Acute Coronary Syndrome, Coronary Artery Disease, Diabetes
Conditions
Brief summary
To compare in diabetic patients eligible for percutaneous coronary intervention (PCI) with minimal exclusion criteria, the efficacy and safety of Abluminus DES+ sirolimus- eluting stents (SES) versus XIENCE Everolimus-Eluting Stents (EES). At least 40% of patients are expected to be affected by multivessel coronary artery disease and 30% with acute coronary syndrome
Detailed description
This study aims to determine which DES will best treat the diabetic population. Specifically, the research question of this trial is to evaluate the use of a novel sirolimus-eluting stent coated with drug-eluting polymer after crimping on the balloon as compared to the standard-of-care EES in the treatment of de novo coronary artery disease in patients with diabetes mellitus. ABILITY is a prospective, multi-center, multinational, randomized, open label, 2-arm parallel group, post-approval study.
Interventions
DEVICEAbluminus DES+ Sirolimus Eluting Stent System (SES)
The Sirolimus-eluting stent manufactured by Envision and distributed by Concept Medical
DEVICEXIENCE Everolimus Eluting Coronary Stent System (XIENCE family)
The Everolimus-eluting stent manufactured and distributed by Abbott Vascular Santa Clara, CA
Sponsors
Concept Medical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
The staff (i.e. research nurses, research coordinators and other practitioners) involved in the follow-up care of study subjects and the Clinical Events Committee (CEC) adjudicators will be blinded to the patient assignment;
Intervention model description
Target lesions should be treated in accordance with the randomization schedule after meeting the clinical and angiographic inclusion and exclusion criteria following the instruction for use of the study stent. Additional lesions (other vessels) may be staged up to 45 days post-index procedure but must be treated with the same stent. Dual antiplatelet therapy must be prescribed in alignment with the Instructions for Use of the DES and the guidelines
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Clinical Inclusion Criteria 1. Patient understands the trial requirements and the treatment procedures and provides written informed consent; 2. Age ≥ 18 years of age (\> 19 years of age for South Korea and ≥ 21 years of age for Singapore); 3. Diabetic patient: either: 1. Patient with a previous documented diagnosis of diabetes mellitus (Type 1 or Type 2) and currently undergoing pharmacological treatment (oral hypoglycemic agents or insulin) 2. Newly diagnosed diabetes: either: i. Fasting plasma glucose (FPG) ≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for ≥8 hours1 or ii. Two-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) following a 75g oral glucose tolerance test or iii. HbA1c level ≥ 7% (53 mmol/mol) Patients who are newly diagnosed are included even if they are not on pharmacological treatment (oral hypoglycemic agents or insulin) 4. Symptomatic coronary artery disease including chronic stable angina, silent ischemia, and non-ST-segment elevation acute coronary syndrome (NSTE-ACS) 5. Patient is eligible for percutaneous coronary intervention (PCI); Previous PCI (with balloon angioplasty or stenting) is allowed if performed \>12 months before index procedure; 6. Patient is willing and able to comply with all protocol-required follow-up evaluations. Angiographic Inclusion Criteria (visual estimate) 7. Presence of ≥1 de novo coronary artery stenosis \>50% in a native coronary artery which can be treated with a stent ranging in diameter from 2.25 to 4.0 mm and can be covered with 1 or multiple stents; and 8. No limitation to the number of treated lesions, number of vessels, or lesion length if the patient is judged eligible for PCI by the treating physician according to the local standard of care.
Exclusion criteria
Clinical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Ischemia-driven TLR | 1 year FU | powered for non-inferiority and sequentially superiority |
| Rate of Target lesion failure TLF | 1 year FU, powered for non-inferiority | composite of cardiovascular death, target vessel myocardial infarction \[MI\], or ischemia driven target lesion revascularization \[idTLR\]) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| co-primary TLR endpoint | 2 Year FU | In case the co-primary TLR endpoint (TLR for non-inferiority) will be demonstrated at 1 year, then the occurrence of ischemia-driven TLR at 2-year FU will be evaluated (efficacy endpoint - superiority) |
| Composite of cardiovascular death, target vessel MI and ischemia-driven TLR (TLF) | 1 year FU | Cardiovascular death is defined as death resulting from cardiovascular causes. The following categories may be collected: 1. Death caused by acute MI 2. Death caused by sudden cardiac, including unwitnessed, death 3. Death resulting from heart failure 4. Death caused by stroke 5. Death caused by cardiovascular procedures 6. Death resulting from cardiovascular hemorrhage 7. 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. |
| Bleeding | 2 year | Bleeding BARC 2 or greater |
| Safety composite endpoint | 1 year (non-inferiority) | Safety composite endpoint of the occurrence of cardiovascular death and target-vessel myocardial infarction (MI) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Technical success | 2 year | 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 TIMI flow 2 or 3 and a \<30% residual stenosis. (As applies to chronic total occlusion - CTO - lesions) |
| Clinical procedural success | 2 year | In the case of percutaneous intervention for obstructive lesions, procedural success is defined as the achievement of a final residual diameter stenosis \< 30% by angiography at the end of the procedure (and without flow limiting arterial dissection and hemodynamically significant translesional pressure gradient) without any in-hospital major adverse events (death, acute onset of limb ischemia, need for urgent/emergent vascular surgery). The balloon inflation and/or stent placement may be preceded by use of adjunctive devices (e.g., percutaneous mechanical thrombectomy, directional or rotational atherectomy, laser, chronic total occlusion crossing device). Ideally, the assessment of the residual stenosis at the end of the procedure should be performed by an angiographic core laboratory. |
| Occurrence of ischemia-driven TLR | 2 year FU | 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. |
| Target vessel revascularization (TVR) | up to 2 years | TLR 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. |
| Composite of cardiovascular death, target vessel MI and ischemia-driven TLR (TLF) | 2 year FU | Cardiovascular death is defined as death resulting from cardiovascular causes. Any MI not clearly attributable to a non-target vessel will be considered as target-vessel 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. |
| Occurrence of cardiovascular death and target-vessel myocardial infarction (MI) | 2 year | Cardiovascular death is defined as death resulting from cardiovascular causes. The following categories may be collected: 1. Death caused by acute MI 2. Death caused by sudden cardiac, including unwitnessed, death 3. Death resulting from heart failure 4. Death caused by stroke 5. Death caused by cardiovascular procedures 6. Death resulting from cardiovascular hemorrhage 7. 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. |
| All-cause mortality | up to 2 years from procedure | all deaths are considered cardiovascular unless an alternate cause is unequivocally established, even among subjects with serious noncardiac comorbidities. |
| Stroke | up to 2 years from procedure | according to Neuro-ARC stroke/TIA criteria |
| Stent thrombosis | 2 year | defined for grade and timing according to the Academic Research Consortium2 |
Countries
Australia, Austria, Bangladesh, Belgium, Brazil, Czechia, France, Germany, India, Ireland, Italy, Malaysia, Mexico, Netherlands, Poland, Singapore, South Korea, Sweden, Switzerland, Taiwan, United Kingdom
Outcome results
None listed