10.1111@pace.13216
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Table 1: Baseline characteristics of NYHA Class I-II and III patients
Clinical Characteristics |
NYHA I-II |
NYHA III |
P-value |
|
|
|
|
Number of Patients, # |
706 |
780 |
|
|
|
|
|
Treatment A (n, %) |
251(36) |
256(33) |
0.267 |
|
|
|
|
Treatment B (n, %) |
228(32) |
267(34) |
0.429 |
|
|
|
|
Treatment C (n, %) |
227(32) |
257(33) |
0.744 |
|
|
|
|
CRT-D (n, %) |
165(23) |
591(76) |
<.001 |
|
|
|
|
Age at Time of Consent, years (mean ± SD) |
62±12 |
64±12 |
<.001 |
|
|
|
|
Female (n, %) |
159(23) |
270(35) |
<.001 |
|
|
|
|
Ejection Fraction, % (mean ± SD) |
27±6 |
25±7 |
0.006 |
|
|
|
|
Ischemic (n, %) |
424(60) |
353(45) |
<.001 |
|
|
|
|
Diabetes Mellitus (n, %) |
201(29) |
280(36) |
0.002 |
|
|
|
|
Hypertension (n, %) |
458(65) |
559(72) |
0.005 |
|
|
|
|
Currently Smoking (n, %) |
130(20) |
115(15) |
0.033 |
|
|
|
|
Atrial Fibrillation (n, %) |
77(11) |
73(9) |
0.302 |
|
|
|
|
Atrial Flutter (n, %) |
18(3) |
18(2) |
0.762 |
|
|
|
|
Treatment for Atrial Arrhythmias (n, %) |
75(80) |
69(68) |
0.054 |
|
|
|
|
Ablation for Atrial Arrhythmias (n, %) |
20(21) |
14(14) |
0.185 |
|
|
|
|
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21
Clinical Characteristics |
NYHA I-II |
NYHA III |
P-value |
|
|
|
|
Coronary Artery Bypass Graft Surgery (n, %) |
180(26) |
185(24) |
0.425 |
|
|
|
|
Myocardial Infarction, (n, %) |
350(51) |
275(36) |
<.001 |
|
|
|
|
Resting Heart Rate, bpm (mean ± SD) |
70.9±12.5 |
73.2±12.5 |
<.001 |
|
|
|
|
Amiodarone (n, %) |
32(5) |
63(8) |
0.005 |
|
|
|
|
ACE Inhibitor/ARB (n, %) |
496(70) |
506(65) |
0.029 |
|
|
|
|
Beta-blocker (n, %) |
671(95) |
719(92) |
0.031 |
|
|
|
|
Aldosterone (n, %) |
233(33) |
307(39) |
0.010 |
|
|
|
|
Diuretic (n, %) |
421(60) |
580(74) |
<.001 |
|
|
|
|
Statins (n, %) |
433(61) |
435(56) |
0.032 |
|
|
|
|
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22
Table 2: Multivariable models for risk of all inappropriate therapy associated with
NYHA Class III vs. Class II patients with ICD and CRT-D in Arm A
A. Inappropriate ICD therapy
Parameter |
Hazard Ratio* |
95% CI |
p-value |
|
|
|
|
|
|
End point: All inappropriate therapy (101 events) |
||||
|
|
|
|
|
ICD patients |
|
|
|
|
|
|
|
|
|
NYHA III vs. NYHA I-II |
2.55 |
1.51 |
– 4.30 |
<0.001 |
|
|
|
|
|
CRT-D patients |
|
|
|
|
|
|
|
|
|
NYHA III vs. NYHA I-II |
3.73 |
1.14 |
– 12.23 |
0.030 |
|
|
|
|
|
*Models adjusted for age, diabetes, and prior atrial arrhythmias
B. Inappropriate ATP
Parameter |
Hazard Ratio* |
95% CI |
p-value |
|
|
|
|
End point: All inappropriate therapy (100 events)
ICD patients
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23
NYHA III vs. NYHA I-II |
2.57 |
1.52 |
– 4.34 |
<0.001 |
|
|
|
|
|
CRT-D patients |
|
|
|
|
|
|
|
|
|
NYHA III vs. NYHA I-II |
3.62 |
1.10 |
– 11.90 |
0.034 |
|
|
|
|
|
*Models adjusted for age, diabetes, and prior atrial arrhythmias
C. Inappropriate therapy for HR<200 bpm
Parameter |
Hazard Ratio* |
95% CI |
p-value |
|
|
|
|
End point: All inappropriate therapy (100 events)
ICD patients
NYHA III vs. NYHA I-II |
2.89 |
|
1.69 |
– 4.94 |
<0.001 |
|
|
|
|
|
|
|
|
CRT-D patients |
|
|
|
|
|
|
|
|
|
NYHA III vs. NYHA I-II |
3.32 |
|
1.01 |
– 10.95 |
0.049 |
|
|
|
|
|
|
*Models adjusted for age, diabetes, and prior atrial arrhythmias
This article is protected by copyright. All rights reserved. 24
Table 3: Multivariable models for risk of all inappropriate therapy with novel vs.
conventional ICD programming in NYHA Class III and NYHA Class I-II patients
Parameter |
Hazard Ratio* |
95% CI |
p-value |
|
|
|
|
End point: All inappropriate therapy in NYHA III patients (72 events) |
|||
|
|
|
|
Arm B vs. Arm A |
0.08 |
0.03 – 0.18 |
<0.001 |
|
|
|
|
Arm C vs. Arm A |
0.17 |
0.09 – 0.32 |
<0.001 |
|
|
|
|
End point: All inappropriate therapy in NYHA I-II patients (74 events) |
|||
|
|
|
|
Arm B vs. Arm A |
0.25 |
0.13 – 0.46 |
<0.001 |
|
|
|
|
Arm C vs. Arm A |
0.28 |
0.15 – 0.52 |
<0.001 |
|
|
|
|
Models adjusted for ICD vs. CRT-D, age, diabetes, and prior atrial arrhythmias
This article is protected by copyright. All rights reserved. 25