Long-Term Outcome of the Randomized DAPA Trial
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).
| Errataetall: |
CommentIn: Circ Arrhythm Electrophysiol. 2021 Jan;14(1):e009422. - PMID 33464943 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
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| Enthalten in: |
Circulation. Arrhythmia and electrophysiology - 13(2020), 11 vom: 20. Nov., Seite e008484 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Haanschoten, Danielle M [VerfasserIn] |
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| Links: |
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| Themen: |
Coronary artery disease |
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| Anmerkungen: |
Date Completed 15.03.2021 Date Revised 16.06.2021 published: Print-Electronic NTR: NTR105 CommentIn: Circ Arrhythm Electrophysiol. 2021 Jan;14(1):e009422. - PMID 33464943 Citation Status MEDLINE |
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| doi: |
10.1161/CIRCEP.120.008484 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM315743816 |
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| 500 | |a CommentIn: Circ Arrhythm Electrophysiol. 2021 Jan;14(1):e009422. - PMID 33464943 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a coronary artery disease | |
| 650 | 4 | |a myocardial infarction | |
| 650 | 4 | |a primary prevention | |
| 650 | 4 | |a ventricular fibrillation | |
| 700 | 1 | |a Elvan, Arif |e verfasserin |4 aut | |
| 700 | 1 | |a Ramdat Misier, Anand R |e verfasserin |4 aut | |
| 700 | 1 | |a Delnoy, Peter Paul H M |e verfasserin |4 aut | |
| 700 | 1 | |a Smit, Jaap Jan J |e verfasserin |4 aut | |
| 700 | 1 | |a Adiyaman, Ahmet |e verfasserin |4 aut | |
| 700 | 1 | |a Demirel, Fatma |e verfasserin |4 aut | |
| 700 | 1 | |a Wellens, Hein J J |e verfasserin |4 aut | |
| 700 | 1 | |a Verheugt, Freek W A |e verfasserin |4 aut | |
| 700 | 1 | |a Ottervanger, Jan Paul |e verfasserin |4 aut | |
| 700 | 0 | |a DAPA Investigators |e verfasserin |4 aut | |
| 700 | 1 | |a Schalij, M J |e investigator |4 oth | |
| 700 | 1 | |a Zijlstra, F |e investigator |4 oth | |
| 700 | 1 | |a Wever, E F D |e investigator |4 oth | |
| 700 | 1 | |a de Boer, M J |e investigator |4 oth | |
| 700 | 1 | |a Boersma, E |e investigator |4 oth | |
| 700 | 1 | |a Robbe, H W J |e investigator |4 oth | |
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