SYTEMATIC REVIEW OF THE SAFETY AND EFFICACY OF PRASUGREL IN PATIENTS WITH ACUTE CORONARY SYNDROME
Main Article Content
Abstract
Background: In the treatment of Acute Coronary Syndrome (ACS), Prasugrel is recommended, alongside aspirin, for adult patients undergoing percutaneous coronary intervention (PCI) to prevent thrombotic events. Objective: This study aims to conduct a systematic review of the efficacy and safety of Prasugrel in ACS. Method: A systematic review method was used to search for studies meeting the inclusion criteria for analysis. Results: A total of 17 studies on safety and 10 studies on efficacy were included in the review. The compiled research findings also indicate that Prasugrel is relatively safe, with follow-up durations in studies typically ranging from 12 months, with the shortest being 30 days and the longest 10 years. Prasugrel has good safety, with life-threatening bleeding ranging from 0.1% to 2.2% and intracranial hemorrhage from 0.16% to 0.3%. There is no statistically significant difference in bleeding risk being found when compared Prasugrel with Ticagrelor. In terms of efficacy, Prasugrel helps reduce major adverse cardiovascular events (MACE) from 1% to 11.1%, and cardiovascular mortality from 0.6% to 3%. Conclusion: The evidence suggests that Prasugrel reduces the risks of cardiovascular events and shows its clinical benefits when compared with other P2Y12 receptor inhibitors.
Article Details
Keywords
Prasugrel; Safety; Efficacy; Acute Coronary Syndrome (ACS)
References
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5. Segev A, Matetzky S, Danenberg H, et al. Contemporary use and outcome of percutaneous coronary interventions in patients with acute coronary syndromes: insights from the 2010 ACSIS and ACSIS-PCI surveys. doi:10.4244/EIJV8I4A73
6. Boer SPM de, Roos-Hesselink JW, Leeuwen MAH van, et al. Excess mortality in women compared to men after PCI in STEMI: An analysis of 11,931 patients during 2000–2009. Int J Cardiol. 2014;176(2):456-463. doi:10.1016/j.ijcard.2014.07.091
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9. Bộ Y tế. Quyết định 5332/QĐ-BYT 2020 tài liệu chuyên môn Thực hành chẩn đoán điều trị động mạch vành. THƯ VIỆN PHÁP LUẬT. February 19, 2024. Accessed March 11, 2024. https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Quyet-dinh-5332-QD-BYT-2020-tai-lieu-chuyen-mon-Thuc-hanh-chan-doan-dieu-tri-dong-mach-vanh-460209.aspx
10. Roe MT, Goodman SG, Ohman EM, et al. Elderly patients with acute coronary syndromes managed without revascularization: insights into the safety of long-term dual antiplatelet therapy with reduced-dose prasugrel versus standard-dose clopidogrel. Circulation. 2013;128(8):823-833. doi:10.1161/CIRCULATIONAHA.113.002303
11. Baker WL, White CM. Role of prasugrel, a novel P2Y (12) receptor antagonist, in the management of acute coronary syndromes. Am J Cardiovasc Drugs. 2009;9(4):213-229. doi:10.2165/1131209-000000000-00000
12. European Public Assessment Report for Efient. European Medicines Agency website. Accessed June 13, 2024. https://www.ema.europa.eu/en/documents/overview/efient-epar-summary-public_en.pdf
13. Bộ Y tế. Thông tư 20/2022/TT-BYT danh mục thanh toán thuốc hóa dược được hưởng bảo hiểm y tế mới nhất. THƯ VIỆN PHÁP LUẬT. January 27, 2024. Accessed March 11, 2024. https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Thong-tu-20-2022-TT-BYT-danh-muc-thanh-toan-thuoc-hoa-duoc-duoc-huong-bao-hiem-y-te-548898.aspx
14. Higgins J, Thomas J. Cochrane Handbook for Systematic Reviews of Interventions.; 2021. https://training.cochrane.org/handbook/current/chapter-i
15. Wiviott SD, Braunwald E, McCabe CH, et al. Prasugrel versus Clopidogrel in Patients with Acute Coronary Syndromes. N Engl J Med. 2007;357(20):2001-2015. doi:10.1056/NEJMoa0706482
16. Viikilä J, Nieminen T, Tierala I, Laine M. Safety of the primary percutaneous coronary intervention strategy combining pre-hospital prasugrel, enoxaparin and in-hospital bivalirudin in acute ST-segment elevation myocardial infarction. BMC Cardiovasc Disord. 2016;16(1):154. doi:10.1186/s12872-016-0333-0
17. Räber L, Klingenberg R, Heg D, et al. Safety of Prasugrel Loading Doses in Patients Pre-Loaded With Clopidogrel in the Setting of Primary Percutaneous Coronary Intervention: Results of a Nonrandomized Observational Study. JACC Cardiovasc Interv. 2015;8(8):1064-1074. doi:10.1016/j.jcin.2015.03.023
18. Bacquelin R, Oger E, Filippi E, et al. Safety of prasugrel in real-world patients with ST-segment elevation myocardial infarction: 1-year results from a prospective observational study (Bleeding and Myocardial Infarction Study). Arch Cardiovasc Dis. 2016;109(1):31-38. doi:10.1016/j.acvd.2015.08.005
19. Kaul U, Sethi A, Arambam P, et al. Safety of Prasugrel in Indian patients - multicentric registry of 1000 cases. Indian Heart J. 2014;66(6):598-601. doi:10.1016/j.ihj.2014.11.001
20. Gill K, Servati N, Flahive J, Fraielli K. Safety and Efficacy of Triple Therapy With Ticagrelor or Prasugrel Versus Clopidogrel After Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction. J Cardiovasc Pharmacol Ther. 2021;26(6):625-629. doi:10.1177/10742484211031436
21. Yetgin T, Boersma E, Smits PC, et al. One-year efficacy and safety of routine prasugrel in patients with acute coronary syndromes treated with percutaneous coronary intervention: results of the prospective rijnmond collective cardiology research study. Neth Heart J Mon J Neth Soc Cardiol Neth Heart Found. 2018;26(7-8):393-400. doi:10.1007/s12471-018-1126-0
22. Ruiz-Nodar JM, Esteve-Pastor MA, Rivera-Caravaca JM, et al. One-year efficacy and safety of prasugrel and ticagrelor in patients with acute coronary syndromes: Results from a prospective and multicentre ACHILLES registry. Br J Clin Pharmacol. 2020;86(6):1052-1061. doi:10.1111/bcp.14213
23. Chon MK, Jung SM, Lee SY, et al. Incidence of Cardiovascular Events and Safety Profile of Prasugrel in Korean Patients With Acute Coronary Syndrome. Circ J Off J Jpn Circ Soc. 2020;84(9):1582-1586. doi:10.1253/circj.CJ-20-0125
24. Jackson LR 2nd, Peterson ED, McCoy LA, et al. Impact of Proton Pump Inhibitor Use on the Comparative Effectiveness and Safety of Prasugrel Versus Clopidogrel: Insights From the Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (TRANSLATE-ACS) Study. J Am Heart Assoc. 2016;5(10). doi:10.1161/JAHA.116.003824
25. Schüpke S, Neumann FJ, Menichelli M, et al. Ticagrelor or Prasugrel in Patients with Acute Coronary Syndromes. N Engl J Med. 2019;381(16):1524-1534. doi:10.1056/NEJMoa1908973
26. Lam ASM, Yan BPY, Lee VWY. Efficacy and safety comparing prasugrel/ticagrelor and clopidogrel in Hong Kong post-acute coronary syndrome patients-A 10-year cohort study. Clin Cardiol. 2021;44(8):1072-1079. doi:10.1002/clc.23653
27. Koyabu Y, Abe S, Sakuma M, et al. Short-term Safety and Mid-term Efficacy of Prasugrel Versus Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention. Intern Med Tokyo Jpn. 2019;58(16):2315-2322. doi:10.2169/internalmedicine.2262-18
28. Liu PY, Su CH, Kuo FY, et al. Prasugrel switching from clopidogrel after percutaneous coronary intervention for acute coronary syndrome in Taiwanese patients: an analysis of safety and efficacy. Cardiovasc Interv Ther. 2022;37(2):269-278. doi:10.1007/s12928-021-00771-w
29. Saito S, Isshiki T, Kimura T, et al. Efficacy and safety of adjusted-dose prasugrel compared with clopidogrel in Japanese patients with acute coronary syndrome: the PRASFIT-ACS study. Circ J Off J Jpn Circ Soc. 2014;78(7):1684-1692. doi:10.1253/circj.cj-13-1482
30. Hagiwara H, Fukuta H, Hashimoto H, et al. A comparison of the safety and effectiveness of prasugrel and clopidogrel in younger population undergoing percutaneous coronary intervention: A retrospective study using a Japanese claims database. J Cardiol. 2021;77(3):285-291. doi:10.1016/j.jjcc.2020.10.001
31. Almendro-Delia M, García-Alcántara Á, de la Torre-Prados MV, et al. Safety and Efficacy of Prasugrel and Ticagrelor in Acute Coronary Syndrome. Results of a “Real World” Multicenter Registry. Rev Espanola Cardiol Engl Ed. 2017;70(11):952-959. doi:10.1016/j.rec.2017.05.003
32. Shahzeb, Ali N, Hadi A, et al. Elective percutaneous coronary interventions-A comparision of efficacy of Clopidogrel and Prasugrel. J Ayub Med Coll Abbottabad JAMC. 2015;27(1):174-177. doi:PMID:%2026182769
33. Daiichi Sankyo. Jasugrel (prasugrel) [package insert]. Drug Administration Vietnam. 2024. Accessed March 1, 2024. https://dichvucong.dav.gov.vn/congbothuoc/index
34. 2023 ESC Guidelines for the management of acute coronary syndromes. Accessed March 26, 2024. https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Acute-Coronary-Syndromes-ACS-Guidelines
2. Steg PG, Goldberg RJ, Gore JM, et al. Baseline characteristics, management practices, and in-hospital outcomes of patients hospitalized with acute coronary syndromes in the Global Registry of Acute Coronary Events (GRACE)*. Am J Cardiol. 2002;90(4):358-363. doi:10.1016/S0002-9149(02)02489-X
3. Pinaire J, Azé J, Bringay S, Cayla G, Landais P. Hospital burden of coronary artery disease: Trends of myocardial infarction and/or percutaneous coronary interventions in France 2009–2014. PLOS ONE. 2019;14(5):e0215649. doi:10.1371/journal.pone.0215649
4. Clinical epidemiology, management and outcome of acute coronary syndromes in the Italian network on acute coronary syndromes (IN-ACS Outcome study): Acute Cardiac Care: Vol 14 , No 2 - Get Access. Accessed September 24, 2024. https://www.tandfonline.com/doi/full/10.3109/17482941.2012.655296
5. Segev A, Matetzky S, Danenberg H, et al. Contemporary use and outcome of percutaneous coronary interventions in patients with acute coronary syndromes: insights from the 2010 ACSIS and ACSIS-PCI surveys. doi:10.4244/EIJV8I4A73
6. Boer SPM de, Roos-Hesselink JW, Leeuwen MAH van, et al. Excess mortality in women compared to men after PCI in STEMI: An analysis of 11,931 patients during 2000–2009. Int J Cardiol. 2014;176(2):456-463. doi:10.1016/j.ijcard.2014.07.091
7. WHO. Cardiovascular diseases (CVD) in Viet Nam. Accessed March 26, 2024. https://www.who.int/vietnam/health-topics/cardiovascular-diseases
8. Nguyen TV, Bui KX, Tran KD, Le D, Nguyen TN. Non-ST elevation acute coronary syndrome in patients aged 80 years or older in Vietnam: An observational study. PLOS ONE. 2020;15(6):e0233272. doi:10.1371/journal.pone.0233272
9. Bộ Y tế. Quyết định 5332/QĐ-BYT 2020 tài liệu chuyên môn Thực hành chẩn đoán điều trị động mạch vành. THƯ VIỆN PHÁP LUẬT. February 19, 2024. Accessed March 11, 2024. https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Quyet-dinh-5332-QD-BYT-2020-tai-lieu-chuyen-mon-Thuc-hanh-chan-doan-dieu-tri-dong-mach-vanh-460209.aspx
10. Roe MT, Goodman SG, Ohman EM, et al. Elderly patients with acute coronary syndromes managed without revascularization: insights into the safety of long-term dual antiplatelet therapy with reduced-dose prasugrel versus standard-dose clopidogrel. Circulation. 2013;128(8):823-833. doi:10.1161/CIRCULATIONAHA.113.002303
11. Baker WL, White CM. Role of prasugrel, a novel P2Y (12) receptor antagonist, in the management of acute coronary syndromes. Am J Cardiovasc Drugs. 2009;9(4):213-229. doi:10.2165/1131209-000000000-00000
12. European Public Assessment Report for Efient. European Medicines Agency website. Accessed June 13, 2024. https://www.ema.europa.eu/en/documents/overview/efient-epar-summary-public_en.pdf
13. Bộ Y tế. Thông tư 20/2022/TT-BYT danh mục thanh toán thuốc hóa dược được hưởng bảo hiểm y tế mới nhất. THƯ VIỆN PHÁP LUẬT. January 27, 2024. Accessed March 11, 2024. https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Thong-tu-20-2022-TT-BYT-danh-muc-thanh-toan-thuoc-hoa-duoc-duoc-huong-bao-hiem-y-te-548898.aspx
14. Higgins J, Thomas J. Cochrane Handbook for Systematic Reviews of Interventions.; 2021. https://training.cochrane.org/handbook/current/chapter-i
15. Wiviott SD, Braunwald E, McCabe CH, et al. Prasugrel versus Clopidogrel in Patients with Acute Coronary Syndromes. N Engl J Med. 2007;357(20):2001-2015. doi:10.1056/NEJMoa0706482
16. Viikilä J, Nieminen T, Tierala I, Laine M. Safety of the primary percutaneous coronary intervention strategy combining pre-hospital prasugrel, enoxaparin and in-hospital bivalirudin in acute ST-segment elevation myocardial infarction. BMC Cardiovasc Disord. 2016;16(1):154. doi:10.1186/s12872-016-0333-0
17. Räber L, Klingenberg R, Heg D, et al. Safety of Prasugrel Loading Doses in Patients Pre-Loaded With Clopidogrel in the Setting of Primary Percutaneous Coronary Intervention: Results of a Nonrandomized Observational Study. JACC Cardiovasc Interv. 2015;8(8):1064-1074. doi:10.1016/j.jcin.2015.03.023
18. Bacquelin R, Oger E, Filippi E, et al. Safety of prasugrel in real-world patients with ST-segment elevation myocardial infarction: 1-year results from a prospective observational study (Bleeding and Myocardial Infarction Study). Arch Cardiovasc Dis. 2016;109(1):31-38. doi:10.1016/j.acvd.2015.08.005
19. Kaul U, Sethi A, Arambam P, et al. Safety of Prasugrel in Indian patients - multicentric registry of 1000 cases. Indian Heart J. 2014;66(6):598-601. doi:10.1016/j.ihj.2014.11.001
20. Gill K, Servati N, Flahive J, Fraielli K. Safety and Efficacy of Triple Therapy With Ticagrelor or Prasugrel Versus Clopidogrel After Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction. J Cardiovasc Pharmacol Ther. 2021;26(6):625-629. doi:10.1177/10742484211031436
21. Yetgin T, Boersma E, Smits PC, et al. One-year efficacy and safety of routine prasugrel in patients with acute coronary syndromes treated with percutaneous coronary intervention: results of the prospective rijnmond collective cardiology research study. Neth Heart J Mon J Neth Soc Cardiol Neth Heart Found. 2018;26(7-8):393-400. doi:10.1007/s12471-018-1126-0
22. Ruiz-Nodar JM, Esteve-Pastor MA, Rivera-Caravaca JM, et al. One-year efficacy and safety of prasugrel and ticagrelor in patients with acute coronary syndromes: Results from a prospective and multicentre ACHILLES registry. Br J Clin Pharmacol. 2020;86(6):1052-1061. doi:10.1111/bcp.14213
23. Chon MK, Jung SM, Lee SY, et al. Incidence of Cardiovascular Events and Safety Profile of Prasugrel in Korean Patients With Acute Coronary Syndrome. Circ J Off J Jpn Circ Soc. 2020;84(9):1582-1586. doi:10.1253/circj.CJ-20-0125
24. Jackson LR 2nd, Peterson ED, McCoy LA, et al. Impact of Proton Pump Inhibitor Use on the Comparative Effectiveness and Safety of Prasugrel Versus Clopidogrel: Insights From the Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (TRANSLATE-ACS) Study. J Am Heart Assoc. 2016;5(10). doi:10.1161/JAHA.116.003824
25. Schüpke S, Neumann FJ, Menichelli M, et al. Ticagrelor or Prasugrel in Patients with Acute Coronary Syndromes. N Engl J Med. 2019;381(16):1524-1534. doi:10.1056/NEJMoa1908973
26. Lam ASM, Yan BPY, Lee VWY. Efficacy and safety comparing prasugrel/ticagrelor and clopidogrel in Hong Kong post-acute coronary syndrome patients-A 10-year cohort study. Clin Cardiol. 2021;44(8):1072-1079. doi:10.1002/clc.23653
27. Koyabu Y, Abe S, Sakuma M, et al. Short-term Safety and Mid-term Efficacy of Prasugrel Versus Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention. Intern Med Tokyo Jpn. 2019;58(16):2315-2322. doi:10.2169/internalmedicine.2262-18
28. Liu PY, Su CH, Kuo FY, et al. Prasugrel switching from clopidogrel after percutaneous coronary intervention for acute coronary syndrome in Taiwanese patients: an analysis of safety and efficacy. Cardiovasc Interv Ther. 2022;37(2):269-278. doi:10.1007/s12928-021-00771-w
29. Saito S, Isshiki T, Kimura T, et al. Efficacy and safety of adjusted-dose prasugrel compared with clopidogrel in Japanese patients with acute coronary syndrome: the PRASFIT-ACS study. Circ J Off J Jpn Circ Soc. 2014;78(7):1684-1692. doi:10.1253/circj.cj-13-1482
30. Hagiwara H, Fukuta H, Hashimoto H, et al. A comparison of the safety and effectiveness of prasugrel and clopidogrel in younger population undergoing percutaneous coronary intervention: A retrospective study using a Japanese claims database. J Cardiol. 2021;77(3):285-291. doi:10.1016/j.jjcc.2020.10.001
31. Almendro-Delia M, García-Alcántara Á, de la Torre-Prados MV, et al. Safety and Efficacy of Prasugrel and Ticagrelor in Acute Coronary Syndrome. Results of a “Real World” Multicenter Registry. Rev Espanola Cardiol Engl Ed. 2017;70(11):952-959. doi:10.1016/j.rec.2017.05.003
32. Shahzeb, Ali N, Hadi A, et al. Elective percutaneous coronary interventions-A comparision of efficacy of Clopidogrel and Prasugrel. J Ayub Med Coll Abbottabad JAMC. 2015;27(1):174-177. doi:PMID:%2026182769
33. Daiichi Sankyo. Jasugrel (prasugrel) [package insert]. Drug Administration Vietnam. 2024. Accessed March 1, 2024. https://dichvucong.dav.gov.vn/congbothuoc/index
34. 2023 ESC Guidelines for the management of acute coronary syndromes. Accessed March 26, 2024. https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Acute-Coronary-Syndromes-ACS-Guidelines