OCT-STEMI: Imaging-guided PCI yielded positive results

WASHINGTON — Use of optical coherence tomography during stent implantation in PCI was associated with comparable rates of major adverse cardiac events and fewer uncovered struts compared with primary PCI alone in patients with STEMI.

Pavel Červinka, MD, PhD, from Faculty Hospital Hradee Králové and Masaryk Hospital in the Czech Republic, presented data from OCT-STEMI, the first longitudinal, randomized trial to evaluate serial OCT in the setting of primary PCI. The researchers enrolled 201 patients with STEMI who were pretreated with aspirin, heparin and clopidogrel. After radial diagnostic angiography, patients were randomly assigned to primary PCI alone guided by angiography (n=96) or primary PCI guided by OCT (n=106). All patients received drug-eluting stents (Promus, Boston Scientific; Biomatrix, Biosensors) and were advised to undergo 12 months of dual antiplatelet therapy.

The primary endpoints included 30-day and 9-month rates of major adverse cardiac events (composite of death, MI and ischemia-driven target lesion revascularization). Other endpoints included the percentage of uncovered struts, percentage area of stenosis and 9-month minimal lumen diameter as evaluated by OCT.

At the 30-day and 9-month follow-up, both groups had low and comparable rates of major adverse cardiac events and similar rates of stent thrombosis and individual components of the composite outcome. At 9 months, the major adverse cardiac events rate was 3% in the OCT-guided group vs. 1% in the angiography-guided group; ischemia-driven TLR was 2% vs. 1%; MI was 1% vs. 0%; mortality was 1% vs. 0%; and stent thrombosis was 1% vs. 1%.

In addition, Červinka reported no significant differences between the groups in angiographic results, including binary in-stent restenosis, late lumen loss, minimal in-stent and in-segment diameter, and minimal lumen area and diameter.

However, the data suggested a trend toward fewer uncovered struts and a smaller area of stenosis in the OCT-guided group, Červinka said. The absolute number of uncovered struts was 11,470/84,882 in the OCT-guided group vs. 12,094/71,578 in the angiography-guided group (P<.001). Area stenosis was 4.4% in the OCT-guided group vs. 15.9% in the angiography-guided group (P=.0011), according to data presented.

Patients enrolled in the trial were well matched in terms of age, sex, smoking status, diabetes, hypertension and CAD. The researchers used more stents in the OCT-guided group (1.4 per patient vs. 1.2 per patient) and OCT-guided PCI was associated with a longer fluoroscopy time (11.2 minutes vs. 8.3 minutes).

“The OCT-STEMI trial demonstrates the potential merit of OCT guidance during drug-eluting stent implantation in primary PCI,” Červinka said in a press release. “The study also indicates that the procedure is safe for STEMI patients, and larger randomized trials with longer-term follow-up are warranted.”

During the press conference, discussion moderator Ori Ben-Yehuda, MD, executive director of the Cardiovascular Research Foundation Clinical Trials Center, said OCT-guided stent implantation will likely be extensively investigated in the future. “There will be a number of follow-up studies trying to optimize use of OCT and to see whether one can make it as standard as IVUS is, as well as to improve outcomes. There will be a lot of effort in that regard.”

Panel discussant David G. Rizik, MD, interventional cardiologist at Scottsdale Healthcare Heart Group, Arizona, said although he considers OCT a valuable technology, he is uncertain whether he will adopt it for use in STEMI. “I see OCT used more in non-STEMI cases, and this was a STEMI trial. I would say its use is invaluable in the cath lab, but I am not seeing enough evidence or proof of concept right now to put this into the treatment algorithm for STEMI.” – by Jennifer Byrne

For more information:

Červinka P. Plenary Session XIII: First Reports #2. Presented at: TCT 2014; Sept. 13-17, 2014; Washington, D.C.

Disclosure: The OCT-STEMI trial was funded by grants from A Care and Boston Scientific. Červinka reports no relevant financial disclosures.