What Coronary Specialists Teach The Vascular Community About Vessel Prep? Tony Das, MD Texas Health, Dallas Dallas, Texas

What Coronary Specialists Teach The Vascular Community About Vessel Prep? Tony Das, MD Texas Health, Dallas Dallas, Texas

Stent Era Lessons on Vessel Preparation Under expanded stent consequences Abrupt closure Subacute thrombosis Restenosis Vessel expansion Tools IVUS for Coronary Area Vessel Preparation Options PTCA Directional Atherectomy- BOAT and OARS Trials Atherectomy- Rotational and Orbital Bioresorbable Coronary stent preparation

Risk Factors for Morbidity and Mortality in PCI Multivessel CAD Lesion Eccentricity Presence of Calcium in the Lesion Female Gender Lesion Length 10 8 6 4 2 0 % of Patients with Major Complications Mutivessel CAD Single Vessel CAD Eccentric Concentric Calcium No Calcium Female Male Bresdlau CE et al. Circulation. 1985;72:1044-1052.

Stent Expansion Lessons IVUS

Stent Underexpansion Consequences: Thrombosis Minimum Cross Sectional Area by IVUS (MSA) Stent Expansion % Significant Segment Stenosis 90 80 70 60 50 40 30 20 10 0 Risks of Stent Thombosis MSA Stent Expansion Significant Stenosis Thrombosis No Thrombosis Kenichi Fuji et al. JACC April 2005;Volume 45, Issue 7. pp 995-998

Stent Underexpansion Consequences: Restenosis IVUS for assessment of ISR MSA of < 5mm 2 associated with absence of restenosis 80 70 60 50 40 30 20 10 0 Risks of Stent Restenosis MSA >5 MSA <4 MSA,3 Restenosis No Restenosis Kenichi Fuji et al.(mintz/leon) Circulation:2004;109:1085-1088

Vessel Preparation Options Rotational and Laser Atherectomy Pre Stent Rotational Atherectomy- vessel prep Post Stent- Underexpanded stent treatment- Stentblation Post Stent Underexpanded- Contrast assisted Laser Ablation Lori Vales et al. Int J. Angio. 2013 Mar; 22(1): 63 68 Ashikaga, et al. Cath Cardiov Interv 2015 Nov;86(5):946-9.

Vessel Preparation Options Directional Atherectomy Developed in 1984 1020 Procedures studied Goal <20% residual stenosis Bigger is Better 100 80 60 40 20 0 CAVEAT Trial Results Crossover Success Immediate Gain MI Composite Restenosis Atherectomy Balloon Topol et al. NEJM 1993; 329;221-227 CAVEAT Trial Comparison of Directional Atherectomy with Coronary Angioplasty in Patients with CAD

Lesion Calcification Impact on DES Implantation in Real-World Patients Severe calcium makes stent expansion difficult and can contribute to higher MACE and mortality rates in complex PCI patients Optimal stent expansion may decrease rates 16 14 12 10 8 6 4 2 May reduce length of stay and complications 0 % Restenosis TLR Stent Thrombosis MACE Calcified Non-Calcified Kawaguchi R, Tsurugaya H, Hoshizaki H, et al. Impact of lesion calcification on clinical and angiographic outcome after sirolimus-eluting stent implantation in real-world patients. Cardiovasc Revasc Med. 2008;9:2-8.

ORBIT II Clinical Data 443 Patients Severely Calcified Cor. Lesions Primary Safety Endpoint: Freedom from 30d MACE 89.6% with performance goal of 82% Primary Efficacy Endpoint (<50% residual and w/o MACE in hospital) 88.9% compared to performance goal of 82% Stent Delivery Success 97.7% 1 yr TLR of 4.7% Chambers JW et. Al. JACC Cardiovasc Interv.2014 May; 7(5);510-8

Compliance 360º Study Design 10 0 Prospective, multi-center Randomized (1:1) Calcified ATK lesions Mean Max Balloon Pressure 4.0+1.3 OAS *p < 0.0001 9.1+3.5 PTA 100 0 % Lesions Requiring Bail-Out 5,3 77.8 OAS PTA *p < 0.0001 OAS + POBA N=25 N=50 POBA N=25 The Lowest Balloon Inflation Pressure Used to Achieve Desired Outcome = Compliance Change

ABSORB Biodegradable Stents vs. DES with OCT Guidance Figure 1. Qualitative and Quantitative Assessment of OCT Characteristics A. An example of incomplete strut apposition (ISA). There are 4 malapposed struts between 10 and 12 o'clock position in A1 B. Tissue prolapse. In the presence of tissue prolapse, defined as tissue protruding between the struts, the prolapse area was measured as the difference between the stent and lumen area (highlighted in green in B2). C. An example of edge dissection (arrow) distal to the BVS. D. A BVS strut fracture. Mettesini A. et al. JACC: CV interv. Volume 7, Issue 7, July 2014. P. 741-50

Three Year Outcomes with Absorb Bioresorbable Scaffold (Individual-Patient-Data Meta-Analysis from the ABSORB trial) 14 12 10 8 6 4 2 0 Target Lesion Failure Target Vessel MI Ischemia driven TLR Cardiac Mortality BVS Everolimus DES Ali ZA, Stone G. et. al. Circulation 2017;136:

Conclusions Coronary Vessel Preparation may have implications on acute procedural and post procedural outcomes Coronary Calcification portends worse outcomes Poor Stent expansion is directly related to increased rates of thrombosis and restenosis Unclear correlation between coronary vessel preparation and peripheral arterial vessel preparation Proponents of Vessel Prep site DEFINITIVE AR and look towards REALITY and DEB trials

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What Coronary Specialists Teach The Vascular Community About Vessel Prep? Tony Das, MD Texas Health, Dallas Dallas, Texas