Intravascular ultrasound IVUS in percutaneous coronary intervention summary

Intravascular ultrasound (IVUS) in percutaneous coronary intervention – summary of key articles Prepared by Radcliffe Cardiology 21 November 2016

Abbreviations CABG: coronary artery bypass grafting CAD: coronary artery disease FFR: fractional flow reserve ISR: in-stent restenosis IVUS: intravascular ultrasound LAD: left anterior descending artery LCX: left circumflex artery LM: left main coronary artery MACE: major adverse cardiac events MLA: minimal lumen area MSA: minimum stent area MLD: minimal lumen diameter PCI: percutaneous coronary intervention POC: polygon of confluence 2

Clinical impact of intravascular ultrasound guidance in drug-eluting stent implantation for unprotected left main coronary disease: pooled analysis at the patient-level of 4 registries de la Torre Hernandez JM, Baz Alonso JA, Gomez Hospital JA, et al. , JACC Cardiovasc Interv, 2014; 7: 244 -54 3

Clinical impact of IVUS guidance in DES implantation for unprotected LM CAD de la Torre Hernandez et al, 2014 Background: Limited evidence for clinical benefit for IVUS guidance in LM disease Methods: • Analysis of 4 large Spanish registries, n=1670 • 505 pts who had DES implantation with IVUS guidance propensity scorematched with 505 patients who received DES without IVUS guidance 4

Clinical impact of IVUS guidance in DES implantation for unprotected LM CAD de la Torre Hernandez et al, 2014 Results: At 3 year follow-up survival free of cardiac death, MI, and TLR: 88. 7% vs 83. 6%; p = 0. 04 for IVUS vs overall population In subgroups with distal LM lesions, endpoint achieved in 90% vs 80. 7%, p=0. 03 Definite and probable stent thrombosis 0. 6% vs 2. 2%, p=0. 4 5

Clinical impact of IVUS guidance in DES implantation for unprotected LM CAD de la Torre Hernandez et al, 2014 6

Clinical impact of IVUS guidance in DES implantation for unprotected LM CAD de la Torre Hernandez et al, 2014 Conclusions: IVUS guidance during PCI is associated with better outcomes in patients with LM disease undergoing revascularization with DES 7

Intravascular ultrasound guidance to minimize the use of iodine contrast in percutaneous coronary intervention: the MOZART (Minimizing c. Ontrast utili. Zation With IVUS Guidance in co. Ronary angioplas. Ty) randomized controlled trial. Mariani, J. Jr, Guedes, C. , Soares, P. , et al. , JACC Cardiovasc Interv, 2014; 7: 1287– 93 8

MOZART Study, Mariani et al, 2014 Background: • Angiography uses iodine contrast agent which is associated with complications (acute kidney injury, volume overload i. e. excess fluid in blood • The use of IVUS may allow reduce usage of contrast 9

MOZART Study, Mariani et al, 2014 Methods: • 83 patients undergoing PCI randomly assigned to angiographic or IVUS guidance and all were treated by a pre-defined strategy • Most had diabetes and many had long, calcified, bifurcated, and complex lesions • Average follow up 4 months 10

MOZART Study, Mariani et al, 2014 Results: • IVUS group used 3 x less contrast dose compared with angiography dose (64. 5 ml vs 20. 0 ml) • Contrast volume/creatinine clearance ratio (measure of renal function) was lower in IVUS group • Procedure on average 14 minutes longer with IVUS compared with angiography (p = 0. 006) • No difference in clinical outcomes between two groups both in hospital and at 4 months 11

MOZART Study, Mariani et al, 2014 Volume of contrast agent used in IVUS and angiography-guided PCI 12

MOZART Study, Mariani et al, 2014 Conclusions: • The use of IVUS was associated with reduced contract use • IVUS imaging should be considered for patients at high risk for contrastinduced acute kidney injury or volume overload undergoing coronary angioplasty 13

Outcomes With Intravascular Ultrasound. Guided Stent Implantation A Meta-Analysis of Randomized Trials in the Era of Drug-Eluting Stents Elgendy, I. Y. , Mahmood, A. N. , Elgendy A. Y. , et al. Circ Cardiovasc Interv. 2016; e 003700. 14

Meta-analysis, IVUS outcomes with DES, Elgendy et al 2016 Background: • When BMS were routinely used, a meta-analysis concluded that IVUSguided stent implantation reduced MACE and target lesion revascularization • In the era of DES, does the use of IVUS still add value? 15

Meta-analysis, IVUS outcomes with DES, Elgendy et al 2016 Methods: • Searched for randomized studies between 2005 and February 2016 • Patients undergoing implantation of a DES randomized to either IVUS-guided or angiography-guided procedures. • Various outcome measures but all included MACE 16

Meta-analysis, IVUS outcomes with DES, Elgendy et al 2016 Results: • 7 RCTs including 3192 patients • Mean follow-up 15 months Post-procedure outcomes • Baseline diameter stenosis and MLD were similar in both groups (latter slightly higher with IVUS) • Postdilation more common in IVUS group (63% vs 48%, P<0. 0001) 17

Meta-analysis, IVUS outcomes with DES, Elgendy et al 2016 Results (continued) Compared with angiography, IVUS guidance is associated with: • 40% lower risk of MACE • 40% lower risk of target lesion revascularization • 54% lower risk of cardiovascular death • 51% lower risk of stent thrombosis • 48% lower risk of myocardial infarction* *not statistically significant 18

Meta-analysis, IVUS outcomes with DES, Elgendy et al 2016 Rate of MACE at mean 15 months follow up 19

Meta-analysis, IVUS outcomes with DES, Elgendy et al 2016 Conclusions IVUS-guided PCI is superior to angiography-guided PCI in reducing the risk of major adverse cardiac events, as well as reducing the risk of target lesion revascularization. 20

Effect of Intravascular Ultrasound-Guided vs Angiography-Guided Everolimus-Eluting Stent Implantation: The IVUS-XPL Randomized Clinical Trial Hong SJ, Kim BK, Shin DH, et al JAMA 2015; 314: 2155 -63 21

IVUS-XPL trial, Hong et al, 2015 Background • Limited clinical trial data to support the use of IVUS-guided drug eluting stent (DES) implantation. • Earlier studies used 1 st generation DES but 2 nd generation exclusively used now. 22

IVUS-XPL trial, Hong et al, 2015 Methods • n=1, 400 • Muliticentre Korean trial • Randomized 1: 1 to receive either IVUS-guided or angiographic-guided everolimus-eluting stent implantation 23

IVUS-XPL trial, Hong et al, 2015 Results • At 1 year, IVUS group had a 48% reduced risk of MACE compared with the angiography group (2. 9% vs 5. 8%, p = 0. 007) • Patients who did not meet IVUS criteria for optimum stent deployment had a significantly higher incidence of MACE compared with those who met IVUS criteria (4. 6% vs 1. 5%, p = 0. 020) • No statistically significant differences in cardiac death, target lesion–related MI, or stent thrombosis 24

IVUS-XPL trial, Hong et al, 2015 Incidence of MACE at 1 year follow up 25

IVUS-XPL trial, Hong et al, 2015 Conclusions • The use of IVUS-guided everolimus-eluting stent implantation, compared with angiography-guided stent implantation, resulted in a significantly lower rate of MACE at 1 year 26