EUROCTO: Revascularization Bests Medical Therapy for Quality of Life in CTO Lesions
The data might not be enough to convince staunch CTO PCI opponents, but they should inform guidelines, the lead investigator says.
PARIS, France—The first randomized study of PCI for coronary chronic total occlusions (CTOs) designed to look at quality of life outcomes shows some improvement with the procedure compared to optimal medical therapy (OMT) at 12 months.
Despite not recruiting the preplanned number of patients for the EUROCTO study, “the results are relevant and demonstrate that PCI of CTO improved the health status regarding angina frequency, physical limitations, and quality of life as compared to OMT and improved the functional class,” said Gerald S. Werner, MD, PhD (Klinikum Darmstadt, Germany), who presented the results here during a late-breaking trial session at EuroPCR. “In experienced hands, periprocedural risk was low, and the 12-month MACCE rate was comparable to OMT, but the long-term safety remains to be evaluated at 36 months.”
So far, the only randomized trial comparing PCI and OMT for CTO lesions—DECISION CTO, which was presented earlier this year—used combined clinical outcomes, not quality of life, for its primary endpoint and came up short. Observational data have hinted at improvement in quality of life factors, which CTO PCI proponents argue are the most important given that the procedure is often performed primarily to improve symptoms and not influence hard outcomes.
For EUROCTO, Werner and colleagues recruited 407 patients with a CTO from 26 participating centers and randomized them 2:1 to PCI or OMT (aspirin, statin, ACE inhibitor where tolerated, plus at least two antianginal agents at maximum tolerated dose) between March 2012 and May 2015. Within the PCI arm, the procedure was successful in 86.3% of patients and one-third received radial access. Ten patients assigned to OMT (7.3%) crossed over into the PCI arm due to ongoing angina.
To meet significance for its primary endpoint—five subscales of the Seattle Angina Questionnaire (SAQ) Health Status survey at 12 months—the data from EUROCTO needed to reach a P value of less than 0.01 due to multiple testing. With about 91% of patients available for analysis, the study showed significant improvement in angina frequency with CTO PCI over OMT (P = 0.009) as well as greater improvements in Canadian Cardiovascular Society angina scores with PCI over OMT (P < 0.001). Improvements in physical limitation, quality of life, angina stability, and treatment satisfaction were numerically higher in the PCI-treated patients.
MACCE at 12 months was similar between the PCI and OMT arms (5.2% vs 6.7%; P = 0.52) and included two non-CTO-related deaths, five MIs, and one stent thrombosis event in the PCI cohort.
The results may or may not convince opponents of CTO PCI of its benefit, but Werner told TCTMD that the EUROCTO data should at least inform future guidelines. As for future studies, “the idea of a primary endpoint related to prognosis in this setting would not be helpful,” he added.
In a discussion following the presentation, panelist Stéphane Rinfret, MD (McGill University Health Centre, Montreal, Canada), commended the study authors on recruiting even the number of patients they did, but questioned the generalizability of the findings because of the trial’s exclusion criteria.
“You may have treated outside the trial more symptomatic patients, and that would have biased your result toward the null hypothesis, [but] you nevertheless found some significant result. But when we look at the baseline quality of life, these patients were around 70/60 in terms of scores for angina frequency,” Rinfret said. Could this, he asked, have possibly explained the difference between the positive EUROCTO results and the neutral DECISION CTO?
Refusing to comment on DECISION CTO due to having “no insight on the data,” Werner said these types of trials “always include the less symptomatic patients. That is observed if you compare COURAGE, for example, with the SAQ observed in SYNTAX. SYNTAX has low scores because it was not a decision not to treat, so in OMT patients will always have a trend toward less symptomatic patients.”
Positive but Maybe Not Enough
Commenting on the study, J. Aaron Grantham, MD (Saint Luke’s Mid America Heart Institute, Kansas City, MO), told TCTMD in an email that EUROCTO is important because many CTO patients “care as much, if not more, about symptom relief as they do about longevity.
“It should be emphasized that the trial was performed by highly experienced CTO operators at recognized centers of excellence in Europe,” he continued. “Even so, it suffered from slow, nonconsecutive enrollment resulting in premature termination at only 40% of the planned enrollment, a problem that uniformly plagues interventional research and always raises the specter of selection bias.”
The trial may be positive, Grantham acknowledged, but CTO PCI can only be definitively designated as the preferred first-line treatment for symptomatic patients with CTOs once “the results are reproduced, the benefits are durable, [and] the procedures are proven safe and cost-effective through additional research. . . . Until then, it remains prudent to offer this therapy to patients who do not respond to, do not tolerate, or do not want a sincere effort at antianginal medical therapy after engaging in a fully informed shared decision-making exercise with their physician.”
The methodology behind treating CTOs “remains controversial and understudied,” he said. “Neither this trial nor the recently reported DECISION CTO trial, which is also seriously flawed, fills this persistent knowledge gap in the field.” Because of that, Grantham called on the “international community” to gain funding for and commit to a trial that can put an end to the debate.
Werner GS. A randomized multicentre trial to evaluate the utilization of revascularization or optimal medical therapy for the treatment of chronic total coronary occlusions. Presented at: EuroPCR 2017. May 18, 2017. Paris, France.
- EUROCTO was partially funded by grants from Asahi and Biosensors.
- Werner and Grantham report no relevant conflicts of interest.