高危患者和糖尿病患者的药物涂层球囊:10 项研究的荟萃分析。

IF 2.1 3区 医学 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS
Monica Verdoia, Matteo Nardin, Andrea Rognoni, Bernardo Cortese
{"title":"高危患者和糖尿病患者的药物涂层球囊:10 项研究的荟萃分析。","authors":"Monica Verdoia, Matteo Nardin, Andrea Rognoni, Bernardo Cortese","doi":"10.1002/ccd.31257","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Despite the improvements in drug eluting stents (DES) technology, suboptimal results have been observed in certain higher-risk subsets of patients, as in diabetes mellitus (DM). Drug-coated balloons (DCB) could represent an alternative to DES in complex populations and anatomies, as in DM.</p><p><strong>Aims: </strong>The present meta-analysis aimed at assessing the role of DCBs in patients with diabetes mellitus.</p><p><strong>Methods: </strong>Studies comparing DCB versus percutaneous coronary revascularization (PCI) with/without DES for PCI in high-risk populations (>30% DM) were included. The primary efficacy endpoint was overall mortality, secondary endpoints were myocardial infarction, target lesion revascularization (TLR), and major adverse cardiovascular events (MACE).</p><p><strong>Results: </strong>We included 10 studies, comprising 2026 patients. Among them, 1002 patients (49.5%) were treated with DCB and 1024 with DES implantation. Among the included studies, 6 only enrolled diabetic patients and 2 had a prevalence of diabetes of 50%. At a mean follow-up of 15.3 months, mortality rate was 3.8% (82 patients), significantly lower with DCB (3.2% vs. 4.9% with DES; odds ratio [OR] [95% confidence interval {CI}] = 0.61 [0.38, 0.97], p = 0.04 p<sub>het</sub> = 0.34. A similar reduction in favor of DCB was observed for MACE (13.6% vs. 17.6%; OR [95% CI] = 0.79 [0.61, 1.04], p = 0.09, p<sub>het</sub> = 0.25), while TLR was significantly reduced only in the diabetic-restricted sub-analysis.</p><p><strong>Conclusion: </strong>In the present meta-analysis, we showed a significant survival benefit and an absolute reduction in MACE and TLR with a DCB-based strategy as compared to DES in high-risk patients, mostly with DM. Future large-scale randomized trials, dedicated to this population, are deserved to confirm our findings.</p><p><strong>What is known: </strong>Complex coronary anatomies and diabetes mellitus (DM) represent the pitfall of drug eluting stents (DES), mainly due to inflammatory and thrombotic complications, which should be reduced with drug-coated balloons (DCB).</p><p><strong>What is new: </strong>We confirmed a significant advantage of DCB versus DES in the treatment of de novo lesions in high-risk patients and mainly in DM, reducing overall mortality, MACE and target lesion revascularization.</p>","PeriodicalId":9650,"journal":{"name":"Catheterization and Cardiovascular Interventions","volume":" ","pages":""},"PeriodicalIF":2.1000,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Drug-coated balloons in high-risk patients and diabetes mellitus: A meta-analysis of 10 studies.\",\"authors\":\"Monica Verdoia, Matteo Nardin, Andrea Rognoni, Bernardo Cortese\",\"doi\":\"10.1002/ccd.31257\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Despite the improvements in drug eluting stents (DES) technology, suboptimal results have been observed in certain higher-risk subsets of patients, as in diabetes mellitus (DM). Drug-coated balloons (DCB) could represent an alternative to DES in complex populations and anatomies, as in DM.</p><p><strong>Aims: </strong>The present meta-analysis aimed at assessing the role of DCBs in patients with diabetes mellitus.</p><p><strong>Methods: </strong>Studies comparing DCB versus percutaneous coronary revascularization (PCI) with/without DES for PCI in high-risk populations (>30% DM) were included. The primary efficacy endpoint was overall mortality, secondary endpoints were myocardial infarction, target lesion revascularization (TLR), and major adverse cardiovascular events (MACE).</p><p><strong>Results: </strong>We included 10 studies, comprising 2026 patients. Among them, 1002 patients (49.5%) were treated with DCB and 1024 with DES implantation. Among the included studies, 6 only enrolled diabetic patients and 2 had a prevalence of diabetes of 50%. At a mean follow-up of 15.3 months, mortality rate was 3.8% (82 patients), significantly lower with DCB (3.2% vs. 4.9% with DES; odds ratio [OR] [95% confidence interval {CI}] = 0.61 [0.38, 0.97], p = 0.04 p<sub>het</sub> = 0.34. A similar reduction in favor of DCB was observed for MACE (13.6% vs. 17.6%; OR [95% CI] = 0.79 [0.61, 1.04], p = 0.09, p<sub>het</sub> = 0.25), while TLR was significantly reduced only in the diabetic-restricted sub-analysis.</p><p><strong>Conclusion: </strong>In the present meta-analysis, we showed a significant survival benefit and an absolute reduction in MACE and TLR with a DCB-based strategy as compared to DES in high-risk patients, mostly with DM. Future large-scale randomized trials, dedicated to this population, are deserved to confirm our findings.</p><p><strong>What is known: </strong>Complex coronary anatomies and diabetes mellitus (DM) represent the pitfall of drug eluting stents (DES), mainly due to inflammatory and thrombotic complications, which should be reduced with drug-coated balloons (DCB).</p><p><strong>What is new: </strong>We confirmed a significant advantage of DCB versus DES in the treatment of de novo lesions in high-risk patients and mainly in DM, reducing overall mortality, MACE and target lesion revascularization.</p>\",\"PeriodicalId\":9650,\"journal\":{\"name\":\"Catheterization and Cardiovascular Interventions\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2024-10-28\",\"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.31257\",\"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.31257","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:尽管药物洗脱支架(DES)技术有所改进,但在糖尿病(DM)等某些高风险亚组患者中观察到的结果并不理想。目的:本荟萃分析旨在评估药物涂层球囊(DCB)在糖尿病患者中的作用:方法:纳入对高危人群(DM>30%)PCI中使用/不使用DES的DCB与经皮冠状动脉血运重建术(PCI)进行比较的研究。主要疗效终点是总死亡率,次要终点是心肌梗死、靶病变血运重建(TLR)和主要不良心血管事件(MACE):我们纳入了 10 项研究,共有 2026 名患者。其中,1002 名患者(49.5%)接受了 DCB 治疗,1024 名患者接受了 DES 植入治疗。在纳入的研究中,有 6 项研究只纳入了糖尿病患者,其中 2 项研究的糖尿病患病率为 50%。在平均 15.3 个月的随访中,死亡率为 3.8%(82 名患者),DCB 明显降低(3.2% 对 4.9% DES;几率比 [OR] [95% 置信区间 {CI}] = 0.61 [0.38, 0.97],P = 0.04 Phet = 0.34)。在MACE(13.6% vs. 17.6%;OR [95% CI] = 0.79 [0.61, 1.04],p = 0.09,phet = 0.25)方面也观察到了类似的有利于DCB的降低,而TLR仅在糖尿病限制的子分析中显著降低:在本荟萃分析中,我们发现在高危患者(主要是糖尿病患者)中,与DES相比,基于DCB的策略具有显著的生存获益,MACE和TLR的绝对值降低。未来专门针对这一人群的大规模随机试验应能证实我们的研究结果:新发现:我们证实,在治疗高危患者(主要是糖尿病患者)的新生病变时,DCB与DES相比具有显著优势,可降低总死亡率、MACE和靶病变血运重建率。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Drug-coated balloons in high-risk patients and diabetes mellitus: A meta-analysis of 10 studies.

Background: Despite the improvements in drug eluting stents (DES) technology, suboptimal results have been observed in certain higher-risk subsets of patients, as in diabetes mellitus (DM). Drug-coated balloons (DCB) could represent an alternative to DES in complex populations and anatomies, as in DM.

Aims: The present meta-analysis aimed at assessing the role of DCBs in patients with diabetes mellitus.

Methods: Studies comparing DCB versus percutaneous coronary revascularization (PCI) with/without DES for PCI in high-risk populations (>30% DM) were included. The primary efficacy endpoint was overall mortality, secondary endpoints were myocardial infarction, target lesion revascularization (TLR), and major adverse cardiovascular events (MACE).

Results: We included 10 studies, comprising 2026 patients. Among them, 1002 patients (49.5%) were treated with DCB and 1024 with DES implantation. Among the included studies, 6 only enrolled diabetic patients and 2 had a prevalence of diabetes of 50%. At a mean follow-up of 15.3 months, mortality rate was 3.8% (82 patients), significantly lower with DCB (3.2% vs. 4.9% with DES; odds ratio [OR] [95% confidence interval {CI}] = 0.61 [0.38, 0.97], p = 0.04 phet = 0.34. A similar reduction in favor of DCB was observed for MACE (13.6% vs. 17.6%; OR [95% CI] = 0.79 [0.61, 1.04], p = 0.09, phet = 0.25), while TLR was significantly reduced only in the diabetic-restricted sub-analysis.

Conclusion: In the present meta-analysis, we showed a significant survival benefit and an absolute reduction in MACE and TLR with a DCB-based strategy as compared to DES in high-risk patients, mostly with DM. Future large-scale randomized trials, dedicated to this population, are deserved to confirm our findings.

What is known: Complex coronary anatomies and diabetes mellitus (DM) represent the pitfall of drug eluting stents (DES), mainly due to inflammatory and thrombotic complications, which should be reduced with drug-coated balloons (DCB).

What is new: We confirmed a significant advantage of DCB versus DES in the treatment of de novo lesions in high-risk patients and mainly in DM, reducing overall mortality, MACE and target lesion revascularization.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
5.40
自引率
8.70%
发文量
419
审稿时长
2 months
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.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信