番茄社区

SAN FRANCISCO -- Optical coherence tomography (OCT) was associated with fewer events down the line for percutaneous coronary intervention (PCI) candidates presenting with intermediate coronary lesions on angiography, the FORZA investigators found.

The 13-month primary endpoint of combined major adverse cardiac events (MACE) or significant angina -- comprising all-cause death, non-fatal MI, target vessel revascularization, or Seattle Angina Questionnaire frequency scale score <90 -- was significantly more common after fractional flow reserve (FFR) guidance than OCT guidance (14.8% vs 8.0%, P=0.048), according to Francesco Burzotta, MD, PhD, of Gemelli University Hospital and Università Cattolica del Sacro Cuore in Rome.

However, no individual endpoint component by itself was shown to put FFR at a disadvantage, Burzotta reported at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting. The results were published simultaneously in .

The FFR arm got stenting if FFR was ≤0.80, and operators sought to achieve FFR 0.90 by the end of the procedure. Most people in this arm had PCI deferred (71.0%).

As for OCT guidance, PCI was performed if area stenosis was ≥75% (or 50%-75% where minimal lumen area is smaller than 2.5 mm² or with plaque rupture), and operators optimized stenting to minimize major stent malapposition, underexpansion, or major edge dissection. PCI deferral occurred in 49.3% of the OCT arm.

In patients with intermediate coronary lesions suitable for invasive evaluation by both OCT or FFR, the selection of OCT is safe, causing initially more PCIs but a lower occurrence of the combined endpoint of MACE or significant angina after 13 months, Burzotta concluded.

Choosing FFR instead was associated with greater odds of medical management alone (62.5% vs 44.8%, P<0.001) and lower costs up to 13 months (costs more than $1,200 cheaper on average, P<0.001).

"At the end of the day, the imaging strategy wins. That's what this suggests," said Gary Mintz, MD, TCT co-director and chief medical officer of the Cardiovascular Research Foundation, and fellow TCT panelists agreed. "And yes, you can parse out the data ... but imaging wins."

This is the first study to test how each modality fares in the larger "gestalt" of guiding the decision to perform PCI or not on top of stent optimization, Mintz suggested at a TCT press conference.

The single-center FORZA trial randomized 350 patients 1:1 to FFR or OCT guidance for PCI.

In total, there were 350 people who had 446 lesions with 30%-80% diameter stenosis on visual estimation. Average age was around 68-69; about three-quarters of participants were men.

Significantly more people in the OCT arm had had a previous MI (29.9% vs 18.8%, P=0.02) and a lesion in the right coronary artery as opposed to the left anterior descending coronary artery or the left circumflex artery.

Burzotta acknowledged that the study was limited by its single-center nature, which limits its generalizability to centers with less experience with FFR and OCT.

"From a practical standpoint, when you're in the cath lab faced with an intermediate lesion, and you recognize the angiogram is an imperfect tool, and you have to have a better way to decide how to treat and whether to treat, there are two competing camps: the physiology camp and the imaging camp," Mintz said.

"In general, the recent data supports physiology to decide 'treatment yes or no' and imaging to optimize the therapy. It jacks up the cost to do both, and people are just not willing to do both even if it makes clinical sense," he continued.

Mintz noted the possibility of generating a lesion-based FFR from OCT. This is a technique that is still under investigation, he said.

And though there's more data on intravascular ultrasound (IVUS) than OCT, imaging-guided stenting in general improves outcomes by "getting rid of the angiographic stent imperfection," Mintz emphasized.

For now, "you're lucky if you do FFR" in the U.S., where the penetrance of OCT and IVUS remain very low, commented Philippe Genereux, MD, of Morristown Medical Center, New Jersey, during the TCT press briefing.

Another TCT late-breaker, the 5-year report of IVUS-XPL, showed sustained clinical benefits from stent implantation in long coronary lesions guided by IVUS rather than angiography.

Comment