presented at the european society of cardiology scientific congress 2006
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FRISC II Trial. Fragmin and Fast Revascularization during Instability in Coronary Artery Disease (FRISC II): Five-Year Follow-up of the FRISC-II Invasive Study. Presented at The European Society of Cardiology Scientific Congress 2006 Presented by Dr. Bo Lagerqvist. - PowerPoint PPT PresentationTRANSCRIPT
Fragmin and Fast Revascularization during Fragmin and Fast Revascularization during Instability in Coronary Artery Disease (FRISC Instability in Coronary Artery Disease (FRISC
II): Five-Year Follow-up of the FRISC-II II): Five-Year Follow-up of the FRISC-II Invasive StudyInvasive Study
Fragmin and Fast Revascularization during Fragmin and Fast Revascularization during Instability in Coronary Artery Disease (FRISC Instability in Coronary Artery Disease (FRISC
II): Five-Year Follow-up of the FRISC-II II): Five-Year Follow-up of the FRISC-II Invasive StudyInvasive Study
Presented atPresented atThe European Society of Cardiology The European Society of Cardiology
Scientific Congress 2006Scientific Congress 2006
Presented by Dr. Bo LagerqvistPresented by Dr. Bo Lagerqvist
FRISC II TrialFRISC II TrialFRISC II TrialFRISC II Trial
www. Clinical trial results.org
FRISC II (5 Year Follow Up): BackgroundFRISC II (5 Year Follow Up): BackgroundFRISC II (5 Year Follow Up): BackgroundFRISC II (5 Year Follow Up): Background
• The goal of this study was to evaluate treatment with an early invasive strategy The goal of this study was to evaluate treatment with an early invasive strategy compared with a conservative management strategy on late clinical events.compared with a conservative management strategy on late clinical events.
• The FRISC II trial was a prospective, randomized trial comparing an early The FRISC II trial was a prospective, randomized trial comparing an early invasive strategy with a conservative management strategy in patients with invasive strategy with a conservative management strategy in patients with unstable coronary artery disease (UA). unstable coronary artery disease (UA).
• At two year follow-up, lower rates of death (3.7% vs 5.4%, p=0.038), MI (9.2% vs At two year follow-up, lower rates of death (3.7% vs 5.4%, p=0.038), MI (9.2% vs 12.7%, p=0.005), and the composite endpoint of death or MI (12.1% vs 16.3%, 12.7%, p=0.005), and the composite endpoint of death or MI (12.1% vs 16.3%, p=0.003) were observed in the invasive strategy group compared with the p=0.003) were observed in the invasive strategy group compared with the conservative management strategy group.conservative management strategy group.
• During the second year, 18 patients died in the invasive group and 19 in the During the second year, 18 patients died in the invasive group and 19 in the conservative group (p=NS).conservative group (p=NS).
• The goal of this study was to evaluate treatment with an early invasive strategy The goal of this study was to evaluate treatment with an early invasive strategy compared with a conservative management strategy on late clinical events.compared with a conservative management strategy on late clinical events.
• The FRISC II trial was a prospective, randomized trial comparing an early The FRISC II trial was a prospective, randomized trial comparing an early invasive strategy with a conservative management strategy in patients with invasive strategy with a conservative management strategy in patients with unstable coronary artery disease (UA). unstable coronary artery disease (UA).
• At two year follow-up, lower rates of death (3.7% vs 5.4%, p=0.038), MI (9.2% vs At two year follow-up, lower rates of death (3.7% vs 5.4%, p=0.038), MI (9.2% vs 12.7%, p=0.005), and the composite endpoint of death or MI (12.1% vs 16.3%, 12.7%, p=0.005), and the composite endpoint of death or MI (12.1% vs 16.3%, p=0.003) were observed in the invasive strategy group compared with the p=0.003) were observed in the invasive strategy group compared with the conservative management strategy group.conservative management strategy group.
• During the second year, 18 patients died in the invasive group and 19 in the During the second year, 18 patients died in the invasive group and 19 in the conservative group (p=NS).conservative group (p=NS).
Presented at ESC 2006Presented at ESC 2006
www. Clinical trial results.org
FRISC II (5 Year Follow Up): Study DesignFRISC II (5 Year Follow Up): Study DesignFRISC II (5 Year Follow Up): Study DesignFRISC II (5 Year Follow Up): Study Design
Presented at ESC 2006Presented at ESC 2006
Primary Endpoint: Composite endpoint of death or MI at 6 monthsPrimary Endpoint: Composite endpoint of death or MI at 6 months Primary Endpoint: Composite endpoint of death or MI at 6 monthsPrimary Endpoint: Composite endpoint of death or MI at 6 months
Early invasive strategy Angiography in all patients and
revascularization if neededn=1222
Early invasive strategy Angiography in all patients and
revascularization if neededn=1222
Conservative Management Strategy:Conservative Management Strategy:Initial medical management with exercise Initial medical management with exercise
testing; angiography if indicatedtesting; angiography if indicatedn=1235n=1235
Conservative Management Strategy:Conservative Management Strategy:Initial medical management with exercise Initial medical management with exercise
testing; angiography if indicatedtesting; angiography if indicatedn=1235n=1235
2457 patients with ischemic symptoms in previous 48 hours accompanied by ECG 2457 patients with ischemic symptoms in previous 48 hours accompanied by ECG changes (ST depression or T wave inversion changes (ST depression or T wave inversion ≥ 0.1 mv) ≥ 0.1 mv) or elevated markers (e.g. CK-MB or elevated markers (e.g. CK-MB
>6 mg/L, troponin T >0.0.10 mg/L) >6 mg/L, troponin T >0.0.10 mg/L) Prospective. Randomized.Prospective. Randomized.
30% female, median age 66 years, mean follow-up 5 years30% female, median age 66 years, mean follow-up 5 yearsAll patients received aspirin; beta blockers given unless contraindicatedAll patients received aspirin; beta blockers given unless contraindicated
2457 patients with ischemic symptoms in previous 48 hours accompanied by ECG 2457 patients with ischemic symptoms in previous 48 hours accompanied by ECG changes (ST depression or T wave inversion changes (ST depression or T wave inversion ≥ 0.1 mv) ≥ 0.1 mv) or elevated markers (e.g. CK-MB or elevated markers (e.g. CK-MB
>6 mg/L, troponin T >0.0.10 mg/L) >6 mg/L, troponin T >0.0.10 mg/L) Prospective. Randomized.Prospective. Randomized.
30% female, median age 66 years, mean follow-up 5 years30% female, median age 66 years, mean follow-up 5 yearsAll patients received aspirin; beta blockers given unless contraindicatedAll patients received aspirin; beta blockers given unless contraindicated
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FRISC II (5 Year Follow Up): Primary EndpointFRISC II (5 Year Follow Up): Primary EndpointFRISC II (5 Year Follow Up): Primary EndpointFRISC II (5 Year Follow Up): Primary Endpoint
19.9%
24.5%
0%
5%
10%
15%
20%
25%
30%
Invasive Strategy Conservative Strategy
19.9%
24.5%
0%
5%
10%
15%
20%
25%
30%
Invasive Strategy Conservative Strategy
• The composite of The composite of death or MI was death or MI was lower in the lower in the invasive strategy invasive strategy (19.9% vs 24.5%, (19.9% vs 24.5%, p=0.009). p=0.009).
• This difference was This difference was largely driven by largely driven by the reduction in MI the reduction in MI (12.9% vs 17.7%, (12.9% vs 17.7%, p=0.002).p=0.002).
Composite of Death or MI at five years Composite of Death or MI at five years (%)(%)
Mor
talit
y at
5 y
ears
Mor
talit
y at
5 y
ears
Presented at ESC 2006Presented at ESC 2006
p=0.009p=0.009
www. Clinical trial results.org
FRISC II FRISC II (5 Year Follow Up)(5 Year Follow Up): Primary Component : Primary Component EndpointsEndpoints
FRISC II FRISC II (5 Year Follow Up)(5 Year Follow Up): Primary Component : Primary Component EndpointsEndpoints
• At five years, At five years, mortality did not differ mortality did not differ between treatment between treatment groups (9.7% vs groups (9.7% vs 10.1%, p=0.69).10.1%, p=0.69).
• There was, however, a There was, however, a significant difference significant difference in MI between the two in MI between the two groups (12.9% vs groups (12.9% vs 17.7%, p=0.002).17.7%, p=0.002).
% o
f pa
tient
s%
of
patie
nts
Presented at ESC 2006Presented at ESC 2006
Mortality and MI at 5 years (%)Mortality and MI at 5 years (%)
9.7%
12.9%
10.1%
17.7%
0%
5%
10%
15%
20%
Death MI
Invasive Strategy Conservative Strategy
9.7%
12.9%
10.1%
17.7%
0%
5%
10%
15%
20%
Death MI
Invasive Strategy Conservative Strategy
p=0.69p=0.69p=0.69p=0.69
p=0.002p=0.002p=0.002p=0.002
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FRISC II (5 Year Follow Up): Primary EndpointFRISC II (5 Year Follow Up): Primary EndpointFRISC II (5 Year Follow Up): Primary EndpointFRISC II (5 Year Follow Up): Primary Endpoint
5.6% 5.9%
0%
2%
4%
6%
Invasive Strategy Conservative Strategy
5.6% 5.9%
0%
2%
4%
6%
Invasive Strategy Conservative Strategy
• There was no There was no difference in cardiac difference in cardiac death between the death between the two groups (5.6% vs two groups (5.6% vs 5.9%, p=0.77).5.9%, p=0.77).
Cardiac Death at five years (%)Cardiac Death at five years (%)
Car
diac
Dea
th a
t 5
year
sC
ardi
ac D
eath
at
5 ye
ars
Presented at ESC 2006Presented at ESC 2006
p=0.77p=0.77
www. Clinical trial results.org
FRISC II (5 Year Follow Up): ConsiderationsFRISC II (5 Year Follow Up): ConsiderationsFRISC II (5 Year Follow Up): ConsiderationsFRISC II (5 Year Follow Up): Considerations
• When analyzed according to patient risk, based on the FRISC When analyzed according to patient risk, based on the FRISC scoring system, investigators found that the benefit of the invasive scoring system, investigators found that the benefit of the invasive strategy at five years was only significant in high-risk patients. strategy at five years was only significant in high-risk patients.
• The decline in the relative mortality benefit between two and five The decline in the relative mortality benefit between two and five years may be related to differences in the rates of years may be related to differences in the rates of revascularization. The difference in absolute in-hospital revascularization. The difference in absolute in-hospital revascularization declined from 63% to 30% by two years between revascularization declined from 63% to 30% by two years between the two treatment arms, with more of the noninvasive patients the two treatment arms, with more of the noninvasive patients undergoing late revascularization.undergoing late revascularization.
• For comparison, the mortality benefit was maintained at five years For comparison, the mortality benefit was maintained at five years in the RITA-3 trial; however, this may reflect differences in the risk in the RITA-3 trial; however, this may reflect differences in the risk of the populations studied.of the populations studied.
• When analyzed according to patient risk, based on the FRISC When analyzed according to patient risk, based on the FRISC scoring system, investigators found that the benefit of the invasive scoring system, investigators found that the benefit of the invasive strategy at five years was only significant in high-risk patients. strategy at five years was only significant in high-risk patients.
• The decline in the relative mortality benefit between two and five The decline in the relative mortality benefit between two and five years may be related to differences in the rates of years may be related to differences in the rates of revascularization. The difference in absolute in-hospital revascularization. The difference in absolute in-hospital revascularization declined from 63% to 30% by two years between revascularization declined from 63% to 30% by two years between the two treatment arms, with more of the noninvasive patients the two treatment arms, with more of the noninvasive patients undergoing late revascularization.undergoing late revascularization.
• For comparison, the mortality benefit was maintained at five years For comparison, the mortality benefit was maintained at five years in the RITA-3 trial; however, this may reflect differences in the risk in the RITA-3 trial; however, this may reflect differences in the risk of the populations studied.of the populations studied.
Presented at Presented at ESC 2006ESC 2006Presented at Presented at ESC 2006ESC 2006
www. Clinical trial results.org
FRISC II (5 Year Follow Up): SummaryFRISC II (5 Year Follow Up): SummaryFRISC II (5 Year Follow Up): SummaryFRISC II (5 Year Follow Up): Summary
• Among patients with unstable angina, an early invasive Among patients with unstable angina, an early invasive strategy was associated with a reduction in mortality strategy was associated with a reduction in mortality compared with a conservative management strategy at two compared with a conservative management strategy at two years. However, through 5 years there was no difference years. However, through 5 years there was no difference in death between treatment strategies.in death between treatment strategies.
• Myocardial infarction was lower for the invasive strategy at Myocardial infarction was lower for the invasive strategy at both two and five years.both two and five years.
• Reductions in the composite of death or MI were limited to Reductions in the composite of death or MI were limited to the high-risk patients.the high-risk patients.
• Among patients with unstable angina, an early invasive Among patients with unstable angina, an early invasive strategy was associated with a reduction in mortality strategy was associated with a reduction in mortality compared with a conservative management strategy at two compared with a conservative management strategy at two years. However, through 5 years there was no difference years. However, through 5 years there was no difference in death between treatment strategies.in death between treatment strategies.
• Myocardial infarction was lower for the invasive strategy at Myocardial infarction was lower for the invasive strategy at both two and five years.both two and five years.
• Reductions in the composite of death or MI were limited to Reductions in the composite of death or MI were limited to the high-risk patients.the high-risk patients.
Presented at ESC 2006Presented at ESC 2006