Impact of recommendations of guidelines in patients with atrial fibrillation submitted coronary stenting

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

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

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  • 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 commonsustained cardiac arrhythmia.-Increasing with age. Arch Intern Med 1995;155:469–73It is a major contributor to stroke and thromboembolism. Guidelines consider specific stroke scores: AHA 2011: CHADS2. ESC 2010: CHA2DS2VASc.
  • 3. CHADS2 Risk Score CHA2DS2VASc Risk Score CHF or LVEF < 40% 1 CHF 1 RISK Hypertension 1 Hypertension 1 SCORES Age > 75 2 Age > 75 1 Diabetes 1 Diabetes 1 Stroke/TIA/ T-E. 2 Stroke or TIA 2 Vascular Disease 1 Age 65 - 74 1 Female 1 Adjusted stroke data: Adjusted stroke data: CHADS2 Patients Adjusted stroke score (n = 1733) rate %/year CHA2DS2VASc Patients Adjusted stroke score (n = 7329) rate (%/year)Recommended management according to 0 120 1.9 Recommended management: according to 0 1 0CHADS1: 2 CHA2DS2VASc: 1 422 1.3 463 2.8 ≥ 2  OAC. INR target: 2.5 (2.0- ≥22  OAC. INR target: 2.52.2 1230 (2.0- 2 523 4.03.0). 3.0). 3 1730 3.2 3 337 1  OAC > ASA. 5.9 14 consider1718 OAC. 4.0 0  No antithrombotic therapy 4 220 8.5 0  No antithrombotic therapy. 5 1159 6.7>ASA. 5 65 12.5 6 679 9.8 6 5 18.2 7 294 9.6 8 82 6.7 JAMA 2001; 285:2864-70 9 14 15.2 Stroke. 2010; 41(12): 2731-8.
  • 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 ofthromboembolic 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 tripletherapy (TT) in rates of thromboembolism and bleeding inpatients with non-valvular AF submitted to stenting, regardingthe 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% 0.585489 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
  • 9. RESULTS-2: PRIMARY END-POINTS: SECONDARY END-POINTS: EFFICACY: SAFETY: p=0.07 p=0.24 p=0.01 p=0.008 p=0.07
  • 10. ADVERSE EVENTS ACCORDING TO CHADS2 SCORE:CHADS2 < 2: 172 patients CHADS2 ≥ 2: 304 patients p=0.19 p=0.019 p=0.34 p=0.36 p=0.35 p=0.11 p=0.023 p=0.12p=0.16 p=0.09 p=0.15 p=0.22 p=0.57 p=0.60
  • 11. ADVERSE EVENTS ACCORDING TO CHA2DS2VASc SCORCHA2DS2VASc < 2: 144 patients CHA2DS2VASc ≥ 2: 326 patients p=0.036 p=0.27 p=0.04 p=0.08 p=0.56 p=0.054 p=0.08 p=0.054 p=0.39 p=0.002 p=0.09 p=0.14 p=0.23 p=0.62 p=0.72
  • 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, thedecision of treatment with DAPT or TT is not always influenced byCHADS2 or CHA2DS2VASc.TT is underused in patients with high thromboembolic risk, whichresults in an increased rate of stroke.TT in patients with low thromboembolic risk shows a tendencytowards more bleeding events without apparent potential benefitcomparing DAPT.
  • 15. CONCLUSION:Our results illustrate how, in real clinical practice, theadherence to guidelines for anticoagulation have benefitialeffects on the outcomes in patients with atrial fibrillation,stressing the importance of the routinary implementation ofguidelines.
  • 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.
  • 17. THANK YOU FOR YOUR ATTENTION
  • 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 theartery disease (%): procedure (%): current event (%): p=0.0001 p=0.28 p=0.24 p=0.22 p=0.22 p=0.15