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

Completed

• Conditions: Drug Eluting Stent; Coronary Disease; STEMI
• Interventions: Device: Biofreedom

• Registration Number: NCT03622203
• Lead Sponsor: A.O.U. Città della Salute e della Scienza

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2018-01-31
• Study Completion: 2018-05-01
• Study First Submitted: 2018-05-18
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-07
• Last Update Submitted: 2018-08-07
• Study First Posted: 2018-08-09
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Real life patients	Biofreedom	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)
STEMI	Biofreedom	Patients with STEMI
Difficult coronary lesions	Biofreedom	Patients with bifurcation and multivessel disease, that is those with an increased risk of ST

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of TLR	At least 6 months	Incidence of target lesion revascularization
Incidence of Myocardial Infarction	At least 6 months	Incidence of Myocardial Infarction
Incidence of MI-TLR	At least 6 months	Incidence of Myocardia Infarction TLR
Incidence of Death	At least 6 months	Incidence of Death
Incidence of Cardiac Death	At least 6 months	Incidence of Cardiac Death