Coronary Heart Disease, Coronary Restenosis
Conditions
Keywords
Drug Eluting Stents, Stents Bare Metal, Stent Thrombosis, Coronary revascularization, Survival
Brief summary
In a previous randomized comparison oral sirolimus plus bare metal stent compared to bare metal stent implantation alone demonstrated at one year of follow up a significant reduction of angiographic and clinical parameters of restenosis (ANMAT resolution number 3366 from June 2004 and Rodriguez A et al JACC,2006,47,1522-1529). In addition previous reported registries from our group with Drug Eluting Stents showed similar amount of reduction in clinical parameters (not angiographic)of restenosis (ERACI III, Rodriguez A et al EuroIntervention 2006,2:53-60). Taking in account that 8.3% of patients treated with oral rapamycin plus Bare Metal Stents(ORAR II Trial JACC 2006)and 8.8% of patients treated with DES developed clinical restenosis (ERACI III Registry, EuroIntervention 2006) the investigators sought to compare differences in overall cost with both revascularization strategies at 1, 2, 3 and 5 years of follow up assuming that safety and efficacy clinical end points would be similar.
Detailed description
Patients with de novo lesions treated in different Institutions in Buenos Aires Argentina were randomized to treat with oral sirolimus plus bare metal stent implantation (100 patients) or DES(100 patients).
Interventions
DRUGOral sirolimus
Oral sirolimus given orally during 14 days plus bare metal stent implantation was compared with DES.Oral sirolimus was given as bolus of 10 mg started day before intervention followed by 3mg per day during 13 days after PCI. 180 mg of Diltiazem was added during oral administration of sirolimus .
DEVICEDrug Eluting stent
Any Drug eluting stent
Sponsors
Centro de estudios en Cardiologia Intervencionista
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indication of revascularization * De novo lesions * Native vessels * Suitable for stent placement
Exclusion criteria
* Acute myocardial infarction within the last 24 hours * In stent restenosis * Previous percutaneous coronary intervention within the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions. | Follow up will be conducted by the coordinating Center at 18 months of follow up | Overall costs expressed in US dollars at 18 months of follow up between Oral Sirolimus Plus BMS vs DES implantation in denovo coronary lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiovascular Events (MACCE) | 18 Months | Death from any cause, myocardial infarction and stroke. Safety was analyzed as MACCE (major adverse cardiovascular events) including death, MI and stroke. |
| Target Vessel Revascularization (TVR) | 18 months | Efficacy end point was TVR as revasacularization of the treated vessel. |
Countries
Argentina
Participant flow
Recruitment details
Between January 2006 to September 2007 we enrolled 200 patients in the trial.
Pre-assignment details
From 1274 patients with coronary angiography, 789 met clinical inclusion criteria, from whom 102 have angiographic exclusion criteria. 487 were excluded for inability for percutaneous coronary intervention (PCI) with drug eluting stent (DES) deployment or refuse to participate in the study; thus 200 patients were included in this randomized trial.
Participants by arm
| Arm | Count |
|---|---|
| Oral Sirolimus + Bare Metal Stent Oral sirolimus plus bare metal stent implantation | 100 |
| Drug Eluting Stents Any Drug Eluting Stents | 100 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 7 |
Baseline characteristics
| Characteristic | Drug Eluting Stents | Oral Sirolimus + Bare Metal Stent | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 42 Participants | 39 Participants | 81 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 61 Participants | 119 Participants |
| Age Continuous | 63.4 years STANDARD_DEVIATION 10.6 | 62.1 years STANDARD_DEVIATION 10.1 | 63.2 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment Argentina | 100 participants | 100 participants | 200 participants |
| Sex: Female, Male Female | 19 Participants | 17 Participants | 36 Participants |
| Sex: Female, Male Male | 81 Participants | 83 Participants | 164 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 100 | 2 / 100 |
| serious Total, serious adverse events | 9 / — | 15 / — |
Outcome results
Primary
Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions.
Overall costs expressed in US dollars at 18 months of follow up between Oral Sirolimus Plus BMS vs DES implantation in denovo coronary lesions.
Time frame: Follow up will be conducted by the coordinating Center at 18 months of follow up
Population: All patients were analyzed for ITT and the imputation technique was LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Sirolimus + Bare Metal Stent | Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions. | 5483 US dollars | Standard Deviation 2165.5 |
| Drug Eluting Stents | Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions. | 7658.2 US dollars | Standard Deviation 3263.4 |
Comparison: We used One way annalysis of a variance for means and standard deviation.p-value: <0.05ANOVA
Secondary
Major Adverse Cardiovascular Events (MACCE)
Death from any cause, myocardial infarction and stroke. Safety was analyzed as MACCE (major adverse cardiovascular events) including death, MI and stroke.
Time frame: 18 Months
Population: It was determinated by ITT and the technique used was LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oral Sirolimus + Bare Metal Stent | Major Adverse Cardiovascular Events (MACCE) | Acute Myocardial Infarction | 6 participants |
| Oral Sirolimus + Bare Metal Stent | Major Adverse Cardiovascular Events (MACCE) | MACCE | 9 participants |
| Oral Sirolimus + Bare Metal Stent | Major Adverse Cardiovascular Events (MACCE) | Stroke | 0 participants |
| Oral Sirolimus + Bare Metal Stent | Major Adverse Cardiovascular Events (MACCE) | Death | 3 participants |
| Drug Eluting Stents | Major Adverse Cardiovascular Events (MACCE) | Stroke | 1 participants |
| Drug Eluting Stents | Major Adverse Cardiovascular Events (MACCE) | MACCE | 15 participants |
| Drug Eluting Stents | Major Adverse Cardiovascular Events (MACCE) | Acute Myocardial Infarction | 9 participants |
| Drug Eluting Stents | Major Adverse Cardiovascular Events (MACCE) | Death | 7 participants |
Comparison: Based on our previous data the incidence of relevant clinical events was similar in both groups (ERACI III and ORAR II)p-value: 0.05Chi-squared
Secondary
Target Vessel Revascularization (TVR)
Efficacy end point was TVR as revasacularization of the treated vessel.
Time frame: 18 months
Population: We analyzed the number of vessels treated per group by ITT and the imputation technique was LOCF.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oral Sirolimus + Bare Metal Stent | Target Vessel Revascularization (TVR) | 14 vessels |
| Drug Eluting Stents | Target Vessel Revascularization (TVR) | 15 vessels |
Comparison: power calculation 80% Hypothesis: No significant diferences between Target Vessel Revascularization (TVR) between both groups.~All events will be recorded and an independent blind for groups clinical events committee will adjudicate each one.p-value: <0.05Chi-squared