Randomized Trial Investigating Clinical Outcomes of Two Sirolimus-Eluting Stents in Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 860
- 试验地点
- 2
- 主要终点
- Rate of Target Lesion Failure (TLF)
研究概览
简要总结
Randomized, controlled, blind, single-center and non-inferiority clinical trial to compare the target lesion failure (TLF) at 12 months in patients with diabetes mellitus who underwent percutaneous coronary intervention with an Orsiro stent vs. Abluminus stent.
详细描述
Worldwide, and especially in Mexico, there is a high incidence of diabetes mellitus (DM), which in turn, confers a higher cardiovascular risk in this population. Diabetic patients undergoing PCI have worse outcomes than non-diabetics regardless of the degree of complexity of their coronary anatomy. Although the 30-day in-hospital outcomes have been similar between diabetic and non-diabetic patients, DM has been invariably associated with greater stent failure with target vessel revascularization (TVR), major adverse cardiovascular event (MACE), and mortality in the long-term follow-up, even with the use of drug-eluting stents. In relation to the above, two of the sirolimus-eluting stents (SES): the Abluminus and the Orsiro, have been considered as promising options in patients with DM. The Abluminus stent has been designed for diabetic patients in order to reduce cardiovascular events. Said stent consists of a cobalt-chromium platform covered with a layer of biodegradable polymer and mounted on a balloon, both sirolimus-releasing. The Rate of target lesion failure (TLF) reported to date in diabetic patients is 3.8%. On the other hand, the Orsiro stent, a cobalt-chromium platform with ultrathin struts, has had favorable results in different clinical settings and patients with different characteristics]; specifically in a subgroup analysis in DM, a TLF rate of 3.5% was reported
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over 18 years of age.
- •Provide informed consent and agree to follow up as stipulated in the protocol.
- •Diabetes mellitus. Whether it is DM 1 or 2 previously diagnosed or newly diagnosed by:
- •Fasting glucose> 126 mg / dl (for study terms, fasting will be defined as the absence of caloric intake for> 8 hours)
- •Tolerance curve to glucose (75 grams of glucose orally) with a glycemia at 2 hours> 200 mg / dl or,
- •HbA1C> 6.5%.
- •Coronary artery disease including chronic coronary syndrome, silent ischemia, or non-ST-segment elevation acute coronary ischemic syndrome.
- •Presence of 1 or more de novo coronary lesions in native coronary arteries with a site of maximum stenosis> 50% that may be amenable to stenting; without limitation in the number of lesions or vessels affected.
排除标准
- •Cardiogenic shock.
- •Allergy to acetylsalicylic acid, clopidogrel, ticagrelor, prasugrel, heparin, sirolimus or contrast medium, which cannot be adequately premedicated.
- •Acute ST-segment elevation myocardial infarction candidate for primary or urgent coronary angioplasty.
- •Left main coronary artery disease.
- •In-stent restenosis.
- •Lesions in venous or arterial grafts.
- •Surgery (cardiac or non-cardiac) planned within 6 months of PCI, unless dual antiplatelet therapy can be continued in the periprocedural period.
- •Inability to provide informed consent.
- •Life expectancy <1 year
结局指标
主要结局
Rate of Target Lesion Failure (TLF)
时间窗: 12 months
To compare the rate of target lesion failure (composed of cardiovascular death, myocardial infarction related to the treated vessel or ischemia driven target lesion revascularization)
次要结局
- Target vessel failure (TVF)(12 months)
- Rate of in-stent restenosis (ISR)(12 months)
- Target vessel revascularization (TVR)(12 months)
- Rate of stent thrombosis (ST)(12 months)
- Cardiovascular Death(12 months)
- Myocardial Infarction (MI)(12 months)
- Target Lesion Revascularization (TLR)(12 months)
- Death caused by other cardiovascular causes.(12 months)
- Major bleeding(12 months)
- Rate of Cerebrovascular Event(12 months)
- Contrast Nephropathy(48 hours)
- Technical Success(12 months)
研究者
Julio Ivan Farjat Pasos
Co-Principal Investigator
Instituto Nacional de Cardiologia Ignacio Chavez