The periprocedural myocardial damage prevention during elective percutaneous coronary intervention as a result of pharmacological preconditioning with an oral form of nicorandil in patients with stable coronary artery disease. Pilot study


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Abstract

The purpose of the study is to prove the effectiveness of pharmacological preconditioning caused by nicorandil in patients with stable coronary heart disease (CHD) during the elective percutaneous coronary intervention (PCI). Materials and methods. We included 88 patients with a stable form of CHD, who were going to pass the elective PCI, in the study. As the method of blind randomization envelope method was used. There were formed two groups or patients: the first group involved 45 patients - were treated with nicorandil (Cordinic, PIQ-FHARMA LLC) (the main group) the other group included 43 patients who were treated by the standard therapy (the comparison group). The basic antianginal therapy was allowed to use in both groups: beta-blockers, calcium antagonists, ATE inhibitors / angiotensin II receptor blockers, statins, acetylsalicylic acid, blockers of P2Y12 receptor platelets. The admission of prolonged form of nitrates before the PCI was allowed in the second group. Patients from the 1st group were to take nicorandil 2 days and 1 day before the PCI at the 30 mg/day dose, then 20 mg orally 2 hours just before PCI, and one more time 6 hours after the PCI - 10 mg nicorandil. Highly sensitive troponin (HS-Tp) as a biomarker of irreversible damage to the myocardium was evaluated before PCI and after PCI in 24 hours. Were used highly sensitive troponin (HF-Tr) and creatine phosphokinase-MB as an irreversible myocardial damage biomarkers. The analysis of which was conducted before PCI and 24 hours after the surgery. Results. The obtained data shows the significant differences of an increase in hs-Tp in 24 hours after PCI in patients with no admission of nicorandil (117 ng/l) as compared with the nicorandil group (73 ng/l), p = 0.04. There were significant differences in the 24 hours increment in hs-Tp in the control group, it was higher (112 ng/l) than in the nicorandil group (67 ng/l), p = 0.03. There was also a significant decrease in CK-MB after 24 hours in the nicorandil group (2.7 ng/L) compared to the control group (2.0 ng/L), p = 0.008. Also the frequency of the troponin increase above the UNL(upper normal level) in the nicorandal group, was significantly (p = 0.03) lower (in 62% of cases compared to 85% of the control group). Conclusion. The prevention of the complications during the percutaneous myocardial revascularization should be considered with the position of the most suitable pharmacological support. The appointment of the oral form of nicorandil (Cordinic, PIQ-FHARMA LLC) for 2 days and 1 day before PCI 30 mg/day, then 20 mg 2 hours before the PCI and 10 mg after 6 hours after the surgery reduces the risk of intraoperative myocardial damage. The obtained data give an opportunity to extend the indications for nicorandil's appointment in the drug support during PCI in patients with stable coronary artery disease.

About the authors

R V Gostishchev

Federal State Budgetary Institution "National Medical Research Center of Cardiology" of the Ministry of Health of Russia

Email: gostiroman@gmail.com
аспирант отд. рентгенэндоваскулярных методов диагностики и лечения НИИ клинической кардиологии им. А.Л. Мясникова Moscow, Russia

G N Soboleva

Federal State Budgetary Institution "National Medical Research Center of Cardiology" of the Ministry of Health of Russia

д.м.н., в.н.с. отд. ангиологии НИИ клинической кардиологии им. А.Л. Мясникова Moscow, Russia

A N Samko

Federal State Budgetary Institution "National Medical Research Center of Cardiology" of the Ministry of Health of Russia

д.м.н., проф., руководитель отд. рентгенэндоваскулярных методов диагностики и лечения НИИ клинической кардиологии им. А.Л. Мясникова Moscow, Russia

A N Rogoza

Federal State Budgetary Institution "National Medical Research Center of Cardiology" of the Ministry of Health of Russia

д.б.н., проф., руководитель отд. новых методов диагностики ФГБУ НМИЦК М3 РФ Moscow, Russia

A A Minasyan

Federal State Budgetary Institution "National Medical Research Center of Cardiology" of the Ministry of Health of Russia

ординатор НИИ клинической кардиологии им. А.Л. Мясникова Moscow, Russia

References

  1. Sarno G, Lagerqvist B, Fröbert O, 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):606-13. doi: 10.1093/eurheartj/ehr479
  2. Жамгырчиев Ш.Т., Фетцер Д.В., Першуков И.В., Левицкий И.В., Самко А.Н., Батыралиев Т.А. Клиническое значение коронарных стентов с лекарственным покрытием. Терапевтический архив. 2007;9:79-84
  3. Самко А.Н., Лупанов В.П., Бакашвили Г.Н., Матчин Ю.Г., Левицкий И.В. Ближайшие и отдаленные результаты применения стентов с лекарственным покрытием эверолимусом Promus и сиролимусом Cypher у больных ИБС с коронарным атеросклерозом. Международный журнал интервенционной кардиоангиологии. 2012;29:9-18.
  4. Nallamothu B.K, Chetcuti S, Mukherjee D, Grossman P.M, Kline-Rogers E, Werns S.W, Bates E.R, Moscucci M. Prognostic implication of troponin I elevation after percutaneous coronary intervention. Am J Cardiol. 2003;91:1272-4.
  5. Kini A.S, Lee P, Marmur J.D, Agarwal A, Duffy M.E, Kim M.C, Sharma S.K. Correlation of postpercutaneous coronary intervention creatine kinase-MB and troponin I elevation in predicting mid - term mortality. Am J Cardiol. 2004;93:18-23.
  6. Cavallini C, Savonitto S, Violini R, Arraiz G, Plebani M, Olivari Z, Rubartelli P, Battaglia S, Niccoli L, Steffenino G, Ardissino D. Impact of the elevation of biochemical markers of myocardial damage on long-103term mortality after percutaneous coronary intervention: results of the CK-MB and PCI study. Eur Heart J. 2005;26:1494-8.
  7. Tricoci P, Leonardi S, White J, White H.D, Armstrong P.W, Montalescot G, Giugliano R.P, Gibson C.M, Van de Werf F, Califf R.M, Harrington R.A, Braunwald E, Mahaffey K.W, Newby L.K. Cardiac troponin after percutaneous coronary intervention and 1-year mortality in non-ST-segment elevation acute coronary syndrome using systematic evaluation of biomarker trends. J Am Coll Cardiol. 2013 Jul 16;62(3):242-51. doi: 10.1016/j.jacc.2013.04.043. Epub 2013 May 15
  8. Saadeddin S.M, Habbab M.A, Siddieg H.H, Al Seeni M.N, Tahery A.B, Dafterdar R.M. Evaluation of 6 cardiac troponin assays in patients with acute coronary syndrome. Saudi Med J. 2003 Oct;24(10):1092-7.
  9. Кардиоваскулярная профилактика. Национальные рекомендации. Кардиоваскулярная терапия и профилактика. 2011;10(6). Приложение 2
  10. Imagawa J, Baxter G.F, Yellon D.M. Myocardial protection afforded by nicorandil and ischaemic preconditioning in a rabbit infarct model in vivo. J Cardiovasc Pharmacol. 1998 Jan;31(1):74-9.
  11. Lee H.C, An S.G, Choi J.H, Lee T.K, Kim J, Kim J.H, Chun K.J, Hong T.J, Shin Y.W, Lee S.K. Effect of intra - coronary nicorandil administration prior to reperfusion in acute ST segment elevation myocardial infarction. Circ J. 2008 Sep;72(9):1425-9.
  12. Ishida H, Higashijima N, Hirota Y, Genka C, Nakazawa H, Nakaya H, Sato T. Nicorandil attenuates the mitochondrial Ca2+ overload with accompanying depolarization of the mitochondrial membrane in the heart. Naunyn Schmiedebergs Arch Pharmacol. 2004 Feb;369(2):192-7. Epub 2003 Dec 18.
  13. Thygesen K, Alpert J, Jaffe A, Simoons M, Chaitman B, et al. Third universal definition of myocardial infarction. European Heart J. 2012;33:2551-67.
  14. Miller W.L, Garratt K.N, Burritt M.F, Reeder G.S, Jaffe A.S. Timing of peak troponin T andcreatine kinase-MB elevations after percutaneous coronary intervention. Chest. 2004;25:275-80.
  15. Lansky A.J, Stone G.W.Periprocedural myocardial infarction:prevalence, prognosis and prevention. Circ Cardiovasc Interv. 2010;3:602-10.
  16. Cavallini C, Verdecchia P, Savonitto S, Arraiz G, Violini R, Olivari Z, Rubartelli P, De Servi S, Plebani M, Steffenino G, Sbarzaglia P, Ardissino D. Italian Atherosclerosis, Thrombosis and Vascular Biology and Society for Invasive Cardiology-GISE Investigators Prognostic value of isolated Troponin I elevation after Percutaneous coronary intervention. Circ Cardiovasc Interv. 2010;3:431-5.
  17. Simoons M.L, van den Brand M, Lincoff M, et al. Minimal myocardial damage during coronary intervention is associated with impaired outcome. Eur Heart J. 1999;20:1112-29.
  18. Abdelmeguid A.E, Topol E.J, Whitlow P.L, et al. Significance of mild transient release of creatineki - nase-MB fraction after percutaneous coronary interventions. Circulation. 1996; 94:1528-36.
  19. Brener S.J, Ellis S.G, Schneider J, Topol E.J. Frequency and longterm impact of myonecrosis after coronary stenting. Eur Heart J. 2002;23:869-76.
  20. Novack V, Pencina M, Cohen D.J, et al. Troponin criteria for myocardial infarction after percuta - neous coronary intervention. Arch Intern Med. 2012;172:502-8.
  21. Tardiff B.E, Califf R.M, Tcheng J.E, et al. Clinical outcomes after detection of elevated cardiac enzymes in patients undergoing percutaneous intervention. J Am Coll Cardiol. 1999;33:88-96.
  22. Harris B.M, Nageh T, Marsden J.T, Thomas M.R, Sherwood R.A. Comparison of cardiac troponin T and I and CK-MB for the detection of minor myocardial damage during interventional cardiac procedures. Ann Clin Biochem. 2000;37:764-9.
  23. Januzzi J.L, Lewandrowski K, Mac Gillivray T.E, Newell J.B, Kathiresan S, Servoss S.J, Lee-Lewandrowski E. A comparison of cardiac troponin T and creatine kinase-MB for patient evaluation after cardiac surgery. J Am Coll Cardiol. 2002;39:1518-23.
  24. Laugaudin G, Kuster N, Petiton A, Leclercq F, Gervasoni R, Macia J.C, Cung T.T, Dupuy A.M, Solecki K, Lattuca B, Cade S, Cransac F, Cristol JP, Roubille F. Kinetics of high - sensitivity cardiac troponin T and I differ in patients with ST-segment elevation myocardial infarction treated by primary coronary intervention. European Heart J: Acute Cardiovascular Care. 2016;5(4):354-63.
  25. Murry C.E, Jenning R.D, Reimer K.A. Preconditioning with ischemia: a delay of lethal cell injury in ischemic myocardium. Circulation. 1986;74(5):1122-36.
  26. Kloner R.A, Jennings R.B. Consequences of brief ischemia: stunning, preconditioning, and their clinical implications: Part 1. Circulation. 2001;104(24):2981-9.
  27. Kloner R.A, Jennings R.B. Consequences of brief ischemia: stunning, preconditioning, and their clinical implications: Part 2. Circulation. 2001;104(25):3158-67.
  28. Гостищев Р.В., Соболева Г.Н., Самко А.Н., Осиев А.Г. Фармакологическое прекондиционирование: в фокусе - никорандил. Российский кардиологический журнал. 2017;8:114-21 doi: 10.15829/1560-4071- 2017-8-114-121
  29. Kloner R.A, Yellon D. Does ischemic preconditioning occur in patients? JACC. 1994;24(4):1333-42.
  30. Turer A.T, Hill J.A. Pathogenesis of myocardial ischemia - reperfusion injury and rationale for therapy. Am J Cardiol. 2010;106:360-8.
  31. Kharbanda R.K. Cardiac conditioning: a review of evolving strategies to reduce ischemia - reperfusion injury. Heart. 2010;96:1179-86.
  32. Лупанов В.П., Максименко А.В. Протективная ишемия в кардиологии. Формы кондиционирования миокарда. Кардиоваскулярная терапия и профилактика. 2011;10(1)
  33. Hausenloy D.J, Ong S.B, Yellon D.M. The mitochondrial permeability transition pore as a target for preconditioning and postconditioning. Basic Res Cardiol. 2009;104(2):189-202.
  34. Писаренко О.И. Ишемическое прекондиционирование: от теории к практике. Кардиология. 2005;9:62-72
  35. Бойцов С.А. Патогенез хронической формы ишемической болезни сердца. В кн.: Руководство по атеросклерозу и ишемической болезни сердца (под ред. акад. Е.И. Чазова). Москва: Медиа Медика, 2007:330-348
  36. Ломиворотов В.В., Пономарев Д.Н., Шмырев В.А. и др. Применение дистанционного ишемического прекондиционирования у кардиохирургических больных. Общая реаниматология. 2011;7(3):63-9
  37. Ishii H, Ichimiya S, Kanashiro M, Amano T, Imai K, Murohara T, Matsubara T. Impact of a single intravenous administration of nicorandil before reperfusion in patients with ST-segment - elevation myocardial infarction. Circulation. 2005 Aug 30;112(9):1284-8.
  38. Ono H, Osanai T, Ishizaka H, Hanada H, Kamada T, Onodera H, Fujita N, Sasaki S, Matsunaga T, Okumura K. Nicorandil improves cardiac function and clinical outcome in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention: role of inhibitory effect on reactive oxygen species formation. Am Heart J. 2004 Oct;148(4):E15.
  39. Ota S, Nishikawa H, Takeuchi M, Nakajima K, Nakamura T, Okamoto S, Setsuda M, Makino K, Yamakado T, Nakano T. Impact of Nicorandil to Prevent Reperfusion Injury in Patients With Acute Myocardial Infarction Sigmart Multicenter Angioplasty Revascularization Trial (SMART). Circ J. 2006;70:1099-104.
  40. Kasama S, Toyama T, Sumino H, Kumakura H, Takayama Y, Ichikawa S, et al. Long - term nicorandil therapy improves cardiac sympathetic nerve activity after reperfusion therapy in patients with first acute myocardial infarction. J Nucl Med. 2007;48:1676-82.
  41. Sakata Y, Nakatani D, Shimizu M, Suna S, Usami M, Matsumoto S, Hara M, Sumitsuji S, Kawano S, Iwakura K, Hamasaki T, Sato H, Nanto S, Hori M, Komuro I. Oral treatment with nicorandil at discharge is associated with reduced mortality after acute myocardial infarction. J Cardiol. 2012 Jan;59(1):14-21. doi: 10.1016/j.jjcc.2011.08.001. Epub 2011 Sep 15.
  42. Yang J, Zhang J, Cui W, et al. Cardioprotective effects of single oral dose of nicorandil before selective percutaneous coronary intervention. Anatolian J Cardiol. 2015;15:125-31.
  43. Izumiya Y, Kojima S, Kojima S, et al. Long - term use of oral nicorandil stabilizes coronary plaque in patients with stable angina pectoris. Atherosclerosis. 2011;214:415-21.
  44. Kawai Y, Hisamatsu K, Matsubara H, Dan K, Akagi S, Miyaji K, Munemasa M, Fujimoto Y, Kusano K.F, Ohe T. Intravenous administration of nicorandil immediately before percutaneous coronary intervention can prevent slow coronary flow phenomenon. Eur Heart J. 2009 Apr;30(7):765-72. doi: 10.1093/eurheartj/ehp077. Epub 2009 Mar 10.
  45. Isono T, Kamihata H, Sutani Y, Motohiro M, Yamamoto S, Kyoui S, Iharada Y, Kurimoto K, Hara K, Takahashi H, Iwasaka T. Nicorandil suppressed myocardial injury after percutaneous coronary intervention. Int J Cardiol. 2008 Jan 11;123(2):123-8. Epub 2007 Mar 8.
  46. Hirohata A, Yamamoto K, Hirose E, Kobayashi Y, Takafuji H, Sano F, Matsumoto K, Ohara M, Yoshioka R, Takinami H, Ohe T. Nicorandil prevents microvascular dysfunction resulting from PCI in patients with stable angina pectoris: a randomised study. Euro Intervention. 2014 Jan 22;9(9):1050-6. doi: 10.4244/EIJV9I9A178
  47. Holmvang L, Jurlander B, Rasmussen C, Thiis J.J, Grande P, Clemmensen P. Use of biochemical markers of infarction for diagnosing perioperative myocardial infarction and early graft occlusion after coronary artery bypass surgery. Chest. 2002;121:103-11.

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