Periprocedural Myocardial Infarction and Clinical Outcome In Bifurcation Lesion Hyeon-Cheol Gwon Cardiac and Vascular Center Samsung Medical Center Sungkyunkwan University School of Medicine
Dr. Hyeon-Cheol Gwon Research fund from Abbott Korea Boston Scientific Korea Medtronic Korea
Peri-procedural MI (PMI) Incidence About 5~30% Mechanisms Epicardial side-branch occlusion Compromise of the microvascular circulation No reflow Distal embolization
Definition of Peri-procedural MI in ARC Recommendation * By arbitrary convention, CK-MB or Troponin > 3 times URL * No solid scientific basis for defining a biomarker threshold * URL = upper reference level Cutlip DE, Circulation 2007
Many Studies Have Been Published Since 1994
Increased Mortality Dose-Dependently Meta-analysis for CK-MB (N=23,230) The risk of mortality from meta-analysis for CK-MB CK-MB > 1~3 URL HR=1.5 (1.2-1.8) CK-MB > 3-5 URL HR=1.8 (1.4-2.4) CK-MB > 5 URL HR=3.1 (2.3-4.2) * URL = upper reference level Ioannidis JPA, JACC 2003
Prognostic Value of PMI Meta-analysis for Troponin (N=15,581) Death for increased troponin Death or MI for increased troponin Nienhuis MB, CCI 2008 * PMI = peri-procedural MI
PMI as a Clinical Endpoint ARMYDA-ACS High dose statin before PCI BBC-One 1-stent vs. 2-stent in bifurcation lesion 1) Hildick-Smith D, BBC-ONE, Circulation 2010 2) Patti G, ARMYDA-ACS, JACC 2007 * PMI = peri-procedural MI
Argument Peri-procedural MI is not as prognostic as spontaneous MI * N=7,773 patients with NSTE-ACS from ACUITY Study Prasad A, JACC 2009 Hazard ratio for subsequent mortality Spontaneous MI: 7.5 (5.0-11.3, p=0.0001) Periprocedural MI: 1.3 (0.9-2.0, p=0.22) No information of level of enzyme elevation or infarct size
Case 1: Periprocedural MI M/68, exertional chest pain for 3 months Baseline CAG Stenting 3.0X18 mm Kissing ballooning Final CAG
Case 2: Spontaneous MI F/51, resting chest pain Baseline CAG Stenting 3.0X18 mm Final CAG
Same Infarct Size, Different Prognosis? Case 1: Periprocedural MI Case 2: Spontaneous MI MI volume: 14.4ml MI volume percentage: 13% MI volume: 12.8 ml MI volume percentage: 13%
Argument The adverse effect of PMI is not the result of myocardial injury, but the reflection of risk factors. Risk fa ctors PMI Clinica l event Not an independent predictor * PMI = peri-procedural MI
PMI in Risk Factor Subgroups The confounding effect of baseline risk factors cannot be fully controlled by any means. If we can analyze the data in each risk factor subgroup, we can reduce the confounding influence of risk factors on clinical event. Risk factors of PMI Hermann J. Peri-procedural myocardial injury: 2005 update, Eur Heart J 2005
Objective The aim of this study was to evaluate the prognosis of peri-procedural myocardial infarction (PMI) in rather homogenous clinical and lesion subset No myocardial infarction Coronary bifurcation lesion treated with drugeluting stent
Methods v From the COBIS (COronary BIfurcation Stenting) registry Inclusion criteria Ø Ø Coronary bifurcation lesions treated solely with at least 1 drug eluting stent Main vessel diameter 2.5 mm and side branch diameter 2.0 mm Exclusion criteria Ø Ø Ø Ø Ø Cardiogenic shock ST-segment elevation acute MI within 48 hours Left main coronary artery bifurcation lesion Myocardial infarction with or without ST elevation (N=229) CK-MB level not available (N=181) * Definition of PMI: peak CK-MB value > 3 times URL
Clinical Characteristics PMI (+) in 10.0% in 1188 patients PMI (+) (n = 119) PMI (-) (n = 1069) p-value Age (years) 65 ± 11 62 ± 10 0.005 Female 48 (40.3) 370 (34.6) 0.22 Diabetes mellitus 26 (21.8) 322 (30.1) 0.06 Smoking 33 (27.7) 240 (22.5) 0.19 Dyslipidemia 42 (35.3) 318 (29.7) 0.21 S-creatinine > 2.0 mg/dl 6 (5.0) 35 (3.3) 0.32 Unstable angina at presentation 70 (58.8) 514 (48.1) 0.033 Left ventricular ejection fraction (%) * 58 ± 11 61 ± 11 0.015 * PMI = peri-procedural myocardial infarction
Angiographic Characteristics PMI (+) PMI (-) p-value (n = 119) (n = 1069) LAD location 82 (68.9) 843 (78.9) 0.013 Multi-vessel disease 73 (61.9) 480 (44.9) < 0.001 Thrombus in main vessel 6 (5.0) 30 (2.8) 0.18 Bifurcation (by Medina classification) 0.89 0,0,1 0,1,0 0,1,1 1,0,0 1,0,1 1,1,0 1,1,1 3 (2.5) 13 (10.9) 15 (12.6) 3 (2.5) 8 (6.7) 13 (10.9) 64 (53.8) 15 (1.4) 108 (10.1) 141 (13.2) 66 (6.2) 64 (6.0) 117 (11.0) 557 (52.2) True bifurcation 87 (73.1) 762 (71.3) 0.69 * PMI = peri-procedural myocardial infarction
Procedural characteristics PMI (+) PMI (-) (n=119) (n=1069) p-value GP IIb/IIIa 5 (4.2) 31 (2.9) 0.43 Paclitaxel-eluting stent in main vessel 39 (33.1) 324 (30.8) 0.62 2-stent technique 26 (21.8) 207 (19.4) 0.52 Multi-lesion PCI 42 (39.6) 255 (27.0) 0.006 Stent total length in main vessel > 30 mm 62 (52.1) 457 (43.4) 0.07 Post-TIMI in main vessel < 3 3 (2.5) 3 (0.3) 0.016 Post-TIMI in side branch < 3 18 (15.1) 48 (4.5) < 0.001 Acute closure in main vessel 2 (1.7) 5 (0.5) 0.15 Acute closure in side branch 18 (15.1) 42 (3.9) < 0.001 Procedural success in main vessel 119 (97.5) 1058 (99.0) 0.16 Procedural success in side branch 69 (58.0) 745 (69.7) 0.009
Independent Risk Factors of PMI Adjusted HR 95% CI p Value Age 65 years 1.49 0.91-2.45 0.11 Unstable angina at presentation 1.37 0.83-2.25 0.22 LV EF < 50% 2.08 1.13-3.82 0.018 Multi-vessel disease 2.28 1.36-3.81 0.002 Location in LAD/diagonal 0.85 0.48-1.49 0.57 PCI-related acute closure in SB 3.34 1.23-9.02 0.018 Post-PCI TIMI <3 in main vessel 3.35 0.17-66.54 0.43 Post-PCI TIMI <3 in side branch 2.00 0.67-5.98 0.22 Final MLD in side branch 1.00 0.64-1.57 0.99 HR : hazard ratio, CI : confidence interval, LAD : left anterior descending coronary artery, TIMI : thro mbolysis in myocardial infarction, MLD : minimal luminal diameter
Clinical Outcomes (Median FU 22.7 months) PMI (+) (n = 119) PMI (-) (n = 1069) p Value Cardiac death 2.5 % 0.7 % 0.07 MI 0.8 % 1.1 % > 0.99 Cardiac death, or MI 3.4% 1.8% 0.28 Target lesion revascularization 3.4 % 5.0 % 0.65 Cerebrovascular accident 0.0 % 1.1 % 0.62 MACE 6.7% 6.3% 0.85 PMI : peri-procedural MI, PCI : percutaneous coronary intervention, TLR : target lesion revasc ularization, MACE: major adverse cardiac event = cardiac death, MI, or TLR
Cardiac Death Log-rank p=0.026 PMI no PMI
MACE Log-rank p=0.67 PMI no PMI MACE = cardiac death, MI, or TLR
Independent predictors of cardiac death HR 95% CI p Value Age 65 4.97 0.99-24.96 0.05 Cerebrovascular accident 2.04 0.41-10.08 0.38 Prior MI 2.31 0.46-11.67 0.31 Creatinine > 2.0 mg/dl 13.06 3.16-54.00 < 0.001 Unstable angina at presentation 2.22 0.56-8.76 0.25 Multi-vessel disease 1.28 0.30-5.59 0.74 Thrombus in main vessel 4.09 0.49-34.40 0.20 Peri-procedural MI 2.59 0.62-10.85 0.19 HR : hazard ratio, CI : confidence interval
Independent predictors of MACE HR 95% CI p-value Dyslipidemia 1.51 0.94-2.41 0.09 Creatinine > 2.0 mg/dl 3.67 1.65-8.18 0.001 Unstable angina at presentation 1.26 0.80-2.00 0.32 PES in main vessel 1.84 1.15-2.95 0.01 Stent length, total 30 mm in main vessel 2.15 1.34-3.46 0.002 Final kissing balloon inflation 2.33 1.45-3.75 0.001 Peri-procedural MI 1.07 0.51-2.23 0.86 HR : hazard ratio, CI : confidence interval, PES : paclitaxel- eluting stent
Limitations Retrospective study Post-PCI CK-MB was not systematically measured Lacked statistical power to detect a small difference of cardiac mortality
Conclusion Peri-procedural MI may not be a significant independent prognostic factor of cardiac death and MACE after coronary bifurcation stenting using contemporary intervention strategies. The larger studies are required to confirm this findings.