Hector M. Garcia-Garcia

Anatomical and clinical characteristics to guide decision making between coronary artery bypass surgery and percutaneous coronary intervention for individual patients: development and validation of SYNTAX score II

BACKGROUNDnThe anatomical SYNTAX score is advocated in European and US guidelines as an instrument to help clinicians decide the optimum revascularisation method in patients with complex coronary artery disease. The absence of an individualised approach and of clinical variables to guide decision making between coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) are limitations of the SYNTAX score. SYNTAX score II aimed to overcome these limitations.nnnMETHODSnSYNTAX score II was developed by applying a Cox proportional hazards model to results of the randomised all comers SYNTAX trial (n=1800). Baseline features with strong associations to 4-year mortality in either the CABG or the PCI settings (interactions), or in both (predictive accuracy), were added to the anatomical SYNTAX score. Comparisons of 4-year mortality predictions between CABG and PCI were made for each patient. Discriminatory performance was quantified by concordance statistics and internally validated with bootstrap resampling. External validation was done in the multinational all comers DELTA registry (n=2891), a heterogeneous population that included patients with three-vessel disease (26%) or complex coronary artery disease (anatomical SYNTAX score ≥33, 30%) who underwent CABG or PCI. The SYNTAX trial is registered with ClinicalTrials.gov, number NCT00114972.nnnFINDINGSnSYNTAX score II contained eight predictors: anatomical SYNTAX score, age, creatinine clearance, left ventricular ejection fraction (LVEF), presence of unprotected left main coronary artery (ULMCA) disease, peripheral vascular disease, female sex, and chronic obstructive pulmonary disease (COPD). SYNTAX score II significantly predicted a difference in 4-year mortality between patients undergoing CABG and those undergoing PCI (p(interaction) 0·0037). To achieve similar 4-year mortality after CABG or PCI, younger patients, women, and patients with reduced LVEF required lower anatomical SYNTAX scores, whereas older patients, patients with ULMCA disease, and those with COPD, required higher anatomical SYNTAX scores. Presence of diabetes was not important for decision making between CABG and PCI (p(interaction) 0·67). SYNTAX score II discriminated well in all patients who underwent CABG or PCI, with concordance indices for internal (SYNTAX trial) validation of 0·725 and for external (DELTA registry) validation of 0·716, which were substantially higher than for the anatomical SYNTAX score alone (concordance indices of 0·567 and 0·612, respectively). A nomogram was constructed that allowed for an accurate individualised prediction of 4-year mortality in patients proposing to undergo CABG or PCI.nnnINTERPRETATIONnLong-term (4-year) mortality in patients with complex coronary artery disease can be well predicted by a combination of anatomical and clinical factors in SYNTAX score II. SYNTAX score II can better guide decision making between CABG and PCI than the original anatomical SYNTAX score.nnnFUNDINGnBoston Scientific Corporation.

3-Dimensional optical coherence tomography assessment of jailed side branches by bioresorbable vascular scaffolds: a proposal for classification.

OBJECTIVESnThe purpose of this study is to assess jailing of side branches (SB) by the everolimus-eluting, bioresorbable vascular scaffold (BVS) with 3-dimensional (3D) optical coherence tomography (OCT) reconstruction.nnnBACKGROUNDnBecause BVS struts at the SB orifice are suspected of being bioresorbed and/or forming a neointimal bridge, OCT has been used to evaluate the struts in detail at that particular site. Our understanding of the 3D relationship of the strut and the SB orifice is limited by the use of 2-dimensional OCT images. Fourier-domain OCT enables reliable 3D reconstruction of coronary vessels.nnnMETHODSnThe ABSORB Cohort B (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) trial is a multicenter single-arm trial to assess the safety and performance of the BVS. Fourier-domain OCT pullbacks (C7-XR system, LightLab Imaging Inc., Westford, Massachusetts) are obtained at pullback speed of 20 mm/s and 3D renderings are performed. The orifices of the SB are assessed visually. The area of SB orifice and the number of strut-free compartments delineated by the BVS struts are evaluated.nnnRESULTSnFifty-one OCT pullbacks were acquired: 33 pullbacks were imaged with Fourier-domain OCT and 27 treated segments had 46 side branches. Three-dimensional assessment was feasible in 87% (40 of 46) of pullbacks. The mean area of the SB orifice was 1.16 +/- 1.02 mm(2). The mean number of strut-free compartments was 2.0 +/- 1.1. The classification of the overhanging struts is proposed.nnnCONCLUSIONSnThis study demonstrates that 3D OCT reconstruction is feasible to evaluate the orifices of SB jailed with BVS. (ABSORB Clinical Investigation, Cohort B; NCT00856856).

IVUS-based imaging modalities for tissue characterization: similarities and differences

Gray-scale intravascular ultrasound (IVUS) is the modality that has been established as the golden standard for in vivo imaging of the vessel wall of the coronary arteries. The use of IVUS in clinical practice is an important diagnostic tool used for quantitative assessment of coronary artery disease. This has made IVUS the de-facto invasive imaging method to evaluate new interventional therapies such as new stent designs and for atherosclerosis progression-regression studies. However, the gray-scale representation of the coronary vessel wall and plaque morphology in combination with the limited resolution of the current IVUS catheters makes it difficult, if not impossible, to identify qualitatively (e.g. visually) the plaque morphology similar as that of histopathology, the golden standard to characterize and quantify coronary plaque tissue components. Meanwhile, this limitation has been partially overcome by new innovative IVUS-based post-processing methods such as: virtual histology IVUS (VH-IVUS, Volcano Therapeutics, Rancho Cordova, CA, USA), iMAP-IVUS (Bostoc Scientific, Santa Clara, CA, USA), Integrated Backscatter IVUS (IB-IVUS) and Automated Differential Echogenicity (ADE).

Natural history of coronary atherosclerosis by multislice computed tomography.

OBJECTIVESnThis study sought to analyze the natural history of coronary atherosclerosis by multislice computed tomography (MSCT) and assess the serial changes in coronary plaque burden, lumen dimensions, and arterial remodeling.nnnBACKGROUNDnMSCT can comprehensively assess coronary atherosclerosis by combining lumen and plaque size parameters.nnnMETHODSnThirty-two patients with acute coronary syndromes underwent 64-slice computed tomography angiography after percutaneous coronary intervention at baseline and after a median of 39 months. All patients received contemporary medical treatment. All available coronary segments in every subject were analyzed. The progression of atherosclerosis per segment and per patient was assessed by means of change in percent atheroma volume (PAV), change in normalized total atheroma volume (TAVnorm), and percent change in TAV (% change in TAV). Serial coronary remodeling was also assessed. Measures of lumen stenosis included percent diameter stenosis (%DS), minimum lumen diameter (MLD), percent area stenosis (%AS), and minimum lumen area (MLA). For each patient, the mean of all matched segments was calculated at the 2 time points. Clinical events at follow-up were documented.nnnRESULTSnThe PAV did not change significantly (-0.15 ± 3.64%, p = 0.72). The mean change in TAVnorm was 47.36 ± 143.24 mm(3) (p = 0.071), and the % change in TAV was 6.7% (p = 0.029). The MLD and MLA increased by 0.15 mm (-0.09 to 0.24, p = 0.039) and 0.52 mm(2) (-0.38 to 1.04, p = 0.034) respectively, which was accompanied by vessel enlargement, with 53% of the patients showing expansive positive remodeling. Patients with clinical events had a larger TAVnorm at baseline (969.72 mm(3) vs. 810.77 mm(3), p = 0.010).nnnCONCLUSIONSnMSCT can assess the progression of coronary atherosclerosis and may be used for noninvasive monitoring of pharmacological interventions in coronary artery disease. (nnnPROSPECTnAn Imaging Study in Patients With Unstable Atherosclerotic Lesions; NCT00180466).

Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1 Year in 1,232 Patients From 3 Study Cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II)

OBJECTIVESnThis study sought to investigate the clinical outcomes based on the assessment of quantitative coronary angiography-maximal lumen diameter (Dmax).nnnBACKGROUNDnAssessment of pre-procedural Dmax of proximal and distal sites has been used for Absorb scaffold size selection in the ABSORB studies.nnnMETHODSnA total of 1,248 patients received Absorb scaffolds in the ABSORB Cohort B (ABSORB Clinical Investigation, Cohort B) study (Nxa0= 101), ABSORB EXTEND (ABSORB EXTEND Clinical Investigation) study (Nxa0= 812), and ABSORB II (ABSORB II Randomized Controlled Trial) trial (Nxa0= 335). The incidence of major adverse cardiac events (MACE) (a composite of cardiac death, any myocardial infarction [MI], and ischemia-driven target lesion revascularization) was analyzed according to the Dmax subclassification of scaffold oversize group versus scaffold nonoversize group.nnnRESULTSnOf 1,248 patients, pre-procedural Dmax was assessed in 1,232 patients (98.7%). In 649 (52.7%) patients, both proximal and distal Dmax values were smaller than the nominal size of the implanted scaffold (scaffold oversize group), whereas in 583 (47.3%) of patients, the proximal and/or distal Dmax were larger than the implanted scaffold (scaffold nonoversize group). The rates of MACE and MI at 1 year were significantly higher in the scaffold oversize group than in the scaffold nonoversize group (MACE 6.6% vs. 3.3%; log-rank pxa0< 0.01, all MI: 4.6% vs. 2.4%; log-rank pxa0= 0.04), mainly driven by a higher MI rate within 1 month post-procedure (3.5% vs. 1.9%; pxa0= 0.08). The independent MACE determinants were both Dmax smaller than the scaffold nominal size (odds ratio [OR]: 2.13, 95% confidence interval [CI]: 1.22 to 3.70; pxa0< 0.01) and the implantation of overlapping scaffolds (OR: 2.10, 95% CI: 1.17 to 3.80; pxa0= 0.01).nnnCONCLUSIONSnImplantation of an oversized Absorb scaffold in a relatively small vessel appears to be associated with a higher 1-year MACE rate driven by more frequent early MI. (ABSORB Clinical Investigation, Cohort B [ABSORB Cohort B], NCT00856856; ABSORB EXTEND Clinical Investigation [ABSORB EXTEND], NCT01023789; ABSORB II Randomized Controlled Trial [ABSORB II], NCT01425281).

Reproducibility of computed tomography angiography data analysis using semiautomated plaque quantification software: implications for the design of longitudinal studies

Reproducibility of the quantitative assessment of atherosclerosis by computed tomography coronary angiography (CTCA) is paramount for the design of longitudinal studies. The purpose of this study was to assess the inter- and intra-observer reproducibility using semiautomated CT plaque analysis software in symptomatic individuals. CTCA was performed in 10 symptomatic patients after percutaneous treatment of the culprit lesions and was repeated after 3xa0years. The plaque quantitative analysis was performed in untreated vessels with mild-to-moderate atherosclerosis and included geometrical and compositional characteristics using semiautomated CT plaque analysis software. A total of 945 matched cross-sections from 21 segments were analyzed independently by a second reviewer to assess inter-observer variability; the first observer repeated all the analyses after 3xa0months to assess intra-observer variability. The observer variability was also compared to the absolute plaque changes detected over time. Agreement was evaluated by Bland–Altman analysis and concordance correlation coefficient. Inter-observer relative differences for lumen, vessel, plaque area and plaque burden were 1.2, 0.6, 2.2, 1.6xa0% respectively. Intra-observer relative differences for lumen, vessel, plaque area and plaque burden were 1.0, 0.4, 0.2, 0.4xa0% respectively. For the average plaque attenuation values the inter- and intra-observer variability was 5 and 2xa0% respectively. For the % low-attenuation-plaque the inter- and intra-observer variability was 16 and 6xa0% respectively. The absolute intra-observer variability for the plaque burden was 1.30xa0±xa01.09xa0%, while the temporal plaque burden difference was 3.55xa0±xa03.02xa0% (pxa0=xa00.001). The present study shows that the geometrical assessment of coronary atherosclerosis by CTCA is highly reproducible within and between observers using semiautomated quantification software and that serial plaque changes can be detected beyond observer variability. The compositional measurements are more variable between observers than geometrical measurements.

Assessment of coronary atherosclerosis by IVUS and IVUS-based imaging modalities: progression and regression studies, tissue composition and beyond

Cardiovascular disease remains the leading cause of mortality, morbidity and disability in the developed world, predominantly affecting the adult population. In the early 1990s coronary heart disease (CHD) was established as affecting one in two men and one in three women by the age of forty. Despite the dramatic progress in the field of cardiovascular medicine in terms of diagnosis and treatment of heart disease, modest improvements have only been achieved when the reduction of cardiovascular mortality and morbidity indices are assessed. To better understand coronary atherosclerosis, new imaging modalities have been introduced. These novel imaging modalities have been used in two ways: (1) for the characterization of plaque types; (2) for the assessment of the progression and regression of tissue types. These two aspects will be discussed in this review.

Chronic total occlusion treatment in post‐CABG patients: Saphenous vein graft versus native vessel recanalization—Long‐term follow‐up in the drug‐eluting stent era

To compare the postprocedural and long‐term clinical outcomes of two groups of patients, all presenting with chronic saphenous vein graft (SVG) occlusion, who underwent either SVG or native vessel reopening.

Incidence and Potential Mechanism(s) of Post-Procedural Rise of Cardiac Biomarker in Patients With Coronary Artery Narrowing After Implantation of an Everolimus-Eluting Bioresorbable Vascular Scaffold or Everolimus-Eluting Metallic Stent.

OBJECTIVESnThis study sought to evaluate the mechanism of post-procedural cardiac biomarker (CB) rise following device implantation.nnnBACKGROUNDnA fully bioresorbable Absorb scaffold, compared with everolimus-eluting metallic stents (EES), might be associated with a higher incidence of periprocedural myocardial injury.nnnMETHODSnIn 501 patients with stable or unstable angina randomized to either Absorb (335 patients) or EES (n = 166) in the ABSORB II trial, 3 types of CB (creatine kinase, creatine kinase-myocardial band, and troponin) were obtained before and after procedure. Per protocol, periprocedural myocardial infarction (PMI) was defined as creatine kinase rise >2× the upper limit of normal with creatine kinase-myocardial band rise.nnnRESULTSnIncidence of side branch occlusion and any anatomic complications assessed by angiography was similar between the 2 treatment arms (side branch occlusion: Absorb: 5.3% vs. Xience: 7.6%, p = 0.07; any anatomic complication: Absorb: 16.4% vs. EES: 19.9%, p = 0.39). Fourteen patients who presented with recent myocardial infarction at entry with normalized creatine kinase-myocardial band according to the protocol were excluded for post-CB analysis. The overall compliance for CB was 97.8%. The CB rise subcategorized in 7 different ranges was comparable between the 2 treatment arms. PMI rate was numerically higher in the Absorb arm according to the per-protocol definitions, and treatment with overlapping devices was the only independent determinant of per-protocol PMI (odds ratio: 5.07, 95% confidence interval: 1.78 to 14.41, p = 0.002).nnnCONCLUSIONSnThere were no differences in the incidence of CB rise and PMI between Absorb and EES. Device overlap might be a precipitating factor of myocardial injury. (ABSORB II Randomized Clinical Trial: A Clinical Evaluation to Compare the Safety, Efficacy, and Performance of Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System Against Xience Everolimus Eluting Coronary Stent System in the Treatment of Subjects With Ischemic Heart Disease Caused by De Novo Native Coronary Artery Lesions [ABSORB II]; NCT01425281).

Assessment of atherosclerotic plaques at coronary bifurcations with multidetector computed tomography angiography and intravascular ultrasound-virtual histology.

AIMSnWe evaluated the distribution and composition of atherosclerotic plaques at bifurcations with intravascular ultrasound-virtual histology (IVUS-VH) and multidetector computed tomography (MDCT) in relation to the bifurcation angle (BA).nnnMETHODS AND RESULTSnIn 33 patients (age 63±11 years, 79% male) imaged with IVUS-VH and MDCT, 33 bifurcations were matched and studied. The analysed main vessel was divided into a 5 mm proximal segment, the in-bifurcation segment, and a 5 mm distal segment. Plaque contours were manually traced on MDCT and IVUS-VH. Plaques with >10% confluent necrotic core and <10% dense calcium on IVUS-VH were considered high risk, whereas plaque composition by MDCT was graded as non-calcified, calcified, or mixed. The maximum BA between the main vessel and the side branch was measured on diastolic MDCT data sets. Overall the mean plaque area decreased from the proximal to the distal segment [8.5±2.8 vs. 6.0±3.0 mm2 (P<0.001) by IVUS-VH and 9.0±2.6 vs. 6.5±2.5 mm2 (P<0.001) by MDCT]. Similarly, the necrotic core area was higher in the proximal compared with the distal segment (1.12±0.7 vs. 0.71±0.7 mm2, P=0.001). The proximal segment had the higher percentage of high-risk plaques (13/25, 52%), followed by the in-bifurcation (6/25, 24%), and the distal segment (6/25, 24%); these plaques were characterized by MDCT as non-calcified (72%) or mixed (28%). The presence of high-risk and non-calcified plaques in the proximal segment was associated with higher BA values (71±19° vs. 55±19°, P=0.028 and 74±20° vs. 50±14°, P=0.001, respectively).nnnCONCLUSIONnThe proximal segment of bifurcations is more likely to contain high-risk plaques, especially when the branching angle is wide.