Stable Angina
Conditions
Keywords
Stable angina, Percutaneous coronary intervention, Optimal medical therapy, Sham-control
Brief summary
In this study the investigators will use careful scientific blinding of patient and their subsequent healthcare staff so that the investigators can determine exactly how much difference coronary angioplasty makes to symptoms and blood supply to the heart. After the 6 weeks blinded phase, all patients will be unblinded and the patients who had undergone sham procedure will be offered the active therapy.
Detailed description
The investigators will perform a multi-centre prospective randomised double-blinded comparison of the treatment of stable angina with percutaneous coronary intervention (PCI) and optimal medical therapy (OMT) versus a sham procedure and OMT. Two hundred patients with stable angina and one or more angiographically significant coronary stenosis of 70% or more in a single vessel that is suitable for angioplasty will be recruited. Baseline investigation of functional capacity and myocardial ischaemic burden will be performed. This will be followed by a coronary angiogram and invasive physiological investigation followed by randomisation to PCI or a sham procedure. Follow-up investigation of functional capacity and myocardial ischaemic burden at 6 weeks will then be performed.
Interventions
PROCEDURECoronary angioplasty
Percutaneous coronary intervention with drug-eluting stents and modern techniques
Sponsors
Volcano Corporation
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Stable angina and at least 1 lesion with angiographic stenosis ≥70% in a single vessel suitable for stent implantation
Exclusion criteria
* Acute coronary syndrome * Previous coronary artery bypass graft surgery * Left main stem disease * Contraindications to PCI or drug-eluting stent (DES) implantation * Heavily calcified or tortuous vessels * Chronic total occlusion in target vessel * Life expectancy \<2yr * Pregnancy * Age \<18yr or \>85yr * Angiographic stenosis ≥ 50% in non-target vessel * Inability to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Time on Treadmill | 6 weeks | Measured in seconds on Modified Bruce exercise treadmill protocol |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 105 |
| 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 | 95 |
| Total | 200 |
Baseline characteristics
| Characteristic | Sham Procedure and Optimum Medical Therapy | Total | Coronary Angioplasty and Optimum Medical Therapy |
|---|---|---|---|
| Age, Continuous | 66.1 years STANDARD_DEVIATION 8.4 | 66 years STANDARD_DEVIATION 9 | 65.9 years STANDARD_DEVIATION 9.5 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 95 participants | 200 participants | 105 participants |
| Sex: Female, Male Female | 23 Participants | 54 Participants | 31 Participants |
| Sex: Female, Male Male | 72 Participants | 146 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 105 | 0 / 95 |
| other Total, other adverse events | 0 / 105 | 0 / 95 |
| serious Total, serious adverse events | 4 / 105 | 14 / 95 |
Outcome results
Primary
Exercise Time on Treadmill
Measured in seconds on Modified Bruce exercise treadmill protocol
Time frame: 6 weeks
Population: No exercise time data available for 1 patient in PCI group and 5 patients in placebo group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Coronary Angioplasty and Optimum Medical Therapy | Exercise Time on Treadmill | 28.4 seconds |
| Sham Procedure and Optimum Medical Therapy | Exercise Time on Treadmill | 11.8 seconds |