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Clinical Outcomes

Risk of angiographic reliance

“For decades, percutaneous coronary intervention (PCI) has largely been guided solely by angiography, despite its well-documented limitations. Angiography offers a two-dimensional view of a three-dimensional structure and does very little to delineate the composition of the coronary artery. Additionally, angiography poorly quantitates the severity and location of calcium, does not provide information about plaque morphology, nor does it provide highly accurate and reproducible lumen sizing. By providing the highest resolution (10-20 μm) images, optical coherence tomography (OCT) promises to change the nature of how patients are treated.”1

OCT Absense of Intravascular Imaging Chart

What clinical data supports intravascular imaging with OCT?

Multiple studies of OCT-guided PCI versus angiography alone suggest that intravascular imaging with OCT is associated with better clinical performance.3

OCT-Guided PCI vs Angiography Studies

STUDY SIZE OUTCOMES
CLI-OPCI I
(EuroIntervention, 2012)
335 pts OCT guided vs 335 pts angio-guided Reduced rate of cardiac death and MACE in patients who underwent OCT-guided intervention.1
ILUMIEN I
(EHJ, 2015)
418 pts OCT imaging influenced physician decision-making pre-PCI in 57% and post-PCI in 27% of all cases.2
ILUMIEN III
(LANCET, 2016)
450 pts (158 OCT, 146 IVUS, 146 ANGIO) OCT-guided PCI resulted in superior stent expansion and procedural success compared to angiography-guided PCI.3
DOCTORS
(CIRC 2016)
240 pts NSTEMI In patients with non–ST-segment elevation acute coronary syndromes, OCT-guided PCI is associated with higher post-procedure FFR than angio-guided PCI.4
PAN-LONDON
(JACC CARD INT, 2018)
1,149 pts OCT, 10,971pts IVUS 75,046 pts angio. OCT-guided PCI was associated with improved procedural outcomes, in-hospital events, and long-term survival compared with standard angiography-guided PCI.5

 

1. CLI-OPCI: DOI: 10.4244/EIJV8I7A125 2. ILUMIEN I European Heart Journal (2015) 36, 3346–3355 doi:10.1093/eurheartj/ehv367 3. ILUMIEN III: Lancet: https://doi.org/10.1016/S0140-6736(16)31922-5 4. DOCTORS: https://doi.org/10.1161/CIRCULATIONAHA.116.024393Circulation. 2016;134:906–917 5. Pan London: JACC Cardiovasc Interv. 2018 Jul 23;11(14):1313-1321. doi: 10.1016/j.jcin.2018.01.274.

Intravascular Imaging vs Angiography Studies

A large body of evidence from randomized trials, observational studies, and meta-analyses demonstrate intravascular imaging guidance is associated with a reduced MACE, MI, ST and CV mortality.4

1. ULTIMATE, ADAPT-DES, IVUS XPL Studies

ULTIMATE5, ADAPT-DES6 and IVUS XPL7 have demonstrated that image-guided PCI compared with angiography-guided reduces the risk of cardiovascular death, TVF and MACE.

optical coherence tomography, ULTIMATE trial demonstrates that targeting optimal stent expansion though imaging improves outcomes

ULTIMATE is a recent randomized controlled clinical trial demonstrating that patient outcomes improve when physicians achieve greater than 90% stent expansion.5 Patients who reached these optimization targets were classified as “optimal PCI” cases and did significantly better than those who did not reach optimized targets.

Optical coherence tomography, ULTIMATE trial demonstrates that targeting optimal stent expansion though imaging improves outcomes

Achieving optimal expansion is proven to reduce rates of adverse cardiac events.8 During PCI, stent underexpansion is an indicator of adverse events, such as stent thrombosis and restenosis.8

stent underexpansion is established as a major predictor of stent failure

2. Meta-Analyses of 20 DES studies (n=29,068)

IVUS-guided stent implantation was associated with better clinical outcomes than angiography-guided DES implantation.9

Outcomes:

DEATH
OR 0.62 (CI: 0.54-0.71), p<0.001
MACE
OR 0.77 (CI: 0.71-0.83), p<0.001
STENT THROMBOSIS
OR 0.59 (CI 0.47-0.73), p<0.001
TVR
OR 0.82 (CI: 0.68-0.98), p=0.03


Abbr: MACE = major adverse cardiac events; OR = odds ratios; CI = confidence intervals
Chart data source: Zhang Y et al. BMC Cardiovasc Dis 2015;15:153

3. Meta-analyses in complex coronary lesions

Meta-analyses of 8 trials (3,276 patients, 1,635 IVUS-guided and 1,641 angiography-guided; with a mean follow-up 1.4 ± 0.5 years.) demonstrates a significant reduction in MACE, TVR, and TLR with IVUS-guided DES implantation in complex coronary lesions.10

OCT Meta Analysis Complex Lesions


Chart data source: Bavishi C and Stone GW. AHJ 2017;185:26-34

References

  1. Reyes, M. The next innovation in PCI is not a stent. The value of OCT. CathLab Digest. Oct 6, 2019. Volume 27, Issue 10.
  2. Bezerra, H. Intravascular OCT in PCI. American College of Cardiology. June 13, 2016.
  3. Prati F., et al. Angiography alone versus angiography plus optical coherence tomography to guide decision-making during percutaneous coronary intervention: the Centro per la Lotta contro l’Infarto-Optimisation of Percutaneous Coronary Intervention (CLI-OPCI) study. EuroIntervention, 2012.
  4. Jones D. A., et al. Angiography Alone Versus Angiography Plus Optical Coherence Tomography to Guide Percutaneous Coronary Intervention: Outcomes From the Pan-London PCI Cohort. JACC Cardiovascular Interventions, 2018 Jul 23;11(14):1313-1321.
  5. Zhang J, et al. Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial. J Am Coll Cardiol. 2018;72(24):3126-3137
  6. Dohi T, et al. Etiology, Frequency, and Clinical Outcomes of Myocardial Infarction After Successful Drug-Eluting Stent Implantation Two-Year Follow-Up From the ADAPT-DES Study Cardiac Catheterization. Circulation: Cardiovascular Interventions. 2015, Vol. 8, No.12.
  7. Hong M et al., IVUS-XPL 5 Year Outcomes, TCT 2019.
  8. Räber L, et al. Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. Eur Heart J. 2018;39(35):3281-3300.
  9. Zhang Y, et al. Comparison of intravascular ultrasound guided versus angiography guided drug eluting stent implantation: a systematic review and meta-analysis. BMC Cardiovascular Disorders, 2015.
  10. Bavishi C, G. Stone, et al. Intravascular ultrasound–guided vs angiography-guided drug-eluting stent implantation in complex coronary lesions: Meta-analysis of randomized trials. AHJ, 2017, Vol. 185, pp.26-34.
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