PDF(Pubmed)
Abstract：
UNASSIGNED: Patients with diabetes mellitus (DM) have worse outcomes following percutaneous coronary intervention than nondiabetic patients. The novel Supreme DES is a biodegradable polymer sirolimus-eluting stent designed to synchronize early drug delivery, limiting the potential for long-term inflammatory response. The purpose of this study was to evaluate the safety and efficacy of the Supreme DES in patients with DM.
UNASSIGNED: This is a prespecified analysis of the diabetic subgroup from the PIONEER III randomized (2:1), controlled trial, comparing the Supreme DES with a durable polymer everolimus-eluting stent (DP-EES). The primary safety and efficacy composite endpoint was target lesion failure at 1 year, a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization.
UNASSIGNED: The PIONEER III trial randomized 1629 patients, of which 494 (30.3%) had DM with 331 (398 lesions) randomly assigned to Supreme DES and 163 (208 lesions) to DP-EES. Among patients with DM, target lesion failure at 1 year was 6.1% (20/331) with Supreme DES vs 3.7% (6/163) with DP-EES (hazard ratio = 1.65; 95% confidence interval = 0.66-4.10, P = .28). The composite of cardiac death or target vessel myocardial infarction was 3.3% (11/331) with Supreme DES and 3.7% (6/163) with DP-EES (hazard ratio = 0.90; 95% confidence interval = 0.33-2.44, P = .83). There were no significant differences in other secondary endpoints.
UNASSIGNED: This prespecified substudy of the PIONEER III trial demonstrated the relative safety and efficacy of the novel Supreme DES when compared with commercially available DP-EES in diabetics at 1 year. Longer term follow-up will be required to ensure continued safety and efficacy of the Supreme DES.
UNASSIGNED: This is a prespecified analysis of the diabetic subgroup from the PIONEER III randomized (2:1), controlled trial, comparing the Supreme DES with a durable polymer everolimus-eluting stent (DP-EES). The primary safety and efficacy composite endpoint was target lesion failure at 1 year, a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization.
UNASSIGNED: The PIONEER III trial randomized 1629 patients, of which 494 (30.3%) had DM with 331 (398 lesions) randomly assigned to Supreme DES and 163 (208 lesions) to DP-EES. Among patients with DM, target lesion failure at 1 year was 6.1% (20/331) with Supreme DES vs 3.7% (6/163) with DP-EES (hazard ratio = 1.65; 95% confidence interval = 0.66-4.10, P = .28). The composite of cardiac death or target vessel myocardial infarction was 3.3% (11/331) with Supreme DES and 3.7% (6/163) with DP-EES (hazard ratio = 0.90; 95% confidence interval = 0.33-2.44, P = .83). There were no significant differences in other secondary endpoints.
UNASSIGNED: This prespecified substudy of the PIONEER III trial demonstrated the relative safety and efficacy of the novel Supreme DES when compared with commercially available DP-EES in diabetics at 1 year. Longer term follow-up will be required to ensure continued safety and efficacy of the Supreme DES.
摘要：
■患有糖尿病（DM）的患者在经皮冠状动脉介入治疗后的结果比非糖尿病患者差。新型SupremeDES是一种可生物降解的聚合物西罗莫司洗脱支架，旨在同步早期药物输送，限制长期炎症反应的可能性。这项研究的目的是评估SupremeDES在DM患者中的安全性和有效性。
■这是来自PIONEERIII随机（2：1）的糖尿病亚组的预设分析，对照试验,比较SupremeDES与耐用的聚合物依维莫司洗脱支架（DP-EES）。主要的安全性和有效性复合终点是1年的目标病变失败，心脏死亡的复合物，靶血管心肌梗死,或临床驱动的靶病变血运重建。
■PIONEERIII试验将1629名患者随机分组，其中494例(30.3%)患有DM,331例(398个病灶)被随机分配至SupremeDES,163例(208个病灶)被随机分配至DP-EES.在DM患者中，SupremeDES治疗1年目标病变失败为6.1%(20/331),DP-EES治疗为3.7%(6/163)(风险比=1.65;95%置信区间=0.66-4.10,P=.28).最高DES和DP-EES的心源性死亡或靶血管心肌梗死的复合率为3.3％（11/331），DP-EES的复合率为3.7％（6/163）（风险比=0.90；95％置信区间=0.33-2.44，P=.83）。其他次要终点无显著差异。
■这项PIONEERIII试验的预设子研究证明了新型SupremeDES在1年糖尿病患者中与市售DP-EES相比的相对安全性和有效性。需要长期随访以确保SupremeDES的持续安全性和有效性。
■这是来自PIONEERIII随机（2：1）的糖尿病亚组的预设分析，对照试验,比较SupremeDES与耐用的聚合物依维莫司洗脱支架（DP-EES）。主要的安全性和有效性复合终点是1年的目标病变失败，心脏死亡的复合物，靶血管心肌梗死,或临床驱动的靶病变血运重建。
■PIONEERIII试验将1629名患者随机分组，其中494例(30.3%)患有DM,331例(398个病灶)被随机分配至SupremeDES,163例(208个病灶)被随机分配至DP-EES.在DM患者中，SupremeDES治疗1年目标病变失败为6.1%(20/331),DP-EES治疗为3.7%(6/163)(风险比=1.65;95%置信区间=0.66-4.10,P=.28).最高DES和DP-EES的心源性死亡或靶血管心肌梗死的复合率为3.3％（11/331），DP-EES的复合率为3.7％（6/163）（风险比=0.90；95％置信区间=0.33-2.44，P=.83）。其他次要终点无显著差异。
■这项PIONEERIII试验的预设子研究证明了新型SupremeDES在1年糖尿病患者中与市售DP-EES相比的相对安全性和有效性。需要长期随访以确保SupremeDES的持续安全性和有效性。
