Ajay J. Kirtane, MD, SM

Center for Interventional Vascular Therapy Columbia University Medical Center /

New York Presbyterian Hospital

Transradial vs. Transfemoral

Access in STEMI:

Should We Randomize?

Conflict of Interest Disclosure

• Ajay J. Kirtane

None

Off-label use will be discussed

Some Commonly Held Beliefs Regarding

Transradial PCI in STEMI Patients

• TRI for STEMI is

cutting-edge therapy

• Clearly bleeding

with TRI in STEMI

• Mortality with TRI

in STEMI

• Non-significant

differences in D2B

time with TRI in

STEMI

• No way I’d ever do a STEMI transradially!

• Not with

bivalirudin/VCD’s; definitional

• Unproven claim, alpha

error

• D2B times will be

longer with STEMI TRI

done by US operators

with less experience

Complications of PCI: Relative

Frequency of Bleeding

• Emergent CABG <0.3%

• Abrupt Closure/Acute ST <0.2%

• Arrhythmia <0.01%

• LST = 0.1% per year

• Bleeding Complications ~5%

from Baim and Grossman

–

-

Access and Non-Access Site

Bleeding after PCI 17,393 pts underwent PCI in REPLACE-2, ACUITY and HORIZONS

925 pts (5.3%) had TIMI major or minor bleeding within 30 days

357 (38.6%) 142

(15.4%)

145 (15.7%)

281 (30.4%)

Access site only (2.1%)

Indeterminate (1.6%)

Non access site (0.8%)

Access + non access site (0.8%)

568

(61.4%)

non access

site related

Source of bleeding (absolute rate)

Indeterminate most likely

intraprocedural (catheter

exchanges) or baseline anemia

with lower transfusion threshold

Verheugt FWA et al. JACC Int 2011;4;191 197

Prognostic Value of Access and Non-Access Site

Bleeding After PCI

Conclusion: Both access site and non-access site bleeding within 30 days of PCI heighten mortality at 1 year, but non-access events have greater prognostic impact.

Study retrospectively categorized bleeding events from 7 randomized

trials (n = 14,180 patients) between June 2000 and May 2011.

1-Year Mortality Adjusted HR 95% CI

No Bleeding 2.5% – –

Access Site 4.5% 1.72 1.19-2.47

Non-Access Site 10.0% 2.78 2.00-3.86

Non-access site bleeding tended to be more severe, with 74.4% of events

ranked ≥ BARC class 2 vs. 47.3% of access site bleeds (P < 0.001).

Ndrepepa G, et al. Circ Cardiovasc Interv.

2013;Epub ahead of print.

- - -

RIVAL MAJOR BLEEDING

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

0.7 0.5

1.9

2.8

0.9

0.5

2.8

Radial Femoral

P<0.001

% pts 4.5

Non CABG Non CABG Non CABG Blood

RIVAL TIMI definition ACUITY Transfusions

definition definition

RIFLE STEACS – results

30-day bleeding rate

p = 1.000

12.2%

6.8%

2.6% 5.4% 5.2%

p = 0.026

Bleedings Access site related Non access site related

femoral arm radial arm

7.8%

p = 0.002

RIFLE STEACS – results

30-day MACCE rate

Cardiac death Myocardial

Infarction

Target Lesion

Revascularization

Cerebrovascular

Accident

femoral arm radial armp = 0.020

p = 1.000 p = 0.604 p = 0.725

9.2%

5.2%

1.4% 1.2% 1.8% 1.2% 0.6% 0.8%

RIVAL: Operator Volumes and

Procedure Characteristics

Radial (n=3507)

Femoral (n=3514)

HR (95% CI) P

value

Operator Annual Volume

PCI/year (median, IQR)

Percent Radial PCI (median, IQR)

300 (190, 400)

40 (25,70)

300 (190, 400)

40 (25, 70)

PCI Success 95.4 95.2 1.01 (0.95-1.07) 0.83

Vascular closure devices used in 26% of femoral group

Jolly et al, Lancet 2011

Learning Curve in Transradial PCI

Case numbers Procedural

Success % Procedural

Success Procedure

duration (min) Fluoroscopy

time (min)

0-20 18/20 90% 48 ± 16 8.7 ± 6.0

20-100 75/80 94.7% 48 ± 19 6.5 ± 4.8

> 100 162/168 96.4% 38 ± 13 5.9 ± 5.0

Individual Operator Learning Curve

Hildick-Smith. CCI 2004; 61:60-68.

Non CABG major bleeding by actual access site used to complete

procedure (not intent to treat)*

*Post Hoc analysis

Can we Rival our

OUS Colleagues

here in the United

States?

Series1

Series4

Series2

TRA for PCI in France/Europe/USA

0

10

20

30

40

50

60

70

80

% T

R P

CI

France

Europe

USA

c/o T. LeFevre

US Transradial Access Update:

NCDR 2007-2012

Only 10.1% of sites used radial access in

>19.2% (90th percentile) of total PCIs performed

Feldman et al, Circulation 2013:127:2295-2306

Radial STEMI-PCI Update - NCDR

r-PCI increased from 0.9% in Q1, 2077

to 6.4% in Q3, 2011 (P < 0.0001)

JACC 2013;61:420-6

SCAI Survey:

Preferred Approach for STEMI PCI

83%

17%

Femoral

Radial

n = 359

Chiang and Kirtane, submitted

Other Unresolved questions in STEMI

Radial (Heparin or Bivalirudin)

vs.

Bivalirudin Femoral + closure device

Bleeding Reductions with Bivalirudin:

REPLACE-2, ACUITY, and HORIZONS

0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

8.0

9.0

10.0

4.1

2.4

Heparin + GP2b3a

Bivalirudin alone

REPLACE-2 0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

8.0

9.0

10.0 8.4

5.0

Heparin + GP2b3a

Bivalirudin alone

HORIZONS-AMI 0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

8.0

9.0

10.0

5.7

3.0

Heparin + GP2b3a

Bivalirudin alone

%

ACUITY

% %

P<0.001

P<0.001

P<0.001

-

Impact of Bleeding Avoidance Strategies NCDR CathPCI Registry 2004-2008: PCI in 1,522,935 pts

Manual compression alone, closure devices, bivalirudin, or both

were used in 35%, 24%, 23%, and 18% of pts, respectively.

Propensity-adjusted bleeding

2.7 2.5 1.9

1.0

0

2

4

6

8

All pts

Majo

r b

leed

ing

(%

)

Manual compression (n=508,455) Vascular closure devices (n=205,606)

Bivalirudin (n=172,471) Bivalirudin + VCD (n=130,378)

23%↓

Adj OR (95%CI) =

0.77 (0.73 – 0.80)

NNT = 148 Adj OR (95%CI) =

0.67 (0.63 – 0.70)

NNT = 118 Adj OR (95%CI) =

0.38 (0.35 – 0.42)

NNT = 70

33%↓ 62%↓

Marso SP et al. JAMA. 2010;303:2156 64

RIVAL Pharmacotherapy

Radial (n=3507)

%

Femoral (n=3514)

%

ASA 99.2 99.3

Clopidogrel 96.0 95.6

LMWH 51.5 51.8

UFH 33.3 31.6

Fondaparinux 10.9 10.8

Bivalirudin 2.2 3.1

GP IIb IIIa inhibitors 25.3 24.0

PCI 65.9 66.8

CABG 8.8 8.3

Access Site and Closure device:

HORIZONS-AMI

Access and closure %

Radial 5.9%

Femoral without VCD 66%

Femoral with VCD 27%

AngioSeal 58.3%

StarClose 32.4%

PerClose 8.7%

Other 0.6%

Highest Priority Short-Term

• Getting US operators trained in transradial

PCI

• Getting trained operators comfortable doing

TRI in STEMI cases Comfort issues

Staffing issues

Fear of the “unknown” vis-à-vis pay for

performance

• Expanding the clinical evidence base

Highest Priority Longer Term

• Expanding the clinical evidence base

• Ensuring high-quality PCI is performed in all

cases as TRI for STEMI continues to

develop Movement beyond D2B as the predominant

STEMI process metric

SCAI Survey:

Variation in Mechanics of STEMI PCI

19%

58%

23%

Start with a guiding catheter for the presumed culprit artery and perform PCI (generally prior to angiography of the non-culprit artery)

Start with a diagnostic catheter for the presumed NON-culprit artery, followed by guide catheter for angiography/PCI of the culprit artery

Start with full diagnostic catheterization (using diagnostic catheters) and then follow with a guide catheter used to treat the culprit artery

n = 361

Chiang and Kirtane, submitted

Summary

• The role of TRI in STEMI patients (in the US

particularly) is emerging, but is still in fact

somewhat controversial currently Trials have involved operators with more

experience than most US operators

Mortality reductions have been out of

proportion to the bleeding benefits

• Thus, it makes good clinical sense to pursue

study of TRI for STEMI Randomization is ESSENTIAL for an

unbiased assessment of this treatment!!