Trial Outcomes & Findings for Prevention of Ischemic Events in Patients With Peripheral Arterial Disease (NCT NCT00761969)
NCT ID: NCT00761969
Last Updated: 2015-11-17
Results Overview
Total number of deaths, cardiovascular deaths, non-fatal myocardial infarctions, ischemic strokes and critical limb ischemia.
Recruitment status
COMPLETED
Target enrollment
1455 participants
Primary outcome timeframe
5 years:
Results posted on
2015-11-17
Participant Flow
This study was conducted by 85 primary care physicians-researchers from Slovenia, acountry with a population of about 2 million. Participating physicians were educated on cardiovascular disease prevention according to the European guidelines attended annual progress report meetings and were visited at least once a year by a study monitor. .
Participant milestones
| Measure |
Peripheral Arterial Disease
Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =\< 0.90.
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice .
|
Control
Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice .
|
|---|---|---|
|
Overall Study
STARTED
|
742
|
713
|
|
Overall Study
COMPLETED
|
542
|
573
|
|
Overall Study
NOT COMPLETED
|
200
|
140
|
Reasons for withdrawal
| Measure |
Peripheral Arterial Disease
Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =\< 0.90.
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice .
|
Control
Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice .
|
|---|---|---|
|
Overall Study
Death
|
112
|
47
|
|
Overall Study
Lost to Follow-up
|
88
|
93
|
Baseline Characteristics
Prevention of Ischemic Events in Patients With Peripheral Arterial Disease
Baseline characteristics by cohort
| Measure |
Peripheral Arterial Disease
n=742 Participants
Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =\< 0.90.
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113).
|
Control
n=713 Participants
Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113).
|
Total
n=1455 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 8.8 • n=39 Participants
|
64.7 years
STANDARD_DEVIATION 9.2 • n=41 Participants
|
64.9 years
STANDARD_DEVIATION 9.0 • n=35 Participants
|
|
Sex: Female, Male
Female
|
277 Participants
n=39 Participants
|
275 Participants
n=41 Participants
|
552 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
465 Participants
n=39 Participants
|
438 Participants
n=41 Participants
|
903 Participants
n=35 Participants
|
|
Region of Enrollment
Slovenia
|
742 participants
n=39 Participants
|
713 participants
n=41 Participants
|
1455 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 5 years:Total number of deaths, cardiovascular deaths, non-fatal myocardial infarctions, ischemic strokes and critical limb ischemia.
Outcome measures
| Measure |
Peripheral Arterial Disease
n=742 Participants
Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =\< 0.90.
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113).
|
Control
n=713 Participants
Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113).
|
|---|---|---|
|
Incidence of Major Cardiovascular Events
Death of all causes
|
112 participants
|
47 participants
|
|
Incidence of Major Cardiovascular Events
Cardiovascular death
|
51 participants
|
17 participants
|
|
Incidence of Major Cardiovascular Events
Non-fatal myocardial infarction
|
50 participants
|
21 participants
|
|
Incidence of Major Cardiovascular Events
Non-fatal ischemic stroke
|
22 participants
|
14 participants
|
|
Incidence of Major Cardiovascular Events
Critical limb ischemia
|
11 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 5 yearsIncidence of coronary, carotid and peripheral arterial revascularization procedures
Outcome measures
| Measure |
Peripheral Arterial Disease
n=742 Participants
Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =\< 0.90.
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113).
|
Control
n=713 Participants
Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113).
|
|---|---|---|
|
Incidence of Revascularization Procedures
Peripheral arterial revascularization
|
183 participants
|
2 participants
|
|
Incidence of Revascularization Procedures
Coronary revascularization
|
64 participants
|
20 participants
|
|
Incidence of Revascularization Procedures
carotid revascularization
|
31 participants
|
8 participants
|
|
Incidence of Revascularization Procedures
Abdominal aortic revascularization
|
6 participants
|
0 participants
|
Adverse Events
Peripheral Arterial Disease
Serious events: 195 serious events
Other events: 284 other events
Deaths: 0 deaths
Control
Serious events: 82 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peripheral Arterial Disease
n=742 participants at risk
Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =\< 0.90.
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113).
|
Control
n=713 participants at risk
Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113).
|
|---|---|---|
|
General disorders
Death of all causes
|
15.1%
112/742 • Number of events 112 • Death of all causes, non-fatal major ischemic events (myocardial infarction, ischemic stroke, critical limb ischemia) and revascularization procedures were recorded yearly for 5 years.
At the time of yearly follow-up, non-fatal major ischemic events and revascularization procedures in the previous year were recorded according to medical records. In case of a "no show" on a scheduled visit, subjects or their relatives and their family physician were actively contacted.
|
6.6%
47/713 • Number of events 47 • Death of all causes, non-fatal major ischemic events (myocardial infarction, ischemic stroke, critical limb ischemia) and revascularization procedures were recorded yearly for 5 years.
At the time of yearly follow-up, non-fatal major ischemic events and revascularization procedures in the previous year were recorded according to medical records. In case of a "no show" on a scheduled visit, subjects or their relatives and their family physician were actively contacted.
|
|
Cardiac disorders
Non-fatal myocardial infarction
|
6.7%
50/742 • Number of events 50 • Death of all causes, non-fatal major ischemic events (myocardial infarction, ischemic stroke, critical limb ischemia) and revascularization procedures were recorded yearly for 5 years.
At the time of yearly follow-up, non-fatal major ischemic events and revascularization procedures in the previous year were recorded according to medical records. In case of a "no show" on a scheduled visit, subjects or their relatives and their family physician were actively contacted.
|
2.9%
21/713 • Number of events 21 • Death of all causes, non-fatal major ischemic events (myocardial infarction, ischemic stroke, critical limb ischemia) and revascularization procedures were recorded yearly for 5 years.
At the time of yearly follow-up, non-fatal major ischemic events and revascularization procedures in the previous year were recorded according to medical records. In case of a "no show" on a scheduled visit, subjects or their relatives and their family physician were actively contacted.
|
|
Nervous system disorders
Non-fatal ischemic stroke
|
3.0%
22/742 • Number of events 22 • Death of all causes, non-fatal major ischemic events (myocardial infarction, ischemic stroke, critical limb ischemia) and revascularization procedures were recorded yearly for 5 years.
At the time of yearly follow-up, non-fatal major ischemic events and revascularization procedures in the previous year were recorded according to medical records. In case of a "no show" on a scheduled visit, subjects or their relatives and their family physician were actively contacted.
|
2.0%
14/713 • Number of events 14 • Death of all causes, non-fatal major ischemic events (myocardial infarction, ischemic stroke, critical limb ischemia) and revascularization procedures were recorded yearly for 5 years.
At the time of yearly follow-up, non-fatal major ischemic events and revascularization procedures in the previous year were recorded according to medical records. In case of a "no show" on a scheduled visit, subjects or their relatives and their family physician were actively contacted.
|
|
Vascular disorders
Critical limb ischemia
|
1.5%
11/742 • Number of events 11 • Death of all causes, non-fatal major ischemic events (myocardial infarction, ischemic stroke, critical limb ischemia) and revascularization procedures were recorded yearly for 5 years.
At the time of yearly follow-up, non-fatal major ischemic events and revascularization procedures in the previous year were recorded according to medical records. In case of a "no show" on a scheduled visit, subjects or their relatives and their family physician were actively contacted.
|
0.00%
0/713 • Death of all causes, non-fatal major ischemic events (myocardial infarction, ischemic stroke, critical limb ischemia) and revascularization procedures were recorded yearly for 5 years.
At the time of yearly follow-up, non-fatal major ischemic events and revascularization procedures in the previous year were recorded according to medical records. In case of a "no show" on a scheduled visit, subjects or their relatives and their family physician were actively contacted.
|
Other adverse events
| Measure |
Peripheral Arterial Disease
n=742 participants at risk
Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =\< 0.90.
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113).
|
Control
n=713 participants at risk
Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD
Implementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113).
|
|---|---|---|
|
Vascular disorders
Peripheral arterial revascularization procedure
|
24.7%
183/742 • Number of events 183 • Death of all causes, non-fatal major ischemic events (myocardial infarction, ischemic stroke, critical limb ischemia) and revascularization procedures were recorded yearly for 5 years.
At the time of yearly follow-up, non-fatal major ischemic events and revascularization procedures in the previous year were recorded according to medical records. In case of a "no show" on a scheduled visit, subjects or their relatives and their family physician were actively contacted.
|
0.28%
2/713 • Number of events 2 • Death of all causes, non-fatal major ischemic events (myocardial infarction, ischemic stroke, critical limb ischemia) and revascularization procedures were recorded yearly for 5 years.
At the time of yearly follow-up, non-fatal major ischemic events and revascularization procedures in the previous year were recorded according to medical records. In case of a "no show" on a scheduled visit, subjects or their relatives and their family physician were actively contacted.
|
|
Vascular disorders
Coronary revascularization procedure
|
8.6%
64/742 • Number of events 64 • Death of all causes, non-fatal major ischemic events (myocardial infarction, ischemic stroke, critical limb ischemia) and revascularization procedures were recorded yearly for 5 years.
At the time of yearly follow-up, non-fatal major ischemic events and revascularization procedures in the previous year were recorded according to medical records. In case of a "no show" on a scheduled visit, subjects or their relatives and their family physician were actively contacted.
|
2.8%
20/713 • Number of events 20 • Death of all causes, non-fatal major ischemic events (myocardial infarction, ischemic stroke, critical limb ischemia) and revascularization procedures were recorded yearly for 5 years.
At the time of yearly follow-up, non-fatal major ischemic events and revascularization procedures in the previous year were recorded according to medical records. In case of a "no show" on a scheduled visit, subjects or their relatives and their family physician were actively contacted.
|
|
Vascular disorders
Carotid revascularization
|
4.2%
31/742 • Number of events 31 • Death of all causes, non-fatal major ischemic events (myocardial infarction, ischemic stroke, critical limb ischemia) and revascularization procedures were recorded yearly for 5 years.
At the time of yearly follow-up, non-fatal major ischemic events and revascularization procedures in the previous year were recorded according to medical records. In case of a "no show" on a scheduled visit, subjects or their relatives and their family physician were actively contacted.
|
1.1%
8/713 • Number of events 8 • Death of all causes, non-fatal major ischemic events (myocardial infarction, ischemic stroke, critical limb ischemia) and revascularization procedures were recorded yearly for 5 years.
At the time of yearly follow-up, non-fatal major ischemic events and revascularization procedures in the previous year were recorded according to medical records. In case of a "no show" on a scheduled visit, subjects or their relatives and their family physician were actively contacted.
|
|
Vascular disorders
Abdominal aortic revascularization
|
0.81%
6/742 • Number of events 6 • Death of all causes, non-fatal major ischemic events (myocardial infarction, ischemic stroke, critical limb ischemia) and revascularization procedures were recorded yearly for 5 years.
At the time of yearly follow-up, non-fatal major ischemic events and revascularization procedures in the previous year were recorded according to medical records. In case of a "no show" on a scheduled visit, subjects or their relatives and their family physician were actively contacted.
|
0.00%
0/713 • Death of all causes, non-fatal major ischemic events (myocardial infarction, ischemic stroke, critical limb ischemia) and revascularization procedures were recorded yearly for 5 years.
At the time of yearly follow-up, non-fatal major ischemic events and revascularization procedures in the previous year were recorded according to medical records. In case of a "no show" on a scheduled visit, subjects or their relatives and their family physician were actively contacted.
|
Additional Information
Ales Blinc, MD, DSc
Department of Vascular Diseases, University of Ljubljana Med Ctr
Phone: +386 1 522 80 32
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place