Impact of renal function on clinical outcomes after PCI in ACS and stable CAD patients treated with ticagrelor: a prespecified analysis of the GLOBAL LEADERS randomized clinical trial

Background: Impaired renal function (IRF) is associated with increased risks of both ischemic and bleeding events. Ticagrelor has been shown to provide greater absolute reduction in ischemic risk following acute coronary syndrome (ACS) in those with versus without IRF. Methods: A pre-specified sub-analysis of the randomized GLOBAL LEADERS trial (n = 15,991) comparing the experimental strategy of 23-month ticagrelor monotherapy (after 1-month ticagrelor and aspirin dual anti-platelet therapy [DAPT]) with 12-month DAPT followed by 12-month aspirin after percutaneous coronary intervention (PCI) in ACS and stable coronary artery disease (CAD) patients stratified according to IRF (glomerular filtration rate < 60 ml/min/1.73 m2). Results: At 2 years, patients with IRF (n = 2171) had a higher rate of the primary endpoint (all-cause mortality or centrally adjudicated, new Q-wave myocardial infarction [MI](hazard ratio [HR] 1.64, 95% confidence interval [CI] 1.35–1.98, padj = 0.001), all-cause death, site-reported MI, all revascularization and BARC 3 or 5 type bleeding, compared with patients without IRF. Among patients with IRF, there were similar rates of the primary endpoint (HR 0.82, 95% CI 0.61–1.11, p = 0.192, pint = 0.680) and BARC 3 or 5 type bleeding (HR 1.10, 95% CI 0.71–1.71, p = 0.656, pint = 0.506) in the experimental versus the reference group. No significant interactions were seen between IRF and treatment effect for any of the secondary outcome variables. Among ACS patients with IRF, there were no between-group differences in the rates of the primary endpoint or BARC 3 or 5 type bleeding; however, the rates of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, MI, or revascularization (pint = 0.028) and net adverse clinical events (POCE and BARC 3 or 5 type bleeding) (pint = 0.045), were lower in the experimental versus the reference group. No treatment effects were found in stable CAD patients categorized according to presence of IRF. Conclusions: IRF negatively impacted long-term prognosis after PCI. There were no differential treatment effects found with regard to all-cause death or new Q-wave MI after PCI in patients with IRF treated with ticagrelor monotherapy. Clinical trial regis

Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies

Objectives: The purpose of this document is to make the output of the International Working Group for Intravascular Optical Coherence Tomography (IWG-IVOCT) Standardization and Validation available to medical and scientific communities, through a peer-reviewed publication, in the interest of improving the diagnosis and treatment of patients with atherosclerosis, including coronary artery disease. Background: Intravascular optical coherence tomography (IVOCT) is a catheter-based modality that acquires images at a resolution of ∼10 μm, enabling visualization of blood vessel wall microstructure in vivo at an unprecedented level of detail. IVOCT devices are now commercially available worldwide, there is an active user base, and the interest in using this technology is growing. Incorporation of IVOCT in research and daily clinical practice can be facilitated by the development of uniform terminology and consensus-based standards on use of the technology, interpretation of the images, and reporting of IVOCT results. Methods: The IWG-IVOCT, comprising more than 260 academic and industry members from Asia, Europe, and the United States, formed in 2008 and convened on the topic of IVOCT standardization through a series of 9 national and international meetings. Results: Knowledge and recommendations from this group on key areas within the IVOCT field were assembled to generate this consensus document, authored by the Writing Committee, composed of academicians who have participated in meetings and/or writing of the text. Conclusions: This document may be broadly used as a standard reference regarding the current state of the IVOCT imaging modality, intended for researchers and clinicians who use IVOCT and analyze IVOCT data

The golden hour of prehospital reperfusion with triple antiplatelet therapy: A sub-analysis from the Ongoing Tirofiban in Myocardial Evaluation 2 (On-TIME 2) trial early initiation of triple antiplatelet therapy

Background It is known that the efficacy of thrombolytic therapy in ST-segment elevation myocardial infarction (STEMI) is highly time dependent with the best efficacy when given within the so-called golden hour. This analysis from the On-TIME 2 trial evaluated the efficacy of triple antiplatelet therapy on initial patency and ST-segment resolution (STR) in relation to time from symptom onset to first medical contact. Methods The On-TIME 2 trial included 1,398 consecutive STEMI patients referred for primary percutaneous coronary intervention (PCI). Patients were randomized to dual (500 mg aspirin and 600 mg clopidogrel) or triple antiplatelet (500 mg aspirin, 600 mg clopidogrel, and tirofiban 25 mu g/kg bolus and 0.15 mu g/kg per minute maintenance infusion for 18 hours) pretreatment in the ambulance. Primary outcome of this sub-analysis was initial patency of the infarct-related vessel and STR before PCI according to time from symptom onset to first medical contact in quartiles. In addition, the incidence of aborted myocardial infarction, defined as the absence of a rise in creatinine kinase, was assessed. Results Initial patency, STR before PCI, and the incidence of aborted myocardial infarction gradually increased with shorter time from symptom onset to first medical contact. Initial Thrombolysis in Myocardial Infarction flow was present in 21.2% in the total population and 26.2%, 21.5%, 18.1%, and 18.8% in the time quartiles, respectively (P for trend = .01). The incidence of complete STR pre-angiography was 16.6% in the total population and 23.4%, 18.2%, 14.7%, and 9.9% in the 4 quartiles, respectively (P for trend <.001). This was largely driven by the effect of triple antiplatelet therapy, which further improved initial patency and STR and led to a significantly higher incidence of aborted myocardial infarction (13.2% vs 8.7%, P = .011), especially in the patients with short duration of symptoms. Conclusion Antiplatelet pretreatment before primary PCI, including a glycoprotein IIb/IIIa blocker, seems to be most effective when given shortly after symptom onset. Further studies should be performed to test this hypothesis. (Am Heart J 2010;160:1079-84.

Optical coherence tomography evaluation of intermediate-term healing of different stent types: systemic review and meta-analysis

AIMS: The intermediate-term incidence of strut malapposition (SM) and uncovered struts (US), and the degree of neointimal thickness (NIT) according to stent type have not been characterized.METHODS AND RESULTS: All studies of >50 patients in which optical coherence tomography was performed between 6 and 12 months after stent implantation were included. The incidences of SM and US were the co-primary end points, while NIT was the secondary end point. A total of 458 citations were initially appraised at the abstract level, and 11 full-text studies (280 652 analysed struts, 921 patients) were assessed. The 6-12 months incidences of SM and US were 5.0 and 7.8%, respectively, and the mean NIT was 206 μm. Biolimus-eluting stents (BES) and bioresorbable vascular scaffolds (BVS) had the highest SM rates (2.7 and 3.8%, respectively), while everolimus-eluting stents (EES) and fast-release zotarolimus-eluting stents (ZES) had the lowest SM rates (0.9 and 0.1%, respectively). BES and sirolimus-eluting stents (SES) had the highest US rates (7.7 and 8.8%, respectively), while bare metal stents (BMS) and ZES had the lowest US rates (0.3 and 0.3%, respectively). BMS had the greatest NIT (340 μm), while SES, EES, and BES had the least NIT.CONCLUSION: Second-generation drug-eluting stents (DES) have better intermediate-term strut apposition and coverage than first-generation DES, BVS, and BMS. EES demonstrate the overall best combination of healing with suppression of neointimal hyperplasia at 6-12 months. Further studies with clinical correlation are warranted to determine the implications of these findings

Correlation between 3D-QCA based FFR and quantitative lumen assessment by IVUS for left main coronary artery stenoses

Objectives: We aimed to evaluate the feasibility of using three dimensional-quantitative coronary angiography (3D-QCA) based fractional flow reserve (FFR) (vessel fractional flow reserve [vFFR], CAAS8.1, Pie Medical Imaging) and to correlate vFFR values with intravascular ultrasound (IVUS) for the evaluation of intermediate left main coronary artery (LMCA) stenosis. Background: 3D-QCA derived FFR indices have been recently developed for less invasive functional lesion assessment. However, LMCA lesions were vastly under-represented in first validation studies. Methods: This observational single-center cohort study enrolled consecutive patients with stable angina, unstable angina, or non-ST-segment elevation myocardial infarction and nonostial, intermediate grade LMCA stenoses who underwent IVUS evaluation. vFFR was computed based on two angiograms with optimal LMCA stenosis projection and correlated with IVUS-derived minimal lumen area (MLA). Results: A total of 256 patients with intermediate grade LMCA stenosis evaluated with IVUS were screened for eligibility; 147 patients met the clinical inclusion criteria and had a complete IVUS LMCA footage available, of them, 63 patients (63 lesions) underwent 3D-QCA and vFFR analyses. The main reason for screening failure was insufficient quality of the angiogram (51 patients,60.7%). Mean age was 65 ± 11 years, 75% were male. Overall, mean MLA within LMCA was 8.77 ± 3.17 mm2, while mean vFFR was 0.87 ± 0.09. A correlation was observed between vFFR and LMCA MLA (r =.792, p =.001). The diagnostic accuracy of vFFR ≤0.8 in identifying lesions with MLA < 6.0 mm2 (sensitivity 98%, specificity 71.4%, area under the curve (AUC) 0.95, 95% confidence interval (CI) 0.89–1.00, p =.001) was good. Conclusions: In patients with good quality angiographic visualization of LMCA and available complete LMCA IVUS footage, 3D-QCA based vFFR a