Registry of transcatheter aortic-valve implantation in high-risk patients.

BACKGROUND: Transcatheter aortic-valve implantation (TAVI) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses. We report the results of a prospective multicenter study of the French national transcatheter aortic-valve implantation registry, FRANCE 2. METHODS: All TAVIs performed in France, as listed in the FRANCE 2 registry, were prospectively included in the study. The primary end point was death from any cause. RESULTS: A total of 3195 patients were enrolled between January 2010 and October 2011 at 34 centers. The mean (±SD) age was 82.7±7.2 years; 49% of the patients were women. All patients were highly symptomatic and were at high surgical risk for aortic-valve replacement. Edwards SAPIEN and Medtronic CoreValve devices were implanted in 66.9% and 33.1% of patients, respectively. Approaches were either transarterial (transfemoral, 74.6%; subclavian, 5.8%; and other, 1.8%) or transapical (17.8%). The procedural success rate was 96.9%. Rates of death at 30 days and 1 year were 9.7% and 24.0%, respectively. At 1 year, the incidence of stroke was 4.1%, and the incidence of periprosthetic aortic regurgitation was 64.5%. In a multivariate model, a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation (EuroSCORE), New York Heart Association functional class III or IV symptoms, the use of a transapical TAVI approach, and a higher amount of periprosthetic regurgitation were significantly associated with reduced survival. CONCLUSIONS: This prospective registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis, in whom TAVI appeared to be a reasonable option. (Funded by Edwards Lifesciences and Medtronic.).

Single high-dose erythropoietin administration immediately after reperfusion in patients with ST-segment elevation myocardial infarction: results of the erythropoietin in myocardial infarction trial.

BACKGROUND: Preclinical studies and pilot clinical trials have shown that high-dose erythropoietin (EPO) reduces infarct size in acute myocardial infarction. We investigated whether a single high-dose of EPO administered immediately after reperfusion in patients with ST-segment elevation myocardial infarction (STEMI) would limit infarct size. METHODS: A total of 110 patients undergoing successful primary coronary intervention for a first STEMI was randomized to receive standard care either alone (n = 57) or combined with intravenous administration of 1,000 U/kg of epoetin ß immediately after reperfusion (n = 53). The primary end point was infarct size assessed by gadolinium-enhanced cardiac magnetic resonance after 3 months. Secondary end points included left ventricular (LV) volume and function at 5-day and 3-month follow-up, incidence of microvascular obstruction (MVO), and safety. RESULTS: Erythropoietin significantly decreased the incidence of MVO (43.4% vs 65.3% in the control group, P = .03) and reduced LV volume, mass, and function impairment at 5-day follow-up (all P < .05). After 3 months, median infarct size (interquartile range) was 17.5 g (7.6-26.1 g) in the EPO group and 16.0 g (9.4-28.2 g) in the control group (P = .64); LV mass, volume, and function were not significantly different between the 2 groups. The same number of major adverse cardiac events occurred in both groups. CONCLUSIONS: Single high-dose EPO administered immediately after successful reperfusion in patients with STEMI did not reduce infarct size at 3-month follow-up. However, this regimen decreased the incidence of MVO and was associated with transient favorable effects on LV volume and function.

Cardiac tamponade in medical patients: a 10-year follow-up survey.

OBJECTIVES: Cardiac tamponade represents a life-threatening condition that may complicate almost any cause of pericarditis. We conducted a 10-year prospective survey on patients with cardiac tamponade requiring an emergency drainage. METHODS: From 1996 to 2005, 114 consecutive patients were admitted to the University Hospital of Brest for medical cardiac tamponade. Data on medical history, and volume, characteristics and histology of the pericardial fluid as well as short- and long-term follow-up data were collected. RESULTS: Malignant disease was the primary cause of medical tamponade (74 patients; 65%), followed by viral history (11; 10%) and intra-pericardial bleeding due to anti-coagulation treatment (4; 3%). In 12 cases, aetiology remained unknown (10%). Pericardiocentesis was immediately performed in 80 cases and surgical pericardiotomy in 34. The mean volume drained was 593 +/- 313 ml. In-hospital mortality was 10% without any difference between malignant and non-malignant diseases (p = 0.8). One-year mortality was 76.5% in patients with malignant disease and 13.3% in those without malignant disease (p < 0.0001). Median survival in case of malignant disease was 150 days. CONCLUSION: Compared to previously published data, our survey shows a decrease in some historical causes of tamponade such as tuberculosis, myxoedema or uraemia. The leading cause is currently malignant disease, which carries a very poor prognosis.

Midterm prognosis of patients with suspected coronary artery disease and normal multislice computed tomographic findings: a prospective management outcome study.

BACKGROUND: The gold standard test for the diagnosis of coronary artery disease (CAD) is conventional coronary angiography (C-CAG). Lately, multislice computed tomographic coronary angiography (MSCT-CAG) demonstrated a high sensitivity and a negative predictive value for a CAD primary diagnosis when compared with C-CAG. The aim of our study is to prospectively assess the safety of ruling out CAD based solely on a normal MSCT-CAG result. METHODS: From June 15, 2004, to January 20, 2006, consecutive patients initially scheduled for C-CAG for a primary diagnosis of CAD underwent MSCT-CAG instead. Patients with a highly calcified coronary network or with an abnormal or a noninterpretable MSCT-CAG result underwent secondary C-CAG and were excluded from the study. We included patients whose diagnosis of CAD was ruled out by a normal MSCT-CAG result; in those patients, C-CAG was not performed. All patients underwent further follow-up with clinical end points (death, subsequent C-CAG, and myocardial infarction). RESULTS: In 141 patients, MSCT-CAG results were considered normal. During the follow-up period (mean, 14.7 months), those patients experienced 0% mortality, a 3.5% rate of subsequent C-CAG, and a 0.7% rate of myocardial infarction. The risks of subsequent death, new referral for C-CAG, or coronary events compare favorably with those following normal C-CAG, which were 0.4%, 4.3%, and 0.6%, respectively. CONCLUSIONS: Multislice computed tomographic CAG safely rules out CAD in patients with suspected disease and allows patients to be managed less invasively, by reducing the number in whom C-CAG has to be performed.

Same-day combined percutaneous coronary intervention and coronary artery surgery.

BACKGROUND: Either percutaneous coronary intervention (PCI) or coronary artery bypass grafting can be chosen for the treatment of multiple-vessel coronary artery disease. We report the results of a hybrid procedure performed on the same day, combining PCI of the right coronary artery and internal mammary artery bypass grafting of the left coronary artery, for the treatment of diffuse extensive lesions. METHODS AND RESULTS: Since January 2000, 70 patients (53 male, mean age 68.5 +/- 10 years) underwent this hybrid revascularization combining primary right coronary artery PCI and, within the next 16 h, left coronary artery grafting with left and/or right internal mammary artery. Thirty-one patients (98%) were treated on the same day. At a mean follow-up of 33 months (range: 2-70 months), 68 patients (97%) were asymptomatic at the time of writing. Three adverse events were reported: 2 were PCI-related, due to failure to take ticlopidine, and 1 was surgery-related, resulting in the patient's death during hospitalization. CONCLUSION: These preliminary results for a same-day combined procedure in patients with diffuse multivessel coronary artery disease are encouraging. This strategy optimizes revascularization when patients are unstable or present very severe coronary lesions, which requiring rapid treatment and are not ideally suitable for PCI management alone.

Accuracy of 16-detector multislice spiral computed tomography in the initial evaluation of dilated cardiomyopathy.

BACKGROUND: Multislice Computed Tomography (MSCT) recently proved its accuracy in the detection of coronary artery disease (CAD). It can also give information about left ventricular function and venous network anatomy. We here sought to validate a MSCT-based strategy in the initial evaluation of patients with dilated cardiomyopathy (DCM). METHODS: 36 patients with DCM underwent cardiac MSCT before conventional coronary angiography with ventriculography. We analysed arterial calcium score (Agatston score equivalent: ASE), coronary stenosis, left ventricular parameters and venous network. RESULTS: The sensitivity of a MSCT-based strategy in detecting significant CAD was 100% and the specificity 80%. The positive and negative predictive values were respectively 67% and 100%. For ASE <1.000 (75% of patients), MSCT detected all non-CAD patients without one (motion artifacts), enabling conventional angiography to be avoided in 21/27 patients (77.7%). For ASE > or =1000, MSCT enabled conventional angiography to be avoided in only 2/9 patients (22.2%). The ventricle was assessable in 83.4% (30 patients) on MSCT. Correlation coefficient Rs with ventriculography were 0.78 (p<0.0001), 0.77 (p<0.0001) and 0.82 (p<0.0001) respectively for end-diastolic volume, end-systolic volume and EF. The venous network was assessable in all patients both on MSCT and angiography. CONCLUSION: In patients undergoing an initial evaluation of DCM, MSCT appears to be an effective alternative to conventional angiography. The following attitude may be proposed: when ASE >1.000, conventional coronary angiography is mandatory due to MSCT's poor interest in such cases; when ASE <1.000, a contrast-enhanced MSCT may, when normal, replace coronary angiography.

Multi-slice computer tomography of left ventricular function with automated analysis software in comparison with conventional ventriculography.

PURPOSE: To evaluate the accuracy of left ventricular volumetric and functional parameters from multi-slice computed tomography using automated analysis software, and to correlate results with those of invasive left ventriculography. MATERIALS AND METHODS: In 145 consecutive patients (mean age, 61 years+/-12) known or suspected to have coronary artery disease, a 16-channel multi-slice computed tomography (Philips Mx8000 IDT 16) was performed using a standard technique. Using short-axis secondary multi-slice computed tomography reformations, we determined end-diastolic and end-systolic left ventricular volumes and ejection fraction with a commercially available analysis software capable of automated contour detection. Conventional left ventriculography was performed according to standard techniques within the following 24 h. Bland-Altman analysis was performed to calculate the limits of agreement and systematic errors between multi-slice computed tomography and conventional left ventriculography. RESULTS: As determined by computer tomography, mean end-systolic (53+/-29 mL) left ventricular volumes had an acceptable correlation with conventional ventriculography (67+/-50 mL; r=0.74; p<0.001) and mean end-diastolic (119+/-33 mL) left ventricular volumes a poor correlation with conventional ventriculography measurements (154+/-69 mL; r=0.41). Left ventricular ejection fraction (57%+/-14 versus 55%+/-14 for conventional ventriculography; r=0.79) showed a very good correlation (p<0.001). Bland-Altman analysis showed acceptable limits of agreement (+/-9.2% for ejection fraction) without systematic errors. CONCLUSION: The use of a multi-slice computed tomography with an automatic calculation software has a good correlation with conventional ventriculography findings and could accurately assess left ventricular function, but should not be used for ventricular volumes, because of biased estimations.

The utilisation of the cardiovascular automated radiation reduction X-ray system (CARS) in the cardiac catheterisation laboratory aids in the reduction of the patient radiation dose.

AIMS: The radiation exposure resulting from cardiovascular procedures may increase the risk of cancer, and/or cause skin injury. Whether the novel cardiovascular automated radiation reduction X-ray system (CARS) can help reduce the patient radiation dose in daily clinical practice remains unknown. The aim of this study was to evaluate the reduction in patient radiation dose with the use of CARS in the cardiac catheterisation laboratory (CCL). METHODS AND RESULTS: This study retrospectively analysed 1,403 consecutives patients who underwent a cardiac catheterisation with coronary angiography (CA) and/or a percutaneous coronary intervention (PCI) in the Brest University Hospital over the course of one year. Patient radiation doses (dose area product and air kerma) were collected and compared between the CCL with (new CCL) and without (control CCL) CARS. Additionally, the patient radiation doses according to femoral versus radial access, procedural complexity and body mass index were compared. The radiation lesion position on the skin was assessed by automatically optimising the X-ray source to image distance (SID) and subsequently generating a radiation Dose-Map for those procedures exceeding 3 Gray of exposure. Overall, 447 patients underwent procedures in the control CCL and 956 in the new CCL. Baseline patient and procedural characteristics were similar between the two groups, with the exception of male gender and primary PCI, which were more prevalent in the new CCL group. Compared to the control CCL, the utilisation of the CARS in the new CCL resulted in a reduction of dose area product by 46% for CA, 56% for PCI alone and 54% for CA and PCI during the same procedure. Of note, radial access generated a higher radiation dose than femoral access (p<0.001). In this study, seven patients had an air kerma exceeding 3 Gray; however, only one patient had a skin dose greater than 3 Gray. CONCLUSIONS: The utilisation of the CARS resulted in a significant reduction in patient radiation doses compared to the control equipment. A real-time Dose-Map may help the operator change the projection during complex procedures to reduce the patient skin dose.

Evolution of spontaneous atherosclerotic plaque rupture with medical therapy: long-term follow-up with intravascular ultrasound.

BACKGROUND: Ruptured coronary atheromatous plaque is generally considered to involve a high risk of subsequent clinical events. Few data are available on the natural evolution of non-culprit-lesion ruptured plaque. We therefore used serial intravascular ultrasound (IVUS) to study how such lesions, detected in the context of a first acute coronary syndrome with elevated troponin I levels, develop. METHODS AND RESULTS: Fourteen patients with 28 distinct plaque ruptures (2+/-1 per patient) without significant associated stenosis (minimal lumen cross-sectional area >4 mm2) were included and systematically treated with 40 mg statin and antiplatelet agent (clopidogrel and aspirin for > or =9 months). Mean clinical and IVUS follow-up was 22+/-13 months (median, 22 months). No clinical event related to the lesion under study occurred. On final IVUS examination, half (14 of 28) of the ruptured plaques had healed, and the degree of stenosis tended to diminish (stenosis, 22+/-17% versus 29+/-17% at baseline; P=0.056). No healing-prediction criterion could be identified. CONCLUSIONS: Nearly 2 years of follow-up found that spontaneous coronary atheromatous plaque rupture without significant stenosis detected on first acute coronary syndrome healed without significant plaque modification in 50% of cases with medical therapy.

Intravascular ultrasound-guided balloon angioplasty compared with stent: immediate and 6-month results of the multicenter, randomized Balloon Equivalent to Stent Study (BEST).

BACKGROUND: Balloon angioplasty guided by intravascular ultrasound (IVUS) makes it possible to choose the balloon size according to the true vessel diameter and to detect suboptimal results requiring subsequent stent implantation. The Balloon Equivalent to STent (BEST) study aimed to assess whether this strategy would give the same results as systematic stenting. METHODS AND RESULTS: A total of 132 of 254 patients were randomized to IVUS-guided percutaneous transluminal coronary angioplasty (aggressive PTCA), and 122 were randomized to stenting (stent group). We hypothesized that a difference of <8% in the 6-month angiographic restenosis rate (primary end point) could be considered noninferior. The aggressive PTCA procedure was longer and had a greater use of contrast medium than stenting. In the aggressive PTCA group, crossover to stent was needed in 58 patients (44%). At 6 months, 20 of 119 patients (16.8+/-6.7%) in the aggressive PTCA group and 21 of 116 patients (18.1+/-7.0%) in the stent group had restenosis. The difference was -1.3%, with an upper limit of 95% confidence interval of 7.1% (ie, less than the noninferiority boundary). The in-stent restenosis rate was higher in the stent group (15.5% versus 5%; P=0.02). The differences in minimum lumen diameter, lumen cross-section area, and 1-year event rate were not significant. CONCLUSIONS: A strategy of IVUS-guided angioplasty with provisional stenting is feasible and safe. At the cost of a more complex procedure, it reduces the stent rate by half, with similar 6-month angiographic IVUS and clinical outcome compared with stent implantation.

Noninvasive assessment of left main coronary stent patency with 16-slice computed tomography.

We investigated the ability of 16-slice computer tomography (CT) to discriminate any restenosis after left main coronary artery stenting in 29 consecutive patients. CT was able to detect all stents and analyze the lumen properly in 27 of 29 cases. With the exception of arrhythmic or heavily calcified segments, multislice CT provides a noninvasive alternative to conventional coronary angiography in the follow-up of left main angioplasty with stenting.

Comparison of Outcome of Transcatheter Aortic Valve Implantation With Versus Without Previous Coronary Artery Bypass Grafting (from the FRANCE 2 Registry).

Previous coronary artery bypass grafting (CABG) increases operative risk in conventional valve replacement. Transcatheter aortic valve implantation (TAVI) has been shown to be successful in high-risk patient subgroups. The present study compared outcome and overall survival in patients who underwent TAVI with and without history of CABG. From January 2010 to December 2011, 683 of the 3,761 patients selected for TAVI in 34 French centers (18%) had a history of CABG. Outcomes (mortality and complications) were collected prospectively according to the Valve Academic Research Consortium (VARC) criteria. Patients with previous CABG were younger, with higher rates of diabetes and vascular disease and higher logistic European System for Cardiac Operative Risk Evaluation (29.8 ± 16.4 vs 20.1 ± 13.0, p <0.001) but lower rates of pulmonary disease. Two types of valve (Edwards SAPIEN and Medtronic CoreValve) were implanted in equal proportions in the 2 groups. The 30-day and 1-year mortality rates from all causes on Kaplan-Meier analysis (9.2% vs 9.7%, p = 0.71; and 19.0% vs 20.2%, p = 0.49, respectively) did not differ according to the history of CABG. There were no significant differences in the Valve Academic Research Consortium complications (myocardial infarction, stroke or vascular, and bleeding complications). On multivariate analysis, CABG was not associated with greater 1-year post-TAVI mortality. In conclusion, previous CABG did not adversely affect outcome in patients who underwent TAVI, which may be an alternative to surgery in high-risk patients with severe aortic stenosis and history of CABG.

6- versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin: the randomized, multicenter ITALIC trial.

BACKGROUND: The currently recommended duration of dual antiplatelet therapy (DAPT) in drug-eluting stent (DES) recipients is 12 months to reduce the risk of late stent thrombosis, particularly in those with acute coronary syndrome (ACS). OBJECTIVES: This study hypothesized that antiplatelet treatment with DAPT for 6 months may be noninferior to 24-month DAPT in aspirin-sensitive patients. METHODS: A multicenter, randomized study assigned patients undergoing implantation of everolimus-eluting stents with confirmed nonresistance to aspirin to receive 6- or 24-month DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post-stenting. RESULTS: A total of 2,031 patients were enrolled in 70 European and Middle Eastern centers. The trial was prematurely terminated due to recruitment problems, leaving 941 patients randomized to 24-month DAPT and 953 to 6-month DAPT. The 2 treatment groups had similar baseline and procedural characteristics. There was no significant difference in the primary endpoint (24-month: 1.5% vs. 6-month: 1.6%; p = 0.85). Noninferiority was demonstrated for 6- versus 24-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: -1.04% to 1.26%; p for noninferiority = 0.0002). There were no significant differences in stent thrombosis or bleeding complications. In the 792 (44%) high-risk patients with ACS, primary and secondary endpoints did not significantly differ (hazard ratio: 1.7 [95% confidence interval: 0.519 to 6.057; p = 0.361]). CONCLUSIONS: Rates of bleeding and thrombotic events were not significantly different according to 6- versus 24-month DAPT after PCI with new-generation DES in good aspirin responders. (Is There A LIfe for DES After Discontinuation of Clopidogrel [ITALICplus]; NCT01476020).

Assessment of carotid artery stenosis before coronary artery bypass surgery. Is it always necessary?

BACKGROUND: Extracranial internal carotid artery stenosis is a risk factor for perioperative stroke in patients undergoing coronary artery bypass surgery (CAB). Although selective and non-selective methods of preoperative carotid screening have been advocated, it remains unclear if this screening is clinically relevant. AIM: To test whether selective carotid screening is as effective as non-selective screening in detecting significant carotid disease. METHODS: The case records of patients consecutively undergoing CAB were reviewed. Patients were stratified retrospectively into high- or low-risk groups according to risk factors for significant carotid stenosis and perioperative stroke: peripheral vascular disease (PVD), carotid bruit, diabetes mellitus, age >70 years and/or history of cerebrovascular disease. Prevalence of carotid stenosis detected by ultrasonography, surgical management and perioperative stroke rates were determined in each group. RESULTS: Overall, 205 consecutive patients underwent preoperative carotid screening. The prevalence of significant carotid stenosis was 5.8%. Univariate analysis confirmed that PVD (P=0.005), carotid bruit (P=0.003) and diabetes mellitus (P=0.05) were significant risk factors for stenosis. Carotid stenosis was a risk factor for stroke (P=0.03). Prevalence of carotid stenosis was higher in the high-risk group (9.1%) than the low-risk group (1.2%) (P<0.05). All concomitant or staged carotid endarterectomies/CAB (5/205) and all patients who had perioperative strokes (5/205) were in the high-risk group (P=0.01). CONCLUSION: In our cohort, selective screening of patients aged >70 years, with carotid bruit, a history of cerebrovascular disease, diabetes mellitus or PVD would have reduced the screening load by 40%, with trivial impact on surgical management or neurological outcomes.

Cardiac multislice spiral computed tomography as an alternative to coronary angiography in the preoperative assessment of coronary artery disease before aortic valve surgery: a management outcome study.

BACKGROUND: Conventional coronary angiography (CA) is still recommended before valvular surgery. Preliminary studies suggest that multislice spiral computed tomography coronary angiography (MSCT-CA) can be used to rule out coronary artery disease (CAD). AIM: To assess prospectively the safety of ruling out CAD before surgery solely on the basis of normal MSCT-CA in patients with severe aortic valve disease. METHODS: We included all consecutive patients scheduled for aortic valve surgery. We first estimated the calcium score (Agatston score equivalent [ASE]). Patients underwent injected MSCT if the ASE was<1000. CA was cancelled when MSCT-CA quality was sufficient and showed no significant CAD. Our primary endpoint was the occurrence of perioperative myocardial infarction in patients who underwent surgery with no prior CA. RESULTS: Between 1st July 2005 and 30th June 2008, we included 199 patients with severe aortic valve disease: 118 men (59%); mean age 69+/-12 years; 63 patients (32%) underwent CA directly because the ASE was > or =1000. Of 136 patients who underwent MSCT-CA, 106 (78%) had a normal MSCT-CA and underwent aortic valve surgery without prior CA; CA was performed in 30 patients because of abnormal (n=18) or bad quality (n=12) MSCT-CA. One patient of the 106 (0.94%, 95% confidence interval 0.17-5.15) had a perioperative myocardial infarction. CONCLUSIONS: When the ASE is <1000, MSCT is safe and may be recommended instead of CA as a first-line means of ruling out CAD in patients with severe aortic valve disease.

Antiplatelet therapy in patients with anticoagulants undergoing percutaneous coronary stenting (from STENTIng and oral antiCOagulants [STENTICO]).

We evaluated the safety and efficacy of dual antiplatelet therapy, in association with oral anticoagulant (OAC) therapy, in patients undergoing percutaneous coronary intervention (PCI). The use of this triple therapy increases the rate of adverse outcomes, as shown by retrospective studies. In this first prospective multicenter registry STENTIng and oral antiCOagulation (STENTICO), all patients with OAC therapy undergoing PCI were included and followed up at 2 and 12 months. A total of 359 patients were included from 40 French centers. In 234 (65.2%; group 1) of these 359 patients, OAC therapy was discontinued (22 +/- 31 days). In 125 patients (34.8%; group 2), triple therapy was continued. The baseline characteristics were similar in the 2 groups. In group 2, a radial approach was more often used (65.6% vs 43.8%, p = 0.003), fewer drug-eluting stents were implanted (33.3% vs 24.8%, p = 0.06), and fewer anti-glycoprotein IIb/IIIa antagonists were prescribed (5.6% vs 8.5%, p = 0.02). The stroke rate did not differ significantly, at 3.0% (95% confidence interval 0.8% to 5.2%) for group 1 versus 0.8% (95% confidence interval -0.8% to 2.4%) in group 2. Severe and moderate bleeding, according to the Global Use of Strategies to Open Coronary Arteries (GUSTO) criteria, occurred in 2.1% and 6.4% of groups 1 and 2, respectively (p = 0.04). A significant difference in bleeding risk was found between the femoral and radial approaches (10.3% vs 3.8%, respectively; p = 0.01). In conclusion, adding dual antiplatelet therapy to pre-existing OAC therapy increases the post-PCI bleeding risk. Temporary discontinuation decreased this bleeding risk but tended to increase the risk of stroke. A radial approach for PCI could be a good alternative to the conventional femoral route to avoid bleeding.

Influence of omeprazole on the antiplatelet action of clopidogrel associated with aspirin: the randomized, double-blind OCLA (Omeprazole CLopidogrel Aspirin) study.

OBJECTIVES: This trial sought to assess the influence of omeprazole on clopidogrel efficacy. BACKGROUND: Clopidogrel has proved its benefit in the treatment of atherothrombotic diseases. In a previous observational study, we found clopidogrel activity on platelets, tested by vasodilator-stimulated phosphoprotein (VASP) phosphorylation, to be diminished in patients receiving proton pump inhibitor (PPI) treatment. METHODS: In this double-blind placebo-controlled trial, all consecutive patients undergoing coronary artery stent implantation received aspirin (75 mg/day) and clopidogrel (loading dose, followed by 75 mg/day) and were randomized to receive either associated omeprazole (20 mg/day) or placebo for 7 days. Clopidogrel effect was tested on days 1 and 7 in both groups by measuring platelet phosphorylated-VASP expressed as a platelet reactivity index (PRI). Our main end point compared PRI value at the 7-day treatment period in the 2 groups. RESULTS: Data for 124 patients were analyzed. On day 1, mean PRI was 83.2% (standard deviation [SD] 5.6) and 83.9% (SD 4.6), respectively, in the placebo and omeprazole groups (p = NS), and on day 7, 39.8% (SD 15.4) and 51.4% (SD 16.4), respectively (p < 0.0001). RESULTS: Omeprazole significantly decreased clopidogrel inhibitory effect on platelet P2Y12 as assessed by VASP phosphorylation test. Aspirin-clopidogrel antiplatelet dual therapy is widely prescribed worldwide, with PPIs frequently associated to prevent gastrointestinal bleeding. The clinical impact of these results remains uncertain but merits further investigation.

Accuracy of multislice computed tomography in the preoperative assessment of coronary disease in patients with aortic valve stenosis.

OBJECTIVES: To evaluate multislice computed tomography (MSCT) as an alternative to coronary angiography, we prospectively studied its diagnostic accuracy for the detection of significant coronary artery lesions in patients with significant aortic valve stenosis undergoing valve surgery. BACKGROUND: In patients with aortic valve stenosis, coronary angiography is still recommended before surgery. Multislice computed tomography is a promising noninvasive technique for the detection of significant coronary artery lesions. METHODS: Fifty-five consecutive patients scheduled for coronary angiography in the preoperative assessment of aortic valve stenosis underwent 16-slice MSCT 24 h before coronary angiography. We analyzed coronary lesions, image quality, and arterial calcium score. RESULTS: The sensitivity of the MSCT-based strategy in detecting significant stenosis was 100%, and its specificity 80%. The positive and negative predictive values were respectively 55% and 100%. For calcium scores <1,000 (77% of patients), MSCT detected all patients without coronary artery disease, enabling conventional coronary angiography to be avoided in 35 of 55 cases (80%). For calcium scores >1,000, MSCT enabled conventional coronary angiography to be avoided in only 6% of cases, either because significant stenosis was found with a possible indication of revascularization, or because the examination was not interpretable. CONCLUSIONS: The results of this initial experience in relatively few patients suggest that MSCT-based coronary angiography may serve as an alternative to invasive coronary angiography to rule out significant coronary artery disease in patients scheduled for elective aortic valve replacement. Larger studies are necessary to fully explore the potential of coronary MSCT to improve preoperative risk stratification.

Is coronary stent deployment and remodeling affected by predilatation? An intravascular ultrasound randomized study Stenting with or without predilation: an IVUS study.

In this intravascular ultrasound (IVUS) randomized trial we compared a strategy of direct stenting (DS) without predilation (n = 30) vs. conventional stenting with predilation (SWP) (n = 30) in patients with suitable type A or B non-calcified lesions in native vessels > or = 3 mm. Optimal deployment was achieved using angiographic criteria without interactive IVUS. The goal of our study was to determine whether stent expansion and coronary remodeling were similar. Maximal pressure inflation was comparable in the two groups (11.4 +/- 2.2 vs. 11.8 +/- 1.9 atm; NS). Stent deployment was obtained in all patients with complete apposition to the vessel wall. DS and SWP resulted in comparable lumen enlargement (5.4 +/- 2.5 vs. 5.5 +/- 2.1 mm2) with an identical mechanism: 66% of lumen enlargement was due to increased enlarged elastic membrane (EEM)-cross sectional area (CSA) (delta = 3.7 +/- 2.1 mm2 and delta = 2.4 +/- 6.8 mm2, respectively, p < 0.49) and 34% was due to a reduced P + M-CSA (delta = 0.02 +/- 6.9 mm2 and delta = 1.2 +/- 6.3 mm2, respectively, p < 0.50). We conclude that at the same maximal pressure inflation the mechanisms of stent expansion are similar in both DS and SWP groups. In this observational study, the IVUS data showed clearly under-expansion of stents in both groups in comparison with previously published CSA values (minimum stent CSA of 7.5 mm2).

Direct coronary stenting without balloon predilation of lesions requiring long stents: immediate and 6-month results of a multicenter prospective registry.

To assess the outcomes of direct coronary stenting (DS) using long stents and examine predictive factors of DS failure, this prospective multicenter registry included 128 consecutive patients who underwent the implantation of stents >or= 18 mm in length without balloon predilation for de novo coronary artery stenoses. Mean lesion and stent lengths were 20.7 +/- 5.4 and 21.4 +/- 3.8 mm, respectively. Rates of DS success, lesion success, and primary success were 82%, 99%, and 97.7%, respectively. At 6 months, rates of MACE and TVR were 12.5% and 6.3%, respectively. In multivariate analysis, factors predictive of DS failure vs. DS success were presence of calcifications (78% vs. 45%; P = 0.004) and reference vessel diameter (2.77 +/- 0.4 vs. 3.13 +/- 0.42 mm; P = 0.0002). DS of complex lesions with stents >or= 18 mm in length was performed safely and with a high success rate. This strategy was less successful in the treatment of small vessels and in presence of calcifications.