ISCHEMIA trial results consistent by CTO status
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Among patients with stable ischemic heart disease enrolled in the ISCHEMIA trial, those with chronic total occlusion lesions had similar outcomes compared with those who did not.
As with the main results of the ISCHEMIA trial, those who had a CTO as determined by coronary CT angiography had similar rates of the primary endpoint of CV death, MI, hospitalization for unstable angina, HF or resuscitated cardiac arrest at 4 years regardless of whether they were assigned an invasive or a conservative strategy, and the same was true for those who did not have a CTO, Cardiology Today Editorial Board Member Sripal Bangalore, MD, MHA, professor of medicine at NYU Langone Health, said during a presentation at the virtual American Heart Association Scientific Sessions.
Also consistent with the main results, those who had a CTO had improved quality of life and angina relief if they were assigned with the invasive strategy compared with the conservative strategy, and the same was true for those without a CTO, Bangalore said.
The researchers analyzed 3,113 patients from the ISCHEMIA cohort who had a coronary CT angiography evaluable for CTO. In that cohort, 1,470 patients (mean age, 64 years; 17% women) had a CTO (total CTO lesions, 1,797; mean per patient, 1.22) and 1,643 (mean age, 62 years; 21% women) did not.
The CTO group was more likely to have prior MI or HF and more likely to have moderate or severe ischemia on a stress test but less likely to have three-vessel disease, a history of angina or new-onset angina within 3 months before randomization compared with the non-CTO group, Bangalore said, noting baseline quality of life metrics were similar in both groups.
Among patients assigned to the invasive strategy, those with a CTO were more likely to receive CABG and less likely to receive PCI compared with those without a CTO, he said.
Medication use did not vary by CTO status, and both those who had a CTO and those who did not have one were more likely to be prescribed dual antiplatelet therapy or an anti-anginal drug other than a beta-blocker or a calcium channel blocker if they were assigned to the conservative strategy vs. the invasive strategy, according to the researchers.
Those assigned the invasive strategy were more likely to receive cardiac catheterization and revascularization than those assigned the conservative strategy, and this was consistent regardless of CTO status, Bangalore said.
The primary endpoint occurred in 12.1% of patients without a CTO and 14.1% of those with one (P = .058), Bangalore said.
Those with a CTO were more likely to die of a CV cause at 4 years than those without one (2.6% vs. 5.2%; P = .003), but other clinical outcomes did not significantly differ by CTO status, he said.
Differences in event rates by invasive vs. conservative strategy did not vary by CTO status except for HF, in which the conservative strategy was better at preventing in those with CTO despite there being no difference between the strategies in those without CTO (P for interaction = .009), Bangalore said.
“Of note, these event rates are pretty low,” he said.
Consistent with the main results, the invasive strategy was associated with elevated procedural MI and reduced spontaneous MI compared with the conservative strategy in both the CTO cohort and the non-CTO cohort, according to the researchers.
The invasive strategy improved quality of life metrics better than the conservative strategy regardless of CTO status, including the Seattle Angina Questionnaire (SAQ)-7 summary score, the SAQ-7 angina frequency score, the SAQ-7 quality of life score, the SAQ-7 physical limitation score, the Rose Dyspnea Scale and the EQ-5D visual analog scale, Bangalore said during the presentation.
“There was a significant and durable benefit of the invasive strategy at improving angina-related quality of life in symptomatic patients with and without chronic total occlusion,” he said.
Perspective
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Roxana Mehran, MD
In all ISCHEMIA substudies, the overall conclusions from the trial are very similar regardless of subgroups. It was a surprise that there was a large number of patients with a CTO present, but to show no significant difference as far as the treatment effect for an invasive approach for patients with a CTO vs. those without one was consistent with the main findings, which is a very important takeaway. One might think of patients with CTO as sicker patients who need to be treated more aggressively, but that was not the case.
This was a study of patients with ischemia and stable coronary disease, some of whom happened to have a CTO. It was not necessarily aimed at treatment of the CTO. But we learned that symptom improvement is important in this population, and that there was not one single subgroup that performed differently, which is profound.
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Bangalore S, et al. FS.01. Cardiac procedural innovation for special patient groups. Presented at: American Heart Association Scientific Sessions; Nov. 13-17, 2020 (virtual meeting).
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