Clinical trial NCT04660240: Randomized Trial Comparing Two Sirolimus-Eluting Stents in Diabetes Mellitus
Official title: Randomized Trial Investigating Clinical Outcomes of Two Sirolimus-Eluting Stents in Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Coronary Artery Disease
Acute Coronary Syndrome
Keywords: Diabetes Mellitus
Albuminus
Orsiro
Percutaneous coronary intervention
Lead sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 860
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Diabetic patients undergoing percutaneous coronary intervention in de novo lesions are going to be randomized to two groups. One will have percutaneous coronary intervention with Abluminus sirolimus eluting stent implantation, and the other will have percutaneous coronary intervention with Orsiro Sirolimus Eluting stent implantation. The implantation of both stents will be guided by angiography only. In a subgroup of both arms (100 patients per group) the implantation will be also guided by intravascular ultrasound.
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Target Lesion Failure (TLF)
timeFrame: 12 months
Secondary outcomes:
measure: Cardiovascular Death
timeFrame: 12 months
measure: Myocardial Infarction (MI)
timeFrame: 12 months
measure: Target Lesion Revascularization (TLR)
timeFrame: 12 months
measure: Target vessel revascularization (TVR)
timeFrame: 12 months
measure: Target vessel failure (TVF)
timeFrame: 12 months
measure: Death caused by other cardiovascular causes.
timeFrame: 12 months
measure: Rate of in-stent restenosis (ISR)
timeFrame: 12 months
measure: Rate of stent thrombosis (ST)
timeFrame: 12 months
measure: Major bleeding
timeFrame: 12 months
measure: Rate of Cerebrovascular Event
timeFrame: 12 months
measure: Contrast Nephropathy
timeFrame: 48 hours
measure: Technical Success
timeFrame: 12 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cardiología Ignacio Chávez
state: Tlalpan
Study officials:
affiliation: Instituto Nacional de Cardiología Ignacio Chávez
name: Guering Eid Lidt, MD
role: STUDY_DIRECTOR
affiliation: Instituto Nacional de Cardiología Ignacio Chávez
name: Julio I Farjat Pasos, MD MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Cardiología Ignacio Chávez
name: Walter O Magaña Ornelas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Cardiología Ignacio Chávez
name: Alejandra D Portillo Romero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Cardiología Ignacio Chávez
name: José A Ayón Martínez, MD
role: PRINCIPAL_INVESTIGATOR
References: