This study assessed the impact of guidelines on anticoagulation therapy in patients with atrial fibrillation (AF) who underwent coronary stenting. The study reviewed 489 AF patients who received percutaneous coronary intervention and stenting (PCI-S). Adherence to CHADS2 and CHA2DS2VASc score guidelines for anticoagulation was variable in clinical practice. Triple therapy (TT) of oral anticoagulation, aspirin, and clopidogrel was underused in high-risk patients, resulting in higher stroke rates. TT in low-risk patients showed a trend toward more bleeding without clear benefit over dual antiplatelet therapy (DAPT). Adherence to guidelines was
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Impact of recommendations of guidelines in patients with atrial fibrillation submitted coronary stenting
1. 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.
2. INTRODUCTION:
Atrial fibrillation (AF) is the most common
sustained cardiac arrhythmia.
-Increasing with age.
Arch Intern Med 1995;155:469–73
It is a major contributor to stroke and thromboembolism.
Guidelines consider specific stroke scores:
AHA 2011: CHADS2.
ESC 2010: CHA2DS2VASc.
4. A particularly challenging situation…
Patients with AF presenting with an ACS/undergoing PCI-S.
PCI-S: Percutaneous Coronary Intervention and Stent implantation.
Antithrombotic therapy in AF and ACS/PCI-S:
- 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.
5. 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.
6. 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.
7. 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.
Follow-up: 1 year Recorded events:
Primary end points: Secondary end points:
Efficacy: Safety:
Thromboembolism/stroke Major bleedings MAE:
MACE: - MACE
- Death - Thromboembolism
- Acute Myocardial Infarction - Major Bleeding
- Target vessel failure (TVF)
ITT
8. RESULTS: CHADS2 ≥ 2 59.3%
CHA2DS2VASc ≥ 2 74.6%
TT DAPT
N=307; 62.8% 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
489 patients with non-
CHADS2 ≥ 2 64.8 % 35.2% 0.17
valvular AF + PCI-S.
CHA2DS2VASc ≥ 2 64.3% 35.2% 0.25
p=0.08 p=0.37 p=0.02
p=0.09 p=0.44 p=0.45
p=0.15
12. RESULTS-5:
MORTALITY: 44 patients (9.2%) died during follow up.
Bleeding events 13 (29.2%)
Thromboembolic events 6 (13.6%)
Sudden death 6 (13.4%)
Cardiogenic shock/HF 18 (41%)
Others 1 (2.3%)
Bleeding events 13 (29.2%)
Hemorrhagic stroke 5 (11.3%) Thromboembolic events 6 (13.6%)
Gastrointestinal bleeding 2 (4.5%) ACS 1 (2.3%)
Tamponade 1 (2.3%) Stent thrombosis 2 (4.5%)
CABG 2 (4.5%) Ischemic stroke 3 (6.8%)
Traumatic brain injury 3 (6.8%)
4 of them had high stroke risk
3 of them had low stroke risk
(CHADS2: ≥ 2).
(CHADS2: 1).
13. RESULTS-6:
Multivariate analysis:
OR p value
Age 1.03 (95% CI 0.96-1.1) 0.42
HTA 2.17 (95% CI 0.37-12.4) 0.38
DM 0.98 (95% CI 0.33-2.89) 0.97
Renal failure 1.48 (95% CI 0.98-2.22) 0.06
CHADS2 1.86 (95% CI 0.93-1.77) 0.076
Previous stroke 5.7 (95% CI 1.0-34) 0.05
DES 0.35 (95% CI 0.13-0.96) 0.03
Triple therapy (TT) 0.35 (95% CI 0.12-0.98) 0.05
14. 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.
15. CONCLUSION:
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.
16. 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
Randomization
BMS 6 weeks
DES 6 months
OAC
ASA 300 mg/day
ASA 100 mg/day
Clopidogrel 75 mg/day
Clopidogrel 75 mg/day
Primary outcome: cardiovascular events.
Secondary outcome: major bleedings.
18. OAC + Clopidogrel:
During follow up:
39 patients.
Total death: 20.5%
68,3% presenting with an ACS.
Cardiovascular death: 17.9%
21 of them (52.5%) CHADS2 ≥ 2. Thromboembolic events: 5%
14.5% previous Stroke. Stroke: 7.6%
35.2% previous PCI. ACS: 5.2%.
31.9% previous AMI. Total bleedings: 15.4%
10% previous CABG. Major bleedings: 7.5%
MACE: 25.6%
MAE: 35.9%
19. RESULTS-2:
Previous coronary Indication of the catheterization Percentage of DES in the
artery disease (%): procedure (%): current event (%):
p=0.0001 p=0.28 p=0.24
p=0.22
p=0.22
p=0.15