ACC.08/SCAI-ACCi2 ACC.08/SCAI-ACCi2

Clinical Trial Summary SlidesClinical Trial Summary Slides

ACCOMPLISH

• Systolic blood pressure ↓ by amlodipine/benazapril, compared with HCTZ/benazapril by 0.7 mm Hg (p < 0.05)

• Primary endpoint : CV mortality, stroke, MI, revascularization, unstable angina, resuscitation from death 9.2% in amlodipine/benazapril arm, compared with 11.4% in HCTZ/benazapril arm (p = 0.0002)

Trial design: Patients with hypertension were randomized to fixed dose amlodipine/benazapril or hydrochlorothiazide (HCTZ)/benazapril. Patients were followed for 3 years.

Results

Conclusions

HCTZ/benazapril(n = 5,721)

Amlodipine/benazapril(n = 5,741)

•Fixed dose combination of amlodipine/benazapril is better than HCTZ/benazapril in reduction in blood pressure as well as cardiovascular endpoints in patients with high-risk hypertension

0

8

12

4

Primary endpoint

11.4 9.2

%

(p = 0.0002)

Presented by Dr. Kenneth Jamerson at SCAI-ACC i2 Summit/ACC 2008

Adjusted Clopidogrel Loading Doses According to VASP Phosphorylation Index Decrease Rate of Major Adverse Cardiovascular Events in Patients

With Clopidogrel Resistance

• 86% of VASP-guided patients overcame resistance with 1-3 extra clopidogrel doses

• MACE: 0% for VASP-guided vs. 9.5% for control (p =0.007)

• Total bleeding: 3.9% vs. 4.8%, respectively (p = 1.0)

Trial design: Patients with clopidogrel resistance (VASP index >50%) randomized to VASP-guided extra clopidogrel dosing (n = 78) or PCI without add’l clopidogrel (n = 84).

Results

Conclusions

• Clopidogrel resistance was reversed with VASP-guided additional clopidogrel dosing

• Effective response to clopidogrel resulted in less MACE and similar bleeding

Bonello L, et al. J Am Coll Cardiol 2008;51: [Published online 29 March 2008]

0

4

8

12

MACE T otal bleeding

(p = 0.007) (p = 1.0)

VASP-guided extra

clopidogrel(n = 78)

No extra clopidogrel

(n = 84)

0 9.5

3.9 4.8%

MACE Total bleeding

A-F

• In-hospital MACE: 11.7% with FilterWire vs. 9.5% with standard PCI (p = ns)

• 30-day MACE: 12% vs. 11% (p = ns), respectively

• TIMI 3 flow post-PCI: 94% vs. 94% (p = ns), respectively

Trial design: NSTEMI patients were randomized to PCI plus FilterWire EZ embolic protection (n = 77) or standard PCI without embolic protection (n = 74).

Results

Conclusions

• FilterWire EZ embolic protection is not beneficial in NSTEMI

• PCI plus FilterWire results in similar in-hospital MACE, 30-day MACE, and TIMI 3 flow post-PCI compared with standard PCI

Presented by Dr. Mark Webster at SCAI-ACC i2 Summit/ACC 2008

(p = ns) (p = ns)

PCI plus embolic

protection

Standard PCI

In-hospital MACE

TIMI 3 flow post-PCI

%

11.7 9.5

94 94

ALLAY

• Change in LV mass index 4.9 ± 1, 4.8 ± 1, and 5.8 ± 0.9 with aliskiren, losartan, and combination, respectively (all p < 0.0001 compared with baseline)

• Aliskiren was noninferior to losartan (p < 0.0001), but combination not superior to losartan alone (p = 0.52)

• Incidence of serious side effects was similar (p = 0.77)

Trial design: Overweight hypertensive patients with evidence of left ventricular (LV) hypertrophy were randomized to aliskiren, losartan, or the combination. Patients were followed for 36 weeks to assess the change in LV mass index on cardiac MRI.

Results

Conclusions

Aliskiren(n = 154)

Losartan(n = 152)

•Aliskiren was noninferior to losartan in reducing LV mass index, but the combination was not superior to losartan alone

•Clinical outcomes studies are awaited

0

4

6

2

Primary endpoint

4.9 4.8

g/m

2

(p < 0.0001*)

(p = 0.52**)

Presented by Dr. Scott Solomon at SCAI-ACC i2 Summit/ACC 2008

5.8

Combination(n = 154)

* Aliskiren vs. losartan for noninferiority

** Combination vs. losartan

ARMYDA-RELOAD

• Approximately one-third had unstable angina

• MACE in entire study: 7% in reload group vs. 9% in placebo group (p = 0.70)

• MACE in ACS patients: 7% vs. 18% respectively, (p = 0.035)

• No major bleeds in either group

Trial design: Patients on chronic clopidogrel therapy (>10 days) undergoing PCI were randomized to an additional 600 mg clopidogrel dose (n = 285) or placebo (n = 283) and followed for 30 days.

Results

Conclusions

• Among unselected patients on chronic clopidogrel, no benefit with reloading

• Clopidogrel reloading may be of benefit in unstable patients

• Favorable bleeding profile with reloading

(p = 0.70) (p = 0.035)

Presented by Dr. Germano Di Sciascio at SCAI-ACC i2 Summit/ACC 2008

Clopidogrel reload

No reload

MACE in entire study

population

MACE in ACS patients

%

7 9

7 18

ASTRAL

• Baseline creatinine, 2.02 mg/dl; glomerular filtration rate, 40 ml/min; mean stenosis, 76%; anti-hypertensive medications, 2.8 per patient

• 93% of revascularized patients received a stent

• At follow-up, no difference in creatinine, blood pressure, time to first renal event, or mortality (p = ns for all outcomes)

Trial design: Patients with significant renal artery stenosis were randomized to angioplasty and/or stenting plus medical therapy (n = 403) or medical therapy alone (n = 403) and followed for 27 months.

Results

Conclusions

• Renal artery revascularization is not superior to medical therapy alone

• Renal artery stenting does not reduce creatinine, blood pressure, time to first renal event, adverse cardiac events, or mortality

(p = ns) (p = ns)

Presented by Dr. Philip Kalra at SCAI-ACC i2 Summit/ACC 2008

Renal stenting

Medical therapy

%

Cardiovascular mortality

Hospitalization for fluid overload or

heart failure

7.4 8.212 14

ATHEROMA

• Significant reduction from baseline in USPIO-defined signal intensity was observed in 80 mg group at 6 and 12 weeks; no difference was observed in low-dose arm at 6 and 12 weeks

• Mean signal difference at 12 weeks between the two groups was 0.24 (p < 0.0001)

Trial design: Patients with carotid stenosis >40% and who demonstrated intraplaque accumulation of ultra small super-paramagnetic iron oxide (USPIO) on MRI at baseline were randomized to either 10 mg or 80 mg atorvastatin daily for 12 weeks.

Results

Presented by Dr. Tjun Tang at SCAI-ACC i2 Summit/ACC 2008

Atorvastatin 10 mg(n = 20)

Atorvastatin 80 mg(n = 20)

•Aggressive lipid-lowering therapy with 80 mg of atorvastatin daily is associated with significant reduction in USPIO-defined inflammation in carotid plaques

•USPIO-defined inflammation represents a novel imaging biomarker

0.20 0.038

Un

its

0

0.3

0.5

0.4

Signal intensity at 12 weeks

(p < 0.0001)

Conclusions0.2

0.1

BRAVE 3

• Mean final infarct size: 15.7% vs. 16.5% in the abciximab and control groups (p = 0.47)

• Death, MI, stroke or urgent revascularization: 5.0% vs. 3.8% in the abciximab and control groups (p = 0.39)

Trial design: Patients with STEMI undergoing PCI were randomized to either abciximab or unfractionated heparin (UFH), after pretreatment with 600 mg of clopidogrel. LV infarct size was evaluated at 5-7 days.

Results

Conclusions

Presented by Dr. Julinda Mehilli at SCAI-ACC i2 Summit/ACC 2008

(p = 0.47)

Abciximab(n = 401)

Placebo(n = 399)

Final infarct size

•No difference in infarct size or clinical outcomes with abciximab in patients with STEMI undergoing PCI following pretreatment with 600 mg of clopidogrel

10

12

14

16

18

20

%

15.7 16.5

ECLIPSE

• 50% interventional procedures; 89% device success

• Time to hemostasis: 4.4 min for closure device and 20.1 min for manual pressure (p < 0.0001)

• Hematoma >6 cm: 1.9% vs. 0.7% (p = 0.67), respectively

Trial design: Patients with diagnostic and interventional coronary/peripheral procedures were randomized to the ExoSeal closure device (n = 267) or manual pressure (n = 134).

Results

Conclusions

• The ExoSeal closure device reduces time to hemostasis compared with manual pressure

• No adverse events in either group

• Nonsignificant increase in large hematomas with ExoSeal closure device

Presented by Dr. Shing-Chiu Wong at SCAI-ACC i2 Summit/ACC 2008

(p < 0.0001) (p = 0.67)

Time to hemostasis

Closure device

Manual pressure

Large (>6 cm) hematoma

min %

4.4 20.1 1.9 0.7

ENHANCE

• Mean carotid IMT 0.0058 ± 0.0037 mm in the simvastatin arm vs. 0.0111 ± 0.0038 mm in the ezetimibe/simvastatin arm (p = 0.29)

• Mean LDL levels 192.7 mg/dl (39% ↓) in simvastatin arm, 141.3 mg/dl in the ezetimibe/simvastatin arm (56% ↓) (p < 0.01)

Trial design: Patients with heterozygous familial hypercholesterolemia were randomized to treatment with ezetimibe/simvastatin 10/80 mg or simvastatin 80 mg alone. Mean change in intima-media thickness (IMT) was measured in the carotid arteries over 2 years.

Results

Conclusions• No additional benefit in carotid IMT reduction at

2 years with ezetimibe/simvastatin compared with high-dose simvastatin alone

• LDL lowering greater with ezetimibe/simvastatin

• Clinical outcomes and adverse events similar

Kastelein JJ, et al. N Engl J Med 2008;358:1431-43

(p < 0.01)

Ezetimibe/ Simvastatin

(n = 357)

Simvastatin(n = 363)

(p = 0.20)

50

100

150

200

141

193

mg

/dl

0

LDL cholesterol New plaque formation

%

0

1

2

4

4.7

2.83

5

GENESIS

• In-stent late loss: 1.40 ± 0.67 mm, 0.96 ± 0.73 mm, and 0.58 ± 0.58 mm in CORIO, SYMBIO, and CoStar arms, respectively

• 6-month MACE: 39.0% vs. 14.4% vs. 2.0% for CORIO, SYMBIO, and CoStar arms

Trial design: In this single-blinded study, patients were randomized 2:2:1 to CORIO (pimecrolimus-eluting), SYMBIO (pimecrolimus- and paclitaxel-eluting), or CoStar (paclitaxel-eluting) control arm.

Results

Conclusions

Presented by Dr. Stefan Verheye at SCAI-ACC i2 Summit/ACC 2008

CORIO(n = 100)

SYMBIO(n = 101)

•First trial to successfully demonstrate dual drug delivery in patients with CAD undergoing PCI

•Pimecrolimus ± paclitaxel is associated with higher incidence of in-stent restenosis and MACE compared with paclitaxel alone

39.8 20.4

%

0

40

10

In-stent restenosis

20

30

7.1

CoStar(n = 49)

HAT

• All-cause mortality: 6.4% for AED and CPR vs. 6.5% for CPR alone (p = 0.77)

• 37.6% of deaths were due to tachyarrhythmia, with remainder due to heart failure or noncardiac causes

• Only 8 patients in each group were resuscitated at home

Trial design: Intermediate-risk patients after an anterior myocardial infarction were randomized to automated external defibrillator (AED) and cardiopulmonary resuscitation (CPR) (n = 3,495) versus CPR alone (n = 3,506) and followed for 37 months.

Results

Conclusions

• AED and CPR are not superior to CPR alone in intermediate-risk patients after an MI

• Relatively few deaths in this population are due to tachyarrhythmia

Bardy GH, et al. N Engl J Med 2008;358:1793-804.

(p = 0.77)

0

4

8

All-cause mortality

%

All-cause mortality

AED and CPR

CPR alone

6.4 6.5

HORIZON-HF

• Systolic blood pressure: ↑ 10 mm Hg with 1.5 mcg/kg/min Istaroxime and ↑ 0.6 mm Hg with placebo (p < 0.001)

• Cardiac index: +0.3 L/min/m2 vs. -0.01 L/min/m2 (p = 0.04), respectively

• LV end-diastolic volume: -14.1 ml vs. +3.9 ml (p = 0.02), respectively

Trial design: Decompensated heart failure patients were randomized to Istaroxime, an inotropic and lusitropic agent (n = 29 for 0.5 mcg/kg/min; n = 30 for 1.0 mcg/kg/min; n = 30 for 1.5 mcg/kg/min) or placebo (n = 31).

Results

Conclusions

• In this dose-finding study, Istaroxime 1.5 mcg/kg/min may be beneficial in improving hemodynamics and diastolic function in patients with decompensated heart failure

Presented by Dr. Mihai Gheorghiade at the SCAI-ACC i2 Summit/ACC 2008

(p = 0.04) (p = 0.02)

Cardiac index Left ventricular end-diastolic

volume

Istaroxime, 1.5 mcg/kg/min

Placebo

L/m

in/m

2

ml

-14.1 +3.9+0.3 -0.01

HYVET

• Trial was terminated early

• Stroke ↓ 30% (p = 0.06), mortality ↓ 21% (p = 0.02), heart failure ↓ 64% (p < 0.001) in indapamide arm compared with placebo

• Number needed to treat at 2 years: 94 for stroke, 40 for mortality

Trial design: Hypertensive geriatric (age >80 years) patients were randomized to indapamide SR 1.5 mg or to placebo. Clinical outcomes were evaluated at 2 years.

Results

Conclusions

Presented by Dr. Nigel Beckett at SCAI-ACC i2 Summit/ACC 2008

(p = 0.06)

Indapamide(n = 1,933)

Placebo(n = 1,912)

Strokes

•Significant mortality benefit with treatment of BP >160 mm Hg in patients older than 80 years

•Newer guidelines will need to consider this group of patients specifically

0

1

5

%

2.6 3.6 10.1 12.3

%

0

5

15

10

Mortality

(p = 0.02)

2

3

4

ISAR-REACT 3

• Primary endpoint: death, MI, urgent target vessel revascularization, or in-hospital major bleeding was similar between the bivalirudin (8.3%) and UFH (8.7%) arms (p = 0.57)

• Bleeding significantly ↓ with bivalirudin compared with UFH: major (33%), minor (31%)

Trial design: Troponin-negative patients undergoing PCI were randomized to either bivalirudin or unfractionated heparin (UFH), after pretreatment with 600 mg of clopidogrel. Clinical outcomes were evaluated at 30 days.

Results

Conclusions

• Bivalirudin is not superior to UFH as adjunct anticoagulation therapy for troponin-negative patients undergoing PCI, who were pretreated with 600 mg of clopidogrel

• Bleeding was significantly reduced with bivalirudin compared with UFH

Presented by Dr. Adnan Kastrati at SCAI-ACC i2 Summit/ACC 2008

(p = 0.57)

Bivalirudin(n = 2,289)

UFH(n = 2,281)

(p = 0.008)

Composite endpoint Major bleeding

%

0

1

2

4

3.1 4.6

3

5

1

9

6

0

2345

78

10 8.3 8.7

%

MEND-CABG II

• Median aortic cross-clamp time of 1.0 hour, internal mammary artery graft used in 90%

• Death or nonfatal MI: 9.3% in MC-1 group and 9.0% in control (p = 0.76)

• All-cause mortality: 1.0% vs. 0.3% at 4 days (p = 0.03) and 1.9% vs. 1.5% at 30 days (p = 0.44), respectively

Trial design: Intermediate-risk patients undergoing CABG were randomized to MC-1 (n = 1,519) or placebo (n = 1,504) and followed for 30 days after surgery.

Results

Conclusions

• In intermediate-risk patients undergoing CABG, MC-1 is not superior to placebo

• MC-1 does not reduce death or MI at 30 days

• MC-1 increased 4-day mortality; however, no difference at 30 days

Alexander JH, et al. JAMA 2008;299:1777-87

(p = 0.03) (p = 0.44)

MC-1 Placebo

4-day mortality 30-day mortality

%

1 0.3

1.9 1.5

MOMENTUM

• Cardiac index: increased to more than 2.4 L/min/m2 (p < 0.0001) with the device

• Death or heart failure hospitalization at 65 days: similar between the two groups (p = ns)

• Major bleeding: 16.5% vs. 5.1% (p = 0.05), respectively

Trial design: Patients with refractory heart failure symptoms were randomized to the Orqis continuous aortic flow augmentation device for 4 days (superimposing low-level continuous flow on pulsatile flow) (n = 109) or continued medical management (n = 59).

Results

Conclusions

• Continuous aortic flow augmentation for 4 days increases cardiac index, although death or heart failure hospitalization is similar

• Major and minor bleeding are increased with the device

Presented by Dr. Barry Greenberg at SCAI-ACC i2 Summit/ACC 2008

(p = 0.005) (p = 0.005)

Continuous aortic flow

augmentation

Medical management

Major bleeding Minor bleeding

%

16.5 5.1 26.6 8.5

ONTARGET

• Telmisartan (16.7%) noninferior; combination (16.3%) not superior to ramipril (16.5%) for primary endpoint (CV death, MI, stroke, heart failure)

• Greater incidence of hypotension in combination (4.8%) and telmisartan (2.7%) groups, compared with ramipril group (1.7%) (p < 0.001)

Trial design: Patients at high risk for cardiovascular events, but without heart failure, were randomized to telmisartan, ramipril, or the combination. Patients were followed for a median of 56 months.

Results

Conclusions

The ONTARGET investigators. N Engl J Med 2008;358:1547-59

Telmisartan(n = 8,542)

Combination(n = 8,502)

•Either telmisartan or ramipril, but not both, can be used in hypertensive patients at high risk for cardiovascular events

•Side effects greater with combination therapy

16.7 16.3

%

0

10

Primary endpoint

20

Ramipril(n = 8,576)

16.5

0

10

15

5

Mortality

11.6 12.5 11.8

%

(p < 0.004*) (p = ns)

* Telmisartan vs. ramipril for noninferiority

ON-TIME 2

• Mean transportation distance: 25 km

• >3 mm ST-elevation post-PCI: 36.6% with tirofiban and 44.3% with placebo (p = 0.026)

• Mortality: 2.3% vs. 4.0% (p = 0.14), respectively

• Major bleeding: 4.0% vs. 2.9% (p = 0.36), respectively

Trial design: STEMI patients who presented to a non-PCI center were randomized to tirofiban prior to transfer for primary PCI (n = 491) or placebo with provisional tirofiban in the catheterization laboratory (n = 493) and followed for 30 days.

Results

Conclusions• In STEMI patients, tirofiban prior to transfer

for PCI is beneficial

• Upstream tirofiban reduces ST-elevation post-PCI and nonsignificantly decreases mortality

• Potential for increased bleeding with upstream tirofiban

Presented by Dr. Christian Hamm at SCAI-ACC i2 Summit/ACC 2008

(p = 0.026) (p = 0.14)

Upstream tirofiban

Provisional tirofiban

>3 mm ST-elevation post-PCI

Mortality

%

36.6 44.3

2.8 4.0

1

PERISCOPE

• Least square mean change in % atheroma volume from baseline ↑ 0.73% in the glimepiride arm while it ↓ 0.16% in the pioglitazone arm (p = 0.002)

• Composite endpoint: CV death, nonfatal MI, or stroke was similar between the glimepiride (2.2%) and pioglitazone (1.9%) arms (p = 0.78).

• CRP, triglycerides ↓, HDL ↑ with pioglitazone

Trial design: Patients with CAD and diabetes were randomized to receive either glimepiride or pioglitazone. Baseline and 18-month IVUS measurements were performed.

Results

Nissen S, et al. JAMA 2008;299:1561-73

glimepiride(n = 273)

•Pioglitazone is better than glimepiride in reducing the progression of CAD in diabetic patients, in the background of optimal medical therapy

•Pioglitazone has a favorable impact on biochemical parameters, with increased side effects

0.73 -0.16

% c

han

ge

in a

ther

om

a v

olu

me

0

0.8

(p = 0.002)

Conclusions

Pioglitazone(n = 270)

0.2

0.4

0.6

-0.2

Primary endpoint CV mortality

%

0.4

0.8

1.2

0

(p = 0.37)

0.36 1.1

PROTECT Pilot

• Fewer patients with rolofylline 30 mg experienced >0.3 mg/dl increase in serum creatinine compared with placebo (p < 0.05)

• Death or rehospitalization for heart failure: 19% with rolofylline 30 mg and 33% for placebo (p = ns)

• No seizures in either group

Trial design: Decompensated heart failure patients were randomized to rolofylline, an adenosine A1 receptor antagonist (30 mg, n = 74; 20 mg, n = 75; 10 mg, n = 74), or

placebo (n = 78).

Results

Conclusions

• Acute decompensated heart failure patients: less renal dysfunction with rolofylline 30 mg

• Possible reduction in death or rehospitalization for heart failure with rolofylline

Presented by Dr. Barry Massie at the SCAI-ACC i2 Summit/ACC 2008

(p = ns)

%

19 33

Death or rehospitalization for heart failure

Rolofylline Placebo

REVERSE

• Patients worsened: 16% with CRT vs. 21% with optimal medical therapy (p = 0.1)

• LV end-systolic volume index: decreased 18.4 ml/m2 vs. 1.3 ml/m2 (p < 0.0001), respectively

• Risk of heart failure hospitalization reduced with CRT (p = 0.03)

Trial design: Patients with LV dysfunction (NYHA class I-II) and wide QRS were randomized to cardiac resynchronization therapy (CRT) (n = 419) or optimal medical therapy (n = 191).

Results

Conclusions

• CRT for mild heart failure does not reduce the percentage of patients that clinically worsen

• CRT improves LV end-systolic volume index and reduces the risk of hospitalization compared with optimal medical therapy

(p = 0.1)

Presented Dr. Cecilia Linde at SCAI-ACC i2 Summit/ACC 2008

16 21%

Percentage worsened

CRT Medical therapy

SEISMIC

• In treatment group, 8.3 years since MI and 31% ejection fraction

• Percentage with serious adverse event: 50% in myoblast group and 36% in control (p = ns)

• Change in ejection fraction: ↑ 0.3% vs. ↓ 0.1% (p = ns), respectively

Trial design: Patients with myocardial scar were randomized to autologous skeletal myoblast cells (n = 31) or medical therapy (n = 16) and followed for 6 months.

Results

Conclusions

• In this small study, implantation of autologous skeletal myoblast cells after MI is feasible

• No apparent excess in serious adverse events

• Potential small increase in ejection fraction with myoblast cells at 6 months follow-up

p = ns p = ns

Presented by Dr. Patrick Serruys at SCAI-ACC i2 Summit/ACC 2008

Autologous skeletal

myoblast cells

Medical therapy

Serious adverse events

Change in ejection fraction

%%

50 36 +0.3 -0.1

1

SPIRIT II

• In-stent late loss 0.11 mm (everolimus) and 0.36 mm (paclitaxel) at 6 months (p < 0.001). Similar at 2 years (0.33 mm vs. 0.34 mm, p = 0.61)

• MACE at 2 years: 6.6% vs. 11.0% (p = 0.31)

• Stent thrombosis at 2 years: 0.9% vs. 1.4% (p = ns)

Trial design: This was a randomized study designed to evaluate the safety and efficacy of the XIENCE V everolimus-eluting stent compared with the TAXUS paclitaxel-eluting stent among patients with de novo coronary lesions.

Results

XIENCE V(n = 223)

•Benefit in in-stent late lumen loss was seen with everolimus compared with paclitaxel at 6 months, but not seen at 2 years

•Clinical outcomes were similar to paclitaxel-eluting stents at 2 years

•Long-term data on stent performance necessary

0.33 0.34

mm

0

0.4

(p = 0.61)

Conclusions

TAXUS(n = 77)

0.1

0.2

0.3

In-stent late loss Stent thrombosis

%

0.4

0.8

1.2

0

(p = ns)

0.36 1.1

Presented by Dr. Patrick Serruys at SCAI-ACC i2 Summit/ACC.08

0.5

1.6

STRADIVARIUS

• Percent atheroma volume: +0.25% for rimonabant vs. +0.51% for placebo (p = 0.22)

• Psychiatric symptoms: 43% vs. 28% (p < 0.001), respectively

• Gastrointestinal track symptoms: 34% vs. 18% (p < 0.001), respectively

Trial design: Obese patients with metabolic syndrome were randomized to the cannabinoid type 1 receptor inhibitor rimonabant 20 mg daily (n = 422) or placebo (n = 417) and underwent IVUS examination after 18 months of treatment.

Results

Conclusions

• Rimonabant is not superior to placebo in reducing percent atheroma volume in obese patients with metabolic syndrome

• Rimonabant results in more psychiatric and gastrointestinal track symptoms compared with placebo

Nissen SE, et al. JAMA 2008;299:1547-60

(p = 0.22) (p < 0.001)

0.25 0.51 43 28

Percent atheroma volume

Psychiatric symptoms

Rimonabant Placebo

% %

TAPAS

• Good myocardial blush: 46% with aspiration and 32% with standard PCI (p < 0.001)

• ST-segment resolution: 57% and 44%, respectively (p < 0.001)

• Death: 2.1% and 4.0%, respectively (p = 0.07)

Trial design: Patients with STEMI were randomized to thrombus aspiration prior to PCI (n = 535) or standard PCI without aspiration (n = 536).

Results

Conclusions

• In STEMI, thrombus aspiration prior to PCI is superior to standard PCI without aspiration

• Thrombus aspiration improves myocardial blush and ST-segment resolution

• Thrombus aspiration may improve adverse events including survival

Svilaas T, et al. N Engl J Med 2008;358:557-67

Thrombus aspiration and PCI (n = 535)

PCI alone(n = 536)

%32

46

2.1 4

Good myocardial blush

Mortality

0

30

60

(p < 0.001) (p = 0.07)

TRANSFER-AMI

• Primary endpoint: death, MI, heart failure, severe recurrent ischemia, or shock 10.5% in pharmacoinvasive arm vs. 16.5% in standard treatment arm (p = 0.0013)

• Reinfarction: 3.3% vs. 6.0% (p = 0.044)

• Recurrent ischemia: 0.2% vs. 2.2% (p = 0.02)

Trial design: Patients with STEMI who presented to centers where timely primary PCI was not feasible were randomized to a pharmacoinvasive strategy (emergent transfer for PCI within 6 hours of fibrinolysis) or to standard treatment after fibrinolysis.

Results

Conclusions

Presented by Dr. Warren Cantor at SCAI-ACC i2 Summit/ACC.08

(p = 0.0013)

Pharmacoinvasive arm

(n = 522)

Standard therapy(n = 508)

Primary endpoint

•Pharmacoinvasive approach safe and efficacious compared with treatment with thrombolytics and transfer for rescue PCI only

•Optimal window: 6 hours

0

10

20

% 10.5

16.53.7 3.6

%

0

1

5

2

3

4

Mortality

(p = 0.94)

VICTORY

• Years since CABG: 3.9 in rosiglitazone group and 3.7 in placebo group

• Saphenous vein graft plaque volume: +0.9% vs. +2.8% (p = 0.22), respectively

• Mortality: no deaths in either group

• MI: 0 vs. 1, respectively

Trial design: Type 2 diabetic patients with prior CABG were randomized to rosiglitazone (n = 98) or placebo (n = 95) after baseline coronary angiography and IVUS.

Results

Conclusions

• Rosiglitazone does not change saphenous vein graft plaque volume in type 2 diabetic patients after CABG

• The incidence of mortality and MI is similar between rosiglitazone and placebo

Presented by Dr. Olivier Bertrand at SCAI-ACC i2 Summit/ACC 2008

(p = 0.22)

Rosiglitazone Placebo

%

Change in saphenous vein graft plaque volume

0.9 2.8

VISION 302

• Binodenoson was noninferior to adenosine. The mean paired summed difference scores difference of binodenoson vs. adenosine images was -0.09 (95% CI -0.44 to 0.27)

• 2nd or 3rd degree AV block was 0% with binodenoson and 3% with adenosine (p = 0.004)

Trial design: Patients with known or suspected CAD undergoing a pharmacologic stress test with SPECT imaging were stratified and randomized to binodenoson or adenosine for the determination of the magnitude of ischemia.

Results

Presented by Dr. James Udelson at SCAI-ACC i2 Summit/ACC 2008

(p = 0.004)

Binodenoson(n = 402)

Adenosine(n = 404)

2nd or 3rd degree AV block

•Binodenoson (selective A2A receptor agonist) is as effective as adenosine (nonselective agonist) as agent for detection of ischemia in pharmacologic stress tests in suspected/known CAD patients

•Side effects are fewer and less intense with binodenoson compared with adenosine

0

1

%

0 3 30 50

%

0

30

50

40

Flushing

(p < 0.05)

2

3

Conclusions

20

10