관상동맥질환 치료를 위한 조타롤리무스 금속형 약물 방출스텐트와에버롤리무스 생체흡수성 약물방출 스텐트 간의 안전성·효과성 비교: 체계적 문헌고찰 및 공통대조군 간접비교
Comparison of Zotarolimus-Eluting Stent and Everolimus-Eluting Bioresorbable Vascular Scaffold in Patient with Coronary Artery Disease: A Systematic Review and Adjusted Indirect Comparison
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Objectives: Recently bioresorbable coronary stent has emerged as new version of percutaneous coronary intervention (PCI) technology. The expected benefits of this new technology are the reduction of stent thrombosis and impairment of coronary vasomotion. However, the comparative outcomes between bioresorbable coronary stent and current drug-eluting stents (DESs) are not known. This study is aimed to compare the safety and effectiveness of emerging bioresorbable coronary stents - everolimus-eluting bioresorbable vascular scaffold (BVS) to the well accepted DES technology - zotarolimus-eluting stent (ZES) - through Systematic Review and Adjusted Indirect Comparison with everolimus eluting stents (EES) for coronary artery disease (CAD) treatments. Methods: A meta-analysis of clinical studies in which patients were randomly assigned to ZES versus EES or BVS versus EES were performed, as well as an indirect comparison of ZES versus EES, with EES common comparator. The primary endpoint was target lesion revascularization (TLR), while the secondary endpoints were a target vessel revascularization (TVR), a death, and a major adverse cardiac event (MACE). Results: Six clinical studies were identified with a total of 7512 patients. Treatments with ZES versus EES were not associated with significant reductions of the TLR [odds ratio (95% confidence interval)=1.13 (0.88, 1.47), p=0.34], TVR [1.05 (0.81, 1.37), p=0.72], death [0.89 (0.64, 1.25), p=0.51], MACE [1.02 (0.85, 1.23), p=0.79] and Stent Thrombosis (ST) [1.35 (0.91, 2.00), p=0.13] BVS versus EES therapy also were not associated with significant reductions of TLR [0.59 (0.14, 2.53), p=0.47], TVR [0.48 (0.11, 1.99), p=0.31], death [0.33 (0.01, 8.20), p=0.50] and MACE [0.41 (0.10, 1.63), p=0.21]. The adjusted indirect comparison found that there were no differences between ZES and BVS in the risk of TLR [1.92 (0.44, 8.31), p=0.61], TVR [2.19 (0.52, 9.14), p=0.29], death [2.70 (0.09, 78.53), p=0.75] and MACE [2.49 (0.61, 10.20), p=0.29]. Conclusion: In patients with CAD, BVS has similar safety and effectiveness as that of ZES. In the case of indirect comparison, ZES and BVS may have comparable results in their effectiveness and safety. Long-term and large-scale randomized studies are required to confirm the study results.
Abstract
Objectives: Recently bioresorbable coronary stent has emerged as new version of percutaneous coronary intervention (PCI) technology. The expected benefits of this new technology are the reduction of stent thrombosis and impairment of coronary vasomotion. However, the comparative outcomes between bioresorbable coronary stent and current drug-eluting stents (DESs) are not known. This study is aimed to compare the safety and effectiveness of emerging bioresorbable coronary stents - everolimus-eluting bioresorbable vascular scaffold (BVS) to the well accepted DES technology - zotarolimus-eluting stent (ZES) - through Systematic Review and Adjusted Indirect Comparison with everolimus eluting stents (EES) for coronary artery disease (CAD) treatments. Methods: A meta-analysis of clinical studies in which patients were randomly assigned to ZES versus EES or BVS versus EES were performed, as well as an indirect comparison of ZES versus EES, with EES common comparator. The primary endpoint was target lesion revascularization (TLR), while the secondary endpoints were a target vessel revascularization (TVR), a death, and a major adverse cardiac event (MACE). Results: Six clinical studies were identified with a total of 7512 patients. Treatments with ZES versus EES were not associated with significant reductions of the TLR [odds ratio (95% confidence interval)=1.13 (0.88, 1.47), p=0.34], TVR [1.05 (0.81, 1.37), p=0.72], death [0.89 (0.64, 1.25), p=0.51], MACE [1.02 (0.85, 1.23), p=0.79] and Stent Thrombosis (ST) [1.35 (0.91, 2.00), p=0.13] BVS versus EES therapy also were not associated with significant reductions of TLR [0.59 (0.14, 2.53), p=0.47], TVR [0.48 (0.11, 1.99), p=0.31], death [0.33 (0.01, 8.20), p=0.50] and MACE [0.41 (0.10, 1.63), p=0.21]. The adjusted indirect comparison found that there were no differences between ZES and BVS in the risk of TLR [1.92 (0.44, 8.31), p=0.61], TVR [2.19 (0.52, 9.14), p=0.29], death [2.70 (0.09, 78.53), p=0.75] and MACE [2.49 (0.61, 10.20), p=0.29]. Conclusion: In patients with CAD, BVS has similar safety and effectiveness as that of ZES. In the case of indirect comparison, ZES and BVS may have comparable results in their effectiveness and safety. Long-term and large-scale randomized studies are required to confirm the study results.
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