Trial Outcomes & Findings for BIOTRONIK Orsiro Pre-Marketing Registration (NCT NCT02870985)

NCT ID: NCT02870985

Last Updated: 2024-03-04

Results Overview

QCA data will be provided by an independent core laboratory. A separate report with descriptive statistics will be provided by the core laboratory in accordance with their guidelines. For the primary endpoint, both the lesion and patient level analysis will be done for 9-month in-stent LLL. The analysis on patient level for FAS is considered as main analysis. Other analysis based on lesion level and/or PPS is only for supportive purposes.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 440 participants
• Primary outcome timeframe: At 9 months post procedure
• Results posted on: 2024-03-04

Participant Flow

recruitment period: July 2015 - September 2016 totally 11 investigational sites(hospitals) in China

Participant milestones

Measure	Abbott Xience Prime™ EES Preparation and percutaneous access should be performed according to the standard hospital practice. Both femoral and radial accesses are accepted. The procedure begins once percutaneous access has been made.Following intracoronary injection of nitroglycerin or isosorbide dinitrate, a baseline angiography of the target vessel must be performed according to the QCA corelab guidelines.The subjects randomized to the comparator arm will be implanted with Abbott everolimus eluting coronary stent(Xience Prime™).	BIOTRONIK Orsiro SES Preparation and percutaneous access should be performed according to the standard hospital practice. Both femoral and radial accesses are accepted. The procedure begins once percutaneous access has been made.Following intracoronary injection of nitroglycerin or isosorbide dinitrate, a baseline angiography of the target vessel must be performed according to the QCA corelab guidelines.The subjects randomized to the experimental arm will be implanted with BIOTRONIK sirolimus eluting coronary stent(Orsiro).
Overall Study STARTED	220	220
Overall Study COMPLETED	220	220
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Abbott Xience Prime™ EES n=220 Participants Preparation and percutaneous access should be performed according to the standard hospital practice. Both femoral and radial accesses are accepted. The procedure begins once percutaneous access has been made.Following intracoronary injection of nitroglycerin or isosorbide dinitrate, a baseline angiography of the target vessel must be performed according to the QCA corelab guidelines.The subjects randomized to the comparator arm will be implanted with Abbott everolimus eluting coronary stent(Xience Prime™).	BIOTRONIK Orsiro SES n=220 Participants Preparation and percutaneous access should be performed according to the standard hospital practice. Both femoral and radial accesses are accepted. The procedure begins once percutaneous access has been made.Following intracoronary injection of nitroglycerin or isosorbide dinitrate, a baseline angiography of the target vessel must be performed according to the QCA corelab guidelines.The subjects randomized to the experimental arm will be implanted with BIOTRONIK sirolimus eluting coronary stent(Orsiro).	Total n=440 Participants Total of all reporting groups
Age, Continuous	58.38 years STANDARD_DEVIATION 8.62 • n=220 Participants	59.05 years STANDARD_DEVIATION 8.48 • n=220 Participants	58.715 years STANDARD_DEVIATION 8.56 • n=440 Participants
Sex: Female, Male Female	78 Participants n=220 Participants	60 Participants n=220 Participants	138 Participants n=440 Participants
Sex: Female, Male Male	142 Participants n=220 Participants	160 Participants n=220 Participants	302 Participants n=440 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment China	220 participants n=220 Participants	220 participants n=220 Participants	440 participants n=440 Participants

PRIMARY outcome

Timeframe: At 9 months post procedure

Population: There were 220 subjects who conducted the procedure in each group.

QCA data will be provided by an independent core laboratory. A separate report with descriptive statistics will be provided by the core laboratory in accordance with their guidelines.

For the primary endpoint, both the lesion and patient level analysis will be done for 9-month in-stent LLL. The analysis on patient level for FAS is considered as main analysis. Other analysis based on lesion level and/or PPS is only for supportive purposes.

Outcome measures

Measure	BIOTRONIK Orsiro SES n=220 Participants Patients implanted with Orsiro SES stents of BIOTRONIK	Abbott Xience Prime™ EES n=220 Participants Patients implanted with Xience Prime™ EES stents of Abbot Laboratories
In-stent Late Lumen Loss at 9 Months as Assessed by the Core Laboratory QCA Analysis	0.05 mm Standard Deviation 0.21	0.07 mm Standard Deviation 0.22

SECONDARY outcome

Timeframe: At 5 years post-procedure

Population: There were 216 subjects who conducted the procedure and finished the 5 years following up in each group.

Main adverse cardiac event include all-cause death, Q wave or non-Q wave myocardial infarction and clinically driven TLR.

The comparison between the two treatment groups for the secondary endpoints will be presented by the same anaysis method as baseline characteristics.

The normally distributed quantitative variables will be compared by Student's t-test and the qualititative vairiables which are not normally distributed will be compared by using Wilcoxon sum-rank test.

Outcome measures

Measure	BIOTRONIK Orsiro SES n=216 Participants Patients implanted with Orsiro SES stents of BIOTRONIK	Abbott Xience Prime™ EES n=216 Participants Patients implanted with Xience Prime™ EES stents of Abbot Laboratories
Number of Participants With Main Adverse Cardiac Event (MACE)	17 Participants	13 Participants

SECONDARY outcome

Timeframe: At 5 years post-procedure

Population: There were 216 subjects who conducted the procedure and finished the 5 years following up in each group.

The MACEs in the test group included 6 cases of all-cause death.Among them:

1. One subject died from upper gastrointestinal hemorrhage, which had no obvious relation to the operation and device.

2. Two subjects died from gastric cancer and COVID-19 complicated with respiratory failure respectively, which was unrelated to the operation and device.

3. One subject died suddenly at home on Day 192 after the baseline operation, with the cause of death unknown.

4. During the 3-year follow-up, subject family member told that he/she had ever been hospitalized for cardiac failure, but died after invalid rescue. The event was determined as cardiac death, of which the relationship with the operation and device cannot be determined.

5. During the 3-year follow-up of another subject, his/her family member told that he/she had died. For which his/her family member was reluctant to provide relevant supporting documents, the relationship with the operation and device cannot be determined.

Outcome measures

Measure	BIOTRONIK Orsiro SES n=216 Participants Patients implanted with Orsiro SES stents of BIOTRONIK	Abbott Xience Prime™ EES n=216 Participants Patients implanted with Xience Prime™ EES stents of Abbot Laboratories
Number of Participants With All-cause Death	6 Participants	6 Participants

SECONDARY outcome

Timeframe: At 5 years post-procedure

Population: There were 216 subjects who conducted the procedure and finished the 5 years following up in each group.

Two subjects with Cardica death in test group:

1. One of the patient died of sudden death at home, with the cause of death unknown.The patient participated in the trial on April 15, 2016. He/She was treated in local hospital for chest tightness and syncope in September 2016. He was considered to have rheumatic heart disease, heart failure and cardiogenic syncope. After treatment, he was improved and discharged from hospital and died in October 2016. The possibility of sudden cardiac death caused by ventricular arrhythmia cannot be excluded.

2. During the 3-year follow-up of a subject, his/her family member told that he/she had ever been hospitalized for cardiac failure, but the subject eventually died after invalid rescue of cardiac failure. As the hospital did not have definite basis for acute myocardial infarction during the event. Therefore, the event was determined as cardiac death, of which the relationship with the operation and device cannot be determined.

Outcome measures

Measure	BIOTRONIK Orsiro SES n=216 Participants Patients implanted with Orsiro SES stents of BIOTRONIK	Abbott Xience Prime™ EES n=216 Participants Patients implanted with Xience Prime™ EES stents of Abbot Laboratories
Number of Participants With Cardiac Death	2 Participants	0 Participants

SECONDARY outcome

Timeframe: At 5 years post-procedure

Population: 220 patients were enrolled in the each group. 5 patients died in the test group, and there was no myocardial infarction during the 5-year follow-up, and 4 patients were lost 5 follow-up. excluding these patients, the analysis population of the test group was 211. 6 patients died in the test group, and there was no myocardial infarction during the 5-year follow-up, and 4 patients were lost 5 follow-up. excluding these patients, the analysis population of the test group was 210.

Including Q-wave and Non Q-wave myocardial infarction. The comparison between the two treatment groups for the secondary endpoints will be presented by the same anaysis method as baseline characteristics.

The normally distributed quantitative variables will be compared by Student's t-test and the qualititative vairiables which are not normally distributed will be compared by using Wilcoxon sum-rank test.

Outcome measures

Measure	BIOTRONIK Orsiro SES n=211 Participants Patients implanted with Orsiro SES stents of BIOTRONIK	Abbott Xience Prime™ EES n=210 Participants Patients implanted with Xience Prime™ EES stents of Abbot Laboratories
Number of Participants With Myocardial Infarction	7 Participants	3 Participants

SECONDARY outcome

Timeframe: At 5 years post-procedure

Population: 4 subjects lost contact in each group at 5 years of follow-up. In the test group, 5 subjects dead, and no happened TVR myocardial infarction, Except for these subjects, the analysis population of the test group is 211. In the control group, 6 subjects dead, and no happened TVR myocardial infarction. Except for these subjects, the analysis population of the control group is 210.

Target vessel-related myocardial infarction

Outcome measures

Measure	BIOTRONIK Orsiro SES n=211 Participants Patients implanted with Orsiro SES stents of BIOTRONIK	Abbott Xience Prime™ EES n=210 Participants Patients implanted with Xience Prime™ EES stents of Abbot Laboratories
Number of Participants With TVR Myocardial Infarction	4 Participants	2 Participants

SECONDARY outcome

Timeframe: At 5 years post-procedure

Population: 4 subjects lost contact in each group at 5 years of follow-up. In the test group, 5 subjects dead, and no happened In-stent thrombus, Except for these subjects, the analysis population of the test group is 211. In the control group, 6 subjects dead, and no happened In-stent thrombus. Except for these subjects, the analysis population of the control group is 210.

During the 5-year clinical follow-up after baseline operation, one stent thrombosis event occurred in the test group. On July 21, 2016, the subject was implanted with the Orsiro Sirolimus-Eluting Coronary Stent System due to coronary heart disease. As the subject developed chest pain again, the coronary angiography reexamination was performed on March 22, 2019. During the operation, the OCT (optical coherence tomography) showed stent thrombosis in the right coronary artery, and then thrombus aspiration was performed. Investigators in the clinical trial center where the subject was enrolled believed that the stent thrombosis identified 972 days after the baseline operation belonged to very late stent thrombosis (VLST). The causes of its occurrence were considered to be related to the stent malapposition caused by insufficient stent expansion during the baseline operation and the possible platelet resistance of the subject.

Outcome measures

Measure	BIOTRONIK Orsiro SES n=211 Participants Patients implanted with Orsiro SES stents of BIOTRONIK	Abbott Xience Prime™ EES n=210 Participants Patients implanted with Xience Prime™ EES stents of Abbot Laboratories
In-stent Thrombus	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At 5 years post-procedure

Population: 4 subjects lost contact in each group at 5 years of follow-up. In the test group, 5 subjects dead, and no happened TLR, Except for these subjects, the analysis population of the test group is 211. In the control group, 6 subjects dead, and no happened TLR. Except for these subjects, the analysis population of the control group is 210.

Target lesion revascularization

Outcome measures

Measure	BIOTRONIK Orsiro SES n=211 Participants Patients implanted with Orsiro SES stents of BIOTRONIK	Abbott Xience Prime™ EES n=210 Participants Patients implanted with Xience Prime™ EES stents of Abbot Laboratories
Number of Participants With TLR	4 Participants	4 Participants

Adverse Events

BIOTRONIK Orsiro SES

Serious events: 82 serious events

Other events: 148 other events

Deaths: 6 deaths

Abbott Xience Prime™ EES

Serious events: 79 serious events

Other events: 141 other events

Deaths: 6 deaths

Serious adverse events

Measure	BIOTRONIK Orsiro SES n=216 participants at risk Preparation and percutaneous access should be performed according to the standard hospital practice. Both femoral and radial accesses are accepted. The procedure begins once percutaneous access has been made.Following intracoronary injection of nitroglycerin or isosorbide dinitrate, a baseline angiography of the target vessel must be performed according to the QCA corelab guidelines.The subjects randomized to the experimental arm will be implanted with BIOTRONIK sirolimus eluting coronary stent(Orsiro). Coronary Stent	Abbott Xience Prime™ EES n=216 participants at risk Preparation and percutaneous access should be performed according to the standard hospital practice. Both femoral and radial accesses are accepted. The procedure begins once percutaneous access has been made.Following intracoronary injection of nitroglycerin or isosorbide dinitrate, a baseline angiography of the target vessel must be performed according to the QCA corelab guidelines.The subjects randomized to the comparator arm will be implanted with Abbott everolimus eluting coronary stent(Xience Prime™). Coronary Stent
Cardiac disorders Atrial fibrillation	1.9% 4/216 • Number of events 5 • At 5 years post-procedure	0.93% 2/216 • Number of events 2 • At 5 years post-procedure
Gastrointestinal disorders Type 2 diabetic patient	0.93% 2/216 • Number of events 2 • At 5 years post-procedure	0.93% 2/216 • Number of events 2 • At 5 years post-procedure
Cardiac disorders Coronary heart disease	4.6% 10/216 • Number of events 11 • At 5 years post-procedure	4.6% 10/216 • Number of events 10 • At 5 years post-procedure
Vascular disorders Cerebral infarction	2.8% 6/216 • Number of events 6 • At 5 years post-procedure	1.9% 4/216 • Number of events 4 • At 5 years post-procedure
Gastrointestinal disorders Gastric diseases	3.7% 8/216 • Number of events 9 • At 5 years post-procedure	3.2% 7/216 • Number of events 10 • At 5 years post-procedure
Cardiac disorders Target lesion revascularization	1.4% 3/216 • Number of events 4 • At 5 years post-procedure	1.9% 4/216 • Number of events 4 • At 5 years post-procedure
Cardiac disorders Target vessel revascularization	4.2% 9/216 • Number of events 10 • At 5 years post-procedure	6.0% 13/216 • Number of events 13 • At 5 years post-procedure
Cardiac disorders Acute coronary syndrome	0.93% 2/216 • Number of events 2 • At 5 years post-procedure	0.00% 0/216 • At 5 years post-procedure
Respiratory, thoracic and mediastinal disorders Pulmonary infection	1.9% 4/216 • Number of events 4 • At 5 years post-procedure	0.93% 2/216 • Number of events 2 • At 5 years post-procedure
Cardiac disorders Non-target vessel revascularization	4.2% 9/216 • Number of events 9 • At 5 years post-procedure	3.7% 8/216 • Number of events 8 • At 5 years post-procedure
Cardiac disorders Unstable angina pectoris	5.1% 11/216 • Number of events 12 • At 5 years post-procedure	6.9% 15/216 • Number of events 22 • At 5 years post-procedure
Cardiac disorders MI(myocardial infarction)	2.8% 6/216 • Number of events 6 • At 5 years post-procedure	1.4% 3/216 • Number of events 3 • At 5 years post-procedure
Cardiac disorders Post- PCI	1.4% 3/216 • Number of events 4 • At 5 years post-procedure	4.2% 9/216 • Number of events 9 • At 5 years post-procedure
General disorders Bosom frowsty chest pain	1.4% 3/216 • Number of events 3 • At 5 years post-procedure	4.2% 9/216 • Number of events 10 • At 5 years post-procedure
Cardiac disorders Heart related diseases	5.1% 11/216 • Number of events 12 • At 5 years post-procedure	2.8% 6/216 • Number of events 6 • At 5 years post-procedure
Renal and urinary disorders Kidney related diseases	3.2% 7/216 • Number of events 7 • At 5 years post-procedure	1.4% 3/216 • Number of events 4 • At 5 years post-procedure
General disorders Other diseases	11.1% 24/216 • Number of events 33 • At 5 years post-procedure	10.6% 23/216 • Number of events 26 • At 5 years post-procedure
Musculoskeletal and connective tissue disorders Dental related diseases	3.7% 8/216 • Number of events 10 • At 5 years post-procedure	2.3% 5/216 • Number of events 5 • At 5 years post-procedure

Other adverse events

Measure	BIOTRONIK Orsiro SES n=216 participants at risk Preparation and percutaneous access should be performed according to the standard hospital practice. Both femoral and radial accesses are accepted. The procedure begins once percutaneous access has been made.Following intracoronary injection of nitroglycerin or isosorbide dinitrate, a baseline angiography of the target vessel must be performed according to the QCA corelab guidelines.The subjects randomized to the experimental arm will be implanted with BIOTRONIK sirolimus eluting coronary stent(Orsiro). Coronary Stent	Abbott Xience Prime™ EES n=216 participants at risk Preparation and percutaneous access should be performed according to the standard hospital practice. Both femoral and radial accesses are accepted. The procedure begins once percutaneous access has been made.Following intracoronary injection of nitroglycerin or isosorbide dinitrate, a baseline angiography of the target vessel must be performed according to the QCA corelab guidelines.The subjects randomized to the comparator arm will be implanted with Abbott everolimus eluting coronary stent(Xience Prime™). Coronary Stent
Cardiac disorders Atrial fibrillation	0.93% 2/216 • Number of events 2 • At 5 years post-procedure	1.4% 3/216 • Number of events 4 • At 5 years post-procedure
Gastrointestinal disorders Type 2 diabetic patient	0.00% 0/216 • At 5 years post-procedure	1.9% 4/216 • Number of events 4 • At 5 years post-procedure
Cardiac disorders Coronary heart disease	3.7% 8/216 • Number of events 8 • At 5 years post-procedure	3.2% 7/216 • Number of events 7 • At 5 years post-procedure
Vascular disorders Cerebral infarction	0.93% 2/216 • Number of events 2 • At 5 years post-procedure	0.93% 2/216 • Number of events 2 • At 5 years post-procedure
Gastrointestinal disorders Gastric diseases	3.2% 7/216 • Number of events 9 • At 5 years post-procedure	1.9% 4/216 • Number of events 4 • At 5 years post-procedure
General disorders Chest tightness of chest pain	25.0% 54/216 • Number of events 73 • At 5 years post-procedure	23.1% 50/216 • Number of events 63 • At 5 years post-procedure
Cardiac disorders Troponin is elevated	6.0% 13/216 • Number of events 14 • At 5 years post-procedure	8.3% 18/216 • Number of events 18 • At 5 years post-procedure
Hepatobiliary disorders hypohepatia	2.8% 6/216 • Number of events 6 • At 5 years post-procedure	1.4% 3/216 • Number of events 3 • At 5 years post-procedure
Cardiac disorders Post-PCI	5.6% 12/216 • Number of events 12 • At 5 years post-procedure	2.3% 5/216 • Number of events 5 • At 5 years post-procedure
General disorders Have a headache giddy	2.3% 5/216 • Number of events 5 • At 5 years post-procedure	1.4% 3/216 • Number of events 3 • At 5 years post-procedure
Cardiac disorders unstable angina pectoris	1.4% 3/216 • Number of events 3 • At 5 years post-procedure	3.2% 7/216 • Number of events 7 • At 5 years post-procedure
Blood and lymphatic system disorders Hypertension	1.4% 3/216 • Number of events 3 • At 5 years post-procedure	1.4% 3/216 • Number of events 3 • At 5 years post-procedure
Cardiac disorders Heart related diseases	6.0% 13/216 • Number of events 14 • At 5 years post-procedure	3.7% 8/216 • Number of events 8 • At 5 years post-procedure
Renal and urinary disorders Kidney related diseases	2.8% 6/216 • Number of events 6 • At 5 years post-procedure	2.8% 6/216 • Number of events 6 • At 5 years post-procedure
General disorders Other diseases	21.8% 47/216 • Number of events 72 • At 5 years post-procedure	21.8% 47/216 • Number of events 67 • At 5 years post-procedure

Additional Information

Prof. Yuejin Yang

Fuwai Hospital

Phone: 008613701151408

Email: yangyjfw@126.com

Results disclosure agreements

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

Restriction type: OTHER