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The Long Term Multi-Center Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) study To reviewers and moderators: These.

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Presentation on theme: "The Long Term Multi-Center Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) study To reviewers and moderators: These."— Presentation transcript:

1 The Long Term Multi-Center Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) study To reviewers and moderators: These are preliminary slides. The figures are going to be upgraded this week and I can send these to you if you email me at connostu@phri.ca 1

2 RE-LY: Results with Dabigatran Etexilate Dabigatran (DE) 150 mg BID and 110 mg BID versus warfarin An 18,113 Patient Global Clinical Trial Mean follow up 2 years DE 150 reduced stroke/SEE by 35% versus warfarin DE 110 non-inferior to warfarin, with 20% reduction in major bleeding Greater than 50% reduction in intracranial bleeding with both doses compared to warfarin Regulatory approval in 79 countries as of November 2012 2 Reference

3 RELY-ABLE Design Descriptive study to assess long-term efficacy and safety of two doses of DE 28 months of additional treatment with DE following RE-LY Patients eligible if completed RE-LY –Alive and on study medication DE blinded dose continued in RELY-ABLE No event adjudication Follow up stopped if study medication discontinued 3

4 Data Analysis Primary analysis RELY-ABLE patients during RELY-ABLE period of follow up Secondary Analyses RELY-ABLE patients followed from beginning of RE-LY to end of RELY-ABLE All dabigatran patients, from beginning of RE-LY to the end of RELY-ABLE 4

5 Patient Flow: RE-LY and RELY-ABLE DE 110DE 150 Randomized to dabigatran in RE-LY60156076 Completed RE-LY alive, on Dabigatran4492 (74.7%)4519 (74.4%) Followed at site participating in RELY- ABLE 3395 (75.6%)3397 (75.2%) Patient enrolled in RELY-ABLE2914 (85.8%)2937 (86.5%) Completed RELY-ABLE still receiving study medication 2511 (86.2%)2508 (85.4%) Continued in RELY-ABLE beyond the 28 month visit 1082 (43.5%) 1104 (44.0%) 5

6 RE-LY Baseline Characteristics: Patients in enrolling or not enrolling in RELY-ABLE 6 RE-LY Patients Not Enrolled in RELY-ABLE RE-LY Patients Enrolled in RELY-ABLE p-values 110 mg (N=3101) 150 mg (N=3139) 110 mg (N=2914) 150 mg (N=2397) Enrolled vs. not enrolled 110 vs 150 mg Age (years); mean, (SD)72 (9) 71 (8) 0.0010.55 Systolic BP-sitting (mmHg); mean, (SD) 131 (18) 0.200.46 Male; number (%)1951 (63)1929 (62)1914 (66)1911 (65)0.030.64 AF diagnosed > 2yrs; number (%)1463 (47)1503 (48)1380 (47)1373 (47)0.890.47 Permanent AF; number (%)1177 (38)1222 (39)955 (33)966 (33)<0.0010.64 Prior stroke or TIA; number (%)614 (20)611 (20)581 (20)622 (21)0.890.28 VKA Experienced; number (%)1475 (48)1524 (49)1536 (53)1525 (52)<0.0010.33 History of Hypertension; number (%)2417 (78)2505 (80)2321 (80)2290 (78)0.110.02 History of MI; number (%)542 (18)551 (18)466 (16)478 (16)0.120.87 History of heart failure; number (%)1147 (37)1121 (36)790 (27)813 (28)<0.0010.29 CHADS 2 risk score; mean, (SD)2 (1) <0.0010.32 Baseline beta blocker; number (%)1853 (60)1892 (60)1931 (66)1980 (67)<0.0010.68 Baseline ARB or ACE I; number (%)2043 (66)2118 (68)1944 (67)1935 (66)0.520.16

7 Event Rates during RE-LY: Enrolled versus not enrolled patients 7 RE-LY Patients Not in RELY-ABLE RE-LY Patients in RELY-ABLE p-values 110 mg (N=3101) event number (rate/year) 150 mg (N=3139) event number (rate/year) 110 mg (N=2914) event number (rate/year) 150 mg (N=2397) event number (rate/year) Enrolled vs. not enrolled 110 vs 150 Major bleed251 (4)309 (5)91 (1) <0.0010.21 Stroke140 (2)106 (2)31 (1)17(0)<0.0010.33 Myocardial infarction 60 (1)67 (1)28 (0)22 (0)<0.0010.30

8 Ischemic Events: RELY-ABLE patients in RELY-ABLE follow up period 8 Event 150 mg (%/yr) 110 mg (%/yr) HR95% CI Stroke or SEE1.461.600.910.69-1.20 All Stroke1.241.380.890.66-1.21 Ischemic1.15 1.240.920.67-1.27 Hemorrhagic0.130.140.890.34-2.30 Myocardial infarction0.69)0.720.960.63-1.45 Pulmonary embolism0.130.111.140.41-3.15

9 Stroke or SEE 9 RELY-ABLE Patients in RELY-ABLE Period

10 Ischemic Events: RE-LY + RELY- ABLE Periods 10 Event Only RELY-ABLE PatientsAll Dabigatran patients 150 mg (%/yr) 110 mg (%/yr) HR95% CI 150 mg (%/yr) 110 mg (%/yr) HR95% CI Stroke or SEE 0.891.050.840.65-1.09 1.251.540.810.68-0.96 All Stroke 0.760.930.810.62-1.08 1.111.400.790.65-0.95 Ischemic 0.710.860.820.62-1.09 1.01 1.290.780.65-0.95 Hemorrhagic 0.060.070.880.34-2.29 0.110.130.910.50-1.64 Myocardial infarction 0.510.570.900.64-1.26 0.710.720.980.77-1.25 Pulmonary embolism 0.070.061.120.43-2.890.14 0.111.230.69-2.18

11 Stroke or Systemic Embolism: RE-LY + RELY-ABLE periods 11 RELY-ABLE Only All Dabigatran

12 Bleeding: RELY-ABLE patients in RELY-ABLE follow up period 12 Event RELY-ABLE Only 150 mg (%/yr) 110 mg (%/yr) HR95% CI Major Bleeding3.742.991.261.04-1.53 Life-threatening1.79 1.571.140.87-1.49 GI1.541.560.990.75-1.31 Intra-cranial0.330.251.310.68-2.51 Extra-cranial3.432.821.231.01-1.49 Fatal0.240.250.940.46-1.89 Minor Bleeding9.708.191.211.07-1.36 RELY-ABLE Period Only

13 Major Bleeding 13 RELY-ABLE Patients in RELY-ABLE Period

14 Bleeding: RE-LY + RELY-ABLE Periods 14 Event RELY-ABLE Only patientsAll Dabigatran patients 110 mg (%/yr) 150 mg (%/y r) HR95% CI 110 mg (%/yr) 150 mg (%/yr) HR95% CI Major Bleeding 2.132.501.181.00-1.382.833.381.201.07-1.35 Life- threatening 1.011.101.080.85-1.361.361.581.160.98-1.38 GI 0.990.981.000.78-1.281.291.521.181.00-1.41 Intra-cranial 0.160.181.090.60-2.000.220.331.450.98-2.16 Extra-cranial 2.022.331.160.0.98-1.372.653.081.171.04-1.32 Fatal0.250.240.940.46-1.890.130.161.250.72-2.16

15 Major Bleeding: 15 RELY-ABLE Only All Dabigatran

16 Net Benefit: RELY-ABLE 16 Event RELY-ABLE 110 mg (%/yr) 150 mg (%/yr) HR95% CI Total mortality 3.103.020.970.80-1.19 Vascular mortality 1.621.671.030.78-1.35 Disabling stroke, life- threatening bleed or death 4.454.531.020.86-1.20 Stroke, systemic embolism, myocardial infarction, pulmonary embolism, major bleed or death 6.897.361.070.94-1.22

17 Total Mortality 17

18 Net Benefit: RE-LY + RELY-ABLE Periods 18 Event RELY-ABLE patients onlyAll dabigatran patients 110 mg (%/yr) 150 mg (%/yr) HR95% CI 110 mg (%/yr ) 150 mg (%/yr) HR95% CI Total mortality 1.581.540.970.80-1.18 3.543.460.980.88-1.09 Vascular mortality o.830.851.030.78-1.35 2.142.090.970.85-1.12 Disabling stroke, life- threatening bleed or death 4.454.531.020.86-1.20 4.834.690.970.88-1.07 Stroke, systemic embolism, myocardial infarction, pulmonary embolism, major bleed or death 6.897.361.070.94-1.22 1.540.1.010.94-1.10

19 Total Mortality: RE-LY + RELY-ABLE Periods 19 All Dabigatran patients

20 0.00.51.001.52.0 OVERALL AGE <65 AGE 65-74 AGE 75+ MALE FEMALE STROKE/ SEE/TIA NONE CHADS 0-1 CHADS 2 CHADS 3+ CCLEAR <50 CCLEAR 50-79 CCLEAR 80 # PTS 12091 2028 5248 4815 7705 4385 2666 9424 3921 4224 3945 49 2379 5655 P(INTER) 0.60 0.14 0.86 0.36 0.64 Stoke or Systemic embolism 150mg better110mg better 0.00.51.001.52.0 P(INTER) 0.95 0.76 0.02 0.44 0.42 Major Bleeding 150mg better110mg better Hazard Ratio 0.00.51.001.52.0 P(INTER) 0.31 0.39 0.04 0.03 0.63 Total Mortality 150mg better110mg better Hazard Ratio Sub-groups: RE-LY + RELY-ABLE

21 Conclusions During 2.3 years of treatment on dabigatran, after RE-LY, rates of stroke and major bleeding remain low on dabigatran Including all dabigatran follow up, there is a dose response effect –With dabigatran 150 mg compared to 110 mg 22% reduction in ischemic stroke 20% increase in major bleeding Very similar mortality 21

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