Table 6. Baseline characteristics of patients in trials included in the efficacy review: CRT for CHF

NYHA classECGPhysical examOther co-morbidities
IIIIIIVAtrial fibrillationPR intervalQRS intervalLVEDDSystolic BPDiastolic BPHR
Trial nameStudy GroupMales n (%)Age mean SDIschemic %%%%n (%)mean SD (msec)mean SD (msec)mean SD (mm)mean SDmean SDmean SDLBBB %LVEF %
Abraham 200261 MIRACLECRT155 (68)64 +/- 1150-901100-167 +/- 2170 +/- 10114 +/- 1869 +/- 1073 +/- 13-22 +/- 6
Control153 (68)65 +/- 1158-9190-165 +/- 2069 +/- 10115 +/- 1868 +/- 1075 +/- 13-22 +/- 6
Auricchio 2002 PATH-CHF62 CRT first11 (46)59 +/- 742-88130190 +/- 34174 +/- 3071 +/- 10--77 +/- 168821 +/- 6
Control first10 (59)60 +/- 56-82180207 +/- 30178 +/- 3475 +/- 13--80 +/- 1310020 +/- 7
All21 (50)60 +/- 729-86140196 +/- 33175 +/- 3273 +/- 11--78 +/- 159321 +/- 7
Bristow 200360 COMPANIONCRT413 (67)6554-87130-159----6922
Control213 (69)6759-82180-156----7023
CRT-ICD399 (67)6655-86140-159----7323
Cazeau 200174 MUSTIC-SRCRT first19 (66)64 +/- 11--1000-172 +/- 22------
Control first24 (83)64 +/- 8--1000-175 +/- 19------
All43 (74)64 +/- 937-1000215 +/- 43174 +/- 2073 +/- 10----23 +/- 7
Garrigue 200270 All13 (100)64 +/- 1246-7733100-208+/- 15----6225 +/- 8
Guidant 200273 CONTAK-CD FDA reportCRT II–IV210 (85)66 +/- 1167326080205 +/- 42160 +/- 27-118 +/- 2167 +/- 1273 +/- 125421 +/- 7
Control II–IV211 (83)66 +/- 11703357100202 +/- 49156 +/- 26-118 +/- 2169 +/- 1275 +/- 145522 +/- 7
CRT III/IV90 (77)66 +/- 116517*73100204 +/- 41164 +/- 27-116 +/- 2068 +/- 1275 +/- 135021 +/-6
Control III/IV86 (78)66 +/- 117110*71190200 +/- 54152 +/- 24-117 +/- 2367 +/- 1474 +/-155421 +/- 6
Leclercq 200274 MUSTIC-AFCRT first21 (84)65 +/- 9-10025 (100)-209 +/- 2170 +/- 9--75 +/- 6-23 +/- 7
Control first14 (78)66 +/- 9-10018 (100)-208 +/- 1266 +/- 7--74 +/- 5-30 +/- 12
All35 (81)65 +/- 84310043 (100)-209 +/- 1868 +/- 8--74 +/- 5-26 +/- 10
Leclercq 2003 RD-CHF** UnpublishedN/aN/a73 +/- 8N/a0N/aN/a23 (52)N/aN/aN/aN/aN/aN/aN/a25 +/-/9
Medtronic 200136 MIRACLE-ICD FDA reportCRT II–IV231 (82)66 +/- 12383260816 (6)-166 +/- 2371 +/- 9113 +/- 1967 +/- 1173 +/- 130.721 +/- 7
Control II–IV217 (80)66 +/- 11323855712 (4)-163 +/- 2270 +/- 9113 +/- 1768 +/- 1273 +/- 13021 +/- 7
CRT III/IV142 (76)67 +/- 1164881249 (26)-165 +/- 2270 +/- 9--71 +/- 127521 +/- 7
Control III/IV136 (77)68 +/- 975891131 (18)-162 +/ -2271 +/- 9--72 +/- 137120 +/- 6

CRT = cardiac resynchronization therapy; FDA = Food and Drug Administration; HR = heart rate; LVEDD = left ventricular end diastolic diameter; LVEF = left ventricular ejection fraction; LBBB = left bundle branch block; N/a = not available; NYHA= New York Heart Association class

*

pre-implant assessment

**

detailed data not available for Leclercq 2003 (RD-CHF) at the time this report was prepared

Note: While the published report for MIRACLE-ICD was used for patients with NYHA Class III or IV symptoms, the FDA report was used for NYHA Class II patients as they were not included in the published MIRACLE-ICD manuscript

From: 3, Results

Cover of Cardiac Resynchronization Therapy for Congestive Heart Failure
Cardiac Resynchronization Therapy for Congestive Heart Failure.
Evidence Reports/Technology Assessments, No. 106.
McAlister F, Ezekowitz J, Wiebe N, et al.

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