Welcome Welcome Ask The ExpertsAsk The Experts

March 24-27, 2007March 24-27, 2007

New Orleans, LANew Orleans, LA

Christopher P. Cannon, MDSenior Investigator, TIMI Study Group

Cardiovascular DivisionBrigham and Women's HospitalAssociate Professor of Medicine

Harvard Medical SchoolBoston, MA

Year in Review 2006Year in Review 2006

C. Michael Gibson, MS, MDAssociate Professor of Medicine

Harvard Medical SchoolChief of Clinical Research

Cardiology DivisionBeth Israel Deaconess Medical Center

Boston, MA

Top Ten Clinical Trials of the Year

Basel Stent Cost-effectiveness Trial-Late Basel Stent Cost-effectiveness Trial-Late Thrombotic Events (BASKET LATE) TrialThrombotic Events (BASKET LATE) Trial Basel Stent Cost-effectiveness Trial-Late Basel Stent Cost-effectiveness Trial-Late Thrombotic Events (BASKET LATE) TrialThrombotic Events (BASKET LATE) Trial

Presented atPresented atThe American College of Cardiology The American College of Cardiology

Scientific Session 2006Scientific Session 2006

Presented by Dr. Matthias E. PfistererPresented by Dr. Matthias E. Pfisterer

BASKET LATE TrialBASKET LATE TrialBASKET LATE TrialBASKET LATE Trial

www. Clinical trial results.org

BASKET LATE Trial: Primary Composite BASKET LATE Trial: Primary Composite EndpointEndpoint

BASKET LATE Trial: Primary Composite BASKET LATE Trial: Primary Composite EndpointEndpoint

4.9

1.3

0

1

2

3

4

5

6

DES BMS

4.9

1.3

0

1

2

3

4

5

6

DES BMS

• In the year In the year following following clopidogrel clopidogrel discontinuation, discontinuation, the primary the primary composite composite endpoint of endpoint of cardiac death or MI cardiac death or MI occurred occurred significantly more significantly more frequently in the frequently in the DES group than in DES group than in the BMS group the BMS group (4.9% vs. 1.3%, (4.9% vs. 1.3%, p=0.01).p=0.01).

Composite of Cardiac death or nonfatal MI Composite of Cardiac death or nonfatal MI (%)(%)

p=0.01p=0.01

% p

atie

nts

% p

atie

nts

Presented at ACC 2006Presented at ACC 2006

www. Clinical trial results.org

BASKET LATE Trial: “Thrombosis-Related BASKET LATE Trial: “Thrombosis-Related Events”Events”

BASKET LATE Trial: “Thrombosis-Related BASKET LATE Trial: “Thrombosis-Related Events”Events”

• There was no significant There was no significant difference in the difference in the occurrence of late stent occurrence of late stent thrombosis (combination thrombosis (combination of angiographic of angiographic documented thrombosis documented thrombosis and thrombotic clinical and thrombotic clinical events) between the DES events) between the DES and BMS groups (2.6% and BMS groups (2.6% vs. 1.3%, p=0.23).vs. 1.3%, p=0.23).

• The median time of the The median time of the late thrombotic event was late thrombotic event was 116 days following 116 days following clopidogrel clopidogrel discontinuation, but discontinuation, but events occurred events occurred throughout the one year throughout the one year follow-up (range 362 follow-up (range 362 days).days).

2.6

1.3

0

1

2

3

DES BMS

2.6

1.3

0

1

2

3

DES BMS

Additional endpoint of Additional endpoint of ““thrombosis-related events” thrombosis-related events”

(%)(%)p=0.23 p=0.23

Presented at ACC 2006Presented at ACC 2006

% p

atie

nts

% p

atie

nts

Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance(CHARISMA)

Deepak L. Bhatt M.D., Keith A. A. Fox M.B.Ch.B., Werner Hacke M.D., Peter B. Berger M.D., Henry R. Black M.D., William E. Boden M.D., Patrice Cacoub M.D.,

Eric A. Cohen M.D., Mark A. Creager M.D., J. Donald Easton M.D., Marcus D. Flather M.D., Steven M. Haffner M.D., Christian W. Hamm M.D., Graeme J. Hankey

M.D., S. Claiborne Johnston M.D., Koon-Hou Mak M.D., Jean-Louis Mas M.D., Gilles Montalescot M.D., Ph.D., Thomas A. Pearson M.D., P. Gabriel Steg M.D., Steven R. Steinhubl M.D., Michael A. Weber M.D., Danielle M. Brennan M.S., Liz

Fabry-Ribaudo M.S.N., R.N., Joan Booth R.N., Eric J. Topol M.D., on behalf of the CHARISMA Investigators

The Cleveland Clinic FoundationThe Cleveland Clinic Foundation

Overall Population: Primary Efficacy Outcome

(MI, Stroke, or CV Death)†

† First Occurrence of MI (fatal or non-fatal), stroke (fatal or non-fatal), or cardiovascular death*All patients received ASA 75-162 mg/day§The number of patients followed beyond 30 months decreases rapidly tozero and there are only 21 primary efficacy events that occurred beyond this time (13 clopidogrel and 8 placebo)

Placebo + ASA*7.3%

Clopidogrel + ASA*6.8%

RRR: 7.1% [95% CI: -4.5%, 17.5%]P=0.22

Months since randomization§

0

2

4

6

8

0 6 12 18 24 30

Cu

mu

lati

ve e

ven

t ra

te (

%)

Bhatt DL, Fox KA, Hacke W, et al. NEJM 2006.

Overall Population: Safety Results

Clopidogrel Placebo + ASA + ASA

Safety Outcome* - N (%) (n=7802) (n=7801) RR (95% CI) p value

GUSTO Severe Bleeding 130 (1.7) 104 (1.3) 1.25 (0.97, 1.61) 0.09

Fatal Bleeding 26 (0.3) 17 (0.2) 1.53 (0.83, 2.82) 0.17

Primary ICH 26 (0.3) 27 (0.3) 0.96 (0.56, 1.65) 0.89

GUSTO Moderate Bleeding 164 (2.1) 101 (1.3) 1.62 (1.27, 2.10) <0.001

*Adjudicated outcomes by intention to treat analysisICH= Intracranial Hemorrhage

Bhatt DL, Fox KA, Hacke W, et al. NEJM 2006.

Population RR (95% CI) p

value

Qualifying CAD, CVD or PAD 0.88 (0.77, 0.998)

0.046(n=12,153)

Multiple Risk Factors 1.20 (0.91, 1.59)0.20 (n=3,284)

Overall Population* 0.93 (0.83, 1.05)0.22 (n=15,603)

Primary Efficacy Results (MI/Stroke/CV Death) by Pre-Specified Entry Category

0.6 0.8 1.41.2

Clopidogrel Better Placebo Better

1.60.4

* A statistical test for interaction showed marginally significant heterogeneity (p=0.045) in treatment response for these pre-specified subgroups of patients

Bhatt DL, Fox KA, Hacke W, et al. NEJM 2006.

Nordman AJ, et al. Hot Line Session. World Congress of Cardiology, September 3, 2006, Barcelona.

Incidence of Late Stent Thrombosis: > 1 Year

RR = 5.7

p = 0.049RR = 5.0

p = 0.02

p = 0.22

Per 1,000 pts

0

1

2

3

4

5

6

7

DES/BMS SES/BMS PES/BMSBavry, Kumbhani, Helton, Borek, Mood, Bhatt. AJM 2006.

0 0 0

Intracoronary Stenting and Antithrombotic Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Regimen: Rapid Early Action for Coronary

Treatment (ISAR-REACT 2) TrialTreatment (ISAR-REACT 2) Trial

Intracoronary Stenting and Antithrombotic Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Regimen: Rapid Early Action for Coronary

Treatment (ISAR-REACT 2) TrialTreatment (ISAR-REACT 2) Trial

Presented atPresented atThe American College of Cardiology The American College of Cardiology

Scientific Session 2006Scientific Session 2006

Presented by Dr. Adnan KastratiPresented by Dr. Adnan Kastrati

ISAR-REACT 2 TrialISAR-REACT 2 TrialISAR-REACT 2 TrialISAR-REACT 2 Trial

www. Clinical trial results.org

ISAR-REACT 2 Trial: Primary Composite ISAR-REACT 2 Trial: Primary Composite EndpointEndpoint

ISAR-REACT 2 Trial: Primary Composite ISAR-REACT 2 Trial: Primary Composite EndpointEndpoint

Presented at ACC 2006Presented at ACC 2006

• The primary The primary composite composite endpoint occurred endpoint occurred less frequently in less frequently in the abciximab the abciximab group compared to group compared to placebo (8.9% vs placebo (8.9% vs 11.9%; relative risk 11.9%; relative risk [RR] 0.75 p=0.03)[RR] 0.75 p=0.03)

8.9%

11.9%

0%

5%

10%

15%

Abciximab Placebo

8.9%

11.9%

0%

5%

10%

15%

Abciximab Placebo

Composite of death, MI, or urgent TVR due to Myocardial Ischemia within 30 days (%)

p=0.03

www. Clinical trial results.org

ISAR REACT 2: Benefit of IIb/IIIa in Tn+ Patients, even after ISAR REACT 2: Benefit of IIb/IIIa in Tn+ Patients, even after Pretreatment with Clopidogrel 600 mg Pretreatment with Clopidogrel 600 mg

Death,MI, or Urg TVR by Troponin (>0.03 µg/L)Death,MI, or Urg TVR by Troponin (>0.03 µg/L)

ISAR REACT 2: Benefit of IIb/IIIa in Tn+ Patients, even after ISAR REACT 2: Benefit of IIb/IIIa in Tn+ Patients, even after Pretreatment with Clopidogrel 600 mg Pretreatment with Clopidogrel 600 mg

Death,MI, or Urg TVR by Troponin (>0.03 µg/L)Death,MI, or Urg TVR by Troponin (>0.03 µg/L)

Adapted with permission from Kastrati A, et al. JAMA. 2006;295:1531-1538.

20

15

10

5

0

0 5 10 15 20 25 30Days After Randomization

Cu

mu

lati

ve R

ate

of

Pri

mar

y E

nd

Po

int,

%

Placebo GroupAbciximab Group

Troponin >0.03 µg/LLog-Rank P = .02

Troponin <0.03 µg/LLog-Rank P = .98

EEnonoxxaparin and aparin and TThrombolysis hrombolysis RReperfusion for eperfusion for AAcute cute Myocardial InfarMyocardial Infarctctionion

ExTRACT-ExTRACT-TIMI 25TIMI 25

ACC 2006ACC 2006

Atlanta, GAAtlanta, GA

Disclosure StatementDisclosure Statement: : Dr. Antman received research grant support via the Dr. Antman received research grant support via the Brigham and Women’s Hospital from sanofi-aventisBrigham and Women’s Hospital from sanofi-aventis

Primary End Point (ITT)Primary End Point (ITT)Death or Nonfatal MIDeath or Nonfatal MI

0

3

6

9

12

15

0 5 10 15 20 25 30

Pri

ma

ry E

nd

Po

int

(%)

Pri

ma

ry E

nd

Po

int

(%)

ENOX

UFH

Relative RiskRelative Risk0.83 (0.77 to 0.90)0.83 (0.77 to 0.90)

P<0.0001P<0.0001

Days Days

9.9%

12.0%

Lost to follow up = 3 Lost to follow up = 3

17% RRR

For Every 1000 Pts For Every 1000 Pts Treated with EnoxaparinTreated with Enoxaparin

-15

-7 -6

4

-20

-15

-10

-5

0

5

Eve

nts

/ 1

000

Pts

Eve

nts

/ 1

000

Pts

Nonfatal Nonfatal reMIreMI

UrgentUrgent Revasc. Revasc.

DeathDeath Nonfatal TIMI Nonfatal TIMI Major BleedMajor Bleed

(No increase in (No increase in nonfatal ICH)nonfatal ICH)

++

MICHELANGELO: MICHELANGELO: Organization to Assess Strategies Organization to Assess Strategies

in Ischemic Syndromes in Ischemic Syndromes (OASIS) 6 Trial(OASIS) 6 Trial

Disclosure

Funded by Organon, Sanofi-Aventis & GSK

Mehta & Yusuf have rec’d grants and honoraria from above companies plus

several others.

Primary Efficacy OutcomePrimary Efficacy OutcomeDeath/MI at 30 Days Death/MI at 30 Days

Days

Cum

ula

tive

Haz

ard

0.0

0.02

0.04

0.06

0.08

0.10

0.12

0 3 6 9 12 15 18 21 24 27 30

UFH/Placebo

Fondaparinux

HR 0.86 95% CI 0.77-0.96

P=0.008

OASIS-6 Trial: Primary EndpointDeath/MI

11.2%

14.0%

0%

2%

4%

6%

8%

10%

12%

14%

Fondaparinux Placebo

11.2%

14.0%

0%

2%

4%

6%

8%

10%

12%

14%

Fondaparinux Placebo

Reduction in Death/MI: Stratum I(No UFH indicated)

P<.05

Reduction in Death/MI: Stratum II(UFH Indicated)

P=NS

The reduction in the primary endpoint at 30 days in the fondaparinux group was driven by Stratum 1, where death/MI occurred less frequently among

fonda. pts than placebo (11.2 vs 14%; HR 0.79, P<.05).

p=0.97p=0.97

8.3% 8.7%

0%

2%

4%

6%

8%

10%

12%

14%

Fondaparinux UFH

8.3% 8.7%

0%

2%

4%

6%

8%

10%

12%

14%

Fondaparinux UFH

There was no difference in Stratum 2, comparing those patients who received fondaparinux vs those who received UFH (8.3% vs 8.7%; HR 0.96, P=NS).

The OASIS-6 Trial Group. JAMA. 2006;295:E1-E12.

The Assessment of the Safety and Efficacy of The Assessment of the Safety and Efficacy of a New Treatment Strategy for Acute a New Treatment Strategy for Acute

Myocardial Infarction (ASSENT-4 PCI) TrialMyocardial Infarction (ASSENT-4 PCI) Trial

The Assessment of the Safety and Efficacy of The Assessment of the Safety and Efficacy of a New Treatment Strategy for Acute a New Treatment Strategy for Acute

Myocardial Infarction (ASSENT-4 PCI) TrialMyocardial Infarction (ASSENT-4 PCI) Trial

ASSENT- 4 PCI TrialASSENT- 4 PCI TrialASSENT- 4 PCI TrialASSENT- 4 PCI Trial

Presented atPresented atThe European Society of CardiologyThe European Society of Cardiology

Hot Line Session 2005Hot Line Session 2005

Presented by Dr. Frans Van de WerfPresented by Dr. Frans Van de Werf

www. Clinical trial results.org

ASSENT- 4 PCI Trial: Mortality at 30 ASSENT- 4 PCI Trial: Mortality at 30 daysdays

ASSENT- 4 PCI Trial: Mortality at 30 ASSENT- 4 PCI Trial: Mortality at 30 daysdays

6.0%

3.8%

0%

2%

4%

6%

8%

TNK + PCI PCI alone

6.0%

3.8%

0%

2%

4%

6%

8%

TNK + PCI PCI alone

•The primary endpoint of mortality was higher in the TNK + PCI treatment group compared with the PCI alone group (6.0% vs 3.8%, p=0.04) at 30 days

Analysis of mortality at 30 days (%)p = 0.04

Presented at ESC 2005Presented at ESC 2005

n=50n=50 n=32n=32

www. Clinical trial results.org

ASSENT-4: In-Hospital Cardiac EventsASSENT-4: In-Hospital Cardiac EventsASSENT-4: In-Hospital Cardiac EventsASSENT-4: In-Hospital Cardiac Events

van de Werf F. Lancet 2006

EventTNK+PCI (%)

PCI Alone

(%) PDeath (30 day) 6.0 3.8 .04Re-MI 4.1 1.9 .01Abrupt vessel closure 1.9 0.1 <.001Repeat TVR 4.4 1.0 <.001Total stroke 1.81 0 <.001ICH 0.97 0 .004Ischemic stroke 0.60 0 .03

Thrombolysis immediately pre-PCIThrombolysis immediately pre-PCI

Gregg W. Stone MD

for the ACUITY Investigators

Gregg W. Stone MD

for the ACUITY Investigators

Prospective, Randomized Comparison of Heparin Plus IIb/IIIa Inhibition and

Bivalirudin With or Without IIb/IIIa Inhibition in Patients with Acute Coronary Syndromes

Prospective, Randomized Comparison of Heparin Plus IIb/IIIa Inhibition and

Bivalirudin With or Without IIb/IIIa Inhibition in Patients with Acute Coronary Syndromes

11.7%11.8% 1.01 (0.90-1.12)<0.001

0.93

0 1 2

Risk ratio±95% CI

Risk ratio±95% CI

Primaryendpoint

Primary Endpoint Measures (ITT)Primary Endpoint Measures (ITT)UFH/Enoxaparin + GPI vs. Bivalirudin + GPIUFH/Enoxaparin + GPI vs. Bivalirudin + GPI

Net clinical outcome

Ischemic composite

Major bleeding

Bivalirudin + IIb/IIIa betterBivalirudin + IIb/IIIa better UFH/Enox + IIb/IIIa betterUFH/Enox + IIb/IIIa better

Bival+ IIb/IIIa

UFH/Enox+ IIb/IIIa

RR (95% CI)p value

(non inferior)(superior)

7.3%7.7% 1.07 (0.92-1.23)0.0150.39

5.7%5.3% 0.93 (0.78-1.10)<0.001

0.38

Upp

er b

oun

dary

non

-infe

riorit

y

0 1 2

Primary Endpoint Measures (ITT)Primary Endpoint Measures (ITT)

Bivalirudin alone betterBivalirudin alone better UFH/Enox + IIb/IIIa betterUFH/Enox + IIb/IIIa better

Risk ratio±95% CI

Risk ratio±95% CI

Primaryendpoint

Bivalalone

UFH/Enox+ IIb/IIIa

RR (95% CI)

Net clinical outcome

Ischemic composite

Major bleeding

Upp

er b

oun

dary

non

-infe

riorit

y

11.7%10.1% 0.86 (0.77-0.97)<0.0010.015

7.3%7.8% 1.08 (0.93-1.24)0.020.32

5.7%3.0% 0.53 (0.43-0.65)<0.001<0.001

p value(non inferior)

(superior)

UFH/Enoxaparin + GPI vs. Bivalirudin AloneUFH/Enoxaparin + GPI vs. Bivalirudin Alone

11.7%11.7% 1.00 (0.89-1.11)<0.001

0.93

0 1 2

Risk ratio±95% CI

Risk ratio±95% CI

Primaryendpoint

Primary Endpoint Measures (ITT)Primary Endpoint Measures (ITT)

Net clinical outcome

Ischemic composite

Major bleeding

Upstream IIb/IIIa

DeferredIIb/IIIa

RR (95% CI)p value

(non inferior)(superior)

7.9%7.1% 1.12 (0.97-1.29)0.060.13

4.9%6.1% 0.80 (0.67-0.95)<0.001

0.01

Upp

er b

oun

dary

non

-infe

riorit

y

Routine Upstream IIb/IIIa vs. Deferred PCI IIb/IIIaRoutine Upstream IIb/IIIa vs. Deferred PCI IIb/IIIa

Deferred PCI GPI betterDeferred PCI GPI better Routine Upstream GPI betterRoutine Upstream GPI better

DREAMDiabetes REduction Assessment with ramipril and rosiglitazone Medication

Cum

ula

tive

Ha

zard

0.0

0.1

0.2

0.3

0.4

0.5

0.6

0 1 2 3 4

Primary Outcome Rosiglitazone

2634 2470 2150 1148 1772635 2538 2414 1310 217

No. at RiskPlacebo Rosiglitazone

DREAM

Primary Outcome: Rosiglitazone

HR = 0.40 (0.35-0.46); P<0.0001

Year

Rosiglitazone

Placebo

Placebo 2634 2470 2150 1148 177

Rosiglita 2635 2538 2414 1310 217

DREAM

Cum

ula

tive

Ha

zard

0.0

0.1

0.2

0.3

0.4

0.5

0.6

0 1 2 3 4

Primary Outcome Ramipril

2646 2510 2277 1240 2002623 2498 2287 1218 194

No. at RiskPlaceboRamipril

Placebo 2646 2510 2277 1240 200

Ramipril 2623 2498 2287 1218 194

Primary Outcome: RamiprilDREAM

Ramipril

Placebo

Year

HR 0.91 (CI 0.81-1.03); P=0.15

Multinational Etoricoxib and Diclofenac Arthritis

Long-term (MEDAL) Study Program

Christopher P. Cannon, MD, Sean P. Curtis, MD, Amarjot Kaur, PhD, Loren Laine, MD, for the MEDAL Steering Committee

Cardiovascular Outcomes Following Long-term Treatment with Etoricoxib vs Diclofenac in Patients with Osteoarthritis and Rheumatoid Arthritis

Etoricoxib (320 events)

Diclofenac (323 events)

Primary Endpoint: Cumulative Incidence of Thrombotic CV EventsPrimary Endpoint: Cumulative Incidence of Thrombotic CV Events

MonthsNo. of patients at risk*

EtoricoxibDiclofenac

16,81916,483

13,359 10,733 8277 6427 4024 80581538326213790110,14212,800

7.0

6.0

5.0

4.0

3.0

2.0

1.0

06 12 18 24 30 36 420

Cu

mu

lati

ve in

cid

ence

(%

) w

ith

95%

CI

Etoricoxib vs diclofenacHR = 0.95 95% CI = (0.81-1.11)

*Per protocol population.

Cumulative Incidence of Confirmed Upper GI Events (Perforations, Ulcers, and Bleeds)*Cumulative Incidence of Confirmed Upper GI Events (Perforations, Ulcers, and Bleeds)*

POBs†

MonthsNo. of patients at risk

EtoricoxibDiclofenac

1741217289

13704 10972 8400 6509 4063 8218203867630680271039613190

3.0

2.5

2.0

1.5

1.0

0.5

06 12 18 24 30 36 420

Cu

mu

lati

ve in

cid

ence

(%

) w

ith

95%

CI

Etoricoxib vs diclofenacHR = 0.69 95% CI = (0.57-0.83)

*ITT (14 days) population. 50.6% of patients were on gastroprotective agents.

Etoricoxib (176 events)

Diclofenac (246 events)

†No significant difference in perforations, obstructions, or major bleeds.

ASTEROIDASTEROIDASTEROIDASTEROIDThe Effect of Very High-Intensity Statin TherapyThe Effect of Very High-Intensity Statin Therapy

on Regression of Coronary Atherosclerosison Regression of Coronary AtherosclerosisThe Effect of Very High-Intensity Statin TherapyThe Effect of Very High-Intensity Statin Therapy

on Regression of Coronary Atherosclerosison Regression of Coronary Atherosclerosis

Steven E. Nissen MDSteven E. Nissen MD

Disclosure

Consulting: AstraZeneca, Abbott, Atherogenics, Bayer, Lipid Sciences, Wyeth, Novartis, Pfizer, Sankyo, Haptogard, Hoffman-LaRoche, Kemia, Takeda, Kowa, Sanofi-Aventis, Protevia, Novo-Nordisk, Eli Lilly, Kos, GlaxoSmithKline, Forbes Medi-tech, Vasogenix,Vascular Biogenics, Isis Pharma, Viron Therapeutics, Roche, and Merck–Schering Plough

Lectures: AstraZeneca and Pfizer

Clinical Trials: AstraZeneca, Eli Lilly, Takeda, Sankyo, Sanofi-Aventis, Pfizer, Atherogenics, and Lipid Sciences.

Companies are directed to pay any honoraria directly to charity. No personal reimbursement is accepted for directing or participating in clinical trials.

ASTEROID: Percent Atheroma VolumeASTEROID: Percent Atheroma VolumeASTEROID: Percent Atheroma VolumeASTEROID: Percent Atheroma Volume

0

20

40

60

80

-7 -6 -5 -4 -3 -2 -1 0 1 2 3 4 5

Numberof

Patients

Regression63.6%

Progression36.4%

Change in Percent Atheroma Volume (%)

Recent Coronary IVUS Progression TrialsRecent Coronary IVUS Progression TrialsRecent Coronary IVUS Progression TrialsRecent Coronary IVUS Progression Trials

-1.2

-0.6

0

0.6

1.2

1.8

50 60 70 80 90 100 110 120

MedianChange

In PercentAtheromaVolume

(%)

Mean Low-Density Lipoprotein Cholesterol (mg/dL)

REVERSALpravastatin

REVERSALatorvastatin

CAMELOTplacebo

A-Plusplacebo

ACTIVATEplacebo

Relationship between LDL-C and Progression Rate

ASTEROIDrosuvastatin

r2= 0.95p<0.001

Clinical Trial Results . orgClinical Trial Results . org

ILLUMINATE: Torcetrapib Trial HaltedILLUMINATE: Torcetrapib Trial Halted

ILLUMINATEILLUMINATE trial, a randomized, double-blind trial, a randomized, double-blind evaluation of the effect of torcetrapib/atorvastatin vs evaluation of the effect of torcetrapib/atorvastatin vs atorvastatin alone on the occurrence of major cardiovascular atorvastatin alone on the occurrence of major cardiovascular events in 15 000 subjects with coronary heart disease or risk events in 15 000 subjects with coronary heart disease or risk equivalents.equivalents.

The Data Safety Monitoring Board (DSMB) The Data Safety Monitoring Board (DSMB) recommended the trial be halted due to an "imbalance of recommended the trial be halted due to an "imbalance of mortality and cardiovascular events." Overall, 82 patients mortality and cardiovascular events." Overall, 82 patients taking the combination of torcetrapib and atorvastatin died, taking the combination of torcetrapib and atorvastatin died, compared with 51 patient deaths in the atorvastatin-alone compared with 51 patient deaths in the atorvastatin-alone arm. arm.

C. Michael Gibson, MS, MDAssociate Professor of Medicine

Harvard Medical SchoolChief of Clinical Research

Cardiology DivisionBeth Israel Deaconess Medical Center

Boston, MA

Preview of ACC CTR agendaPreview of ACC CTR agenda

Saturday, March 24, 2007  

4:00-6:30 p.m. ClinicalTrialResults.org Overview

Michael Gibson, MS, MD, Christopher Cannon, MD & Jeffrey J. Popma, MD

Sunday, March 25, 2007  

9:00-9:30 a.m. New Approaches to Chronic Anticoagulation: Factor XA Inhibition Michael Gibson, MS, MD

9:30-10:00 a.m.Transitioning Between Antithrombins in the Cath Lab:

from REPLACE-II and ACUITY Michael Gibson, MS, MD

10:00-10:45 a.m. ACUITY: Long Term Results & SPIRIT III Gregg Stone, MD

12:00-12:30 p.m. Are all Xa Inhibitors the Same? Graham Turpie, MD

12:30-1:00 p.m. Pay For Performance: What Does it Mean, What will be its Impact in CV Care Jim Hoekstra, MD

1:00-1:30 p.m. FUSION II Clyde Yancy, MD

1:30-2:00 p.m. EVEREST Marvin Konstam, MD

2:00-2:30 p.m. Drug Eluting StentsMichael Gibson, MS, MD &

Sanjay Kaul, MD

2:30-3:00 p.m. Pretreatment with Thienopyridines Michael Gibson, MS, MD

3:00-3:30 p.m. Pharmacotherapy for High Risk PCI Michael Gibson, MS, MD

3:30-4:00 p.m. ECLIPSE Solomon Aronson, MD

4:00-4:30 p.m. ARMYDA-ACS Giuseppe Patti, MD

4:30-5:00 p.m. STARR Eva M. Lonn, MD

  Monday, March 26, 2007  

9:00-9:30 a.m. LDL or HDL: Which is More Important? Christopher Cannon, MD

9:30-10:00 a.m. Cardiovascular Risk with COX-IIs--MEDAL Program Christopher Cannon, MD

10:00-10:30 a.m FUSION II Clyde Yancy, MD

10:30 - 11:00 a.m Use of Vasoactive Agents in HF and NAPAClyde Yancy, MD & Mark

Russo, MS, MD

11:00-11:30 a.m AntiPlatelet Therapy in ACS and PCI Stephen Wiviott, MD

11:30-12:00 p.m. TRIP Paul Gurbel, MD

1:00-1:30 p.m. Appropriate Use of Lytics: Adherence to the Guidelines Frank Peacock, MD

1:30-2:00 p.m.Targeting Hemoglobin and the Use of Erythropoietin and Transfusion in Cardiac

Patients Peter McCullough, MD

2:15-2:45 p.m.Incorporating Patient Risk into Decisions Regarding the Optimal Reperfusion

Strategy for ST Elevation MI Duane Pinto, MD

4:00-4:30 p.m. Critical Review of Recent Lipid Studies Christopher Cannon, MD

4:30-5:00 p.m. Cardiovascular Risk with COX-IIs--MEDAL Program Christopher Cannon, MD

  Tuesday, March 27, 2007  

9:00-9:30 a.m. Effect of Aspirin Dose on Platelet Reactivity in Diabetic Patients Paul Gurbel, MD

9:30-10:00 a.m. What Have We Learned from the CRUSADE Registry? Eric Peterson, MD, MPH

10:30-11:00 a.m Potential Utility of rNAPC2 in ACS. Robert Giugliano, MD

11:00-11:30 a.mEfficacy and Safety of Fondaparinux in Elderly Patients With ST-Segment Elevation

Myocardial Infarction: Data From the OASIS 6 Trial Ron Peters, MD

11:30-12:00 p.m. TRIUMPH Judith Hochman, MD

12:00-12:30 p.m. RACE Chris Granger, MD

12:30-1:00 p.m. COURAGE William Boden, MD

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