Editor’s note: In this guest post Sanjay Kaul (Cedars-Sinai) explains why it is unlikely that the ORBITA trial will have a big impact on clinical practice.
Guest Post: Will ORBITA Change Clinical Practice? The Role of Perverse Economic Incentives.
by Sanjay Kaul, MD (Cedars-Sinai Medical Center)
Sanjay Kaul
Shortly after celebrating the 40th anniversary of PCI, first pioneered by the maverick radiologist and cardiologist, Andreas Greuntzig, on September 16, 1977, the field of interventional cardiology was rocked by the results of the relatively small, but boldly innovative ORBITA trial. The seminal observation that 42% of the antianginal benefit of PCI in stable single vessel coronary disease could be attributed to a placebo effect (increment in exercise time with placebo divided by increment in exercise time with PCI, i.e., 11.8/22.4) came as a huge surprise to many, leading the editorialists to question whether the results of the ORBITA trial were the “last nail in the coffin for PCI in stable angina?” They argued “these ORBITA data put PCI in the category of other abandoned therapies for cardiovascular disease…procedures for which the initial apparent benefit was later shown in sham-controlled blinded studies to actually be due to the placebo effect”, and “based on these data, all cardiology guidelines should be revised to downgrade the recommendation for PCI in patients with angina despite use of medical therapy.” Are the rumors of the demise of PCI in stable angina greatly exaggerated?
To answer this question, one need only go a decade back when the results of another seminal study, the COURAGE trial, were first reported at the 2007 Scientific Sessions of the ACC in New Orleans. The trial showed that coronary interventional procedures added little to optimal medical therapy (OMT) with respect to the long-term outcome of patients with stable coronary disease when used as initial therapy. That was the first major jolt to interventional cardiology as it burst the myth that PCI prevents MI and prolongs survival in stable coronary disease. The guidelines and appropriateness criteria were revised to incorporate the findings of the COURAGE trial emphasizing that PCI should ideally be considered for symptom relief in patients with >1 significant stenosis amenable to revascularization who continue to have refractory angina and who have objective evidence of ischemia despite optimal guideline directed medical therapy (GDMT). And yet there has been very little impact of the COURAGE results on clinical practice. In one study, only half of the non-acute PCIs were deemed appropriate (satisfying all 3 criteria mentioned above), and 12% of PCIs were deemed inappropriate (not satisfying the 3 criteria). There are several potential explanations, including emotional, psychological, and monetary considerations among others.
Given the poor track record of COURAGE, what impact will ORBITA have on clinical practice? In my opinion, the perverse economic incentives will play a major role. Let me elaborate. The current measure of productivity used to calculate compensation of physicians is the so-called relative value unit (RVU). This metric is also often used to judge the ‘value’ and success of a physician. Each physician is assigned a standardized annual RVU goal; if this goal is not met, the bonus (and sometimes salary) is adjusted downward. This is a disturbing trend towards corporatization of medicine that rewards providing service and generating revenue over cost saving and creating value and goodwill among the patients it serves. For example, doing invasive procedures such as stenting earns a bunch of RVUs, typically averaging 20 RVUs. In contrast, the currency for office visit consultation that includes patiently listening, examining and counseling patients is 1 RVU. I sometimes see patients seeking a second opinion who are inappropriately recommended PCI for stable disease. What should be the currency for avoiding 1 such inappropriate PCI?
- · Same as for 1 office visit consultation, i.e., 1 RVU
- · Penalty for loss of revenue from avoiding stenting, i.e., -20 RVU
- · Reward for reduced resource utilization and cost saving related to initial stenting, expense and risk of combined antiplatelet therapy, and the costs and challenges of perioperative management, i.e., 40 RVU
The ORBITA findings are seminal—they demonstrate that placebo-controlled studies of PCI in single vessel disease are feasible, and they help clarify the science underlying the antianginal effect of PCI. However, unless and until we stop endorsing remunerative medicine, and start rewarding evidence-based or truly ‘value-based’ medicine, it is unlikely that ORBITA will have a major impact on clinical practice. Scientific evidence should trump psychological, emotional and monetary issues in decision making.
More on ORBITA:
Dr Kaul’s succinctly stated views are troubling to a potential patient.It appears that evidence-based medicine will not get currency ever!
When I was a university teacher I concluded that doling out rewards for excellent teaching was a foolish practice because there was no reliable way of identifying the best teachers. (By contrast it was remarkably simple to identify bad teachers.)
I am therefore suspicious of systems of paying doctors that may well be vulnerable to similar problems.