Trial Outcomes & Findings for Carotid Occlusion Surgery Study (NCT NCT00029146)

Results Overview

2 yr Kaplan-Meier estimates of the proportions.Proportions expressed as percentages for reporting purposes. Ipsilateral ischemic stroke is defined as the clinical diagnosis of a focal neurological deficit due to cerebral ischemia clinically localizable within the internal carotid artery territory distally to the symptomatic occluded internal carotid artery that lasts for more than 24 hours. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

700 participants

Primary outcome timeframe

within 2 yrs of randomization

Results posted on

2012-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	Surgical Group Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy	Non-surgical Group Receives best current practice medical therapy
Overall Study STARTED	97	98
Overall Study COMPLETED	95	97
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Surgical Group Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy	Non-surgical Group Receives best current practice medical therapy
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

Carotid Occlusion Surgery Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Surgical Group n=97 Participants Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy	Non-surgical Group n=98 Participants Receives best current practice medical therapy	Total n=195 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	76 Participants n=5 Participants	71 Participants n=7 Participants	147 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants	27 Participants n=7 Participants	48 Participants n=5 Participants
Age Continuous	58 years STANDARD_DEVIATION 9 • n=5 Participants	58 years STANDARD_DEVIATION 9 • n=7 Participants	58 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	37 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	69 Participants n=5 Participants	61 Participants n=7 Participants	130 Participants n=5 Participants
Region of Enrollment United States	93 participants n=5 Participants	94 participants n=7 Participants	187 participants n=5 Participants
Region of Enrollment Canada	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: within 2 yrs of randomization

Population: Intention to treat principle.All participants analyzed in the group to which they were originally randomized.

2 yr Kaplan-Meier estimates of the proportions.Proportions expressed as percentages for reporting purposes. Ipsilateral ischemic stroke is defined as the clinical diagnosis of a focal neurological deficit due to cerebral ischemia clinically localizable within the internal carotid artery territory distally to the symptomatic occluded internal carotid artery that lasts for more than 24 hours. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.

Outcome measures

Outcome measures
Measure	Surgical Group n=97 Participants Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy	Non-surgical Group n=98 Participants Receives best current practice medical therapy
Surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-surgery; Non-surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-randomization	21.0 percentage of participants Interval 12.8 to 29.2	22.7 percentage of participants Interval 13.9 to 31.6

SECONDARY outcome

Timeframe: within 2 yrs of randomization

Population: Intention to treat principle.All participants analyzed in the group to which they were originally randomized.

2 yr Kaplan-Meier estimates of the proportions. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours

Outcome measures

Outcome measures
Measure	Surgical Group n=97 Participants Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy	Non-surgical Group n=98 Participants Receives best current practice medical therapy
All Stroke	23.4 percentage of participants Interval 14.8 to 32.0	26.9 percentage of participants Interval 17.6 to 36.2

SECONDARY outcome

Timeframe: within two years after randomization

Population: Intention to treat principle.All participants analyzed in the group to which they were originally randomized.

2 yr Kaplan-Meier estimates of the proportions. Disabling stroke is defined as a modified Barthel Index of \<12/20 at the first scheduled return visit more than 3 months after the stroke occurred

Outcome measures

Outcome measures
Measure	Surgical Group n=97 Participants Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy	Non-surgical Group n=98 Participants Receives best current practice medical therapy
Disabling Stroke	5.9 percentage of participants Interval 0.8 to 10.4	2.4 percentage of participants Interval 0.0 to 5.6

SECONDARY outcome

Timeframe: within 2 years after randomization

Population: Intention to treat principle.All participants analyzed in the group to which they were originally randomized.

2 yr Kaplan-Meier estimates of the proportions. Fatal stroke is a stroke that in the investigator's opinion led directly to the participants death within 30 days of occurrence

Outcome measures

Outcome measures
Measure	Surgical Group n=97 Participants Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy	Non-surgical Group n=98 Participants Receives best current practice medical therapy
Fatal Stroke	1.0 percentage of participants Interval 0.0 to 3.1	2.4 percentage of participants Interval 0.0 to 5.6

SECONDARY outcome

Timeframe: within 2 years after randomization

Population: Intention to treat principle.All participants analyzed in the group to which they were originally randomized.

2 yr Kaplan-Meier estimates of the proportions. Death of any cause

Outcome measures

Outcome measures
Measure	Surgical Group n=97 Participants Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy	Non-surgical Group n=98 Participants Receives best current practice medical therapy
Death	1.0 percentage of participants Interval 0.0 to 3.1	5.1 percentage of participants Interval 0.2 to 9.9

SECONDARY outcome

Timeframe: at 2 years after randomization or end of trial. Worst case imputed for death and missing values

Population: Intention to treat principle.All participants analyzed in the group to which they were originally randomized.

Proportion with modified Rankin score, dichotomized 0 or 1 vs 2-6.The modifed Rankin (0-6) describes the degree of functional disability. A lower score indicates less functional disability.

Outcome measures

Outcome measures
Measure	Surgical Group n=97 Participants Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy	Non-surgical Group n=98 Participants Receives best current practice medical therapy
Modified Rankin 0-1	49.5 percentage of participants Interval 39.5 to 59.4	42.9 percentage of participants Interval 33.1 to 52.7

SECONDARY outcome

Timeframe: at 2 years after randomization or end of trial. Worst case imputed for death and missing values

Population: Intention to treat principle.All participants analyzed in the group to which they were originally randomized.

Proportion with Modified Rankin score at 2 yrs, dichotomized 0-2 vs 3-6. The modifed Rankin (0-6) describes the degree of functional disability. A lower score indicates less functional disability.

Outcome measures

Outcome measures
Measure	Surgical Group n=97 Participants Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy	Non-surgical Group n=98 Participants Receives best current practice medical therapy
Modified Rankin 0-2	70.1 percentage of participants Interval 61.0 to 79.2	74.5 percentage of participants Interval 65.9 to 83.1

SECONDARY outcome

Timeframe: at 2 years after randomization or end of trial. Worst case imputed for death and missing values

Population: Intention to treat principle.All participants analyzed in the group to which they were originally randomized.

Modified Barthel Index dichotomized 19-20 vs \<= 18. The modifed Barthel Index(0-20) describes the degree of independence in day-to-day self-care activities. A higher score indicates greater independence.

Outcome measures

Outcome measures
Measure	Surgical Group n=97 Participants Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy	Non-surgical Group n=98 Participants Receives best current practice medical therapy
Modified Barthel Index 19-20	70.1 percentage of participants	71.4 percentage of participants

SECONDARY outcome

Timeframe: at 2 years after randomization or end of trial. Worst case imputed for death and missing values

Population: Intention to treat principle.All participants analyzed in the group to which they were originally randomized.

Summary Stroke Specific Quality of Life score (1-4) askes how self-reported overall quality of life compares with with that before stroke. A higher score indicates is better.

Outcome measures

Outcome measures
Measure	Surgical Group n=97 Participants Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy	Non-surgical Group n=98 Participants Receives best current practice medical therapy
Summary SS-QOL Score	3.82 units on a scale Interval 3.6 to 4.04	3.58 units on a scale Interval 3.37 to 3.79

SECONDARY outcome

Timeframe: within 2 years of randomization

Population: On-treatment analysis removing four participants assigned to the surgical group who never underwent surgery and censoring on the day of surgery three participants assigned to the nonsurgical group who underwent EC-IC bypass surgery.

2 yr Kaplan-Meier estimates of the proportions.Proportions expressed as percentages for reporting purposes. Ipsilateral ischemic stroke is defined as the clinical diagnosis of a focal neurological deficit due to cerebral ischemia clinically localizable within the internal carotid artery territory distally to the symptomatic occluded internal carotid artery that lasts for more than 24 hours. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.

Outcome measures

Outcome measures
Measure	Surgical Group n=93 Participants Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy	Non-surgical Group n=98 Participants Receives best current practice medical therapy
Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-surgery; Non-surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-randomization	20.8 percentage of participants Interval 12.4 to 29.1	22.3 percentage of participants Interval 13.3 to 31.2

POST_HOC outcome

Timeframe: within 2 years after randomization

Population: Intention to treat principle.All participants analyzed in the group to which they were originally randomized.

2 yr Kaplan-Meier estimates of the proportions. Any stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.

Outcome measures

Outcome measures
Measure	Surgical Group n=97 Participants Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy	Non-surgical Group n=98 Participants Receives best current practice medical therapy
Any Stroke or Death	23.4 percentage of participants Interval 14.8 to 32.0	29.9 percentage of participants Interval 20.1 to 39.8

OTHER_PRE_SPECIFIED outcome

Timeframe: within 30 days after surgery

Population: Intention-to-treat. All assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy

Outcome measures

Outcome measures
Measure	Surgical Group n=97 Participants Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy	Non-surgical Group Receives best current practice medical therapy
Any Stroke or Death Within 30 Days After Surgery	14 participants	—

Adverse Events

Surgical Group

Serious events: 14 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-surgical Group

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Surgical Group n=97 participants at risk Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy	Non-surgical Group n=98 participants at risk Receives best current practice medical therapy
Nervous system disorders Fatal stroke	1.0% 1/97 • Number of events 1 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed	0.00% 0/98 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed
Nervous system disorders Non-fatal Stroke	13.4% 13/97 • Number of events 13 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed	2.0% 2/98 • Number of events 2 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed
Nervous system disorders Transient ischemic attack	4.1% 4/97 • Number of events 4 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed	0.00% 0/98 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed
Respiratory, thoracic and mediastinal disorders Respiratory distress	2.1% 2/97 • Number of events 2 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed	0.00% 0/98 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed
Nervous system disorders Epidural/subdural hematoma	2.1% 2/97 • Number of events 2 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed	0.00% 0/98 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed
Nervous system disorders Seizure	2.1% 2/97 • Number of events 2 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed	0.00% 0/98 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed
Surgical and medical procedures Surgical site infection	1.0% 1/97 • Number of events 1 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed	0.00% 0/98 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed
Cardiac disorders Hypotension	1.0% 1/97 • Number of events 1 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed	0.00% 0/98 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed
Cardiac disorders Myocardial ischemia/infarction	1.0% 1/97 • Number of events 1 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed	0.00% 0/98 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed
Endocrine disorders Hypoglycemia	1.0% 1/97 • Number of events 1 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed	0.00% 0/98 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed
Blood and lymphatic system disorders Deep venous thrombosis	1.0% 1/97 • Number of events 1 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed	0.00% 0/98 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed
Blood and lymphatic system disorders Pulmonary embolism	1.0% 1/97 • Number of events 1 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed	0.00% 0/98 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed
Cardiac disorders Atrial fibrillation/flutter	1.0% 1/97 • Number of events 1 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed	0.00% 0/98 • Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization Only serious adverse events were assessed

Other adverse events

Adverse event data not reported

Additional Information

William J. Powers, MD

University of North Carolina at Chapel HIll

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place