Trial Outcomes & Findings for POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI) (NCT NCT03508219)

NCT ID: NCT03508219

Last Updated: 2025-09-15

Results Overview

POCE defined as a composite measure of: All-cause mortality, Stroke (Modified Ranking Scale (mRS) ≥1), Any Myocardial infarction (MI) (includes non target vessel territory), Any unplanned revascularization for ischemia (includes all target and nontarget vessels). OPC based on data collected in Excel-study. The safety and efficacy of the BiOSS LIM C® stent with respect to a PoCE at 12 months in a real world LM bifurcation population compared with a pre-specified performance goal was not confirmed. The POLBOS LM study showed that the BiOSS LIM C® stent was not non-inferior to the XIENCE stent for percutaneous treatment of the LM disease.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 130 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2025-09-15

Participant Flow

The protocol aimed for 260 patients; 130 were enrolled in 14 interventional cardiology centers in Europe: Poland (8), Italy (2), and France (4). The last patient enrolled signed the informed consent on April 15th 2020, and underwent the index procedure on April 16th 2020. The last 12-month follow-up visit took place on 15 April 2021.

Participant milestones

Measure	BiOSS LIM C The treatment strategy consists of contemporary PCI of the left-main bifurcation, using the BiOSS LIM C stent system, following diagnostic angiography demonstrating significant distal unprotected left main disease and local Heart Team discussion applying the anatomic SYNTAX Score.
Overall Study STARTED	130
Overall Study COMPLETED	121
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	BiOSS LIM C The treatment strategy consists of contemporary PCI of the left-main bifurcation, using the BiOSS LIM C stent system, following diagnostic angiography demonstrating significant distal unprotected left main disease and local Heart Team discussion applying the anatomic SYNTAX Score.
Overall Study Death	2
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	4
Overall Study Missed visit	2

Baseline Characteristics

POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI)

Baseline characteristics by cohort

Measure	BiOSS LIM C n=130 Participants The treatment strategy consists of contemporary PCI of the left-main bifurcation, using the BiOSS LIM C stent system, following diagnostic angiography demonstrating significant distal unprotected left main disease and local Heart Team discussion applying the anatomic SYNTAX Score.
Age, Continuous	67.7 Years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	103 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	130 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Syntax Score	19.5 Scores on a scale STANDARD_DEVIATION 8.6 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Intention-to-treat population

POCE defined as a composite measure of: All-cause mortality, Stroke (Modified Ranking Scale (mRS) ≥1), Any Myocardial infarction (MI) (includes non target vessel territory), Any unplanned revascularization for ischemia (includes all target and nontarget vessels). OPC based on data collected in Excel-study. The safety and efficacy of the BiOSS LIM C® stent with respect to a PoCE at 12 months in a real world LM bifurcation population compared with a pre-specified performance goal was not confirmed. The POLBOS LM study showed that the BiOSS LIM C® stent was not non-inferior to the XIENCE stent for percutaneous treatment of the LM disease.

Outcome measures

Measure	BiOSS LIM C Arm n=130 Participants Experimental arm
Non-inferiority Comparison of Patient-oriented Composite Endpoint (PoCE) of BiOSS LIM C to a Pre-specified Objective Performance Goal (OPC).	38.0 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Intention-to-treat

PoCE is defined as a composite of all-cause death, stroke, any MI, and any revascularization

Outcome measures

Measure	BiOSS LIM C Arm n=130 Participants Experimental arm
Patient-oriented Composite Endpoint (PoCE)	38.0 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Intention-to-treat

Target Vessel Failure is defined as the composite of cardiac death, target vessel MI, and clinically indicated target vessel revascularization

Outcome measures

Measure	BiOSS LIM C Arm n=130 Participants Experimental arm
Target Vessel Failure	28.5 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Intention-to-treat

Target Lesion Failure is defined as a composite of cardiac death, target vessel MI, and clinically indicated target lesion revascularization

Outcome measures

Measure	BiOSS LIM C Arm n=130 Participants Experimental arm
Target Lesion Failure	27.7 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Intention-to-treat

Occurrence of death of any cause

Outcome measures

Measure	BiOSS LIM C Arm n=130 Participants Experimental arm
Mortality	1.6 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Intention-to-treat

Occurrence of stroke (with a modified Rankin Scale >=1)

Outcome measures

Measure	BiOSS LIM C Arm n=130 Participants Experimental arm
Stroke	1.6 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Intention-to-treat

Occurrence of myocardial infarction

Outcome measures

Measure	BiOSS LIM C Arm n=130 Participants Experimental arm
Myocardial Infarction	19.0 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Intention-to-treat

Occurrence of any revascularization (percutaneous coronary intervention or coronary artery bypass grafting)

Outcome measures

Measure	BiOSS LIM C Arm n=130 Participants Experimental arm
Revascularization	20.3 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Intention-to-treat population

Occurrence of any stent thrombosis according to standard definitions provided by the Academic Research Consortium

Outcome measures

Measure	BiOSS LIM C Arm n=130 Participants Experimental arm
Stent Thrombosis	0.8 Percentage of participants

Adverse Events

BiOSS LIM C

Serious events: 43 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Measure	BiOSS LIM C n=130 participants at risk The treatment strategy consists of contemporary PCI of the left-main bifurcation, using the BiOSS LIM C stent system, following diagnostic angiography demonstrating significant distal unprotected left main disease and local Heart Team discussion applying the anatomic SYNTAX Score.
Hepatobiliary disorders Abnormal liver function	0.77% 1/130 • Number of events 1 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Cardiac disorders Acute pulmonary edema	0.77% 1/130 • Number of events 1 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Blood and lymphatic system disorders Anemia	3.1% 4/130 • Number of events 4 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Cardiac disorders Atrial arrhythmia	1.5% 2/130 • Number of events 2 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Blood and lymphatic system disorders Bleeding	3.8% 5/130 • Number of events 5 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Cardiac disorders Bradycardia	1.5% 2/130 • Number of events 2 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.77% 1/130 • Number of events 1 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Cardiac disorders Cardiac tamponade	0.77% 1/130 • Number of events 1 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Cardiac disorders Chest pain	2.3% 3/130 • Number of events 3 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Cardiac disorders Coronary stenosis	2.3% 3/130 • Number of events 3 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Psychiatric disorders Depression	0.77% 1/130 • Number of events 1 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.77% 1/130 • Number of events 1 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Renal and urinary disorders Glomerulonephritis	1.5% 2/130 • Number of events 2 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Cardiac disorders Heart failure	1.5% 2/130 • Number of events 2 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Cardiac disorders In-stent restenosis	20.0% 26/130 • Number of events 26 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Cardiac disorders Low ejection fraction	0.77% 1/130 • Number of events 1 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
General disorders Medication error	0.77% 1/130 • Number of events 1 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Cardiac disorders Myocardial infarction	6.9% 9/130 • Number of events 9 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Cardiac disorders Pericardial effusion	1.5% 2/130 • Number of events 2 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Skin and subcutaneous tissue disorders Phlebitis	0.77% 1/130 • Number of events 1 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.5% 2/130 • Number of events 2 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.77% 1/130 • Number of events 1 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Nervous system disorders Presyncope	0.77% 1/130 • Number of events 1 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Nervous system disorders Stroke	1.5% 2/130 • Number of events 2 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.
Renal and urinary disorders Urinary retention	0.77% 1/130 • Number of events 1 • From enrollment until end of follow-up, up to 12 months. Only severe adverse events were captured systematically.

Other adverse events

Adverse event data not reported

Additional Information

Ernest Spitzer, MD

European Cardiovascular Research Institute (ECRI-10)

Phone: 0031102062828

Email: e.spitzer@ecri-trials.com

Results disclosure agreements

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