Trial Outcomes & Findings for Multicenter Postmarket Surveillance Registry Evaluating Performance and Long Term Safety of the Presillion Stent (NCT NCT00968019)

NCT ID: NCT00968019

Last Updated: 2013-03-13

Results Overview

Major adverse cardiac and cerebral events are defined as an adjudicated composite of cardiac death, myocardial infarction (Q-wave and non Q-wave), emergent coronary artery bypass surgery and target vessel revascularization (TVR). The primary safety measure was the composite of MACE up to 12 months follow up. In order to show the safety of the device, the MACE rate was compared with the performance goal for bare metal stents(experience with bare metal stents in clinical trials suggested that the 12 month MACE rate should be about 25.0%).

• Recruitment status: COMPLETED
• Target enrollment: 318 participants
• Primary outcome timeframe: at 12 months follow-up
• Results posted on: 2013-03-13

Participant Flow

Participant milestones

Measure	Treated With Presillion Stent Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Overall Study STARTED	318
Overall Study COMPLETED	303
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multicenter Postmarket Surveillance Registry Evaluating Performance and Long Term Safety of the Presillion Stent

Baseline characteristics by cohort

Measure	Treated With Presillion Stent n=318 Participants Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Age Continuous	65.5 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants
Sex: Female, Male Male	248 Participants n=5 Participants
Region of Enrollment Portugal	56 participants n=5 Participants
Region of Enrollment Spain	262 participants n=5 Participants

PRIMARY outcome

Timeframe: at 12 months follow-up

Population: No formal statistical significance testing was performed. Descriptive statistics were calculated for all relevant variables (mean, standard deviation, median and ranges for the continuous variables and with frequencies and % for the discrete variables). Subjects who discontinued prematurely were included in the analysis and were not replaced.

Major adverse cardiac and cerebral events are defined as an adjudicated composite of cardiac death, myocardial infarction (Q-wave and non Q-wave), emergent coronary artery bypass surgery and target vessel revascularization (TVR).

The primary safety measure was the composite of MACE up to 12 months follow up. In order to show the safety of the device, the MACE rate was compared with the performance goal for bare metal stents(experience with bare metal stents in clinical trials suggested that the 12 month MACE rate should be about 25.0%).

Outcome measures

Measure	Treated With Presillion Stent n=308 Participants Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Major Cardiac Adverse Events (Including Cardiac Death, Myocardial Infarction (Q-wave and Non Q-wave) and Clinically Driven TLR (Target Lesion Revascularization))	9 participants

SECONDARY outcome

Timeframe: Peri-procedure up to discharge

Population: 318 patients treated with the Presillion stent in up to two de novo coronary artery lesions (354 lesions)

Device success defined as achievement of a final diameter stenosis of <50% (by visual estimate), using the assigned device only

Outcome measures

Measure	Treated With Presillion Stent n=354 Lesions Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Device Success	98.9 percentage of device success

SECONDARY outcome

Timeframe: Peri-procedure up to discharge

Population: 318 patients treated with the Presillion stent in up to two de novo coronary artery lesions (354 lesions)

Lesion success defined as the attainment of <50% final diameter stenosis (by visual estimate) using any percutaneous method.

Outcome measures

Measure	Treated With Presillion Stent n=354 Lesion Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Lesion Success	98.6 percentage of lesion Success

SECONDARY outcome

Timeframe: Peri-procedure up to discharge

Population: 318 patients treated with the Presillion stent in up to two de novo coronary artery lesions (354 lesions)

Procedural success defined as achievement of a final diameter stenosis of <50% (by visual estimate) using any percutaneous method, without the occurrence of death, MI (Myocardial Infarction), or repeat revascularization of the target lesion during the hospital stay

Outcome measures

Measure	Treated With Presillion Stent n=354 Lesions Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Procedural Success	97.2 percentage of Procedural Success

SECONDARY outcome

Timeframe: Up to 30 days

Population: 309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)

Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel

Outcome measures

Measure	Treated With Presillion Stent n=311 Lesions Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Clinically Driven TLR	2 participants

SECONDARY outcome

Timeframe: Up to 30 days

Population: 309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)

Target vessel revascularization (TVR) is defined as any clinically driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.

Outcome measures

Measure	Treated With Presillion Stent n=311 Lesions Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Clinically Driven TVR	2 participants

SECONDARY outcome

Timeframe: Up to 30 days

Population: 309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)

Target vessel failure includes any target vessel revascularization as well as any MI or any cardiac death that cannot be clearly attributed to a non-target vessel.

Target vessel failure will be reported when:

1. MI occurs in territory not clearly attributed to a vessel other than the target vessel.

2. Cardiac death not clearly due to a non-target vessel endpoint.

3. Target vessel revascularization is performed.

Outcome measures

Measure	Treated With Presillion Stent n=311 Lesions Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Target Vessel Failure	7 participants

SECONDARY outcome

Timeframe: Up to 30 days

Population: 309 patients treated with the Presillion stent in up to two de novo coronary artery lesions (311 lesions)

A positive diagnosis of myocardial infarction is made when one of the following criteria is met:

1. Typical rise and/or fall of biochemical markers of myocardial necrosis together with evidence of ischemia with at least one of the following:

• ischemic symptoms
• ECG changes indicative of ischemia (ST segment elevation or depression)
• Development of pathological Q waves in the ECG
• Imaging evidence of new an equivocal loss of viable myocardium or new regional wall motion abnormality

2. Pathological findings of an acute myocardial infarction

Outcome measures

Measure	Treated With Presillion Stent n=311 Lesions Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Myocardial Infarction	6 participants

SECONDARY outcome

Timeframe: Up to 30 days

Outcome measures

Measure	Treated With Presillion Stent n=309 Participants Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Major Bleeding	0 participants

SECONDARY outcome

Timeframe: Up to 30 days

Outcome measures

Measure	Treated With Presillion Stent n=309 Participants Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Stroke	0 participants

SECONDARY outcome

Timeframe: Up to 30 days

Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.

Outcome measures

Measure	Treated With Presillion Stent n=309 Participants Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Stent Thrombosis	2 participants

SECONDARY outcome

Timeframe: up to 12 months

Population: 303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)

Target Lesion Revascularization (TLR) is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel

Outcome measures

Measure	Treated With Presillion Stent n=308 Lesions Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Clinically Driven TLR	5 participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: 303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)

Target vessel revascularization (TVR) is defined as any clinically driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.

Outcome measures

Measure	Treated With Presillion Stent n=308 Lesions Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Clinically Driven TVR	5 participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: 303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)

Target vessel failure includes any target vessel revascularization as well as any MI or any cardiac death that cannot be clearly attributed to a non-target vessel.

Target vessel failure will be reported when:

1. MI occurs in territory not clearly attributed to a vessel other than the target vessel.

2. Cardiac death not clearly due to a non-target vessel endpoint.

3. Target vessel revascularization is performed.

Outcome measures

Measure	Treated With Presillion Stent n=308 Lesions Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Target Vessel Failure	11 participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: 303 patients treated with the Presillion stent in up to two de novo coronary artery lesions (308 lesions)

A positive diagnosis of myocardial infarction is made when one of the following criteria is met:

1. Typical rise and/or fall of biochemical markers of myocardial necrosis together with evidence of ischemia with at least one of the following:

• ischemic symptoms
• ECG changes indicative of ischemia (ST segment elevation or depression)
• Development of pathological Q waves in the ECG
• Imaging evidence of new an equivocal loss of viable myocardium or new regional wall motion abnormality

2. Pathological findings of an acute myocardial infarction

Outcome measures

Measure	Treated With Presillion Stent n=308 Lesions Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Myocardial Infarction	8 participants

SECONDARY outcome

Timeframe: Up to 12 months

Outcome measures

Measure	Treated With Presillion Stent n=303 Participants Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Major Bleeding	0 participants

SECONDARY outcome

Timeframe: Up to 12 months

Thrombosis is defined as the formation of blood clot derived from aggregation of red cells or platelets obstructing the lumen of the vessel.

Outcome measures

Measure	Treated With Presillion Stent n=303 Participants Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Stent Thrombosis	2 participants

SECONDARY outcome

Timeframe: Up to 12 months

Outcome measures

Measure	Treated With Presillion Stent n=303 Participants Patients treated with the Presillion stent in up to two de novo coronary artery lesions
Stroke	0 participants

Adverse Events

Treated With Presillion Stent

Serious events: 39 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treated With Presillion Stent n=318 participants at risk Patients treated with the Presillion stent in up to two de novo coronary artery lesions
General disorders Mortality	1.6% 5/318 • Number of events 5 • Up to 12 months
Cardiac disorders Myocardial infarction	2.5% 8/318 • Number of events 8 • Up to 12 months
Vascular disorders Revascularization	4.1% 13/318 • Number of events 13 • Up to 12 months
Vascular disorders Bleeding or vascular event	1.3% 4/318 • Number of events 4 • Up to 12 months
General disorders Serious Adverse Events not related to the study device	2.8% 9/318 • Number of events 9 • Up to 12 months

Other adverse events

Measure	Treated With Presillion Stent n=318 participants at risk Patients treated with the Presillion stent in up to two de novo coronary artery lesions
General disorders Signs that do not interfere, or interferes but does not hinder, with the subject's usual activity	5.3% 17/318 • Number of events 17 • Up to 12 months

Additional Information

Mayda Lopez-Belmonte, PhD

Johnson and Johnson Medical Iberia

Phone: +34 91 7228481

Email: tlopezbe@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place