Trial Outcomes & Findings for Comparative Effectiveness of Oral Anticoagulants (NCT NCT01847547)

NCT ID: NCT01847547

Last Updated: 2014-06-06

Results Overview

Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

• Recruitment status: COMPLETED
• Target enrollment: 5982 participants
• Primary outcome timeframe: From treatment initiation until end of follow-up; up to 20 months
• Results posted on: 2014-06-06

Participant Flow

This is an observational study. Patients were not actively recruited in this study. The data source was the UnitedHealth database.

11882 patients fulfilled the in- and ex-clusion criteria. Only 5982 patients remained after matching on the Propensity Score.

Participant milestones

Measure	Dabigatran Propensity score matched patients starting treatment with dabigatran	Warfarin Propensity score matched patients starting treatment with warfarin
Overall Study STARTED	2991	2991
Overall Study COMPLETED	2991	2991
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Effectiveness of Oral Anticoagulants

Baseline characteristics by cohort

Measure	Dabigatran n=2991 Participants Propensity score matched patients starting treatment with dabigatran	Warfarin n=2991 Participants Propensity score matched patients starting treatment with warfarin	Total n=5982 Participants Total of all reporting groups
Age, Continuous	63.86 years STANDARD_DEVIATION 10.99 • n=113 Participants	63.26 years STANDARD_DEVIATION 11.04 • n=163 Participants	63.60 years STANDARD_DEVIATION 11.01 • n=160 Participants
Sex: Female, Male Female	943 Participants n=113 Participants	877 Participants n=163 Participants	1820 Participants n=160 Participants
Sex: Female, Male Male	2048 Participants n=113 Participants	2114 Participants n=163 Participants	4162 Participants n=160 Participants

PRIMARY outcome

Timeframe: From treatment initiation until end of follow-up; up to 20 months

Population: Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.

Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

Outcome measures

Measure	Dabigatran n=2991 Participants Propensity score matched patients starting treatment with dabigatran	Warfarin n=2991 Participants Propensity score matched patients starting treatment with warfarin
Incidence Rate of Stroke	29.09 events per 1000 person years	31.59 events per 1000 person years

PRIMARY outcome

Timeframe: From treatment initiation until end of follow-up; up to 20 months

Population: Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.

Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.

Outcome measures

Measure	Dabigatran n=2991 Participants Propensity score matched patients starting treatment with dabigatran	Warfarin n=2991 Participants Propensity score matched patients starting treatment with warfarin
Incidence Rate of Major Bleeding	60.00 events per 1000 person years	66.72 events per 1000 person years

SECONDARY outcome

Timeframe: From treatment initiation until end of follow-up; up to 20 months

Population: Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.

Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

Outcome measures

Measure	Dabigatran n=2991 Participants Propensity score matched patients starting treatment with dabigatran	Warfarin n=2991 Participants Propensity score matched patients starting treatment with warfarin
Incidence Rate of Myocardial Infarction	16.90 events per 1000 person years	14.73 events per 1000 person years

SECONDARY outcome

Timeframe: From treatment initiation until end of follow-up; up to 20 months

Population: Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.

Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

Outcome measures

Measure	Dabigatran n=2991 Participants Propensity score matched patients starting treatment with dabigatran	Warfarin n=2991 Participants Propensity score matched patients starting treatment with warfarin
Incidence Rate of Venous Thromboembolism	8.83 events per 1000 person years	34.79 events per 1000 person years

SECONDARY outcome

Timeframe: From treatment initiation until end of follow-up; up to 20 months

Population: Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.

Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

Outcome measures

Measure	Dabigatran n=2991 Participants Propensity score matched patients starting treatment with dabigatran	Warfarin n=2991 Participants Propensity score matched patients starting treatment with warfarin
Incidence Rate of Deep Vein Thrombosis	7.23 events per 1000 person years	27.35 events per 1000 person years

SECONDARY outcome

Timeframe: From treatment initiation until end of follow-up; up to 20 months

Population: Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.

Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

Outcome measures

Measure	Dabigatran n=2991 Participants Propensity score matched patients starting treatment with dabigatran	Warfarin n=2991 Participants Propensity score matched patients starting treatment with warfarin
Incidence Rate of Pulmonary Embolism	3.21 events per 1000 person years	13.65 events per 1000 person years

SECONDARY outcome

Timeframe: From treatment initiation until end of follow-up; up to 20 months

Population: Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.

Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

Outcome measures

Measure	Dabigatran n=2991 Participants Propensity score matched patients starting treatment with dabigatran	Warfarin n=2991 Participants Propensity score matched patients starting treatment with warfarin
Incidence Rate of Major Lower Gastrointestinal Bleeding	35.52 events per 1000 person years	30.57 events per 1000 person years

SECONDARY outcome

Timeframe: From treatment initiation until end of follow-up; up to 20 months

Population: Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.

Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

Outcome measures

Measure	Dabigatran n=2991 Participants Propensity score matched patients starting treatment with dabigatran	Warfarin n=2991 Participants Propensity score matched patients starting treatment with warfarin
Incidence Rate of Major Urogenital Bleeding	0.0 events per 1000 person years	0.0 events per 1000 person years

SECONDARY outcome

Timeframe: From treatment initiation until end of follow-up; up to 20 months

Population: Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.

Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

Outcome measures

Measure	Dabigatran n=2991 Participants Propensity score matched patients starting treatment with dabigatran	Warfarin n=2991 Participants Propensity score matched patients starting treatment with warfarin
Incidence Rate of Major Other Bleeding	32.25 events per 1000 person years	46.41 events per 1000 person years

SECONDARY outcome

Timeframe: From treatment initiation until end of follow-up; up to 20 months

Population: Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.

Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

Outcome measures

Measure	Dabigatran n=2991 Participants Propensity score matched patients starting treatment with dabigatran	Warfarin n=2991 Participants Propensity score matched patients starting treatment with warfarin
Incidence Rate of Transient Ischemic Attack	11.27 events per 1000 person years	12.61 events per 1000 person years

SECONDARY outcome

Timeframe: From treatment initiation until end of follow-up; up to 20 months

Population: Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.

Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.

Outcome measures

Measure	Dabigatran n=2991 Participants Propensity score matched patients starting treatment with dabigatran	Warfarin n=2991 Participants Propensity score matched patients starting treatment with warfarin
Incidence Rate of Major Upper Gastrointestinal Bleeding	4.82 events per 1000 person years	7.34 events per 1000 person years

SECONDARY outcome

Timeframe: From treatment initiation until end of follow-up; up to 20 months

Population: Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.

Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

Outcome measures

Measure	Dabigatran n=2991 Participants Propensity score matched patients starting treatment with dabigatran	Warfarin n=2991 Participants Propensity score matched patients starting treatment with warfarin
Incidence Rate of Stroke or Systemic Embolism	39.73 events per 1000 person years	60.38 events per 1000 person years

SECONDARY outcome

Timeframe: From treatment initiation until end of follow-up; up to 20 months

Population: Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.

Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

Outcome measures

Measure	Dabigatran n=2991 Participants Propensity score matched patients starting treatment with dabigatran	Warfarin n=2991 Participants Propensity score matched patients starting treatment with warfarin
Incidence Rate of Systemic Embolism	11.27 events per 1000 person years	30.55 events per 1000 person years

SECONDARY outcome

Timeframe: From treatment initiation until end of follow-up; up to 20 months

Population: Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.

Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

Outcome measures

Measure	Dabigatran n=2991 Participants Propensity score matched patients starting treatment with dabigatran	Warfarin n=2991 Participants Propensity score matched patients starting treatment with warfarin
Incidence Rate of Ischemic Stroke	27.40 events per 1000 person years	32.71 events per 1000 person years

SECONDARY outcome

Timeframe: From treatment initiation until end of follow-up; up to 20 months

Population: Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.

Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

Outcome measures

Measure	Dabigatran n=2991 Participants Propensity score matched patients starting treatment with dabigatran	Warfarin n=2991 Participants Propensity score matched patients starting treatment with warfarin
Incidence Rate of Hemorrhagic Stroke	4.02 events per 1000 person years	3.14 events per 1000 person years

SECONDARY outcome

Timeframe: From treatment initiation until end of follow-up; up to 20 months

Population: Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.

Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9.

Outcome measures

Measure	Dabigatran n=2991 Participants Propensity score matched patients starting treatment with dabigatran	Warfarin n=2991 Participants Propensity score matched patients starting treatment with warfarin
Incidence Rate of Stroke Uncertain Classification	20.98 events per 1000 person years	14.70 events per 1000 person years

SECONDARY outcome

Timeframe: From treatment initiation until end of follow-up; up to 20 months

Population: Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.

Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

Outcome measures

Measure	Dabigatran n=2991 Participants Propensity score matched patients starting treatment with dabigatran	Warfarin n=2991 Participants Propensity score matched patients starting treatment with warfarin
Incidence Rate of Major Intracranial Bleeding	9.65 events per 1000 person years	7.34 events per 1000 person years

SECONDARY outcome

Timeframe: From treatment initiation until end of follow-up; up to 20 months

Population: Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.

Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.

Outcome measures

Measure	Dabigatran n=2991 Participants Propensity score matched patients starting treatment with dabigatran	Warfarin n=2991 Participants Propensity score matched patients starting treatment with warfarin
Incidence Rate of Major Extracranial Bleeding	56.70 events per 1000 person years	63.53 events per 1000 person years

SECONDARY outcome

Timeframe: From treatment initiation until end of follow-up; up to 20 months

Population: Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.

Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.

Outcome measures

Measure	Dabigatran n=2991 Participants Propensity score matched patients starting treatment with dabigatran	Warfarin n=2991 Participants Propensity score matched patients starting treatment with warfarin
Incidence Rate of Major Gastrointestinal Bleeding	37.14 events per 1000 person years	31.63 events per 1000 person years

Adverse Events

Dabigatran

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Warfarin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place