IMPACT OF RECOMMENDATIONS OF GUIDELINES IN

PATIENTS WITH ATRIAL FIBRILLATION SUBMITTED

CORONARY STENTING

María Mutuberria, Antonia Sambola, Eduard Bosch, Bruno García del Blanco, F. Alfonso, A.

Cequier, Hector Bueno, O. Rodriguez, Jose Antonio Barrabés, Pilar Tornos, Nadia Llavero, David

Garcia Dorado.

Àrea del Cor. Hospital Universitario Vall d´Hebrón. Barcelona. Spain.

INTRODUCTION:

Atrial fibrillation (AF) is the most common

sustained cardiac arrhythmia.

-Increasing with age.

It is a major contributor to stroke and thromboembolism.

Guidelines consider specific stroke scores:

AHA 2011: CHADS2.

ESC 2010: CHA2DS2VASc.

Arch Intern Med 1995;155:469–73

RISK

SCORES

CHADS2 Risk Score

CHF 1

Hypertension 1

Age > 75 1

Diabetes 1

Stroke or TIA 2

CHADS2

score

Patients

(n = 1733)

Adjusted stroke

rate %/year

0 120 1.9

1 463 2.8

2 523 4.0

3 337 5.9

4 220 8.5

5 65 12.5

6 5 18.2

JAMA 2001; 285:2864-70

Adjusted stroke data:

CHA2DS2VASc Risk Score

CHF or LVEF < 40% 1

Hypertension 1

Age > 75 2

Diabetes 1

Stroke/TIA/ T-E. 2

Vascular Disease 1

Age 65 - 74 1

Female 1

CHA2DS2VASc

score

Patients

(n = 7329)

Adjusted stroke

rate (%/year)

0 1 0

1 422 1.3

2 1230 2.2

3 1730 3.2

4 1718 4.0

5 1159 6.7

6 679 9.8

7 294 9.6

8 82 6.7

9 14 15.2

Stroke. 2010; 41(12): 2731-8.

Adjusted stroke data:

Recommended management according to

CHADS2:

≥ 2 OAC. INR target: 2.5 (2.0-

3.0).

1 OAC > ASA.

0 No antithrombotic therapy

>ASA.

Recommended management: according to

CHA2DS2VASc:

≥ 2 OAC. INR target: 2.5 (2.0-

3.0).

1 consider OAC.

0 No antithrombotic therapy.

A particularly challenging situation…

Patients with AF presenting with an ACS/undergoing PCI-S.

Antithrombotic therapy in AF and ACS/PCI-S:

PCI-S: Percutaneous Coronary Intervention and Stent implantation.

- No prospective randomized trials have been reported addressing this issue.

- The optimal treatment for these patients according to different levels of

thromboembolic risk is nowadays undefined.

- Current guidelines recommendations are based on consensus documents,

retrospective studies and expert´s opinion.

OBJECTIVE:

The purpose of this study was to assess the impact of triple

therapy (TT) in rates of thromboembolism and bleeding in

patients with non-valvular AF submitted to stenting, regarding

the use of CHADS2 and CHA2DS2VASc scores.

METHODS:

- Retrospective multicenter study, from 2007 to 2011.

- Population: patients with non-valvular AF undergoing PCI-S.

- Exclusion criteria: life expectancy < 3 months, impossibility of follow-up.

Recorded data during admission:

- Patients clinical characteristics

- CHADS2 score

- CHA2DS2VASc score

- PCI details (at attending interventional cardiologist discretion).

- Antithrombotic therapy at discharge (at attending clinician discretion).

After discharge… check medication and complications.

Follow-up: 1 year Recorded events:

METHODS-2: - Major bleeding:

- Hb drop ≥ 4 g/dl, requiring transfusion of ≥2 IU of blood or corrective

surgery.

- Cerebral haemorrhage or retroperitoneal haemorrhage.

- Cardiovascular events: CV death, acute myocardial infarction, target vessel

failure, stroke/peripheral thromboembolism, or stent thrombosis.

Safety:

Major bleedings

Secondary end points:

MAE:

- MACE

- Thromboembolism

- Major Bleeding

Efficacy:

Thromboembolism/stroke

MACE:

- Death

- Acute Myocardial Infarction

- Target vessel failure (TVF)

Primary end points:

ITT

489 patients with non-

valvular AF + PCI-S.

RESULTS:

TT N=307; 62.8%

DAPT N=182; 37.2%

p value

Age, y 76.0 ± 7.2 72.8 ± 7.7 0.016

Sex (Female) 25.8% 24.2% 0.585

CHADS2 ≥ 2 64.8 % 35.2% 0.17

CHA2DS2VASc ≥ 2 64.3% 35.2% 0.25

p=0.02

p=0.45

p=0.37

p=0.09

p=0.15

p=0.44

p=0.08

CHADS2 ≥ 2 59.3%

CHA2DS2VASc ≥ 2 74.6%

RESULTS-2:

PRIMARY END-POINTS:

p=0.01

SAFETY: EFFICACY: p=0.07

SECONDARY

END-POINTS:

p=0.008

p=0.07

p=0.24

ADVERSE EVENTS ACCORDING TO CHADS2 SCORE:

CHADS2 < 2: CHADS2 ≥ 2:

p=0.16

p=0.19

p=0.15

p=0.60

p=0.36

p=0.22

p=0.11

172 patients 304 patients

p=0.019

p=0.09 p=0.023

p=0.57

p=0.34

p=0.12

p=0.35

ADVERSE EVENTS ACCORDING TO CHA2DS2VASc SCORE:

CHA2DS2VASc < 2: CHA2DS2VASc ≥ 2: 144 patients 326 patients

p=0.09

p=0.036

p=0.62

p=0.054

p=0.04

p=0.054

p=0.08

p=0.14

p=0.08

p=0.002

p=0.72

p=0.56

p=0.27

p=0.23

p=0.39

MORTALITY: 44 patients (9.2%) died during follow up.

3 of them had low stroke risk

(CHADS2: 1).

RESULTS-5:

Bleeding events

Thromboembolic events

Sudden death

Cardiogenic shock/HF

Others

13 (29.2%)

6 (13.6%)

6 (13.4%)

18 (41%)

1 (2.3%)

Bleeding events

Hemorrhagic stroke

Gastrointestinal bleeding

Tamponade

CABG

Traumatic brain injury

13 (29.2%)

5 (11.3%)

2 (4.5%)

1 (2.3%)

2 (4.5%)

3 (6.8%)

Thromboembolic events

ACS

Stent thrombosis

Ischemic stroke

6 (13.6%)

1 (2.3%)

2 (4.5%)

3 (6.8%)

4 of them had high stroke risk

(CHADS2: ≥ 2).

OR p value

Age

HTA

DM

Renal failure

CHADS2

Previous stroke

DES

Triple therapy (TT)

1.03 (95% CI 0.96-1.1)

2.17 (95% CI 0.37-12.4)

0.98 (95% CI 0.33-2.89)

1.48 (95% CI 0.98-2.22)

1.86 (95% CI 0.93-1.77)

5.7 (95% CI 1.0-34)

0.35 (95% CI 0.13-0.96)

0.35 (95% CI 0.12-0.98)

0.42

0.38

0.97

0.06

0.076

0.05

0.03

0.05

RESULTS-6:

Multivariate analysis:

CONCLUSIONS:

In real life, in patients with non-valvular AF undergoing PCI-S, the

decision of treatment with DAPT or TT is not always influenced by

CHADS2 or CHA2DS2VASc.

TT is underused in patients with high thromboembolic risk, which

results in an increased rate of stroke.

TT in patients with low thromboembolic risk shows a tendency

towards more bleeding events without apparent potential benefit

comparing DAPT.

Our results illustrate how, in real clinical practice, the

adherence to guidelines for anticoagulation have benefitial

effects on the outcomes in patients with atrial fibrillation,

stressing the importance of the routinary implementation of

guidelines.

CONCLUSION:

Efficacy and safety of DAPT compared with TT.

MUSICA-2 STUDY.

Patients in AF with low-moderate thromboembolic risk

(CHADS2≤2) submitted to PCI-S

Sample size: 304 patients

Design: multicentric, randomized, open-label

OAC

ASA 100 mg/day

Clopidogrel 75 mg/day

BMS 6 weeks

DES 6 months

Randomization

ASA 300 mg/day

Clopidogrel 75 mg/day

Primary outcome: cardiovascular events.

Secondary outcome: major bleedings.

THANK YOU FOR YOUR ATTENTION

OAC + Clopidogrel:

39 patients.

68,3% presenting with an ACS.

21 of them (52.5%) CHADS2 ≥ 2.

14.5% previous Stroke.

35.2% previous PCI.

31.9% previous AMI.

10% previous CABG.

During follow up:

Total death: 20.5%

Cardiovascular death: 17.9%

Thromboembolic events: 5%

Stroke: 7.6%

ACS: 5.2%.

Total bleedings: 15.4%

Major bleedings: 7.5%

MACE: 25.6%

MAE: 35.9%

RESULTS-2:

Percentage of DES in the

current event (%):

Indication of the catheterization

procedure (%):

Previous coronary

artery disease (%):

p=0.24 p=0.28

p=0.22

p=0.0001

p=0.15

p=0.22