"European Union Interest in Global Trials & Endpoints.“

TREAT Initiative Thinktank/incubator

Jean-Philippe Collet

JP. COLLET, DISCLOSURE: Research Grants (to the Institution) from Abbott Vascular, Bristol Myers Squibb,

Boston Scientific, Cordis, Eli-Lilly, Fédération Française de Cardiologie, Fondation de France, Guerbet Medical,

INSERM, Medtronic, Sanofi-Aventis Group, Société Française de Cardiologie; Consulting or Lecture Fees from

Zsra-Zeneca, Bayer, Bristol-Myers Squibb, Daichi-Sankyo, Eli-Lilly, Sanofi-Aventis Group, Servier

Background: a great variability of TRI and no data in women

Vascular access in ACUITY 450 centers in 17 countries

Radial (798) Femoral (11988)

Hamon et al. TCT 2006

Major bleeding:

3.0% radial vs. 4.8% femoral,

p=0.02

What works well? A constant improvement over time

Preliminary Results

Immediate vs Delayed Intervention for Acute Coronary Syndromes

IMMEDIATE DELAYED

Radial access (%) 87.4 81.8

Culprit artery

Left main trunk, (%) 4.1 7.3

Left anterior descending artery, (%) 48.6 45.0

Circumflex artery, (%) 24.7 29.1

Right coronary artery, (%) 24.7 25.2

Coronary bypass graft, (%) 2.1 2.0

Percutaneous Coronary Intervention, (%) 80.1 69.5

Stent (at least one), (% of PCI) 94.0 96.2

DES (at least one), (% of PCI) 47.9 55.2

Number of stents/patient, mean

sd 1.2

0.9 1.2

1.0

CABG surgery, (%) 11.0 11.3

JAMA. 2009;302(9):947-954

Women=1/3 and GPIIb/IIIa in 100%

Preliminary Results

Sites of Major Bleedings

1- Gastro-Intestinal 4

2- Puncture-related 4

3- Hemopericardium 2

4- Intracranial 1

5- Epistaxis 1

6- Hematoma (not puncture-related) 1

unknown 7

One patient had 2 bleeding events

n

JAMA. 2009;302(9):947-954

You may avoid puncture-related bleeding

Acute STEMI Treated with primary PCI and intravenous enoxaparin Or UFH to Lower ischemic and bleeding events at short- and Long-term

follow-up (Investigator-driven study)

UFH (n=460)

ENOXAPARIN (n=450)

Radial artery access, % (n) Other artery access, % (n)

66% (305) 34% (155)

69% (309) 31% (141)

Stent implanted (among PCI patients) , % (n)

Thrombectomy (among PCI patients) , % (n)

94% (366)

44% (173)

96% (364)

48% (184)

Glycoprotein IIb/IIIa before start of PCI,% (n) Abciximab

Eptifibatide

Tirofiban

77% (357) 64% (295)

11% (54)

2% (8)

71% (313) 62% (277)

8% (34)

0.4% (2)

Medications before/during hospitalization — % (n)

Aspirin

Clopidogrel < 300mg

> 300 and < 600mg

> 600 and < 900mg

> 900mg

Beta-blockers

ACE-inhibitors

Statins

94% (434)

93% (427)

37% (171)

37% (172)

25% (113)

1% (4)

84% (385)

72% (333)

83% (382)

96% (431)

94% (422)

37% (168)

39% (174)

22% (101)

2% (7)

88% (398)

75% (336)

87% (392)

All Safety Endpoints %

of p

atie

nts

P = NS for all

Protocole definitions

(STEEPLE)

2.4 2.72.92.3

0

2

4

6

8

10

12

14

Index Procedure by

Country Czech

N=507

Germany

N=500

Greece

N=558

Nordic

N=496

AusH

N=496

Benelux

N=484

PCI Procedure

With Stent 490 (96.6%) 482 (96.4%) 538 (96.4%) 480 (96.8%) 467 (94.2%) 467 (96.5%)

Without Stent 17 (3.4%) 18 (3.6%) 20 (3.6%) 16 (3.2%) 29 (5.8%) 17 (3.5%)

Type of Stent

BMS only 408 (83.3%) 327 (68.4%) 102 (19.0%) 305 (63.5%) 314 (67.4%) 307 (66.3%)

DES only 69 (14.1%) 139 (29.1%) 417 (77.5%) 154 (32.1%) 137 (29.4%) 145 (31.3%)

BMS & DES stents used 13 (2.7%) 12 (2.5%) 19 (3.5%) 21 (4.4%) 15 (3.2%) 11 (2.4%)

Access Site

Femoral 418 (82.4%) 488 (97.8%) 545 (97.7%) 315 (63.5%) 375 (75.6%) 408 (84.6%)

Radial 89 (17.6%) 11 (2.2%) 13 (2.3%) 181 (36.5%) 121 (24.4%) 74 (15.4%)

What is the priority?

−Identify reasons for non adoption

−Set up An European Radial Program

Radial vs. Femoral Access

Jolly et al. Am Heart J 2009

MAJOR BLEEDING DEATH / MI / STROKE

RIVIERA study

27%

11%

10%

52%

Europe

Africa

South America

Asia

7962 consecutive patients enrolled for elective or

primary PCI in 144 hospitals across 23 countries

Montalescot et al. Int J Cardiol. 2007

8% of primary PCI

Independent Predictors of Bleeding

Female gender

Radial access

IMAG + SG

Number of stents (ref=1)

0

2

> 2

GP IIb/IIIa inhibitor

Beta blocker

ACE or ARA2

Anticoagulation

Enoxaparin vs. UFH

Other vs. UFH

Lower risk Higher risk

0 1 2 3 4 5

OR (95% CI)

Montalescot et al. Int J Cardiol. 2007

Independent Predictors of Death or MI

Clinical presentation*

NSTE-ACS

STEMI ≤ 12 hours

STEMI > 12 hours

Radial access

LADCA

Number of stents (ref=1)

0

2

≥ 3

Thienopyridine before PCI

GP IIb/IIIa inhibitor

Nitrate

Antiarrhythmic drug

Anticoagulation

Enoxaparin vs. UFH

Other vs. UFH

0 1 5 10 15 20

OR (95% CI)

Montalescot et al. Int J Cardiol. 2007

Reasons for adoption of radial Patient preference (comfort)

Shortens hospitalization (day case PCI program)

“New” technical aspects of PCI, widely applicable

Literature shows improved outcomes

Cost = 0

Reasons for non-adoption of radial

Lack of teachers

Learning curve

Spasm (nitrates/calcium blockers)

Tortuosities (technical skills and tricks)

Occlusion (anticoagulation + 5/6F catheters)

Radial vs femoral in STEMI non-randomized

Similar procedural success

More dual access site required with radial

Similar procedure time

Contrast and radiation less with radial

Shorter length of stay with radial

Hetherington et al. Heart, 2009

Conclusions

A radial program starts with coronary angios, then elective PCI

When learning curve is finished, and radial used in more than 2/3 of scheduled cases, no reason not to perform radial primary PCI

The benefits seen in elective PCI are even more obvious in primary PCI

Femoral access limited to specific cases