Randomized Trial Comparing Two Sirolimus-Eluting Stents in Diabetes Mellitus

Coronary Artery Disease Clinical Trial

— INC-DM  

Official title:

Randomized Trial Investigating Clinical Outcomes of Two Sirolimus-Eluting Stents in Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04660240
• Other study ID #: INCAR-DG-DI-342-2020
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 1, 2025

Study information

• Verified date: February 2024
• Source: Instituto Nacional de Cardiologia Ignacio Chavez
• Contact: Alejandra D Portillo Romero, MD
• Phone: +52 55 5573 2911
• Email: aleportilloromero[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 860
• Est. completion date: September 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Diabetes Mellitus

Intervention

Device:
• Abluminus Sirolimus Eluting Stent System (ASES)
The procedure will be conducted in accordance with the CE mark instructions for use for the ASES. The need or not for postdilation in any segment of the stent will be at the discretion of the operator, seeking its adequate expansion and apposition. To consider PCI to be successful, residual stenosis must be less than or equal to 30% by angiography at the end of the procedure, including the absence of coronary dissection that compromises distal flow or a hemodynamically significant pressure gradient across the lesion.
• Orsiro Sirolimus Eluting Coronary Stent System (OSES)
The procedure will be conducted in accordance with the CE mark instructions for use for the OSES. The need or not for postdilation in any segment of the stent will be at the discretion of the operator, seeking its adequate expansion and apposition. To consider PCI to be successful, residual stenosis must be less than or equal to 30% by angiography at the end of the procedure, including the absence of coronary dissection that compromises distal flow or a hemodynamically significant pressure gradient across the lesion.

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Cardiología Ignacio Chávez	Mexico City	Tlalpan

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cardiologia Ignacio Chavez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Target Lesion Failure (TLF)	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)	12 months
Secondary	Cardiovascular Death	Cardiovascular death is defined as death resulting from cardiovascular causes. The following categories may be collected: Death caused by acute MI; Death caused by sudden cardiac, including unwitnessed, death; Death resulting from heart failure; Death caused by stroke; Death caused by cardiovascular procedures; Death resulting from cardiovascular hemorrhage; Death resulting from other cardiovascular cause; Any MI not clearly attributable to a non-target vessel will be considered as target-vessel MI.; Percutaneous coronary intervention (PCI) related MI is termed type 4a MI.; Coronary artery bypass grafting (CABG) related MI is termed type 5 MI. Revascularization is clinically driven if the target lesion diameter stenosis is > 50% by quantitative coronary angiography (QCA) and the subject has clinical or functional ischemia which cannot be explained by another native coronary or bypass graft lesion.	12 months
Secondary	Myocardial Infarction (MI)	Compare the myocardial infarction related to the treated vessel between both groups.; (according to the 4th international definition of myocardial infarction) detection of an increase or decrease in cardiac troponin values with at least 1 of the values above the upper reference limit of the 99th percentile and at least 1 of the following conditions : Symptoms of acute myocardial ischemia.; New ischemic changes in the electrocardiogram.; Appearance of pathological Q waves.; Imaging evidence of loss of viable myocardium or new regional abnormalities in myocardial wall mobility following a pattern compatible with ischemic etiology.; Identification of a coronary thrombus by angiography with intracoronary imaging or by autopsy; Any MI that cannot be clearly attributed to a vessel other than the revascularized one will be considered as MI related to the treated vessel.	12 months
Secondary	Target Lesion Revascularization (TLR)	Revascularization is clinically driven if the target lesion diameter stenosis is > 50% by quantitative coronary angiography (QCA) and the subject has clinical or functional ischemia which cannot be explained by another native coronary or bypass graft lesion.	12 months
Secondary	Target vessel revascularization (TVR)	TVR is a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.	12 months
Secondary	Target vessel failure (TVF)	To compare the rate of target vessel failure (composed of cardiovascular death, myocardial infarction related to the treated vessel or ischemia driven target vessel revascularization)	12 months
Secondary	Death caused by other cardiovascular causes.	Compare death from any cause between the two groups.; The following categories will be collected: Malignancy.; Pulmonary causes.; Infection.; Gastrointestinal causes.; Accident / trauma.; Caused by failure of another non-cardiovascular organ.; Other non-cardiovascular causes.; Death that cannot be attributed to any of the aforementioned categories due to lack of information will be considered cardiovascular in terms of study outcomes.	12 months
Secondary	Rate of in-stent restenosis (ISR)	Compare the rate of stent edge restenosis between both groups. Stenosis> 50% of the diameter and one or more of the following: symptoms suggestive of ischemia, electrocardiographic changes suggestive of ischemia, significant pressure gradient across the lesion; or a> 70% reduction in luminal area, even in the absence of data suggestive of ischemia.; The categories will be collected according to the Waksman In-Stent Restenosis Classification: Type I: mechanical; IA Underexpansion; IIA Stent fracture; Type II: Biologic; IIA Intimal hyperplasia; IIB Neoatherosclerosis, noncalcified; IIC Neoatherosclerosis, calcified; Type III: Mixed pattern: Combined mechanical and biologic etiology; Type IV: Chronic total occlusion; Type V: >2 layers of stent	12 months
Secondary	Rate of stent thrombosis (ST)	Compare the rate of stent thrombosis between both groups, According to the definition of the Academic Research Consortium (ARC) -2: Definitive thrombosis.; Probable thrombosis.; Silent occlusion.; Temporality: acute (0-24 hours), subacute (> 24 hours to 30 days), late (> 30 days to 1 year) and very late (> 1 year).	12 months
Secondary	Major bleeding	Compare the incidence of bleeding complications according to The Bleeding Academic Research Consortium 2 (BARC-2) scale: 3 or greater.	12 months
Secondary	Rate of Cerebrovascular Event	Compare the rate of cerebrovascular event between both groups according to Neuro-ARC stroke/ Transient ischemic attack (TIA) criteria.	12 months
Secondary	Contrast Nephropathy	Creatinine increase >0.5 mg / dl or >25% over baseline at 48 hours after the procedure.	48 hours
Secondary	Technical Success	Technical success is defined as the ability to cross the occluded segment with both a wire and a balloon, and successfully open the artery; the restoration of antegrade Thrombolysis In Myocardial Infarction (TIMI) flow 2 or 3 and a <30% residual stenosis.	12 months