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Long-Term Outcome of the Randomized DAPA Trial
Danielle M Haanschoten1, Arif Elvan1, Anand R Ramdat Misier1
1Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands (D.M.H., A.E., A.R.R.M., P.P.H.M.D., J.J.J.S., A.A., F.D., J.P.O.).
Insights
Prophylactic implantable cardioverter-defibrillator (ICD) implantation in high-risk ST-segment-elevation myocardial infarction patients after primary percutaneous coronary intervention significantly reduced 3-year and long-term mortality. Early ICDs offer a survival benefit in these selected patients.
Area of Science:
- Cardiology
- Interventional Cardiology
- Electrophysiology
Background:
- The DAPA trial investigated the survival benefit of prophylactic implantable cardioverter-defibrillators (ICDs) in high-risk patients post-ST-segment-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI).
- High-risk criteria included left ventricular ejection fraction <30%, primary ventricular fibrillation, Killip class ≥2, or TIMI flow <3 after primary PCI.
Purpose of the Study:
- To evaluate the efficacy of early prophylactic ICD implantation in reducing all-cause mortality in high-risk STEMI patients undergoing primary PCI.
- To assess the long-term impact of ICDs on total and cardiac mortality in this patient population.
Main Methods:
- A randomized, multicenter, controlled trial comparing ICD implantation versus conventional medical therapy.
- 266 high-risk STEMI patients were enrolled, with ICDs implanted 30-60 days post-MI.
- The primary endpoint was all-cause mortality at 3 years, with additional long-term survival assessment.
Main Results:
- After 3 years, all-cause mortality was significantly lower in the ICD group (5% vs. 13%).
- Over a median 9-year follow-up, total mortality (18% vs. 38%) and cardiac mortality were significantly reduced with ICDs.
- Appropriate ICD therapy was observed in 9 patients within 3 years.
Conclusions:
- Despite premature termination and underpowering, the DAPA trial suggests that early prophylactic ICD implantation reduces total and cardiac mortality in high-risk STEMI patients treated with primary PCI.
- The findings support the use of ICDs in selected high-risk post-MI patients to improve long-term survival.
Background:
The randomized DAPA trial (Defibrillator After Primary Angioplasty) aimed to evaluate the survival benefit of prophylactic implantable cardioverter defibrillator (ICD) implantation in early selected high-risk patients after primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction.
Methods:
A randomized, multicenter, controlled trial compared ICD versus conventional medical therapy in high-risk patients with primary percutaneous coronary intervention, based on one of the following factors: left ventricular ejection fraction <30% within 4 days after ST-segment-elevation myocardial infarction, primary ventricular fibrillation, Killip class ≥2 or TIMI (Thrombolysis in Myocardial Infarction) flow <3 after percutaneous coronary intervention. ICD was implanted 30 to 60 days after MI. Primary end point was all-cause mortality at 3 years follow-up. The trial prematurely ended after inclusion of 266 patients (38% of the calculated sample size). Additional survival assessment was performed in February 2019 for the primary end point.
Results:
A total of 266 patients, 78.2% males, with a mean age of 60.8±11.3 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 significant lower in the ICD group (5% versus 13%, hazard ratio, 0.37 [95% CI, 0.15-0.95]) after 3 years follow-up. Appropriate ICD therapy occurred in 9 patients at 3 years follow-up (5 within the first 8 months after implantation). After a median long-term follow-up of 9 years (interquartile range, 3-11), total mortality (18% versus 38%; hazard ratio, 0.58 [95% CI, 0.37-0.91]), and cardiac mortality (hazard ratio, 0.52 [95% CI, 0.28-0.99]) was significant lower in the ICD group. Noncardiac death was not significantly different between groups. Left ventricular ejection fraction increased ≥10% in 46.5% of the patients during follow-up, and the extent of improvement was similar in both study groups.
Conclusions:
In this prematurely terminated and thus underpowered randomized trial, early prophylactic ICD implantation demonstrated lower total and cardiac mortality in patients with high-risk ST-segment-elevation myocardial infarction treated with primary percutaneous coronary intervention. Registration: URL: https://www.trialregister.nl; Unique identifier: Trial NL74 (NTR105).
