Coronary Sinus Reducer Fails in Angina Trial
A single-center trial found the device did not improve blood flow, angina symptoms, or quality of life versus a sham procedure.
Updated on Nov. 4, 2026 in Heart Disease
The REMEDY-PILOT trial, presented at TCT 2026, found that a coronary sinus reducer did not improve coronary microvascular function, symptoms, or quality of life compared with a sham procedure in patients with refractory angina. The device was found to be safe and feasible.
Why it matters
Refractory angina without obstructed coronary arteries is difficult to treat, and the trial suggests this device is not an effective option for this population at this stage. The results point to the need for further study before reducer therapies can be considered for angina with nonobstructed arteries and coronary microvascular dysfunction.
The trial randomized 54 patients with a median age of 64 years, 44% of whom were women, and found no difference in the primary endpoint versus sham (P = .72). Only one device-related adverse event, a case of tamponade, was reported, and the longer-term role of the device remains undetermined.
The players
Shockwave Medical
Shockwave Medical is a medical device company that manufactures the Shockwave Reducer evaluated in the trial.
Imperial College London
Imperial College London is a leading UK research university whose investigators led the REMEDY-PILOT study.
Royal Brompton Hospital
Royal Brompton Hospital is a London cardiothoracic center known for its heart and lung care and research.
The details
Investigators at Imperial College London and Royal Brompton Hospital randomized patients with refractory angina and coronary microvascular dysfunction but no obstructed coronary arteries to either a Shockwave Reducer implant or a sham procedure. Neither the number of daily angina episodes nor any of six Seattle Angina Questionnaire domains differed between groups.
Timeline
Primary endpoint was measured at 6 months after the procedure.
Results were presented at TCT 2026.
Health Landscape
Angina with nonobstructed coronary arteries remains an area where randomized evidence for interventions is still being built, and REMEDY-PILOT adds a sham-controlled result to that effort. The trial's negative primary endpoint places a coronary sinus reducer among the therapies that have not yet shown benefit in this population.
For people living with angina but no blocked arteries, this trial indicates that the reducer device does not relieve symptoms, so it should not be expected to improve daily angina or quality of life. Patients should continue to discuss treatment options with their cardiologist, as further research is still needed.
The takeaway
The trial shows that a device can be safe yet still fail to improve symptoms, so safety alone should not be taken as evidence of benefit. Treatment decisions for angina without obstructed arteries should await the longer-term analyses now underway.
Further reading
Explore more on Heart Disease and how device trials are evaluated for chest pain without blocked arteries.
Source note: This article includes information reported by Healio.
