Meds Sans PCI Judged Okay for Chronic Total Occlusions in DECISION-CTO, but Methods Questioned

Marlene Busko

March 22, 2017

WASHINGTON, DC — In patients with chronic total occlusion (CTO) of a coronary artery, medical therapy was not inferior to PCI for the primary outcome of a composite of death, MI, stroke, or any revascularization at 3 years, in the prospective, randomized Drug-Eluting Stent Versus Optimal Medical Therapy In Patients With Coronary Chronic Total Occlusion (DECISION-CTO) trial[1].

Moreover, patients who had optimal medical therapy alone did not report worse angina or quality of life at 3 years than patients who underwent PCI of the completely occluded vessel.

"Optimal medical therapy could be a reasonable initial treatment strategy for coronary chronic total occlusion compared with percutaneous coronary intervention," Dr Seung-Jung Park (University of Ulsan college of Medicine, Asan Medical Center, Seoul, South Korea) reported, presenting these findings at the American College of Cardiology (ACC) 2017 Scientific Sessions.

Findings from this first randomized trial comparing the two strategies for CTO in some ways conflict with those from observational studies that have favored CTO revascularization. But DECISION-CTO had several methodologic limitations, according to some experts.

Notably, as panelist Dr Antonio Columbo (EMO-GVM Centro Cuore Columbus, Milan, Italy) said, these findings were in "selected" patients.

"I don't believe all CTO lesions should be opened; in some cases, optimal medical treatment is quite enough," Park told heartwire from Medscape. He agreed that the trial participants had mild disease and reflect Asian patients with CTO who typically have a low SYNTAX score.

"I'm sure there was some selection bias," cochair Dr Martin B Leon (Columbia University Medical Center, New York) told heartwire . "We had tremendous advances in the success of CTO therapy, and we think that the aggregate of nonrandomized data still suggests clinical benefit; we need more randomized trials before we can make definitive statements."

"Whether patients are going to say 'do the CTO procedure now or wait until I can't take it any more' when they are refractory to medical therapy, I think a lot of patients would probably kick the can down the road." Dr Nils Johnson (McGovern Medical School at UTHealth, Houston, TX) told heartwire .

"I would read this trial as being very supportive for saying that some patients with CTOs are quite stable and you can wait . . . until they're refractory to medical therapy." These patients probably represent "a large slice of the pie."

Enrollment Stopped Early Due to Slow Pace

DECISION-CTO planned to randomize 1284 patients with coronary CTO to either optimal medical therapy or optimal medical therapy plus PCI at 19 cardiac centers mainly in Korea, but also in India, Indonesia, Thailand, and Taiwan.

Patients had to have silent ischemia, stable angina, or ACS and new CTO (a coronary artery obstruction with TIMI flow grade 0 of at least 3 months' duration).

All patients were prescribed guideline-derived optimal medical treatment that included aspirin, P2Y12-receptor inhibitors (for >12 months for patients who had PCI), beta-blockers, calcium-channel blockers, nitrate, ACE inhibitors/angiotensin receptor blockers (ARBs), and statins. Half were randomized to PCI.

Because of the slow pace, trial enrollment was stopped in September 2016 as recommended by the data and safety monitoring board, when 834 patients had been enrolled (398 in the medical-therapy group and 417 in the PCI group).

At baseline, the patients had a mean age of 62, and 82% were male; 74% had stable angina; 20% had unstable angina; and 6% had acute MI.

Patients in both groups had a mean SYNTAX score of 21 and similar cardiovascular risk factors. Patients in the medical group had two stents and those in the PCI group had 2.4 stents (P<0.001).

The CTO-PCI procedure was a success in 91% of the cases.

At the 3-year follow-up, in the intention-to-treat population, the primary end point occurred in 20.6% of patients in the optimal-medical-therapy group vs 19.6% of patients in the PCI group (adjusted HR 0.91; P=0.54).

There were no significant differences between the optimal-medical-therapy group and the PCI group in rates of death (4.4% and 3.0%, respectively; P=0.25), MI (10.7% and 8.4%, respectively; P=0.24), stroke (1.3% and 1.0%, respectively; P=0.11) or repeat revascularization (10.4% and 8.6%, respectively; P=0.38).

The Seattle Angina Questionnaire (SAQ) physical limitation, angina stability, treatment satisfaction, angina frequency, and quality-of-life scores were comparable in the two groups, throughout the follow-up.

"COURAGE Study of CTOs"

As assigned discussant, Dr David E Kandzari (Piedmont Heart Institute, Atlanta, GA) also described what he saw as methodologic weaknesses of the trial. For example, he noted, the study started enrolling patients 6 years ago and changed its primary end points and sample sizes.

 "What's also troubling is that through the 3-year primary end-point analysis approximately only half of the patients are represented in the Kaplan Meier analyses . . . and 1-year health-status measures," he noted.

"In a study that in many ways resembles the COURAGE trial, in its design, conduct, end points, and even in the outcomes, we should also be reminded of the likelihood for substantial crossover to revascularization," Kandzari continued. More than 20% of patients randomized to medical therapy alone underwent PCI.

"I think David Kandzari's comments were right in a lot of ways, that it's the COURAGE study of CTOs,"  Johnson told heartwire .

"Given the slow rate of enrollment—I think there was a lot of off-trial CTO PCI at those centers during that era—there probably was just a low-risk population [enrolled], and [such patients] tend to all do well no matter what you do."

Dr Nallamothu Brahmajee (University of Michigan, Ann Arbor, MI), who was not at the session, told heartwire that "the biggest criticisms [of DECISION-CTO] have been related to the slow enrollment, early termination, high loss to follow-up and reasonably high crossover. All of these can affect assessments of efficacy of optimal medical therapy vs CTO PCI. "

The other major concerns were the "curious" choice of a primary end point that assessed all-cause death, MI, stroke, and repeat revascularization rather than quality of life and the fact that the study population was not limited to patients with angina despite medical therapy.

DECSION-CTO "doesn't change my practice, and I don't think it'll change the practice of many interventionalists in the US currently," according to Brahmajee. "Its biggest impact will be on pushing for more trials in this space. We desperately need randomized data here.

"There are a lot of potential patients that could be impacted by these procedures, and it's clear that we don't understand when and in whom they'll be most beneficial."

The operators had a success rate that exceeded 90%, so these were skilled operators, he observed.

"I wasn't surprised by no differences in angina given how the patient population was described—in my experience medical therapy can be very good for stable patients."

The trial was funded by the CardioVascular Research Foundation in South Korea.

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