Clinical trial NCT03622203: Outcome of CHAllenging lesioNs and Patients Treated With Polymer Free Drug-CoatEd Stent
Official title: Outcome of CHAllenging lesioNs and Patients Treated With Polymer Free Drug-CoatEd Stent ("Biofreedom"): the CHANCE a Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Drug Eluting Stent
STEMI
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of POCE (primary patient-oriented endpoint)
timeFrame: At least 6 months
Secondary outcomes:
measure: Incidence of Death
timeFrame: At least 6 months
measure: Incidence of Myocardial Infarction
timeFrame: At least 6 months
measure: Incidence of TLR
timeFrame: At least 6 months
measure: Incidence of Cardiac Death
timeFrame: At least 6 months
measure: Incidence of MI-TLR
timeFrame: At least 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Città della Salute e Della Scienza di Torino
name: Fabrizio D'Ascenzo
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Urban P, Meredith IT, Abizaid A, Pocock SJ, Carrie D, Naber C, Lipiecki J, Richardt G, Iniguez A, Brunel P, Valdes-Chavarri M, Garot P, Talwar S, Berland J, Abdellaoui M, Eberli F, Oldroyd K, Zambahari R, Gregson J, Greene S, Stoll HP, Morice MC; LEADERS FREE Investigators. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk. N Engl J Med. 2015 Nov 19;373(21):2038-47. doi: 10.1056/NEJMoa1503943. Epub 2015 Oct 14.
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citation: Gallone G, D'Ascenzo F, Boccuzzi G, Cortese B, Di Biasi M, Omede P, Capodanno D, Cerrato E, Vicinelli P, Infantino V, Poli A, Ugo F, Conrotto F, Grigis G, Varbella F, Latini RA, D'Urbano M, Montabone A, Senatore G, Ferrara E, D'Amico M, De Ferrari GM, Ielasi A. Real-world reasons and outcomes for 1-month versus longer dual antiplatelet therapy strategies with a polymer-free BIOLIMUS A9-coated stent. Catheter Cardiovasc Interv. 2020 Sep 1;96(3):E248-E256. doi: 10.1002/ccd.28757. Epub 2020 Feb 3.
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