Effectiveness and Safety of Biolimus A9TM-Eluting stEnt in Patients with AcUTe Coronary sYndrome; A Multicenter, Observational Study (BEAUTY Study)
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Purpose: This study sought to determine the 1-year clinical effectiveness and safety of a biodegradable, polymer-containing BiolimusA9TM-eluting stent (BES) in Korean patients with acute coronary syndrome (ACS). Materials and Methods: A total of 1000 ACS patients with 1251 lesions who underwent implantation of BESs at 22 centers in Koreawere enrolled between May 2011 and July 2013. We assessed major adverse cardiac events (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinical-driven target vessel revascularization at 12 months. Results: Patient mean age was 62.6±11.4 years. 72.8% of the patients were male, 28.5% had diabetes, 32.8% had multi-vessel disease (MVD), and 47.9% presented with acute MI (AMI). The mean global registry of acute coronary events risk score of all patients was 103.0±27.6. The number of stents per patient was 1.3±0.6. The incidences of MACE and definite stent thrombosis at 12 months were 3.9% and 0.2%, respectively. On multivariate Cox-regression analysis, age ≥65 years was identified as an independent predictorsof 1-year MACE (hazard ratio=2.474; 95% confidence interval=1.202−5.091). Subgroup analyses revealed no significant differences in the incidence of MACE between patients with and without diabetes (4.3% vs. 3.7%, p=0.667), between those who presented with and without AMI (4.4% vs. 3.4%, p=0.403), and between those with and without MVD (4.6% vs. 3.5%, p=0.387). Conclusion: Our study demonstrated excellent 1-year clinical outcomes of BES implantation in patients at low-risk for ACS.
Abstract
Purpose: This study sought to determine the 1-year clinical effectiveness and safety of a biodegradable, polymer-containing BiolimusA9TM-eluting stent (BES) in Korean patients with acute coronary syndrome (ACS). Materials and Methods: A total of 1000 ACS patients with 1251 lesions who underwent implantation of BESs at 22 centers in Koreawere enrolled between May 2011 and July 2013. We assessed major adverse cardiac events (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinical-driven target vessel revascularization at 12 months. Results: Patient mean age was 62.6±11.4 years. 72.8% of the patients were male, 28.5% had diabetes, 32.8% had multi-vessel disease (MVD), and 47.9% presented with acute MI (AMI). The mean global registry of acute coronary events risk score of all patients was 103.0±27.6. The number of stents per patient was 1.3±0.6. The incidences of MACE and definite stent thrombosis at 12 months were 3.9% and 0.2%, respectively. On multivariate Cox-regression analysis, age ≥65 years was identified as an independent predictorsof 1-year MACE (hazard ratio=2.474; 95% confidence interval=1.202−5.091). Subgroup analyses revealed no significant differences in the incidence of MACE between patients with and without diabetes (4.3% vs. 3.7%, p=0.667), between those who presented with and without AMI (4.4% vs. 3.4%, p=0.403), and between those with and without MVD (4.6% vs. 3.5%, p=0.387). Conclusion: Our study demonstrated excellent 1-year clinical outcomes of BES implantation in patients at low-risk for ACS.
참고문헌 (29)
- Joner M, "Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk", J Am Coll Cardiol, 48, pp.193~202 (2006)[DOI]
- Nakazawa G, "Delayed arterial healing and increased late stent thrombosis at culprit sites after drug-eluting stent placement for acute myocardial infarction patients: an autopsy study", Circulation, 118, pp.1138~1145 (2008)[DOI]
- Nasuno T, "The wound healing response after implantation of a drugeluting stent is impaired persistently in the long term", Heart Vessels, 31, pp.985~989 (2016)[DOI]
- Byrne RA, "Randomized, non-inferiority trial of three limus agenteluting stents with different polymer coatings: the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST-4) Trial", Eur Heart J, 30, pp.2441~2449 (2009)[DOI]
- Windecker S, "Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial", Lancet, 372, pp.1163~1173 (2008)[DOI]
- Stefanini GG, "Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention: a pooled analysis of individual patient data from the ISAR-TEST 3, ISAR-TEST 4, and LEADERS randomized trials", Eur Heart J, 33, pp.1214~1222 (2012)[DOI]
- Grube E, "BioMatrix Biolimus A9-eluting coronary stent: a next-generation drug-eluting stent for coronary artery disease", Expert Rev Med Devices, 3, pp.731~741 (2006)[DOI]
- Byrne RA, "Polymer coatings and delayed arterial healing following drug-eluting stent implantation", Minerva Cardioangiol, 57, pp.567~584 (2009)
- Finn AV, "Vascular responses to drug eluting stents: importance of delayed healing", Arterioscler Thromb Vasc Biol, 27, pp.1500~1510 (2007)[DOI]
- Smits PC, "Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, non-inferiority trial", Lancet, 381, pp.651~660 (2013)[DOI]
- Palmerini T, "Clinical outcomes with bioabsorbable polymerversus durable polymer-based drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis", J Am Coll Cardiol, 63, pp.299~307 (2014)[DOI]
- Ayman Tantawy, "Nobori-Biolimus-Eluting Stents versus Resolute Zotarolimus-Eluting Stents in Patients Undergoing Coronary Intervention: A Propensity Score Matching", Yonsei Medical Journal, 58(2), pp.290~295 (2017), 연세대학교의과대학[DOI]
- Levine GN, "Expert consensus document: World Heart Federation expert consensus statement on antiplatelet therapy in East Asian patients with ACS or undergoing PCI", Nat Rev Cardiol, 11, pp.597~606 (2014)[DOI]
- Luscher TF, "Diabetes and vascular disease: pathophysiology, clinical consequences, and medical therapy: Part II", Circulation, 108, pp.1655~1661 (2003)[DOI]
- Moreno PR, "New aspects in the pathogenesis of diabetic atherothrombosis", J Am Coll Cardiol, 44, pp.2293~2300 (2004)[DOI]
- Mahmud E, "Clinical efficacy of drug-eluting stents in diabetic patients: a meta-analysis", J Am Coll Cardiol, 51, pp.2385~2395 (2008)[DOI]
- Kang SH, "Everolimus-eluting versus sirolimus-eluting coronary stents in patients with and without diabetes mellitus", EuroIntervention, 10, pp.74~82 (2014)[DOI]
- Kubo T, "Assessment of vascular response after drug-eluting stents implantation in patients with diabetes mellitus: an optical coherence tomography sub-study of the J-DESsERT", Heart Vessels, 31, pp.465~473 (2016)[DOI]
- Kim BK, "Optical coherence tomography analysis of strut coverage in biolimus- and sirolimus-eluting stents: 3-month and 12-month serial follow-up", Int J Cardiol, 168, pp.4617~4623 (2013)[DOI]
- Park KH, "The impact of triple anti-platelet therapy for endothelialization and inflammatory response at overlapping bioabsorbable polymer coated drug-eluting stents in a porcine coronary model", Int J Cardiol, 168, pp.1853~1858 (2013)[DOI]
- Nakazawa G, "Comparison of vascular response between durable and biodegradable polymer-based drug-eluting stents in a porcine coronary artery model", EuroIntervention, 10, pp.717~723 (2014)[DOI]
- 임경섭, "Histopathological Comparison among Biolimus, Zotarolimus and Everolimus-Eluting Stents in Porcine Coronary Restenosis Model", Korean Circulation Journal, 43(11), pp.744~751 (2013), 대한심장학회
- de Waha A, "Long-term outcomes of biodegradable polymer versus durable polymer drug-eluting stents in patients with diabetes a pooled analysis of individual patient data from 3 randomized trials", Int J Cardiol, 168, pp.5162~5166 (2013)[DOI]
- Raber L, "Biolimus-eluting stents with biodegradable polymer versus bare-metal stents in acute myocardial infarction: two-year clinical results of the COMFORTABLE AMI trial", Circ Cardiovasc Interv, 7, pp.355~364 (2014)[DOI]
- Tomai F, "One-year outcome from an all-comers population of patients with ST-segment elevation myocardial infarction treated with biolimus-eluting stent with biodegradable polymer", Catheter Cardiovasc Interv, 85, pp.352~358 (2015)[DOI]
- Zhang YJ, "Biolimus-eluting stent with biodegradable polymer improves clinical outcomes in patients with acute myocardial infarction", Heart, 101, pp.271~278 (2015)[DOI]
- Cockburn J, "Clinical outcomes with 6 months dual antiplatelet therapy after implantation of biolimus-A9 drug eluting coronary stents", Int J Cardiol, 172, pp.185~189 (2014)[DOI]
- Camenzind E, "Modifying effect of dual antiplatelet therapy on incidence of stent thrombosis according to implanted drugeluting stent type", Eur Heart J, 35, pp.1932~1948 (2014)[DOI]
- Colombo A, "Dual antiplatelet therapy after drug-eluting stents--how long to treat", N Engl J Med, 371, pp.2225~2226 (2014)[DOI]