Summary
Invasive intervention following NSTEMI or unstable angina pectoris in the population aged ≥ 80 years is controversial. In the After Eighty Study, early invasive intervention proved superior to conservative management in a study population with a mean age of 85 years.
- After Eighty Study
- elderly
- conservative management
- early invasive intervention
- NSTEMI
- percutaneous coronary intervention
- randomized controlled trial
- unstable angina pectoris
- NCT01255540
- cardiology & cardiovascular medicine clinical trials
Early invasive intervention after medical stabilization following NSTEMI or unstable angina pectoris (UAP) was superior to conservative management in participants aged ≥ 80 years in the After Eighty Study [NCT01255540]. The results were reported by Nicolai Tegn, MD, Rikshospitalet Oslo University Hospital, Oslo, Norway.
Patients aged ≥ 75 years represent approximately a third of all patients with NSTEMI and UAP [Jokhadar M, Wenger NK. Clin Interv Aging. 2009]. However, this population is underrepresented in clinical trials; only 1 previous randomized trial, the Italian Elderly ACS Study [Savonitto S et al. JACC Cardiovasc Interv. 2012], has been conducted exclusively in this age group. The role of invasive management in patients aged ≥ 80 years following NSTEMI or UAP is a matter of debate, Prof Tegn said.
Of 4187 patients who were screened, 457 patients (mean age 85 years), who were medically stabilized after presenting with a syndrome consistent with NSTEMI/UAP, were enrolled in the After Eighty Study, an open-label randomized trial, conducted at 17 centers in Norway between 2010 and 2014. The primary reasons for the exclusion from the study were short life expectancy (< 1 year), inability to comply with study protocol, refusal to participate, and clinical instability. Participants in the invasively treated group (n = 229) were 45% women; in the conservatively treated group (n = 228), 56% of participants were women.
Baseline medical history and risk factors were similar between the 2 groups. In both groups, > 90% of participants had troponin elevation, 97% were receiving aspirin 75 mg, and > 80% were receiving platelet inhibitors, β-blockers, and statins. The study’s primary end point was a composite of myocardial infarction (MI), need for urgent revascularization, stroke, and death.
Among participants in the invasively treated group, angiography revealed stenosis in ≥ 1 vessel in 74% (n = 165); 49% (n = 107) underwent percutaneous coronary intervention and 3% (n = 6) underwent coronary artery bypass grafting. In 90% (n = 198) of participants who underwent revascularization, radial access was used. Participants in both groups received optimal medical treatment.
After a median follow-up of 1.5 years, 41% (n = 93) of invasively treated participants met the composite primary end point, compared with 61% (n = 140) of those treated conservatively (rate ratio [RR], 0.48; 95% CI, 0.37 to 0.63; P < .00001).
MI occurred in 17% of invasively treated participants (n = 39) vs 30% (n = 69) of those treated conservatively (RR, 0.5; P < .0003). Urgent revascularization was required in 2% (n = 5) of invasively treated participants vs 11% (n = 24) of those treated conservatively (RR, 0.19; P = .0001). The composite of death plus MI occurred in 35% (n = 81) of invasively treated participants vs 48% (n = 109) of those treated conservatively (RR, 0.54; P < .0001). The 2 groups did not differ significantly in rates of stroke (P = .26), death from any cause (P = .53), or bleeding complications (no P values reported).
In summary, in a highly selected randomized cohort with a mean age of 85 years, an early invasive treatment strategy after medical stabilization following NSTEMI or UAP had statistically significantly superior results compared with a conservative management strategy, with no increase in bleeding complications. The radial approach was used in 90% of the study patients.
- © 2015 SAGE Publications