Supplemental Methods -cdn.com



SupplementSupplemental MethodsPatient recruitmentPROSPECT was a prospective study aiming to examine the natural history of atherosclerosis as assessed by angiography and IVUS. A total of 697 patients with ACS across 37 sites in the United States and Europe underwent 3-vessel greyscale and VH-IVUS after undergoing successful and uncomplicated PCI for the treatment of all lesions attributed to the index event. All patients recruited provided written informed consent.Clinical inclusion criteria:1. Age ≥ 18 years. 2. ACS (unstable angina, non ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation myocardial infarction (STEMI) with ≥10 minutes of angina or anginal equivalent consistent with unstable angina or myocardial infarction (MI) within 72 hours, with either elevated cardiac biomarkers (CK-MB or troponin) or ST-segment deviation of >1 mm in ≥2 contiguous electrocardiographic leads.3. Patient agrees and is able to follow all protocol procedures.4. Patient provides written, informed consent.Angiographic inclusion criteria were:Successful and uncomplicated PCI performed in one or two major epicardial coronary arteries (including their branches). Successful PCI was defined as residual diameter stenosis of < 50% in all lesions with TIMI-3 flow in all vessels. Uncomplicated PCI was defined as the absence of intra-procedural chest pain or ST-segment changes lasting > 10 minutes, sustained vessel closure, slow or no re-flow, side branch loss, distal embolization, perforation, residual dissection, or requirement for cardiopulmonary resuscitation, cardioversion or defibrillation, pacemaker insertion, intubation, intra-aortic balloon insertion or intravenous pressors.Clinical exclusion criteria:STEMI within 24 hours.Serum creatinine ≥2.5 mg/dl.Decompensated hypotension, heart failure, shock, refractory ventricular arrhythmias, acute conduction system disease, implanted defibrillator, or left ventricular ejection fraction ≤ 30%.Known severe allergy, hypersensitivity or contraindication to aspirin, heparin, thienopyridines or contrast which cannot be adequately pre-medicated.Stroke or transient ischemic attack within 6 months.Significant gastrointestinal or urinary bleed within the past 6 months, coagulopathy, bleeding diathesis, or refusal of blood transfusions.Percutaneous coronary intervention (PCI) within 6 months or any prior bypass graft surgery.Prior or planned heart transplant or any other organ transplant.Anticipated life expectancy < 1 year.Prior participation in the study or current enrolment in another investigational study that has not reached its primary endpoint.Pregnant or nursing patients and those who plan pregnancy in the period up to one year following index procedure. Female patients of child-bearing potential must have had a negative pregnancy test done within 7 days prior to the index procedure.Angiographic exclusion criteria were:1. PCI required in all 3 major epicardial coronary arteries.2. Anatomy not suitable for 3-vessel IVUS.3. Left main coronary artery culprit lesion.4. Any remaining lesion with diameter stenosis > 50% after PCI.5. Coronary artery bypass graft surgery planned within 1-year after PCI.VH-IVUS was performed in all main coronary arteries (6 to 8cm of the proximal segments) after the administration of intra-coronary glyceryl trinitrate. Data were acquired with 20MHz Eagle-Eye Gold catheters (Volcano Corporation, Rancho Cordova, California, USA) using motorized pullback at 0.5mm/s. Radiofrequency data were gathered in diastole at each R-wave peak by patient-specific ECG-gating. A total of 2811 plaques were identified the analysis of which was performed offline by the Cardiovascular Research Foundation core laboratory, using the Volcano Image Analysis Software. Independent study clinicians verified all major adverse cardiovascular events (MACE) defined as the composite of death from cardiac causes, cardiac arrest, myocardial infarction, or rehospitalization due to unstable or progressive angina according to the Braunwald Unstable Angina Classification and the Canadian Cardiovascular Society Angina Classification). An independent review panel adjudicated each suspected MACE and on the basis of follow-up angiography, MACE were adjudicated to culprit lesions or at previously untreated coronary segments (non-culprit lesions). In the cases where follow-up angiography was not available, the site associated with the event was classified as indeterminate. In patients with multiple non-culprit MACE the first event was chosen.Biomechanical modelingPlaque geometry was constructed from VH-IVUS data using an in-house MATLAB code (D3Plaque, Cambridge, UK). Any frames where PB < 40% were excluded from biomechanical analysis, as these were considered non-atherosclerotic regions. As in vivo data are recorded during diastole, circumferential shrinkage was applied to generate a zero-pressure condition for computational simulation as previously describedPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UYW5nPC9BdXRob3I+PFllYXI+MjAwOTwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA 3 and include; arterial vessel wall, c1=0.138 kPa, D1=3.833 kPa, D2=18.803; fibrous tissue, c1=0.186 kPa, D1=5.769 kPa, D2=18.219 and necrotic core, c1=0.046 kPa, D1=4.885 kPa, D2=5.426. The material properties of dense calcification were derived by fitting a Young’s modulus of 184 MPa derived from experimental work ADDIN EN.CITE <EndNote><Cite><Author>Ebenstein</Author><Year>2009</Year><RecNum>306</RecNum><DisplayText><style face="superscript">4</style></DisplayText><record><rec-number>306</rec-number><foreign-keys><key app="EN" db-id="traf29rx2s0w0tew2sbxstw505590s0wrz2d">306</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Ebenstein, D. M.</author><author>Coughlin, D.</author><author>Chapman, J.</author><author>Li, C.</author><author>Pruitt, L. A.</author></authors></contributors><titles><title>Nanomechanical properties of calcification, fibrous tissue, and hematoma from atherosclerotic plaques</title><secondary-title>J Biomed Mater Res A</secondary-title></titles><periodical><full-title>J Biomed Mater Res A</full-title></periodical><pages>1028-37</pages><volume>91</volume><number>4</number><dates><year>2009</year></dates><isbn>1552-4965 (Electronic)&#xD;1549-3296 (Linking)</isbn><urls></urls></record></Cite></EndNote>4: c1=1.147×105 kPa, D1=7.673×104 kPa and D2=2.838×10-8. The motion of each atherosclerotic component is governed by kinetic equations as:ρvi,tt=σij,j (i, j=1, 2)where [vi] and [σij] are the displacement vector and stress tensor, respectively, ρ is the density of each component and t stands for time. The entire plaque geometric model was meshed using 9-node quadrilaterals (generating approximately 10,000 elements and 40,000 nodes per model). Displacement and strain were assumed to be large. There was no relative movement at the interface of atherosclerotic components and the relative energy tolerance was set to be 0.005. Two adjacent points were fixed to prevent rigid body displacement. PSS was used to characterize the mechanical loading within the plaque structure in the peri-luminal region (0.2mm maximum depth from the luminal contour). Dynamic loading conditions were generated from coronary pressure recordings taken at the time of the procedure. Pressure at the outer boundary was set to zero. All simulations were performed using ADINA 8.6.1 (ADINA R&D, Inc., USA) software.Statistical AnalysisThe method of propensity score matching was as follows:1. Only lesions with plaque burden ≥ 60% were included.2. NCLs with MACE : NCLs with no MACE =1:2.3. One lesion per patient.4. If a patient had multiple NCL MACE and multiple NCLs with plaque burden≥60%, the lesion associated with the first MACE was chosen.5. If a patient had multiple NCLs with PB ≥ 60%, the lesion with the greatest PB was chosen.6. Patients with NCL MACE related to NCL that were not identified at baseline or without valid VH-IVUS data were eliminated from the analysis.7. Propensity matching parameters: Patient level parameters: Insulin treated DM, prior PCI, age (continuous) and gender.Lesion level parameters: Plaque burden at MLA (minimum lumen area), MLA, plaque phenotype (TCFA, ThCFA, other)Plaque burden at MLA and MLA was used as continuous variable.Multiple imputations were performed on the matching variables to avoid losing lesions/patients when running the logistic regression on subjects with missing values for some of the variables. The propensity score (per patient) was calculated as an average of the propensity scores from 10 imputed datasets.The 2:1 matching was performed using a caliper of 0.5 (0.2 multiplied by the logit of the standard deviation of the propensity score). ADDIN EN.CITE <EndNote><Cite><Author>Austin</Author><Year>2011</Year><RecNum>6640</RecNum><DisplayText><style face="superscript">5</style></DisplayText><record><rec-number>6640</rec-number><foreign-keys><key app="EN" db-id="v9rw9dfzlzpfxmefzw65vrd7std0aawestsa" timestamp="1548684786">6640</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Austin, P. C.</author></authors></contributors><auth-address>Institute for Clinical Evaluative Sciences, Toronto, Ont., Canada. peter.austin@ices.on.ca</auth-address><titles><title>Optimal caliper widths for propensity-score matching when estimating differences in means and differences in proportions in observational studies</title><secondary-title>Pharm Stat</secondary-title></titles><periodical><full-title>Pharm Stat</full-title></periodical><pages>150-61</pages><volume>10</volume><number>2</number><keywords><keyword>Aged</keyword><keyword>Aged, 80 and over</keyword><keyword>Confidence Intervals</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Monte Carlo Method</keyword><keyword>*Propensity Score</keyword><keyword>Risk</keyword></keywords><dates><year>2011</year><pub-dates><date>Mar-Apr</date></pub-dates></dates><isbn>1539-1612 (Electronic)&#xD;1539-1604 (Linking)</isbn><accession-num>20925139</accession-num><urls><related-urls><url> Important patient demographics and VH-IVUS characteristics before and after propensity score matching are demonstrated in Supplemental Table 1.Supplemental ResultsPositive predictive value of high PSS and high HIThe positive predictive value of high PSS and high HI in identifying lesions that proceed to MACE was calculated for the entire plaque population as well all plaque subtypes described in Figure 6 (all plaques=60.6%, VH-TCFA=63.6%, PB ≥ 70%=56.3%, MLA ≤4mm2=66.7%, VH-TCFA+MLA ≤4mm2 =75% VH-TCFA+PB ≥ 70% = 55.6%).Supplemental References ADDIN EN.REFLIST 1.Tang D, Teng Z, Canton G, Hatsukami TS, Dong L, Huang X and Yuan C. Local critical stress correlates better than global maximum stress with plaque morphological features linked to atherosclerotic plaque vulnerability: an in vivo multi-patient study. Biomed Eng Online. 2009;8:15.2.Huang Y, Teng Z, Sadat U, Hilborne S, Young VE, Graves MJ and Gillard JH. Non-uniform shrinkage for obtaining computational start shape for in-vivo MRI-based plaque vulnerability assessment. J Biomech. 2011;44:2316-9.3.Teng Z, Zhang Y, Huang Y, Feng J, Yuan J, Lu Q, Sutcliffe MP, Brown AJ, Jing Z and Gillard JH. Material properties of components in human carotid atherosclerotic plaques: a uniaxial extension study. Acta Biomater. 2014;10:5055-63.4.Ebenstein DM, Coughlin D, Chapman J, Li C and Pruitt LA. Nanomechanical properties of calcification, fibrous tissue, and hematoma from atherosclerotic plaques. J Biomed Mater Res A. 2009;91:1028-37.5.Austin PC. Optimal caliper widths for propensity-score matching when estimating differences in means and differences in proportions in observational studies. Pharm Stat. 2011;10:150-61.Supplemental Table 1. Patient demographics and VH-IVUS characteristics before and after propensity score matchingBefore Propensity Score MatchingAfter Propensity Score MatchingCharacteristicMACE (n=35)No MACE (n=384)p-valueMACE (n=35)No MACE (n=66)p-valuePatient characteristicsAge, years54.9 [49.1 - 65.7]58.8 [51.4 - 67.4 ]0.2154.9 [49.1 - 65.7]58.8 [50.1 - 66.4]0.42Male 29/35 (82.9)202/384(52.6)0.2729/35 (82.9)53/66 (80.3)0.75Diabetes 10/35 (28.6)60/383 (15.7)0.0510/35 (28.6)13/66 (19.7)0.31Body Mass Index (kg/m2)29.8 [25.3 - 32.9]27.8 [ 25.1 - 31.1]0.1329.8 [25.3 - 32.9]27.7 [24.9 - 30.8]0.15Prior Myocardial Infarction 4/35 (11.4)42/383 (11.0)1.00 4/35 (11.4)9/66 (13.6)1.00CAD (stenosis≥50%) 6/32 (18.8)48/377 (12.7)0.416/32 (18.8)13/65 (20.0)0.88Previous PCI 5/35 (14.3)39/383 (10.2)0.405/35 (14.3)9/66 (13.6)1.00Family History of CAD13/28 (46.4)150/338 (44.4)0.8313/28 (46.4)25/57 (43.9)0.82Hypertension Requiring Medication 19/33 (57.6)181/383 (47.3)0.2619/33 (57.6)34/65 (52.3)0.62Hypercholesterolemia 15/28 (53.6)162/360 (45.0)0.3815/28 (53.6)32/65 (49.2)0.70History of Tobacco Use19/35 (54.3)186/379 (49.1)0.5619/35 (54.3)29/66 (43.9)0.32Clinical Presentation (STEMI)10/35 (28.6) 113/384(29.4)0.9210/35 (28.6)13/66 (19.7)0.31Clinical Presentation (NSTEMI) 24/35 (68.6)255/384 (66.4)0.7924/35 (68.6)48/66 (72.7)0.66Clinical Presentation (UA)1/35 (2.9)16/384 (4.2)1.001/35 (2.9)5/66 (7.6)0.66Tot. Cholesterol/HDL-Cholesterol 4.6 [3.5 - 5.5] 4.3 [3.4 - 5.3]0.274.6 [3.5 - 5.5]4.3 [3.2 - 5.0]0.26Metabolic Syndrome 16/34 (47.1)176/372 (47.3)0.9816/34 (47.1)29/63 (46.0)0.92VH-IVUS characteristicsLesion PhenotypeVH-TCFA20/35 (57.1)121/384 (31.5)0.00220/35 (57.1)31/66 (47.0)0.33VH-ThCFA12/35 (34.3)169/384 (44.0)0.2712/35 (34.3)26/66 (39.4)0.61VH-PIT2/35 (5.7)85/384 (22.1)0.022/35 (5.7)9/66 (13.6)0.32VH-FCa1/35 (2.9)5/384 (1.3)0.411/35 (2.9)0/66 (0.0)0.35 VH-FT0/35 (0.0)4/384 (1.0)1.00/35 (0.0)0/66 (0.0)NAVH-TCFA or VH-ThCFA32/35 (91.4)290/384 (75.5)0.0332/35 (91.4)57/66 (86.4)0.54Plaque Data% NC Volume15.5 [9.0 - 21.5]13.0 [7.4 - 19.3]0.3015.5 [9.0 - 21.5]14.9 [8.8 - 23.1]0.73% DC Volume6.1 [2.7 - 9.8]5.3 [2.4 - 9.1]0.476.1 [2.7 - 9.8]6.3 [3.6 - 9.4]0.95% FT Volume60.7 [54.5 - 65.9]59.1 [54.0 - 64.0]0.5360.7 [54.5 - 65.9]57.6 [53.7 - 62.0]0.22% FF Volume15.2 [10.9 - 22.5]18.4 [12.2 - 26.1]0.1515.2 [10.9 - 22.5]16.4 [10.2 - 23.2]0.78MLA Site Data% NC CSA (%)13.9 [8.7 - 25.1]14.3 [6.5 - 22.7]0.3213.9 [8.7 - 25.1]16.6 [8.9 - 29.1]0.44% DC CSA (%)5.0 [2.3 - 10.9]4.2 [1.4 - 9.4]0.505.0 [2.3 - 10.9]6.0 [2.0 - 11.4]0.73% FT CSA (%)61.1 [53.7 - 68.8]60.5 [51.3 - 66.4]0.3161.1 [53.7 - 68.8]58.7 [49.0 - 64.2]0.11% FF CSA (%)11.1 [7.0 - 22.0]16.1 [8.6 - 26.4]0.1111.1 [7.0 - 22.0]12.6 [5.8 - 22.2]0.80Data present as median (interquartile range) or n (%).CAD=coronary artery disease; HDL=high-density lipoprotein; LDL=low-density lipoprotein; NSTEMI=non-ST segment-elevation myocardial infarction; STEMI= ST segment-elevation myocardial infarction; UA=unstable anginaSupplemental Table 2. Drug therapy on discharge and over follow-upMedicationsMACE (n=35)No MACE (n=66)p-valueCardiac Medications???Statins: Discharge80.0% (28/35)87.9% (58/66)0.29Statins: 1095-Days78.1% (25/32)83.6% (46/55)0.52????Lipid Lowering (not Statin): Discharge20.0% (7/35)9.1% (6/66)0.13Lipid Lowering (not Statin): 1095-Days31.3% (10/32)10.9% (6/55)0.02????Any Lipid Lowering: Discharge91.4% (32/35)89.4% (59/66)1.00Any Lipid Lowering: 1095-Days90.6% (29/32)85.5% (47/55)0.74????Aspirin: Discharge97.1% (34/35)92.4% (61/66)0.66Aspirin: 1095-Days93.8% (30/32)89.1% (49/55)0.70????Clopidogrel: Discharge97.1% (34/35)95.5% (63/66)1.00Clopidogrel: 1095-Days40.6% (13/32)40.0% (22/55)0.95????Ticlopidine: Discharge2.9% (1/35)4.5% (3/66)1.00????Thienopyridines: Discharge97.1% (34/35)97.0% (64/66)1.00Thienopyridines: 1095-Days40.6% (13/32)40.0% (22/55)0.95????Coumadin: Discharge0.0% (0/35)1.5% (1/66)1.00Coumadin: 365-Days0.0% (0/35)1.8% (1/57)1.00????ACE Inhibitors: Discharge60.0% (21/35)68.2% (45/66)0.41ACE Inhibitors: 1095-Days46.9% (15/32)61.8% (34/55)0.18????ARB: Discharge5.7% (2/35)12.3% (8/65)0.49ARB: 1095-Days15.6% (5/32)23.6% (13/55)0.37????Beta Blockers: Discharge85.7% (30/35)92.4% (61/66)0.31Beta Blockers: 1095-Days84.4% (27/32)76.4% (42/55)0.37????Non-Cardiac Medications???Diabetic Medication: Discharge25.7% (9/35)16.7% (11/66)0.28Diabetic Medication: 1095-Days25.0% (8/32)16.4% (9/55)0.33????HRT: Discharge2.9% (1/35)4.5% (3/66)1.00HRT: 1095-Days3.1% (1/32)1.8% (1/55)1.00Data are presented as % (n)ACE=angiotensin-converting enzyme; ARB=angiotensin II receptor blocker; HRT=hormone replacement therapySupplemental Table 3. Patient quantitative coronary analysisCharacteristicMACE (n=35)No MACE (n=66)p-valueTotal length of coronary tree, mm411.0 [375.0, 498.0]437.2 [400.5, 484.5]0.42Average length of NCL, mm37.1 [16.7, 53.4]23.6 [10.4, 48.2]0.12Any lesions with DS% ≥50%45.7% (16/35)52.6% (30/57)0.52Number of Diseased VesselsNo. with 1 vessel CAD (DS>30%)8.6% (3/35)18.2% (12/66)0.20Number with 2 vessel CAD40.0% (14/35)37.9% (25/66)0.83Number with 3 vessel CAD51.4% (18/35)43.9% (29/66)0.47Number of Vessels with lesionsNumber of vessels with lesions2.0 [1.0, 3.0]2.0 [1.0, 2.0]0.27Number of vessels with lesions: 08.6% (3/35)16.7% (11/66)0.37Number of vessels with lesions: 125.7% (9/35)24.2% (16/66)0.87Number of vessels with lesions: 237.1% (13/35)39.4% (26/66)0.82Number of vessels with lesions: 328.6% (10/35)19.7% (13/66)0.31Number of lesionsNumber of lesions4.0 [3.0, 5.0]3.0 [1.0, 4.0]0.01Side branch lesions with DS>50%5.7% (2/35)3.0% (2/66)0.61Side branch lesion with DS>75%0.0% (0/35)1.5% (1/66)1.00Data are present as median (interquartile range) or % (n)CAD=coronary artery disease; DS=diameter stenosis; NCL=non-culprit lesions PCI=percutaneous coronary intervention; QCA=quantitative coronary analysisSupplemental Table 4. Grayscale IVUS non-culprit lesion characteristics ?CharacteristicMACE (n=35)No MACE (n=66)p-valueLesion DataLesion Length (mm)30.4 [19.5 - 41.4]24.3 [15.7 - 36.7]0.11Total EEM Volume (mm3)474.1 [286.3 - 684.7]373.0 [183.4 - 602.3]0.09Total Lumen Volume (mm3)191.1 [130.0 - 288.5]165.9 [85.6 - 249.2]0.10Plaque Volume (%)55.0 [51.7 - 60.0]55.0 [52.0 - 59.7]0.86Av. EEM CSA (mm3/mm)15.4 [12.1 - 20.1]15.6 [12.7 - 18.2]0.61Av. Lumen CSA (mm3/mm)7.0 [5.4 - 8.4]6.7 [5.7 - 8.1]0.97Av. Plaque + Media CSA (mm3/mm)8.2 [6.8 - 11.6]8.4 [7.1 - 10.6]Morphology DataEcholucent Plaque 12/35 (34.3) 8/66 (12.1) 0.008Plaque Rupture 2/35 (5.7)4/66 (6.1)1.00MLA Site DataEEM CSA (mm2)13.5 [10.9 - 17.5]14.9 [11.3 - 17.6]0.81MLA (mm2)4.1 [3.2 - 4.9]4.0 [3.4 - 5.1]0.62MLA≤4mm2 16/35 (45.7)31/66 (47.0) 0.90Plaque & Media CSA (mm2) 9.6 [7.7 - 12.2]10.4 [7.8 - 12.4]0.96Plaque Burden (%)70.1 [68.6 - 74.8]70.5 [66.9 - 73.3]0.35Plaque Burden ≥70% (20/35) (57.1) 35/66 (53.0) 0.69Min. Lumen Diameter (mm)2.09 [1.91 - 2.20]2.10 [1.91 - 2.27]0.38Remodeling Index0.88 [0.81 - 1.01]0.95 [0.85 - 1.04]0.17Data are present as median (interquartile range) or n (%).CSA=cross-sectional area; EEM=external elastic membrane; MLA=minimum luminal area ................
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