The Missing Link in Vascular Device Trials

Today’s reimbursement models increasingly require physicians to be cost-conscious. Including cost analyses in trials will help them make good choices.

Atherosclerotic peripheral artery disease (PAD), venous thromboembolic disease and aortic diseases represent one of the largest composite of diseases facing the world today.  With the expanding catalogue of endovascular technologies, the enthusiasm to adopt them into clinical practice has been unprecedented. 

Physicians appreciate the lower intensity of procedures with catheter-based interventions, resulting in fewer complications, shorter hospital lengths of stay and presumably similar outcomes. In addition, if there is failure of the intervention at some time point, an opportunity exists to repeat the intervention.

Most recently, two drug-device combination products have gained FDA approval: a paclitaxel-coated nitinol self-expanding stent (Cook) and a paclitaxel-coated percutaneous transluminal angioplasty balloon (CR Bard).  Many believe that these devices will transform the endovascular management of PAD in the lower extremities.

However, with approval, questions remain: Is this new device so much better for patients that it is worth the extra premium in price? How much better must a device be to gain a premium price? What is the price premium? Who makes that decision, and with what metrics?

The measures commonly used to gain PAD device approval include patency, target lesion revascularization rates and safety. It is time for cost-effectiveness to become at least a predefined secondary analysis.  Studies must include collection of full procedural costs, costs of surveillance of device efficacy and safety after hospital discharge to a prespecified time point and the costs of subsequent interventions for failure of the index procedure.

I understand that this is an added burden to the trials; however, decisions by Accountable Care Organizations (ACOs) are going to depend on this data. 

Consider this scenario: a patient presents with progressive intermittent claudication of the right leg. She has medication-controlled diabetes, is on a statin for hypercholesterolemia and has been trying to decrease her tobacco use. She struggles to perform her factory job due to her exertional limb discomfort. She has a 7 cm mid-superficial femoral artery occlusion with excellent inflow, outflow and normal runoff to her foot.  There are multiple options for the management of this patient:

A supervised exercise-walking program. This has been shown to dramatically improve pain-free walking distance. It is low cost and relatively low risk. But it is not covered by most insurers; it takes at least six months to work; and it requires highly motivated participants.

Surgical bypass graft. This is rarely performed for intermittent claudication due to the known morbidity and associated mortality. In addition, this is costly, requires three- to seven-day hospitalizations and makes future revascularizations more challenging.

Endovascular therapy. In most centers in the U.S., this patient would be offered catheter-based interventions as the first-line treatment.  But which one? The options include percutaneous transluminal angioplasty (PTA) with bare balloon; PTA with a scoring balloon; drug-coated balloon; atherectomy; bare nitinol self-expanding stent(s); and drug-eluting stent(s).

If the physician practices in a fee-for-service environment, the cost of the technology has little bearing on the decision-making. However, in this era of employed physician models within ACOs, physicians will be forced to begin to consider costs. The device cost is not  the only factor.  Associated management requirements and the need for imaging surveillance are among critical factors. 

Physicians and systems currently have no way to access the data, yet if included in clinical trials, results would play a key role in the decision-making. Patients, payers, policy makers and physicians all must come to grips with the need for cost-effectiveness data as new trials in vascular devices are planned. Without it, I am afraid that Draconian decisions will become the norm.