CRT 23: IVUS vs QCA-Guided PCI for Coronary Artery Stenosis: The OPTIMAL Trial

Aug 18, 2023

CRT 23: IVUS vs QCA-Guided PCI for Coronary Artery Stenosis: The OPTIMAL Trial

In this short interview, we are joined by Dr Jose De La Torre Hernandez (Hospital Universitario Marques de Valdecilla, ES) to provide an update on the OPTIMAL Randomized Controlled Trial, sponsored by the European Cardiovascular Institute. In this ongoing study, 800 patients will be randomized to receive either intravascular ultrasound-guided percutaneous coronary intervention (PCI) or qualitative angiography-guided PCI for the treatment of left main coronary stenosis.

Questions:
1. What was the rationale behind this study?
2. What was the patient population, current enrollment status and study design?
3. What is the potential impact of the results of this trial?
5. What are the next steps for OPTIMAL?

Recorded remotely from Santander, 2023.

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Content

0.54 -> Hello, my name is Jose De La Torre Hernandez.

4.653 -> I am the responsible chief

6.24 -> of the Internal and Cardiology Department

8.64 -> in the Hospital Universitario Marque de Valdecilla

10.617 -> in Santander in Spain.

12.627 -> (bouncy music)

16.08 -> The rationale for the OPTIMAL trial is very clear

18.75 -> because the LM PCI is a procedure

20.643 -> that is becoming very common

22.8 -> after trials demonstrating that it's equivalent to CABG

26.58 -> in terms of long-term outcomes,

30.06 -> that LM PCI should be done with head quality,

33 -> given the relevance of the location of this disease.

36.3 -> Then there is a possibility

37.44 -> of using only angiography for the guidance

39.5 -> of the procedure or relying on intravascular imaging,

43.29 -> particularly intravascular ultrasound imaging.

46.11 -> There are registries,

47.16 -> mostly registries and very small trials,

49.56 -> only two very small trials, comparing angio guidance

53.13 -> versus IVUS guidance

54.51 -> and all of them consistently suggest a benefit

57.27 -> in favour of IVUS guidance

59.28 -> in terms of cardiac death, MI, thrombosis, et cetera.

63.96 -> But there is not really,

66.3 -> is lacking definitely a relevant trial, properly sized,

69.87 -> well designed, and that is the reason why we are running

72.45 -> with the OPTIMAL trial.

73.95 -> This is a randomised trial with a target

76.86 -> of 800 patients to be randomised

78.84 -> to IVUS guidance versus angio-guidance

81.48 -> and these patients are over 18 years old.

85.41 -> They have left main disease

87.66 -> with indication for revascularization based on ischemia

91.65 -> or even in basic examination with, for example,

96.324 -> pressure wire

97.69 -> and the PCI procedure is considered appropriate

100.8 -> by the heart team positioned in the institution.

103.62 -> Then these patients that have a clear and well-established

106.29 -> indication for LM PCI are those that we can randomise

110.79 -> for the OPTIMAL trial.

112.05 -> Of course, we have a set of different exclusion criteria.

115.26 -> We cannot randomise patients with non ST-segment MI

118.924 -> at the moment of the procedure

121.56 -> or patients with previous CABG

124.26 -> and other criteria like low expectancy of life

127.14 -> that are common to these studies.

129.87 -> We have three countries involved:

132.18 -> UK, Italy, and Spain, nearly 30 institutions

137.1 -> and we are now, this is the criteria

140.144 -> and with the flow chart, the procedure

145.044 -> is just to schedule

147.36 -> the PCI and to follow after the randomization

150.757 -> the angio guidance or the IVUS guidance.

153.15 -> In case of angiography guidance,

154.95 -> you just do the procedure up to your criteria,

157.68 -> and in case of IVUS, it's necessary that you perform

161.79 -> at least it is mandatory, absolutely mandatory,

164.28 -> a final IVUS of the stenting of the left main.

168.06 -> If only one stent you can do is mandatory,

170.667 -> the IVUS examination of the one single stent,

174.12 -> in case of two stents, is mandatory.

176.1 -> The IVUS running through the two of the stents implanted

180.09 -> and we have established optimization criteria.

183.3 -> Several targets that you have to meet

185.91 -> in order to consider, there is an optimization

188.4 -> of the procedure based on.

190.8 -> The potential impact is really huge

193.41 -> because nowadays the recommendation of IVUS guidance

196.62 -> for an LM PCI is as class 2, 2A,

200.4 -> which is in favour of the usage

201.72 -> but is not definitely encouraging the operators

205.59 -> to apply and, in fact,

207.78 -> worldwide, the penetration, the use

209.91 -> of IVUS guidance for this procedures

211.41 -> is not really very high.

213.48 -> Maybe in nation countries it's high,

215.4 -> it's maybe 80%, but in western countries,

217.71 -> in European Union or in United States,

220.828 -> this penetration is between 20 and 40%

223.827 -> and it's because all over the world, people, the operators,

228.27 -> cardiologists, considered there is not enough evidence.

231.137 -> Then the impact is that in case of positive results,

234.75 -> the recommendation could be upgraded

236.22 -> to class 1 and the practical,

238.65 -> the use in real practice of IVUS-guidance in LM PCI

241.98 -> will increase definitely, which is a great benefit

244.83 -> for our patients.

246.18 -> Of course, OPTIMAL, we are close to finish enrollment

249.9 -> because we have nearly, not definitely,

253.35 -> but nearly 700 patients included,

255 -> we have to reach the the 800 target

257.79 -> and we expect to do so in June, July.

260.79 -> Then we have two years of follow-up

264 -> because the primary outcome is established for two years,

267.3 -> but at the same time that we are going, waiting for this,

270.54 -> we are going to do a strict follow-up

272.16 -> with adequate adjudication of the different outcomes

276.03 -> of different events by properly designed committees.

279.27 -> We also plan to perform some analysis,

282.24 -> of analysis that are going to address aspects.

284.55 -> For example, what are the best criteria for optimization?

287.49 -> Whether there is a prognostic way

288.756 -> that the different criteria

289.62 -> we have used?

291.12 -> The differential effects, of IVUS guidance

292.62 -> according to the lesion location in the main distal

294.84 -> ostial and IVUS derived outcome.

297.84 -> Then the next steps is finishing enrollment in June,

302.64 -> we study in June, maybe July.

304.23 -> Then two years follow-up, good follow-up, strict follow-up

307.71 -> without losing patients and then prepare the main manuscript

311.73 -> and also work on different sub-analyses.

315.48 -> I think that OPTIMAL is going to be

317.46 -> an important landmark trial,

319.02 -> building really the evidence for the use of imaging guidance

323.512 -> in complex PCI.

325.38 -> In this case, it's for left main,

327.81 -> there are other trials, like, for example,

329.82 -> like achievement that are addressing the same issue

332.741 -> but for other complex lesions like calcified lesions,

335.73 -> osteo lesions, other bifurcations, CTOs, et cetera,

339.93 -> then it's an important trial that is part

343.71 -> of a building that is intended to support

347.76 -> and to give strong evidence for intravascular imaging

350.4 -> guidance of PCI, particularly in complex settings.

Source: https://www.youtube.com/watch?v=TMp1L17LTes