Relationship Between Femoral Vascular Closure Devices and Short-Term Mortality From 271 845 Percutaneous Coronary Intervention Procedures Performed in the United Kingdom Between 2006 and 2011: A Propensity Score-Corrected Analysis From the British Cardiovascular Intervention Society.

BACKGROUND: The impact of vascular closure devices (VCDs) via the femoral arterial access site on short-term mortality in patients undergoing percutaneous coronary intervention is currently unknown. METHODS AND RESULTS: The association between femoral arterial vascular access site management (manual pressure [including external clamp] versus VCD) and 30-day mortality was examined in a national real-world registry of 271 845 patients undergoing percutaneous coronary intervention for elective, non-ST-segment-elevation myocardial infarction and ST-segment-elevation myocardial infarction indications in the United Kingdom between 2006 and 2011. Crude and propensity score-corrected analyses were performed using Cox regression, with additional analyses undertaken in clinically relevant subgroups; 40.1% (n=109 001) of subjects were treated with manual pressure and 59.9% (n=162 844) with VCD. Subjects treated with VCD had fewer comorbidities and were less likely to present with ST-segment-elevation myocardial infarction and cardiogenic shock (P<0.001). Crude 30-day mortality was lower in the group treated with VCD compared with manual pressure (hazard ratio [HR], 0.58; 95% confidence interval [CI], 0.54-0.61; 1.4% versus 2.4%, log rank P<0.0001), findings that were substantially reduced but persisted after propensity score correction (HR, 0.91; 95% CI, 0.86-0.97; 1.8% versus 2.0% versus P<0.001). A more pronounced association of VCD with a reduction in 30-day mortality was evident in females (HR, 0.85; 95% CI, 0.77-0.94; Pinteraction=0.037), presentation with acute coronary syndrome (HR, 0.88; 95% CI, 0.83-0.94; Pinteraction=0.0027), or recent lysis (HR, 0.63; 95% CI, 0.40-1.01; Pinteraction=0.0001). CONCLUSIONS: When compared with manual pressure, VCD was associated with a minor short-term (30-day) prognostic benefit after propensity score correction in the global population and clinically relevant subgroups. The potential for residual confounding factors impacting on short-term mortality cannot be excluded, despite the study having measured and balanced all recorded confounder factors.

Everolimus-eluting stents and paclitaxel-eluting stents in patients presenting with myocardial infarction: insights from the two-year results of the COMPARE prospective randomised controlled trial.

AIMS: Although large clinical trials have shown that everolimus-eluting stents (EES) significantly reduce target vessel revascularisation (TVR), myocardial infarction (MI) and stent thrombosis (ST) compared to paclitaxel-eluting stents (PES) in diverse populations, there is a paucity of data comparing EES and PES in patients presenting with MI. METHODS AND RESULTS: We performed a post hoc subgroup analysis on COMPARE, an all-comer trial comparing EES to PES. We identified 863 patients (EES=434, PES=429 treated for MI: 452 ST-elevation MI (STEMI) and 411 non ST-elevation MI (NSTEMI). EES was associated with a significant reduction in the primary endpoint, a composite of all-cause mortality, MI, and TVR, at two years (RR=0.57; 95% CI: 0.40-0.83, p=0.002). While the effect was more marked in the STEMI (RR=0.51; 95% CI: 0.30-0.87, p=0.01) than the NSTEMI subgroup (RR=0.65; 95% CI: 0.39-1.08, p=0.09), the interaction p-value (0.5) suggests that a difference in treatment effect between presentations is unlikely. ST rates were significantly lower with EES (RR=0.30; 95% CI: 0.12-0.73, p=0.005). CONCLUSIONS: At two years, EES results are superior to PES in terms of safety and efficacy endpoints in treatment of MI.

Cardiovascular risk profile of patients included in stent trials; a pooled analysis of individual patient data from randomised clinical trials: insights from 33 prospective stent trials in Europe.

AIMS: Few data document trends in cardiovascular (CV) risk-factors in patients with or without previous symptomatic CV disease. We assessed the prevalence and trends in (non) modifiable CV risk-factors, and the use of cardioprotective therapies in patients enrolled in coronary stent trials. METHODS AND RESULTS: This analysis included prospective data on 10,253 mainly European adults who were enrolled in 32 coronary stent studies between 1995 and 2006. Data was collected at the time of enrolment using a standardised patient clinical record form, and was analysed by considering three consecutive time periods: 1995-1997 (I), 1998-2002 (II) and 2003-2006 (III) rendering approximately equal numbers per period. Overall the proportion of active smokers remained constant (Period I to III: 28%, 27%, 21%, p=0.45), however the proportion increased in females below 50 years (about 2%/ year, R.RR: 1.20, P: 0.05 period III versus I). Prevalent diabetes increased (16%, 17%, 25%; p=0.029). The prevalence of a body-mass index (BMI) ≥25 kg/m² was high, but no trend was observed (69%, 68%, 70%; p=0.24). The proportion of patients with elevated blood pressure (i.e., ≥140/90 mmHg, in diabetes ≥130/80 mmHg) remained unchanged (55%, 50.%, 53%; p=0.22), despite an increase in the number of patients taking anti-hypertensive agents (84%, 89%, 90%; p=0.30). Conversely, the proportion of patients with elevated total cholesterol (i.e., ≥4.5 mmol/L) decreased (80%, 66%, 52%; p=0.002), which was consistent with the increase in patients taking lipid lowering drugs (32%, 62%, 69%; p=0.083). The portion of patients reaching therapeutic targets for blood lipids improved, but no improvement was seen in blood pressure control (p=0.29). CONCLUSIONS: There is an unmet clinical need in primary and secondary CV prevention in Europe. Patients requiring PCI are an important target population in whom lifestyle changes and aggressive secondary preventative measures should be aimed. Ultimately PCI should open the door towards optimising secondary prevention.

Value of age, creatinine, and ejection fraction (ACEF score) in assessing risk in patients undergoing percutaneous coronary interventions in the 'All-Comers' LEADERS trial.

BACKGROUND: The age, creatinine, and ejection fraction (ACEF) score (age/left ventricular ejection fraction+1 if creatinine >2.0 mg/dL) has been established as an effective predictor of clinical outcomes in patients undergoing elective coronary artery bypass surgery; however, its utility in "all-comer" patients undergoing percutaneous coronary intervention is yet unexplored. METHODS AND RESULTS: The ACEF score was calculated for 1208 of the 1707 patients enrolled in the LEADERS trial. Post hoc analysis was performed by stratifying clinical outcomes at the 1-year follow-up according to ACEF score tertiles: ACEF(low) ≤1.0225, 1.0225< ACEF(mid) ≤1.277, and ACEF(high) >1.277. At 1-year follow-up, there was a significantly lower number of patients with major adverse cardiac event-free survival in the highest tertile of the ACEF score (ACEF(low)=92.1%, ACEF(mid)=89.5%, and ACEF(high)=86.1%; P=0.0218). Cardiac death was less frequent in ACEF(low) than in ACEF(mid) and ACEF(high) (0.7% vs 2.2% vs 4.5%; hazard ratio=2.22, P=0.002) patients. Rates of myocardial infarction were significantly higher in patients with a high ACEF score (6.7% for ACEF(high) vs 5.2% for ACEF(mid) and 2.5% for ACEF(low); hazard ratio=1.6, P=0.006). Clinically driven target-vessel revascularization also tended to be higher in the ACEF(high) group, but the difference among the 3 groups did not reach statistical significance. The rate of composite definite, possible, and probable stent thrombosis was also higher in the ACEF(high) group (ACEF(low)=1.2%, ACEF(mid)=3.5%, and ACEF(high)=6.2%; hazard ratio=2.04, P<0.001). CONCLUSIONS: ACEF score may be a simple way to stratify risk of events in patients treated with percutaneous coronary intervention with respect to mortality and risk of myocardial infarction.

Differential protein biomarker expression and their time-course in patients with a spectrum of stable and unstable coronary syndromes in the Integrated Biomarker and Imaging Study-1 (IBIS-1).

OBJECTIVES: IBIS-1 was a pilot study undertaken to correlate coronary imaging with circulating biomarker expression in patients with stable angina, unstable angina and acute myocardial infarction. We hypothesized that patients at high risk of future events could be identified in the future by a combination of high risk plaque features by plaque echogenicity and palpography and a set of circulating blood biomarkers. RESULTS AND METHODS: We assessed the expression of conventional biomarkers and novel marker protein microarray (170 analytes) over 6 months. There were no strong correlations observed between conventional biomarkers and coronary imaging in non-culprit artery. Proteomic microarray was performed in 66 patients. Seventy eight (45%) analytes showed dynamic changes over time. Using hierarchical clustering and principal component analysis two subsets of biomarkers were identified: initial up-regulation and decrease over time (D-dimer, hepatocyte growth factor, CXCL9/MIG, platelet factor 4/CXCL4, CTACK, C-6 Kine, follistatin, and FGF-7) and the opposite increase (PAI-1- anti-apoptotic protein and I-309--chemokine induced on the human endothelium by Lp(a)). CONCLUSIONS: Proteomic analysis identifies dynamic patterns in circulating biomarkers in a wide range of patients with coronary artery disease. Further large natural history studies are needed to better define multibiomarker sets for identification of patients at risk of future CV events.

A comparison of the distribution of necrotic core in bifurcation and non-bifurcation coronary lesions: an in vivo assessment using intravascular ultrasound radiofrequency data analysis.

AIMS: High-risk plaques are prone to develop at the site of coronary vessel bifurcations. The distribution of necrotic core at bifurcation lesions (BL) is known, however, little has been described on the necrotic core distribution in non-BLs. Therefore we compared the distribution of necrotic core between BL and non-BLs in coronary arteries using IVUS-VH imaging. METHODS AND RESULTS: A total of 129 patients (112 non-BL and 108 BL) were included. The lesions were divided into upstream and downstream segments according the location of the minimum lumen area (MLA) within the plaque. In BLs, compositional analysis showed no differences between the three segments. The necrotic core in contact with the lumen that was located in the downstream segment was significantly larger. While in non-BLs, this was not significantly different between segments. Plaque burden in BLs was 56.60±5.79% vs. 55.50±4.54% in non-BLs, p=0.04. Mean necrotic core area was larger in BLs 0.84±0.55mm2 vs. 0.70±0.49mm2, p=0.048. Mean percentage necrotic core was 15.48±8.02% vs. 14.51±7.64%, p=0.37. There was a trend towards a greater content of necrotic core in contact with the lumen in BLs. The percentage of frames with a major confluent pool of necrotic core in contact with the lumen >10% in BLs was 11.78±17.18 vs. 8.95±17.86 in non-BLs, p=0.065. There was a statistically significant difference in the frequency of IVUS derived thin capped fibroatheromas between bifurcation lesions 20 vs. 13 in non-bifurcation lesions, p=0.03. CONCLUSIONS: Bifurcation lesions appear to have a larger plaque burden with a different plaque composition compared to non-bifurcation lesions. This may partly explain the adverse outcomes seen following treatment of bifurcation lesions in contemporary practice.

The SYNTAX score revisited: a reassessment of the SYNTAX score reproducibility.

OBJECTIVES: To reassess the reproducibility of the SYNTAX score. BACKGROUND: The SYNTAX score appears to have an important role to play in the evaluation of patients with complex coronary artery disease undergoing revascularisation. However, the calculation of the SYNTAX score relies on the subjective assessment of lesions using coronary angiography, and therefore is subject to intra-and inter-observer variability. METHODS: The SYNTAX score was calculated in 100 patients randomly selected from the SYNTAX trial, on two occasions 8 weeks apart, by a team made up of three interventional cardiologists. The weighted kappa values were compared with values obtained 1 year previously, when core lab analysts assessed the intra-observer reproducibility amongst the same patient cohort. RESULTS: The mean +/- standard deviation difference in SYNTAX score was 2.1 +/- 7.6. The respective weighted kappa values for the number of lesions, bifurcation lesions, ostial lesions, and total occlusions were 0.62, 0.36, 0.66, and 0.91 compared with 0.59, 0.41, 0.63, and 0.82 in the previous core lab assessment. The weighted kappa for the intra-observer reproducibility of the SYNTAX score grouped into deciles was 0.54, and according to the terciles < or = 22, >22-< or = 32, >32 was 0.51 both indicating a moderate level of agreement beyond the level of chance. In the previous assessment, the comparative kappa values were 0.45 and 0.53. CONCLUSIONS: The SYNTAX score has moderate intra-observer reproducibility when assessed by a team of three interventional cardiologists, which is consistent with a prior evaluation performed by core lab analysts. The scoring of bifurcation lesions remains the main source of inconsistency.

The impact of body mass index on the one year outcomes of patients treated by percutaneous coronary intervention with Biolimus- and Sirolimus-eluting stents (from the LEADERS Trial).

The aim of this analysis was to assess the effect of body mass index (BMI) on 1-year outcomes in patients enrolled in a contemporary percutaneous coronary intervention trial comparing a sirolimus-eluting stent with a durable polymer to a biolimus-eluting stent with a biodegradable polymer. A total of 1,707 patients who underwent percutaneous coronary intervention were randomized to treatment with either biolimus-eluting stents (n = 857) or sirolimus-eluting stents (n = 850). Patients were assigned to 1 of 3 groups according to BMI: normal (<25 kg/m(2)), overweight (25 to 30 kg/m(2)), or obese (>30 kg/m(2)). At 1 year, the incidence of the composite of cardiac death, myocardial infarction, and clinically justified target vessel revascularization was assessed. In addition, rates of clinically justified target lesion revascularization and stent thrombosis were assessed. Cox proportional-hazards analysis, adjusted for clinical differences, was used to develop models for 1-year mortality. Forty-five percent of the patients (n = 770) were overweight, 26% (n = 434) were obese, and 29% (n = 497) had normal BMIs. At 1-year follow-up, the cumulative rate of cardiac death, myocardial infarction, and clinically justified target vessel revascularization was significantly higher in the obese group (8.7% in normal-weight, 11.3% in overweight, and 14.5% in obese patients, p = 0.01). BMI (hazard ratio 1.47, 95% confidence interval 1.02 to 2.14, p = 0.04) was an independent predictor of stent thrombosis. Stent type had no impact on the composite of cardiac death, myocardial infarction, and clinically justified target vessel revascularization at 1 year in the 3 BMI groups (hazard ratio 1.08, 95% confidence interval 0.63 to 1.83, p = 0.73). In conclusion, BMI was an independent predictor of major adverse cardiac events at 1-year clinical follow-up. The higher incidence of stent thrombosis in the obese group may suggest the need for a weight-adjusted dose of clopidogrel.

Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial.

BACKGROUND: Everolimus-eluting and paclitaxel-eluting stents, compared with bare metal stents, reduced the risk of restenosis in clinical trials with strict inclusion and exclusion criteria. We compared the safety and efficacy of the second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice. METHODS: We randomly assigned 1800 consecutive patients (aged 18-85 years) undergoing percutaneous coronary intervention at one centre to treatment with everolimus-eluting or paclitaxel-eluting stents. The primary endpoint was a composite of safety and efficacy (all-cause mortality, myocardial infarction, and target vessel revascularisation) within 12 months. Patients were not told which stent they had been allocated. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT01016041. FINDINGS: Follow-up was completed in 1797 patients. The primary endpoint occurred in 56 (6%) of 897 patients in the everolimus-eluting stent group versus 82 (9%) of 903 in the paclitaxel-eluting stent group (relative risk 0.69 [95% CI 0.50-0.95], p value for superiority=0.02). The difference was attributable to a lower rate of stent thrombosis (6 [<1%] vs 23 [3%], 0.26 [0.11-0-64], p=0.002), myocardial infarction (25 [3%] vs 48 [5%], 0.52 [0.33-0.84], p=0.007), and target vessel revascularisation (21 [2%] vs 54 [6%], 0.39 [0.24-0.64], p=0.0001). Cardiac death, non-fatal myocardial infarction, or target lesion revascularisation occurred in 44 [5%] patients in the everolimus-eluting stent group versus 74 [8%] patients in the paclitaxel-eluting stent group, p value for superiority was 0.005. INTERPRETATION: The everolimus-eluting stent is better than the second generation paclitaxel-eluting stent in unselected patients in terms of safety and efficacy. On the basis of our results, we suggest that paclitaxel-eluting stents should no longer be used in everyday clinical practice. FUNDING: Unrestricted grants from Abbott Vascular and Boston Scientific.

Effect of clopidogrel discontinuation at 1 year after drug eluting stent placement on soluble CD40L, P-selectin and C-reactive protein levels: DECADES (Discontinuation Effect of Clopidogrel After Drug Eluting Stent): a multicenter, open-label study.

Antiplatelet therapy with clopidogrel has been shown to reduce major adverse cardiac events in acute coronary syndromes and after percutaneous interventions. This effect is not only due to its anti-platelet effect but also possibly due to an anti-inflammatory effect. The effect of clopidogrel cessation after one year of therapy on markers of inflammation has been investigated in diabetics and showed an increase in platelet aggregation as well as hsCRP and surface P-selectin levels. This was an exploratory multicenter prospective open-label single arm study of 98 non-diabetic patients who had received one or more drug eluting stents and were coming to the end of their 12 months course of clopidogrel therapy. The effect of clopidogrel cessation on expression of biomarkers: sCD40L, soluble P-selectin and hsCRP was measured right before clopidogrel cessation (day 0), and subsequently at 1, 2, 3 and 4 weeks after drug withdrawal. A median increase in sCD40L expression from 224 to 324.5 pg/ml was observed between baseline and 4 weeks after clopidogrel cessation, which corresponded to a 39% mean percent change based on an ANCOVA model (P < 0.001). Over the 4 weeks observation period the change in sCD40L expression correlated weakly with soluble P-selectin levels (at 4 weeks Spearman's correlation coefficient = 0.32; P = 0.0024). Increase in P-selectin expression from baseline was statistically significant at week 1 and 2. Conversely, hsCRP level decreased by 21% at 1 week (P = 0.008) and was still reduced by 18% by 4 weeks (P = 0.062). The change in sCD40L expression appeared to vary with the type of drug eluting stent. Patients treated with drug eluting stents at 1 year after implantation display significant increase in sCD40L and decrease in hsCRP after clopidogrel cessation. Further studies should elucidate if this increase in sCD40L levels reflects solely the removal of the inhibitory effects of clopidogrel on platelet activity or rather an increase in pro-inflammatory state. The latter hypothesis may be less likely given decrease in hsCRP levels. Randomized studies are urgently needed to establish potential link of clopidogrel discontinuation and vascular outcomes.

Synergistic effect of cardiovascular risk factors on necrotic core in coronary arteries: a report from the global intravascular radiofrequency data analysis registry.

OBJECTIVES: This study explored whether an individual or a cluster of risk factors affects the extent of necrotic core (NC) assessed by intravascular ultrasound (IVUS) radiofrequency data (RFD) analysis. BACKGROUND: Several systemic diseases contribute to the development of coronary artery disease. METHODS: The Global Intravascular Radiofrequency Data Analysis Registry was a prospective, multicenter, nonrandomized database that enrolled 990 patients with coronary artery disease in whom 1 major coronary artery was imaged by IVUS-RFD. For the multivariable analysis, the population was divided into 4 classes: young women, young men (both 62 years). Mean NC area was categorized as 1: top quartile (>or=0.62 mm(2)) or as 0: lower 3 quartiles. RESULTS: Young patients had less NC compared with older patients (0.40 +/- 0.36 mm(2) of NC vs. 0.50 +/- 0.46 mm(2) in old patients, p = 0.0007). Nondiabetic patients had less NC than diabetic patients (0.43 +/- 0.41 mm(2) of NC vs. 0.51 +/- 0.44 mm(2) in diabetic patients, p = 0.02). The NC area was lower in normotensive patients (0.40 +/- 0.36 mm(2)) than in hypertensive patients (0.48 +/- 0.44 mm(2)) (p = 0.02). In the bivariate analysis, age, hypertension, diabetes, and prior coronary artery bypass graft were statistically significant, however in logistic regression analysis, only age (odds ratio [OR]: 1.023, 95% confidence interval [CI]: 1.009 to 1.037, p = 0.001) and diabetes (OR: 1.636, 95% CI: 1.174 to 2.279, p = 0.004) remained statistically significant. In a per-class logistic regression analyses including only diabetes as covariate, the OR in young women was 2.1 (95% CI: 0.77 to 6.0, p = 0.14), in young men the OR was 1.6 (95% CI: 0.90 to 2.7, p = 0.11), in old women the OR was 2.3 (95% CI: 1.09 to 4.9, p = 0.03), and in old men the OR was 1.6 (95% CI: 0.96 to 2.7, p = 0.07). Further, when only patients with diabetes and hypertension were included, young men (OR: 2.0, p = 0.041), old women (OR: 3.04, p = 0.046), and old men (OR: 2.2, p = 0.025) were significant. CONCLUSIONS: Individually and collectively, age and diabetes mellitus are associated with an increase in NC by IVUS-RFD analysis.

Computed tomography in total coronary occlusions (CTTO registry): radiation exposure and predictors of successful percutaneous intervention.

AIMS: There is no mention in the current "appropriateness criteria for CTCA" of the need of CTCA investigation prior to an attempt at recanalisation of a CTO. To define better the role of CTCA in the treatment of patients with CTOs, we performed CTCA in a consecutive cohort of eligible patients who were scheduled for percutaneous recanalisation of a CTO. METHODS AND RESULTS: Symptomatic patients due to a CTO suitable for percutaneous treatment were included. One hundred and thirty-nine (142 CTOs) patients were studied. Overall success rate was 62.7%. By CTCA, the occlusion length was 24.9 +/- 18.3 vs. 30.7 +/- 20.7 mm in successful and failed cases (p = 0.1), but the frequency of patients with an occlusion length >15 mm was different, i.e., 63.2% vs. 82.7%, respectively (p = 0.02). Severe calcification, (> 50% CSA) was more prevalent in failed cases (54.7% vs. 35.9%, p = 0.03). Calcification at the entry of the occlusion was present in 58.5% of the failures vs. 41.6% of the successful cases (p = 0.04), while calcium at the exit was not different. The length of calcification was 8.5 +/- 8.4 vs. 5.5 +/- 6.6 mm in the failed and successful cases respectively (p = 0.027). By multivariable analysis, the only independent predictor of procedural success was the absence of severe calcification as defined by CTCA. The mean effective radiation dose of the PCI was 39.3 +/- 30.1 mSv. The mean effective radiation dose of CT scan was 22.4 mSv: 19.2 +/- 6.5 mSv for contrast-enhanced scan, 3.2 +/- 1.7 mSv for calcium scoring scan. CONCLUSIONS: More severe calcified patterns, as assessed by CTCA, are seen in failed cases. The radiation exposure during a CT scan prior to a CTO PCI is considerable, and further studies are required to determine whether this extra diagnostic study is warranted.

Three-year clinical outcome of percutaneous treatment of bifurcation lesions in multivessel coronary artery disease with the sirolimus-eluting stent: insights from the Arterial Revascularisation Therapies Study, part II (ARTS II).

AIMS: The long-term impact of treating bifurcation lesions on the overall outcome of patients with multivessel coronary disease treated percutaneously with drug-eluting stents is unknown. This analysis determined the influence of bifurcation treatment using sirolimus-eluting stents on 3-year clinical outcomes. METHODS AND RESULTS: Of the 607 patients (2,160 lesions) in the ARTS II study, 324 patients underwent revascularisation procedures involving treatment of at least one bifurcation (465 lesions). Three-year outcomes were compared to those without bifurcations. Despite more diffuse and complex disease in the bifurcation group, survival free of adverse events was equivalent in the two groups. At 3-years, there was no difference in rate of overall MACCE (20.2% vs. 18.5%, p=NS) or any of the component events between the bifurcation and the non-bifurcation group. There was a trend for a higher rate of definite stent thrombosis in the bifurcation group (4.6 vs 2.1%, p=0.1), but in multivariate analysis the CK value post-procedure served as the only independent predictor of definite stent thrombosis (p=0.015), with the presence of a bifurcation lesion of borderline significance (p=0.056). CONCLUSIONS: In multivessel disease treated by PCI with DES, the presence of bifurcation disease had no adverse influence on 3-year clinical outcomes.

Multivessel coronary revascularization in patients with and without diabetes mellitus: 3-year follow-up of the ARTS-II (Arterial Revascularization Therapies Study-Part II) trial.

OBJECTIVES: The purpose of this study was to assess the 3-year outcome of coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) using sirolimus-eluting stents (SES) in patients who had multivessel coronary artery disease with and without diabetes mellitus. BACKGROUND: The optimal method of revascularization in diabetic patients remains in dispute. METHODS: The ARTS-II (Arterial Revascularization Therapies Study-Part II) trial is a single-arm study (n = 607) that included 159 diabetic patients treated with SES whose 3-year clinical outcome was compared with that of the historical diabetic and nondiabetic arms of the randomized ARTS-I trial (n = 1,205, including 96 diabetic patients in the CABG arm and 112 in the PCI arm). RESULTS: At 3 years, among nondiabetic patients, the incidence of the primary composite of death, CVA, myocardial infarction (MI), and repeat revascularization (major adverse cardiac and cerebrovascular events [MACCE]), was significantly lower in ARTS-II than in ARTS-I PCI (adjusted odds ratio [OR]: 0.41; 95% confidence interval [CI]: 0.26 to 0.64) and similar to ARTS-I CABG. The ARTS-II patients were at significantly lower risk for death, CVA, and MI as compared with both the ARTS-I PCI (adjusted OR: 0.55; 95% CI: 0.34 to 0.91) and ARTS-I CABG patients (adjusted OR: 0.56; 95% CI: 0.35 to 0.92). Among diabetic patients, the incidence of MACCE in ARTS-II was similar to that of both PCI and CABG in ARTS-I. Conversely, the incidence of death, CVA, and MI was significantly lower in ARTS-II than in ARTS-I PCI (adjusted OR: 0.67; 95% CI: 0.27 to 1.65) and was similar to that of ARTS-I CABG. CONCLUSIONS: At 3 years, PCI using SES for patients with multivessel coronary artery disease seems to be safer and more efficacious than PCI using bare-metal stents, irrespective of the diabetic status of the patient. Hence, PCI using SES appears to be a valuable alternative to CABG for both diabetic and nondiabetic patients.

Morphology discrimination in implantable cardioverter-defibrillators: consistency of template match percentage during atrial tachyarrhythmias at different heart rates.

BACKGROUND: Morphology discrimination (MD) in implantable cardioverter-defibrillators (ICDs) is based on the comparison of the ventricular electrogram during tachycardia with a stored reference template obtained during baseline rhythm. However, the effect of heart rate on the template match percentage during supraventricular tachyarrhythmias (SVT) is not known. The purpose of this study was to evaluate the performance of the template match percentage during SVT at different heart rates. METHODS AND RESULTS: Stored electrograms of 868 tachyarrhythmias from 88 patients with a dual-chamber ICD (St Jude Medical, USA) were analysed by the investigators. The effect of heart rate on template match percentage was estimated by regression analysis. For performance measures, data were corrected for multiple episodes in a patient by using the generalized estimating equation method. The mean template match percentage was 86.6 +/- 22.2% (median 100%) for SVT episodes. No significant differences in template match percentage between fast [ventricular cycle length (CL) 300-350 ms] and slow (ventricular CL >400 ms) SVTs were observed (85.4 +/- 27.0 vs. 87.1 +/- 19.7%). Using nominal settings, MD alone provided sensitivity and specificity of 70.2% and 89.4% overall, respectively. Morphology discrimination in conjunction with rate branch analysis, sudden onset, and stability yielded sensitivity and specificity of 98.5% and 91.2%, respectively. CONCLUSION: Morphology discrimination has a consistently high template match percentage during SVTs, which is independent of ventricular CL. The consistent high match percentage results in high specificity for arrhythmia discrimination.

Relation of plaque size to necrotic core in the three major coronary arteries in patients with acute coronary syndrome as determined by intravascular ultrasonic imaging radiofrequency.

According to pathologic studies, the content of a necrotic core increases in a "linear fashion" as plaque enlarges. In addition, these 2 plaque characteristics have been associated with plaque vulnerability. This study assessed the relation between plaque cross-sectional area (CSA) and content of necrotic core (NC). Twenty-five patients (75 arteries) with acute coronary syndrome were studied. In total, 7,834 CSAs were analyzed. An analysis of plaque CSA in percentiles was performed (median 5.5 mm(2), interquartile range 3.7 to 7.8); subsequently, plaque CSA values were categorized as small (< or = 3.7 mm(2)), medium (>3.7 to < or = 7.8 mm(2)), and large (>7.8 mm(2)). There was a difference in content of the NC between arteries within each plaque CSA category. This observation was confirmed in a multivariate analysis in which only 2 variables remained statistically significant, plaque CSA (estimate 1.34, SE 0.05, p <0.0001) and studied artery (left anterior descending coronary artery, estimate 0.29, SE 0.08, p = 0.0003; left circumflex coronary artery, estimate 0.23, SE 0.07, p = 0.0014; and these vs the right coronary artery). In conclusion, the NC and plaque increase in patients with acute coronary syndromes.

Relevant and redundant lung function parameters in discriminating asthma from COPD.

A relevant set of lung function parameters, derived from spirometry, flow-volume curves, diffusion capacity and bodyplethysmography, to discriminate asthma from COPD was established via logistic regression analysis. All new patients, referred to the outpatient clinic and later defined as asthma or COPD, underwent extensive lung function testing with reversibility testing. Logistic regression was used to calculate the probability to be a COPD or asthma patient. Selection of relevant parameters was done via 1] forward-, 2] backward-, 3] stepwise selection and 4] the best score method. All four methods were supplemented by bootstrapping to obtain a validated selection and estimation of the logistic regression parameters. The area under the ROC curve (mean+/-sd) for respectively the forward, backward, stepwise and best score selection method is 0.9348+/-0.0115, 0.9346+/-0.0115, 0.9348+/-0.0115 and 0.9296+/-0.0121. The TLCO, VA and the postdilator MEF50, VC and PEF were selected as the most relevant parameters in discriminating asthma from COPD: they appeared most often as relevant discriminators in 500 bootstrapped samples: TLco was present in all bootstrapped samples and VA, postdilator MEF50, VC and PEF in resp. 70.8%, 46.2%, 42.8% and 36.8%. Bodyplethysmography derived parameters turned out to be of limited value. Diffusion capacity testing and spirometry/flow-volume curve after administration of bronchodilators are the methods of choicewhen having to chose between asthma or COPD.

Evaluation of morphology discrimination for ventricular tachycardia diagnosis in implantable cardioverter-defibrillators.

BACKGROUND: To reduce inappropriate therapy from implantable cardioverter-defibrillators (ICDs), electrogram morphology discrimination has been developed to improve arrhythmia discrimination without compromising device safety. OBJECTIVES: The purpose of this study was to determine the accuracy of the morphology discrimination algorithm for detecting ventricular tachycardia (VT). METHODS: Stored electrograms of 795 tachyarrhythmias from 106 patients with a St. Jude Medical ICD (51 single-chamber and 55 dual-chamber) were analyzed by the investigators. The data were analyzed for morphology discrimination alone, sudden onset and stability, and morphology discrimination in combination with sudden onset and stability. Data were corrected for multiple episodes within a patient with the generalized estimating equation method. RESULTS: Using the nominal template match of 60%, morphology discrimination alone provided sensitivity and specificity of 78% and 95% for single-chamber ICDs and 63% and 92% for dual-chamber ICDs, respectively. Based on the receiver operator characteristic curve, the optimal-match percent threshold was 80% to 85% but at the expense of specificity. Morphology discrimination combined with sudden onset and stability increased sensitivity to 98% with specificity of 86% in single-chamber devices. In dual-chamber devices, the loss in sensitivity is compensated by rate branch analysis, yielding a sensitivity of 98%. CONCLUSION: Arrhythmia discrimination based on electrogram morphology has the potential to reject atrial tachyarrhythmias. However, there is a risk for underdetection of ventricular tachyarrhythmias if arrhythmia discrimination is primarily based on morphology. To guarantee patient safety in single-chamber devices, the morphology discrimination algorithm must be programmed in combination with established detection algorithms. In dual-chamber devices, loss of sensitivity is compensated by the V > A rate branch.

Reproducibility of intravascular ultrasound radiofrequency data analysis: implications for the design of longitudinal studies.

OBJECTIVES: The purpose of this study was to assess in vivo the reproducibility of tissue characterization using spectral analysis of intravascular ultrasound (IVUS) radiofrequency data (IVUS-VH). BACKGROUND: Despite the need for reproducibility data to design longitudinal studies, such information remains unexplored. METHODS AND RESULTS: IVUS-VH (Volcano Corp., Rancho Cordova, USA) was performed in patients referred for elective percutaneous intervention and in whom a non-intervened vessel was judged suitable for a safe IVUS interrogation. The IVUS catheters used were commercially available catheters (20 MHz, Volcano Corp., Rancho Cordova, USA). Following IVUS-VH acquisition, and after the disengagement and re-engagement of the guiding catheter, an additional acquisition was performed using a new IVUS catheter. Fifteen patients with 16 non-significant lesions were assessed by 2 independent observers. The relative inter-catheter differences regarding geometrical measurements were negligible for both observers. The inter-catheter relative difference in plaque cross-sectional area (CSA) was 3.2% for observer 1 and 0.5% for observer 2. The limits of agreement for (observer 1 measurements) lumen, vessel, plaque and plaque burden measurements were 0.82, -1.10 mm(2); 0.80, -0.66 mm(2); 1.08, -0.66 mm(2); and 5.83, -3.89%; respectively. Limits of agreement for calcium, fibrous, fibrolipidic and necrotic core CSA measurements were 0.22, -0.25 mm(2); 1.02, -0.71 mm(2); 0.61, -0.65 mm(2); and 0.43, -0.38 mm(2) respectively. Regarding the inter-observer agreement, the limits of agreement for lumen, vessel, plaque and plaque burden measurements were 2.61, -2.09 mm(2); 2.20-3.03 mm(2); 1.70, -3.04 mm(2); and 9.16, -16.41%; respectively, and for calcium, fibrous, fibrolipidic and necrotic core measurements of 0.08, -0.09 mm(2); 0.89, -1.28 mm(2); 0.74, -1.06 mm(2); and 0.16, -0.20 mm(2); respectively. CONCLUSIONS: The present study demonstrates that the geometrical and compositional output of IVUS-VH is acceptably reproducible.