Randomized Trial Comparing Two Sirolimus-Eluting Stents in Diabetes Mellitus (INC-DM)

National Institute of Cardiology Ignacio Chavez

Status: Enrolling

Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Diabetes Mellitus

Treatments: Device: Orsiro Sirolimus Eluting Coronary Stent System (OSES); Device: Abluminus Sirolimus Eluting Stent System (ASES)

Study type: Interventional

Funder types: Other

Identifiers

NCT04660240

INCAR-DG-DI-342-2020

Details and patient eligibility

About

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.

Full 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

Enrollment: 860 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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860 participants in 2 patient groups

Abluminus Sirolimus Eluting Stent System (ASES)

Active Comparator group

Description:

The Abluminus sirolimus eluting stent manufactured by Envision and distributed by Concept Medical.

Treatment:

Device: Abluminus Sirolimus Eluting Stent System (ASES)

Orsiro Sirolimus Eluting Coronary Stent System (OSES)

Experimental group

Description:

The Orsiro sirolimus eluting stent manufactured by Biotronik.

Treatment:

Device: Orsiro Sirolimus Eluting Coronary Stent System (OSES)