Several New Areas of Research with Significant Potential Patient Care Implications for Better Therapy
Stroke Prevention with Less Bleeding
The OCEANIC AF trial uses a Factor XI inhibitor which is a new type of blood thinner to prevent strokes in patients who have atrial fibrillation. Stroke risks are high in these patients unless they take blood thinners. Current blood thinners, either acting agents such as dabigatran, Eliquis, Xarelto or warfarin (Coumadin) have significant bleeding risks. The new Factor XI inhibitor, asundexian, has properties which, on preliminary studies, suggest the ability to prevent strokes with less bleeding risks.
Prevention of heart attacks. The SOSAMI setting uses a new potent inhibitor of platelet clotting to supplement current blood thinners in use after heart attacks (myocardial infarction). This blood thinner is self-administered by an injectable pen by patients when they have the onset of symptoms suggesting a recurrent heart attack. They then go to the emergency room for conventional therapy. This new blood thinner may help dissolve clots before they cause permanent damage.
The PREVAIL study uses a new type of drug for cholesterol management called CEPT inhibitor. This medication actually shifts cholesterol into blood and the bad cholesterol (LDL) to the good cholesterol (HDL) which permits the cholesterol to be removed from the body more quickly and remove cholesterol from potential cholesterol formations within blood vessels. This is used to enhance existing cholesterol-lowering therapies with a goal of reducing strokes and heart attacks.
Cholesterol is carried by several proteins in the blood. One of these is called lipoprotein(a). It is found in 10-20% of the population. This form of cholesterol conveys increased risks of strokes and heart attacks. No current therapy is available to significantly reduce this type of cholesterol. Two new trials are underway. The HORIZON (open trial) uses two different compounds injected periodically under the skin to reduce Lp(a). Preliminary studies indicate a very strong ability to reduce lipoprotein(a) and these trials will help prove its ability to reduce subsequent heart attacks.
A new 4-lead pacemaker has promise in reducing symptoms of congestive heart failure. About 20% of all patients with heart failure have slow nerves in the heart and are potential candidates for a 3-lead pacemaker which has been in use for over 20 years. However, about 25% of these patients failed to achieve major improvement in heart muscle function. It is felt that a fourth pacemaker lead placed within the left sided pumping chamber of the heart can enhance heart muscle strength. This pacemaker is as small as a grain of rice placed in the heart via catheter and receives it power source through an ultrasound generator placed in the left chest wall. This works in synchrony with existing 3-lead pacemakers to potentially enhance heart muscle performance and reduce heart failure symptoms.
A new pacemaker-like device called the Optimizer has been available to treat weak heart muscle for some time, initially developed through a clinical trial here at Stern called FIX-HF. This is now available for patients with weak heart muscles to supplement other cardiac medicines. It works by causing increased calcium release within the heart muscle proteins to make the heart beat stronger.
This same device is now being investigated in patients with heart failure who have only moderate degrees of heart muscle weakness or stiffness. This trial is called Aim HIGHer utilizing this device in patients with this type of heart muscle problem for which there really is no current medication approved for this type of heart failure.
A similar type of device which combines the ability to strengthen the heart with the ability to correct abnormal rhythms (defibrillator) will be studies as an initial implant in patients who have weak heart muscle who need both protection from their regular heart rhythm and increased pumping force and have exhibited continued heart muscle weakness despite the use of all maximum available medications.
The future is bright for heart patients and the opportunity to participate in clinical trials provides them with meaningful benefits above and beyond what is currently available via standard care.