Waiel Abusnina, Brian C Case, Cheng Zhang, Kalyan R Chitturi, Vaishnavi Sawant, Abhishek Chaturvedi, Dan Haberman, Lior Lupu, Jospeh A Sutton, Syed W Ali, Teshome Deksissa, Shreejana Pokharel, Sevket T Ozturk, Adrian Margulies, Itsik Ben-Dor, Hayder D Hashim, Lowell F Satler, Hector M Garcia-Garcia, Ron Waksman
{"title":"生物可降解与耐久性聚合物涂层依维莫司洗脱支架在上市后真实世界研究中的长期临床结果。","authors":"Waiel Abusnina, Brian C Case, Cheng Zhang, Kalyan R Chitturi, Vaishnavi Sawant, Abhishek Chaturvedi, Dan Haberman, Lior Lupu, Jospeh A Sutton, Syed W Ali, Teshome Deksissa, Shreejana Pokharel, Sevket T Ozturk, Adrian Margulies, Itsik Ben-Dor, Hayder D Hashim, Lowell F Satler, Hector M Garcia-Garcia, Ron Waksman","doi":"10.1002/ccd.31292","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Long-term clinical data on biodegradable-polymer (BP) drug-eluting stents (DES) are limited. The objective of this study was to assess the long-term safety and efficacy of the BP-DES SYNERGY compared to XIENCE V, a durable-polymer (DP)-DES.</p><p><strong>Methods: </strong>We compared patients treated with BP-DES or DP-DES at our center from 2008 to 2020. The primary outcome was major adverse cardiac events (MACE), defined as the composite of all-cause death, Q-wave myocardial infarction (MI), and target vessel revascularization (TVR). Secondary endpoints were all-cause death, Q-wave MI, target lesion revascularization (TLR), and stent thrombosis (ST).</p><p><strong>Results: </strong>A total of 4255 patients underwent propensity-score matching, and 380 patients from each cohort were matched. There was no significant difference between BP-DES and DP-DES concerning MACE (5-year estimates: 21.6% vs. 26.6%, log-rank p = 0.259). Furthermore, there was no difference in the TLR rate (5-year estimates: 7.3% vs. 8.6%, log-rank p = 0.781). All-cause death (5-year estimates: 13.6% vs. 12.9%, log-rank p = 0.72) and Q-wave MI (5-year estimates: 0.53% vs. 1.7%, log-rank p = 0.427) were also comparable between the two groups. Of note, the rate of very late ST was very low and similar between the groups (5-year estimates: 0.26% vs. 0.64%, log-rank p = 0.698).</p><p><strong>Conclusion: </strong>BP-DES and DP-DES demonstrate similar safety and efficacy at 5-year follow-up. 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All-cause death (5-year estimates: 13.6% vs. 12.9%, log-rank p = 0.72) and Q-wave MI (5-year estimates: 0.53% vs. 1.7%, log-rank p = 0.427) were also comparable between the two groups. Of note, the rate of very late ST was very low and similar between the groups (5-year estimates: 0.26% vs. 0.64%, log-rank p = 0.698).</p><p><strong>Conclusion: </strong>BP-DES and DP-DES demonstrate similar safety and efficacy at 5-year follow-up. Both can be used for the effective treatment of coronary artery disease.</p>\",\"PeriodicalId\":9650,\"journal\":{\"name\":\"Catheterization and Cardiovascular Interventions\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2024-11-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Catheterization and Cardiovascular Interventions\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/ccd.31292\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Catheterization and Cardiovascular Interventions","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/ccd.31292","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
摘要
背景：生物可降解聚合物（BP）药物洗脱支架（DES）的长期临床数据有限。本研究旨在评估BP-DES SYNERGY与耐久性聚合物（DP）-DES XIENCE V相比的长期安全性和有效性：我们对 2008 年至 2020 年在本中心接受 BP-DES 或 DP-DES 治疗的患者进行了比较。主要结局是主要心脏不良事件（MACE），定义为全因死亡、Q波心肌梗死（MI）和靶血管血运重建（TVR）的综合结果。次要终点为全因死亡、Q波心肌梗死、靶病变血管再通（TLR）和支架血栓形成（ST）：共有 4255 名患者进行了倾向分数匹配，每个队列中有 380 名患者进行了匹配。BP-DES 和 DP-DES 在 MACE 方面没有明显差异（5 年估计值：21.6% 对 26.6%，对数秩 P = 0.259）。此外，TLR 率也没有差异（5 年估计值：7.3% 对 8.6%，log-rank p = 0.781）。两组的全因死亡率（5 年估计值：13.6% 对 12.9%，对数秩 p = 0.72）和 Q 波 MI（5 年估计值：0.53% 对 1.7%，对数秩 p = 0.427）也相当。值得注意的是，极晚期 ST 的发生率非常低，且两组之间的发生率相似（5 年估计值：0.26% vs. 0.64%，log-rank p = 0.698）：结论：BP-DES 和 DP-DES 在 5 年随访中表现出相似的安全性和有效性。结论：BP-DES 和 DP-DES 在 5 年随访中显示出相似的安全性和有效性，两者都可用于冠心病的有效治疗。
Long-Term Clinical Outcomes of Biodegradable- Versus Durable-Polymer-Coated Everolimus-Eluting Stents in Real-World Post-Marketing Study.
Background: Long-term clinical data on biodegradable-polymer (BP) drug-eluting stents (DES) are limited. The objective of this study was to assess the long-term safety and efficacy of the BP-DES SYNERGY compared to XIENCE V, a durable-polymer (DP)-DES.
Methods: We compared patients treated with BP-DES or DP-DES at our center from 2008 to 2020. The primary outcome was major adverse cardiac events (MACE), defined as the composite of all-cause death, Q-wave myocardial infarction (MI), and target vessel revascularization (TVR). Secondary endpoints were all-cause death, Q-wave MI, target lesion revascularization (TLR), and stent thrombosis (ST).
Results: A total of 4255 patients underwent propensity-score matching, and 380 patients from each cohort were matched. There was no significant difference between BP-DES and DP-DES concerning MACE (5-year estimates: 21.6% vs. 26.6%, log-rank p = 0.259). Furthermore, there was no difference in the TLR rate (5-year estimates: 7.3% vs. 8.6%, log-rank p = 0.781). All-cause death (5-year estimates: 13.6% vs. 12.9%, log-rank p = 0.72) and Q-wave MI (5-year estimates: 0.53% vs. 1.7%, log-rank p = 0.427) were also comparable between the two groups. Of note, the rate of very late ST was very low and similar between the groups (5-year estimates: 0.26% vs. 0.64%, log-rank p = 0.698).
Conclusion: BP-DES and DP-DES demonstrate similar safety and efficacy at 5-year follow-up. Both can be used for the effective treatment of coronary artery disease.
期刊介绍：
Catheterization and Cardiovascular Interventions is an international journal covering the broad field of cardiovascular diseases. Subject material includes basic and clinical information that is derived from or related to invasive and interventional coronary or peripheral vascular techniques. The journal focuses on material that will be of immediate practical value to physicians providing patient care in the clinical laboratory setting. To accomplish this, the journal publishes Preliminary Reports and Work In Progress articles that complement the traditional Original Studies, Case Reports, and Comprehensive Reviews. Perspective and insight concerning controversial subjects and evolving technologies are provided regularly through Editorial Commentaries furnished by members of the Editorial Board and other experts. Articles are subject to double-blind peer review and complete editorial evaluation prior to any decision regarding acceptability.
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