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MIR's presentation of Maria Mutuberria at the 6th VHIR Scientific Session. Watch the video after the last slide.
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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