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In this multicenter trial, 3561 patients with stable chest pain at intermediate risk for obstructive coronary artery disease were randomly assigned to undergo CT or invasive coronary angiography. Over 3.5 years of follow-up, there was no significant between-group difference in the risk of major adverse cardiovascular events. Major procedure-related complications were less common with CT.

In this trial involving 2492 patients, coronary revascularization guided by iFR, as compared with fractional flow reserve-guided revascularization, was within the prespecified margin for noninferiority with respect to major adverse cardiac events. For the past 20 years, physiological measurements obtained during invasive procedures have been used to guide coronary revascularization. Pioneering work supported the use of flow measurements to make safe decisions about revascularization, 1 , 2 but this approach was soon superseded by the use of fractional flow reserve (FFR), which measures pressure as a surrogate of flow to estimate the severity of stenosis. 3 – 5 FFR was successful largely because of its technical simplicity and because clinical trials showed that it was associated with improved clinical outcomes after percutaneous coronary intervention (PCI). 6 , 7 Consequently, FFR is now included in the appropriate-use criteria for . . .

In a randomized trial, patients with coronary artery disease underwent PCI guided by either the instantaneous wave-free ratio or fractional flow reserve. At 1 year, iFR-guided PCI was noninferior to FFR-guided PCI with respect to the rate of major adverse cardiac events. Coronary revascularization is warranted only if a patient has one or more coronary-artery stenoses that are hemodynamically important. Large randomized studies have shown that fractional flow reserve (FFR) is superior to angiographic assessment for the detection of hemodynamically important coronary-artery stenoses and that use of FFR to guide coronary revascularization improves clinical outcomes. 1 – 3 FFR is measured by advancing a coronary-pressure guidewire distal to a stenotic lesion and then administering adenosine to assess the pressure gradient across the lesion during hyperemia. Studies have shown that resting indexes (derived from the pressure measurement at rest, without the administration of adenosine) have . . .

Background The advantages and disadvantages of direct invasive coronary angiography (ICA) and coronary computed tomographic angiography (CCTA) + ICA were compared in patients with suspected chronic coronary syndrome (CCS) who presented with angina symptoms or who had nonangina chest pain with abnormal electrocardiogram results. Methods A total of 1200 patients who met the inclusion criteria at TEDA International Cardiovascular Hospital from January 2021 to December 2022 were randomly divided into two groups at a 1:1 ratio: the CCTA + ICA strategy (CCTA group) and the direct ICA strategy (ICA group). The baseline data were collected. All patients in the CCTA group underwent CCTA examination first. If these results showed positive obstructive coronary artery disease (CAD), then typical angina with coronary artery stenosis ranging from 50 to 70% or vascular segments could not be analysed due to severe calcification, so ICA was further performed for definitive diagnosis, and the ICA results were taken as the final diagnosis. All patients in the ICA group underwent ICA examination directly. Demographic data, cardiovascular risk factors, biochemical criteria, chest pain classification, coronary vessel lesion severity and drug use were compared between the two groups. All patients were followed for 1 year after discharge to observe major adverse cardiovascular events (MACE). The differences in unnecessary ICA rates, 1-year MACE rates, allergic reactions to contrast agents and hospitalization costs between the two groups were analysed. On the basis of the baseline clinical data of patients included in this study, a risk prediction model for obstructive CAD was established by logistic regression. Results (1) There were 592 patients in the CCTA group and 594 patients in the ICA group. The percentage of unnecessary ICA procedures was 7.5% in the CCTA group and 55.2% in the ICA group ( P  < 0.001), which was a decrease of 86.4%. (2) Eighteen patients in the CCTA group were readmitted for severe angina, 4 of whom underwent unplanned percutaneous coronary intervention (PCI). Eight patients in the ICA group were readmitted for severe angina, 2 of whom underwent unplanned PCI. There were no cardiac deaths, nonfatal myocardial infarctions or strokes in either group over the 1-year follow-up. There was no statistically significant difference in the rate of MACE-free survival between the two groups (97.0% vs. 98.7%, log-rankχ²=1.996, P  = 0.158). (3) Allergic reactions to contrast agent were observed in 28 patients in the CCTA group and 16 in the ICA group ( P  = 0.190). (4) The median hospitalization cost in the CCTA group was $1259.54, and that in the ICA group was $1399.41, which was a significant difference ( P  < 0.001) and a decrease of 9.99%. (5) Based on the combination of the logistic regression forward selection method and backward elimination method, variables with P  < 0.05, including creatinine, age, physical activity-induced symptoms, hyperlipidaemia, diabetes and smoking history, were selected from the baseline data of patients to predict obstructive CAD. The above variables were used to establish a risk prediction model for obstructive CAD. The area under the ROC curve (AUC) of this model was 0.721, indicating good predictive ability. Conclusion In patients with suspected CCS, including typical angina, atypical angina and nonangina chest pain with abnormal electrocardiogram results, the use of CCTA as a first-line diagnostic test can reduce the unnecessary incidence of ICA and hospitalization costs without increasing the incidence of MACE. A risk prediction model of obstructive CAD was established on the basis of the baseline data of the patients enrolled in this study, providing a clinical basis for the decision to use CCTA or ICA. Patients with a low probability of obstructive CAD can be given priority for CCTA, whereas patients with a high probability can be given priority for ICA.

Objectives To evaluate the feasibility of a double-acquisition coronary CT angiography (CCTA) protocol in the presence and absence of an intravenous (IV) vasodilator infusion for detecting vasospastic angina. Methods Twenty patients with a high clinical probability of vasospastic angina were enrolled. All subjects underwent baseline CCTA without a vasodilator in the early morning followed by a catheterized coronary angiography with ergonovine provocation test. Within 3 days, all subjects underwent repeat CCTA during a continuous IV infusion of nitrate. Vasospastic angina as detected by CCTA was defined as significant stenosis (≥50 %) with negative remodelling without definite plaques or diffuse small diameter (<2 mm) of a major coronary artery with a beaded appearance on baseline CT that completely dilated on IV nitrate CT. The CCTA results were compared to the catheterized ergonovine provocation test as the reference standard. Results Among 20 patients, the catheterized ergonovine provocation test detected vasospasm in 15 patients. The sensitivity, specificity, positive predictive value and negative predictive value of CCTA in a per-patient-based analysis were 73, 100, 100 and 56 %, respectively. Conclusions Double-acquisition CCTA in the presence and absence of IV infusion of nitrate allows noninvasive detection of vasospastic angina with moderate sensitivity and high specificity. Key Points • Limited data exist regarding the efficacy of CCTA in detecting vasospastic angina . • We propose a double-acquisition CCTA protocol with and without IV nitrate injections . • This protocol provides 100% specificity and moderate sensitivity (73%) in spasm detection .

Background Stable coronary artery disease (CAD), recently termed chronic coronary syndrome (CCS), is a highly prevalent disease. Current treatment strategies often include a relevant placebo effect. The hypothesis is that visual angiographic demonstration of the coronary arteries before and after successful percutaneous coronary intervention (PCI) by itself reduces the symptom burden of stable CAD/CCS. Design and methods The PLA-pCi-EBO-pilot-trial is a prospective, multi-center, randomized, controlled investigator-initiated pilot trial to study the effect of visual demonstration of successful PCI on quality of life (QoL) and angina pectoris (AP) in patients with symptomatic stable CAD/CCS. All patients with stable CAD/CCS and successful PCI will be screened. One hundred forty four patients with a frequency of AP ≥ 2/week will be randomized 1:1 stratified for AP frequency > 1/day. The control group will receive the common written procedural report on the procedure. Patients in the intervention group will additionally be given a printout picture of their coronary angiogram both before and after PCI. Primary endpoints are change in the Seattle Angina Questionnaire (SAQ)-derived QoL score 1 and 6 months after PCI. Secondary endpoints are changes in other SAQ-derived scores and dyspnea (NYHA score) 1 and 6 months after PCI. Discussion The PLA-pCi-EBO-pilot-trial evaluates the effect of visual angiographic result demonstration on disease symptoms and QoL in patients with stable CAD/CCS on top of PCI. A positive outcome of our study would encourage the routine use of angiographic picture demonstration and has thus the potential to change daily routine in the catheterization laboratory. Trial registration German Clinical Trials Register DRKS00017524 . Registered on 5 July 2019

Background Rapid access chest pain clinics have facilitated the early diagnosis and treatment of patients with coronary heart disease and angina. Despite this important service provision, coronary heart disease continues to be under-diagnosed and many patients are left untreated and at risk. Recent advances in imaging technology have now led to the widespread use of noninvasive computed tomography, which can be used to measure coronary artery calcium scores and perform coronary angiography in one examination. However, this technology has not been robustly evaluated in its application to the clinic. Methods/design The SCOT-HEART study is an open parallel group prospective multicentre randomized controlled trial of 4,138 patients attending the rapid access chest pain clinic for evaluation of suspected cardiac chest pain. Following clinical consultation, participants will be approached and randomized 1:1 to receive standard care or standard care plus ≥64-multidetector computed tomography coronary angiography and coronary calcium score. Randomization will be conducted using a web-based system to ensure allocation concealment and will incorporate minimization. The primary endpoint of the study will be the proportion of patients diagnosed with angina pectoris secondary to coronary heart disease at 6 weeks. Secondary endpoints will include the assessment of subsequent symptoms, diagnosis, investigation and treatment. In addition, long-term health outcomes, safety endpoints, such as radiation dose, and health economic endpoints will be assessed. Assuming a clinic rate of 27.0% for the diagnosis of angina pectoris due to coronary heart disease, we will need to recruit 2,069 patients per group to detect an absolute increase of 4.0% in the rate of diagnosis at 80% power and a two-sided P value of 0.05. The SCOT-HEART study is currently recruiting participants and expects to report in 2014. Discussion This is the first study to look at the implementation of computed tomography in the patient care pathway that is outcome focused. This study will have major implications for the management of patients with cardiovascular disease. Trial registration ClinicalTrials.gov Identifier: NCT01149590

BackgroundDrug-eluting stent-induced vasospastic angina (DES-VSA) has emerged as a novel complication in the modern era of percutaneous coronary intervention (PCI). Although beta blockers (BBs) are generally recommended for coronary heart disease, they may promote incidence of DES-VSA. This study aimed to compare the effects of calcium channel blockers (CCBs) perceived to be protective against DES-VSA and BBs on subsequent coronary events after second-generation drug-eluting stent implantation.MethodsIn this multicentre prospective, randomised study, 52 patients with coronary artery disease who underwent PCI for a single-vessel lesion with everolimus-eluting stent placement were randomised into post-stenting BB (N=26) and CCB (N=26) groups and followed for 24 months to detect any major cardiovascular events (MACE). A positive result on acetylcholine provocation testing during diagnostic coronary angiography (CAG) at 9 months was the primary endpoint for equivalence. MACE included all-cause death, non-fatal myocardial infarction, unstable angina, cerebrovascular disease or coronary revascularisation for stable coronary artery disease after index PCI.ResultsAt 9 months, 42 patients (80.8%) underwent diagnostic coronary angiography and acetylcholine provocation testing. Among them, seven patients in each group were diagnosed with definite vasospasm (intention-to-treat analysis 26.9% vs 26.9%, risk difference 0 (−0.241, 0.241)). Meanwhile, the secondary endpoint, 24-month MACE, was higher in the CCB group (19.2%) than in the BB group (3.8%) (p=0.01). In detail, coronary revascularisation for stable coronary artery disease was the predominant endpoint that contributed to the greater proportion of MACE in the CCB group (CCB (19.2%) vs BB (3.8%), p=0.03).ConclusionsThe incidence of acetylcholine-induced coronary artery spasms did not differ between patients receiving BBs or CCBs at 9 months after PCI. However, a higher incidence of 2-year MACE was observed in the CCB group, suggesting the importance of BB administration.Trial registration numberThis study was registered at the Japanese University Hospital Medical Information Network (UMIN) Clinical Trial Registry (The Prospective Randomized Trial for Optimizing Medical Therapy After Stenting: Calcium-Beta Trial; UMIN000008321, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009536).

Background/Objectives: A large number of patients with coronary artery disease experience angina that is not suitable for revascularization and is refractory to conventional medical therapy. Laboratory and preclinical studies have provided evidence for the safety and potential efficacy of autologous CD34+ stem cell therapies as treatment for angina. Clinical studies investigating intramyocardial transplantation of autologous CD34+ stem cells by catheter injection for patients with refractory angina show that this is safe and feasible. It remains unclear whether intracoronary infusion of CD34+ stem cells exerts beneficial effects in patients with angina as well. We addressed this question with a controlled clinical trial by enrolling 112 patients with refractory angina. Previous trials have investigated the safety and beneficial effects of CD34+ cells isolated from granulocyte colony-stimulating factor-mobilized peripheral blood; in our trial, we isolated CD34+ cells directly from the patient’s bone marrow. Methods: One hundred and twelve patients with diffuse triple-vessel disease and Canadian Cardiovascular Society class III or IV angina were enrolled in a double-blind, randomized (1:1), placebo-controlled study. Patients received optimal medical treatment but were not candidates for mechanical revascularization (percutaneous coronary intervention or coronary artery bypass grafting). Fifty-six patients (27 women and 29 men aged 42–80 years) were enrolled in the treatment group, and 56 patients (28 women and 28 men aged 43–80 years) who received optimal medical treatment and intracoronary saline injections were enrolled in the placebo control group. Bone marrow was collected from all enrolled patients at a volume of 120–150 ml each in both groups. Selections of CD34+ cells were performed by a CE-marked device approved by the Security, Food and Drug Administration of China. Coronary angiography had been performed before enrollment in this study. Results: No myocardial infarction was observed during intracoronary infusion. The intracoronary infusion of cells or saline did not result in cardiac enzyme elevation, cardiac perforation or pericardial effusion. No arrhythmia, such as ventricular tachycardia or ventricular fibrillation, was induced by intracoronary infusion. No serious adverse events occurred in either group. The reduction in the frequency of angina episodes per week 3 and 6 months after infusion was significantly higher in the treatment group (–14.6 ± 4.8 at 3 months and –15.6 ± 4.0 at 6 months) than in the control group (–4.5 ± 0.3 and –3.0 ± 1.2, respectively; p < 0.01). Other efficacy parameters such as nitroglycerine usage, exercise time and the Canadian Cardiovascular Society class also showed an improvement in the treatment group compared to the control group. A significant improvement in myocardial perfusion was noted in the treatment group compared to the control group, as measured by single-photon emission computed tomography. Conclusions: This randomized trial investigating intracoronary infusion of autologous CD34+ cells in patients with intractable angina shows the safety and feasibility of this therapy and provides evidence for efficacy.

AbstractObjectiveTo determine whether coronary computed tomography angiography (CTA) should be performed in patients with any clinical probability of coronary artery disease (CAD), and whether the diagnostic performance differs between subgroups of patients.DesignProspectively designed meta-analysis of individual patient data from prospective diagnostic accuracy studies.Data sourcesMedline, Embase, and Web of Science for published studies. Unpublished studies were identified via direct contact with participating investigators.Eligibility criteria for selecting studiesProspective diagnostic accuracy studies that compared coronary CTA with coronary angiography as the reference standard, using at least a 50% diameter reduction as a cutoff value for obstructive CAD. All patients needed to have a clinical indication for coronary angiography due to suspected CAD, and both tests had to be performed in all patients. Results had to be provided using 2×2 or 3×2 cross tabulations for the comparison of CTA with coronary angiography. Primary outcomes were the positive and negative predictive values of CTA as a function of clinical pretest probability of obstructive CAD, analysed by a generalised linear mixed model; calculations were performed including and excluding non-diagnostic CTA results. The no-treat/treat threshold model was used to determine the range of appropriate pretest probabilities for CTA. The threshold model was based on obtained post-test probabilities of less than 15% in case of negative CTA and above 50% in case of positive CTA. Sex, angina pectoris type, age, and number of computed tomography detector rows were used as clinical variables to analyse the diagnostic performance in relevant subgroups.ResultsIndividual patient data from 5332 patients from 65 prospective diagnostic accuracy studies were retrieved. For a pretest probability range of 7-67%, the treat threshold of more than 50% and the no-treat threshold of less than 15% post-test probability were obtained using CTA. At a pretest probability of 7%, the positive predictive value of CTA was 50.9% (95% confidence interval 43.3% to 57.7%) and the negative predictive value of CTA was 97.8% (96.4% to 98.7%); corresponding values at a pretest probability of 67% were 82.7% (78.3% to 86.2%) and 85.0% (80.2% to 88.9%), respectively. The overall sensitivity of CTA was 95.2% (92.6% to 96.9%) and the specificity was 79.2% (74.9% to 82.9%). CTA using more than 64 detector rows was associated with a higher empirical sensitivity than CTA using up to 64 rows (93.4% v 86.5%, P=0.002) and specificity (84.4% v 72.6%, P<0.001). The area under the receiver-operating-characteristic curve for CTA was 0.897 (0.889 to 0.906), and the diagnostic performance of CTA was slightly lower in women than in with men (area under the curve 0.874 (0.858 to 0.890) v 0.907 (0.897 to 0.916), P<0.001). The diagnostic performance of CTA was slightly lower in patients older than 75 (0.864 (0.834 to 0.894), P=0.018 v all other age groups) and was not significantly influenced by angina pectoris type (typical angina 0.895 (0.873 to 0.917), atypical angina 0.898 (0.884 to 0.913), non-anginal chest pain 0.884 (0.870 to 0.899), other chest discomfort 0.915 (0.897 to 0.934)).ConclusionsIn a no-treat/treat threshold model, the diagnosis of obstructive CAD using coronary CTA in patients with stable chest pain was most accurate when the clinical pretest probability was between 7% and 67%. Performance of CTA was not influenced by the angina pectoris type and was slightly higher in men and lower in older patients.Systematic review registrationPROSPERO CRD42012002780.