TY - JOUR
T1 - Long-Term Outcome of the Randomized DAPA Trial
AU - Haanschoten, Danielle M.
AU - Elvan, Arif
AU - Misier, Anand R. Ramdat
AU - Delnoy, Peter Paul H. M.
AU - Smit, Jaap Jan J.
AU - Adiyaman, Ahmet
AU - Demirel, Fatma
AU - Wellens, Hein J. J.
AU - Verheugt, Freek W. A.
AU - Ottervanger, Jan Paul
AU - DAPA Investigators
N1 - Funding Information:
Medtronic Inc was the sponsor of the study and provided financial and technical support. The firm had no interference with the design of the study protocol, data collection or data analysis.
Publisher Copyright:
© 2020 Lippincott Williams and Wilkins. All rights reserved.
PY - 2020/11
Y1 - 2020/11
N2 - 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 = 2 or TIMI (Thrombolysis in Myocardial Infarction) flowResults: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: ; Unique identifier: Trial NL74 (NTR105).
AB - 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 = 2 or TIMI (Thrombolysis in Myocardial Infarction) flowResults: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: ; Unique identifier: Trial NL74 (NTR105).
KW - coronary artery disease
KW - myocardial infarction
KW - primary prevention
KW - ventricular fibrillation
KW - IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR
KW - SUDDEN CARDIAC DEATH
KW - ELEVATION MYOCARDIAL-INFARCTION
KW - EJECTION FRACTION
KW - TASK-FORCE
KW - ASSOCIATION
KW - RISK
KW - INTERVENTION
KW - DYSFUNCTION
KW - GUIDELINES
U2 - 10.1161/circep.120.008484
DO - 10.1161/circep.120.008484
M3 - Article
C2 - 33003972
SN - 1941-3149
VL - 13
JO - Circulation-Arrhythmia and Electrophysiology
JF - Circulation-Arrhythmia and Electrophysiology
IS - 11
M1 - 008484
ER -