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Importance: Vascular complications after transfemoral transcatheter aortic valve implantation (TAVI) remain an important cause of procedure-related morbidity. Routine reversal of anticoagulation with protamine at the conclusion of transfemoral TAVI could reduce complications, but data remain scarce., Objective: To evaluate the efficacy and safety of routine protamine administration after transfemoral TAVI., Design, Setting, and Participants: The ACE-PROTAVI trial was an investigator-initiated, double-blind, placebo-controlled randomized clinical trial performed at 3 Australian hospitals between December 2021 and June 2023 with a 1-year follow-up period. All patients accepted for transfemoral TAVI by a multidisciplinary heart team were eligible for enrollment., Interventions: Eligible patients were randomized 1:1 between routine protamine administration and placebo., Main Outcomes and Measures: The coprimary outcomes were the rate of hemostasis success and time to hemostasis (TTH), presented as categorical variables and compared with a χ2 test or as continuous variables as mean (SD) or median (IQR), depending on distribution. The major secondary outcome was a composite of all-cause death, major and minor bleeding complications, and major and minor vascular complications after 30 days, reported in odds ratios (ORs) with 95% CIs and P values., Results: The study population consisted of 410 patients: 199 patients in the protamine group and 211 in the placebo group. The median (IQR) patient age in the protamine group was 82 (77-85) years, and 68 of 199 patients receiving protamine (34.2%) were female. The median (IQR) patient age in the placebo group was 80 (75-85) years, and 89 of 211 patients receiving the placebo (42.2%) were female. Patients receiving up-front protamine administration had a higher rate of hemostasis success (188 of 192 patients [97.9%]) than patients in the placebo group (186 of 203 patients [91.6%]; absolute risk difference, 6.3%; 95% CI, 2.0%-10.6%; P = .006); in addition, patients receiving up-front protamine had a shorter median (IQR) TTH (181 [120-420] seconds vs 279 [122-600] seconds; P = .002). Routine protamine administration resulted in a reduced risk of the composite outcome in the protamine group (10 of 192 [5.2%]) vs the placebo group (26 of 203 [12.8%]; OR, 0.37; 95% CI, 0.1-0.8; P = .01). This difference was predominantly driven by the difference in the prevalence of minor vascular complications. There were no adverse events associated with protamine use., Conclusions and Relevance: In the ACE-PROTAVI randomized clinical trial, routine administration of protamine increased the rate of hemostasis success and decreased TTH. The beneficial effect of protamine was reflected in a reduction in minor vascular complications, procedural time, and postprocedural hospital stay duration in patients receiving routine protamine compared with patients receiving placebo., Trial Registration: anzctr.org.au Identifier: ACTRN12621001261808.

Intermediate coronary artery stenosis, defined as visual angiographic stenosis severity of between 30-70%, is present in up to one quarter of patients undergoing coronary angiography. Patients with this particular lesion subset represent a distinct clinical challenge, with operators often uncertain on the need for revascularization. Although international guidelines appropriately recommend physiological pressure-based assessment of these lesions utilizing either fractional flow reserve (FFR) or quantitative flow ratio (QFR), there are specific clinical scenarios and lesion subsets where the use of such indices may not be reliable. Intravascular imaging, mainly utilizing intravascular ultrasound (IVUS) and optical coherence tomography (OCT) represents an alternate and at times complementary diagnostic modality for the evaluation of intermediate coronary stenoses. Studies have attempted to validate these specific imaging measures with physiological markers of lesion-specific ischaemia with varied results. Intravascular imaging however also provides additional benefits that include portrayal of plaque morphology, guidance on stent implantation and sizing and may portend improved clinical outcomes. Looking forward, research in computational fluid dynamics now seeks to integrate both lesion-based physiology and anatomical assessment using intravascular imaging. This review will discuss the rationale and indications for the use of intravascular imaging assessment of intermediate lesions, while highlighting the current limitations and benefits to this approach., Competing Interests: Conflicts of Interest: The authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/cdt-20-226). The series “Intracoronary Imaging” was commissioned by the editorial office without any funding or sponsorship. ATB reports other from Abbott Vascular, other from Boston Scientific, outside the submitted work. The authors have no other conflicts of interest to declare., (2020 Cardiovascular Diagnosis and Therapy. All rights reserved.)

Background: Uncertainty remains as to whether females benefit as much as males from percutaneous coronary intervention (PCI) in the setting of an acute coronary syndrome (ACS)., Methods: We compared 802 women with 2151 men presenting with ACS, undergoing PCI from April 2004 to October 2006 from the Melbourne Interventional Group registry. Clinical characteristics, in-hospital, 30-day and 1-year outcomes were compared., Results: Women were older (69.6 ± 11.6 vs. 62.17 ± 12.3 years, p<0.001), and had more diabetes (27.1% vs. 19.6%, p<0.001) and hypertension (70.3% vs. 53.9%, p<0.001) than men. Women were less likely to present with ST-elevation myocardial infarction (30.5% vs. 37.9%, p<0.001). Bleeding (3.6% vs. 0.8%, p<0.001) was higher among women. Thirty-day mortality (4.7 vs. 2.4%, p<0.001) and MACE (10.1 vs. 6.4%, p<0.001) were higher in women. Gender was an independent predictor of overall MACE at 30 days (OR 1.45, 95% CI 1.04-2.02, p=0.03) but not death. At 12 months, there were no significant differences in mortality (6.4% vs. 4.8%, p=0.09), myocardial infarction (5.5% vs. 5.0%, p=0.64), target vessel revascularization (7.9% vs. 7.0%, p=0.42) and MACE (16.3% vs. 14%, p=0.13) between women and men., Conclusions: There is an early hazard amongst women undergoing PCI for ACS, but not at 12 months. These data suggest that gender should not affect the decision to offer PCI but further gender specific studies are warranted., (Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.)

Background: Percutaneous coronary intervention (PCI) for high-grade stenosis of the left main coronary artery with bare-metal stents has been limited by restenosis, and most patients are managed with coronary artery bypass grafting (CABG). Recently, drug-eluting stents (DES) have reduced instent restenosis after PCI, but their role in the treatment of left main disease remains unclear., Aims: The aim of this study was to determine the outcomes after utilizing DES to treat left main disease., Methods: Twenty consecutive symptomatic patients with >50% angiographic stenosis of the left main coronary artery with no prior history of CABG ["unprotected left main" (ULM)] underwent PCI with DES. Patients were divided into two groups based on the presence (Group A, n=5) or absence (Group B, n=15) of preprocedural cardiogenic shock. At follow up (median, 14 months), cumulative major adverse cardiac events (MACE-death, myocardial infarction, or target vessel revascularization) were determined., Results: Sixteen (80%) of 20 patients were at high risk for CABG because of comorbidity, advanced age, or cardiogenic shock. Procedural success was 100% (20/20). Three of five patients in Group A (60%) died in hospital and the two surviving patients experienced no MACE at follow up. In Group B (n=15), there was no in-hospital MACE, but one patient died suddenly 8 weeks postprocedure [cumulative MACE of 7% (1/15)]., Conclusions: Our study demonstrates the feasibility of ULM treatment with DES with acceptable medium-term outcomes. While CABG remains the best form of revascularization for the majority of patients with ULM, DES should be considered in those who are at high risk.

In-stent restenosis (ISR) remains a challenging problem in percutaneous coronary intervention and the optimal treatment strategy remains unclear. The aim of this study was to compare the 18 month clinical outcomes in patients receiving sirolimus-eluting stents (SES) with vascular brachytherapy (VBT) for the treatment of ISR. Twenty-five consecutive patients treated with VBT were compared with 29 patients who had SES deployment for ISR. Major adverse cardiac events (MACE) were defined as a combination of death from cardiac causes, nonfatal myocardial infarction, or repeat TVR. At 18 month follow-up, the MACE rate was significantly lower in the SES compared with the VBT group (14% vs 40%, P=.03). One patient in the VBT group developed late stent thrombosis (at 10 months) and died; there was no stent thrombosis in the SES group. This observational study, taken with other recent reports, offers further credence to the use of SES for ISR. The results of randomized comparisons with VBT are awaited with interest.

Aims: Coronary artery disease is the major cause of death in patients with end-stage renal failure on dialysis. This study aimed to assess the predictive value of a single cardiac troponin I (cTnI), and also the kinetics of serial values., Methods: Since cTnI is a potential biomarker of cardiac outcome, the present study examined single cTnI measurements (n = 88 patients) and its predictive value for future cardiac events, and a kinetic substudy of serial weekly cTnI measured for 8 weeks (n = 57) in a group of patients on hemodialysis., Results: Single cTnI measurements: 9 patients (10.2%) had a detectable cTnI at baseline and 79 patients (89.8%) had a negative baseline cTnI. There were no significant differences in age, sex, history of ischemic heart disease, diabetes, smoking or dyslipidemia between patients with detectable and negative cTnI. At the end of 9 months, the rate of combined primary endpoints, which included myocardial infarction, cardiac death and cardiac revascularization, was significantly higher in the patients with a detectable baseline cTnI (55.6%), compared to patients with a negative cTnI (6.3%) (p = 0.0007). Serial weekly cTnI measurements: significant fluctuations in cTnI were noted over time; 27% of patients with an undetectable cTnI measured at baseline had subsequent detectable levels in the serial follow-up., Conclusion: A single detectable cTnI in asymptomatic patients on hemodialysis defines patients at high risk of future cardiac events. However, the incidence of detectable cTnI levels is markedly increased when serial weekly measurements are performed. The clinical significance of detectable serial measurements of cTnI is the focus of ongoing studies.

Inhibitors of the platelet receptor glycoprotein (GP) IIb--IIIa are a novel and potent class of antithrombotic drugs for the management of patients with non-ST-segment elevation acute coronary syndromes (ACS) and those undergoing percutaneous coronary intervention (PCI). Pharmacodynamic studies with three currently approved agents in this class (abciximab [ReoPro, Centocor, Inc., Malvern, Pennsylvania, and Eli Lilly & Company, Indianapolis, Indiana]; eptifibatide [INTEGRILIN, COR Therapeutics, Inc., South San Francisco, California, and Key Pharmaceuticals, Inc., Kenilworth, New Jersey]; and tirofiban HCI [Aggrastat, Merck & Co., Inc., Whitehouse Station, New Jersey]) all sought to identify dosing regimens that would establish and maintain >80 % inhibition of ex vivo platelet aggregation throughout the duration of intravenous infusion. Direct comparison of these prior studies is difficult, however, because the assays used different anticoagulants (sodium citrate [abciximab, tirofiban HCI] or D-phenylalanyl-L-prolyl-L-arginine chloromethyl ketone [PPACK] [eptifibatide]) and different concentrations of the platelet agonist adenosine diphosphate (ADP) (5 micromol [tirofiban HCI] or 20 micromol [abciximab, eptifibatide]). More recent work has attempted to overcome these limitations by using similar assay conditions for all GP IIb--IIIa inhibitors. These studies have indicated that the concentrations of all three agents required to provide the targeted effect for platelet inhibition are considerably higher in the presence of an anticoagulant that does not chelate calcium ions (e.g., heparin or PPACK) than in the presence of calcium-chelating anticoagulant (i.e., sodium citrate). Of the three currently approved GP IIb--IIIa inhibitors, eptifibatide is the only agent whose approved dosing is based on an ex vivo platelet aggregation assay that uses such an anticoagulant. Additionally, Kereiakes et al. have recently reported that the high levels of platelet inhibition (>80 %), using PPACK as an anticoagulant and ADP (20 micromol) as an agonist, are more consistently achieved with the approved dosing regimen of eptifibatide. The antiplatelet effect of abciximab showed more interpatient variability, whereas the median inhibition of ex vivo platelet aggregation with the approved dosing regimen for tirofiban HCl was <80 % at almost all time points during drug infusion.