Cortisone or Drug Eluting Stents (DES) as Compared to Bare Metal Stents (BMS) to EliminAte Restenosis
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease Ischemic Heart Disease Atherosclerosis |
Drug: Prednisone Device: Drug eluting coronary stent Device: Bare metal coronary stent |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Clinical and Angiographic Outcome of Patients Treated With Bare Metal Stent (BMS) Implantation Compared With Drug Eluting Stents or BMS Plus Systemic Prednisone Therapy. A Randomized, Multicentre Study. |
- Incidence of cardiac death, myocardial infarction, recurrence of angina at rest or need to repeat revascularization at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Cost-efficacy analysis of the study at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 375 |
| Study Start Date: | October 2006 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Sham Comparator: 1
Bare Metal Stenting
|
Device: Bare metal coronary stent
Stenting with BMS only
|
|
Active Comparator: 2
Stenting with DES
|
Device: Drug eluting coronary stent
Stenting with DES (Cypher or Taxus)
|
|
Experimental: 3
Bare metal stenting and administration of prednisone
|
Drug: Prednisone
Bare metal stenting with administration of oral prednisone as described in the protocol
|
Detailed Description:
Design of the study
It is very important to underline that this is a "spontaneous" study, i.e. not receiving sponsorship from pharmaceutical industries, stent manufacturers, or any other financial source. This independence from economic interests would contribute to exclude conflicts of interest that may bias the results of the study that is aimed at testing the applicability and the clinical efficacy of this therapy. Furthermore, the assessment of the DES in public hospitals, and beyond the spectrum of the industry-supported studies may offer interesting results of the real life use of these devices.
One of the purposes of the study is a cost-effectiveness analysis. Centers participating in the study should therefore perform PCI according to their common practice with no interference in their decision-making process or technical approach to PCI because of the inclusion of the patients into a randomized study; this is aimed at obtaining an as real as possible situation of the daily practice. Being an spontaneous research, neither a fee will be provided for the enrollment of patients, nor free stents will be given.
The allocation of patients into a BMS or DES treatment will be decided by randomization, and the stents implanted will be selected according to the operator's preference.
The study will include three different groups of patients:
- Control group: receiving BMS;
- DES group: receiving DES;
- Prednisone group: receiving BMS and oral prednisone
Principal objective of the study: is the comparison of the primary endpoint obtained in a control group of patients treated with BMS versus two alternative study groups:
- DES
- BMS and oral prednisone All assuming a similar adjunctive conventional medical treatment.
Secondary endpoint of the study are:
- cost-effectiveness analysis. This will be calculated considering all patients enrolled in the study and analyzed after one year of the treatment. The analysis will take into account the procedural cost of the PCI material, the cost of the medical treatment in the first year of follow-up and the number of event-free days at follow-up. The cost-efficacy analysis will be obtained from the ratio between the cost of the event-free day of follow-up and the possibility of MACE considered in the primary endpoint of the study.
- comparison of the angiographic results. This will be calculated in all patients enrolled.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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).
Contacts and Locations| Italy | |
| Istituto Clinico Humanitas | |
| Milano, Italy, 20089 | |
| Ospedale Maggiore della Carità | |
| Novara, Italy, 28100 | |
| European Hospital | |
| Rome, Italy, 00149 | |
| Ospedale San Giovanni Bosco | |
| Torino, Italy, 10100 | |
| Università di Verona | |
| Verona, Italy, 37126 | |
| Study Chair: | Corrado Vassanelli, MD | Università di Verona |
| Study Director: | Flavio Ribichini, MD | Università di Verona |
| Principal Investigator: | Valeria Ferrero, MD | Università di Verona |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Flavio Ribichini, MD, Universita di Verona |
| ClinicalTrials.gov Identifier: | NCT00369356 History of Changes |
| Other Study ID Numbers: | CEREA-DES |
| Study First Received: | August 24, 2006 |
| Last Updated: | January 20, 2013 |
| Health Authority: | Italy: The Italian Medicines Agency |
Additional relevant MeSH terms:
|
Atherosclerosis Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Prednisone |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 17, 2013