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

NCT03622203 | Completed DMC FDA Device

• 1 other identifier: CHANCE
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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:

• 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

Conditions

Coronary Disease; Drug Eluting Stent; STEMI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incidence of Death

  At least 6 months

• Incidence of Myocardial Infarction

  At least 6 months

• Incidence of TLR

  At least 6 months

• Incidence of Cardiac Death

  At least 6 months

• Incidence of MI-TLR

  At least 6 months

Study Arms (3)

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)

Device: Biofreedom

Difficult coronary lesions

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

Device: Biofreedom

STEMI

Patients with STEMI

Device: Biofreedom

Interventions

Biofreedom DEVICE

Use of Biofreedom in real life patients

Difficult coronary lesions; Real life patients; STEMI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• clinical less than 18 years old or more than 80
• interventional last remaing vessel

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead

Related Publications (8)

• Mauri L, Kereiakes DJ, Yeh RW, Driscoll-Shempp P, Cutlip DE, Steg PG, Normand SL, Braunwald E, Wiviott SD, Cohen DJ, Holmes DR Jr, Krucoff MW, Hermiller J, Dauerman HL, Simon DI, Kandzari DE, Garratt KN, Lee DP, Pow TK, Ver Lee P, Rinaldi MJ, Massaro JM; DAPT Study Investigators. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med. 2014 Dec 4;371(23):2155-66. doi: 10.1056/NEJMoa1409312. Epub 2014 Nov 16.

  PMID: 25399658 BACKGROUND

• 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.

  PMID: 26466021 BACKGROUND

• Garot P, Morice MC, Tresukosol D, Pocock SJ, Meredith IT, Abizaid A, Carrie D, Naber C, Iniguez A, Talwar S, Menown IBA, Christiansen EH, Gregson J, Copt S, Hovasse T, Lurz P, Maillard L, Krackhardt F, Ong P, Byrne J, Redwood S, Windhovel U, Greene S, Stoll HP, Urban P; LEADERS FREE Investigators. 2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents. J Am Coll Cardiol. 2017 Jan 17;69(2):162-171. doi: 10.1016/j.jacc.2016.10.009. Epub 2016 Oct 30.

  PMID: 27806919 BACKGROUND

• D'Ascenzo F, Bollati M, Clementi F, Castagno D, Lagerqvist B, de la Torre Hernandez JM, ten Berg JM, Brodie BR, Urban P, Jensen LO, Sardi G, Waksman R, Lasala JM, Schulz S, Stone GW, Airoldi F, Colombo A, Lemesle G, Applegate RJ, Buonamici P, Kirtane AJ, Undas A, Sheiban I, Gaita F, Sangiorgi G, Modena MG, Frati G, Biondi-Zoccai G. Incidence and predictors of coronary stent thrombosis: evidence from an international collaborative meta-analysis including 30 studies, 221,066 patients, and 4276 thromboses. Int J Cardiol. 2013 Jul 31;167(2):575-84. doi: 10.1016/j.ijcard.2012.01.080. Epub 2012 Feb 22.

  PMID: 22360945 BACKGROUND

• Naber CK, Urban P, Ong PJ, Valdes-Chavarri M, Abizaid AA, Pocock SJ, Fabbiocchi F, Dubois C, Copt S, Greene S, Morice MC; LEADERS FREE Investigators. Biolimus-A9 polymer-free coated stent in high bleeding risk patients with acute coronary syndrome: a Leaders Free ACS sub-study. Eur Heart J. 2017 Apr 1;38(13):961-969. doi: 10.1093/eurheartj/ehw203.

  PMID: 27190095 BACKGROUND

• Blackwelder WC. "Proving the null hypothesis" in clinical trials. Control Clin Trials. 1982 Dec;3(4):345-53. doi: 10.1016/0197-2456(82)90024-1.

  PMID: 7160191 BACKGROUND

• 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.

  PMID: 32012453 DERIVED

• D'Ascenzo F, Gallone G, Boccuzzi G, Cortese B, Di Biasi M, Capodanno D, Vicinelli P, Infantino V, Poli A, Grigis G, Varbella F, De Ferrari GM, Ielasi A; Collaborators. Dual antiplatelet therapy strategies and clinical outcomes in patients treated with polymer-free biolimus A9-coated stents. EuroIntervention. 2020 Feb 7;15(15):e1358-e1365. doi: 10.4244/EIJ-D-19-00450.

  PMID: 31334704 DERIVED

MeSH Terms

Conditions

Coronary Disease; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Fabrizio D'Ascenzo

  Città della Salute e Della Scienza di Torino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: August 9, 2018
• Study Start: January 1, 2016
• Primary Completion: January 31, 2018
• Study Completion: May 1, 2018
• Last Updated: August 9, 2018

Record last verified: 2018-08