice, Park said, “the follow-up strategy for patients who have undergone PCI or CABG has not yet been determined.” Particularly, he added, “it could be more problematic in high-risk PCI patients with high-risk anatomical or clinical features. Therefore, we conducted this POST-PCI trial comparing the follow-up strategy with routine stress testing versus follow-up.” of standard care. up strategy in high-risk PCI patients”.
The investigators randomly assigned 1,706 patients with high-risk anatomical or clinical features who had undergone PCI to a follow-up strategy of routine functional testing, including nuclear stress testing, exercise or stress electrocardiography. echocardiographyto 1 year or to standard care only.
High-risk anatomic features included left main or bifurcation disease; restenotic or long and diffuse lesions; or bypass graft disease. High-risk clinical features included diabetes mellitus, chronic kidney diseaseor enzyme positive acute coronary syndrome.
The mean age of the patients was 64.7 years; 21.0% had left main trunk disease, 43.5% bifurcation disease, 69.8% multivessel disease, 70.1% diffuse long lesions, 38.7% diabetes and 96.4% He had been treated with a drug-eluting stent.
At 2 years, a primary outcome event had occurred in 46 of 849 patients (Kaplan-Meier estimate, 5.5%) in the functional test group and in 51 of 857 (Kaplan-Meier estimate, 6.5%). 0%) in the standard care group. group (hazard ratio, 0.90; 95% CI, 0.61 – 1.35; P = .62). There were no differences between groups in the components of the primary outcome.
Secondary endpoints included invasive coronary angiography or repeat revascularization. At 2 years, 12.3% of patients in the functional test group and 9.3% in the standard care group had undergone invasive coronary angiography (difference, 2.99 percentage points; 95% CI , −0.01 to 5.99 percentage points), and 8.1% and 5.8% of patients, respectively, underwent a new revascularization procedure (difference, 2.23 percentage points; CI of 95%, −0.22 to 4.68 percentage points).
Positive stress test results were more common with nuclear imaging than with exercise electrocardiogram or stress echocardiography, the authors noted. Subsequent coronary angiography and repeat revascularization were more common in patients with positive nuclear stress imaging and exercise ECG than in those with discordant nuclear imaging and exercise ECG results.
POST-PCI was funded by the CardioVascular Research Foundation and the Daewoong Pharmaceutical Company. DW Park reports grants from the Cardiovascular Research Foundation and the Daewoong Pharmaceutical Company. Tamis-Holland reports “other” Pfizer funding outside of the featured work. Wilson reports no relevant disclosures.
Congress of the European Society of Cardiology (ESC) 2022. Presented on August 28, 2022.