Perkütan koroner girişim yapılmış gerçek yaşam hastalarında ikili antitrombosit tedavi kullanımının PRECISE-DAPT, DAPT skorlarına göre değerlendirilmesi ve bu skorların stent trombozu, ciddi kanama ile ilişkisi

Yıl 2020, Cilt: 13 Sayı: 1, 137 - 147, 21.01.2020

Evrim Şimşek , Yavuz Selim Kılıç Azem Akıllı

https://doi.org/10.31362/patd.646639

Öz

Amaç:
Perkütan koroner girişim (PKG) sonrası ikili
antitrombosit tedavi (İATT) süresinin belirlenmesinde PRECISE-DAPT ve DAPT
skorlarının kullanılmasını önerilmektedir. Bu risk skorlarını gerçek yaşam
validasyonu ise bulunmamaktadır. Günlük pratikte PKG sonrası İATT alan
hastaların tedavi sürelerinin risk skorlarına göre değerlendirilmesi, stent
trombozu ve ciddi kanama ile bu risk skorlarının ilişkisini araştırılması
amaçlanmıştır.

Gereç
ve Yöntem: Ocak-Mayıs 2019
tarihleri arasında çalışma merkezine başvuran en az 1 yıl önce PKG yapılmış
hastalar incelenmiştir. Hastaların kullandıkları İATT süreleri, takip süresi
içinde gelişen stent trombozu ve ciddi kanama ( BARC³3) olayları sorgulanmış ve gruplar arasında
PRECISE-DAPT ile DAPT skorları karşılaştırılmıştır.

Bulgular:
Çalışmaya 366 hasta dahil edilmiştir. Ortalama takip
süresi 17,57±4,8 aydır. Hastaların ortalama yaşı 61±11 ve %54,4’ü kadındı. Hastaların %81,4’ü akut
koroner sendrom (AKS) tanısına sahipti. Stent trombozu olan 20(%5,5) hasta
saptanmıştır. Ciddi kanama 17(%4,6) hastada izlenmiştir. Stent trombozu
olaylarının %70(14)’i 1. yılın sonunda gelişmiştir. Bu hastaların 12’si yüksek
DAPT, düşük PRECISE-DAPT skoruna sahipken sadece 2’si İATT alırken; 10’u tek
asetilsalisilik asit almaktaydı. Ciddi kanama hastaların %4,6 (17)’sında gelişmiştir.
Hastalardan 15’i yüksek PRECISE-DAPT skoruna sahipti ve 10’u 6 aydan uzun İATT
alırken kanama gerçekleşmiştir. Kanama gelişen hastaların ortalama PRECISE-DAPT
skoru anlamlı olarak daha yüksekti. (40,59±14,7’e karşı 23,80±20       p<0,001) Tromboz gelişen hastalarda
da DAPT skoru anlamlı olarak daha yüksekti. (3,10±1,25’e karşı 1,81±1,27 p<0,001)

Sonuç:
PRECISE-DAPT ve DAPT skorları PKG uygulanmış İATT
altındaki gerçek yaşam hastalarında da sırasıyla artmış kanama ve stent
trombozu ile ilişkilidir. Günlük pratikte hastalarda İATT süresi belirlenirken
mevcut skorların kullanılması hastaların gereksiz uzun ya da kısa İATT almasını
ve kötü sonlanımları önleyebilir.

Anahtar Kelimeler

İkili antitrombosit tedavisi, risk skorları, kanama, stent trombozu

Evaluation of the use of dual antiplatelet therapy according to PRECISE-DAPT and DAPT scores in real-life patients undergoing percutaneous coronary intervention and their relationship with stent thrombosis and severe bleeding

Öz

Purpose: PRECISE-DAPT and DAPT scores are recommended to
determine the duration of dual antiplatelet therapy (DAPT) after percutaneous
coronary intervention (PCI). There is no real-life validation of these risk
scores. The aim of this study was to evaluate the duration of treatment
according to risk scores and to investigate the relationship between stent
thrombosis, severe hemorrhage and these risk scores.

Materials and Methods: Patients who had undergone
PCI at least 1 year ago and admitted to study hospital were evaluated for the
study. DAPT duration, stent thrombosis, severe hemorrhage (BARC³3) events were investigated
and PRECISE-DAPT, DAPT scores were compared between the groups.

Results: Three hundred and sixty-six patients were included
in the study. Mean follow-up was 17.57±4.8 months, mean age was 61±11 and 54.4% of the patients were female. 81.4% of the patients had acute
coronary syndrome. 5.5% (20) of them had stent thrombosis. 14 of the stent
thrombosis occurred 1 year after PCI. Even 12 of these patients had high DAPT
and low PRECISE-DAPT scores, only 2 received DAPT; 10 of them were taking only
acetylsalicylic acid. 4.6% (17) of the patients had severe bleeding
and 15 of them had a high PRECISE-DAPT score and 10 of them had bleeding while
receiving DAPT for more than 6 months. The mean PRECISE-DAPT score of the patients with bleeding was
significantly higher. (40.59±14.7 vs. 23.80±20 p<0.001) DAPT score was
also significantly higher in patients with thrombosis. (3.10±1.25 vs. 1.81±1.27 p<0.001)

Conclusion: PRECISE-DAPT and DAPT
scores are associated with increased bleeding and stent thrombosis also in
real-life patients, respectively.
During clinical practice, the use of current scores for DAPT duration may prevent
unnecessary long or short treatment periods and this approach could prevent
poor outcomes.

Anahtar Kelimeler

Dual antiplatelet therapy, risk scores, bleeding, stent thrombosis

Kaynakça

• 1. Valgimigli, M., et al., 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). European Heart Journal, 2017. 39(3): p. 213-260.
• 2. Amin, A.P., et al., Nuisance bleeding with prolonged dual antiplatelet therapy after acute myocardial infarction and its impact on health status. J Am Coll Cardiol, 2013. 61(21): p. 2130-8.
• 3. Genereux, P., et al., Incidence, Predictors, and Impact of Post-Discharge Bleeding After Percutaneous Coronary Intervention. J Am Coll Cardiol, 2015. 66(9): p. 1036-45.
• 4. Costa, F., et al., Derivation and validation of the predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy (PRECISE-DAPT) score: a pooled analysis of individual-patient datasets from clinical trials. Lancet, 2017. 389(10073): p. 1025-1034.
• 5. Capodanno, D. and D.J. Angiolillo, Tailoring duration of DAPT with risk scores. Lancet, 2017. 389(10073): p. 987-989.
• 6. Howard, C.E., et al., Extended Duration of Dual-Antiplatelet Therapy After Percutaneous Coronary Intervention: How Long Is Too Long? J Am Heart Assoc, 2019. 8(20): p. e012639.
• 7. Hahn, J.Y., et al., Effect of P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy on Cardiovascular Events in Patients Undergoing Percutaneous Coronary Intervention: The SMART-CHOICE Randomized Clinical Trial. Jama, 2019. 321(24): p. 2428-2437.
• 8. Mauri, L., et al., Twelve or 30 Months of Dual Antiplatelet Therapy after Drug-Eluting Stents. New England Journal of Medicine, 2014. 371(23): p. 2155-2166.
• 9. Yeh, R.W., et al., Development and Validation of a Prediction Rule for Benefit and Harm of Dual Antiplatelet Therapy Beyond 1 Year After Percutaneous Coronary Intervention. JAMA, 2016. 315(16): p. 1735-1749.
• 10. group, D.s. DAPT risk calculator. [cited 2019; Available from: https://www.acc.org/tools-and-practice-support/mobile-resources/features/dapt-risk-calculator
• 11. group, P.-D.s. PRECISE-DAPT risk calculator. [cited 2019; Available from: http://www.precisedaptscore.com/predapt/webcalculator.html
• 12. Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials. Circulation, 2007. 115(17): p. 2344-2351.
• 13. Mehran, R., et al., Standardized Bleeding Definitions for Cardiovascular Clinical Trials. Circulation, 2011. 123(23): p. 2736-2747.
• 14. Helft, G., et al., Stopping or continuing clopidogrel 12 months after drug-eluting stent placement: the OPTIDUAL randomized trial. Eur Heart J, 2016. 37(4): p. 365-74.
• 15. Watanabe, H., et al., Effect of 1-Month Dual Antiplatelet Therapy Followed by Clopidogrel vs 12-Month Dual Antiplatelet Therapy on Cardiovascular and Bleeding Events in Patients Receiving PCI: The STOPDAPT-2 Randomized Clinical Trial. Jama, 2019. 321(24): p. 2414-2427.
• 16. Lee, C.W., et al., Optimal duration of dual antiplatelet therapy after drug-eluting stent implantation: a randomized, controlled trial. Circulation, 2014. 129(3): p. 304-12.
• 17. Bonaca, M.P., et al., Long-Term Use of Ticagrelor in Patients with Prior Myocardial Infarction. New England Journal of Medicine, 2015. 372(19): p. 1791-1800.
• 18. Virmani, R., et al., Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation, 2004. 109(6): p. 701-5.
• 19. Sarno, G., et al., Lower risk of stent thrombosis and restenosis with unrestricted use of 'new-generation' drug-eluting stents: a report from the nationwide Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Eur Heart J, 2012. 33(5): p. 606-13.
• 20. Subherwal, S., et al., Baseline risk of major bleeding in non-ST-segment-elevation myocardial infarction: the CRUSADE (Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA Guidelines) Bleeding Score. Circulation, 2009. 119(14): p. 1873-82.
• 21. Flores-Rios, X., et al., Comparison of the performance of the CRUSADE, ACUITY-HORIZONS, and ACTION bleeding risk scores in STEMI undergoing primary PCI: insights from a cohort of 1391 patients. Eur Heart J Acute Cardiovasc Care, 2013. 2(1): p. 19-26.
• 22. Wallentin, L., et al., Ticagrelor versus Clopidogrel in Patients with Acute Coronary Syndromes. New England Journal of Medicine, 2009. 361(11): p. 1045-1057.
• 23. Neumann, F.-J., et al., 2018 ESC/EACTS Guidelines on myocardial revascularization. European Heart Journal, 2018. 40(2): p. 87-165