presented at the european society of cardiology scientific congress 2006

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Fragmin and Fast Revascularization Fragmin and Fast Revascularization during Instability in Coronary during Instability in Coronary Artery Disease (FRISC II): Five-Year Artery Disease (FRISC II): Five-Year Follow-up of the FRISC-II Invasive Follow-up of the FRISC-II Invasive Study Study Presented at Presented at The European Society of Cardiology The European Society of Cardiology Scientific Congress 2006 Scientific Congress 2006 Presented by Dr. Bo Lagerqvist Presented by Dr. Bo Lagerqvist FRISC II Trial FRISC II Trial

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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 Presentation

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Page 1: Presented at The European Society of Cardiology  Scientific Congress 2006

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

Page 2: Presented at The European Society of Cardiology  Scientific Congress 2006

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

Page 3: Presented at The European Society of Cardiology  Scientific Congress 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

Page 4: Presented at The European Society of Cardiology  Scientific Congress 2006

www. Clinical trial results.org

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

Page 5: Presented at The European Society of Cardiology  Scientific Congress 2006

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

Page 6: Presented at The European Society of Cardiology  Scientific Congress 2006

www. Clinical trial results.org

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

Page 7: Presented at The European Society of Cardiology  Scientific Congress 2006

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

Page 8: Presented at The European Society of Cardiology  Scientific Congress 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