Consistent CTO: New Trial Finds Benefit of PCI for Total Occlusion

Patrice Wendling

June 04, 2018

PARIS — Findings from the prospective Consistent CTO study offer a bit of optimism for complex chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in highly symptomatic patients.

In a contemporary cohort of 210 patients, 90% of CTOs were opened with Synergy (Boston Scientific) stents implanted, with complete revascularization of the target territory in 98.6%.

The primary outcome of target vessel failure (TVF) at 12 months occurred in 5.24% of patients — well within the performance target of less than 15%.

There also were substantial gains in quality of life 12 months after successful CTO PCI, Simon J. Walsh, MD, Belfast Health and Social Care Trust, Northern Ireland, said in a hotline session at the Congress of the European Association of Percutaneous Cardiovascular Intervention (EuroPCR) 2018.

"There's been a lot of skepticism about the long-term results of complex CTO recanalization and still some skeptics on the benefits of symptoms," session co-chair Farrel Hellig, MD, Sunninghill and Sunward Park Hospitals, Johannesburg, South Africa, told | Medscape Cardiology. "While this is not randomized, these were extremely difficult lesions with excellent 1-year procedural durability and symptom relief.
"So I think it was very important data and may be the first step in reducing the skepticism about the value of CTO PCI," he said.

CTO PCI took a hit after the DECISION-CTO trial, in which PCI failed to show a significant benefit over optimal medical therapy in major adverse cardiac events (MACE), angina frequency, or quality of life at 3 years. The subsequent EURO-CTO trial found significantly less angina and a trend toward fewer physical limitations at 12 months with CTO PCI vs medical therapy, but the randomized trial was stopped early with just 40% of its planned enrollment and excluded patients who were very symptomatic.

Walsh pointed out that the Conventional Antegrade vs Sub-Intimal Synergy Stenting in Chronic Total Occlusions (Consistent CTO) study enrolled patients who were "extremely limited." Before PCI, 58.1% of patients reported problems with mobility on the EQ-5D Health Questionnaire, 25.8% with self-care, 64.5% with usual activities, 71% with pain/discomfort, and 56.5% with anxiety/depression.

Among 207 patients with clinical follow-up, the percentage of patients reporting problems declined significantly at 12 months for all domains except self-care.

On the Seattle Angina Questionnaire (SAQ), where higher scores indicate better function, scores increased at 12 months for physical limitation (53.4 to 75.16), anginal stability (41.26 to 66.89), anginal frequency (62.62 to 82.92), treatment satisfaction (90.99 to s 95.07), and disease perception (43.45 to 71.76; for all comparisons, P < .001).

"If you look at DECISION CTO, EuroCTO, other randomized studies, you see that a lot of relatively asymptomatic people are going in….  Therefore it's hard to demonstrate a significant change in symptoms," Walsh said. "Whereas for our patients, we weren't afraid of randomizing them to medical therapy. They all got treated properly and under those circumstances, we had very symptomatic patients at baseline and the SAQ rose substantially at 12 months and was durable."

Following the presentation, however, panelist Jim Nolan, University Hospital North Staffordshire, Stoke-on-Trent, United Kingdom, remarked, "The skeptic, of which I'm not one, might say that the sham effect of what you've done to these people is gigantic and accounts for all the quality-of-life improvements that you see."

Walsh replied that it's a reasonable question but data from 1000 patients in the OPEN CTO registry show that people who have unsuccessful PCI have no real significant gains in quality of life.

"Yes, it's not randomized; yes, we don't have sham data yet, but the key message here is that there's substantial gains for quality of life for people with very complicated disease and hugely beneficial outcomes with durable results, despite almost 100 millimeters of stent," he said.

At baseline, the mean J-CTO score was 2.4 and mean lesion length was 29.1 mm. The CTO was in the right coronary artery in 62% of cases, left anterior descending artery in 22%, and left circumflex artery in 15%. Patients received a mean of 2.8 stents (85.6 ± 33.2 mm) in an average procedure time of 122 minutes with 44.6 minutes of fluoroscopy.

The primary CTO approach was antegrade wire escalation (AWE) in 60% of cases. The final approach was AWE in 34%, retrograde wire escalation in 18%, antegrade dissection re-entry in 18%, and retrograde dissection re-entry in 30%. Two strategies were used in 41.4% of patients and three strategies in 9.1%.

Complications rates were in line with published data as the pericardiocentesis rate was 1%, any perforation 5.38%, bleeding requiring transfusion 1.9%, and any vascular complication 6.2%, Walsh said.

Stent thrombosis occurred in 1.4% of patients and MACE in 10%, with no cardiac deaths. Diabetes, present in about one in five patients, was a significant predictor of MACE, mainly driven by target vessel revascularization, he said.

"These are very impressive results and a short operating time also, that suggests these operators are extremely experienced," panelist Imad Alhaddad, MD, Jordan Hospital Medical Center, Amman, said following the presentation.

"These are really encouraging data because often a CTO operator gets questions about what the long-term outcome will be from these procedures and you again confirmed what we saw in EuroCTO about symptom reduction," Hellig remarked.

Consistent CTO was sponsored by the European Cardiovascular Research Center, with an unrestricted grant from Boston Scientific. Walsh reports consulting for Boston Scientific. Hellig reports receiving personal fees from Boston Scientific, Medtronic, Volcano, and Edwards Lifesciences. Alhaddad reports no relevant financial relationships.

Congress of the European Association of Percutaneous Cardiovascular Intervention (EuroPCR) 2018. Presented May 24, 2018.

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