The claims are bold. "Even if you have multiple coronary blockages and have been advised coronary artery bypass graft surgery (CABG) due to recent advancements in stent technology & techniques, you most likely have a nonsurgical option."
That's according to NocoBye.com, a startup that advertises itself as the "Uber of interventional cardiology" that can connect patients who have been told they need CABG with highly skilled interventional cardiologists ("physicians par excellence") who may be able to treat them with stents instead.
NocoBye takes its name from the phrase, "no to coronary byepass," but the site tells an incomplete story about percutaneous coronary artery intervention (PCI) and CABG, according to cardiac surgeon Mario Gaudino, MD, who practices at Weill Cornell Medical Center in New York City. "My first reaction was to jump in my chair and to say, 'That's unbelievable that they are doing that,' " he told Medscape Medical News.
"We believe patient choice is very important," NocoBye's chief technical officer, Affan Farooq, MD, said in an interview. "Fifteen years ago, people didn't have the option. Now they do because of advances in drug eluting stents and the level of training in interventional cardiology." However, cardiac surgeons and interventional cardiologists Medscape interviewed challenged NocoBye's presentation of the body of scientific research and questioned whether the website can connect patients with the high-quality second opinions it advertises.
The NocoBye website lists 22 articles as "supporting scientific data" and four under the heading, "conflicting scientific data." But some of the articles cited as supportive for PCI actually show a survival benefit for CABG among patients with severe coronary artery disease, Gaudino said. An example is a metanalysis of 11 randomized trials published in the Lancet in 2018. He also pointed to the results of the extended SYNTAX trial and the diverging survival curves of patients assigned to CABG or PCI in the EXCEL trial after 5 years of follow-up. "You put all these together and it's hard to deny that as a patient, you should be informed of the fact that if you choose the surgical treatment, your chances of being alive in the years after the procedure are higher," he said.
The assertion that the EXCEL long-term findings show that the two procedures are equal is the subject of heated debate among surgeons and interventional cardiologists, and the trial's data have come under scrutiny.
The overall data don't indicate that every patient needs surgery, however, said Gaudino; older patients with noncardiac comorbidities may be more interested in short-term quality of life than in long-term survival benefit, and if they prefer PCI, that's "perfectly reasonable."
"This to me looks like it's preying on a vulnerable population that's looking for an answer that's anything but surgery," said cardiothoracic surgeon Michael Mack, MD, of Baylor University Medical Center, Dallas, Texas. "This is basically trolling for patients."
The NocoBye homepage shows a table that compares CABG with PCI.
A table on NocoBye's website.
Mack pointed out that that table oversimplifies too much and uses negatively biased language against surgery, such as "chest sawed open" to indicate sternotomy. The table says that infections are "common" in bypass surgery but are "uncommon" in stenting, but the incidence of infection in surgery is less than 1%, Mack said. Calling the 5- and 10-year survival rates for the two procedures "comparable" is "not true" and depends on the patient population, he said, and referenced the SYNTAX, FREEDOM, and NOBLE trials. "It oversimplifies it and it's deceiving."
NocoBye is a physician-driven startup with a team of about five people, according to Farooq. His interventional cardiologist partners, who he said wanted to remain anonymous, have seen their field advance, yet patients have not been given the option of PCI instead of CABG. Farooq is currently pursuing training in emergency medicine. One of the interventional cardiologists brought him on because he knows how to code and develop apps, he said.
"We fully support a 'HEART TEAM' approach to patient care with input from both a Cardiologist and a Cardiac surgeon and agree that in some instances CABG may be the appropriate choice," NocoBye's website reads. "However, we give patients the ability to obtain a quick and easy second opinion from a local interventional cardiologist."
Requirements for becoming a "physician par excellence" involve a background check, forms attesting to the doctors' procedure volumes (at least 75 PCI cases annually and at least 10 cases annually of PCI with a mechanical support device such as Impella), and checks as to whether licenses are up to date. Farooq said 10 doctors are on board to be matched with patients and that more have applied, but the startup is not disclosing their names for privacy reasons. He said that since the NocoBye website went live about a year ago, 20 to 25 patients have looked to be matched.
The requirement that an interventional cardiologist must perform 75 PCI cases annually is not a high standard high-volume operators may perform several hundred procedures yearly, according to interventional cardiologist B. Hadley Wilson, MD, of the Sanger Heart and Vascular Institute of Atrium Health in Charlotte, North Carolina. "I am a little concerned that the numbers they put forward are really a minimum of what's required to continue to practice in most hospitals," he told Medscape.
"There may be a role for a website like this," Hadley said, but "it needs to be done with high standards, not minimum standards, and should be done where they truly offer a heart team approach, not one individual interventional cardiologist." Hadley is a member of the American College of Cardiology's board of trustees but said his opinions are his own on this subject.
NocoBye's site also references the evolving interventional cardiology subspecialty of complex high-risk indicated procedures (CHIPs). After completing CHIP training programs, one of the issues trainees raise is how to advertise their additional expertise, said interventional cardiologist E. Magnus Ohman, MBBS, of Duke University Medical Center, Durham, North Carolina, who has been involved in developing such programs. They may tell their colleagues or patients, but is a website like NocoBye's appropriate? "I can see why it's happening," he said of the website. "None of our decisions are infallible, and we should encourage second opinions," he added, but his question is, "Can this group offer a reasonable second opinion?"
CHIP fellowships and training courses are often supported by grants from the manufacturers of stents and mechanical support devices. NocoBye is currently self-funded and is not yet bringing in revenue, Farooq said. "Our first priority is patients. We want to educate people."
When Medscape pointed out that not all cardiologists would agree with the presentation of the evidence on NocoBye's website, Farooq replied, "The thing about medicine is it's discussion and debate. You look at everything from an angle, get feedback, and see somebody else's perspective, too."
Tricia Ward, cardiology executive editor, contributed reporting. Ellie Kincaid is Medscape's associate managing editor. She has previously written about healthcare for Forbes, the Wall Street Journal, and Nature Medicine.
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