Trial Outcomes & Findings for PIONEER III Trial to Assess Safety and Efficacy of the BuMA Supreme™ Drug Coated Coronary Stent in Patients With Coronary Disease (NCT NCT03168776)
NCT ID: NCT03168776
Last Updated: 2026-01-27
Results Overview
TLF is defined as the composite of cardiac death, target vessel related myocardial infarction (TV-MI), and clinically-driven target lesion revascularization (TLR)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1629 participants
Primary outcome timeframe
12 months
Results posted on
2026-01-27
Participant Flow
Participant milestones
| Measure |
BuMA Supreme Coronary Stent System
BuMA Supreme DES: Implant BuMA Supreme stent only
|
Xience or Promus Everolimus Stent System
Xience or Promus DES: Implant XIENCE family or Promus family only
|
|---|---|---|
|
Overall Study
STARTED
|
1086
|
543
|
|
Overall Study
ITT Analysis Population - Sufficient Data to Evaluate Primary Endpoint
|
1058
|
530
|
|
Overall Study
ITT Completed 12-Month Clinical F/U
|
1042
|
522
|
|
Overall Study
COMPLETED
|
1042
|
522
|
|
Overall Study
NOT COMPLETED
|
44
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PIONEER III Trial to Assess Safety and Efficacy of the BuMA Supreme™ Drug Coated Coronary Stent in Patients With Coronary Disease
Baseline characteristics by cohort
| Measure |
BuMA Supreme Coronary Stent System (ITT)
n=1086 Participants
The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA).
|
Durable Polymer EES (XIENCE or Promus DES) (ITT)
n=542 Participants
The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems.
|
Total
n=1628 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age ≥65
|
567 Participants
n=25 Participants
|
272 Participants
n=25 Participants
|
839 Participants
n=50 Participants
|
|
Age, Customized
Age <65
|
519 Participants
n=25 Participants
|
270 Participants
n=25 Participants
|
789 Participants
n=50 Participants
|
|
Sex: Female, Male
Female
|
258 Participants
n=25 Participants
|
148 Participants
n=25 Participants
|
406 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
828 Participants
n=25 Participants
|
394 Participants
n=25 Participants
|
1222 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
91 Participants
n=25 Participants
|
53 Participants
n=25 Participants
|
144 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
941 Participants
n=25 Participants
|
455 Participants
n=25 Participants
|
1396 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
54 Participants
n=25 Participants
|
34 Participants
n=25 Participants
|
88 Participants
n=50 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Asian
|
129 Participants
n=25 Participants
|
63 Participants
n=25 Participants
|
192 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=25 Participants
|
19 Participants
n=25 Participants
|
53 Participants
n=50 Participants
|
|
Race (NIH/OMB)
White
|
868 Participants
n=25 Participants
|
427 Participants
n=25 Participants
|
1295 Participants
n=50 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
53 Participants
n=25 Participants
|
33 Participants
n=25 Participants
|
86 Participants
n=50 Participants
|
|
Region of Enrollment
Canada
|
70 Participants
n=25 Participants
|
36 Participants
n=25 Participants
|
106 Participants
n=50 Participants
|
|
Region of Enrollment
Netherlands
|
124 Participants
n=25 Participants
|
62 Participants
n=25 Participants
|
186 Participants
n=50 Participants
|
|
Region of Enrollment
Belgium
|
76 Participants
n=25 Participants
|
38 Participants
n=25 Participants
|
114 Participants
n=50 Participants
|
|
Region of Enrollment
United States
|
479 Participants
n=25 Participants
|
231 Participants
n=25 Participants
|
710 Participants
n=50 Participants
|
|
Region of Enrollment
Japan
|
108 Participants
n=25 Participants
|
55 Participants
n=25 Participants
|
163 Participants
n=50 Participants
|
|
Region of Enrollment
United Kingdom
|
45 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
70 Participants
n=50 Participants
|
|
Region of Enrollment
Switzerland
|
11 Participants
n=25 Participants
|
8 Participants
n=25 Participants
|
19 Participants
n=50 Participants
|
|
Region of Enrollment
Spain
|
138 Participants
n=25 Participants
|
67 Participants
n=25 Participants
|
205 Participants
n=50 Participants
|
|
Region of Enrollment
France
|
35 Participants
n=25 Participants
|
20 Participants
n=25 Participants
|
55 Participants
n=50 Participants
|
|
Height
|
171.33 cm
STANDARD_DEVIATION 9.76 • n=25 Participants
|
170.64 cm
STANDARD_DEVIATION 9.92 • n=25 Participants
|
171.10 cm
STANDARD_DEVIATION 9.81 • n=50 Participants
|
|
Weight (kg)
|
85.68 Kg
STANDARD_DEVIATION 19.69 • n=25 Participants
|
85.70 Kg
STANDARD_DEVIATION 19.17 • n=25 Participants
|
85.68 Kg
STANDARD_DEVIATION 19.52 • n=50 Participants
|
|
Body Mass Index (kg/m^2)
|
29.06 kg/m^2
STANDARD_DEVIATION 5.71 • n=25 Participants
|
29.32 kg/m^2
STANDARD_DEVIATION 5.66 • n=25 Participants
|
29.15 kg/m^2
STANDARD_DEVIATION 5.69 • n=50 Participants
|
|
Systolic Blood Pressure (mmHg)
|
134.1 mmHg
STANDARD_DEVIATION 22.1 • n=25 Participants
|
133.8 mmHg
STANDARD_DEVIATION 22.1 • n=25 Participants
|
134.0 mmHg
STANDARD_DEVIATION 22.1 • n=50 Participants
|
|
Diastolic Blood Pressure (mmHg)
|
74.9 mmHg
STANDARD_DEVIATION 12.6 • n=25 Participants
|
75.0 mmHg
STANDARD_DEVIATION 12.6 • n=25 Participants
|
74.9 mmHg
STANDARD_DEVIATION 12.6 • n=50 Participants
|
|
Pulse (bpm)
|
68.9 bpm
STANDARD_DEVIATION 12.8 • n=25 Participants
|
69.2 bpm
STANDARD_DEVIATION 12.4 • n=25 Participants
|
69.0 bpm
STANDARD_DEVIATION 12.6 • n=50 Participants
|
PRIMARY outcome
Timeframe: 12 monthsTLF is defined as the composite of cardiac death, target vessel related myocardial infarction (TV-MI), and clinically-driven target lesion revascularization (TLR)
Outcome measures
| Measure |
BuMA Supreme Coronary Stent System (ITT)
n=1058 Participants
The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA).
|
Durable Polymer EES (XIENCE or Promus DES) (ITT)
n=530 Participants
The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems.
|
|---|---|---|
|
Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements
TLF
|
5.4 percentage of subjects with TLF
Interval 4.1 to 6.9
|
5.1 percentage of subjects with TLF
Interval 3.4 to 7.3
|
|
Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements
Cardiac Death
|
0.3 percentage of subjects with TLF
Interval 0.1 to 0.8
|
0.8 percentage of subjects with TLF
Interval 0.2 to 1.9
|
|
Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements
Target vessel MI
|
3.4 percentage of subjects with TLF
Interval 2.4 to 4.7
|
4.2 percentage of subjects with TLF
Interval 2.6 to 6.2
|
|
Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements
Clinically Driven TLR
|
2.3 percentage of subjects with TLF
Interval 1.5 to 3.4
|
0.9 percentage of subjects with TLF
Interval 0.3 to 2.2
|
SECONDARY outcome
Timeframe: Assessed at 30 days, 6 months, 12 months, and up to 5 yearsPopulation: Number of participants with Cardiac Death
Any death due to proximate cardiac cause (e.g., MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death.
Outcome measures
| Measure |
BuMA Supreme Coronary Stent System (ITT)
n=1086 Participants
The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA).
|
Durable Polymer EES (XIENCE or Promus DES) (ITT)
n=543 Participants
The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems.
|
|---|---|---|
|
Number of Participants With Cardiac Death
30 Days
|
2 Participants
|
1 Participants
|
|
Number of Participants With Cardiac Death
6 Months
|
3 Participants
|
3 Participants
|
|
Number of Participants With Cardiac Death
12 Months
|
3 Participants
|
4 Participants
|
|
Number of Participants With Cardiac Death
5 Years
|
25 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Assessed at 30 days, 6 months, 12 months, and up to 5 yearsAll-cause death, myocardial infarction, or target vessel revascularization (reported as a composite)
Outcome measures
| Measure |
BuMA Supreme Coronary Stent System (ITT)
n=1086 Participants
The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA).
|
Durable Polymer EES (XIENCE or Promus DES) (ITT)
n=543 Participants
The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems.
|
|---|---|---|
|
Number of Participants With Major Adverse Cardiac Events (MACE)
30 Days
|
39 Participants
|
22 Participants
|
|
Number of Participants With Major Adverse Cardiac Events (MACE)
6 Months
|
58 Participants
|
33 Participants
|
|
Number of Participants With Major Adverse Cardiac Events (MACE)
12 Months
|
79 Participants
|
39 Participants
|
|
Number of Participants With Major Adverse Cardiac Events (MACE)
5 Years
|
210 Participants
|
113 Participants
|
SECONDARY outcome
Timeframe: Assessed at 30 days, 6 months, 12 months, and up to 5 yearsDefined according to the modified Third Universal Definition as evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia.
Outcome measures
| Measure |
BuMA Supreme Coronary Stent System (ITT)
n=1086 Participants
The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA).
|
Durable Polymer EES (XIENCE or Promus DES) (ITT)
n=543 Participants
The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems.
|
|---|---|---|
|
Number of Participants With Myocardial Infarction (MI)
30 Days
|
36 Participants
|
21 Participants
|
|
Number of Participants With Myocardial Infarction (MI)
6 Months
|
43 Participants
|
22 Participants
|
|
Number of Participants With Myocardial Infarction (MI)
12 Months
|
51 Participants
|
24 Participants
|
|
Number of Participants With Myocardial Infarction (MI)
5 Years
|
87 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Assessed at 30 days, 6 months, 12 months, and up to 5 yearsDefinite or probable (ARC-defined), classified as early, late, or very late
Outcome measures
| Measure |
BuMA Supreme Coronary Stent System (ITT)
n=1086 Participants
The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA).
|
Durable Polymer EES (XIENCE or Promus DES) (ITT)
n=543 Participants
The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems.
|
|---|---|---|
|
Number of Participants With Stent Thrombosis
30 Days
|
7 Participants
|
2 Participants
|
|
Number of Participants With Stent Thrombosis
6 Months
|
7 Participants
|
2 Participants
|
|
Number of Participants With Stent Thrombosis
12 Months
|
8 Participants
|
2 Participants
|
|
Number of Participants With Stent Thrombosis
5 Years
|
26 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Assessed at 30 days, 6 months, 12 months, and up to 5 yearsEvaluated as components and as a composite of BARC Type 3 or 5 bleeding, including: Type 3a: Over bleeding plus hemoglobin drop of 3 to \<5 g/dL\* (provided hemoglobin drop is related to bleed); Any transfusion with over bleeding Type 3b: Overt bleeding plus hemoglobin drop ≥5 g/dL\* (provided hemoglobin drop is related to bleed); Cardiac tamponade; Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid); Bleeding requiring intravenous vasoactive agents Type 3c: Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal); Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed comprising vision Type 5: Fatal bleeding
Outcome measures
| Measure |
BuMA Supreme Coronary Stent System (ITT)
n=1086 Participants
The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA).
|
Durable Polymer EES (XIENCE or Promus DES) (ITT)
n=543 Participants
The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems.
|
|---|---|---|
|
Number of Participants With Bleeding Complications (BARC Definitions)
30 Days
|
8 Participants
|
2 Participants
|
|
Number of Participants With Bleeding Complications (BARC Definitions)
6 Months
|
14 Participants
|
2 Participants
|
|
Number of Participants With Bleeding Complications (BARC Definitions)
12 Months
|
24 Participants
|
5 Participants
|
|
Number of Participants With Bleeding Complications (BARC Definitions)
5 Years
|
44 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Post-ProcedureDefined as attainment of \<30% residual stenosis, as measured by quantitative coronary angiography (QCA) using any percutaneous method \[evaluated post-procedure\]
Outcome measures
| Measure |
BuMA Supreme Coronary Stent System (ITT)
n=1275 Number of Lesions Treated
The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA).
|
Durable Polymer EES (XIENCE or Promus DES) (ITT)
n=656 Number of Lesions Treated
The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems.
|
|---|---|---|
|
Lesion Success
|
1271 Number of Lesions Treated
|
653 Number of Lesions Treated
|
SECONDARY outcome
Timeframe: Post-ProcedureDefined as attainment of \<30% residual stenosis of the target lesion measured by QCA using the assigned device \[evaluated post-procedure\]
Outcome measures
| Measure |
BuMA Supreme Coronary Stent System (ITT)
n=1086 Participants
The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA).
|
Durable Polymer EES (XIENCE or Promus DES) (ITT)
n=648 Total Number of Devices
The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems.
|
|---|---|---|
|
Device Success
|
1212 Total Number of Devices
|
640 Total Number of Devices
|
SECONDARY outcome
Timeframe: Post procedure/Prior to Discharge, an average of 3 daysDefined as lesion success without the occurrence of in-hospital MACE \[evaluated in-hospital\]
Outcome measures
| Measure |
BuMA Supreme Coronary Stent System (ITT)
n=1074 Participants
The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA).
|
Durable Polymer EES (XIENCE or Promus DES) (ITT)
n=537 Participants
The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems.
|
|---|---|---|
|
Procedure Success
|
1042 Participants
|
514 Participants
|
SECONDARY outcome
Timeframe: Assessed at 30 days, 6 months, 12 months, and up to 5 yearsAny repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. A revascularization is considered clinically driven if angiography at follow-up shows a percent diameter stenosis ≥ 70% (by core lab quantitative coronary angiography assessment) OR percent diameter stenosis ≥ 50% (by core lab quantitative coronary angiography assessment) accompanied by one of the following:103 1. a positive history of recurrent angina pectoris, presumably related to the target vessel; 2. objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent) presumably related to the target vessel; 3. abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve).
Outcome measures
| Measure |
BuMA Supreme Coronary Stent System (ITT)
n=1086 Participants
The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA).
|
Durable Polymer EES (XIENCE or Promus DES) (ITT)
n=543 Participants
The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems.
|
|---|---|---|
|
Clinically-driven Target Vessel Revascularization (TVR)
In-Hospital Prior to Discharge
|
2 Participants
|
2 Participants
|
|
Clinically-driven Target Vessel Revascularization (TVR)
30 Days
|
8 Participants
|
2 Participants
|
|
Clinically-driven Target Vessel Revascularization (TVR)
6 Months
|
21 Participants
|
11 Participants
|
|
Clinically-driven Target Vessel Revascularization (TVR)
12 Months
|
38 Participants
|
16 Participants
|
|
Clinically-driven Target Vessel Revascularization (TVR)
5 years
|
98 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: Assessed at 30 days, 6 months, 12 months, and up to 5 yearsThe composite of cardiac death, target vessel-related myocardial infarction, and clinically-driven target vessel revascularization.
Outcome measures
| Measure |
BuMA Supreme Coronary Stent System (ITT)
n=1086 Participants
The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA).
|
Durable Polymer EES (XIENCE or Promus DES) (ITT)
n=543 Participants
The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems.
|
|---|---|---|
|
Target Vessel Failure (TVF)
In-Hospital Prior to Discharge
|
26 Participants
|
19 Participants
|
|
Target Vessel Failure (TVF)
30 Days
|
34 Participants
|
21 Participants
|
|
Target Vessel Failure (TVF)
6 Months
|
47 Participants
|
30 Participants
|
|
Target Vessel Failure (TVF)
12 Months
|
66 Participants
|
34 Participants
|
|
Target Vessel Failure (TVF)
5 Years
|
146 Participants
|
82 Participants
|
Adverse Events
Durable Polymer EES (XIENCE or Promus DES) (ITT)
Serious events: 113 serious events
Other events: 0 other events
Deaths: 41 deaths
BuMA Supreme Coronary Stent System (ITT)
Serious events: 210 serious events
Other events: 0 other events
Deaths: 79 deaths
Serious adverse events
| Measure |
Durable Polymer EES (XIENCE or Promus DES) (ITT)
n=543 participants at risk
The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems.
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BuMA Supreme Coronary Stent System (ITT)
n=1086 participants at risk
The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA).
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|---|---|---|
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Cardiac disorders
MACE
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20.8%
113/543 • Number of events 323 • 5 Years
For all adverse events that represented a potential endpoint event, all relevant medical information (including clinically relevant imaging data, ECG data, and the results of relevant laboratory testing performed as part of the standard of care) was collected and retained as part of the research file to support adverse event analysis and adjudication. Coding by organ class was not performed in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed
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19.3%
210/1086 • Number of events 323 • 5 Years
For all adverse events that represented a potential endpoint event, all relevant medical information (including clinically relevant imaging data, ECG data, and the results of relevant laboratory testing performed as part of the standard of care) was collected and retained as part of the research file to support adverse event analysis and adjudication. Coding by organ class was not performed in this study. Other \[Not Including Serious\] Adverse Events were not monitored/assessed
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Other adverse events
Adverse event data not reported
Additional Information
Eric Cao, VP Clinical & Regulatory affairs
Nova Vascular
Phone: 408-646-1320
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place