Two ‘Evidence-Based Pathways’ for Stable Angina: ORBITA-2 Editorial

Thanks to results from the ORBITA-2 randomized trial, there are now two “evidence-based pathways” for the treatment of patients with stable angina, according to a newly published editorial.  

Harvey White, DSc (Te Whatu Ora – Health New Zealand/Auckland City Hospital), who wrote the editorial, says that physicians and patients can start with medical therapy, intensify treatment as necessary, and then go for PCI if medication fails to relieve symptoms. The other option is to choose PCI as the initial therapy without the use of antianginal medication. If PCI doesn’t sufficiently relieve patient symptoms, then medical therapy can be added, according to White.

Published December 21, 2023, in the New England Journal of Medicine, the editorial accompanies the full results of ORBITA-2, which were initially released when the placebo-controlled trial was presented during the American Heart Association 2023 Scientific Sessions in Philadelphia, PA, last month.

“The benefits and risks of both pathways should be discussed with the patient, including the risks of PCI, the prevalence of stent thrombosis (0.5% per year), and the need for dual antiplatelet therapy with the associated risk of bleeding,” writes White. “Patients should express a preference, which is paramount.”

The ORBITA-2 data were reported by TCTMD when presented in the fall. Among 301 symptomatic patients with documented ischemia and mostly single-vessel disease, PCI significantly reduced the angina symptom score, a benefit driven by a reduction in the number of daily angina episodes, when compared with a placebo procedure. Exercise time and quality of life were also improved with PCI.

The study headlined the Top Coronary Artery Disease News of 2023, even if interventional cardiologists weren’t particularly surprised by the results. At the time, Sanjit Jolly, MD (McMaster University/Population Health Research Institute, Hamilton, Canada), called ORBITA-2 an “important proof of concept” study showing that PCI does improve patient symptoms, something clinicians knew intrinsically.

In a “Beyond the Data” discussion of the most newsworthy trials of 2023, David J. Cohen, MD (St. Francis Hospital, Roslyn, NY), said ORBITA-2 “answered the fundamental question that has never been addressed in all the years of doing this procedure, which is: does [PCI] do what we think it does? The answer is yes, it does.”

Regarding the implications of ORBITA-2, Cohen told host Mamas A. Mamas, BMBCh, DPhil (Keele University, Stoke-on-Trent, England), that while the clinical guidelines recommend medical therapy to start, many patients head straight to the cath lab for PCI if they present with angina symptoms and have evidence of ischemia. “In the US, it’s not going to change practice,” he said. “We’re already there.”

Mary N. Walsh, MD (Ascension St. Vincent Heart Center, Indianapolis, IN), added to the conversation by saying that medical therapy for symptomatic patients with ischemic disease remains a “hard sell.”  Patients, she noted, still mistakenly consider stenting a “fix” for coronary artery disease.      

The culture is very different in the United Kingdom, said Mamas, senior clinical editor at TCTMD. When presented with a choice between PCI or medical therapy, patients will choose the less invasive route first. “I would say that the majority of PCIs in the UK are following failed medical therapy,” said Mamas. On the basis of ORBITA-2, however, he’ll now more frequently present PCI as a valid first-line treatment in appropriate patients, he said.

In his editorial, White stresses that choice of PCI or medical therapy will depend on the angiographic findings, adding that implanting a stent in a small branch vessel of a patient at high risk for stent thrombosis may be inappropriate. Future studies on the cost-effectiveness of PCI will be needed, too, particularly if ORBITA-2 leads to an increase in PCI for patients with stable angina, says White.