DOCTORS Trial Supports OCT Imaging to Guide PCI Strategy

August 29, 2016—The European Society of Cardiology (ESC) announced the presentation of the results of the DOCTORS (Does Optical Coherence Tomography [OCT] Optimize Results of Stenting) study at the ESC 2016 Congress in Rome, Italy. The DOCTORS study showed that OCT can visualize the coronary arteries in patients undergoing percutaneous coronary intervention (PCI) and leads to better outcomes compared to standard angiography-guided PCI. The lead investigator of the DOCTORS study, Nicolas Meneveau, MD, et al simultaneously published the results online ahead of print in Circulation.

In the ESC announcement, Prof. Meneveau reported that in patients with non–ST-segment elevation acute coronary syndromes, OCT “provided useful additional information beyond that obtained by angiography alone and impacted directly on physician decision-making.” He added that using catheter-based OCT imaging to check vessel size, lesion characteristics, and stent positioning and expansion “led to a change in procedural strategy in half of cases.” 

Prof. Meneveau, who is from University Hospital Jean Minjoz, in Besançon, France, cautioned, “Additional prospective randomized studies with clinical endpoints are required before it can be recommended for standard use.”

As summarized by ESC, the multicenter trial was composed of 240 patients with non–ST-segment elevation acute coronary syndromes who were randomized 1:1 to standard fluoroscopy-guided PCI alone (angio group) or with the addition of OCT, which was performed an average of 3.8 times (before, during, and after the procedure).

Prof. Meneveau stated that overall, OCT was associated with better functional outcome than PCI guided by fluoroscopy alone. 

The study’s primary endpoint of fractional flow reserve was significantly better in the OCT group as compared to the angio group (0.94 vs 0.92; P = .005).  The number of patients with a postprocedural fractional flow reserve > 0.9 was significantly higher in the OCT group (82.5% vs 64.2%; P = .0001).

Compared with angiography, OCT allowed clinicians to see significantly more thrombi (69% vs 47%; P = .0004) and calcifications (45.8% vs 9%; P < .0001) before stent implantation. This resulted in more frequent antiplatelet use in the OCT group (53.3% vs 35.8%). Also, OCT was significantly more likely to reveal stent underexpansion (42% vs 10.8%), incomplete lesion coverage (20% vs 17%), and edge dissection (37.5% vs 4%) compared to angiography. Stent malapposition, which is not visible under fluoroscopy alone, was observed in 32% of patients undergoing OCT.

The DOCTORS investigators found that these observations led to the more frequent use of poststent overinflation in the OCT group  (43% vs 12.5%; P < .0001) and a lower percentage of residual stenosis (7% vs 8.7%; P = .01).

Prof. Meneveau noted that the addition of OCT increased procedure time as well patients’ exposure to fluoroscopy and contrast medium, but this did not increase complications such as periprocedural myocardial infarction or impaired kidney function. “Findings of the DOCTORS study add to the cumulating body of evidence in favor of a potential benefit of OCT to guide angioplasty. The improvement in functional outcomes could translate into a clinical benefit in the longer term,” concluded Prof. Meneveau in the ESC press release.