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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