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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-05-01

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:

1. 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)
2. and patients with bifurcation and multivessel disease, that is those with an increased risk of ST \[4\]
3. 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:

1. 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
2. Interventional

* Bifurcation (both provisional both 2 stents)
* Multivessel
* Ostial

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Detailed Description

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

Conditions

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Coronary Disease Drug Eluting Stent STEMI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Real life patients

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)

Biofreedom

Intervention Type DEVICE

Use of Biofreedom in real life patients

Difficult coronary lesions

Patients with bifurcation and multivessel disease, that is those with an increased risk of ST

Biofreedom

Intervention Type DEVICE

Use of Biofreedom in real life patients

STEMI

Patients with STEMI

Biofreedom

Intervention Type DEVICE

Use of Biofreedom in real life patients

Interventions

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Biofreedom

Use of Biofreedom in real life patients

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 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
2. Interventional

* Bifurcation (both provisional both 2 stents)
* Multivessel
* Ostial

Exclusion

1. clinical less than 18 years old or more than 80
2. interventional last remaing vessel

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No