Angiographic Lesion Discordance in Women Presenting With Ischemic Heart Disease: Comparison of Visual Assessment, Quantitative Coronary Angiography, and Quantitative Flow Ratio.

BACKGROUND: Although visual assessment of stenosis severity is routinely used to guide coronary revascularization, there are concerns about its accuracy, especially in women, who present a higher variability in coronary anatomy and ischemic heart disease (IHD). The aim of this study was to assess whether quantitative coronary angiography (QCA) and quantitative flow ratio (QFR) could provide better discrimination of coronary stenosis severity and functional significance than visual assessment alone in women with IHD. METHODS: Coronary angiography was performed in a cohort of women with ischemic symptoms and non-invasive stress perfusion imaging. Visual assessment was done by blinded operators in clinical practice, while QCA and QFR were analyzed in an independent core laboratory. RESULTS: Ninety-nine consecutive patients with 101 lesions were included in the registry, and QFR was successfully measured in 81 lesions (80.2%). Visual assessment provided higher readings of angiographic severity than QCA in 50.5% (n = 51) of lesions. Mean absolute difference between QCA and visual assessment was significantly higher in lesions with >70% diameter stenosis (DS) (25.3 ± 7.3%), compared with both the 40%-55% (9.3 ± 6.8%; P<.001) and the <40% groups (7.0 ± 6.0%; P<.001). QFR was >0.80 in 33.3% of lesions with visually defined >70% DS, while all lesions with QCA-defined >70% DS had QFR ≤0.80. CONCLUSIONS: Interventional cardiologists' visual assessment results in a higher degree of coronary stenosis than QCA. Among women with ischemic symptoms and non-invasive stress perfusion imaging, additional lesion assessment by QCA and QFR may improve operators' ability to determine which patients and lesions will benefit from coronary revascularization.

Comparison of Physician Visual Assessment With Quantitative Coronary Angiography in Assessment of Stenosis Severity in China.

Importance: Although physician visual assessment (PVA) of stenosis severity is a standard clinical practice to support decisions for coronary revascularization, there are concerns about its accuracy. Objective: To compare PVA with quantitative coronary angiography (QCA) as a means of assessing stenosis severity among patients undergoing percutaneous coronary intervention (PCI) in China. Design, Setting, and Participants: A cross-sectional study (2012-2013) of a random subset of 1295 patients from the China Patient-centered Evaluative Assessment of Cardiac Events (PEACE) Prospective PCI Study was carried out. The PEACE Prospective PCI study recruited a consecutive sample of patients undergoing PCI at 35 hospitals in 18 provinces of China. The coronary angiograms of this subset of participants were reviewed using QCA by 2 independent core laboratories blinded to PVA readings. Main Outcomes and Measures: Differences between PVA and QCA assessments of stenosis severity for lesions for which PCI was performed and variation of these differences among hospitals and physicians, stratified by the diagnosis of acute myocardial infarction (AMI). Results: In patients without AMI, the mean (SD) age was 62 (10) years, and 217 (31.5%) were women; in patients with AMI, the mean (SD) age was 60 (11) years, and 153 (25.2%) were women. The mean (SD) percent diameter stenosis by PVA was 16.0% (11.5%) greater than that by QCA in patients without AMI and 10.2% (12.3%) in those with AMI (P < .001 for both comparisons). In patients without AMI, of 837 lesions with 70% or more stenosis by PVA, 427 (50.6%) were less than 70% by QCA; in patients with AMI, similar patterns were observed to a lesser extent. Among patients without AMI, only 4 (0.47%) lesions were additionally assessed with fractional flow reserve. Among 30 hospitals, the difference between PVA and QCA readings of stenosis severity varied from 7.6% (95% CI, 0.4%-14.7%) to 21.3% (95% CI, 17.1%-24.9%) among non-AMI patients. Across 57 physicians, this difference varied from 6.9% (95% CI, -1.4%-15.3%) to 26.4% (95% CI, 21.5%-31.4%). Conclusions and Relevance: For coronary lesions treated with PCI in China, PVA reported substantially higher readings of stenosis severity than QCA, with large variation across hospitals and physicians. These findings highlight the need to improve the accuracy of information used to guide treatment decisions in catheterization laboratories.

Sex-based differences in bleeding and long term adverse events after percutaneous coronary intervention for acute myocardial infarction: three year results from the HORIZONS-AMI trial.

BACKGROUND: Studies have shown sex-based disparities in ST-segment elevation myocardial infarction (STEMI) management and prognosis. We sought to compare women and men undergoing primary percutaneous coronary intervention (PCI) for STEMI in a large, prospective, contemporary context. METHODS: The Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial randomized 3,602 patients (23.4% women and 76.6% men) with STEMI presenting within 12 hr of onset of symptoms to bivalirudin or heparin plus glycoprotein IIb/IIIa inhibitors and to PCI with drug-eluting or bare metal stents. RESULTS: Compared with men, women presented later after symptom onset and were more often treated with medical management alone (6.9% vs. 4.7%; P = 0.01). Women had significantly higher rates of 3-year major adverse cardiac events (MACE) and major bleeding. After adjusting for baseline differences, female sex remained an independent predictor of major bleeding (hazard ratio [HR] 1.81, 95% confidence interval [CI] 1.41-2.33; P < 0.0001) but not of MACE (HR 1.09; 95% CI 0.91-1.32; P = 0.35). CONCLUSIONS: This study found that women with STEMI are at increased risk of bleeding as compared to men. While female sex may not directly contribute to increased risk of MACE, it is, however, associated with the presence of comorbidities that increase the risk of ischemic events long-term. Further dedicated studies are needed to confirm these findings and to assess strategies to optimize both the initial emergent treatment and long-term management in this high-risk subset. © 2014 Wiley Periodicals, Inc.

Comparison of clinical interpretation with visual assessment and quantitative coronary angiography in patients undergoing percutaneous coronary intervention in contemporary practice: the Assessing Angiography (A2) project.

BACKGROUND: Studies conducted decades ago described substantial disagreement and errors in physicians' angiographic interpretation of coronary stenosis severity. Despite the potential implications of such findings, no large-scale efforts to measure or improve clinical interpretation were subsequently undertaken. METHODS AND RESULTS: We compared clinical interpretation of stenosis severity in coronary lesions with an independent assessment using quantitative coronary angiography (QCA) in 175 randomly selected patients undergoing elective percutaneous coronary intervention at 7 US hospitals in 2011. To assess agreement, we calculated mean difference in percent diameter stenosis between clinical interpretation and QCA and a Cohen weighted κ statistic. Of 216 treated lesions, median percent diameter stenosis was 80.0% (quartiles 1 and 3, 80.0% and 90.0%), with 213 (98.6%) assessed as ≥70%. Mean difference in percent diameter stenosis between clinical interpretation and QCA was 8.2±8.4%, reflecting an average higher percent diameter stenosis by clinical interpretation (P<0.001). A weighted κ of 0.27 (95% confidence interval, 0.18-0.36) was found between the 2 measurements. Of 213 lesions considered ≥70% by clinical interpretation, 56 (26.3%) were <70% by QCA, although none were <50%. Differences between the 2 measurements were largest for intermediate lesions by QCA (50% to <70%), with variation existing across sites. CONCLUSIONS: Physicians tended to assess coronary lesions treated with percutaneous coronary intervention as more severe than measurements by QCA. Almost all treated lesions were ≥70% by clinical interpretation, whereas approximately one quarter were <70% by QCA. These findings suggest opportunities to improve clinical interpretation of coronary angiography.

Operator versus core laboratory assessment of angiographic reperfusion markers in patients undergoing primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction.

BACKGROUND: Thrombolysis In Myocardial Infarction (TIMI) flow and Myocardial Blush Grade (MBG) are important prognostic indicators before and after primary percutaneous coronary intervention (PCI) in ST-segment-elevation myocardial infarction; however, the concordance and relative prognostic utility of operator (Op) versus angiography core laboratory (ACL) assessed TIMI flow and MBG are unknown. METHODS AND RESULTS: Baseline and final Op and ACL TIMI flow and MBG assessment were compared from the Harmonizing Outcomes with RevascularIZatiON and Stents in AMI trial in 3345 patients undergoing primary PCI using Cohen's κ coefficient. κ Was highest for pre-PCI TIMI flow (0.51, representing moderate agreement) and lowest for post-PCI MBG (0.20, representing fair agreement). Discordance between Op and ACL for final TIMI flow (0 to 2 versus 3) occurred in 12.9% of patients and for final MBG (0 to 1 versus 2 to 3) in 22.4%. Among 415 patients with final TIMI flow 0 to 2 by ACL, Op scoring was TIMI flow 3 in 267 (64.3%). Similarly, among 706 patients with final MBG 0 to 1 by ACL, 563 (79.7%) were classified as MBG 2 to 3 by Op. Post-PCI TIMI 3 flow and MBG 2 to 3 strongly correlated with 3-year survival, as assessed by both Op and ACL (P<0.0001). Mortality was intermediate in patients in whom ACL and Op were discordant, without marked prognostic differences between the discordant groups. CONCLUSIONS: Op and ACL assessment of angiographic markers of reperfusion in ST-segment-elevation myocardial infarction demonstrates fair to moderate agreement. Op tended to favorably grade unfavorable ACL results. Nonetheless, both Op and ACL assessment of reperfusion strongly inform prediction of 3-year mortality.

Advances in the hospital management of patients following an out of hospital cardiac arrest.

The outcome for patients after an out-of-hospital cardiac arrest (OHCA) has been poor over many decades and single interventions have mostly resulted in disappointing results. More recently, some regions have observed better outcomes after redesigning their cardiac arrest pathways. Optimised resuscitation and prehospital care is absolutely key, but in-hospital care appears to be at least as important. OHCA treatment requires a multidisciplinary approach, comparable to trauma care; the development of cardiac arrest pathways and cardiac arrest centres may dramatically improve patient care and outcomes. Besides emergency medicine physicians, intensivists and neurologists, cardiologists are playing an increasingly crucial role in the post-resuscitation management, especially by optimising cardiac output and undertaking urgent coronary angiography/intervention.

Relationship between angiographic dynamic and densitometric assessment of myocardial reperfusion and survival in patients with acute myocardial infarction treated with primary percutaneous coronary intervention: the harmonizing outcomes with revascularization and stents in AMI (HORIZONS-AMI) trial.

OBJECTIVES: We evaluated 2 different methods of assessing tissue myocardial perfusion (TMP) and its impact on long-term mortality in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND: Although primary percutaneous coronary intervention restores brisk epicardial flow in approximately 90% of patients with STEMI, normal TMP is less commonly achieved. Tissue myocardial perfusion has been shown to correlate mostly with early clinical outcomes. METHODS: We analyzed the outcomes of 3,267 patients in the HORIZONS-AMI study according to final TMP, assessed by angiographic dynamic (Dyn) and densitometric (Den) methods. Multivariable analysis was performed to identify the independent influence of TMP grade 2/3 on late survival. RESULTS: Dyn TMP 2/3 was achieved in 2,600 patients (79.6%), whereas Den TMP 2/3 was achieved in 2,483 (76.0%). Mortality was significantly lower in those with Dyn TMP 2/3 compared with TMP 0/1 at 30 days (1.1% vs 6.9%, P < .0001) and at 3 years (5.1% vs 11.2%, P < .0001). Similar results were obtained with Den TMP. Dyn TMP 2/3 was an independent predictor of mortality at both time points (HR 0.21, 95% CI 0.12-0.37, P < .0001 and HR 0.53, 95% CI 0.38-0.73, P < .0001, respectively), as was Den TMP. Survival was comparable in patients with TMP 2 and TMP 3. CONCLUSIONS: Angiographic TMP can be assessed reliably using either Dyn or Den methods and is a powerful, independent predictor of early and late mortality after primary percutaneous coronary intervention in STEMI.

Development of a blood-based gene expression algorithm for assessment of obstructive coronary artery disease in non-diabetic patients.

BACKGROUND: Alterations in gene expression in peripheral blood cells have been shown to be sensitive to the presence and extent of coronary artery disease (CAD). A non-invasive blood test that could reliably assess obstructive CAD likelihood would have diagnostic utility. RESULTS: Microarray analysis of RNA samples from a 195 patient Duke CATHGEN registry case:control cohort yielded 2,438 genes with significant CAD association (p < 0.05), and identified the clinical/demographic factors with the largest effects on gene expression as age, sex, and diabetic status. RT-PCR analysis of 88 CAD classifier genes confirmed that diabetic status was the largest clinical factor affecting CAD associated gene expression changes. A second microarray cohort analysis limited to non-diabetics from the multi-center PREDICT study (198 patients; 99 case: control pairs matched for age and sex) evaluated gene expression, clinical, and cell population predictors of CAD and yielded 5,935 CAD genes (p < 0.05) with an intersection of 655 genes with the CATHGEN results. Biological pathway (gene ontology and literature) and statistical analyses (hierarchical clustering and logistic regression) were used in combination to select 113 genes for RT-PCR analysis including CAD classifiers, cell-type specific markers, and normalization genes.RT-PCR analysis of these 113 genes in a PREDICT cohort of 640 non-diabetic subject samples was used for algorithm development. Gene expression correlations identified clusters of CAD classifier genes which were reduced to meta-genes using LASSO. The final classifier for assessment of obstructive CAD was derived by Ridge Regression and contained sex-specific age functions and 6 meta-gene terms, comprising 23 genes. This algorithm showed a cross-validated estimated AUC = 0.77 (95% CI 0.73-0.81) in ROC analysis. CONCLUSIONS: We have developed a whole blood classifier based on gene expression, age and sex for the assessment of obstructive CAD in non-diabetic patients from a combination of microarray and RT-PCR data derived from studies of patients clinically indicated for invasive angiography. CLINICAL TRIAL REGISTRATION INFORMATION: PREDICT, Personalized Risk Evaluation and Diagnosis in the Coronary Tree, http://www.clinicaltrials.gov, NCT00500617.

Incidence and clinical consequences of acquired thrombocytopenia after antithrombotic therapies in patients with acute coronary syndromes: results from the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial.

BACKGROUND: The aim of the study was to investigate the incidence and clinical consequences of acquired thrombocytopenia in patients with acute coronary syndromes (ACS) in the ACUITY trial. METHODS: We examined 10,836 patients with ACS randomized to receive heparin plus glycoprotein (GP) IIb/IIIa inhibitor, bivalirudin plus GP IIb/IIIa inhibitor, or bivalirudin monotherapy. RESULTS: Acquired thrombocytopenia developed in 740 (6.8%) patients; mild (100,000-150,000 platelets/mm³), moderate (50,000-100,000 platelets/mm³), and severe (< 50,000 platelets/mm³) developed in 656 (6%), 51 (0.5%), and 33 (0.3%) patients, respectively. Patients with acquired thrombocytopenia, compared with those without, were more likely to develop major bleeding (14% vs 4.3%, P < .0001) at 30 days and had higher rates of mortality (6.5% vs 3.4%, P < .0001) at 1 year. By multivariate analysis, acquired thrombocytopenia was an independent predictor of major bleeding at 30 days (hazard ratio [HR] 1.68, 95% CI 1.04-2.72, P = .03). Moderate and severe acquired thrombocytopenia were predictors of mortality at 1 year (HR 2.89, 95% CI 0.92-9.06, P = .06, and HR 3.41, 95% CI 1.09-10.68, P = .03, respectively). Compared to heparin plus GP IIb/IIIa inhibitor, bivalirudin monotherapy was associated with less declines in platelet count by >25% (7.6% vs 5.6%, P = .0009) and >50% (1.4% vs 0.7%, P = .004) from baseline. CONCLUSIONS: Acquired thrombocytopenia occurs in approximately 1 in 14 patients with ACS treated with antithrombin and antiplatelet medications and is strongly associated with hemorrhagic and ischemic complications. Compared to an anticoagulant regimen including a GP IIb/IIIa inhibitor, administration of bivalirudin monotherapy appears to be associated with less frequent declines in platelet count.

New approaches for the assessment of vessel sizes in quantitative (cardio-)vascular X-ray analysis.

This paper presents new approaches for the assessment of the arterial and reference diameters in (cardio-)vascular X-ray images, designed to overcome the problems experienced in conventional quantitative coronary and vascular angiography approaches. In single or "straight" vessel segments, the arterial and reference diameter directions were made independent of each other in order to be able to measure the minimal lumen diameter (MLD) more accurately, especially in curved vessel segments. For ostial segments, an extension of this approach was used, to allow measurement of ostial lesions in sidebranches more proximal than using conventional methods. Furthermore, two new bifurcation approaches were developed. The validation study shows that the straight segment approach results in significant smaller MLDs (on average 0.032 mm) and the ostial approach achieves on average an increase in %DS of 3.8% and an increase in lesion length of 0.59 mm due to loosening the directional constraint. The validation of our new bifurcation approaches in phantom data as well as clinical data shows only small differences between pre- and post-intervention measurements of the reference diameters outside the bifurcation core (errors smaller than 0.06 mm) and the bifurcation core area (errors smaller than 1.4% for phantom data). In summary, these new approaches have led to further improvements in the quantitative analyses of (cardio-)vascular X-ray angiographies.

Prognostic modeling of individual patient risk and mortality impact of ischemic and hemorrhagic complications: assessment from the Acute Catheterization and Urgent Intervention Triage Strategy trial.

BACKGROUND: Both ischemic and hemorrhagic complications increase mortality rate in acute coronary syndromes. Their frequency and relative importance vary according to individual patient risk profiles. We sought to develop prognostic models for the risk of myocardial infarction (MI) and major bleeding to assess their impact on risk of death and to examine the manner in which alternative antithrombotic regimens affect these risks in individual patients. METHODS AND RESULTS: The Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial randomized 13 819 patients with acute coronary syndrome to heparin plus a glycoprotein IIb/IIIa inhibitor, bivalirudin plus a glycoprotein IIb/IIIa inhibitor, or bivalirudin alone. By logistic regression, there were 5 independent predictors of MI within 30 days (n=705; 5.1%) and 8 independent predictors of major bleeding (n=645; 4.7%), only 2 of which were common to both event types. In a covariate-adjusted, time-updated Cox regression model, both MI and major bleeding significantly affected subsequent mortality rate (hazard ratios, 2.7 and 2.9, respectively; both P<0.001). Treatment with bivalirudin versus heparin plus a glycoprotein IIb/IIIa inhibitor was associated with a nonsignificant 8% increase in MI and a highly significant 50% decrease in major bleeding. Given the individual patient risk profiles and the fact that bivalirudin prevented approximately 6 major bleeds for each MI that might occur from its use, the estimated reduction in bleeding was greater than the estimated increase in MI by bivalirudin alone rather than heparin plus a glycoprotein IIb/IIIa inhibitor for nearly all patients. CONCLUSIONS: Consideration of the individual patient risk profile for MI and major bleeding and the relative treatment effects of alternative pharmacotherapies permits personalized decision making to optimize therapy of patients with acute coronary syndrome. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00093158.

Intravascular ultrasound assessment of the incidence and predictors of edge dissections after drug-eluting stent implantation.

OBJECTIVES: We used intravascular ultrasound (IVUS) to assess incidence, predictors, morphology, and angiographic findings of edge dissections after drug-eluting stent (DES) implantation. BACKGROUND: DES implantation strategies differ compared with bare-metal stenting; coronary dissections after DES implantation have not been well studied. METHODS: We studied 887 patients with 1,045 non-in-stent restenosis lesions in 977 native arteries undergoing DES implantation with IVUS imaging. RESULTS: Eighty-two dissections were detected; 51.2% (42 of 82) involved the proximal and 48.8% (40 of 82) the distal stent edge. Residual plaque area (8.0 +/- 4.3 mm(2) vs. 5.2 +/- 3.0 mm(2), p < 0.0001); plaque burden (52.2 +/- 11.7% vs. 36.2 +/- 15.3%, p < 0.0001); plaque eccentricity (8.4 +/- 5.5 vs. 4.0 +/- 3.4, p < 0.0001); and stent edge symmetry (1.2 +/- 0.1 vs. 1.1 +/- 0.1, p = 0.02) were larger; plaque burden > or =50% was more frequent (62.0% vs. 17.2%, p < 0.0001); calcium deposits (52.1% vs. 35.2%, p = 0.03) more common; and lumen-to-stent-edge-area ratio (0.9 +/- 0.2 vs. 1.0 +/- 0.2, p < 0.0001) was smaller in the edge dissection group compared with the nondissection group. Intramural hematomas occurred in 34.1% (28 of 82) of dissections. When compared with nonhematoma dissections, residual plaque and media area (6.4 +/- 2.5 mm(2) vs. 8.9 +/- 4.6 mm(2), p = 0.04) was smaller, and stent edges less asymmetric (1.1 +/- 0.1 vs. 1.2 +/- 0.1, p = 0.009) in the dissection with hematoma group. Independent predictors of any stent edge dissection were residual plaque eccentricity (odds ratio [OR]: 1.4, p = 0.02), lumen-to-stent-edge-area ratio (OR: 0.0, p = 0.007), and stent edge symmetry (OR: 1.2, p = 0.02 for each 0.01 increase). CONCLUSIONS: IVUS identified edge dissections after 9.2% of DES implantations. Residual plaque eccentricity, lumen-to-stent-edge-area ratio, and stent edge symmetry predicted coronary stent edge dissections. Dissections in less diseased reference segments more often evolved into an intramural hematoma.

Gastrointestinal bleeding in patients with acute coronary syndromes: incidence, predictors, and clinical implications: analysis from the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial.

OBJECTIVES: We assessed the incidence, predictors, and outcomes of gastrointestinal bleeding (GIB) in patients with acute coronary syndromes (ACS). BACKGROUND: GIB is a potential hemorrhagic complication in patients with ACS treated with antithrombotic and/or antiplatelet medications. The clinical outcomes associated with GIB in this setting have not been systematically studied. METHODS: In the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial, 13,819 patients with moderate- and high-risk ACS, enrolled at 450 centers in 17 countries between August 2003 and December 2005, were randomized to the open-label use of 1 of 3 antithrombin regimens (heparin plus a glycoprotein IIb/IIIa inhibitor, bivalirudin plus a glycoprotein IIb/IIIa inhibitor, or bivalirudin monotherapy). RESULTS: GIB within 30 days occurred in 178 patients (1.3%). Older age, baseline anemia, longer duration of study drug administration before angiogram, smoking, ST-segment deviation>or=1 mm, and diabetes were identified as independent predictors of GIB. On multivariable analysis, GIB was strongly associated with 30-day all-cause mortality (hazard ratio [HR]: 4.87 [interquartile range (IQR) 2.61 to 9.08], p<0.0001), cardiac mortality (HR: 5.35 [IQR 2.71 to 10.59], p<0.0001), and composite ischemia (HR: 1.94 [IQR 1.14 to 3.30], p=0.014), as well as with 1-year all-cause mortality (HR: 3.97 [IQR 2.64 to 5.99], p<0.0001), cardiac mortality (HR: 3.77 [IQR 2.14 to 6.63], p<0.0001), myocardial infarction (HR: 1.74 [IQR 1.01 to 3.02], p=0.047), and composite ischemia (HR: 1.90 [IQR 1.37 to 2.64], p=0.0001). Patients who experienced GIB had significantly higher rates of stent thrombosis compared with patients without GIB (5.8% vs. 2.4%, p=0.009). CONCLUSIONS: GIB is a serious condition in the scenario of ACS and is independently associated with mortality and ischemic complications.

Volumetric intravascular ultrasound assessment of neointimal hyperplasia and nonuniform stent strut distribution in sirolimus-eluting stent restenosis.

The neointimal hyperplasia (IH) distribution pattern of in-stent restenotic lesions after sirolimus-eluting stent (SES) implantation has not been well described. We identified 48 in-stent restenotic lesions (41 patients) after SES implantation and performed volumetric intravascular ultrasound analyses. Lumen area, stent area, and IH area at the minimal lumen area site were 2.7 +/- 1.0, 5.4 +/- 1.9, and 2.7 +/- 1.4 mm(2), respectively. IH area at the minimal lumen site was larger in the group with a stent area > or =5.0 mm(2) than the group with a stent area <5.0 mm(2) (3.7 +/- 1.3 vs 1.9 +/- 0.8 mm(2), p <0.001). There were fewer visualized stent struts in lesions with a minimum stent area > or =5.0 mm(2) at the minimum lumen site compared with those with a stent area <5.0 mm(2) (0.69 +/- 0.25 vs 0.83 +/- 0.16, p = 0.04). When we compared lesions in patients with diabetes mellitus with patients without diabetes, minimum lumen areas, percent IH at minimal lumen area, percent IH, and neointima-free stent length were identical. In conclusion, (1) lesions without SES underexpansion at the minimum lumen site had more IH and greater nonuniform stent strut distribution compared with restenotic SESs that were underexpanded, and (2) the IH response did not appear to be more aggressive in patients with diabetes mellitus than in those without diabetes mellitus.

Intravascular ultrasonic assessment of stent diameters derived from manufacturer's compliance charts.

We used intravascular ultrasound (IVUS) to assess the accuracy of manufacturers' stent balloon compliance charts. Many interventional cardiologists rely on manufacturers' compliance charts to select stent size and optimize stent diameters according to inflation pressures during percutaneous procedures. We randomly selected 212 patients who had de novo coronary lesions that had been treated with a single, bare metal, > or =3.0-mm stent (Bx velocity, NIR, TETRA/PENTA, S660/S670/S7) under IVUS guidance. Cases of stent overlap and postdilatation with another balloon were excluded. Predicted stent diameters were derived from each manufacturer's compliance charts, and stent size and final maximal deployment pressures were derived from each physician's report. IVUS-measured minimum stent diameters (range 1.4 to 4.0 mm, mean 2.79 +/- 0.48) were smaller than predicted diameters (range 3.1 to 4.57 mm, mean 3.79 +/- 0.44). The ratio of IVUS to predicted diameters ranged from 44% to 97% (mean 74 +/- 10%). This finding was common to all 3 stent sizes: 74 +/- 12% for 3.0 mm, 73 +/- 9% for 3.5 mm, and 74 +/- 9% for 4.0-mm stents (p = 0.9). This finding was also common to all 4 stent manufacturers, 72 +/- 8% for Boston Scientific, 76 +/- 11% for Guidant, 73 +/- 9% for Cordis, and 74 +/- 11% for Medtronic (p = 0.13), and to different stent lengths. Only 3.8% of the stents achieved 90% of the predicted minimum stent diameters, and only 24.6% achieved 80% of the predicted minimum stent diameters. In conclusion, in human coronary arteries, minimal stent diameter measured by IVUS is significantly smaller than that predicted by in vitro compliance charts. These differences are independent of stent manufacturer, length, diameter, and deployment pressure.

Intravascular ultrasound assessment of lesions with target vessel failure after sirolimus-eluting stent implantation.

Intravascular ultrasound (IVUS) evaluation was performed in 33 lesions with sirolimus-eluting stent (SES) failure: 4 thromboses, 26 in-stent restenoses (including 6 edge stenoses), 4 new stenoses >5 mm proximal to the stent, and 1 patient with no evidence of the implanted SES (presumably because of embolization). A minimum stent area <5.0 mm(2) (stent underexpansion) was observed in 67% of all SES failures (in particular, 67% of intrastent restenosis); negative remodeling was observed in 4 of 6 stent edge restenoses, and new lesions were secondary to an increase in plaque area.

Prognostic utility of comparative methods for assessment of ST-segment resolution after primary angioplasty for acute myocardial infarction: the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial.

OBJECTIVE: This study was done to assess and compare the prognostic significance of multiple methods for measuring ST-segment elevation resolution (STR) following primary percutaneous coronary intervention (PCI). BACKGROUND: Resolution of ST-segment elevation (STE) is a powerful predictor of both infarct-related artery patency and mortality in acute myocardial infarction (AMI). Recent thrombolytic studies have suggested that simple measures of STR may be as powerful as more complex algorithms. The optimal method of assessing STR following primary PCI has not been studied. METHODS: We analyzed 700 patients with technically adequate baseline and post-PCI electrocardiograms from the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial. Five methods were used to assess STR: 1) summed %STR across multiple leads (SigmaSTR); 2) %STR in the single lead with maximum baseline STE (MaxSTR); 3) absolute maximum STE before the procedure; 4) absolute maximum STE after intervention (MaxSTPost); and 5) a categorical variable based upon MaxSTPost (High Risk). RESULTS: At 30 days, SigmaSTR, MaxSTR, and MaxSTPost all correlated strongly with mortality (p = 0.004, p = 0.005, and p < 0.0001, respectively) and the combined end point of mortality or reinfarction (p = 0.001, p = 0.001, and p < 0.0001). At one year, SigmaSTR and MaxSTPost correlated with mortality (p = 0.04, p = 0.0001), reinfarction (p = 0.02, p = 0.0015), and the combined end point (p = 0.02, p < 0.0001). By multivariate analysis, only the simpler measures of MaxSTPost and High Risk categorization independently predicted all outcomes at both time points. CONCLUSIONS: The STR following primary PCI in AMI correlates strongly with mortality and reinfarction, independent of target vessel patency. The simple measure of the maximal residual degree of STE after primary PCI is a strong independent predictor of both survival and freedom from reinfarction at 30 days and 1 year.

Intravascular ultrasound assessment of ulcerated ruptured plaques: a comparison of culprit and nonculprit lesions of patients with acute coronary syndromes and lesions in patients without acute coronary syndromes.

BACKGROUND: It is not clear why some plaque ruptures lead to acute coronary syndromes (ACS) but others do not. METHODS AND RESULTS: We analyzed 80 plaque ruptures in 74 patients and compared culprit lesions of ACS patients with nonculprit lesions of ACS patients and lesions of non-ACS patients; both culprit and nonculprit plaque ruptures were studied in 6 of 54 ACS patients. Intravascular ultrasound findings suggesting thrombus were observed more frequently in culprit lesions of ACS patients (n=35) compared with nonculprit lesions of ACS patients (n=19) and lesions of non-ACS patients (n=26): 60% versus 32% versus 8% (P<0.001). At the minimal lumen site, smaller lumen areas (3.3+/-1.5 versus 5.4+/-2.6 versus 6.1+/-2.0 mm2, P<0.001) and greater area stenosis (61+/-15% versus 50+/-14% versus 46+/-18%, P=0.002) and plaque burden (80+/-8% versus 71+/-8% versus 69+/-10%, P<0.001) were observed in culprit lesions of ACS patients compared with nonculprit lesions of ACS patients and lesions of non-ACS patients. Lesions were longer (18.7+/-6.4 versus 154.9+/-6.1 versus 12.0+/-4.9 mm, P<0.001) and rupture site remodeling indices were greater (1.26+/-0.21 versus 1.24+/-0.21 versus 1.09+/-0.05, P=0.002). Independent predictors of culprit plaque ruptures in ACS patients were smaller minimum lumen areas (P=0.02) and presence of thrombus (P=0.01). CONCLUSIONS: Ruptured plaques in culprit lesions of ACS patients have smaller lumens; greater plaque burdens, area stenosis, and remodeling indices; and more thrombus. Plaque rupture itself does not lead to symptoms. The association of plaque rupture with a smaller lumen area and/or thrombus formation causes lumen compromise and leads to symptoms.