Outcome of CHAllenging lesioNs and Patients Treated With Polymer Free Drug-CoatEd Stent

Study Overview
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Brief Summary
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Length of DAT (Dual Antiplatelet therapy) represents one of the most challenging choices for interventional cardiologist. Prolonged DAT reduces risk of subsequent MI (Myocardial Infarction) with an increase in major bleedings, consequently with a neutral effect on survival [1]. Recently a Polymer-free Drug-Coated coronary stent has been tested in a randomized controlled trial with only one month of DAT due to its peculiar features, with an increased efficacy compared to BMS (Bare Metal Stent) and with a not negligible risk of ST at one year (about 2%)[2,3]. The RCT despite its promising design (inclusion of high risk patients like those with previous bleeding or with severe renal disease) showed a major limitation, that is: patients who are often offered a Biofreedom in real life, that is those with active cancer or needing major surgery or on OAT (Oral Anticoagulation) and patients with bifurcation and multivessel disease, that is those with an increased risk of ST [4] STEMI patients [5] were underrepresented (less than 30%). Consequently we performed this multicenter study to evaluate safety and efficacy of Biofreedom in real life patients. POCE (a composite end point of death, myocardial infarction, target lesion revascularization) and DOCE (cardiac death, MI-TLR and TLR) will be the primary end points, while its single components will be the secondary ones along stent thrombosis and with bleedings (Barc classification). At least 12 months The Leaders FREE (2) reported an incidence of MACE of 9.4% at one year in overall patients. If there is a true difference in favour of the experimental treatment of 1.2%, then 870 patients are required to be 80% sure that the upper limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will exclude a difference when compared to non selected patients of more than 2% [5] All patients implanting Biofreedom with these prespecified analysis: Clinical Diabetic patients (both insulin and not insulin depenent) Requiring oral anticoagulation On active cancer (that is requiring chemio or radio-therapy and or surgery) Requiring surgery STEMI Interventional Bifurcation (both provisional both 2 stents) Multivessel Ostial

Detailed Description
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Our interest is to test the performance of these stents in real life patients

Official Title
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Outcome of CHAllenging lesioNs and Patients Treated With Polymer Free Drug-CoatEd Stent (Biofreedom): the CHANCE a Multicenter Study

Conditions
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STEMI, Coronary Disease, Drug Eluting Stent

Intervention / Treatment
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* Device: Biofreedom


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical Diabetic patients (both insulin and not insulin depenent) Requiring oral anticoagulation On active cancer (that is requiring chemio or radio-therapy and or surgery) Requiring surgery STEMI Interventional Bifurcation (both provisional both 2 stents) Multivessel Ostial Exclusion clinical less than 18 years old or more than 80 interventional last remaing vessel

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Real life patients<br>Patients who are often offered a Biofreedom in real life, that is those with active cancer or needing major surgery or on OAT (Oral Anticoagulation) | Device: Biofreedom<br>* Use of Biofreedom in real life patients<br>|
| Difficult coronary lesions<br>Patients with bifurcation and multivessel disease, that is those with an increased risk of ST | Device: Biofreedom<br>* Use of Biofreedom in real life patients<br>|
| STEMI<br>Patients with STEMI | Device: Biofreedom<br>* Use of Biofreedom in real life patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of POCE (primary patient-oriented endpoint) | Incidence of POCE (a composite and mutual exclusive end point of death, myocardial infarction, target lesion revascularization) | At least 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Death | Incidence of Death | At least 6 months | 
| Incidence of Myocardial Infarction | Incidence of Myocardial Infarction | At least 6 months | 
| Incidence of TLR | Incidence of target lesion revascularization | At least 6 months | 
| Incidence of Cardiac Death | Incidence of Cardiac Death | At least 6 months | 
| Incidence of MI-TLR | Incidence of Myocardia Infarction TLR | At least 6 months |