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":null,"pages":null},"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. 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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.
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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