Studies demonstrate benefits of OCT guidance over angiography for PCI
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Key takeaways:
- OCT-guided PCI conferred greater minimal stent area vs. angiography-guided PCI in the CALPISO trial.
- OCT-guided PCI was linked to more procedural success vs. angiography-guided PCI in DOCTORS-LM.
In two trials, OCT-guided PCI demonstrated superiority in imaging endpoints and improved procedural success compared with angiography and fluoroscopy alone, speakers reported.
The results of the prospective, randomized, superiority CALIPSO trial and the multicenter, randomized DOCTORS-LM trial were presented at EuroPCR.
The CALIPSO trial
For the CALIPSO trial, Nicolas Amabile, MD, PhD, interventional cardiologist at the Institut Cardiovasculaire Paris Sud at Hôpital Jacques Cartier, Massy, France, and colleagues evaluated the superiority of OCT-guided PCI compared with angiography-guided PCI for calcified lesions as well as the safety of the OCT-guided strategy.
“During the past years, different intracoronary imaging-based management algorithms have been proposed for these lesions, but the data supporting this approach are currently scarce,” Amabile said during a press conference.
The study included 143 patients with a stable culprit coronary lesion with moderate to severe calcification considered possible to cross with an OCT catheter. Participants were randomly assigned to OCT-guided or angiography-guided PCI.
The OCT-guided strategy involved lesion preparation according to a standardized OCT algorithm; stent sizing according to the OCT analysis following a pre-PCI run; mandatory stenting postdilation; and a post-PCI OCT run and PCI optimization if required.
The mean age of participants was about 73 years, of which more than half were men and nearly one-quarter had undergone prior PCI. In the majority of patients, the culprit vessel was the left anterior descending artery.
The primary endpoint was post-PCI minimal stent area on final OCT.
Lesion preparation was different in the OCT arm compared with the angiography arm, with noncompliant balloon angioplasty being the preferred method in the OCT group (63% vs. 39%), whereas intravascular lithotripsy was preferred in the angiography group (12% vs. 46%). Use of rotational atherectomy was similar between the two groups.
Amabile reported that the primary endpoint was superior in the OCT-guided PCI arm, with a mean post-PCI minimal stent area of 6.9 mm2 compared with 5.3 mm2 in the angiography arm.
Moreover, there was no significant difference between the two groups with respect to procedure duration, total X-ray dose and contrast medium volume, according to the presentation.
“The post-PCI minimal stent area achieved in the OCT group was superior to that achieved with angio guidance, meeting the primary endpoint of the trial,” Amabile said during the presentation. “OCT-guided PCI also resulted in significantly greater average stent expansion and lower malapposition than angiography. However, the superiority in terms of imaging endpoints will translate into clinical benefits should be now assessed in future trials.”
The DOCTORS-LM trial
For the DOCTORS-LM trial, Nicolas Meneveau, MD, PhD, chief of the cardiology department at University Hospital Besancon, France, and colleagues evaluated whether OCT-guided PCI was superior to angiography-guided PCI of the left main artery as assessed by fractional flow reserve.
Their study included 197 patients with non-STEMI, unstable or stable angina or documented silent ischemia, significant left main stenosis and a SYNTAX score of 22 or less.
The mean age was 71 years, of which men comprised more than three-quarters and nearly half had a prior PCI.
Participants were randomly assigned to OCT-guided or angiography-guided PCI.
In the OCT group, stent length and diameter was guided by OCT run pre-stenting, and OCT run post-stenting was conducted to check for stent deployment, malapposition, edge dissection and crushed stent.
The primary endpoint was the average of three consecutive post-PCI FFR measures, which did not differ significantly between OCT-guided and angiography-guided PCI groups (P = .5237). However, Meneveau reported higher procedural success in the OCT group compared with angiography (58.9% vs. 34.4%; P = .0009), which was mainly driven by less malapposition (13.3% vs. 35.5%; P = .0005) and less stent crush (0% vs. 8.6%; P = .0045).
At 1 year, the occurrence of major adverse cardiac events was similar between the two groups (P = .25), but there was less clinically driven target lesion revascularization in the OCT arm compared with the fluoroscopy arm (1% vs. 8%; P = .01).
“Compared with angioplasty guided by fluoroscopy alone, OCT-guided PCI left main angioplasty had no significant impact on the function result of the procedure, as assessed by absolute fractional flow reserve measurement,” Meneveau said during the press conference. “OCT yielded significantly greater procedural success, specifically in terms of stent malposition and crushed stents. There was no significant difference in MACE rates, but significantly fewer target lesion revascularizations.
“Additional larger randomized studies focusing on clinical endpoints are required to confirm this potential benefit at 1 year,” he said.
Reference:
- Meneveau N, et al. First results of randomized trials on advanced plaque modification techniques and intracoronary imaging. Presented at: EuroPCR; May 14-17, 2024; Paris.
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Amabile N, et al. First results of randomized trials on advanced plaque modification techniques and intracoronary imaging. Presented at: EuroPCR; May 14-17, 2024; Paris.
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