Trial Outcomes & Findings for Evaluation of HealinG of Polymer-Free Biomlimus A9-Coated Stent by Optical Coherence Tomography (EGO-BIOFREEDOM) (NCT NCT01760876)

Last Updated: 2017-08-14

Results Overview

The percentage of strut coverage and category of coverage (A to F) from 1 month to 9 months by longitudinal sequential OCT assessments. A. Definitely uncovered - strut not covered by tissue, and both sides appear square; B. Uncovered with abnormal in-stent tissue - strut covered by irregular tissue or fibrin, and both sides appear square; C. Partially uncovered - strut partially covered by tissue but only one side has a smooth continuous shoulder; D. Covered (protruding) - strut covered by thin continuous tissue on both sides but still extending into the lumen; E. Covered (embedded) - strut covered by continuous tissue or neointima and not interrupting the smooth lumen contour; F. Covered (proliferative) - strut covered with excessive growth of neointima with thickness \>0.3 mm.

Recruitment status

COMPLETED

Study phase

Target enrollment

106 participants

Primary outcome timeframe

1 to 9 months

Results posted on

2017-08-14

Participant Flow

From Dec 20, 2012 to July 24, 2014, 106 patients enrolled for BioFreedom stent implantation and agreed to participate in the study at Queen Mary Hospital, Hong Kong.

100 patients should be enrolled and randomly assigned to 5 monthly groups (n = 20:20:20:20:20) but 6 patients could not complete all the 3 OCT assessments (0 to 9 months) for reasons stated below and therefore a total of 106 patients were enrolled with BioFreedom study stents implanted and agreed for the study.

Participant milestones

Participant milestones
Measure	Biofreedom Stent Coronary intervention: The BioFreedom drug coated study stent (DCS) is a polymer-free biolimus A9 coated drug stent. 100 patients needed to complete 3 OCT assessments over 9 months:- (1) at baseline (n = 100) for best stent optimization, (2) at 5 monthly groups (randomly assigned in 1 to 5 months n= 20:20:20:20:20) for early healing profile, and (3) at 9 months (n = 100) for neointima metrics.
Overall Study STARTED	106
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Biofreedom Stent Coronary intervention: The BioFreedom drug coated study stent (DCS) is a polymer-free biolimus A9 coated drug stent. 100 patients needed to complete 3 OCT assessments over 9 months:- (1) at baseline (n = 100) for best stent optimization, (2) at 5 monthly groups (randomly assigned in 1 to 5 months n= 20:20:20:20:20) for early healing profile, and (3) at 9 months (n = 100) for neointima metrics.
Overall Study Non-cardiac death (head injury)	1
Overall Study Carcinoma of prostate	1
Overall Study Impaired renal function	1
Overall Study Major depression	1
Overall Study Very poor baseline OCT quality	2

Baseline Characteristics

Evaluation of HealinG of Polymer-Free Biomlimus A9-Coated Stent by Optical Coherence Tomography (EGO-BIOFREEDOM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Biofreedom Stent n=104 Participants Coronary intervention: The BioFreedom drug coated study stent (DCS) is a polymer-free abluminally coated Biolimus A9 coated drug stent. 100 patients needed to complete 3 OCT assessments over 9 months:- (1) at baseline (n = 100) for best stent optimization, (2) at 5 monthly groups (randomly assigned in 1 to 5 months n= 20:20:20:20:20) for early healing profile, and (3) at 9 months (n = 100) for neointima metrics.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=5 Participants
Age, Categorical >=65 years	55 Participants n=5 Participants
Age, Continuous	63.99 years STANDARD_DEVIATION 10.71 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	89 Participants n=5 Participants
Region of Enrollment Hong Kong	104 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 to 9 months

Population: 100 patients treated with BF stents and randomly assigned to 5 monthly groups (n = 20:20:20:20:20) at 1 to 5 months receiving OCT follow-up, and then 100 patients altogether at 9 months for another follow-up.

Outcome measures

Outcome measures
Measure	Biofreedom Stent n=100 Participants The healing profile (curve) in terms of percentage strut coverage of the BioFreedom Stent increased from a median of 85.77%, 86.95%, 88.56%, 96.79%, and 97.14% in the first 5 months, to 99.55% at 9 months.
OCT Findings on Coverage (Degree of Endothelialisation/Coverage) From 1 to 9 Months. 1 Month (n=20)	85.77 percentage of strut coverage (D+E+F) Interval 79.1 to 90.25
OCT Findings on Coverage (Degree of Endothelialisation/Coverage) From 1 to 9 Months. 2 Month (n=20)	86.95 percentage of strut coverage (D+E+F) Interval 81.55 to 94.44
OCT Findings on Coverage (Degree of Endothelialisation/Coverage) From 1 to 9 Months. 3 Month (n=20)	88.56 percentage of strut coverage (D+E+F) Interval 84.62 to 97.63
OCT Findings on Coverage (Degree of Endothelialisation/Coverage) From 1 to 9 Months. 4 Month (n=20)	96.79 percentage of strut coverage (D+E+F) Interval 94.31 to 98.7
OCT Findings on Coverage (Degree of Endothelialisation/Coverage) From 1 to 9 Months. 5 Month (n=20)	97.14 percentage of strut coverage (D+E+F) Interval 95.31 to 99.01
OCT Findings on Coverage (Degree of Endothelialisation/Coverage) From 1 to 9 Months. 9 Month (n=100)	99.55 percentage of strut coverage (D+E+F) Interval 98.17 to 99.93

SECONDARY outcome

Timeframe: 9 months and 12 months

Secondary endpoints would consist of OCT endpoints (neointimal area, neointimal thickness, neointimal volume, and percentage neointimal volume ), QCA endpoints (late lumen loss at 9 months), and clinical endpoints (MACE, including stent thrombosis up to 12 months). A subgroup analysis will be performed for DM patients.

Outcome measures

Outcome data not reported

Adverse Events

Biofreedom Stent

Serious events: 30 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Biofreedom Stent n=104 participants at risk The BioFreedom drug coated study stent (DCS) is a polymer-free abluminally coated Biolimus A9 coated drug stent. 100 patients needed to complete 3 OCT assessments over 9 months:- (1) at baseline (n = 100) for best stent optimization, (2) at 5 monthly groups (randomly assigned in 1 to 5 months n= 20:20:20:20:20) for early healing profile, and (3) at 9 months (n = 100) for neointima metrics.
Nervous system disorders Non-cardiac death from fall	3.3% 1/30 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Cardiac disorders Admitted for "chest pain" in between 9 months	1.9% 2/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Nervous system disorders Admitted with left side numbness / stroke	0.96% 1/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Gastrointestinal disorders Admitted for upper gastrointestinal bleeding	0.96% 1/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Respiratory, thoracic and mediastinal disorders Admitted for shortness of breath	1.9% 2/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Respiratory, thoracic and mediastinal disorders Admitted for chest infection	0.96% 1/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Gastrointestinal disorders Admitted for Colonoscopy	1.9% 2/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Blood and lymphatic system disorders Admitted for epistaxis	0.96% 1/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Nervous system disorders Admitted for epileptic attack	0.96% 1/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Vascular disorders Admitted for Hematoma at Vascular Femoral Access Site	0.96% 1/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Reproductive system and breast disorders Admitted for Acute Dermatitis	0.96% 1/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Musculoskeletal and connective tissue disorders Admitted for low back pain	0.96% 1/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Musculoskeletal and connective tissue disorders Admitted for Acute Traumatic Closed Fracture of Left Foot	0.96% 1/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Renal and urinary disorders Admitted for skin rashes, lower limb oedema	0.96% 1/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Cardiac disorders 3 cases of in-stent restenosis at 9 months follow-up	2.9% 3/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Cardiac disorders Admitted for Non-target Lesion Revascularization	0.96% 1/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Investigations Admitted For Atypical Chest Pain	0.96% 1/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Renal and urinary disorders Admitted For Fluid Retention	0.96% 1/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Renal and urinary disorders Admitted For Lower Leg Oedema	0.96% 1/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Investigations Admitted For Palpitation	0.96% 1/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Respiratory, thoracic and mediastinal disorders Admitted For Upper Respiratory Tract Infection	0.96% 1/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Renal and urinary disorders Admitted For Urinary Tract Infection	0.96% 1/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Cardiac disorders Admitted For NSTEMI	0.96% 1/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Investigations Admitted For Pyrexia of Unknown Origin	0.96% 1/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).
Hepatobiliary disorders Admitted For Biliary Stone At Common Bile Duct	0.96% 1/104 • 1 year clinical follow up. 4 patients withdrew (1 renal failure, 1 emotionally unstable,1 died from fall and 1 withdrew due to personal reasons).

Other adverse events

Adverse event data not reported

Additional Information

Prof. Stephen Wai-luen LEE

Queen Mary Hospital,University of Hong kong

Phone: (852) 22555409 or 28181314

Email: [email protected] ; [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place