Drug Eluting Stents versus Bare Metal Stents in ST- Segment Elevation Myocardial Infarction

Yıl 2019, Cilt: 11 Sayı: 1, 62 - 68, 25.03.2019

Adnan Kaya Mustafa Adem Tatlısu

https://doi.org/10.18521/ktd.446137

Cited By: 1

Öz

Background:
The aim of this study was to compare the effectiveness
and safety of drug eluting stents (DES) with bare metal stents (BMS) in
patients presented with ST- segment elevation myocardial infarction (STEMI) in
a real world setting.

Methods:
One thousand five hundred ninety six STEMI patients
treated with primary percutaneous coronary intervention from January 2013 to
March 2016 were enrolled to study. One thousand one hundred ninety four of them
received BMS while 402 of them received DES. Patients were analyzed for major
adverse cardiac events (MACE) and stent thrombosis (ST).   

Results: There was no difference at 30 days in relation of
MACE, all cause death, re-MI, TVR, TLR and ST. The cumulative incidence of MACE
was significantly higher in DES group (9,2% vs. 7,0%, p = 0.02) at 1 year. Stent thrombosis and
re-MI incidence were significantly higher in DES group (4,2% vs. 2,6%, p = 0.028, 6,9% vs. 4,8%, p = 0.015) respectively at 1 year.
There was no statistically significant difference in relation of all cause
death, TVR and TLR at 1 year. The statistically differences between groups
vanished at 2 year and the groups looked similar. Male gender (HR, 1.40; 95% CI, 1.00 to 1.94; p = 0.043) and presence of DM (HR, 1.73; 95% CI, 1.29 to 2.32; p<0,001) were found to be independent predictors of 2-year MACE.

Conclusion: Our
study showed effectiveness and safety of DES in STEMI. Despite increased
incidence of MACE, re-MI and ST in 1-year, DES was found to be non-inferior to
BMS at 2-year follow up.

Anahtar Kelimeler

Drug-eluting stents, Bare-metal stents, ST elevation Myocardial Infarction

ST-Segment Yükselmeli Miyokard İnfarktüsünde Çıplak Metal Stentler ve İlaç kaplı Stentlerin Karşilaştırılması

Öz

Amaç: Bu çalışmada ST segment elevasyonlu myokard enfarktüsünde
ilaç kaplı stentleri ve çıplak metal stentleri karşılaştırmak istedik. 

Gereç ve Yöntem: Çalışmamıza merkezimize Ocak 2013 ve Mart 2016
tarihleri arasında başvuran toplam 1596 ST segment elevasyonlu myokard
enfarktüsü alındı. Katılımcılar çıplak metal stent grubu (n=1194) ve ilaç kaplı
stent grubu (n=402) olarak iki gruba ayrıldı. Hastalar major kardiyak sonlanım
acısından değerlendirildi. 
Bulgular: Grublar arasında ilk 30 günde major kardiyak sonlanım
ve tüm ölüm açısından fark olmamasına rağmen, toplam major kardiyak sonlanım
insidansı (9,2% vs. 7,0%, p=0.02), stent thrombozu (4,2% vs. 2,6%, p=0.028) ve
tekrar myokard enfarktüsü (6,9% vs. 4,8%, p=0.015) ilaç kaplı stent grubunda
yüksek bulundu. Bununla birlikte toplam mortalitede, hedef damar ve lezyon
revaskülarizasyonunda istatiksel anlamlı fark bulunmadı. Major kardiyak
sonlanım ve toplam mortalite 2 yıllık takipte gruplar arasında benzer bulundu.
Erkek cinsiyet (HR, 1.40; 95% CI, 1.00 to 1.94; p = 0.043) ve diyabet varlığı
(HR, 1.73; 95% CI, 1.29 to 2.32; p<0,001) major kardiyak sonlanım için
bağımsız prediktör olarak saptandı.
Sonuç: Sonuclarımız ilaç kaplı stentlerin çıplak metal
stentler ile karşılaştırıldığında hem etkili hem de güvenli oldugunu gösterdi. 

Anahtar Kelimeler

Çıplak metal stent, ilaç kaplı stent, ST yükselmeli Myokard enfarktüsü

Kaynakça

• 1. Wijns, W., Kolh, P., Danchin, N., Di Mario, C., Falk, V., Folliguet, T., . & von Segesser, L. Guidelines on myocardial revascularization. European heart journal, 2010; 31: 2501-55.2. De Luca, G., Suryapranata, H., Stone, G. W., Antoniucci, D., Biondi-Zoccai, G., Kastrati, A., ... & Marino, P. Coronary stenting versus balloon angioplasty for acute myocardial infarction: a meta-regression analysis of randomized trials. International journal of cardiology, 2008: 126: 37-44.3. Spaulding, C., Teiger, E., Commeau, P., Varenne, O., Bramucci, E., Slama, M., ... & Henry, P. Four-year follow-up of TYPHOON (trial to assess the use of the CYPHer sirolimus-eluting coronary stent in acute myocardial infarction treated with BallOON angioplasty). JACC: Cardiovascular Interventions, 2011: 4: 14-23.4. Stone, G. W., Witzenbichler, B., Guagliumi, G., Peruga, J. Z., Brodie, B. R., Dudek, D., ... & HORIZONS-AMI Trial Investigators. Heparin plus a glycoprotein IIb/IIIa inhibitor versus bivalirudin monotherapy and paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction (HORIZONS-AMI): final 3-year results from a multicentre, randomised controlled trial. The Lancet, 2011;377: 2193-204.5. Cutlip, D. E., Windecker, S., Mehran, R., Boam, A., Cohen, D. J., van Es, G. A., ... & Academic Research Consortium. Clinical end points in coronary stent trials a case for standardized definitions. Circulation, 2007; 115: 2344-51.6. Angioplasty Substudy Investigators. A clinical trial comparing primary coronary angioplasty with tissue plasminogen activator for acute myocardial infarction. The Global Use of Strategies to Open Occluded Coronary Arteries in Acute Coronary Syndromes (GUSTO IIb). N Engl J Med, 1997; 336: 1621-8.7. Guo N, Maehara A, Mintz GS, He Y, Xu K, Wu X, Lansky AJ, Witzenbichler B, Guagliumi G, Brodie B, Kellett MA Jr, Dressler O, Parise H, Mehran R, Stone GW. Incidence, mechanisms, predictors, and clinical impact of acute and late stent malapposition after primary intervention in patients with acute myocardial infarction: an intravascular ultrasound substudy of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial. Circulation. 2010; 122: 1077–84. 8. Grines, C. L., Cox, D. A., Stone, G. W., Garcia, E., Mattos, L. A., Giambartolomei, A., ... & O'Neill, W. W.. Coronary angioplasty with or without stent implantation for acute myocardial infarction. New England Journal of Medicine, 1999; 341: 1949-56.9. Stone, G. W., Grines, C. L., Cox, D. A., Garcia, E., Tcheng, J. E., Griffin, J. J., ... & Rutherford, B. D. Comparison of angioplasty with stenting, with or without abciximab, in acute myocardial infarction. New England Journal of Medicine, 2002; 346: 957-66.10. Laarman GJ, Suttorp MJ, Dirksen MT, van Heerebeek L, Kiemeneij F, Slagboom T, van der Wieken LR, Tijssen JG, Rensing BJ, Patterson M. Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention. N Engl J Med. 2006;355:1105–13. 11. Daemen J, Tanimoto S, García-García HM, Kukreja N, van de Sande M, Sianos G, de Jaegere PP, van Domburg RT, Serruys PW. Comparison of three-year clinical outcome of sirolimus- and paclitaxel-eluting stents versus bare metal stents in patients with ST-segment elevation myocardial infarction (from the RESEARCH and T-SEARCH Registries). Am J Cardiol. 2007;99:1027–32.12. De Luca, G., Stone, G. W., Suryapranata, H., Laarman, G. J., Menichelli, M., Kaiser, C., ... & Pittl, U. Efficacy and safety of drug-eluting stents in ST-segment elevation myocardial infarction: a meta-analysis of randomized trials. International journal of cardiology,2009;133: 213-22.13. Kastrati, A., Dibra, A., Spaulding, C., Laarman, G. J., Menichelli, M., Valgimigli, M., ... & Seyfarth, M. Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction. European heart journal, 2007; 28: 2706-13.14. Pasceri, V., Patti, G., Speciale, G., Pristipino, C., Richichi, G., & Di Sciascio, G. Meta-analysis of clinical trials on use of drug-eluting stents for treatment of acute myocardial infarction. American heart journal,2007; 153: 749-54.15. Stone, G. W., Lansky, A. J., Pocock, S. J., Gersh, B. J., Dangas, G., Wong, S. C., ... & Dudek, D. Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction. New England Journal of Medicine, 2009; 360:1946-59.16. Kushner, F. G., Hand, M., Smith, S. C., King, S. B., Anderson, J. L., Antman, E. M., ... & Green, L. A. 2009 focused updates: ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction (updating the 2004 guideline and 2007 focused update) and ACC/AHA/SCAI guidelines on percutaneous coronary intervention (updating the 2005 guideline and 2007 focused update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines.Journal of the American College of Cardiology, 2009; 54(23), 2205-41.17. Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Juni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet 2007;369:667–678.18. Park DW, Park SW, Park KH, Lee BK, Kim YH, Lee CW, Hong MK, Kim JJ, Park SJ. Frequency of and risk factors for stent thrombosis after drug-eluting stent implantation during long-term follow-up. The American journal of cardiology. 2006; 98:352-6.19. Kastrati A, Mehilli J, Pache J, Kaiser C, Valgimigli M, Kelbæk H, Menichelli M, Sabate´ M, Suttorp MJ, Baumgart D, Seyfarth M, Pfisterer ME, Scho¨mig A. Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 2007;356:1030–1039.20. Stone GW, Ellis SG, Cannon L, Mann JT, Greenberg JD, Spriggs D, O’Shaughnessy CD, DeMaio S, Hall P, Popma JJ, Koglin J, Russell ME. Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial. JAMA 2005;294:1215–23.21. Ault KA, Cannon CP, Mitchell J, McCahan J, Tracy RP, Novotny WF, Reimann JD, Braunwald E. Platelet activation in patients after an acute coronary syndrome: results from the TIMI-12 trial. Thrombolysis in myocardial infarction. J Am Coll Cardiol 1999;33:634–9. 22. Inoue T, Sohma R, Miyazaki T, Iwasaki Y, Yaguchi I, Morooka S. Comparison of activation process of platelets and neutrophils after coronary stent implantation versus balloon angioplasty for stable angina pectoris. Am J Cardiol 2000;86:1057–6223. Luscher TF, Steffel J, Eberli FR, Joner M, Nakazawa G, Tanner FC, Virmani R. Drug-eluting stent and coronary thrombosis: biological mechanisms and clinical implications. Circulation 2007;115:1051–58.24. Rousan, T. A., Pappy, R. M., Chen, A. Y., Roe, M. T., & Saucedo, J. F. Impact of diabetes mellitus on clinical characteristics, management, and in-hospital outcomes in patients with acute myocardial infarction (from the NCDR). The American journal of cardiology, 2014; 114: 1136-44.
• 2. De Luca, G., Suryapranata, H., Stone, G. W., Antoniucci, D., Biondi-Zoccai, G., Kastrati, A., ... & Marino, P. Coronary stenting versus balloon angioplasty for acute myocardial infarction: a meta-regression analysis of randomized trials. International journal of cardiology, 2008: 126: 37-44
• 3. Spaulding, C., Teiger, E., Commeau, P., Varenne, O., Bramucci, E., Slama, M., ... & Henry, P. Four-year follow-up of TYPHOON (trial to assess the use of the CYPHer sirolimus-eluting coronary stent in acute myocardial infarction treated with BallOON angioplasty). JACC: Cardiovascular Interventions, 2011: 4: 14-23.
• 4. Stone, G. W., Witzenbichler, B., Guagliumi, G., Peruga, J. Z., Brodie, B. R., Dudek, D., ... & HORIZONS-AMI Trial Investigators. Heparin plus a glycoprotein IIb/IIIa inhibitor versus bivalirudin monotherapy and paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction (HORIZONS-AMI): final 3-year results from a multicentre, randomised controlled trial. The Lancet, 2011;377: 2193-204.
• 5. Cutlip, D. E., Windecker, S., Mehran, R., Boam, A., Cohen, D. J., van Es, G. A., ... & Academic Research Consortium. Clinical end points in coronary stent trials a case for standardized definitions. Circulation, 2007; 115: 2344-51.
• 6. Angioplasty Substudy Investigators. A clinical trial comparing primary coronary angioplasty with tissue plasminogen activator for acute myocardial infarction. The Global Use of Strategies to Open Occluded Coronary Arteries in Acute Coronary Syndromes (GUSTO IIb). N Engl J Med, 1997; 336: 1621-8.
• 7. Guo N, Maehara A, Mintz GS, He Y, Xu K, Wu X, Lansky AJ, Witzenbichler B, Guagliumi G, Brodie B, Kellett MA Jr, Dressler O, Parise H, Mehran R, Stone GW. Incidence, mechanisms, predictors, and clinical impact of acute and late stent malapposition after primary intervention in patients with acute myocardial infarction: an intravascular ultrasound substudy of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial. Circulation. 2010; 122: 1077–84.
• 8. Grines, C. L., Cox, D. A., Stone, G. W., Garcia, E., Mattos, L. A., Giambartolomei, A., ... & O'Neill, W. W.. Coronary angioplasty with or without stent implantation for acute myocardial infarction. New England Journal of Medicine, 1999; 341: 1949-56.
• 9. Stone, G. W., Grines, C. L., Cox, D. A., Garcia, E., Tcheng, J. E., Griffin, J. J., ... & Rutherford, B. D. Comparison of angioplasty with stenting, with or without abciximab, in acute myocardial infarction. New England Journal of Medicine, 2002; 346: 957-66.
• 10. Laarman GJ, Suttorp MJ, Dirksen MT, van Heerebeek L, Kiemeneij F, Slagboom T, van der Wieken LR, Tijssen JG, Rensing BJ, Patterson M. Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention. N Engl J Med. 2006;355:1105–13.
• 11. Daemen J, Tanimoto S, García-García HM, Kukreja N, van de Sande M, Sianos G, de Jaegere PP, van Domburg RT, Serruys PW. Comparison of three-year clinical outcome of sirolimus- and paclitaxel-eluting stents versus bare metal stents in patients with ST-segment elevation myocardial infarction (from the RESEARCH and T-SEARCH Registries). Am J Cardiol. 2007;99:1027–32.
• 12. De Luca, G., Stone, G. W., Suryapranata, H., Laarman, G. J., Menichelli, M., Kaiser, C., ... & Pittl, U. Efficacy and safety of drug-eluting stents in ST-segment elevation myocardial infarction: a meta-analysis of randomized trials. International journal of cardiology,2009;133: 213-22.
• 13. Kastrati, A., Dibra, A., Spaulding, C., Laarman, G. J., Menichelli, M., Valgimigli, M., ... & Seyfarth, M. Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction. European heart journal, 2007; 28: 2706-13.
• 14. Pasceri, V., Patti, G., Speciale, G., Pristipino, C., Richichi, G., & Di Sciascio, G. Meta-analysis of clinical trials on use of drug-eluting stents for treatment of acute myocardial infarction. American heart journal,2007; 153: 749-54.
• 15. Stone, G. W., Lansky, A. J., Pocock, S. J., Gersh, B. J., Dangas, G., Wong, S. C., ... & Dudek, D. Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction. New England Journal of Medicine, 2009; 360:1946-59.
• 16. Kushner, F. G., Hand, M., Smith, S. C., King, S. B., Anderson, J. L., Antman, E. M., ... & Green, L. A. 2009 focused updates: ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction (updating the 2004 guideline and 2007 focused update) and ACC/AHA/SCAI guidelines on percutaneous coronary intervention (updating the 2005 guideline and 2007 focused update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines.Journal of the American College of Cardiology, 2009; 54(23), 2205-41.
• 17. Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Juni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet 2007;369:667–678.
• 18. Park DW, Park SW, Park KH, Lee BK, Kim YH, Lee CW, Hong MK, Kim JJ, Park SJ. Frequency of and risk factors for stent thrombosis after drug-eluting stent implantation during long-term follow-up. The American journal of cardiology. 2006; 98:352-6.
• 19. Kastrati A, Mehilli J, Pache J, Kaiser C, Valgimigli M, Kelbæk H, Menichelli M, Sabate´ M, Suttorp MJ, Baumgart D, Seyfarth M, Pfisterer ME, Scho¨mig A. Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 2007;356:1030–1039.
• 20. Stone GW, Ellis SG, Cannon L, Mann JT, Greenberg JD, Spriggs D, O’Shaughnessy CD, DeMaio S, Hall P, Popma JJ, Koglin J, Russell ME. Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial. JAMA 2005;294:1215–23.
• 21. Ault KA, Cannon CP, Mitchell J, McCahan J, Tracy RP, Novotny WF, Reimann JD, Braunwald E. Platelet activation in patients after an acute coronary syndrome: results from the TIMI-12 trial. Thrombolysis in myocardial infarction. J Am Coll Cardiol 1999;33:634–9.
• 22. Inoue T, Sohma R, Miyazaki T, Iwasaki Y, Yaguchi I, Morooka S. Comparison of activation process of platelets and neutrophils after coronary stent implantation versus balloon angioplasty for stable angina pectoris. Am J Cardiol 2000;86:1057–62
• 23. Luscher TF, Steffel J, Eberli FR, Joner M, Nakazawa G, Tanner FC, Virmani R. Drug-eluting stent and coronary thrombosis: biological mechanisms and clinical implications. Circulation 2007;115:1051–58.
• 24. Rousan, T. A., Pappy, R. M., Chen, A. Y., Roe, M. T., & Saucedo, J. F. Impact of diabetes mellitus on clinical characteristics, management, and in-hospital outcomes in patients with acute myocardial infarction (from the NCDR). The American journal of cardiology, 2014; 114: 1136-44.