{"title":"在糖尿病患者中植入可生物降解聚合物涂层西罗莫司洗脱支架后的良好结果:来自INDOLIMUS-G糖尿病登记的结果。","authors":"Anurag Polavarapu, Raghava Sarma Polavarapu, Jayesh Prajapati, Asif Raheem, Kamlesh Thakkar, Shivani Kothari, Ashok Thakkar","doi":"10.1155/2015/265670","DOIUrl":null,"url":null,"abstract":"<p><p>Objective. The main aim is to evaluate safety, efficacy, and clinical performance of the Indolimus (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) sirolimus-eluting stent in high-risk diabetic population with complex lesions. Methods. It was a multicentre, retrospective, non-randomized, single-arm study, which enrolled 372 diabetic patients treated with Indolimus. The primary endpoint of the study was major adverse cardiac events (MACE), which is a composite of cardiac death, target lesion revascularization (TLR), target vessel revascularization (TVR), myocardial infarction (MI), and stent thrombosis (ST). The clinical follow-ups were scheduled at 30 days, 6 months, and 9 months. Results. The mean age of the enrolled patients was 53.4 ± 10.2 years. A total of 437 lesions were intervened successfully with 483 stents (1.1 ± 0.3 per lesion). There were 256 (68.8%) male patients. Hypertension and totally occluded lesions were found in 202 (54.3%) and 45 (10.3%) patients, respectively. The incidence of MACE at 30 days, 6 months and 9 months was 0 (0%), 6 (1.6%), and 8 (2.2%), respectively. The event-free survival at 9-month follow-up by Kaplan Meier method was found to be 97.8%. Conclusion. The use of biodegradable polymer coated sirolimus-eluting stent is associated with favorable outcomes. The results demonstrated in our study depict its safety and efficacy in diabetic population. </p>","PeriodicalId":14448,"journal":{"name":"International Journal of Vascular Medicine","volume":"2015 ","pages":"265670"},"PeriodicalIF":2.5000,"publicationDate":"2015-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1155/2015/265670","citationCount":"2","resultStr":"{\"title\":\"Favorable Outcomes after Implantation of Biodegradable Polymer Coated Sirolimus-Eluting Stents in Diabetic Population: Results from INDOLIMUS-G Diabetic Registry.\",\"authors\":\"Anurag Polavarapu, Raghava Sarma Polavarapu, Jayesh Prajapati, Asif Raheem, Kamlesh Thakkar, Shivani Kothari, Ashok Thakkar\",\"doi\":\"10.1155/2015/265670\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Objective. The main aim is to evaluate safety, efficacy, and clinical performance of the Indolimus (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) sirolimus-eluting stent in high-risk diabetic population with complex lesions. Methods. It was a multicentre, retrospective, non-randomized, single-arm study, which enrolled 372 diabetic patients treated with Indolimus. The primary endpoint of the study was major adverse cardiac events (MACE), which is a composite of cardiac death, target lesion revascularization (TLR), target vessel revascularization (TVR), myocardial infarction (MI), and stent thrombosis (ST). The clinical follow-ups were scheduled at 30 days, 6 months, and 9 months. Results. The mean age of the enrolled patients was 53.4 ± 10.2 years. A total of 437 lesions were intervened successfully with 483 stents (1.1 ± 0.3 per lesion). There were 256 (68.8%) male patients. Hypertension and totally occluded lesions were found in 202 (54.3%) and 45 (10.3%) patients, respectively. The incidence of MACE at 30 days, 6 months and 9 months was 0 (0%), 6 (1.6%), and 8 (2.2%), respectively. The event-free survival at 9-month follow-up by Kaplan Meier method was found to be 97.8%. Conclusion. The use of biodegradable polymer coated sirolimus-eluting stent is associated with favorable outcomes. The results demonstrated in our study depict its safety and efficacy in diabetic population. </p>\",\"PeriodicalId\":14448,\"journal\":{\"name\":\"International Journal of Vascular Medicine\",\"volume\":\"2015 \",\"pages\":\"265670\"},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2015-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1155/2015/265670\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Vascular Medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1155/2015/265670\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2015/9/2 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"PERIPHERAL VASCULAR DISEASE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Vascular Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1155/2015/265670","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2015/9/2 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"PERIPHERAL VASCULAR DISEASE","Score":null,"Total":0}
引用次数: 2
摘要
目标。主要目的是评估Indolimus (Sahajanand Medical Technologies Pvt. Ltd., Surat, India)西罗莫司洗脱支架在复杂病变的高危糖尿病人群中的安全性、有效性和临床表现。方法。这是一项多中心、回顾性、非随机、单组研究,纳入了372例接受吲哚莫司治疗的糖尿病患者。研究的主要终点是主要心脏不良事件(MACE),即心源性死亡、靶病变血运重建术(TLR)、靶血管血运重建术(TVR)、心肌梗死(MI)和支架血栓形成(ST)的复合。临床随访时间分别为30天、6个月和9个月。结果。入组患者的平均年龄为53.4±10.2岁。共成功介入437个病变,置入483个支架(每个病变1.1±0.3个)。男性256例(68.8%)。高血压202例(54.3%),病变完全闭塞45例(10.3%)。30天、6个月和9个月MACE发生率分别为0(0%)、6(1.6%)和8(2.2%)。Kaplan Meier法随访9个月无事件生存率为97.8%。结论。生物可降解聚合物涂层西罗莫司洗脱支架的使用与良好的结果相关。本研究结果显示了其在糖尿病人群中的安全性和有效性。
Favorable Outcomes after Implantation of Biodegradable Polymer Coated Sirolimus-Eluting Stents in Diabetic Population: Results from INDOLIMUS-G Diabetic Registry.
Objective. The main aim is to evaluate safety, efficacy, and clinical performance of the Indolimus (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) sirolimus-eluting stent in high-risk diabetic population with complex lesions. Methods. It was a multicentre, retrospective, non-randomized, single-arm study, which enrolled 372 diabetic patients treated with Indolimus. The primary endpoint of the study was major adverse cardiac events (MACE), which is a composite of cardiac death, target lesion revascularization (TLR), target vessel revascularization (TVR), myocardial infarction (MI), and stent thrombosis (ST). The clinical follow-ups were scheduled at 30 days, 6 months, and 9 months. Results. The mean age of the enrolled patients was 53.4 ± 10.2 years. A total of 437 lesions were intervened successfully with 483 stents (1.1 ± 0.3 per lesion). There were 256 (68.8%) male patients. Hypertension and totally occluded lesions were found in 202 (54.3%) and 45 (10.3%) patients, respectively. The incidence of MACE at 30 days, 6 months and 9 months was 0 (0%), 6 (1.6%), and 8 (2.2%), respectively. The event-free survival at 9-month follow-up by Kaplan Meier method was found to be 97.8%. Conclusion. The use of biodegradable polymer coated sirolimus-eluting stent is associated with favorable outcomes. The results demonstrated in our study depict its safety and efficacy in diabetic population.