Periprocedural Ischemic Complications Research Articles

Transfemoral Stenting of Stenoses at the Common Carotid Artery Origin Using an Anchoring Technique With a Balloon Protection Device

BACKGROUND: Transfemoral stenting of stenoses at the common carotid artery (CCA) origin is technically difficult because of poor stability of the guiding catheter. OBJECTIVE: To describe an anchoring technique using a balloon protection device that provides excellent stability of the guiding catheter. METHODS: Four patients (5 stenotic lesions) with stenosis of the CCA origin underwent transfemoral stenting with a balloon protection device (PercuSurge GuardWire; Medtronic, Santa Rosa, California). These 5 stenotic lesions of the CCA origin included 1 on the right side and 4 on the left side. Two of the stenoses were symptomatic, and 3 were asymptomatic. A balloon-expandable stent (Express LD stent; Boston Scientific, Natick, Massachusetts) was used in all patients. RESULTS: All stenoses were successfully dilated. With the balloon protection device as an anchor in all patients, the guiding catheter was highly stable during the procedure. There were no intraprocedural or periprocedural ischemic complications in any patients. None of the patients developed a stroke during a mean follow-up period of 8.4 months. CONCLUSION: The anchoring technique using a balloon protection device is useful for transfemoral stenting of stenoses at the CCA origin. ABBREVIATIONS: CCA, common carotid artery ECA, external carotid artery ICA, internal carotid artery PTA, percutaneous transluminal angioplasty

Treatment of symptomatic basilar artery atheronatous ischemic disease with Wingspan stent system

Objective To explore the safety and efficacy of the Wingspan stenting of basilar artery atherosclerosis stenosis though the analysis of single center massive clinical data. Methods Ninety one consecutive patients received Wingspan stenting because of basilar artery stenosis in our center from July 2007 to April 2013. The patients were classified into three groups: early term (n=30), middle term (n=30), and late term (n=31) according to the operation time in our center. The basic clinical data and the factors which may affect the ischemic events were retrospectively analysed,t test andChi-Square test were used to analyze the factors related to the periprocedural ischemic complications. Results All of patients were stented successfully and the technical success rate was 100% (91/91). The mean stenosis was reduced from (82.2±5.8)% to (15.9±5.7)%; strokes or death happened in 13 cases within 30 days, including perforator stroke in 8 patients (8.8%, 8/91), thrombosis in 4 patients (4.4%, 4/91), subarachnoid hemo rrhage in 1 patient (1.1%, 1/91) , 2 patients with disabling or fatal strokes. Lesions involving in the middle segment of basal artery (P=0.049), long-segment disease (P=0.002), severe stenosis (P=0.001) may be a risk factor affecting perioperative ischemic stroke, and the surgeons' surgical technique was not risk factors for ischemic complications (P=1.000). Seventy seven patients (84.6%, 77/91) had the clinical follow-up and the mean follow-up period was (31.3±15.1) months. Four patients suffered from posterior circulation strokes during the clinical follow-up, one of them (1.3%, 1/77) had disabling stroke, another 3 patients (3.9%, 3/77) suffered from TIA. The 2-year accumulate probability of stroke (any stroke or death within 30 days and stroke in the territory of the qualifying artery beyond 30 days) was 16% (95%CI, 8.2% to 23.8%). Forty six patients had the imaging follow-up and the mean follow-up period was (9.5±8.3) months, 6 patients (13.0%,6/46) had in- stent restenosis (ISR) and 2/6 patient had the symptomatic ISR. Conclusions The stroke or death rate of symptomatic basilar atherosclerosis Wingspan stenting within 30 days is high, but the disabling or fatal stroke rate is low. The middle segment of basilar artery involved, the long stenosis, the severe atherosclerosis may be the factors related to the periprocedural ischemic strokes. The incidence of disabling or fatal strokes was low following Wingspan stenting. Key words: Atherosclerosis; Basilar artery; Stent; Stenosis

E-065 Clinical Treatment Result of Carotid Artery Stenting in Japan: Comparison of Periprocedural Ischemic Complication by Embolic Protection Devices

Carotid artery stenting (CAS) was approved in Japan in October 2007. Since then, several embolic protection devices (EPD) and stents for CAS have become available.We investigated the clinical treatment results...

Balancing the risks of stent thrombosis and major bleeding during primary percutaneous coronary intervention

This editorial refers to ‘Bivalirudin is superior to heparins alone with bailout GPIIb/IIIa Inhibitors in patients with ST-segment elevation myocardial infarction transported emergently for primary percutaneous coronary intervention: a pre-specified analysis from the EUROMAX trial’[†][1], by U. Zeymer et al ., on page 2460. Two feared peri-procedural complications of primary percutaneous coronary intervention (PCI) are stent thrombosis (ST) and major bleeding. Although rare, ST is associated with high rates of myocardial infarction and death.1 Potent antithrombotic therapy around the time of PCI markedly reduces the risk of ST, but increases bleeding hazard ( Figure 1 ). Historically, the anticoagulant of choice for PCI has been unfractionated heparin (UFH). Glycoprotein inhibitors (GPI) added to heparin significantly reduce peri-procedural ischaemic complications, but increase major bleeding and the need for transfusions. There has been a consistent association between major bleeding and increased mortality.2 In PCI for elective indications and across the spectrum of acute coronary syndrome (ACS), the direct thrombin inhibitor bivalirudin is non-inferior to heparin plus GPI with respect to overall ischaemic complications, but significantly decreases major bleeding. Figure 1 Balancing reductions in stent thrombosis with increases in major bleeding. PCI, percutaneous coronary intervention. In this issue of European Heart Journal , an important pre-specified analysis by Zeymer et al. uses the European Ambulance Acute Coronary Syndrome Angiography (EUROMAX) study population to compare patients receiving bivalirudin with patients receiving heparins [UFH or low-molecular weight heparin (LMWH)] with routine GPI use (defined as initiation before or during coronary angiography) and patients receiving heparins with only bailout GPI use (defined as initiation after the start of PCI). This study expands on the original EUROMAX findings by reporting a significant difference in the composite primary endpoint of death or major bleeding that favours bivalirudin over heparins with routine GPI use and heparins with bailout GPI use (5.1 vs. … [1]: #fn-1

Effect of Pitavastatin on Preventing Ischemic Complications with Carotid Artery Stenting: A Multicenter Prospective Study—EPOCH-CAS Study

Periprocedural ischemic stroke is one problem associated with carotid artery stenting (CAS). This study was designed to assess whether preoperative statin therapy reduces the risk of periprocedural ischemic complications with CAS. In this prospective study at 11 centers, patients with carotid artery stenosis (symptomatic ≥50%, asymptomatic ≥80%) and a high risk of carotid endarterectomy but without previous statin treatments were divided into two groups by low-density lipoprotein cholesterol (LDL-C) levels. With LDL-C ≥120 mg/dl, the pitavastatin-treated (PS) group received pitavastatin at 4 mg/day. With LDL-C <120 mg/dl, the non-PS group received no statin therapy. After 4 weeks, both groups underwent CAS. Frequencies of new ipsilateral ischemic lesions on diffusion-weighted imaging within 72 h after CAS and cerebrovascular events (transient ischemic attack, stroke, or death) within 30 days were assessed. Among the 80 patients enrolled, 61 patients (PS group, n = 31; non-PS group, n = 30) fulfilled the inclusion criteria. New ipsilateral ischemic lesions were identified in 8 of 31 patients (25.8%) in the PS group and 16 of 30 patients (53.3%) in the non-PS group (P = 0.028). Cerebrovascular events occurred in 0 patients in the PS group and in 3 of 30 patients (10.0%) in the non-PS group (P = 0.071). Multivariate analyses demonstrated the pitavastatin treatment (β = 0.74, 95% confidence interval 0.070-1.48, P = 0.042) to be an independent factor for decreasing post-CAS ischemic lesions. Pretreatment with pitavastatin significantly reduced the frequency of periprocedural ischemic complications with CAS.

P-018 Effect of pitavastatin on preventing ischaemic complications with carotid artery stenting: a multicentre prospective study

BackgroundCarotid artery stenting (CAS) is becoming an alternative to carotid endarterectomy (CEA). However, periprocedural ischaemic stroke is one problem associated with CAS. Statin therapy can reportedly reduce periprocedural complication rates...

Glycoprotein IIb-IIIa inhibitors – Do we still need them?

Platelets play central role in thrombotic events in acute coronary syndromes (ACS) and during percutaneous coronary interventions (PCI). Platelet activation occurs through various mechanisms and all culminate in expression of the surface GP IIb-IIIa receptors which mediate their aggregation and thrombosis. Glycoprotein IIb-IIIa inhibitors (GPI) remain the most powerful antiplatelet agents by inhibiting this final common pathway of platelet activation. The role of GPI in the treatment of coronary ischemic events has evolved through the past 20 years. Given their potent antiplatelet activity and consistent anti-ischemic benefit in major trials, they were an integral part of antiplatelet – antithrombin portfolio in the treatment of ACS and during PCI over a decade. However, the advent of stents and thienopyridine ticlopidine and later clopidogrel made periprocedural ischemic complications less common and GPI had slowly lost its importance in routine low-risk PCI. Though GPI reduced periprocedural ischemic complications, increased bleeding events continued to be a major problem. In the recent years, bleeding has increasingly been recognized as a major determinant of clinical outcomes both with ACS and PCI. Recently, the availability of bivalirudin as an equally effective and safer periprocedural anticoagulant, heparin and GPI have slowly been pushed to second place over the entire spectrum of coronary interventions. The newer antiplatelets which provide rapid and more consistent antiplatelet action further reduced the role of GPI to a very small subset of patients where ischemic risk far exceeds the thrombotic risk.1–3 This editorial briefly evaluates the current role of GPI in the background of recent major studies with newer antiplatelets and bivalirudin.

TCT-551 Prophylactic Use of Intracoronary Nicardipine in Conjunction with Distal Protection Devices During Vein Graft Intervention: Synergistic Effect of Combining Drugs and Devices

Percutaneous coronary intervention (PCI) of saphenous vein grafts (SVG) is associated with a high risk of complications due to distal embolization and no-reflow. Although distal protection devices are routinely used, periprocedural ischemic complications still occur in up to 10% of SVG interventions

Combined surgical and endovascular treatment of complex cerebrovascular diseases in the hybrid operating room

BackgroundAlthough most neurovascular diseases can be treated either by microsurgical or endovascular means, a subset of patients may require a combined approach. Patient transfer from the operating room (OR) to...

Antiplatelet therapy in percutaneous coronary intervention: recent advances in oral antiplatelet agents

Dual antiplatelet therapy with aspirin and clopidogrel, in conjunction with heparin, is the most common antithrombotic strategy in percutaneous coronary intervention (PCI) used to reduce peri-procedural ischaemic complications. However, there remains significant inter-individual variability in post-treatment platelet inhibition with this current established therapy. This review focuses on recent developments in oral antiplatelet agents used in PCI, which promise to overcome, at least in part, current shortfalls. Genetic polymorphisms and medication interactions involving CYP3A4 or CYP2C19, patient compliance and higher platelet reactivity in certain subgroups, such as those with diabetes, are important factors contributing to inter-individual variability in post-treatment platelet inhibition. Higher clopidogrel doses have been associated with improved clinical outcomes, especially in those presenting with acute coronary syndrome. Newer agents, namely prasugrel and ticagrelor, have been shown to have greater potency and superior clinical outcomes. However, this comes with a price of increased bleeding complications. Whereas more potent antiplatelet therapies are associated with improved outcome, balancing the risk of bleeding and peri-procedural ischaemic complications remains a key aspect to consider when choosing among the ever-increasing number of agents available. The role of intravenous glycoprotein IIb/IIIa (GPIIb/IIIa) needs to be re-examined in the current context of such potent oral antiplatelet agents. Further research will hopefully help to determine the preferred antithrombotic strategy in patients undergoing PCI.

Anticoagulant Therapy for Percutaneous Coronary Intervention

Received June 2, 2009; accepted November 16, 2009. Percutaneous coronary intervention (PCI) is the most commonly performed invasive therapeutic cardiac procedure and plays an important role in the treatment of ischemic heart disease. Since the first description of coronary angioplasty in a human by Gruntzig,1 the technique, equipment, and associated pharmacotherapy have undergone substantial evolution, leading to significant improvements in periprocedural complications.2 In particular, procedural anticoagulant therapy has been the focus of numerous clinical trials, and several options are now available and supported by practice guidelines; each agent has both advantages and disadvantages, and procedural pharmacotherapy continues to be a focus of drug development. The purpose of this review is to summarize the goals of anticoagulant therapy during PCI, the pharmacokinetics and pharmacodynamics of available agents, and the clinical data surrounding each agent and to identify new agents in development. The goals of pharmacotherapy during PCI are 2-fold: (1) to mitigate the sequelae of iatrogenic plaque rupture from balloon angioplasty or stenting and (2) to reduce the risk of thrombus formation on intravascular PCI equipment. Central to these thrombotic events is thrombin (factor IIa). Iatrogenic damage to the endothelium during PCI leads to increased expression of tissue factor, activation of the coagulation cascade, and formation of activated factor Xa. This ultimately leads to the generation of thrombin, conversion of fibrinogen to fibrin, and thrombus formation.3 In addition to its effects on fibrin, thrombin also directly activates platelets, enhances platelet aggregation, and is proinflammatory.4 Because of its multiple actions in promoting thrombosis, the focus of most anticoagulant agents is thrombin inhibition. Available agents for use include unfractionated heparin (UFH), low-molecular-weight heparins (LMWH, of which enoxaparin has the largest body of clinical data), the synthetic pentasaccharides (of which fondaparinux has the largest body of clinical data), and the …

Week‐Long High‐Maintenance Dose Clopidogrel Regimen Achieves Better Platelet Aggregation Inhibition than a Standard Loading Dose before Percutaneous Coronary Intervention: Results of a Double‐Blind, Randomized Clinical Trial

Adequate platelet inhibition before percutaneous coronary intervention (PCI) reduces periprocedural and long-term ischemic complications. Reduced response to clopidogrel has been associated with subsequent major adverse cardiovascular events. Strategies to optimize platelet inhibition pre-PCI are under investigation. This study evaluated the effect on platelet aggregation of four different dosing regimens of clopidogrel given before elective PCI in a randomized, prospective, double-blind, and placebo-controlled design. One hundred twenty participants were randomized to one of four groups of clopidogrel: (a) 300 mg on the day prior to angiography; (b) 600 mg on the day prior to angiography; (c) 300 mg followed by 75 mg daily started 1 week prior to angiography; and (d) 300 mg followed by 150 mg daily started 1 week prior to angiography. Platelet aggregation was assessed by light transmission aggregometry (LTA) after stimulation with adenosine diphosphate 20 microM at baseline and at the time of diagnostic coronary angiography. The absolute change in platelet aggregation between these two time points was considered the main outcome measure. At the time of diagnostic coronary angiography, the 300-mg/150-mg daily regimen achieved the greatest decrease in platelet aggregation (37 +/- 19%), while the 300 mg regimen provided the smallest (20 +/- 22%), an absolute difference between the two groups of 17.2 +/- 5.1% (P = 0.005). A 300-mg loading dose of clopidogrel followed by 150 mg daily for 1 week prior to coronary angiography provides more effective platelet inhibition, as defined by LTA, compared to the standard 300-mg loading dose regimen at the time of coronary intervention.

Effects of Unfractionated Heparin and Glycoprotein IIb/IIIa Antagonists Versus Bivalirdin on Myeloperoxidase Release From Neutrophils

OBJECTIVES The objective of this study was to determine whether adjunctive therapy during percutaneous coronary intervention (PCI) affects markers of systemic inflammation or platelet activation. Despite different mechanisms of action, direct-thrombin inhibition with bivalirudin during PCI provided similar protection from periprocedural and chronic ischemic complications as compared with unfractionated heparin (UFH) plus planned use of GPIIb/IIIa antagonists in the REPLACE-2 and ACUITY trials. Patients undergoing nonurgent PCI of a native coronary artery were randomized to receive adjunctive therapy with bivalirudin or UFH+eptifibatide. Interleukin (IL)-6 and C-reactive protein (CRP) transiently increased in both groups after PCI. In the UFH+eptifibatide, but not the bivalirudin group, myeloperoxidase (MPO) levels were elevated 2.3-fold above baseline (P=0.004) immediately after PCI. In an in vitro assay, heparin and to a lesser extent enoxaparin, but not bivalirudin or eptifibatide, stimulated MPO release from and binding to neutrophils and neutrophil activation. A mouse model of endoluminal femoral artery denudation was used to investigate further the importance of MPO in the context of arterial injury. Adjuvant therapy during PCI may have undesired effects on neutrophil activation, MPO release, and systemic inflammation.

Intracoronary Macrothrombus Formation During Percutaneous Coronary Intervention Despite Optimal Activated Clotting Time Using Bivalirudin

The occurrence of intracoronary thrombus during percutaneous coronary intervention (PCI) is a well-known complication. It has been estimated that it complicates approximately 6% of all coronary procedures. Patients at highest risk for this complication include those with acute ischemic syndromes or with angiographically apparent thrombus. Since the development of PCI, intravenous unfractionated heparin (UFH) has remained the primary antithrombotic therapy for the prevention of periprocedural ischemic complications. The availability of a rapid "point of care'' test for dose individualization (the activated clotting time [ACT]) has facilitated this process. Other forms of antithrombotic therapies such as direct thrombin inhibitors or low-molecular-weight heparin have been proposed as more effective anticoagulants during PCI. Bivalirudin is a direct thrombin inhibitor proven to decrease post-PCI ischemic complication rate compared with UFH and have a lower vascular complication rate compared with glycoprotein IIb/IIIa receptor antagonists. We herein report a case of acute macrothrombus formation during PCI despite adequate ACT achieved with bivalirudin.

Comparison of Enoxaparin Versus Heparin During Elective Percutaneous Coronary Intervention Performed With Either Eptifibatide or Tirofiban (The ACTION Trial)

Limited data are available with regard to the pharmacodynamics and safety of combining enoxaparin with glycoprotein IIb/IIIa inhibition during elective percutaneous coronary interventions (PCIs). We randomized 200 patients to receive open-label enoxaparin (0.75 mg/kg intravenous bolus) or unfractionated heparin (60 U/kg intravenous bolus) and eptifibatide or tirofiban during PCI. This yielded 4 groups of combination therapy (50 patients/group). The first 10 patients per group had anti-Xa activity and inhibition of platelet aggregation measured at baseline, and at 5 minutes, 10 minutes, 4 hours, and 24 hours. All patients received aspirin and clopidogrel therapy before PCI. Patients who received enoxaparin and heparin achieved therapeutic peak anti-Xa activity observed shortly after drug administration. At 4 hours, a differential anticoagulant effect was observed, with patients who received enoxaparin having a more gradual decrease in anti-Xa activity. Patients who received eptifibatide achieved >80% inhibition of platelet aggregation soon after initiation of therapy more often than did those who received tirofiban. Type of heparin did not affect inhibition of platelet aggregation. Compared with patients who received heparin, periprocedural myocardial infarction and bleeding events occurred less frequently among those who received enoxaparin (14% vs 8% and 10% vs 5%); however, these differences were not statistically significant. Three cases of intraprocedural thrombus occurred among patients who received enoxaparin. Two patients received concomitant tirofiban therapy. Compared with unfractionated heparin, similar levels of anticoagulation and platelet inhibition are achieved with enoxaparin when concomitant therapy with eptifibatide or tirofiban is used during elective PCI, without an observed increase in early bleeding events or periprocedural ischemic complications.

Value of monitoring activated clotting time when bivalirudin is used as the sole anticoagulation agent for percutaneous coronary intervention

Anticoagulation during percutaneous coronary intervention (PCI) requires the monitoring of activated clotting time (ACT) to protect from periprocedural ischemic and bleeding complications; however, the optimal ACT values have not been established when PCI is performed with bivalirudin. After 495 consecutive patients treated for coronary artery disease with PCI received bivalirudin as a single anticoagulation agent, it was found that ACT is reproducible when bivalirudin is used during PCI and does not correlate with clinical events.

Unfractionated versus fractionated heparin for percutaneous coronary intervention.

Since the advent of percutaneous coronary intervention (PCI), intravenous unfractionated heparin has been the primary antithrombotic therapy to prevent periprocedural ischemic complications. As compared with unfractionated heparin, low molecular weight heparins (LMWHs) have a greater bioavailability and a more predictable therapeutic response. In several recent studies of patients undergoing PCI, LMWHs have been shown to be as safe and effective as unfractionated heparin; given their better pharmacokinetic profile and the lack of need for coagulation monitoring, they have the potential to replace unfractionated heparin during coronary interventions. This article reviews the current status of anticoagulation therapy with unfractionated heparin and LMWHs in the cardiac catheterization laboratory.

Optimization of platelet therapy.

Percutaneous coronary intervention produces vessel wall injury and activation of platelets that are responsible for producing peri-procedural ischemic complications. The importance of adequate antiplatelet therapy during coronary intervention to reduce platelet mediated ischaemic complications has been recognized for some time. Until recently, adjunctive treatment with aspirin was the only available antiplatelet therapy after coronary intervention that had demonstrated benefit. During the last decade, newer and more potent agents have demonstrated consistent reductions in ischaemic events after intervention and appear to have some enduring effect. Additionally, optimization of antiplatelet therapy with aspirin and the thienopyridines after coronary stenting has been an important advance allowing for the current liberal use of coronary stents.

Prospective, Randomized, Multicenter Comparison of Laser-Facilitated Balloon Angioplasty Versus Stand-Alone Balloon Angioplasty in Patients With Obstructive Coronary Artery Disease

Objectives. The goal of this study was to examine the relative safety and efficacy of laser-facilitated percutaneous transluminal coronary angioplasty (PTCA) versus “stand-alone” PTCA.Background. Plaque debulking with lasing before PTCA may result in improved lumen dimensions and decreased rates of periprocedural ischemic complications, thus improving short- and long-term outcomes after percutaneous intervention. The mid-infrared holmium:yttrium-aluminum-garnet (YAG) laser has been shown to be effective in a variety of plaque subtypes and may be particularly useful in high risk acute ischemic syndromes.Methods. A total of 215 patients (mean [±SD] age 61 ± 12 years) with 244 lesions were prospectively randomized at 14 clinical centers to laser versus stand-alone PTCA. After laser treatment, all patients underwent PTCA; 148 patients (69%) had unstable angina.Results. The procedural success rate without major catheterization laboratory complications was similar in patients assigned to laser treatment or PTCA alone (96.6% vs. 96.9%, p = 0.88), as was the in-hospital clinical success rate (89.7% vs. 93.9%, p = 0.27). There was no difference in postprocedural diameter stenosis after laser treatment compared with PTCA (18.3% ± 13.6% vs. 19.5% ± 15.1%, p = 0.50). However, use of the laser, versus PTCA alone, did result in significantly more major and minor procedural complications (18.0% vs. 3.1%, p = 0.0004), myocardial infarctions (4.3% vs. 0%, p = 0.04) and total in-hospital major adverse events (10.3% vs. 4.1%, p = 0.08). At a mean follow-up time of 11.2 ± 7.7 months, there were no differences in late or event-free survival in patients assigned to laser treatment versus PTCA alone.Conclusions. Compared with stand-alone PTCA, laser-facilitated PTCA results in a more complicated hospital course, without immediate or long-term benefits.

Anti-HCV seroprevalence in pregnant women in France.

In a study designed to assess the prevalence of antibodies to hepatitis C virus (HCV) in pregnant women, anti-HCV positivity in French pregnant women was twice as high as that found in French blood donors. Positive ELISA 2 results were confirmed by positive RIBA 2 in most subjects, and seven of nine RIBA 2 positive patients also tested positive for HCV-RNA by PCR. High rates of anti-HCV positivity were seen among immigrant pregnant women, partly because of false positive results with ELISA 2. RIBA 2 results suggested that the prevalence of HCV infection was not any higher in immigrant compared with French pregnant women.