LongTerm Clinical Outcomes with Use of Intravascular Ultrasound

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Long-Term Clinical Outcomes with Use of Intravascular Ultrasound for the Treatment of Coronary Ostial

Long-Term Clinical Outcomes with Use of Intravascular Ultrasound for the Treatment of Coronary Ostial Lesions Jay S. Patel MD, Jeremiah P. Depta MD, Yogesh Patel MD, Shriti K. Masrani MD, Eric Novak MS, Alan Zajarias MD, Howard I. Kurz MD, John M. Lasala MD Ph. D, Richard G. Bach MD, Jasvindar Singh MD

Jayendrakumar S. Patel, MD I/we have no real or apparent conflicts of interest to

Jayendrakumar S. Patel, MD I/we have no real or apparent conflicts of interest to report.

Ostial Lesions are Technically Challenging Operational definition: Within 3 mm of the origin of

Ostial Lesions are Technically Challenging Operational definition: Within 3 mm of the origin of the left main, RCA, or major coronary vessel. Higher rate of adverse events • MACE (combined death, MI, target vessel revascularization) • Target lesion revascularization

Benefits of Lesion Assessment with IVUS can help optimize PCI for coronary ostial lesions

Benefits of Lesion Assessment with IVUS can help optimize PCI for coronary ostial lesions Pre-intervention • Characterize plaque morphology, including degree of calcification • Determine vessel size & lesion length to maximize stent dimensions • Mark the true ostium for precise stent placement

Benefits of Lesion Assessment with IVUS Post-intervention • Determine if stent is adequately sized

Benefits of Lesion Assessment with IVUS Post-intervention • Determine if stent is adequately sized & well expanded • Assess lesion coverage • Identify complications potentially missed by angiography To date, outcomes with use of IVUS guided PCI for ostial coronary lesions are unknown

Is the use of IVUS during PCI of coronary ostial lesions associated with improved

Is the use of IVUS during PCI of coronary ostial lesions associated with improved clinical outcomes?

PCI Performed between 7/02 -8/10: n = 9, 122 patients De novo aorto-ostial or

PCI Performed between 7/02 -8/10: n = 9, 122 patients De novo aorto-ostial or major coronary vessel** lesions: n = 274 patients Final Cohort: n = 225 patients, 233 lesions IVUS: 82 patients, 84 lesions No IVUS: 143 patients, 149 lesions Retrospective observational single center study Excluded: n = 49 patients 1. Branch ostial lesions: IVUS (n = 8) and no IVUS (n = 31) 2. Lost to follow-up: IVUS (n = 7) and no IVUS (n = 3) **Major coronary vessel definition 1. Left anterior descending 2. Left circumflex 3. Ramus intermedius

Outcomes Patients were grouped according to IVUS [pre and/or postintervention] vs. no IVUS Patients

Outcomes Patients were grouped according to IVUS [pre and/or postintervention] vs. no IVUS Patients were followed from the date of index stenting through 7/7/2012 (mean f/u of 4. 2 ± 2. 5 years) Primary Outcome: Composite of cardiovascular death, MI, TLR Secondary Outcomes: • Composite of MI and TLR • Cardiovascular death • MI • TLR (lesion level) • Periprocedural MI • Stent thrombosis (lesion level) Academic Research Consortium Guidelines: Circulation 2007; 115: 2344 -2351

Statistical Methods Propensity Score Adjusted Analysis Propensity scores were used as an adjustment factor

Statistical Methods Propensity Score Adjusted Analysis Propensity scores were used as an adjustment factor in Cox Proportional Hazard modeling for each outcome. Built on the following variables: • Age • Male • Diabetes mellitus • HTN • Hyperlipidemia • Smoker • Prior PCI • Prior CABG • PAD • CKD • Heart failure • STEMI • NSTEMI • USA • Stable angina • Asymptomatic/atypical chest pain • Clopidogrel • Beta blocker • ACE inhibitor / ARB • Statin • # of stents • Stent length • Stent diameter • Stent type (DES v. BMS)

Variable IVUS (n= 82) No IVUS (n=143) p-value 65. 4 ± 13. 9 67.

Variable IVUS (n= 82) No IVUS (n=143) p-value 65. 4 ± 13. 9 67. 5 ± 11. 8 0. 23 46 (56%) 82 (57%) 0. 89 Diabetes 31 (38%) 47 (33%) 0. 47 Hypertension 72 (88%) 126 (88%) 1. 00 Hyperlipidemia 65 (79%) 116 (81%) 0. 74 Smoker 41 (50%) 75 (52%) 0. 78 PCI 30 (37%) 57 (40%) 0. 67 CABG 23 (28%) 43 (30%) 0. 88 PAD 23 (28%) 25 (17%) 0. 09 CKD 17 (21%) 20 (14%) 0. 20 CHF 32 (39%) 41 (58%) 0. 89 Age (years) Male Medical History

Clinical Presentation Diagnosis at PCI No IVUS (n=143) 9 (6%) p-value STEMI IVUS (n=

Clinical Presentation Diagnosis at PCI No IVUS (n=143) 9 (6%) p-value STEMI IVUS (n= 82) 9 (11%) NSTEMI 25 (30%) 34 (24%) 0. 28 Unstable angina 28 (34%) 76 (53%) 0. 008 Stable angina 16 (20%) 19 (13%) 0. 25 4 (5%) 5 (3%) 0. 73 Asymptomatic or atypical chest pain 0. 31 The majority of patients (80%) presented with acute coronary syndrome (ACS).

Discharge Medications Aspirin Clopidogrel IVUS (n= 82) 82 (100%) 81 (99%) No IVUS (n=143)

Discharge Medications Aspirin Clopidogrel IVUS (n= 82) 82 (100%) 81 (99%) No IVUS (n=143) 143 (100%) 141 (99%) p-value Coumadin 13 (16%) 19 (13%) 0. 69 Beta blocker Calcium channel blocker ACE/ARB 67 (82%) 26 (32%) 122 (85%) 43 (30%) 0. 57 0. 88 54 (66%) 94 (66%) 1. 00 Statin 77 (94%) 134 (94%) 1. 00

Ostial Lesion Characteristics Lesion Location IVUS (n= 84) No IVUS (n=149) p-value Aorto-ostial 38

Ostial Lesion Characteristics Lesion Location IVUS (n= 84) No IVUS (n=149) p-value Aorto-ostial 38 (45%) 71 (48%) 0. 72 Left main 10 (12%) 13 (9%) 0. 49 Right coronary 28 (33%) 58 (39%) 0. 48 Major coronary vessel 46 (55%) 78 (52%) 0. 72 Left anterior descending 27 (32%) 45 (30%) 0. 77 Left circumflex 15 (18%) 26 (17%) 1. 00 4 (5%) 7 (5%) 1. 00 Ramus intermedius

Intervention Characteristics Variable IVUS (n= 84) No IVUS (n=149) p-value Mean # stents 1.

Intervention Characteristics Variable IVUS (n= 84) No IVUS (n=149) p-value Mean # stents 1. 2 ± 0. 5 1. 2 ± 0. 7 0. 98 1 (1%) 4 (3%) 0. 66 Bare-metal stent(s) 16 (19%) 28 (19%) 1. 00 Drug-eluting stent(s) 67 (80%) 117 (79%) 0. 87 Mean stent length (mm) 13. 0 ± 5. 6 12. 9 ± 5. 8 0. 78 Mean stent diameter (mm) 3. 3 ± 0. 5 3. 2 ± 0. 5 0. 23 Rotational atherectomy 23 (27%) 46 (31%) 0. 65 Angioplasty only

How was IVUS Used? Strategy Aorto-ostial (n= 38) Major coronary (n=46) p-value (for lesion

How was IVUS Used? Strategy Aorto-ostial (n= 38) Major coronary (n=46) p-value (for lesion type) Used pre-stenting to mark ostium & size vessel 24 (63%) 27 (59%) 0. 82 Used post-stenting 34 (89%) 46 (100%) 0. 04 Used pre- & poststenting 20 (53%) 27 (59%) 0. 66

Post-stenting IVUS Findings Total (n = 80) Aorto-ostial (n= 38) Major coronary (n=46) p-value

Post-stenting IVUS Findings Total (n = 80) Aorto-ostial (n= 38) Major coronary (n=46) p-value Well apposed stent/no complications/complete lesion coverage 35 (44%) 12 (35%) 23 (50%) 0. 25 Complete ostial lesion coverage 72 (90%) 29 (85%) 43 (93%) 0. 27 Abnormalities requiring additional intervention 45 (56%) 22 (65%) 23 (50%) 0. 25 Edge dissection 4 (5%) 2 (6%) 2 (4%) 1. 00 Plaque shift 3 (4%) 2 (6%) 1 (2%) 0. 57 32 (40%) 16 (47%) 16 (35%) 0. 36 Stent malapposition 2 (3%) 0 (0%) 2 (4%) 0. 51 Incomplete ostial coverage 8 (10%) 5 (15%) 3 (7%) 0. 27 Stent underexpansion

85 y/o Female with Unstable Angina

85 y/o Female with Unstable Angina

85 y/o F - Ostial RCA IVUS

85 y/o F - Ostial RCA IVUS

IVUS-Guided Marking & Stenting of Ostium

IVUS-Guided Marking & Stenting of Ostium

Post-stenting IVUS

Post-stenting IVUS

Clinical Outcomes – Univariate Analysis Variable No IVUS (n=149) 55 (38%) p-value CV death,

Clinical Outcomes – Univariate Analysis Variable No IVUS (n=149) 55 (38%) p-value CV death, MI, TLR IVUS (n= 84) 16 (19%) MI or TLR 10 (12%) 48 (33%) <0. 001 CV death MI Stent thrombosis 7 (9%) 6 (7%) 0 (0%) 12 (8%) 26 (18%) 1 (<1%) 1. 00 0. 03 1. 00 Periprocedural MI 2 (2%) 7 (5%) 0. 49 TLR 6 (7%) 37 (25%) 0. 002 0. 004 Subset analysis of IVUS group: A lower rate of MI was seen in lesions that underwent both pre- and post-stenting IVUS compared with the use of only pre- or post-stenting IVUS (2% v. 14%, p = 0. 08).

Rate of TLR by Vessel Type – Univariate Analysis Lesion Location IVUS (n= 84)

Rate of TLR by Vessel Type – Univariate Analysis Lesion Location IVUS (n= 84) No IVUS (n=149) p-value Aorto-ostial 2/38 (5%) 14/71 (20%) 0. 05 Left main 0/10 (0%) 0/13 (0%) - Right coronary 2/28 (7%) 14/58 (24%) 0. 08 Major coronary vessels 4/46 (9%) 23/78 (29%) 0. 007 Left anterior descending 3/27 (11%) 14/45 (31%) 0. 08 Left circumflex 1/15 (7%) 7/26 (27%) 0. 22 Ramus intermedius 0/4 (0%) 2/7 (29%) 0. 49

Cox Proportional Hazard Model Clinical Outcome Unadjusted Propensity Score Adjusted HR (95% CI) p-value

Cox Proportional Hazard Model Clinical Outcome Unadjusted Propensity Score Adjusted HR (95% CI) p-value CV death, MI, TLR 0. 60 (0. 34 -1. 05) 0. 07 0. 54 (0. 29 -0. 99) 0. 04 MI or TLR 0. 44 (0. 22 -0. 88) 0. 02 0. 39 (0. 18 -0. 83) 0. 01 CV death 1. 41 (0. 53 -3. 75) 0. 49 1. 11 (0. 37 -3. 32) 0. 86 MI 0. 48 (0. 20 -1. 18) 0. 11 0. 31 (0. 11 -0. 85) 0. 02 TLR 0. 36 (0. 15 -0. 95) 0. 02 0. 42 (0. 17 -1. 02) 0. 06 No differences were observed between aorto-ostial and major coronary vessel lesions in any of the clinical outcomes. No statistically significant interactions for IVUS and ostial lesion type were observed in any of the clinical outcomes.

Limitations • Retrospective, observational • Selection bias: IVUS v. No-IVUS groups • Unmeasured confounders

Limitations • Retrospective, observational • Selection bias: IVUS v. No-IVUS groups • Unmeasured confounders not accounted for in propensity score adjusted analysis • Quantitative coronary angiography not performed

Conclusions • IVUS guided PCI of coronary ostial lesions is associated with improved clinical

Conclusions • IVUS guided PCI of coronary ostial lesions is associated with improved clinical outcomes: • Lower rates of MI and TLR • Possibly mediated by correcting stent underexpansion, geographical miss, & other findings not visualized by angiography • Prospective investigation is warranted to fully evaluate the role of IVUS guidance in improving long term outcomes.

Acknowledgements Division of Cardiovascular Medicine Richard G Bach MD Jeremiah P Depta MD John

Acknowledgements Division of Cardiovascular Medicine Richard G Bach MD Jeremiah P Depta MD John Lasala MD Ph. D Shriti K Masrani MD Eric Novak MS Yogesh Patel MD Jasvindar Singh MD Alan Zajarias MD Division of Medical Education Hemant Godara MD Mike Nassif MD Nidhi Patel