Atrial antitachycardia pacing and managed ventricular pacing in bradycardia patients with paroxysmal or persistent atrial tachyarrhythmias: the MINERVA randomized multicentre international trial.
OBJECTIVE
Atrial fibrillation (AF) is a common comorbidity in bradycardia patients. Advanced pacemakers feature atrial preventive pacing and atrial antitachycardia pacing (DDDRP) and managed ventricular pacing (MVP), which minimizes unnecessary right ventricular pacing. We evaluated whether DDDRP and MVP might reduce mortality, morbidity, or progression to permanent AF when compared with standard dual-chamber pacing (Control DDDR).


RESULTS
In a randomized, parallel, single-blind, multi-centre trial we enrolled 1300 patients with bradycardia and previous atrial tachyarrhythmias, in whom a DDDRP pacemaker had recently been implanted. History of permanent AF and third-degree atrioventricular block were exclusion criteria. After a 1-month run-in period, 1166 eligible patients, aged 74 ± 9 years, 50% females, were randomized to Control DDDR, DDDRP + MVP, or MVP. Analysis was intention-to-treat. The primary outcome, i.e. the 2-year incidence of a combined endpoint composed of death, cardiovascular hospitalizations, or permanent AF, occurred in 102/385 (26.5%) Control DDDR patients, in 76/383 (19.8%) DDDRP + MVP patients [hazard ratio (HR) = 0.74, 95% confidence interval 0.55-0.99, P = 0.04 vs. Control DDDR] and in 85/398 (21.4%) MVP patients (HR = 0.89, 95% confidence interval 0.77-1.03, P = 0.125 vs. Control DDDR). When compared with Control DDDR, DDDRP + MVP reduced the risk for AF longer than 1 day (HR = 0.66, 95% CI 0.52-0.85, P < 0.001), AF longer than 7 days (HR = 0.52, 95% CI 0.36-0.73, P < 0.001), and permanent AF (HR = 0.39, 95% CI 0.21-0.75, P = 0.004).


CONCLUSIONS
In patients with bradycardia and atrial tachyarrhythmias, DDDRP + MVP is superior to standard dual-chamber pacing. The primary endpoint was significantly lowered through the reduction of the progression of atrial tachyarrhythmias to permanent AF.


BACKGROUND
NCT00262119.
Institute of Cardiology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, S.Orsola-Malpighi University Hospital, Via Massarenti 9, 40138 Bologna, Italy giuseppe.boriani@unibo.it.
Giuseppe
G
Boriani
Kennemer Gasthuis, Haarlem, The Netherlands.
Raymond
R
Tukkie
First Department of Cardiology, Evagelismos General Hospital, Athens, Greece.
Antonis S
AS
Manolis
Department of Cardiology, Hospital Clinic, University of Barcelona, Barcelona, Spain.
Lluis
L
Mont
Akademisches Lehrkrankenhaus der Elisabethinen, Linz, Austria.
Helmut
H
Pürerfellner
Cardiology Department, S. Filippo Neri Hospital, Rome, Italy.
Massimo
M
Santini
Institute of Cardiology, Maggiore Hospital, Crema, Italy.
Giuseppe
G
Inama
Cardiology Department, G. Mazzini Hospital, Teramo, Italy.
Paolo
P
Serra
Institute of Cardiology, Hospital de Santa Maria, Lisboa, Portugal.
João
J
de Sousa
Cardiology Department, S. Anna Hospital, Como, Italy.
Giovanni Luca
GL
Botto
Medtronic Clinical Research Institute, Regional Clinical Centre, Rome, Italy.
Lorenza
L
Mangoni
Medtronic Clinical Research Institute, Regional Clinical Centre, Rome, Italy.
Andrea
A
Grammatico
Institute of Internal Medicine and Cardiology, University of Florence, Florence, Italy.
Luigi
L
Padeletti
D000368:Aged; D001281:Atrial Fibrillation / Q000150:complications / Q000401:mortality / Q000628:therapy*; D001919:Bradycardia / Q000150:complications / Q000401:mortality / Q000628:therapy*; D002304:Cardiac Pacing, Artificial / Q000009:adverse effects / Q000379:methods*; D017281:Cost of Illness; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D011788:Quality of Life; D012307:Risk Factors; D016037:Single-Blind Method; D016896:Treatment Outcome
Atrial antitachycardia pacing; Atrial fibrillation; Bradycardia; Managed ventricular pacing; Pacemaker