Trial Outcomes & Findings for Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina (NCT NCT02062593)

NCT ID: NCT02062593

Last Updated: 2024-01-22

Results Overview

Measured in seconds on Modified Bruce exercise treadmill protocol

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 230 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2024-01-22

Participant Flow

Participant milestones

Measure	Coronary Angioplasty and Optimum Medical Therapy Percutaneous coronary intervention and optimal medical therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques	Sham Procedure and Optimum Medical Therapy Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques
Overall Study STARTED	105	95
Overall Study COMPLETED	105	91
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Coronary Angioplasty and Optimum Medical Therapy n=105 Participants Percutaneous coronary intervention and optimal medical therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques	Sham Procedure and Optimum Medical Therapy n=95 Participants Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques	Total n=200 Participants Total of all reporting groups
Age, Continuous	65.9 years STANDARD_DEVIATION 9.5 • n=105 Participants	66.1 years STANDARD_DEVIATION 8.4 • n=95 Participants	66 years STANDARD_DEVIATION 9 • n=200 Participants
Sex: Female, Male Female	31 Participants n=105 Participants	23 Participants n=95 Participants	54 Participants n=200 Participants
Sex: Female, Male Male	74 Participants n=105 Participants	72 Participants n=95 Participants	146 Participants n=200 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	105 participants n=105 Participants	95 participants n=95 Participants	200 participants n=200 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: No exercise time data available for 1 patient in PCI group and 5 patients in placebo group.

Measured in seconds on Modified Bruce exercise treadmill protocol

Outcome measures

Measure	Coronary Angioplasty and Optimum Medical Therapy n=104 Participants Percutaneous coronary intervention and optimal medical therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques	Sham Procedure and Optimum Medical Therapy n=90 Participants Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques
Exercise Time on Treadmill	28.4 seconds Interval 11.6 to 45.1	11.8 seconds Interval -7.8 to 31.3

Adverse Events

Coronary Angioplasty and Optimum Medical Therapy

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Procedure and Optimum Medical Therapy

Serious events: 14 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Coronary Angioplasty and Optimum Medical Therapy n=105 participants at risk Percutaneous coronary intervention and optimal medical therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques	Sham Procedure and Optimum Medical Therapy n=95 participants at risk Placebo percutaneous coronary intervention and optimal medical therapy with risk factor modification and anti-anginal therapy Coronary angioplasty: Percutaneous coronary intervention with drug-eluting stents and modern techniques
Blood and lymphatic system disorders Major bleeding	1.9% 2/105 • Number of events 2 • Total study time 12 weeks	3.2% 3/95 • Number of events 3 • Total study time 12 weeks
Nervous system disorders Acute confusion	0.95% 1/105 • Number of events 1 • Total study time 12 weeks	0.00% 0/95 • Total study time 12 weeks
Cardiac disorders Crossover to PCI	0.00% 0/105 • Total study time 12 weeks	4.2% 4/95 • Number of events 4 • Total study time 12 weeks
Cardiac disorders Wire snapped required snare retrieval	0.95% 1/105 • Number of events 1 • Total study time 12 weeks	0.00% 0/95 • Total study time 12 weeks
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/105 • Total study time 12 weeks	2.1% 2/95 • Number of events 2 • Total study time 12 weeks
Cardiac disorders Acute coronary syndrome	0.00% 0/105 • Total study time 12 weeks	1.1% 1/95 • Number of events 1 • Total study time 12 weeks
Cardiac disorders Hospitalisation for atypical chest pain	0.00% 0/105 • Total study time 12 weeks	1.1% 1/95 • Number of events 1 • Total study time 12 weeks
Cardiac disorders Hospitalisation for right heart failure	0.00% 0/105 • Total study time 12 weeks	1.1% 1/95 • Number of events 1 • Total study time 12 weeks
Musculoskeletal and connective tissue disorders Hospitalisation for leg pain	0.00% 0/105 • Total study time 12 weeks	1.1% 1/95 • Number of events 1 • Total study time 12 weeks
Immune system disorders Severe drug reaction	0.00% 0/105 • Total study time 12 weeks	1.1% 1/95 • Number of events 1 • Total study time 12 weeks

Other adverse events

Adverse event data not reported

Additional Information

Rasha Al-Lamee

Imperial College London

Phone: +447976276923

Email: r.al-lamee13@imperial.ac.uk

Results disclosure agreements

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