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EXPLORE: CTO PCI within 7 days of STEMI PCI appears safe, feasible
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In patients who undergo PCI for STEMI, additional PCI for chronic total occlusions within 1 week after primary PCI appears to be safe and feasible, according to results from the EXPLORE trial.
The publication confirms results presented at the Transcatheter Cardiovascular Therapeutics Scientific Symposium in October 2015.
In the investigator-initiated, randomized, two-arm trial with masked endpoint evaluation, researchers analyzed 304 patients (mean age, 60 years) enrolled at 14 centers between November 2007 and April 2015.
Eligible participants presented with STEMI within 12 hours of symptom onset and were found to have concurrent CTO in a non-infarct-related artery during successful STEMI PCI. The researchers randomly allocated patients to undergo further PCI of the CTO within 7 days of primary PCI (n = 150) or a conservative approach involving no CTO PCI (n= 154) for at least 4 months, except when clinically driven due to severe symptoms necessitating invasive treatment.
There were no significant disparities in baseline characteristics between the groups, according to the researchers.
Patients were seen for clinical follow-up at 1 and 4 months. At 4 months, cardiac MRI was performed. The study’s co-primary endpoints were left ventricular ejection fraction and LV end-diastolic volume (LVEDV) at 4 months, as evaluated by cardiac MRI. Secondary endpoints included infarct size and regional myocardial function. On average, patients assigned to the CTO PCI group underwent the procedure on day 5.
According to the findings, the CTO PCI arm had a 77% investigator-reported procedural success rate and a 73% adjudicated success rate.
The researchers found that, at 4-month follow-up, the CTO PCI group had a mean LVEF of 44.1 ± 12.2% vs. 44.8 ± 11.9% in the no–CTO PCI arm (P = .6). The CTO PCI group had a mean LVEDV of 215.6 ± 62.5 mL vs. 212.8 ± 60.3 mL in the no–CTO PCI arm (P = .7).
In a subgroup analysis, researchers found a significant interaction between treatment randomization and 4-month LVEF in patients whose CTO was located in the left anterior descending coronary artery. Patients who had concurrent CTO in the left anterior descending coronary artery had higher 4-month LVEF if they underwent CTO PCI vs. those who did not undergo CTO PCI (47.2% vs. 40.4%; P = .02).
According to the researchers, there was an interaction between CTO location and treatment allocation in terms of LVEDV (P = .04). No other significant interactions were revealed in additional subgroup analyses.
In a related editorial, Emmanouil S. Brilakis, MD, PhD, of the Minneapolis Heart Institute, and colleagues wrote that CTO PCI is an important tool and should be used judiciously based on patient needs.
“If the goal of CTO PCI is to improve [LV] systolic function and remodeling in patients with STEMI who have concomitant CTO, the answer for most patients would be ‘no,’ with the possible exception of patients with left anterior descending coronary artery CTOs, who derived benefit in the exploratory EXPLORE subgroup analysis,” Brilakis and colleagues wrote. “However, if the goal is to improve symptoms, the answer in most cases would be ‘yes,’ as long as the patient understands the indications for, potential benefits of, and risks of the procedure.” – by Jennifer Byrne
Disclosure: The study was investigator-initiated with a research grant from Abbott Vascular International. Please see the full study for a list of the researchers’ relevant financial disclosures. Brilakis reports receiving consultant and speaker honoraria from Abbott Vascular, Asahi, Cardinal Health, Elsevier, GE Healthcare and St. Jude Medical, receiving research support from Boston Scientific and InfraRedx, and his spouse is an employee of Medtronic. Please see the full editorial for a list of the other authors’ relevant financial disclosures.
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