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Selected patients at high risk of sudden cardiac death after ST-elevation myocardial infarction (STEMI) may benefit from early implantable cardioverter-defibrillator (ICD) use, according to results from the Defibrillator After Primary Angioplasty (DAPA) trial presented by Doctor Danielle Haanschoten (Isala Heart Centre, Zwolle, Netherlands) in a Hot Line Session yesterday.
The risk of death is highest in the first 6 months following myocardial infarction (MI).1,2 However, current ESC Guidelines recommend a delay of at least 6 weeks after MI before considering eligibility for prophylactic ICD implantation.3 “The DAPA trial aimed to evaluate the survival benefit of early prophylactic ICD implantation in high-risk STEMI patients treated with primary percutaneous coronary intervention (PCI), an area where data have been lacking,” explains Dr. Haanschoten. “Previously, the MADIT II landmark trial had clearly shown a benefit with ICD after MI in patients with reduced left ventricular (LV) function, but implantation was much later after MI, with a mean of 6.7 years.”
In the DAPA randomised controlled trial, patients at high risk of death after PCI—those with either TIMI flow <3 after PCI, LV ejection fraction (LVEF) <30%, Killip class ≥2 or primary ventricular fibrillation—were randomised to conventional medical therapy with or without early (i.e., within 30–60 days of PCI) implantation of a single-chamber ICD.2 The primary endpoint was all-cause mortality after 3 years follow-up. Secondary endpoints included cardiac mortality (heart failure-related deaths, arrhythmia-related deaths, sudden cardiac death) and non-cardiac mortality.
After enrolment of 266 patients, the DAPA trial was stopped prematurely in 2013 by the Data Safety Monitoring Committee due to the slow inclusion rate (the trial required 700 patients to be powered to demonstrate a significant difference between the arms). Yesterday, Dr. Haanschoten presented results from an additional survival assessment that was performed in February 2019 after a median of nine years’ follow-up.
In a patient population with mainly large anterior infarctions and mean time from MI until ICD implantation of 50 days, 24.4% of patients in the ICD group died compared with 35.5% of patients in the control group (hazard ratio [HR] 0.58; 95% confidence interval [CI] 0.37–0.91; p=0.02). “The all-cause survival curves showed signs of divergence within the first year and continued to diverge throughout the nine-year follow-up period. The difference was mainly driven by cardiac deaths,” comments Doctor Arif Elvan (Director of the Research Institute of Isala Heart Centre, Zwolle, Netherlands). The risk of cardiac death was 11.5% in patients who had an ICD implanted vs 18.5% in those receiving medical therapy alone (HR 0.52; 95% CI 0.28–0.99). Non-cardiac deaths were not significantly different between the arms.
“LVEF was reassessed after 18 months and in 46% of the patients, LV function had significantly improved in both study arms. Despite this, the survival benefit of early ICD implantation was preserved throughout the follow-up period,” says Dr. Haanschoten.
“This finding is particularly important as, at present, LVEF is the most important selection criterion for prophylactic ICD implantation, and current guidelines do not recommend prophylactic ICD implantation in patients with LVEF >30%,” she continues. “What the DAPA trial results suggest is that we need more sophisticated risk stratification tools beyond LVEF to select patients eligible for early ICD implantation, for example, magnetic resonance images or electrophysiological studies. However, some caution is needed in interpreting these data as the DAPA trial was stopped prematurely.”
Dr. Elvan concludes, “Although we had lower-than-planned enrolment, we followed patients for longer than originally planned and performed this additional survival assessment. The findings of DAPA suggest that early (<90 days) prophylactic implantation of an ICD reduces the risk of death in selected high-risk STEMI patients treated with primary PCI. We now need further studies to confirm these findings and establish if changes in clinical practice should be considered.”
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