Patrice Wendling

May 26, 2017

PARIS, FRANCE — Quality of life appears better for patients with chronic total occlusion (CTO) who underwent PCI with optimal medical therapy (OMT) compared with OMT alone in the EuroCTO trial, but it was far from a conclusive win[1].

At 12 months, the PCI group had a lower frequency of angina than the OMT group on the Seattle Angina Questionnaire (SAQ) health status survey (P=0.009).

Improvements were numerically better in the PCI group in physical limitation and quality of life, and comparable between groups for the remaining SAQ subscales of angina stability and treatment satisfaction.

In addition, the trial was stopped prematurely because of slow recruitment, with just 369 evaluable patients or 40% of its planned enrollment.

Nevertheless, PCI CTO should be considered "a primary option in symptomatic patients" and "is a safe and effective treatment option in expert hands," lead author Dr Gerald S Werner (Klinikum Darmstadt, Germany) reported during a late-breaking trials session here at EuroPCR 2017.

EuroCTO is the first randomized trial designed to assess health status in patients with a CTO treated with PCI vs OMT, though nonrandomized evidence suggests a quality of life benefit with PCI.

As reported earlier this year by heartwire from Medscape, however, the DECISION-CTO trial failed to show significant differences between CTO PCI and OMT in major adverse cardiac events and secondary outcomes such as angina reduction and quality of life at 3 years.

"Our study is one piece in the foundation for CTO PCI, and DECISION-CTO rather is not, but the reasons are to be explained when we know more about that study," Werner told heartwire. "They had a high crossover rate, but also some PCI patients who never received PCI, so [it was] a really mixed population for an intention-to-treat analysis.

"Both studies show that in a selection process, highly symptomatic patients do not enter these studies, therefore we need to keep the study conduct as close to the intention to treat as possible, which we achieved in our trial."

Asked by heartwire whether the EuroCTO results are sufficient to change practice or influence guidelines, Dr Deepak L Bhatt (Brigham and Women's Hospital, Harvard Medical School, Boston, MA) wrote in an email, "No. We really need much larger randomized studies. For the time being, CTO attempts should generally be reserved for highly symptomatic patients on maximally tolerated medical therapy with evidence of significant residual ischemia."

In the Hands of Experts

EuroCTO was conducted between March 2012 and May 2015 at 26 European centers with expert CTO operators. Originally planned to enroll 1200 patients for its safety outcome at 3 years, slow recruitment forced the goal to be revised to 600 patients for the primary end point of the SAQ five subscales at 12 months.

Ultimately 396 patients with stable coronary disease were randomly assigned to receive PCI with a biolimus-eluting stent plus OMT or OMT (aspirin, statin, an ACE inhibitor where tolerated, plus at least two antianginal agents at maximum tolerated dose). Patients with multivessel disease had non-CTO lesions treated before randomization.

A significance level of 0.01 was used for the primary end point because of multiple testing; all events were adjudicated by a clinical events committee.

The procedural success rate was 86.3% (255 of 259 patients) and PCI complication rate 2.9%. Ten OMT patients (7.3%) crossed over to PCI because of ongoing angina. At 12 months, MACE rates were comparable in the PCI and OMT groups (5.2% vs 6.7%; P=0.52).

During a discussion of the data, the panel pointed out that patients had somewhat moderate angina frequency scores at baseline and questioned the generalizability of the results.

Werner noted that ACS patients were excluded and that they limited the location of the CTO to the major locations of the arterial tree to avoid irrelevant lesions. Also, very symptomatic patients were excluded because they wouldn't agree to be randomized or the physician considered it unethical.

"The major issue for taking the results to clinical practice is that the operator should be successful in his or her attempt; and some of the reason for showing a positive outcome in our study was the low crossover rate and high success rate," he told heartwire.

CTO is found in up to 18% of patients with stable CAD but only about 5% are actually treated with PCI, Werner noted. There are no comparative data to support why interventionalists in their use of PCI discriminate between a 90% lesion and 100% chronic occlusion, just the historic perception that CTO PCI is more difficult.

"Success rates were at 50% to 60% with low long-term patency, but this has changed in the last 5 to 10 years, and the guidelines need to recognize that," he said.

While disagreeing on whether the findings should shift practice, Bhatt acknowledged the challenge of enrolling patients in procedural trials like EuroCTO.

"Interventionalists/surgeons are often so convinced the procedures they do are useful, they do not enroll their patients in trials. Then when the results come out (such as COURAGE, CORAL, ART), the response is that the results are not generalizable to daily clinical practice and/or the results would have been better if only the operators were more skilled.

"The real solution here is to have the intellectual humility to enroll patients into large, representative randomized trials instead of not participating and then criticizing the results," he said.

The study was supported by grants from Biosensors and Asahi. Werner has reported no relevant financial relationships. Bhatt reports serving on the advisory board for Medscape and CME steering committee for WebMD.

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