Cortisone or Drug Eluting Stents (DES) as Compared to Bare Metal Stents (BMS) to EliminAte Restenosis

NCT00369356 | Completed Phase 2 DMC

• 1 other identifier: CEREA-DES
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 5

Brief Summary

The possibility of using the new drug eluting stents (DES) technology has significantly changed the mid-term outcome of percutaneous coronary interventions (PCI) in terms of reduced recurrence of angina. The way interventionalists accomplish their work is changing accordingly, with a strong trend to a wider use of DES and a consequent perceived patients' clinical benefit. Evidences supporting the superiority of DES in reducing ischemic recurrence after PCI compared to traditional stents (BMS) are available from randomized studies. A recent meta-analyses underlines that: DES are superior to BMS in reducing clinical recurrence of ischemia, DES and BMS offer identical results in terms of death and infarction, Rapamycin and paclitaxel DES offer similar results. The aim of our study is to perform a multicenter, randomized study to assess the clinical efficacy and safety of the oral prednisone therapy after PCI as a possible systemic alternative to currently available BMS and DES. Furthermore, the study aims at analyzing the clinical outcome of the commercially available DES in the context of an independent research and a cost-benefit comparison with BMS and oral steroids.

Conditions

Coronary Artery Disease; Ischemic Heart Disease; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Incidence of cardiac death, myocardial infarction, recurrence of angina at rest or need to repeat revascularization at 12 months.

  12 months

Secondary Outcomes (2)

• Angiographic restenosis according to the late loss measurement after 6 to 9 months of the procedure. A DS% =>50 at in-segment analysis will be considered as restenosis.

  9 months

• Cost-efficacy analysis of the study at 12 months.

  12 months

Study Arms (3)

1

SHAM COMPARATOR

Bare Metal Stenting

Device: Bare metal coronary stent

2

ACTIVE COMPARATOR

Stenting with DES

Device: Drug eluting coronary stent

3

EXPERIMENTAL

Bare metal stenting and administration of prednisone

Drug: Prednisone

Interventions

Prednisone DRUG

Bare metal stenting with administration of oral prednisone as described in the protocol

3

Drug eluting coronary stent DEVICE

Stenting with DES (Cypher or Taxus)

2

Bare metal coronary stent DEVICE

Stenting with BMS only

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with diagnosed CAD (either SVD or MVD) with signs or symptoms of myocardial ischemia, scheduled for percutaneous revascularization are all candidates.
• Either native vessels and SVG can be included with de-novo or recurrent lesions.
• Lesions causing a diameter stenosis \>50% in a main coronary artery (LAD, RCA, LCx) or their principal branches (Dg, OM, PL, PDA).

You may not qualify if:

• Diabetes
• Age over 80 years old
• Recent Q wave myocardial infarction (less than 2 weeks)
• Severe hypertension, uncontrolled despite medical treatment
• Gastric ulcer or symptomatic gastritis
• Neoplasia
• Renal failure (creatinine \>2.5)
• Left main disease, or left main equivalent (proximal LAD and proximal LCx), or three vessel disease involving the proximal segments of the 3 main coronary branches
• Suboptimal angiographic result of PCI (DS% \>30% or TIMI flow \<grade 3)
• Contraindications to high-doses of steroids (immunosuppression, active infective disease, osteoporosis, recent use of high doses of steroids).

Sponsors & Collaborators

• Universita di Verona: lead
• Regione Piemonte: collaborator

Study Sites (5)

Istituto Clinico Humanitas

Milan, Milano, 20089, Italy

Location

Ospedale Maggiore della Carità

Novara, Novara, 28100, Italy

Location

European Hospital

Rome, Rome, 00149, Italy

Location

Ospedale San Giovanni Bosco

Torino, Torino, 10100, Italy

Location

Università di Verona

Verona, Verona, 37126, Italy

Location

Related Publications (10)

• Versaci F, Gaspardone A, Tomai F, Ribichini F, Russo P, Proietti I, Ghini AS, Ferrero V, Chiariello L, Gioffre PA, Romeo F, Crea F; Immunosuppressive Therapy for the Prevention of Restenosis after Coronary Artery Stent Implantation Study. Immunosuppressive Therapy for the Prevention of Restenosis after Coronary Artery Stent Implantation (IMPRESS Study). J Am Coll Cardiol. 2002 Dec 4;40(11):1935-42. doi: 10.1016/s0735-1097(02)02562-7.

  PMID: 12475452 BACKGROUND

• Ribichini F, Ferrero V, Agostini M, Vassanelli C. Immunosuppression against restenosis. Efficacy of a radiofrequency guidewire and oral prednisone in achieving and maintaining coronary artery patency after stenting. Cardiovasc Revasc Med. 2005 Jul-Sep;6(3):124-5. doi: 10.1016/j.carrev.2005.08.006. No abstract available.

  PMID: 16275609 BACKGROUND

• Ferrero V, Ribichini F, Rognoni A, Marino P, Brunelleschi S, Vassanelli C. Comparison of efficacy and safety of lower-dose to higher-dose oral prednisone after percutaneous coronary interventions (the IMPRESS-LD study). Am J Cardiol. 2007 Apr 15;99(8):1082-6. doi: 10.1016/j.amjcard.2006.11.064. Epub 2007 Mar 6.

  PMID: 17437731 BACKGROUND

• Ribichini F, Ferrero V, Rognoni A, Marino P, Brunelleschi S, Vassanelli C. Percutaneous treatment of coronary bifurcations: lesion preparation before provisional bare metal stenting and subsequent immunosuppression with oral prednisone. The IMPRESS-Y study. J Interv Cardiol. 2007 Apr;20(2):114-21. doi: 10.1111/j.1540-8183.2007.00250.x.

  PMID: 17391219 BACKGROUND

• Ribichini F, Tomai F, Paloscia L, Di Sciascio G, Carosio G, Romano M, Verna E, Galli M, Tamburino C, De Cesare N, Pirisi R, Piscione F, Lanteri G, Ferrero V, Vassanelli C; DESIRE investigators. Steroid-eluting stents in patients with acute coronary syndrome: the dexamethasone eluting stent Italian registry. Heart. 2007 May;93(5):598-600. doi: 10.1136/hrt.2006.098467. Epub 2006 Sep 27.

  PMID: 17005712 BACKGROUND

• Ribichini F, Joner M, Ferrero V, Finn AV, Crimins J, Nakazawa G, Acampado E, Kolodgie FD, Vassanelli C, Virmani R. Effects of oral prednisone after stenting in a rabbit model of established atherosclerosis. J Am Coll Cardiol. 2007 Jul 10;50(2):176-85. doi: 10.1016/j.jacc.2007.03.031. Epub 2007 Jun 22.

  PMID: 17616304 BACKGROUND

• Ferrero V, Ribichini F, Pesarini G, Brunelleschi S, Vassanelli C. Glucocorticoids in the prevention of restenosis after coronary angioplasty: therapeutic potential. Drugs. 2007;67(9):1243-55. doi: 10.2165/00003495-200767090-00001.

  PMID: 17547469 BACKGROUND

• Ribichini F, Tomai F, De Luca G, Boccuzzi G, Presbitero P, Pesarini G, Ferrero V, Ghini AS, Abukaresh R, Aurigemma C, De Luca L, Zavalloni D, Soregaroli D, Marino P, Garbo R, Zanolla L, Vassanelli C; CEREA-DES investigators. Immunosuppressive therapy with oral prednisone to prevent restenosis after PCI. A multicenter randomized trial. Am J Med. 2011 May;124(5):434-43. doi: 10.1016/j.amjmed.2010.11.027.

  PMID: 21531233 RESULT

• Ribichini F, Tomai F, Pesarini G, Zivelonghi C, Rognoni A, De Luca G, Boccuzzi G, Presbitero P, Ferrero V, Ghini AS, Marino P, Vassanelli C; CEREA-DES Investigators. Long-term clinical follow-up of the multicentre, randomized study to test immunosuppressive therapy with oral prednisone for the prevention of restenosis after percutaneous coronary interventions: Cortisone plus BMS or DES veRsus BMS alone to EliminAte Restenosis (CEREA-DES). Eur Heart J. 2013 Jun;34(23):1740-8. doi: 10.1093/eurheartj/eht079. Epub 2013 Mar 14.

  PMID: 23492671 DERIVED

• Ribichini F, Tomai F, De Luca G, Boccuzzi G, Presbitero P, Pesarini G, Ferrero V, Ghini AS, Pastori F, De Luca L, Zavalloni D, Soregaroli D, Garbo R, Franchi E, Marino P, Minelli M, Vassanelli C. A multicenter, randomized study to test immunosuppressive therapy with oral prednisone for the prevention of restenosis after percutaneous coronary interventions: cortisone plus BMS or DES versus BMS alone to eliminate restenosis (CEREA-DES) - study design and rationale. J Cardiovasc Med (Hagerstown). 2009 Feb;10(2):192-9. doi: 10.2459/JCM.0b013e32831f9176.

  PMID: 19377384 DERIVED

Related Links

• website containing detailed protocol and info for the patient and the GP (needs registration). Contains also the web-based CRF (only available for participating centers)

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Corrado Vassanelli, MD

  Università di Verona

  STUDY CHAIR

• Flavio Ribichini, MD

  Università di Verona

  STUDY DIRECTOR

• Valeria Ferrero, MD

  Università di Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 24, 2006
• First Posted: August 29, 2006
• Study Start: October 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: January 1, 2011
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

IT (5)