SAN DIEGO – Patients aged 80 years and older benefit from more invasive early treatment after non-ST-elevation myocardial infarction or unstable angina, the After Eighty Trial showed.
After a median follow-up of 1.5 years, an invasive strategy that included coronary angiography significantly reduced the primary endpoint of myocardial infarction (MI), need for urgent revascularization, stroke, and death from 61% with optimal medical treatment to 41% (risk ratio, 0.48; P value < .00001).
That drop was driven primarily by significantly fewer MIs (17% vs. 30%; RR, 0.50; P = .0003) and urgent revascularizations (2% vs. 11%; RR, 0.19; P = .0001), lead author Dr. Nicolai Tegn reported at the American College of Cardiology/Cardiovascular Research Foundation Innovation in Intervention Summit.
Dr. Nicolai Tegn
There were no significant differences between the invasive and conservative strategy groups in rates of stroke (3% vs. 6%; RR, 0.61; P = .26) or all-cause death (25% vs. 27%; RR, 0.87; P = .53).
The composite of death and MI, however, significantly favored the invasive group (35% vs. 48%; RR, 0.54; P < .0001), he said during a latebreaking clinical trial session.
After Eighty randomly assigned 457 patients, aged 80 years or older, to either optimal medical therapy with no invasive treatments or coronary angiography at a percutaneous coronary intervention (PCI) center the day after inclusion, plus optimal medical therapy after about 4-5 hours if PCI was not performed or about 6-18 hours if it was. Of the 225 patients receiving angiography, 48% went on to balloon angioplasty and/or coronary stenting, and 3% had bypass surgery.
Patients 80 years or older account for roughly one-third of all patients with non-STEMI and unstable angina, but they are underrepresented in clinical trials. As a result, the role of an early invasive strategy, and even an invasive strategy at all, in those elderly patients is still a subject of debate, observed Dr. Tegn, a cardiologist from Rikshospitalet, Oslo University Hospital, Oslo.
The study demonstrated that an invasive strategy is superior to a conservative strategy in patients at least 80 years with NSTEMI or unstable angina, he concluded.
After Eighty is a welcome study because of the under-representation of the elderly in clinical trials, Dr. David Kandzari, director of interventional cardiology at the Piedmont Heart Center in Atlanta, said during a press briefing at the meeting. But it raises the challenge of identifying patients in clinical practice with the same qualifying characteristics, he added, given that the study population represents only 10% of the entire screened population,
There was also a fairly high prevalence of patients who angiographically did not have significant coronary artery disease, yet MI and stroke rates were quite considerable.
That said, “the study in other ways reminds us that the coronary anatomy does not know the age of the patient, meaning that the findings of a benefit of an early invasive strategy seem consistent with previous studies we know across the management of patients with acute coronary syndromes,” Dr. Kandzari said.
After Eighty investigators screened 4,187 elderly patients presenting at 17 community hospitals in Norway with non-STEMI or unstable angina, with or without ST-segment depression in ECG, and normal or elevated troponin T or I levels. Patients had to have no chest pain or other ischemic symptoms after medical treatment and mobilization.
In all, 3,730 patients were excluded for life expectancy less than 12 months because of a serious comorbidity; ongoing or recent bleeding; inability to comply with protocol; clinically unstable including ongoing ischemia; refusal to participate; logistic reasons; or other reasons.
The average age was 84.7 years in the invasive group (range 80-93 years) and 84.9 years in the conservative group (range 80-94 years).
Medical treatment during the index admission included 75 mg aspirin in 97% of both the invasive and conservative groups, clopidogrel (85% vs. 82%), ticagrelor (both 5%), angiotensin-converting enzyme (ACE) inhibitor/angiotensin receptor blockers (ARB) (43% vs. 50%), beta blocker (83% vs. 85%), statins (90% vs. 85%), loop or thiazide diuretics (41% vs. 33%), calcium channel blocker (20% vs. 21%), nitrates (45% vs. 55%), warfarin (17% vs. 9%), low molecular-weight heparin (both 76% ), and dabigatran in one patient in each group.
Medical therapy at discharge in the invasive and conservative groups was aspirin (both 93%), clopidogrel (both 72%), ticagrelor (both 4%), ACE inhibitor/ARB (52% vs. 54%), beta blockers (both 84%), statins (90% vs. 86%), diuretics (45% vs. 38%), calcium channel blocker (24% vs. 23%), nitrates (34% vs. 48%), warfarin (21% vs. 14%), rivaroxaban (three patients in both groups), and dabigatran (one patient vs. six patients).