Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities

Conditions

Peripheral Artery Disease

Keywords

Rivaroxaban, Xarelto, Aspirin, Acetylic salicylic acid, Anticoagulant, Peripheral artery disease, Peripheral arterial disease, Revascularization, Acute limb ischemia, Amputation, Cardiovascular events

Brief summary

The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the heart and brain (CV death, MI, or stroke) or the legs (acute limb ischemia or major amputation) in patients who had undergone recent procedure(s) to improve the blood flow of their legs.

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Rivaroxaban in Peripheral Artery Disease After Revascularization: Worst Events and Net Outcomes in VOYAGER PAD.

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2021-11-0121 citations

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Abstract 13474: Rivaroxaban Reduces Major Cardiovascular and Limb Events in Patients With the High-risk Triad of Chronic Kidney Disease, Peripheral Artery Disease and Recent Lower Extremity Revascularization: Insights From VOYAGER PAD

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Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization

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10.1161/circulationaha.120.050465

Rivaroxaban in Peripheral Artery Disease after Revascularization

Marc P. Bonaca, Rupert Bauersachs, Sonia S. Anand, E. Sebastian Debus, Mark R. Nehler et al. (22 authors)

New England Journal of Medicine2020-03-28925 citations

10.1056/nejmoa2000052

Interventions

DRUGRivaroxaban (Xarelto, BAY59-7939)

2.5 mg, twice daily, orally, tablet

DRUGRivaroxaban-Placebo

matching placebo, twice daily, orally, tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Age ≥50 * Documented moderate to severe symptomatic lower extremity atherosclerotic peripheral artery disease * Technically successful peripheral revascularization distal to the external iliac artery for symptomatic PAD (Peripheral artery disease) within the last 10 days prior to randomization

Exclusion criteria

* Patients undergoing revascularization for asymptomatic PAD or mild claudication without functional limitation of the index leg. * Patients undergoing revascularization of the index leg to treat an asymptomatic or minimally symptomatic restenosis of a bypass graft or target lesion restenosis. * Prior revascularization on the index leg within 10 days of the qualifying revascularization. * Planned dual antiplatelet therapy (DAPT) use for the qualifying revascularization procedure of clopidogrel in addition to Acetylic salicylic acid (ASA) for \>6 months after the qualifying revascularization procedure; it is strongly recommended that any course of clopidogrel is kept to the minimum necessary in accordance with local standard of care and international practice guidelines (typically 30 days, or up to 60 days for some drug-coated products or devices) and is only allowed for up to 6 months for complex procedures or devices in the investigator's opinion that require longer use. * Planned use of any additional antiplatelet agent other than clopidogrel and ASA after the qualifying revascularization procedure.

Design outcomes

Primary

Measure	Time frame	Description
Primary Efficacy Outcome: Number of Participants With Composite of Myocardial Infarction (MI), Ischemic Stroke, Cardiovascular Death, Acute Limb Ischemia (ALI) and Major Amputation Due to a Vascular Etiology	For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean time in follow-up survival time until ECOD that date was 1109.76 days.	Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.
Primary Safety Outcome: Number of Participants With TIMI (Thrombolysis in Myocardial Infarction) Major Bleeding	For each participant, the first occurrence of the primary safety outcome after randomization up until 2 days after permanent stop of study drug (rivaroxaban or rivaroxaban placebo).	Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.

Secondary

Measure	Time frame	Description
Number of Participants With Hospitalization for a Coronary or Peripheral Cause (Either Lower Limb) of a Thrombotic Nature	For each participant, the first occurrence of the efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1154.04 days	Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.
Number of Participants With Composite of MI, Ischemic Stroke, All-cause Mortality (ACM), ALI, and Major Amputation of a Vascular Etiology	For each participant, the first occurrence of the composite efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1085.13 days	Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.
Number of Participants With Composite of MI, All-cause Stroke, Cardiovascular (CV) Death, Acute Limb Ischemia (ALI), and Major Amputation of a Vascular Etiology	For each participant, the first occurrence of the composite efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1108.29 days	Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.
Number of Participants With Composite of MI, Ischemic Stroke, Coronary Heart Disease (CHD) Death, ALI, and Major Amputation of a Vascular Etiology	For each participant, the first occurrence of the composite efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1108.79 days.	Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.
Number of Participants With Venous Thromboembolic (VTE) Events	For each participant, the first occurrence of the outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1187.65 days	Venous thromboembolic events were reported by investigator only.
Secondary Safety Outcome: Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeding	For each participant, the first occurrence of the major bleeding events according to the ISTH classification after randomization up until 2 days after permanent stop of study drug (rivaroxaban or rivaroxaban placebo).	Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.
Secondary Safety Outcome: Number of Participants With BARC (Bleeding Academic Research Consortium) Type 3b and Above Bleeding Events	For each participant, the first occurrence of the type 3b and above bleeding events according to the BARC classification after randomization up until 2 days after permanent stop of study drug (rivaroxaban or rivaroxaban placebo)	Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered
Number of Mortality (All-cause)	For each participant, the first occurrence of the outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1188.48 days	—
Number of Participants With an Unplanned Index Limb Revascularization for Recurrent Limb Ischemia (Subsequent Index Leg Revascularization That Was Not Planned or Considered as Part of the Initial Treatment Plan at the Time of Randomization)	For each participant, the first occurrence of the efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1062.48 days.	Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.

Countries

Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, Estonia, Finland, France, Germany, Hungary, Italy, Japan, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, United States

Participant flow

Recruitment details

Study was conducted at 548 centers which screened participants (534 sites randomized participants) worldwide between 18 Aug 2015 (first patient's first visit) and 27 Nov 2019 (last patient's last visit).

Pre-assignment details

A total of 6772 participants were screened, of which 6564 were randomly assigned to either of the two treatment arms.

Participants by arm

Arm	Count
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od Participants were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)	3,286
Rivaroxaban Placebo Bid + Aspirin 100 mg od Participants were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily	3,278
Total	6,564

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	3	3
Overall Study	Withdrawal by Subject	8	12

Baseline characteristics

Characteristic	Rivaroxaban Placebo Bid + Aspirin 100 mg od	Total	Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od
Age, Continuous	67.0 Years	67 Years	67.0 Years
Race (NIH/OMB) American Indian or Alaska Native	4 Participants	5 Participants	1 Participants
Race (NIH/OMB) Asian	482 Participants	966 Participants	484 Participants
Race (NIH/OMB) Black or African American	71 Participants	155 Participants	84 Participants
Race (NIH/OMB) More than one race	2 Participants	3 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	62 Participants	131 Participants	69 Participants
Race (NIH/OMB) White	2656 Participants	5303 Participants	2647 Participants
Sex: Female, Male Female	857 Participants	1704 Participants	847 Participants
Sex: Female, Male Male	2421 Participants	4860 Participants	2439 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	327 / 3,256	304 / 3,248
other Total, other adverse events	725 / 3,256	729 / 3,248
serious Total, serious adverse events	948 / 3,256	927 / 3,248

Outcome results

Primary

Primary Efficacy Outcome: Number of Participants With Composite of Myocardial Infarction (MI), Ischemic Stroke, Cardiovascular Death, Acute Limb Ischemia (ALI) and Major Amputation Due to a Vascular Etiology

Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.

Time frame: For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean time in follow-up survival time until ECOD that date was 1109.76 days.

Population: Intention-to-treat analysis set (ITT Set): Comprised all randomized participants.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od	Primary Efficacy Outcome: Number of Participants With Composite of Myocardial Infarction (MI), Ischemic Stroke, Cardiovascular Death, Acute Limb Ischemia (ALI) and Major Amputation Due to a Vascular Etiology	508 Participants
Rivaroxaban Placebo Bid + Aspirin 100 mg od	Primary Efficacy Outcome: Number of Participants With Composite of Myocardial Infarction (MI), Ischemic Stroke, Cardiovascular Death, Acute Limb Ischemia (ALI) and Major Amputation Due to a Vascular Etiology	584 Participants

Comparison: IxRS: Interactive web/voice response systemp-value: =0.004395% CI: [0.76, 0.96]Log Rank

Primary

Primary Safety Outcome: Number of Participants With TIMI (Thrombolysis in Myocardial Infarction) Major Bleeding

Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.

Time frame: For each participant, the first occurrence of the primary safety outcome after randomization up until 2 days after permanent stop of study drug (rivaroxaban or rivaroxaban placebo).

Population: Safety analysis set (SAF Set): Comprised all treated participants, i.e. randomized participants who received at least one dose of study drug (rivaroxaban or rivaroxaban placebo).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od	Primary Safety Outcome: Number of Participants With TIMI (Thrombolysis in Myocardial Infarction) Major Bleeding	62 Participants
Rivaroxaban Placebo Bid + Aspirin 100 mg od	Primary Safety Outcome: Number of Participants With TIMI (Thrombolysis in Myocardial Infarction) Major Bleeding	44 Participants

p-value: =0.069595% CI: [0.97, 2.1]Log Rank

Secondary

Number of Mortality (All-cause)

Time frame: For each participant, the first occurrence of the outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1188.48 days

Population: Intention-to-treat analysis set (ITT Set): Comprised all randomized participants.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od	Number of Mortality (All-cause)	321 Participants
Rivaroxaban Placebo Bid + Aspirin 100 mg od	Number of Mortality (All-cause)	297 Participants

p-value: =0.832295% CI: [0.92, 1.27]Log Rank

Secondary

Number of Participants With an Unplanned Index Limb Revascularization for Recurrent Limb Ischemia (Subsequent Index Leg Revascularization That Was Not Planned or Considered as Part of the Initial Treatment Plan at the Time of Randomization)

Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.

Time frame: For each participant, the first occurrence of the efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1062.48 days.

Population: Intention-to-treat analysis set (ITT Set): Comprised all randomized participants.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od	Number of Participants With an Unplanned Index Limb Revascularization for Recurrent Limb Ischemia (Subsequent Index Leg Revascularization That Was Not Planned or Considered as Part of the Initial Treatment Plan at the Time of Randomization)	584 Participants
Rivaroxaban Placebo Bid + Aspirin 100 mg od	Number of Participants With an Unplanned Index Limb Revascularization for Recurrent Limb Ischemia (Subsequent Index Leg Revascularization That Was Not Planned or Considered as Part of the Initial Treatment Plan at the Time of Randomization)	655 Participants

p-value: =0.01495% CI: [0.79, 0.99]Log Rank

Secondary

Number of Participants With Composite of MI, All-cause Stroke, Cardiovascular (CV) Death, Acute Limb Ischemia (ALI), and Major Amputation of a Vascular Etiology

Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.

Time frame: For each participant, the first occurrence of the composite efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1108.29 days

Population: Intention-to-treat analysis set (ITT Set): Comprised all randomized participants.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od	Number of Participants With Composite of MI, All-cause Stroke, Cardiovascular (CV) Death, Acute Limb Ischemia (ALI), and Major Amputation of a Vascular Etiology	514 Participants
Rivaroxaban Placebo Bid + Aspirin 100 mg od	Number of Participants With Composite of MI, All-cause Stroke, Cardiovascular (CV) Death, Acute Limb Ischemia (ALI), and Major Amputation of a Vascular Etiology	588 Participants

p-value: =0.005195% CI: [0.76, 0.96]Log Rank

Secondary

Number of Participants With Composite of MI, Ischemic Stroke, All-cause Mortality (ACM), ALI, and Major Amputation of a Vascular Etiology

Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.

Time frame: For each participant, the first occurrence of the composite efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1085.13 days

Population: Intention-to-treat analysis set (ITT Set): Comprised all randomized participants.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od	Number of Participants With Composite of MI, Ischemic Stroke, All-cause Mortality (ACM), ALI, and Major Amputation of a Vascular Etiology	614 Participants
Rivaroxaban Placebo Bid + Aspirin 100 mg od	Number of Participants With Composite of MI, Ischemic Stroke, All-cause Mortality (ACM), ALI, and Major Amputation of a Vascular Etiology	679 Participants

p-value: =0.014595% CI: [0.79, 0.99]Log Rank

Secondary

Number of Participants With Composite of MI, Ischemic Stroke, Coronary Heart Disease (CHD) Death, ALI, and Major Amputation of a Vascular Etiology

Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.

Time frame: For each participant, the first occurrence of the composite efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1108.79 days.

Population: Intention-to-treat analysis set (ITT Set): Comprised all randomized participants.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od	Number of Participants With Composite of MI, Ischemic Stroke, Coronary Heart Disease (CHD) Death, ALI, and Major Amputation of a Vascular Etiology	433 Participants
Rivaroxaban Placebo Bid + Aspirin 100 mg od	Number of Participants With Composite of MI, Ischemic Stroke, Coronary Heart Disease (CHD) Death, ALI, and Major Amputation of a Vascular Etiology	528 Participants

p-value: =0.000495% CI: [0.71, 0.91]Log Rank

Secondary

Number of Participants With Hospitalization for a Coronary or Peripheral Cause (Either Lower Limb) of a Thrombotic Nature

Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.

Time frame: For each participant, the first occurrence of the efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1154.04 days

Population: Intention-to-treat analysis set (ITT Set): Comprised all randomized participants.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od	Number of Participants With Hospitalization for a Coronary or Peripheral Cause (Either Lower Limb) of a Thrombotic Nature	262 Participants
Rivaroxaban Placebo Bid + Aspirin 100 mg od	Number of Participants With Hospitalization for a Coronary or Peripheral Cause (Either Lower Limb) of a Thrombotic Nature	356 Participants

p-value: <0.000195% CI: [0.62, 0.85]Log Rank

Secondary

Number of Participants With Venous Thromboembolic (VTE) Events

Venous thromboembolic events were reported by investigator only.

Time frame: For each participant, the first occurrence of the outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1187.65 days

Population: Intention-to-treat analysis set (ITT Set): Comprised all randomized participants.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od	Number of Participants With Venous Thromboembolic (VTE) Events	25 Participants
Rivaroxaban Placebo Bid + Aspirin 100 mg od	Number of Participants With Venous Thromboembolic (VTE) Events	41 Participants

p-value: =0.023595% CI: [0.37, 1]Log Rank

Secondary

Secondary Safety Outcome: Number of Participants With BARC (Bleeding Academic Research Consortium) Type 3b and Above Bleeding Events

Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered

Time frame: For each participant, the first occurrence of the type 3b and above bleeding events according to the BARC classification after randomization up until 2 days after permanent stop of study drug (rivaroxaban or rivaroxaban placebo)

Population: Safety analysis set (SAF Set): Comprised all treated participants, i.e. randomized participants who received at least one dose of study drug (rivaroxaban or rivaroxaban placebo).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od	Secondary Safety Outcome: Number of Participants With BARC (Bleeding Academic Research Consortium) Type 3b and Above Bleeding Events	93 Participants
Rivaroxaban Placebo Bid + Aspirin 100 mg od	Secondary Safety Outcome: Number of Participants With BARC (Bleeding Academic Research Consortium) Type 3b and Above Bleeding Events	73 Participants

p-value: =0.097995% CI: [0.95, 1.76]Log Rank

Secondary

Secondary Safety Outcome: Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeding

Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.

Time frame: For each participant, the first occurrence of the major bleeding events according to the ISTH classification after randomization up until 2 days after permanent stop of study drug (rivaroxaban or rivaroxaban placebo).

Population: Safety analysis set (SAF Set): Comprised all treated participants, i.e. randomized participants who received at least one dose of study drug (rivaroxaban or rivaroxaban placebo).

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od	Secondary Safety Outcome: Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeding	140 Participants
Rivaroxaban Placebo Bid + Aspirin 100 mg od	Secondary Safety Outcome: Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeding	100 Participants

p-value: =0.006895% CI: [1.1, 1.84]Log Rank

Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Primary Efficacy Outcome: Number of Participants With Composite of Myocardial Infarction (MI), Ischemic Stroke, Cardiovascular Death, Acute Limb Ischemia (ALI) and Major Amputation Due to a Vascular Etiology

Primary Safety Outcome: Number of Participants With TIMI (Thrombolysis in Myocardial Infarction) Major Bleeding

Number of Mortality (All-cause)

Number of Participants With an Unplanned Index Limb Revascularization for Recurrent Limb Ischemia (Subsequent Index Leg Revascularization That Was Not Planned or Considered as Part of the Initial Treatment Plan at the Time of Randomization)

Number of Participants With Composite of MI, All-cause Stroke, Cardiovascular (CV) Death, Acute Limb Ischemia (ALI), and Major Amputation of a Vascular Etiology

Number of Participants With Composite of MI, Ischemic Stroke, All-cause Mortality (ACM), ALI, and Major Amputation of a Vascular Etiology

Number of Participants With Composite of MI, Ischemic Stroke, Coronary Heart Disease (CHD) Death, ALI, and Major Amputation of a Vascular Etiology

Number of Participants With Hospitalization for a Coronary or Peripheral Cause (Either Lower Limb) of a Thrombotic Nature

Number of Participants With Venous Thromboembolic (VTE) Events

Secondary Safety Outcome: Number of Participants With BARC (Bleeding Academic Research Consortium) Type 3b and Above Bleeding Events

Secondary Safety Outcome: Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeding