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BACKGROUND: Patients with obstructive left main coronary artery disease are usually treated with coronary-artery bypass grafting (CABG). Randomized trials have suggested that drug-eluting stents may be an acceptable alternative to CABG in selected patients with left main coronary disease. METHODS: We randomly assigned 1905 eligible patients with left main coronary artery disease of low or intermediate anatomical complexity to undergo either percutaneous coronary intervention (PCI) with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). Anatomic complexity was assessed at the sites and defined by a Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score of 32 or lower (the SYNTAX score reflects a comprehensive angiographic assessment of the coronary vasculature, with 0 as the lowest score and higher scores [no upper limit] indicating more complex coronary anatomy). The primary end point was the rate of a composite of death from any cause, stroke, or myocardial infarction at 3 years, and the trial was powered for noninferiority testing of the primary end point (noninferiority margin, 4.2 percentage points). Major secondary end points included the rate of a composite of death from any cause, stroke, or myocardial infarction at 30 days and the rate of a composite of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses. RESULTS: At 3 years, a primary end-point event had occurred in 15.4% of the patients in the PCI group and in 14.7% of the patients in the CABG group (difference, 0.7 percentage points; upper 97.5% confidence limit, 4.0 percentage points; P=0.02 for noninferiority; hazard ratio, 1.00; 95% confidence interval, 0.79 to 1.26; P=0.98 for superiority). The secondary end-point event of death, stroke, or myocardial infarction at 30 days occurred in 4.9% of the patients in the PCI group and in 7.9% in the CABG group (P

Background: The DUTCH PEERS (TWENTE II) trial (clinicaltrials.gov NCT01331707) is a randomised, multicenter, single-blinded, investigator initiated all-comers trial. All coronary syndromes were permitted with no limit for lesion length, reference size, or number of lesions or diseased vessels to be treated. In total, 1811 patients were 1:1 randomised to cobalt chromium-based zotarolimuseluting stents (ZES) versus platinum chromium-based everolimus-eluting stents (EES). These durable polymer-based drug-eluting stents (DES) were developed to facilitate device deliverability and to improve stent apposition to the vessel wall. Purpose: We assessed the 4-year clinical outcome of the DUTCH PEERS trial in terms of safety and efficacy. Methods: Clinical outcome was assessed by means of follow-up data of the trial participants. The primary endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel-related myocardial infarction (MI) or target vessel revascularization. Secondary endpoints included the individual components of the TVF and the incidence of definite-or-probable stent thrombosis. Endpoints were analyzed by the logrank test by comparing the time to the endpoint, using the Kaplan-Meier method. Independent contract research organizations performed the study monitoring and clinical event adjudication. Results: The 4-year clinical follow-up data were available in 1802 patients (99.5%; 4 patients were lost to follow-up and 5 withdrew consent). The ZES and EES groups showed favourable outcomes with a similar incidence of TVF (12.1% vs. 12.1%; Logrank p=0.95). The rates of the individual components of TVF were also similar for both stent arms: cardiac death (3.9% vs. 3.7%; Logrank p=0.78); target vessel-related MI (3.2% vs. 2.5%; Logrank p=0.38); and target vessel revascularization (6.8% vs. 7.5%; Logrank p=0.55), respectively. In addition, the incidence of definite-or-probable stent thrombosis was similar for patients treated with ZES versus EES (1.5% vs. 1.2%; Logrank p=0.67). Conclusion: At 4-year follow-up, ZES and EES showed similar and sustained results in terms of safety and efficacy for treating all-comer patients.

Aim High-density lipoproteins (HDLs) have several potentially protective vascular effects. Most clinical studies of therapies targeting HDL have failed to show benefits vs. placebo. Objective To investigate the effects of an HDL-mimetic agent on atherosclerosis by intravascular ultrasonography (IVUS) and quantitative coronary angiography (QCA). Design and setting A prospective, double-blinded, randomized trial was conducted at 51 centres in the USA, the Netherlands, Canada, and France. Intravascular ultrasonography and QCA were performed to assess coronary atherosclerosis at baseline and 3 (2-5) weeks after the last study infusion. Patients Five hundred and seven patients were randomized; 417 and 461 had paired IVUS and QCA measurements, respectively. Intervention Patients were randomized to receive 6 weekly infusions of placebo, 3 mg/kg, 6 mg/kg, or 12 mg/kg CER-001. Main outcome measures The primary efficacy parameter was the nominal change in the total atheroma volume. Nominal changes in per cent atheroma volume on IVUS and coronary scores on QCA were also pre-specified endpoints. Results The nominal change in the total atheroma volume (adjusted means) was −2.71, −3.13, −1.50, and −3.05 mm3 with placebo, CER-001 3 mg/kg, 6 mg/kg, and 12 mg/kg, respectively (primary analysis of 12 mg/kg vs. placebo: P = 0.81). There was also no difference among groups for the nominal change in per cent atheroma volume (0.02, −0.02, 0.01, and 0.19%; nominal P = 0.53 for 12 mg/kg vs. placebo). Change in the coronary artery score was −0.022, −0.036, −0.022, and −0.015 mm (nominal P = 0.25, 0.99, 0.55), and change in the cumulative coronary stenosis score was −0.51, 2.65, 0.71, and −0.77% (compared with placebo, nominal P = 0.85 for 12 mg/kg and nominal P = 0.01 for 3 mg/kg). The number of patients with major cardiovascular events was 10 (8.3%), 16 (13.3%), 17 (13.7%), and 12 (9.8%) in the four groups. Conclusion CER-001 infusions did not reduce coronary atherosclerosis on IVUS and QCA when compared with placebo. Whether CER-001 administered in other regimens or to other populations could favourably affect atherosclerosis must await further study. Name of the trial registry: Clinicaltrials.gov; Registry's URL: http://clinicaltrials.gov/ct2/show/NCT01201837?term=cer-001&rank=2; Trial registration number: NCT01201837

BACKGROUND Women report more often chest pain following percutaneous coronary intervention (PCI), yet little is known about the impact of age on these symptoms. We aimed to assess age and gender-related differences in chest pain following PCI with newergeneration drug-eluting stents (DES). METHODS A patient-level pooled analysis of the TWENTE and DUTCH PEERS randomized trials (NCT01066650; NCT01331707) was performed, in which patients were treated with newer generation permanent polymer DES. The primary endpoint of both studies was target vessel failure (TVF); secondary endpoints included MACE (composite of any death, any myocardial infarction (MI), emergent CABG or target lesion revascularization) and POCE (composite of any death, any MI and any revascularization). RESULTS Clinical follow-up was available in 3,188 patients (99.8%). Women had more risk factors including diabetes (24.2% vs. 17.8%, p65 years. Women 65 years, both women and men reported similar levels of chest pain at rest or mild exertion (8.8% and 8.7%, p=0.76); in this subgroup gender did not independently predict chest pain (adjusted OR 1.27 95%-CI:0.8-1.9, p=0.26). Nevertheless, in women and men similar 3-year rates of TVF, MACE, and POCE were found (11.6% vs. 11.3%, p=0.81; 13.6% vs. 12.5%, p=0.43; 18.8% vs. 18.0%, p=0.60, respectively). CONCLUSION While for both genders the incidence of adverse cardiovascular events was low and similar, women

International audience; Aim To optimize conventional coronary optical coherence tomography (OCT) images using the attenuation-compensated technique to improve identification of plaques and the external elastic lamina (EEL) contourMethods and results The attenuation-compensated technique was optimized via manipulating contrast exponent C, and compression exponent N, to achieve an optimal contrast and signal-to-noise ratio (SNR). This was applied to 60 human coronary lesions (38 native and 22 stented) ex vivo conventional coronary OCT images acquired from heart autopsies of 10 patients and matching histology was available as reference. Three independent reviewers assessed the conventional and attenuation-compensated OCT images blindly for plaque characteristics and EEL detection. Conventional OCT and compensated OCT assessment were compared against histology. Using an optimized algorithm, the attenuation-compensated OCT images had a 2-fold improvement in contrast between different tissues in both stented and non-stented epicardial coronaries (P < 0.05). Overall sensitivity and specificity for plaque classification increased from 84 to 89% and from 92 to 94%, respectively, with substantial agreement among the three reviewers (Fleiss' Kappa k, 0.72 and 0.71, respectively). Furthermore, operators were 2.5 times more likely to identify the EEL contour in the attenuation-compensated OCT images (k = 0.72) than in the conventional OCT images (k = 0.36)Conclusion The attenuation-compensated technique can be retrospectively applied to conventional OCT images and improves the detection of plaque characteristics and the EEL contour. This approach could complement conventional OCT imaging in the evaluation of plaque characteristics and quantify plaque burden in the clinical setting.

OBJECTIVES The purpose of this study was to investigate the safety and efficacy of new-generation drug-eluting stents (DES) versus early-generation DES in women undergoing complex percutaneous coronary intervention (CPCI). BACKGROUND Whether the benefits of new-generation DES are preserved in women undergoing complex percutaneous revascularization is unknown. METHODS We pooled patient-level data from women enrolled in 26 randomized trials of DES. Study population was categorized according to the presence or absence of CPCI, which was defined as the composite of total stent length >30 mm, ≥2 stents implanted, ≥2 lesions treated, or bifurcation lesion as target vessel. The primary endpoint was major adverse cardiovascular events (MACE) defined as a composite of all-cause mortality, myocardial infarction, or target lesion revascularization at 3 years of follow-up. RESULTS Of 10,241 women included in the pooled database, 4,629 (45%) underwent CPCI. Compared with non-CPCI, women who underwent CPCI had a higher 3-year risk of MACE (adjusted hazard ratio [HR]: 1.63; 95% confidence interval [CI]: 1.45 to 1.83; p < 0.0001). In women who underwent CPCI, use of new-generation DES was associated with significantly lower 3-year risk of MACE (adjusted HR: 0.81; 95% CI: 0.68 to 0.96), target lesion revascularization (adjusted HR: 0.74; 95% CI: 0.57 to 0.95), and definite or probable stent thrombosis (ST) (adjusted HR: 0.50; 95% CI: 0.30 to 0.83). The benefit of new-generation DES on efficacy and safety outcomes was uniform between CPCI and non-CPCI groups, without evidence of interaction. By landmark analysis, new-generation DES were associated with low rates (≤0.4%) of very-late ST irrespective of procedural complexity. CONCLUSIONS Women undergoing CPCI remain at higher risk of adverse events. The long-term ischemic benefits of new-generation DES platforms are uniform among complex and non-complex percutaneous revascularization procedures in women.

The most effective treatment for pericardial effusion and cardiac tamponade is removal of the pericardial fluid. Surgical pericardiotomy is associated with high mortality and morbidity. Similarly, subcostal percutaneous blind pericardiocentesis was reported to have unacceptably high mortality and complication rates. Major complications associated with blind needle punctures are right heart penetration, hemopericardium, puncture of the coronary arteries, liver and lung bleeding. Even under fluoroscopic guidance and electrocardiographic needle monitoring high complication rates persist. Pericardial drainage has been often inadequate, with frequent recurrences of significant pericardial effusions. Two-dimensional echocardiographically guided pericardiocentesis is reported to improve efficacy and safety of percutaneous puncture. Moreover, it allows immediate verification of the procedural success. We evaluated the efficacy and safety of an echocardiographically guided contrast agent controlled pericardiocentesis. This is a retrospective, descriptive study on 126 consecutive patients who underwent percutaneous pericardiocentesis at the University Hospital Essen, Germany, from 1995 to June 2000. There were 51 women (41%) and 75 men (55%) with a mean age of 52 +/- 14 years. Standard techniques for quantification of pericardial effusion were used. Depending on the localization of the pericardial effusion an apical or subxiphoidal approach was chosen. The puncture was performed under echocardiographic guidance and the position of the needle was controlled by injection of contrast agent. Over a long guidewire a pigtail catheter was inserted through a sheath for further drainage of pericardial fluid. The catheter was removed after a maximum of 48 hours to avoid infection of the pericardial cavity. An apical approach was chosen in 98 patients (78%), a subcostal in 28 patients (22%). The procedure was successful in 99% of the attempts. No death or clinical complication occurred. The maximal pericardial diameter measured by two-dimensional echocardiography was 32 +/- 16 mm before and 5.3 +/- 2 mm after drainage. The calculated pericardial effusion was 657 +/- 342 ml. A fluid volume of 605 +/- 342 ml could be drained. In all patients a pericardial catheter was placed for 1.4 +/- 0.8 days. Recurrence of pericardial effusion occurred in 18 patients (14%). Of these, 15 patients underwent repeated successful pericardiocentesis (2.5 +/- 0.8), and 3 patients were referred to surgical pericardiotomy. Pericardiocentesis under echocardiographic contrast agent guidance is a safe, successful and cost effective procedure for diagnostic and therapeutic drainage of pericardial effusion. Two-dimensional echocardiography allows localization of the optimal puncture site as well as the quantification of the effusion depth. The injection of contrast agents into the pericardial cavity improves the safety and accuracy of the procedure. Even recurrent pericardial effusions can be treated successfully.

Objective: Due to the side effects of antiretroviral therapy and long term survival there is an increasing concern of an elevated rate of cardiovascular diseases in HIV-infected patients. The present study analysed the cardiovascular risk profile and the probability of cardiovascular events in HIV-infected patients, due to differences of gender. Methods: Cardiovascular risk factors of 309 HIV-infected adults, including 240 males were analysed. Overall 10-years probability for cardiovascular events was evaluated by the Framingham algorithm. Results: Gender differences were detected in cardiovascular risk factors such as lipid values, blood pressure and the rate of smoking. Tobacco use was much more common in HIV-infected males compared with HIV-infected females (67.5% vs. 49.3%; p < 0.001). Although no significant difference was noticed in total cholesterol (5.49 ± 0.09 vs. 5.53 ± 0.19 mmol/L, p = 0.84), the HDL-cholesterol concentration was significantly lower (1.09 ± 0.03 vs. 1.36 ± 0.06 mmol/L, p < 0.001) and the triglyceride concentration higher (3.01 ± 0.21 vs. 2.06 ± 0.26 mmol/L, p = 0.02) in HIV-infected males compared to HIV-infected females. Additionally, systolic blood pressure was higher in HIV-infected males compared with HIV-infected females (123.1 ± 1.1 vs. 115.4 ± 2.1 mmHg, p < 0.01). No significant differences were detected in HbA1c - concentrations between both groups (5.15 ± 0.07 vs. 5.31 ± 0.11,p = 0.26). The overall 10-years probability for cardiovascular events was 8.7% (median) in HIV-infected males and 1.7% in HIV-infected females (p < 0.0001). Conclusions: In the present study, we observed gender differences in the cardiovascular risk profile of HIV-infected individuals. The risk of premature atherosclerosis and associated cardiovascular events was significantly higher in HIV-infected males.

Objective: In recent years, concerns have been growing about an elevated rate of cardiovascular diseases in HIV-infected patients due to side effects of antiretroviral therapy. The present study analyses the cardiovascular risk profile and the probability of cardiovascular events with regard to the age of HIV-infected patients. Methods: Cardiovascular risk factors of 309 HIV-infected adults were analysed. Patients were divided into four groups: 18-30 years (group 1), 31-40 years (group 2), 41-50 years (group 3), > 50 years (group 4). Overall 10-years probability for cardiovascular events was evaluated by the Framingham algorithm. Results: Differences between the groups were detected in cardiovascular risk factors including changes in lipid- and glucose metabolism. Lipid values increased with elevated age, such as total cholesterol concentration (group 1 vs. group 4: 4.71 ± 0.20 to 6.36 ± 0.21 mmol/L, p < 0.05), LDL-cholesterol concentration (2.86 ± 0.17 vs. 4.17 ± 0.21 mmol/L, p < 0.05) and triglyceride concentration (1.56 ± 0.14 vs. 3.48 ± 0.40 mmol/L, p < 0.05). HDL-cholesterol concentration (Mean ± SEM: 1.15 ± 0.03 mmol/L) did not show a significant different. Glucose concentration increased with elevated age in HIV-infected patients (5.28 ± 0.19 vs. 6.46 ± 0.24 mmHg, p < 0.05), but there was no significant difference in HbA1c - concentration, blood pressure and smoking rate between the groups. The overall 10-years probability for cardiovascular events was higher in group 1 (median: 1.9%) than in group 4 (20.5%; p < 0.01). Conclusions: The risk of cardiovascular events is related to the age in HIV-infected patients. Therefore, an increased duration of life due to a more effective antiretroviral therapy will have a significant impact on the rate of cardiovascular events in this patient population. In the future, further increase of cardiovascular events in HIV-infected patients may be expected.

Intracoronary ultrasound (ICUS) is an imaging technique which can provide a cross-sectional image of coronary arteries and implanted stents. Different stents may have individual ICUS imaging characteristics. To investigate the imaging characteristics and three-dimensional (3-D) reconstruction of different coronary stent designs, we examined 26 different stents using ICUS in vitro. All stents could be well visualized with planar ICUS. In 18 stents, 3-D imaging succeeded in reconstructing the spatial stent architecture. This was not possible in the other 8 stents, most probably because of predominantly transversally-orientated strut architecture, the small size of the strut wire width, the limited ICUS lateral catheter resolution, and the smoothing and interpolation algorithms applied for 3-D reconstruction. ICUS in vitro provides a means of identifying coronary stent structures which may be applicable in vivo. Three-D reconstruction of the entire stent architecture in vitro can be achieved in stents with mesh or slotted tube design, while stents with coil design and thin strut wires can only be partially reconstructed.

Intravascular ultrasound (IVUS) permits the detailed examination of coronary stent apposition and expansion in vivo. IVUS assessment of the extent and distribution of in-stent neointima at follow-up is an ideal model for the evaluation of new antiproliferative drugs that aim at a reduced in-stent neointimal hyperplasia. Recently, automated systems for three-dimensional reconstruction and analysis of IVUS images have been developed. This manuscript illustrates the methodology and clinical use of automated three-dimensional IVUS analysis systems during coronary stenting, and highlights the first randomized trials to apply such a technique for the assessment of in-stent neointima.

Background Intravascular ultrasound (IVUS) offers a new modality by which to image the vessel wall in high resolution. The aim of the study was to classify atherosclerotic lesions using IVUS according to American Heart Association (AHA) recommendation. Methods IVUS was performed using a 20 or 30 MHz mechanically rotated catheter in 190 patients (aged from 35 to 75 years, mean 59 +/- 9 years) who presented with suspicion of coronary artery disease based on clinical examination. Results Of the 190 patients, 49 (26%) (group A) were found to have normal or nearly normal coronary arteries, whereas the other 141 (74%) (group B) had significant angiographic stenosis (> 50% luminal narrowing). IVUS image interpretation was based on the recommendation of the Committee on Vascular Lesions of the Council on Atherosclerosis (AHA). In group A, a total of 822 segments were evaluated with IVUS; 444 (54%) were found to have plaque formation. Among these 444 segments, type II lesions were found in 145 (33%), type III lesions in 110 segments (25%), type IV and Va lesions in 169 segments (38%), and type Vb in 18 segments (4%). The severity of plaque area stenosis increased from type II to IV. In group B, only the most stenotic segments (n = 141) on angiography were selected for analysis. No significant differences were found among different lesion types with respect to the severity of plaque area stenosis. Type Vb and Vc lesions presented mainly, but not exclusively, as stable angina, whereas type VI lesions presented mainly as unstable angina. Some patients (12%) with stable angina had complicated lesions (type VIa-VIc). Conclusions It is now possible to use intravascular ultrasound to classify atherosclerotic lesions according to the AHA recommendations that were based on histological examination. Standardized reports of IVUS can now be based on these recommendations. Even in angiographically normal coronary arteries, advanced atherosclerotic lesions are found, explaining the potential risk of acute coronary syndromes in this group of patients. In patients with angiographically severe coronary disease, clinical symptoms correlate mainly with plaque characteristics, rather than with the severity of stenosis.