TOPLINE:

In patients with non-ST-elevation myocardial infarction (NSTEMI) and frailty, an initial invasive strategy caused early harm followed by late benefit, resulting in a neutral effect on survival at 3 years, randomized trial results suggested.

METHODOLOGY:

• The MOSCA-FRAIL trial, conducted at 13 hospitals in Spain, included 167 adults (mean age, 86 years) with frailty (Clinical Frailty Scale [CFS] score > 4) and NSTEMI, who were randomized to a routine invasive (coronary angiography and revascularization if feasible) or a conservative (medical treatment with coronary angiography only if recurrent ischemia) strategy.
• The main results, reported previously, showed no significant differences in the number of days alive and out of the hospital at 1 year, but worse outcomes were observed among patients who underwent invasive treatment. This secondary analysis looked at whether those findings changed with extended follow-up.

TAKEAWAY:

• After a median follow-up in the total population of 1113 days, there were no differences in the number of days alive between the two groups, with a restricted mean survival time of 3.13 years in the invasive group and 3.06 years in the conservative group.
• However, patients who received invasive treatment tended to have shorter survival in the first year (invasive minus conservative, −28 days), an effect that gradually neutralized later on, and invasive treatment significantly improved survival time in the landmark analysis after the first year (invasive minus conservative, 192 days).
• Early harm was more evident in the subgroup with a CFS score > 4.
• No differences were found for the secondary endpoints.

IN PRACTICE:

In patients with frailty and NSTEMI, an initial invasive strategy caused early harm followed by late benefit, resulting in a neutral effect on survival at 3 years. Patients with the highest levels of frailty (CFS > 4) seem to be most susceptible to the early harm, whereas the invasive strategy seemed to improve survival in patients with lower levels of frailty (CFS = 4); however, caution in interpreting this finding is warranted given the small number of patients in this subgroup. The researchers point out that the traditional primary endpoint of major adverse cardiac events used in clinical trials investigating invasive treatment may not be appropriate for patients with frailty, as noncardiac events exceeded cardiac events during the follow-up in this population. They concluded that an initial conservative strategy may be more appropriate for patients with NSTEMI and high levels of frailty, findings that will provide valuable insights for clinical decision-making in this vulnerable patient population.

SOURCE:

The study, led by Juan Sanchis, PhD, University Clinic Hospital of València, València, Spain, was published online in JAMA Network Open on March 6.

LIMITATIONS:

In the extended follow-up of the MOSCA-FRAIL, events were not centrally adjudicated, which raises the possibility of potential overestimation or underreporting of events. Enrollment into the study was relatively slow, and not all consecutive patients were considered for randomization; in addition, the CFS score could be biased by subjective considerations. These facts could have led to a patient selection bias. The wide 95% CIs of the restricted mean survival time estimates underscore the inconclusiveness of these results, thus necessitating cautious interpretation. Therefore, the findings should be viewed as exploratory and hypothesis-generating rather than conclusive.

DISCLOSURES:

This study was supported by grants from Spain’s Ministry of Science and Innovation through the Carlos III Health Institute: Fondo Europeo de Desarrollo Regional and by a grant from the Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares.