Coronary Heart Disease, Type 2 Diabetes
Conditions
Keywords
coronary artery disease, diabetes mellitus, everolimus, paclitaxel stents
Brief summary
The TUXEDO-India is a prospective, single blind, multi-center randomized clinical trial to assess the TAXUS Element™ in a consecutive population of diabetic patients with coronary artery disease undergoing coronary revascularization. Approximately 1,830 patients with single or multi lesion, multi vessel coronary artery or saphenous vein graft disease ranging in vessels ranging from 2.25 mm to 4.0 mm in diameter by visual estimate will be enrolled in a 1:1 randomization to TAXUS Element™ vs. XIENCE™ Prime in India at up to 50 clinical sites, to demonstrate the safety and effectiveness of TAXUS Element™ in an unrestricted population. Procedural Endpoints: * Device success, defined as attainment of \< 30% residual stenosis of the target lesion (visual assessment) using the TAXUS Element™ or XIENCE™ Prime stent. * Lesion success defined as attainment of \< 30% residual stenosis (visual assessment) using any percutaneous method. * Procedure success defined as lesion success without the occurrence of in-hospital MACE. * Procedure complication rate including composite and individual angiographic occurrence of dissection ≥B, distal embolization, no reflow, slow flow, abrupt closure, or perforation.
Detailed description
Primary Endpoint: Composite safety endpoint of Target Vessel Failure (TVF) rate at 12 months post-index procedure: * Cardiac Death related to target vessel * Target Vessel Myocardial Infarction (TV-MI) * Target Vessel Revascularization (TVR) Secondary Endpoint: Clinical endpoints measured at 30, 180 days, and 1 and 2 years post index procedure: * TVF rate (primary endpoint 1 year) * Target Vessel Revascularization (TVR) rate * Target Lesion Revascularization (TLR) * Composite of cardiac death or target vessel MI * Composite of all deaths, all MI, all revascularizations * Major Adverse Cardiac Events (MACE) which is the composite endpoint of cardiac death, all myocardial infarction, and TLR * MI (Q-wave and non-Q-wave) rate * Cardiac death rate * Non-cardiac death rate * All death rate * Cardiac death or MI rate * All death or MI rate * Stent thrombosis rate (definite or probable by Academic Research Consortium \[ARC\] definitions) Periprocedural endpoints: * Technical success rate * Clinical procedural success rate Anti-platelet Therapy A loading dose of either Clopidogrel (300mg, 600mg recommended), Ticlopidine (500mg), or Prasugrel (60mg) must be given to the patient prior to index procedure. Thereafter, Clopidogrel (75mg daily), Ticlopidine (250mg twice daily), Prasugrel (10mg) must be given for at least 12 months after stent implantation. If the protocol mandated (loading and or daily) dosage conflicts with local DFU, the local DFU should take precedence. Aspirin (ASA): Must be administered concomitantly with Clopidogrel, Ticlopidine or Prasugrel and then continued indefinitely Sample Size Parameters: The expected 12 month TVF rate for both groups is estimated to be 8.4% based on the data available from the SPIRIT IV trial. Given the non-inferiority margin (delta) of 4% with equal expected means and a one-sided 5% significance level, 824 patients in each group will provide at least 90% power to reject the null hypothesis if it is false. When allowance is made for 10% attrition, approximately 915 patients are required per each treatment group. Therefore, the necessary total sample size for the trial is 1,830 patients.
Interventions
DEVICETAXUS Element™ Paclitaxel-Eluting Stent System
Texus Element is the next generation Boston Scientific paclitexel-eluting coronary sten and received DCGI approval on April 13th, 2010.
DEVICEXience PRIME Everolimus-Eluting Stent System
The Everolimus-eluting stent manufactured and distributed by Abbott Vascular Santa Clara, CA, as Xience Prime.
Sponsors
Boston Scientific Corporation
Max Neeman Medical International Ltd.
Fortis Escorts Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
CI1. Patient must have a diagnosis of diabetes mellitus (Type 1 or Type 2) defined according to the American Diabetes Association as history of one of the followings : 1. Two hour plasma glucose \>200 mg/dL (11.1 mmol/L) following a 75g oral glucose tolerance test 2. Random plasma glucose \>200 mg/dL 3. A fasting plasma glucose level \>126 mg/dL (7.0 mmol/L) 4\. Elevated HbA1c level 6.5 And currently undergoing pharmacological treatment 5.Patients admitted with ACS NSTEMI and HbA1c \> 7 can be included even if they were not on pharmacological treatment. CI2. Patient (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed CI3. Patient is eligible for percutaneous coronary intervention (PCI) CI4. Patient has symptomatic coronary artery disease or documented silent ischemia. CI5. Patient is willing to comply with all protocol-required follow-up evaluations. Angiographic Inclusion Criteria (visual estimate) AI1. Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) 2.25 mm and 4.0 mm. Treatment of up to 3 de novo target lesions is allowed with a maximum of two denovo target lesions per epicardial vessel. AI2. Target lesion length must measure 34 mm (by visual estimate) AI3. Target lesion must be in a major coronary artery or branch with visually estimated stenosis 50% and \<100% with Thrombolysis in Myocardial Infarction (TIMI) flow 1. AI4. If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria. AI5. Non-study percutaneous intervention for lesions in a target vessel (including side branches) is allowed if performed 9 months prior to the index procedure. AI6. Non study percutaneous interventions for lesions in a non target vessel are allowed in the following circumstances: 1. Unsuccessful, or complicated bare metal stent, balloon dilatation, cutting balloon, atherectomy, thrombectomy, and laser treatments are allowed if performed 30 days prior to the index procedure. 2. Drug-eluting stent treatment is permitted if performed 90 days prior to index procedure. AI7. Non study, percutaneous interventions for lesion(s) in a target vessel (including side branches) or non-target vessel are allowed if performed 9 months after the index procedure.
Exclusion criteria
CE1. Patient has known allergy to the study stent system or protocol-required concomitant medications (e.g., stainless steel, platinum, chromium, nickel, iron, thienopyridines, aspirin, radiographic contrast medium) that cannot be adequately pre-medicated. CE2. Patient has any other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 12 months CE3. Acute or chronic renal dysfunction (creatinine \> 2.0 mg/dl or 177 μmol/l) CE4. Currently participating in another investigational drug or device study Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite safety endpoint of Target Vessel Failure (TVF) rate at 12 months post-index procedure: • Cardiac Death related to target vessel • Target Vessel Myocardial Infarction (TV-MI) • Target Vessel Revascularization (TVR) | 12 Months | TVS is defined as any ischemia-driven revascularization of the target vessel( TVR), MI (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Event (MACE) | Measured at 30,180 days,and 1 and 2 years post index procedure | MACE defined as a composite of death, MI (Q-wave and non-Q-wave), emergent coronary artery bypass surgery (CABG), or target lesion revascularization (TLR) by repeat PTCA, or CABG. |
| Cardiac death rate | Measured at 30,180 days,and 1 and 2 years post index procedure | — |
| Non-Cardiac death rate | Measured at 30,180 days,and 1 and 2 years post index procedure | — |
| All death or MI rate | Measured at 30,180 days,and 1 and 2 years post index procedure | — |
| All Death / MI / TVR Rate | Measured at 30,180 days,and 1 and 2 years post index procedure | — |
| Stent Thrombosis Rate | Measured at 30,180 days,and 1 and 2 years post index procedure | Stent thrombosis(ST) rate defined using ARC definition of definite and probable stent thrombosis and categorized as early, late or very late. |
| Target Lesion Revascularization (TLR) TVF rate (primary endpoint 1 year) Target Vessel Revascularization rate Target Lesion Revascularization Composite of cardiac death or target vessel | Measured at 30,180 days,and 1 and 2 years post index procedure | — |
| Ischemia Driven Target Lesion Revascularization (TLR) Rate TVF rate (primary endpoint 1 year) Target Vessel Revascularization rate Target Lesion Revascularization Composite of cardiac death or target vessel | Measured at 30,180 days,and 1 and 2 years post index procedure | — |
| Target Vessel Failure (TVF) | Measured at 30,180 days,and 1 and 2 years post index procedure | — |
| Ischemia Driven Target Vessel Revascularization (TVR) | Measured at 30,180 days,and 1 and 2 years post index procedure | — |
| Target Lesion Failure Rate | Measured at 30,180 days,and 1 and 2 years post index procedure | Target Lesion Failure Rate defined as any ischemia-driven revascularization of the target lesion (TLR), MI (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel |
| Myocardial Infarction(MI) rate | Measured at 30,180 days,and 1 and 2 years post index procedure | Q-wave and Non-Q-wave, cumulative and individual |
Other
| Measure | Time frame | Description |
|---|---|---|
| Lesion Success | Baseline | Lesion success defined as attainment of \<30% residual stenosis (visual assessment) uring any percutaneous method |
| Procedure Success | Baseline | Procedure success defined as lesion success without the occurrence of in-hospital MACE. |
| Procedural complication rate | Baseline | Procedural complication rate including composite and individual angiographic occurrence of dissection, distal embolization, no reflow, slow flow, abrupt closure, or perforation |
| Device Success | Baseline | Device Success Defined as attainment of \<30% residual stenosis of the target lesion (visual assessment) using the TAXUS Element or XIENCE Prime stent. |
Countries
India
Outcome results
None listed