Randomized Trial Comparing Two Sirolimus-Eluting Stents in Diabetes Mellitus

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.

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

Conditions5

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