Registry data highlight importance of clinical conditions in treating CTO lesions

Cardiovascular Research Technologies 2011

Issue: April 2011

Cardiovascular Research Technologies 2011

New one-year data from the IRCTO registry have suggested that outcome of treatment of chronic total occlusion lesions was related to patient clinical conditions as opposed to strategy of treatments in Italy where prevalence of these lesions is roughly 12%.

According to presenter Alfredo R. Galassi, MD, director, Diagnostic and Cardiovascular Interventional Laboratory, Ferrarotto Hospital University, Catania, Italy and investigator on the trial, the incidence and prevalence of coronary chronic total occlusion [CTO] lesions, as well as the demographic characteristics of patients affected by CTO’s, are unknown.

“The aim [of the study] was to assess the prevalence, demographics, clinical characteristics and therapeutic strategy of patients with CTOs in order to improve the management of patients with chronically occluded coronary arteries,” he said.

The study included 1,777 consecutive patients who underwent coronary angiography from 12 centers throughout Italy for the Italian Registry on Chronic Total Occlusion (IRCTO). The patients had at least one CTO in a main coronary artery for greater than 3 months duration with vessel size greater than >2.5 mm at coronary angiography.

Overall, investigators reported 1,968 CTOs among patients. One month unadjusted clinical outcome did not result in a statistically significant difference in death, stroke or MI, among patients treated with percutaneous coronary intervention, CABG or optimal medical therapy. However, at 12 months, compared with optimal medical therapy, rates of death and acute MI but not stroke were significantly less in patients treated with PCI.

According to univariate analysis, predictors of hard events included ejection fraction <35% (OR=1.76; 95% CI, 1.12-2.77), multivessel disease (OR=2.07; 95% CI, 1.13-3.80) and age (OR=1.06; 95% CI, 1.04-1.08).

Additionally, concluded Galassi, patients with a successful PCI had a better outcome than those without one (P=.03). – by Brian Ellis

For more information:

Galassi A. Presented at: Cardiovascular Research Technologies 2011. Feb. 27-March 1, 2011; Washington, D.C. .

There is now a remarkable consistency from data from Italy. In fact, this represents, by my count, the 12^th study that would suggest through indirect comparison and minding the biases both with regard to treatment and selection of these patients that there is a consistency across these observational studies demonstrating improved survival and freedom from adverse events over an immediate long-term follow-up—follow-up, in some observation studies, that extends now beyond many years.

That said, however, we still need a large randomized trial that would help refine the benefit of CTO revascularization from hard clinical endpoints. However, to design a trial based on hard clinical endpoints like mortality, you have to think about the limitations of sample size and statistical power. And probably what is more relevant is a composite that would reflect not only mortality in itself but avoidance of future ischemic events and rehospitalization and very importantly a benefit with regard to quality of life.

It is noteworthy, however, that in this Italian registry there is a lower representation of patients with multivessel disease and patients with reduced left ventricular function in part reflecting clinicians’ discretion to refer patients to surgery or to treat them with medical therapy alone. But it’s important to realize that these are some of the patients who derive the greatest relative treatment effect from CTO revascularization.

– David E. Kandzari, MD

Director, Interventional Cardiology Research, Scripps Clinic

La Jolla, California

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