Patients undergoing PCI
Q. Is there any guidance on completeness of revascularisation?
A. It is strongly recommended that PCI is considered, and if feasible attempted, on all significant coronary lesions in major proximal coronary vessels subtending viable myocardium. It is up to the MDT to decide whether complete or nearly complete revascularisation is feasible in each patient. If not the patient should not be enrolled in the trial.
Q. If a patient is randomised to PCI + OMT and undergoes PCI but revascularisation is not possible, what action should be taken in regards to documentation and the patient continuing in the trial?
A. REVIVED is being analysed according to intention to treat, which means that the patient should remain in the trial and follow up should be conducted as normal. Any deviations from normal protocol will be documented in the eCRF.
Q. Could there an element of the placebo effect at work for patients receiving PCI considering there is no sham procedure?
A. Possibly. There could also possibly a degree of the placebo effect in all PCI procedures so this is no different from in the trial.
Q. Does the patient have to be optimised on optimal medical therapy before being randomised?
A. No. Patients recruited for REVIVED should in most cases already be optimised or on the trajectory for optimisation but are not required to be on the optimal doses. This is the responsibility of the treating physician and not stipulated by the trial other than the OMT treatment guidelines which are provided in an SOP.
Q. There are some doubts about the effectiveness of aspirin for heart failure. Should we be using Clopidogrel instead?
A. All concerns about aspirin in heart failure are currently only theoretical. Anti-platelet use in OMT will not be specified and should be dictated by usual local practice.
Q. What are the rules for crossover?
A. Crossover will only be allowed in the protocol if patients meet class I indications for PCI, namely Acute Coronary Syndromes or the development of limiting (CCS class 3 or 4) angina.