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

Sponsor

Universita di Verona (Other)

Overall Status

Completed

CT.gov ID

NCT00369356

Collaborator

Regione Piemonte (Other)

375

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Ischemic Heart Disease Atherosclerosis	Drug: Prednisone Device: Drug eluting coronary stent Device: Bare metal coronary stent	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

375 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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.

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Istituto Clinico Humanitas	Milano	Italy	20089
2	Ospedale Maggiore della Carità	Novara	Italy	28100
3	European Hospital	Rome	Italy	00149
4	Ospedale San Giovanni Bosco	Torino	Italy	10100
5	Università di Verona	Verona	Italy	37126