Abstract Background Concerns have been raised about radiation dose of coronary CT angiography. Although high-pitch acquisition technique yields high potential for radiation dose savings, it is more ...vulnerable to artifacts, which impair diagnostic image quality. Objective The purpose of this study was to compare 2 scan strategies for coronary CT angiography: a high-pitch helical scan first or a conventional scan first strategy. Methods In this prospective, multicenter trial, we randomized 303 consecutive patients with a low and stable heart rate to either of the aforementioned mentioned strategies. Intravenous β-blockers were administered to achieve target heart rates. All scans were performed on a second-generation dual-source CT scanner. In case of nondiagnostic image quality, coronary CT angiography was allowed to be repeated. The primary end point was to demonstrate noninferior image quality in the high-pitch group. Image quality was assessed on a 4-point scale (1: nondiagnostic, 4: excellent). Secondary end point was total radiation dose. Results In the high-pitch helical first group, repeat scanning was necessary in 21 patients compared with 14 patients in the conventional first scan group ( P = .25). Image quality in the high-pitch group was noninferior compared to the conventional scan group (3.81 ± 0.35 vs 3.83 ± 0.37; P for noninferiority <.0001). The total effective radiation dose estimate was 58% lower in the high-pitch group (2.0 ± 2.4 vs 4.7 ± 4.8 mSv; P < .0001). Conclusions In patients with a low and stable heart rate diagnostic image quality can be maintained with a high-pitch helical scan first strategy while 58% of radiation dose can be saved.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Abstract Objectives The goal of this study was to determine the long-term prognostic value of coronary computed tomography angiography (CTA) among patients with diabetes mellitus (DM) compared with ...nondiabetic subjects. Background The long-term prognostic value of coronary CTA in patients with DM is not well established. Methods Patients enrolled in the CONFIRM (Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter) registry with 5-year follow-up data were identified. The extent and severity of coronary artery disease (CAD) were analyzed at baseline coronary CTA and in relation to outcomes between diabetic and nondiabetic patients. CAD according to coronary CTA was defined as none (0% stenosis), nonobstructive (1% to 49% stenosis), or obstructive (≥50% stenosis). Time to death (and in a subgroup, time to major adverse cardiovascular event) was estimated by using multivariable Cox proportional hazards models. Results A total of 1,823 patients were identified as having DM with 5-year clinical follow-up and were propensity-matched to 1,823 patients without DM (mean age 61.8 ± 10.9 years; 54.4% male). Patients with DM did not exhibit a heightened risk of death compared with the propensity-matched nondiabetic subjects in the absence of CAD on coronary CTA (risk-adjusted hazard ratio HR of DM: 1.32; 95% confidence interval CI: 0.78 to 2.24; p = 0.296). Patients with DM were at increased risk of dying compared with nondiabetic subjects in the setting of nonobstructive CAD (in the propensity-matched cohort: HR, 2.10; 95% CI: 1.43 to 3.09; p < 0.001) with a mortality risk greater than nondiabetic subjects with obstructive disease (p < 0.001). In a risk-adjusted hazard analysis among patients with DM, both per-patient obstructive CAD and nonobstructive CAD conferred an increase in all-cause mortality risk compared with patients without atherosclerosis on coronary CTA (nonobstructive disease—HR: 2.07; 95% CI: 1.33 to 3.24; p = 0.001; obstructive disease—HR: 2.22; 95% CI: 1.47 to 3.36; p < 0.001). Conclusions Among patients with DM, nonobstructive and obstructive CAD according to coronary CTA were associated with higher rates of all-cause mortality and major adverse cardiovascular events at 5 years, and this risk was significantly higher than in nondiabetic subjects. Importantly, patients with DM without CAD according to coronary CTA were at a risk comparable to that of nondiabetic subjects.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Abstract Objectives The purpose of this study was to examine sex-specific associations, if any, between per-vessel coronary artery disease (CAD) extent and the risk of major adverse cardiovascular ...events (MACE) over a 5-year study duration. Background The presence and extent of CAD diagnosed by coronary computed tomography angiography (CTA) is associated with increased short-term mortality and MACE. Nevertheless, some uncertainty remains regarding the influence of sex on these findings. Methods 5,632 patients (mean age 60.2 ± 11.8 years, 36.5% women) from the CONFIRM (Coronary CT Angiography Evaluation for Clinical Outcomes: An International Multicenter) registry were followed for 5 years. Obstructive CAD was defined as ≥50% luminal stenosis in a coronary vessel. Using Cox proportional hazards models, we calculated the hazard ratio (HR) for incident MACE among women and men, defined as death or myocardial infarction. Results Obstructive CAD was more prevalent in men (42% vs. 26%; p < 0.001), whereas women were more likely to have normal coronary arteries (43% vs. 27%; p < 0.001). There were a total of 798 incident MACE events. After adjustment, there was a strong association between increased MACE risk and nonobstructive CAD (HR: 2.16 for women, 2.56 for men; p < 0.001 for both), obstructive 1-vessel CAD (HR: 3.69 and 2.66; p < 0.001), 2-vessel CAD (HR: 3.92 and 3.55; p < 0.001), and 3-vessel/left main CAD (HR: 5.94 and 4.44; p < 0.001). Further exploratory analyses of atherosclerotic burden did not identify sex-specific patterns predictive of MACE. Conclusions In a large prospective coronary CTA cohort followed long-term, we did not observe an interaction of sex for the association between MACE risk and increased per-vessel extent of obstructive CAD. These findings highlight the persistent prognostic significance of anatomic CAD subsets as detected by coronary CTA for the risk of MACE in both women and men.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Abstract Objectives This study sought to develop a clinical model that identifies patients with and without high-risk coronary artery disease (CAD). Background Although current clinical models help ...to estimate a patient's pre-test probability of obstructive CAD, they do not accurately identify those patients with and without high-risk coronary anatomy. Methods Retrospective analysis of a prospectively collected multinational coronary computed tomographic angiography (CTA) cohort was conducted. High-risk anatomy was defined as left main diameter stenosis ≥50%, 3-vessel disease with diameter stenosis ≥70%, or 2-vessel disease involving the proximal left anterior descending artery. Using a cohort of 27,125, patients with a history of CAD, cardiac transplantation, and congenital heart disease were excluded. The model was derived from 24,251 consecutive patients in the derivation cohort and an additional 7,333 nonoverlapping patients in the validation cohort. Results The risk score consisted of 9 variables: age, sex, diabetes, hypertension, current smoking, hyperlipidemia, family history of CAD, history of peripheral vascular disease, and chest pain symptoms. Patients were divided into 3 risk categories: low (≤7 points), intermediate (8 to 17 points) and high (≥18 points). The model was statistically robust with area under the curve of 0.76 (95% confidence interval CI: 0.75 to 0.78) in the derivation cohort and 0.71 (95% CI: 0.69 to 0.74) in the validation cohort. Patients who scored ≤7 points had a low negative likelihood ratio (<0.1), whereas patients who scored ≥18 points had a high specificity of 99.3% and a positive likelihood ratio (8.48). In the validation group, the prevalence of high-risk CAD was 1% in patients with ≤7 points and 16.7% in those with ≥18 points. Conclusions We propose a scoring system, based on clinical variables, that can be used to identify patients at high and low pre-test probability of having high-risk CAD. Identification of these populations may detect those who may benefit from a trial of medical therapy and those who may benefit most from an invasive strategy.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
To assess the value of coronary computed tomographic angiography (CCTA) in the prediction of cardiac events in asymptomatic patients, 451 consecutive asymptomatic patients who underwent CCTA from ...December 2003 to November 2007 were retrospectively analyzed. The primary end point of the study was the occurrence of cardiac events, defined as cardiac death, nonfatal myocardial infarction, unstable angina requiring hospitalization, and late revascularization (>90 days after CCTA) during a median follow-up period of 27.5 months. Secondary end points were the prevalence of nonobstructive coronary lesions and the number of patients reclassified regarding their cardiovascular risk. Two hundred twenty-nine patients (54%) had nonobstructive coronary lesions, and 107 patients (24%) obstructive coronary artery disease. During follow-up, there were 2 cases of unstable angina and 8 revascularizations for stable angina. Patients with obstructive coronary artery disease had a significantly higher event rate than those without obstructive CAD (risk ratio 13.9, 95% confidence interval 4.0 to 48.0). In 217 patients (48%), the clinically assessed cardiovascular risk could be reclassified by CCTA from intermediate or high to low risk. In conclusion, although the event rate was low in asymptomatic patients, CCTA could reliably predict further cardiac events and could reclassify 2/3 of patients regarding their cardiovascular risk.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
The original text in the manuscript published in the American Heart Journal (2012;163:938-45) reads as follows:"Because most of the patients will not be able to provide full informed consent before ...randomization, an individualized informed consent process covering 4 different scenarios has been validated and approved by the central ethical committee at the University of Leipzig, Germany, and also all local ethical committees.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background Female sex independently predicts bleeding risk after percutaneous coronary intervention (PCI). Bivalirudin is safer than abciximab plus heparin in patients with non–ST-segment elevation ...myocardial infarction (NSTEMI). Thus, a greater benefit of bivalirudin in women would be expected. Methods We performed a sex-based analysis of the patients with NSTEMI (n = 1,721, 399 women) enrolled in the ISAR-REACT 4 trial and randomized to receive bivalirudin or abciximab plus heparin. Main outcome was a 30-day composite of death, large recurrent myocardial infarction, urgent target vessel revascularization, or major bleeding. Secondary outcome was 1-year composite of death, myocardial infarction, or target vessel revascularization. Results No difference in the main outcome was observed in groups with bivalirudin or abciximab plus heparin: 12.6% versus 15.5% (hazard ratio HR 0.81, 95% CI 0.48-1.37) among women and 10.6% versus 9.5% (HR 1.12, 95% CI 0.77-1.64) among men. Major bleeding occurred in 4.5% in the bivalirudin group versus 7.5% in the abciximab plus heparin group (HR 0.60, 95% CI 0.26-1.39) among women and 2.0% versus 3.8% (HR 0.52, 0.27-1.02) among men. At 1 year, the secondary outcome was observed in 24.1% in the bivalirudin group versus 28.7% in the abciximab plus heparin group among women, HR of 0.80 (95% CI 0.55-1.17), and in 20.6% and 19.0%, respectively, HR of 1.10 (95% CI 0.86-1.40) among men. Conclusion Despite a higher peri-PCI bleeding risk in women, bivalirudin is as effective as and safer than abciximab plus heparin in women and men with NSTEMI undergoing PCI.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Abstract Background The diagnostic performance of multidetector row CT to detect coronary artery stenosis has been evaluated in numerous single-center studies, with only limited data from large ...cohorts with low-to-intermediate likelihood of coronary disease and in multicenter trials. The Multicenter Evaluation of Coronary Dual-Source CT Angiography in Patients with Intermediate Risk of Coronary Artery Stenoses (MEDIC) trial determines the accuracy of dual-source CT (DSCT) to identify persons with at least 1 coronary artery stenosis among patients with low-to-intermediate pretest likelihood of disease. Methods The MEDIC trial was designed as a prospective, multicenter, international trial to evaluate the diagnostic performance of DSCT for the detection of coronary artery stenosis compared with invasive coronary angiography. The study includes 8 sites in Germany, India, Mexico, the United States, and Denmark. The study population comprises patients referred for a diagnostic coronary angiogram because of suspected coronary artery disease with an intermediate pretest likelihood as determined by sex, age, and symptoms. All evaluations are performed by blinded core laboratory readers. Results The primary outcome of the MEDIC trial is the accuracy of DSCT to identify the presence of coronary artery stenoses with a luminal diameter narrowing of 50% or more on a per-vessel basis. Secondary outcome parameters include per-patient and per-segment diagnostic accuracy for 50% stenoses and accuracy to identify stenoses of 70% or more. Furthermore, secondary outcome parameters include the influence of heart rate, Agatston score, body weight, body mass index, image quality, and diagnostic confidence on the accuracy to detect coronary artery stenoses >50% on a per-vessel basis. Conclusion The results of the MEDIC trial will assess the clinical utility of coronary CT angiography in the evaluation of patients with intermediate pretest likelihood of coronary artery disease.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Objectives We sought to investigate the long-term efficacy of oral sirolimus therapy and its impact on the incidence of de novo malignancies in the OSIRIS (Oral Sirolimus to Inhibit Recurrent ...In-Stent Stenosis) trial population. Background The OSIRIS trial showed a significant reduction of angiographic restenosis with an oral adjunctive sirolimus treatment for in-stent restenosis. The long-term efficacy of oral sirolimus therapy is unknown. Methods Three hundred patients with in-stent restenosis were randomly assigned to receive placebo, a cumulative loading dose of 8 mg (usual-dose), or 24 mg (high-dose) of sirolimus over 3 days (2 days before and the day of intervention) followed by maintenance therapy of 2 mg/day for 7 days. The primary outcome of this analysis was the incidence of composite of death, myocardial infarction, and target vessel revascularization at 4-year follow-up. Secondary outcome was the incidence of newly diagnosed malignancies. Results No significant differences were observed between placebo, usual-, and high-dose sirolimus treatment groups regarding primary outcome (33.3%, 39.4%, and 31.3%, respectively; p = 0.46), death (5.9%, 9.1%, and 11.1%, respectively; p = 0.41), target vessel revascularization (30.4%, 30.3%, and 22.2%, respectively; p = 0.33), and rate of newly diagnosed malignancies (7.8%, 3.0%, and 11.1%, respectively; p = 0.09). Conclusions The benefit in the reduced need for repeat intervention observed at 1 year with high-dose oral sirolimus therapy was attenuated over 4 years. Moreover, this regimen was associated with numerical yet not a significant increase in newly diagnosed malignancies without augmenting the malignancy-induced risk of death. (Oral Sirolimus for In-Stent Restenosis OSIRUS trial; NCT00859183 )
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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