Randomized Trial Investigating Clinical Outcomes of Two Sirolimus-Eluting Stents in Diabetes Mellitus (INC-DM)

  • STATUS
    Recruiting
  • End date
    Sep 1, 2024
  • participants needed
    860
  • sponsor
    Instituto Nacional de Cardiologia Ignacio Chavez
Updated on 28 October 2022
diabetes
angiography
stenosis
sirolimus
fasting
hba1c
percutaneous coronary intervention
ischemia
hemoglobin a1c

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

Details
Condition Diabetes Mellitus, Coronary Artery Disease, Acute Coronary Syndrome
Treatment Abluminus Sirolimus Eluting Stent System (ASES), Orsiro Sirolimus Eluting Coronary Stent System (OSES)
Clinical Study IdentifierNCT04660240
SponsorInstituto Nacional de Cardiologia Ignacio Chavez
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

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
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