Good Early Outcomes With PCI in Complex Patients Unsuited to Surgery: OPTIMUM

For patients with complex coronary artery disease deemed ineligible for surgery, the short-term risk of death with PCI is considerably lower than the evaluating surgeon’s risk estimate, according to results from the OPTIMUM registry. Moreover, PCI-treated patients stand to gain marked improvements in health status, including quality of life.

The positive short-term results underscore the importance of coronary revascularization with PCI in these complex patients, provided that the percutaneous procedure can be performed safely, say researchers.  

“Patients with complex coronary anatomy deemed ineligible for coronary artery bypass graft surgery represent an escalating patient population,” said lead investigator David Kandzari, MD (Piedmont Heart Institute, Atlanta, GA), noting that roughly one in five patients with multivessel disease or left main CAD are turned down for surgery for various reasons. “The societal guidelines offer limited, if any, decision-making related to complex coronary disease management if surgery is not an option.”

When presenting the results during late-breaking clinical science session at TCT 2021, Kandzari also noted these patients are systematically excluded from clinical trials and there are no contemporary data with regard to PCI in this population.

With that in mind, investigators established the OPTIMUM registry to track patients with multivessel or left main CAD deemed ineligible for CABG surgery who were treated with percutaneous revascularization. OPTIMUM, an investigator-initiated, prospective study, enrolled 750 patients deemed ineligible for surgery by the site heart team, which consisted of an interventional cardiologist and surgeon; all patients were treated with PCI. Initially, investigators planned to also study the clinical outcomes of patients who received medical therapy alone, but the study protocol was modified to include only patients treated with PCI given its increasing use.

Among the 726 patients (mean age 70 years; 31.5% women), 57% had diabetes, 48.2% had a prior MI, 32.8% had a prior revascularization, and 16.4% had previously undergone CABG surgery. More than one-third had chronic kidney disease, and nearly 25% of patients had NYHA class III/IV heart failure. The most common reason for revascularization was stable or unstable angina.

A poor distal target/conduit (18.9%), severe LV dysfunction/nonviable myocardium (16.8%), severe pulmonary disease (10.1%), frailty/immobility (9.7%), and prior sternotomy (8.7%) were the most common reasons surgeons turned patients down for CABG. In terms of the complexity of the PCI, 80% of patients had severe calcification, bifurcation disease, and lesions greater than 20 mm in length. Chronic total occlusions were common (57.0%), and the average SYNTAX score was 32.4, with 45.3% of patients having a high SYNTAX score (≥ 33).     

At 30 days, the observed rate of death was 5.6%, which was similar to the predicted risk of death using the STS and EuroSCORE II risk calculators (5.3% and 5.7%, respectively). In contrast, the site surgeon’s predicted risk of death was 10.4%. Tellingly, however, by 6 months, 12.3% of the patients treated with PCI had died.

“The mortality rate more than doubled, reflecting the high-risk nature of this population,” said Kandzari, referring to the change from 30 to 180 days.

Among survivors at 6 months, investigators saw improvements in patient-reported health status, with significant improvements in quality of life and reductions in angina frequency. More than 82% of patients had no angina at 6 months compared with 40.5% at baseline, while 11.6% reported monthly episodes, down from 31.9% at baseline. In total, 6% reported weekly/daily angina, which was down from 27.7% prior to PCI.

Reconsider Patients for Surgery?

Patrick Serruys, MD, PhD (National University of Ireland, Galway), who led the SYNTAX trial comparing surgery to PCI in patients with three-vessel and left main CAD, noted that the SYNTAX study included a nested registry of patients ineligible for surgery who were treated with PCI. Among those patients, the EuroSCORE was 5.8%, which lines up with OPTIMUM. At 30 days, the rate of all-cause mortality was 3.1%.

Right now, the researchers are pulling together 10-year follow-up on PCI-treated SYNTAX patients ineligible for surgery, said Serruys: after a decade, the mortality rate is north of 55%.

“At the time of the enrollment, they were 70 years old,” said Serruys, “so we shouldn’t be amazed that 10 years later only 45% survive.”     

Jennifer A. Rymer, MD, MBA (Duke University School of Medicine, Durham, NC), questioned whether the lower rate of death at 30 days when compared with surgical estimates should prompt surgeons to possibly reconsider these complex patients for CABG surgery.

“That’s one of the most common interpretations of these data,” said Kandzari. “If surgeons are overestimating risk, is that the art of medicine or is it the science, when the science is showing us a different result. Keep in mind, though, that these models—STS and EuroSCORE II—were intended to assess surgical mortality and here we’re looking at the relationship to PCI-related mortality. It would be misleading of us to believe that the actual surgical mortality rates are exactly what the STS and EuroSCORE risk [scores] predicted in such a sickly population.”

Perhaps, he added, one interpretation might be that PCI mitigates the risk estimated by the surgeons given the absence of periprocedural morbidity and complications associated with an invasive surgery.   

Kandzari pointed that that many risk calculators, among them STS and EuroSCORE II, do not capture all of the risk characteristics that impact a surgeon’s reasons for turning down patients. In the present study, for example, more than a third of reasons listed by the heart team as reasons for deeming patients ineligible for surgery are not captured by those risk scores, he said.