The randomized Defibrillator After Primary Angioplasty (DAPA) trial aimed to evaluate the survival advantage of prophylactic implantable cardioverter-defibrillator (ICD) implantation in early selected high-risk patients after primary percutaneous coronary intervention for ST-segment–elevation myocardial infarction. A controlled, multicenter, randomized trial compared conventional medical therapy versus ICD in high-risk patients with primary percutaneous coronary intervention, based on one of the following factors:
- left ventricular ejection fraction <30% within four days after ST-segment–elevation myocardial infarction,
- primarily ventricular fibrillation,
- Killip class ≥2 or TIMI (Thrombolysis in Myocardial Infarction) flow <3 after percutaneous coronary intervention.
The ICD was implanted 30 to 60 days after MI. The primary endpoint was all-cause mortality at three years follow-up. However, the trial untimely ended after 266 patients (38% of the calculated sample size). Additional survival assessment was performed in February 2019 for the primary endpoint.
Of 266 patients, 78.2% males, with a mean age of 60.8 years, were enrolled. One hundred thirty-one patients were randomized to the ICD arm and 135 patients to the control arm. All-cause mortality was significantly lower in the ICD group (5% vs. 13%) after three years of follow-up. Appropriate ICD therapy occurred in 9 patients at three years follow-up (5 within the first eight months after implantation). After a median long-term follow-up of nine years, total mortality (18% vs. 38%) and cardiac mortality were significantly lower in the ICD group. Noncardiac death was not significantly different between groups. Left ventricular ejection fraction increased greater than or equal to 10% in 46.5% of the patients during follow-up, and the extent of improvement was similar in both study groups.
In conclusion, the untimely dismissed and underpowered randomized trial suggested that early prophylactic ICD implantation demonstrated lower cardiac and total mortality in patients with high-risk ST-segment elevation MI treated with primary percutaneous coronary intervention.
Ref: https://www.ahajournals.org/doi/10.1161/CIRCEP.120.008484
