Basic HTML Version

|  | Table of Contents |  | View Full Version

Page 48 - Abbott
P. 48

    After RHC and sensor implantation, all patients had follow-up study visits at 1 month, 3 months, 6 months, and every 6 months
                   thereafter until study termination.
                   Study Endpoints
                   The primary and secondary endpoints were evaluated after 6 months of patient follow-up. The primary safety endpoints were
                   1) Freedom from device / system-related complications (DSRC), and 2) Freedom from pressure sensor failures. The primary efficacy
                   endpoint was the rate of HF hospitalizations. All hospitalizations were adjudicated by an independent Clinical Events Committee
                   (CEC) who were blinded to treatment assignment. Secondary endpoints were tested in a hierarchical fashion and included changes
                   in PA pressures, proportion of subjects hospitalized for HF, days alive outside of the hospital for HF, and quality of life. Because
                   blinded follow-up continued until the last patient completed 6 months of follow-up, the average patient follow-up was much longer
                   (17.6 months) and pre-specified supplementary analyses were conducted on the full duration of follow-up data (Randomized
                   Access).
                   Patient Demographics and Disposition
                   575 patients were consented for trial enrollment and underwent right heart catheterization (RHC). Of these 575 patients, 25 (4.3%)
                   underwent a RHC but did not receive an implant primarily because of anatomical/physiological conditions identified during the RHC.
                   Of the 550 randomized patients, 270 were assigned to the Treatment group and 280 to the Control group. The two groups were
                   similar with respect to baseline characteristics (see table below).
                   Table 2.  Patient Demographics
                                                    Randomized Group

                                                    Treatment             Control
                                                                                                      2
                   Variables                        (N=270)               (N=280)                p-value
                   Age (years)                      61.3 ± 12.98 (270)    61.8 ± 12.73 (280)     0.5927
                   Male                             194/270 (71.9%)       205/280 (73.2%)        0.7745
                   Race (White)                     196/270 (72.6%)       205/280 (73.2%)        0.9236
                   Systolic BP (mmHg)               121.2 ± 22.52 (270)   123.2 ± 21.01 (280)    0.1286
                   Heart Rate (bpm)                 72.4 ± 12.91 (269)    73.0 ± 12.14 (280)     0.4873
                   BMI                              30.5 ± 6.50 (270)     30.9 ± 7.35 (280)      0.6228
                   BUN (mg/dL)                      29.6 ± 17.99 (248)    28.1 ± 16.17 (267)     0.6325
                   Creatinine (mg/dL)               1.4 ± 0.47 (270)      1.4 ± 0.42 (280)       0.5560
                   GFR (mL/min/1.73m²)              60.4 ± 22.50 (270)    61.8 ± 23.20 (280)     0.5638
                   Ejection Fraction (EF>=40%)      62/270 (23.0%)        57/279 (20.4%)         0.5343
                   Cardiac Output (L/min)           4.5 ± 1.41 (270)      4.6 ± 1.54 (278)       0.5499
                   Cardiac Index (L/min/m²)         2.1 ± 0.59 (270)      2.2 ± 0.64 (278)       0.4405
                   PVR                              2.9 ± 2.02 (270)      2.7 ± 1.82 (278)       0.4609
                   PA Wedge Pressure (mmHg)         17.5 ± 7.97 (270)     19.0 ± 8.12 (280)      0.0276
                   PA Mean Pressure (mmHg)          28.9 ± 9.92 (270)     29.9 ± 10.05 (280)     0.3021
                   CRT-D/ICD Implant                179/270 (66.3%)       197/280 (70.4%)        0.3145
                   Ischemic Cardiomyopathy          158/270 (58.5%)       174/280 (62.1%)        0.4327
                   Hypertension                     207/270 (76.7%)       220/280 (78.6%)        0.6100
                   Hyperlipidemia                   204/270 (75.6%)       218/280 (77.9%)        0.5458
                   Coronary Artery Disease          182/270 (67.4%)       202/280 (72.1%)        0.2290
                   History of MI                    134/270 (49.6%)       137/280 (48.9%)        0.9320
                   Diabetes Mellitus                130/270 (48.1%)       139/280 (49.6%)        0.7337
                   AFIB                             120/270 (44.4%)       135/280 (48.2%)        0.3932
                   COPD                             76/270 (28.1%)        83/280 (29.6%)         0.7078
                   ACE/ARB use                      205/270 (75.9%)       222/280 (79.3%)        0.3584
                   Beta Blocker use                 243/270 (90.0%)       256/280 (91.4%)        0.6595

                   The mean follow-up during Randomized Access was 17.6 months for a total duration of approximately 800 patient years. During the
                   course of Randomized Access, 93 patients in the Treatment group and 110 patients in the Control group exited the study with the
                   primary reason being death.
                   A total of 347 patients (177 in the Treatment group and 170 in the Control group) completed Randomized Access and entered Open
                   Access. The mean follow-up during Open Access was 13 months for a total duration of approximately 400 patient years. During the
                   course of Open Access, 58 patients in the Treatment group and 43 patients in the Control group exited the study with the primary
                   reason being death.

                   2  Wilcoxon Rank-Sum Test for continuous measures and Fisher's exact test for categorical measures.

                                                                44

| 43 44 45 46 47 48 49 50 51 52 53 |