Objectives This study sought to determine the diagnostic accuracy of 64-slice computed tomographic coronary angiography (CTCA) to detect or rule out significant coronary artery disease (CAD). ...Background CTCA is emerging as a noninvasive technique to detect coronary atherosclerosis. Methods We conducted a prospective, multicenter, multivendor study involving 360 symptomatic patients with acute and stable anginal syndromes who were between 50 and 70 years of age and were referred for diagnostic conventional coronary angiography (CCA) from September 2004 through June 2006. All patients underwent a nonenhanced calcium scan and a CTCA, which was compared with CCA. No patients or segments were excluded because of impaired image quality attributable to either coronary motion or calcifications. Patient-, vessel-, and segment-based sensitivities and specificities were calculated to detect or rule out significant CAD, defined as ≥50% lumen diameter reduction. Results The prevalence among patients of having at least 1 significant stenosis was 68%. In a patient-based analysis, the sensitivity for detecting patients with significant CAD was 99% (95% confidence interval CI: 98% to 100%), specificity was 64% (95% CI: 55% to 73%), positive predictive value was 86% (95% CI: 82% to 90%), and negative predictive value was 97% (95% CI: 94% to 100%). In a segment-based analysis, the sensitivity was 88% (95% CI: 85% to 91%), specificity was 90% (95% CI: 89% to 92%), positive predictive value was 47% (95% CI: 44% to 51%), and negative predictive value was 99% (95% CI: 98% to 99%). Conclusions Among patients in whom a decision had already been made to obtain CCA, 64-slice CTCA was reliable for ruling out significant CAD in patients with stable and unstable anginal syndromes. A positive 64-slice CTCA scan often overestimates the severity of atherosclerotic obstructions and requires further testing to guide patient management.
Abstract Objectives The goal of this study was to compare survival between transcatheter mitral valve (MV) repair using MitraClip system (Abbott Vascular, Santa Clara, California), MV-surgery, and ...conservative treatment in high-surgical-risk patients symptomatic with severe mitral valve regurgitation (MR). Background Up to 50% of patients with symptomatic severe MR are denied for surgery due to high perioperative risk. Transcatheter MV repair might be an alternative. Methods Consecutive patients (n = 139) treated with transcatheter MV repair were included. Comparator surgically (n = 53) and conservatively (n = 59) treated patients were identified retrospectively. Surgical risk was based on the logistic European System for Cardiac Operative Risk Evaluation (log EuroSCORE) or the presence of relevant risk factors, as judged by the heart team. Results The log EuroSCORE was higher in the transcatheter MV repair group (23.9 ± 16.1%) than in the surgically (14.2 ± 8.9%) and conservatively (18.7 ± 13.2%, p < 0.0001) treated patients. Left ventricular ejection fraction was higher in surgical patients (43.9 ± 14.4%, p = 0.003), with similar values for the transcatheter MV repair (36.8 ± 15.3%) and conservatively treated (34.5 ± 16.5%) groups. After 1 year of follow-up, the transcatheter MV repair and surgery groups showed similar survival rates (85.8% and 85.2%, respectively), whereas 67.7% of conservatively treated patients survived. The same trend was observed after the second and third years. After weighting for propensity score and controlling for risk factors, both the transcatheter MV repair (hazard ratio HR: 0.41, 95% confidence interval CI: 0.22 to 0.78, p = 0.006) and surgical (HR: 0.52, 95% CI: 0.30 to 0.88, p = 0.014) groups showed better survival than the conservatively treated group. The transcatheter MV repair and surgical groups did not differ (HR: 1.25, 95% CI: 0.72 to 2.16, p = 0.430). Conclusions Despite a higher log EuroSCORE, high-surgical-risk patients with symptomatic severe MR treated with transcatheter MV repair show similar survival rates compared with surgically treated patients, with both displaying survival benefit compared with conservative treatment.
The aim of this study was to compare clinical outcome at 5 years in patients with complete and incomplete revascularization treated with coronary artery bypass grafting (CABG) and percutaneous ...coronary intervention (PCI) with drug-eluting stents. Baseline and procedural angiograms and surgical case-record forms were centrally assessed for completeness of revascularization. Patients treated with PCI for incomplete revascularization were stratified according to Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score tertiles. Complete revascularization was achieved in 360 of 588 patients (61.2%) in the PCI with sirolimus-eluting stent group and 477 of 567 patients (84.1%) in the CABG group (p <0.05). There was no significant difference in 5-year survival without major adverse cardiac and cerebrovascular events (MACCEs; death, cerebrovascular accident, myocardial infarction, and any revascularization) between patients with complete and incomplete revascularization treated with PCI or CABG. Survival free from MACCEs in patients with incomplete revascularization treated with PCI was significantly lower than those with complete revascularization treated with CABG (hazard ratio 1.66, 0.96 to 1.80, log-rank p = 0.001). The 5-year MACCE-free survival in patients with incomplete revascularization treated with PCI stratified according to SYNTAX score tertiles showed a significantly lower MACCE survival in the higher SYNTAX tertile compared to the low (hazard ratio 0.56, 0.32 to 0.96, log-rank p = 0.04) and intermediate (hazard ratio 0.50, 0.28 to 0.91, log-rank p = 0.02) tertiles, whereas survival between the low and intermediate SYNTAX tertiles was not significantly different (hazard ratio 1.13, 0.60 to 2.13, log-rank p = 0.71). In conclusion, this study suggests that patients with complex coronary disease, in whom complete revascularization cannot be achieved with PCI, should be offered surgical revascularization. However, in those patients with less complex disease, PCI is a valid alternative even if complete revascularization cannot be achieved.
Abstract Background It is uncertain whether a diagnostic strategy supplemented by early coronary computed tomography angiography (CCTA) is superior to contemporary standard optimal care (SOC) ...encompassing high-sensitivity troponin assays (hs-troponins) for patients suspected of acute coronary syndrome (ACS) in the emergency department (ED). Objectives This study assessed whether a diagnostic strategy supplemented by early CCTA improves clinical effectiveness compared with contemporary SOC. Methods In a prospective, open-label, multicenter, randomized trial, we enrolled patients presenting with symptoms suggestive of an ACS at the ED of 5 community and 2 university hospitals in the Netherlands. Exclusion criteria included the need for urgent cardiac catheterization and history of ACS or coronary revascularization. The primary endpoint was the number of patients identified with significant coronary artery disease requiring revascularization within 30 days. Results The study population consisted of 500 patients, of whom 236 (47%) were women (mean age 54 ± 10 years). There was no difference in the primary endpoint (22 9% patients underwent coronary revascularization within 30 days in the CCTA group and 17 7% in the SOC group p = 0.40). Discharge from the ED was not more frequent after CCTA (65% vs. 59%, p = 0.16), and length of stay was similar (6.3 h in both groups; p = 0.80). The CCTA group had lower direct medical costs (€337 vs. €511, p < 0.01) and less outpatient testing after the index ED visit (10 4% vs. 26 10%, p < 0.01). There was no difference in incidence of undetected ACS. Conclusions CCTA, applied early in the work-up of suspected ACS, is safe and associated with less outpatient testing and lower costs. However, in the era of hs-troponins, CCTA does not identify more patients with significant CAD requiring coronary revascularization, shorten hospital stay, or allow for more direct discharge from the ED. (Better Evaluation of Acute Chest Pain with Computed Tomography Angiography BEACON; NCT01413282 )
Abstract Objectives The study sought to determine long-term clinical effects of combining catheter ablation (CA) and left atrial appendage (LAA) occlusion (LAAO) in a single procedure. Background CA ...relieves symptoms in atrial fibrillation (AF), but freedom from AF is not assured. Thus, oral anticoagulation (OAC) remains necessary in high stroke risk patients. LAAO has proved a viable alternative for preventing thromboembolic complications. Methods Symptomatic patients with drug-refractory AF (CHADS2 ≥1) and indications for LAAO were included. Transesophageal echocardiography was performed to assess LAA size/anatomy/thrombus. After CA, LAAO was performed using the Watchman device (Atritech, Inc., Plymouth, Minnesota, Minnesota). At 3 months, OAC was switched to aspirin/clopidogrel if LAAO criteria were met. Results From September 2009 to October 2013, 62 patients (22 female, 64 ± 8 years of age, CHADS2 2.5) underwent combined procedures. Indications for LAAO included history of stroke despite OAC (29.0%), contraindications for OAC (24.2%), high stroke risk (24.2%), and miscellaneous reasons (22.6%). LAAO resulted in complete acute closure in all, with a median number of 1 device. After a median follow-up of 38 (range: 25 to 45) months, 95% of the patients met the criteria for successful sealing and 78% could discontinue OAC, while recurrence of AF was documented in 42%. During long-term follow-up, 3 ischemic strokes were observed with an annual stroke risk of 1.7%, which is lower than the expected annual risk of 6.5%. Conclusions LAAO combined with CA for AF can be performed successfully and safely in a single procedure, with a lower than expected stroke rate. Further studies are necessary to determine which patients benefit most from the combined therapy.
Objectives The purpose of this study was to investigate whether FX06 would limit infarct size when given as an adjunct to percutaneous coronary intervention. Background FX06, a naturally occurring ...peptide derived from human fibrin, has been shown to reduce myocardial infarct size in animal models by mitigating reperfusion injury. Methods In all, 234 patients presenting with acute ST-segment elevation myocardial infarction were randomized in 26 centers. FX06 or matching placebo was given as intravenous bolus at reperfusion. Infarct size was assessed 5 days after myocardial infarction by late gadolinium enhanced cardiac magnetic resonance imaging. Secondary outcomes included size of necrotic core zone and microvascular obstruction at 5 days, infarct size at 4 months, left ventricular function, troponin I levels, and safety. Results There were no baseline differences between groups. On day 5, there was no significant difference in total late gadolinium enhanced zone in the FX06 group compared with placebo (reduction by 21%; p = 0.207). The necrotic core zone, however, was significantly reduced by 58% (median 1.77 g interquartile range 0.0, 9.09 g vs. 4.20 g interquartile range 0.3, 9.93 g; p < 0.025). There were no significant differences in troponin I levels (at 48 h, −17% in the FX06 group). After 4 months, there were no longer significant differences in scar size. There were numerically fewer serious cardiac events in the FX06-treated group, and no differences in adverse events. Conclusions In this proof-of-concept trial, FX06 reduced the necrotic core zone as one measure of infarct size on magnetic resonance imaging, while total late enhancement was not significantly different between groups. The drug appears safe and well tolerated. (Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury F.I.R.E.; NCT00326976 )
Predictors of Coronary Stent Thrombosis van Werkum, Jochem W., MD; Heestermans, Antonius A., MD; Zomer, A. Carla, MD ...
Journal of the American College of Cardiology,
04/2009, Letnik:
53, Številka:
16
Journal Article
Recenzirano
Odprti dostop
Objectives This study sought to comprehensively identify predictors of stent thrombosis (ST). Background Given the devastating consequences of ST, efforts should be directed toward risk ...stratification to identify patients at highest risk for ST. Methods Consecutive patients with angiographic ST were enrolled. Patients who did not suffer from a ST were randomly selected in a 2:1 ratio and were matched for: 1) percutaneous coronary intervention (PCI) indication; 2) same date of index PCI; and 3) same interventional center. Results Of 21,009 patients treated with either a bare-metal or drug-eluting stent, 437 patients (2.1%) presented with a definite ST. A total of 140 STs were acute, 180 were subacute, 58 were late, and 59 were very late. Undersizing of the coronary stent, Thrombolysis In Myocardial Infarction flow grade <3, present malignancy, presence of intermediate coronary artery disease proximal and distal to the culprit lesion, dissection, lack of aspirin, bifurcation lesions, ejection fraction <30%, and younger age were associated with ST. The lack of clopidogrel therapy at the time of ST in the first 30 days after the index PCI (hazard ratio HR: 36.5, 95% confidence interval CI: 8.0 to 167.8), between 30 days and 6 months after the index PCI (HR: 4.6, 95% CI: 1.4 to 15.3), and beyond 6 months (HR: 5.9, 95% CI: 1.7 to 19.8) after the index PCI was strongly associated with ST. Conclusions Important correlates of ST were identified. Discontinuation of clopidogrel, undersizing of the coronary stent, present malignancy, and intermediate (≥50% to <70% stenosis) coronary artery disease proximal to the culprit lesion were the strongest predictors of ST.
Reply Meijboom, W. Bob, MD; Meijs, Matthijs F.L., MD; Schuijf, Joanne D., MD, PhD ...
Journal of the American College of Cardiology,
2009, Letnik:
53, Številka:
19
Journal Article
PDF
