In patients, undergoing percutaneous intervention (PCI) in complex coronary lesions, intravascular imaging is superior to angiography in reducing the risk of target lesion failure (TLF). This is shown by the results of a randomized trial.
Previous studies came to the same conclusion, but this time the benefit was demonstrated in a multicenter, well-powered, randomized trial, as study leader Dr. Joo Yong Hahn reported at the annual meeting of the American College of Cardiology and the World Heart Federation in New Orleans.The results were simultaneously published in the «New England Journal of Medicine»
The earlier studies «were inconclusive,» Hahn said, noting that even the randomized trials did not have sufficient follow-up duration or did not cover a wide range of types of complex PCIs.
In this clinical outcomes study, called RENOVATE-COMPLEX-PCI, 1639 patients who received «complex PCI» in 20 South Korean clinics were randomized in a 2:1 ratio to either intravascular imaging PCI or angiography alone. Nine types of complex coronary lesions were considered for participation in the study, including bifurcated lesions, long lesions (expected stent length ≥ 38 mm), total coronary occlusions, lesions requiring multiple stents, severely calcified lesions, and lesions in multiple vessels.
Intravascular imaging in the experimental arm could be performed using either intravascular ultrasound (IVUS) or optical coherence tomography (OCT).Since one method may be more suitable for certain patients and lesions than the other, the type of intravascular imaging in the experimental group was selected at the discretion of the treating investigator, Hahn (Sungkyunkwan University, Seoul) further reported.
The primary TLF endpoint was defined as death from cardiovascular causes, MI associated with the target vessel, and revascularization of the target vessel.
Risk reduction of> 35% observed
After a median follow-up of 2.1 years, the lower incidence of TLF in the PCI group using intravascular imaging (7.7% vs. 12.3%) corresponded to a risk reduction of 36% (hazard ratio 0.64; P = 0.008).
Intravascular imaging was associated with a numerical reduction in each component of TLF. For death from cardiovascular causes, the confidence interval remained below the unit line (HR 0.47; 95% CI 0.24-0.93).
Although this did not apply to target vessel-related MI (HR 0.74, 95% CI 0.45-1.22) or target vascular revascularization (HR 0.66; 95% CI 0.36-1.22), it did apply to TLF without procedure-related MI (HR 0.59; 95% CI 0.39-0.90) and cardiac death or target vessel-related MI (HR 0.63; 95% CI 0.42-0.93).
With few exceptions, «all secondary outcomes «moved in the right direction» in favor of intravascular imaging, including death from any cause (HR 0.71.95% CI 0.44-1.15), reported Rooster.
Of the 1,092 patients who underwent PCI using intravascular imaging, there were no significant baseline differences compared to the 547 patients who underwent angiography.The median age was 65.5 years. Most (79%) were male. About half (51%) had acute coronary syndrome, the rest had stable ischemic heart disease. The proportion of patients with hypertension (61%), dyslipidaemia (51%) and diabetes (38%) was significant. About 18% of patients were smokers, 24% had already had PCI, and 7% had already suffered a heart attack.
The stent types were similar in both groups and were inserted via a radial access. In both groups, a successful procedure was performed in about 98% of cases. Almost all patients were discharged with a statin and a P2Y12 inhibitor, and the other specific postprocedural drugs were similar in both groups.
Advantage of intravascular imaging consistent
The complex lesions were diffuse lesions of long coronary arteries in most cases (55%), but other types of complex PCIs, including bifurked lesions (22%), chronic total occlusions (20%), severely calcified lesions (14%) and ostial lesions of a major coronary artery (15%) were also represented.For all these lesion types, intravascular imaging was preferred to angiography for TLF, at least numerically. Possible exceptions were lesions requiring at least three stents (HR 1.24; 95% CI 0.49-3.18), but confidence intervals were wide.
The study was open-label, but Hahn reported that the imaging analyses were performed in a nuclear laboratory and the events were assessed by a committee whose members knew nothing about belonging to the study group.
An unanswered question is that of cost. As intravascular imaging makes PCI more expensive compared to angiography, cost-effectiveness analyses are needed to support the decision to apply this approach to all complex PCI patients. These analyses are planned.
Because of the consistency of these study results with previous studies, which showed almost all the same thing, «the world of intravascular imaging has been talking,» Dr. Wayne B. Batchelor, director of interventional cardiology, Inova Heart and Vascular Institute, told Fairfax.»The only question now is when the interventional community will listen.»
Batchelor predicted that this data will change the mindset of many doctors «to shift the debate from why you do it [intravascular imaging] to why you don’t. In the United States, only about 15% of PCIs are performed with intravascular imaging, and these [results] suggest that this number needs to be increased.» Although there are technical reasons, such as diffuse lesions or small vessels, that prevent intravascular imaging from being used in any complex patient, he believes the data are compelling.
This article originally appeared on MDedge.com, part of the Medscape Professional Network.It was translated by Dr. Petra Kittner.
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