The hybrid approach opened chronic total occlusion (CTO) in almost 9 of 10 patients, despite the initial crossing strategy being successful in only 55% of cases, in what is thought to be the largest study to date of hybrid CTO percutaneous coronary intervention (PCI).
Among 3122 CTO PCIs in the PROGRESS CTO registry, the technical and procedural success rates were 87% and 85%, respectively.
As seen in prior studies, annual CTO PCI volume was independently associated with a higher procedural success (odds ratio [OR], 1.21). Other positive predictors were adequate distal landing zone (OR, 1.40), interventional collaterals (OR, 1.82), and left anterior descending coronary artery (LAD) CTO target vessel (OR, 1.67).
The late-breaking results were reported today at the Society for Cardiovascular Angiography and Interventions (SCAI) 2018 Scientific Sessions and published online in JACC Cardiovascular Interventions.
“I know there are multiple critics right now for CTO PCI and of PCI of stable coronary heart disease in general based on the ORBITA trial,” senior study author, Emmanouil S Brilakis, MD, PhD, from the Minneapolis Heart Institute, Abbott Northwestern Hospital, Minnesota, told theheart.org | Medscape Cardiology. “It depends on your interpretation but in my mind there is benefit.”
“And now we’re showing that you can get this done with close to 90% success within several sites with a 3% complication rate,” he said. “That’s a pretty good benchmark.”
Other multicenter studies of highly skilled operators have achieved similar success rates with hybrid CTO PCI, which emphasizes opening the occluded vessel using all feasible techniques. But success has been harder to achieve in unselected patients, with Brilakis reporting a success rate just 2 years ago of only 59% in an unselected US population.
In addition, medical therapy was found to be as good as CTO PCI in the controversial DECISION-CTO study. Further roiling the field was ORBITA, the first sham-controlled PCI trial, in which exercise capacity and angina symptoms were not significantly different between real or sham PCI in patients with stable angina and single-vessel coronary artery disease.
At the same time, EuroCTO demonstrated significant improvement in quality of life 12 months after CTO PCI with optimal medical therapy vs OMT alone, Brilakis notes.
“You will never have the perfect trial with 10,000 patients to answer whether there are reduced events,” he said. “But at the same time, you do now have data that there is symptomatic benefit and this can be done with multiple operators with good success. So that reinforces the idea that this is potentially something that can be considered in multiple patients.”
The present analysis, led by postdoctoral research fellow, Peter Tajti, MD, Minneapolis Heart Institute, involved 3055 patients enrolled in the PROGRESS CTO registry between January 2012 and November 2017 at 18 US centers, 1 European center, and 1 Russian center. Technical success was defined as CTO revascularization with less than 30% residual diameter stenosis and restoration of TIMI antegrade flow grade 3, and procedural success as technical success without any in-hospital complications.
Most patients were symptomatic (88.56%) and had stable (64.33%) or unstable (18.20%) angina. The mean J-CTO (Multicenter Chronic Total Occlusion Registry of Japan) score was 2.43 and PROGRESS CTO score 1.32.
The CTO target lesion was located in the right coronary artery in 55.22%, LAD in 23.81%, and left circumflex coronary artery in 19.91%.
Technical success rates declined with increasing lesion complexity (96.9%, 94.84%, 89.14%, and 81.26% for J-CTO scores of 0, 1, 2, and 3 or greater; P < .0001). Failure to cross with a guidewire was the most common reason for CTO PCI failure (86%).
The retrograde approach was used more frequently and efficiently in complex lesions, whereas antegrade wire escalation was the most common initial approach (75%) but was more efficient in lower complexity lesions. The final successful crossing strategy was antegrade wire escalation in 46%, the retrograde approach in 24%, and antegrade dissection re-entry in 19%.
In-hospital major adverse cardiovascular events (MACE) occurred in 3.04% of patients, driven largely by death (0.85%), acute MI (1.08%), and stroke (0.26%). MACE was higher in failed procedures (7.54% vs 2.37%) and with the more complex crossing techniques (antegrade wire escalation, antegrade dissection re-entry, or retrograde crossing; 1.09% vs 2.96% vs 5.61%; both comparisons P < .0001).
“Our results provide important benchmarking for discussion about the risk and benefit ratio of CTO PCI with patients or with other providers,” Tajti said during a press briefing at the meeting. “The major focus of upcoming research should be bridging the gap of what is currently achieved at most centers and what can be achieved in the future.”
In an accompanying editorial, Gregg W Stone, MD, Columbia University Medical Center, New York City, described the study as “the magnum opus of CTO PCI technique” but also noted that procedural complications must be taken into account, along with contrast nephropathy, bleeding, radiation exposure, and costs, when considering the risk-benefit balance of the procedure.
The focus now needs to shift to appropriate patient selection and demonstration of clinical use; and ensuring that most patients with CTOs who can derive benefit are provided access to expert care, Stone said.
CTO PCI should be performed by experienced operators at dedicated centers to achieve optimal results, but patient preferences are also a component, Brilakis said.
“We should let the patient make the decision because if the patient is feeling highly limited, is it fair for the physician to limit the patient’s access to different options because the physician himself or herself is not convinced?” he said. “And that’s what’s happening quite often, is that people who have CTOs, although they’re highly symptomatic, are being told, ‘There is nothing that can be done for you,’ despite there being a potential therapy.”
For patients and providers still on the fence, the Sham-controlled Intervention to Improve QOL in CTOs trial (SHINE-CTO), currently enrolling patients at some of its 15 sites, may provide important answers, Brilakis and Stone noted.
PROGRESS-CTO was funded by the Abbott Northwestern Hospital Foundation. Tajti reports no relevant financial relationships. Brilakis reports consulting and speaking honoraria from Abbott Vascular, ACIST Medical Systems, Amgen, Asahi Intecc USA, Cardiovascular Systems, Elsevier, GE Healthcare, Medicure, Medtronic, and Nitiloop; research support from Boston Scientific and Osprey; and serving on the board of directors of Cardiovascular Innovations Foundation and board of trustees of SCAI. Stone is a consultant to Matrizyme.
JACC Cardiovasc Interv. Published April 26, 2018. Abstract, Editorial
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