Trial Outcomes & Findings for Study of Oral Rapamycin Plus Bare Metal Stents vs Drug Eltuting Stents (NCT NCT00552669)

Results Overview

Overall costs expressed in US dollars at 18 months of follow up between Oral Sirolimus Plus BMS vs DES implantation in denovo coronary lesions.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

200 participants

Primary outcome timeframe

Follow up will be conducted by the coordinating Center at 18 months of follow up

Results posted on

2010-06-02

Participant Flow

Between January 2006 to September 2007 we enrolled 200 patients in the trial.

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.

Participant milestones

Participant milestones
Measure	Oral Sirolimus + Bare Metal Stent Oral sirolimus plus bare metal stent implantation	Drug Eluting Stents Any Drug Eluting Stents
Overall Study STARTED	100	100
Overall Study COMPLETED	97	93
Overall Study NOT COMPLETED	3	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Oral Sirolimus + Bare Metal Stent Oral sirolimus plus bare metal stent implantation	Drug Eluting Stents Any Drug Eluting Stents
Overall Study Death	3	7

Baseline Characteristics

Study of Oral Rapamycin Plus Bare Metal Stents vs Drug Eltuting Stents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Sirolimus + Bare Metal Stent n=100 Participants Oral sirolimus plus bare metal stent implantation	Drug Eluting Stents n=100 Participants Any Drug Eluting Stents	Total n=200 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	61 Participants n=5 Participants	58 Participants n=7 Participants	119 Participants n=5 Participants
Age, Categorical >=65 years	39 Participants n=5 Participants	42 Participants n=7 Participants	81 Participants n=5 Participants
Age Continuous	62.1 years STANDARD_DEVIATION 10.1 • n=5 Participants	63.4 years STANDARD_DEVIATION 10.6 • n=7 Participants	63.2 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	83 Participants n=5 Participants	81 Participants n=7 Participants	164 Participants n=5 Participants
Region of Enrollment Argentina	100 participants n=5 Participants	100 participants n=7 Participants	200 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Overall costs expressed in US dollars at 18 months of follow up between Oral Sirolimus Plus BMS vs DES implantation in denovo coronary lesions.

Outcome measures

Outcome measures
Measure	Oral Sirolimus + Bare Metal Stent n=100 Participants Oral sirolimus plus bare metal stent implantation	Drug Eluting Stents n=100 Participants Any Drug Eluting Stents
Differences in Costs Between Two Revascularization Strategies for de Novo Coronary Lesions.	5483 US dollars Standard Deviation 2165.5	7658.2 US dollars Standard Deviation 3263.4

SECONDARY outcome

Timeframe: 18 Months

Population: It was determinated by ITT and the technique used was LOCF.

Death from any cause, myocardial infarction and stroke. Safety was analyzed as MACCE (major adverse cardiovascular events) including death, MI and stroke.

Outcome measures

Outcome measures
Measure	Oral Sirolimus + Bare Metal Stent n=100 Participants Oral sirolimus plus bare metal stent implantation	Drug Eluting Stents n=100 Participants Any Drug Eluting Stents
Major Adverse Cardiovascular Events (MACCE) MACCE	9 participants	15 participants
Major Adverse Cardiovascular Events (MACCE) Death	3 participants	7 participants
Major Adverse Cardiovascular Events (MACCE) Acute Myocardial Infarction	6 participants	9 participants
Major Adverse Cardiovascular Events (MACCE) Stroke	0 participants	1 participants

SECONDARY outcome

Timeframe: 18 months

Population: We analyzed the number of vessels treated per group by ITT and the imputation technique was LOCF.

Efficacy end point was TVR as revasacularization of the treated vessel.

Outcome measures

Outcome measures
Measure	Oral Sirolimus + Bare Metal Stent n=131 Participants Oral sirolimus plus bare metal stent implantation	Drug Eluting Stents n=142 Participants Any Drug Eluting Stents
Target Vessel Revascularization (TVR)	14 vessels	15 vessels

Adverse Events

Oral Sirolimus + Bare Metal Stent

Serious events: 9 serious events

Other events: 9 other events

Deaths: 0 deaths

Drug Eluting Stents

Serious events: 15 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oral Sirolimus + Bare Metal Stent n=100 participants at risk Oral sirolimus plus bare metal stent implantation	Drug Eluting Stents n=100 participants at risk Any Drug Eluting Stents
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non Cardiac Death	2.0% 2/100 • Number of events 9 • One year	3.0% 3/100 • Number of events 15 • One year
Vascular disorders Stroke	0.00% 0/100 • Number of events 9 • One year	1.0% 1/100 • Number of events 15 • One year
Cardiac disorders Acute Myocardial Infarction	6.0% 6/100 • Number of events 9 • One year	9.0% 9/100 • Number of events 15 • One year
Cardiac disorders Cardiac Death	1.0% 1/100 • Number of events 9 • One year	4.0% 4/100 • Number of events 15 • One year

Other adverse events

Other adverse events
Measure	Oral Sirolimus + Bare Metal Stent n=100 participants at risk Oral sirolimus plus bare metal stent implantation	Drug Eluting Stents n=100 participants at risk Any Drug Eluting Stents
Immune system disorders Allergy	3.0% 3/100 • Number of events 9 • One year	2.0% 2/100 • Number of events 2 • One year
Gastrointestinal disorders diarrhea	6.0% 6/100 • Number of events 9 • One year	0.00% 0/100 • Number of events 2 • One year

Additional Information

Alfredo Rodriguez, MD, PHD

Centro de Estudios en Cardiologia Intervencionista

Phone: 541149648721

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place