Urgent PCI Research Articles

COST-EFFECTIVENESS OF TRANSRADIAL PERCUTANEOUS CORONARY INTERVENTION: A DECISION-ANALYTIC MODEL

Methods: We developed a decision-analytic model of costs and bleeding events of transradial vs. transfemoral PCI using inputs from 4 hospitals, and direct PCI costs from each hospital’s respective cost accounting system. Independent costs of radial PCI, urgent vs. elective PCI indication and bleeding complications were identiied by a linear regression model and used as model inputs. The eficacy measure was major bleeding as deined by the NCDR.

Abstract 169: Neurological and Cardiovascular Outcomes After Cardiac Arrest at 6 Regional Interventional Cardiology Centers in the United States, 2007-2011

Background: We characterized adverse events and outcomes among cardiac arrest (CA) survivors treated between 2007-2011 at six regional interventional cardiology (PCI) centers in the United States. Methods: Demographics, clinical features, adverse events, cardiovascular outcomes, and 6-month neurological outcomes of 663 sequential patients were retrospectively and prospectively entered into a secure, web-based registry (INTCAR). The overall survival of patients with VT/VF and PEA/asystole was calculated, and an expected “survival index” for each center developed Results: Patients were characterized as mean 61.3 (+14.9) years old, 69.2% male, 58.8% initial VT/VF, 23.5 (+16.3) minutes “downtime”. On admission, 31.1% had shock, 26% STEMI, 38.6% underwent urgent coronary angiography, and 20.2% urgent PCI. Moderate or severe left ventricular dysfunction was present in 63% patients on presentation and 49.5% at hospital discharge (P<0.001). Frequent adverse events were shock requiring vasopressors (81.6%) or balloon counterpulsation (9.5%), shivering requiring neuromuscular blockade (74.8%), hyperglycemia (66.1%), electrolyte disturbances (62.9%), arrhythmias (37.9%), seizures (26.5%), pneumonia (25%), and bleeding (9.5%). Of 370/663 (55.8%) patients that died during hospitalization, at a median of 4.7 (+3.9) days, discontinuation of life support occurred in 52%, and the cause of death was reported as neurological in 64.6% or cardiovascular in 35.4%. Good neurological outcome at 6 months was as follows: Overall (all rhythms) 38.2%, of VT/VF 53.2%, of PEA/Asystole 17.9 %, of those with shock on admission 38.1%. When corrected for case mix (%VT/VF vs. PEA/asystole), the ratio of actual to anticipated survival varied among centers from 0.87 to 1.43. Among patients surviving to discharge, 54.2% had reportedly normal left ventricular (LV) function, 29.2% moderate LV dysfunction, and 16.6% severe LV dysfunction. Of 282 patients surviving to 6-month follow-up, 89.7% were categorized as CPC1-2 and 10.3% as CPC 3-4. Conclusions: Across a geographically diverse group of PCI centers in the United States routinely employing therapeutic hypothermia for neuroprotection, cardiac arrest outcomes at centers employing TH and PCI were favorable.

Abstract 24: Postresuscitation Care Practices Following Cardiac Arrest at 6 Regional Interventional Cardiology Centers in the United States, 2007-2011

Background: We characterized post-resuscitation care practices in cardiac arrest (CA) survivors at six regional PCI centers in the United States. Methods: Demographics, hospital course, and treatments of 663 cardiac arrest survivors were retrospectively and prospectively entered into a secure, web-based registry (INTCAR). Interhospital variability was evaluated, and group practices compared to AHA guidelines. Results: Mean age was 61 (+14.9) years, 69.2% male, 58.8% VT/VF, 23.5 (+16.3) minutes from arrest to return of spontaneous circulation (ROSC), 31.1% had shock and 26% STEMI at admission. 50% patients were received in transfer, at estimated mean distance of 37.2 miles and 72.4 (+26.6) minutes from initial ED presentation to destination. Overall, 38.6% underwent urgent cardiac catheterization and 20.2% urgent PCI. 98% patients received therapeutic hypothermia (TH), using a surface cooling device (98.6%), cold fluids (18%), ice packs (29.7%), or an intravascular cooling device (1.2%). 74.9% patients received neuromuscular blockade during hypothermia. Mean time from ROSC to initiation of TH was 178 (+142) minutes, and ROSC to target temperature 375 (+197) minutes. The highest volume center had shorter time from ROSC to onset of therapeutic hypothermia (97+87 vs 178+142 minutes, P<0.001) and target temperature (314+346 vs. 375+197 minutes, P<0.001) than the group mean. 15.5% patients underwent MRI, 41.7% head CT, 33.6% continuous EEG monitoring, 16.5% IABP, and 9.5% AICD placement. Urgent coronary angiography at admission varied from 15-58%; this and other differences in treatment were incompletely explained by case mix (% STEMI admissions). Conclusions: Standard post-resuscitation care practices approximated AHA guidelines for comprehensive cardiac arrest centers, but with substantial variability of practice among institutions. Where such variability exists, such as the utilization of urgent coronary angiography and revascularization in unresponsive patients at the time of hospital admission, future research should scientifically define best practices.

E0603 The inhospital mortality and its determinants for elderly patients with acute myocardial infarction

ObjectiveTo explore the inhospital mortality and its determinants for elderly patients with acute myocardial infarction.MethodTotally four hundreds and ninety nine patients with acute myocardial infarction, hospitalised in our hospital from...

Rotational atherectomy for fibro‐calcific coronary artery disease in drug eluting stent era: Procedural outcomes and angiographic follow‐up results

The aim of this study was to examine the binary re-stenosis rates, procedural success, and in hospital outcomes following treatment of fibro-calcified coronary lesion with rotational atherectomy in drug eluting stent era. Binary restenosis rates have remained high with the use of bare metal stents following rotational atherectomy in calcified lesions. There is limited data available following rotational atherectomy in drug eluting stent era. We evaluated the procedural and angiographic outcomes following a consecutive series of 516 procedures treated with rotational atherectomy followed by stenting. We compared the results between Rota + Drug eluting stent (DES) and Rota + bare metal stent (BMS) groups. Procedural success was achieved in 97.1% of the lesions with overall low in hospital adverse events (death in 1.1%, Q MI in 1.3%, Non Q MI in 5.3%, and urgent repeat PCI in 0.4%). There was significant reduction in the binary restenosis rates following Rota + DES use as compared to Rota + BMS use (11% vs. 28.1%, P < 0.001; OR = 3.17, 95% CI: 1.76-5.93) and similar reduction was seen in the target lesion revascularization (10.6% vs. 25%, P = 0.001; OR = 2.81, 95% CI: 1.53-5.14). We have identified ostial lesions, chronic total occlusion lesions, and use of bare metal stents as independent predictors of restenosis in this group of patients. Rotational atherectomy can be performed with high success rates and low complications, and rotational atherectomy followed by drug eluting stent implantation significantly reduces binary restenosis rates in fibrocalcific lesions as compared to rotational atherectomy and bare metal stents.

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 …

Safety and Exploratory Efficacy of the Novel Thrombin Receptor (PAR-1) Antagonist SCH530348 for Non-ST-Segment Elevation Acute Coronary Syndrome

A previous phase 2 study of patients undergoing non-urgent PCI treated with SCH530348 plus aspirin and clopidogrel tended to reduce MACE without increased bleeding. This study evaluated the safety of SCH530348 in Japanese patients with NSTE ACS. Subjects (117), in whom PCI was planned, received standard-of-care (aspirin, ticlopidine, and heparin) and were randomized 4:1 to receive either SCH530348 (20 or 40 mg loading dose followed by 1 mg/d or 2.5 mg/d for 60 days) or placebo. The key safety endpoint was TIMI major and minor bleeding in the PCI cohort (n=92). The key exploratory efficacy endpoint was MACE and death within 60 days. Addition of SCH530348 to standard-of-care did not significantly increase the rate of TIMI major and minor bleeding (or non-TIMI bleeding) in the primary cohort. Incidence (non-MACE) and discontinuation of AEs were similar across groups. PCI subjects treated with SCH530348 plus standard-of-care experienced a significant reduction in periprocedural MI compared with standard-of-care alone (16.9% vs 42.9%, respectively; p=0.013). There were no deaths or any other MACE. SCH530348 added to standard-of-care did not result in excess bleeding in Japanese subjects with NSTE ACS but significantly reduced the incidence of periprocedural MI in subjects undergoing urgent PCI.

The Impact of Diabetes Mellitus on Two‐Year Mortality Following Contemporary Percutaneous Coronary Intervention: Implications for Revascularization Practice

To assess the impact of diabetes on 2-year mortality in current PCI practice. In patients with coronary artery disease undergoing revascularization, diabetes mellitus is associated with higher mortality. A retrospective analysis was done of all patients undergoing PCI at our tertiary center between January 2000 and December 2004. There were 6,160 PCI procedures performed in 5,759 patients who received at least one stent. Of these patients, 801 (13.9%) were diabetic and 4,958 (86.1%) were nondiabetic. The primary outcome measure of the study was all-cause mortality. All patients were followed up for a period of 2 years. Multivariate logistic regression analysis was used to test for a potential independent association between diabetic status and follow-up mortality. Before adjustment, a trend toward higher mortality was observed in diabetic patients compared to non-diabetics at 1 year (3.2% vs 2.4%) and 2 years (5.1% vs 3.8%), P = 0.12. Independent predictors for mortality were increasing age, renal dysfunction, peripheral vascular disease, NYHA class >2, urgent PCI, treating left main stem lesions, vessel diameter < or = 2.5 mm, and 3-vessel disease. The use of drug-eluting stent was associated with a reduction in mortality. Diabetes was found to have no independent impact on mortality following PCI (odds ratio = 1.08; 95% confidence intervals = 0.73-1.60; P = 0.71). The presence of diabetes was not an independent predictor of mortality following PCI. A diabetic patient that does not require insulin treatment and has no evidence of macro- or microvascular diabetic disease could enjoy a PCI outcome similar to nondiabetic subjects.

A Case of Swan-Gantz Catheterization to PLSCV Caused Electrical Storm During Treatment of the Acute Heart Failure

A case of 61 years old man, he was admitted due to sick day. He had diabetes mellitus inadequate control. The acute heart failure (AHF) due to the acute coronary syndrome developed after ten days of hospitalization. We performed urgent PCI after we received tracheal intubation and having inserted IABP. The findings were proximal of LAD total, mid of LCX 90%, distal of RCA 75%. We detained STENT to LAD and LCX.We did withdrawal the IABP and replaced the Swan-Gantz catheter to the left internal jugular vein, after four days of the AHF onset.

Improving antiplatelet therapy for atherothrombotic disease

Morbidity and mortality in patients with atherothrombotic disease remain high despite the use of antiplatelet therapy with aspirin and an ADP receptor antagonist. Selective inhibition of the principal protease-activated receptor (PAR)-1 for thrombin, the most potent agonist for platelet activation, represents a promising novel strategy to reduce thrombosis and ischaemic events. SCH 530348, a potent thrombin receptor antagonist (TRA) selective for PAR-1, has been evaluated in preclinical studies, demonstrating complete and sustained inhibition of thrombin/TRAP-induced platelet aggregation without a concomitant increase in the risk of bleeding. Phase 2 studies in patients undergoing non-urgent or urgent PCI showed that treatment with SCH 530348 in addition to the standard of care (aspirin plus an ADP receptor antagonist) is not associated with an increased risk of TIMI bleeding and is well tolerated, with a rate of adverse events comparable to standard therapy alone. These studies also demonstrated that the use of SCH 530348 in combination with aspirin and an ADP receptor antagonist may reduce the incidence of major adverse cardiac events, specifically periprocedural myocardial infarction, vs aspirin plus an ADP receptor antagonist alone. On the basis of these encouraging results, 2 ongoing large phase 3 randomized trials are evaluating the efficacy and safety of SCH 530348 in combination with the standard-of-care therapy in approximately 35,000 patients with NSTE ACS or established atherosclerosis.

Intracoronary bivalirudin for no reflow reversal: a second chance to treat this disorder?

No reflow, defined as failure to restore normal myocardial blood flow despite removal of coronary obstruction, is a not rare complication of ST-elevation acute myocardial infarction. We here describe the case of an old patient experiencing inferior and right ventricle myocardial infarction complicated by cardiogenic shock, anaemia and thrombocytopenia. We managed it with urgent PCI using thrombus aspirator, that determined onset of no reflow, that we successfully managed with intracoronary bivalirudin. We showed how bivalirudin, a drug whose use is increasing in the catheterization laboratories, could be safely used via the intracoronary route to treat no reflow phenomenon due to distal microembolization in a complex patient.

Development of an optimized multimarker strategy for early risk assessment of patients with acute coronary syndromes

Background A multitude of biomarkers have been suggested for early risk-assessment in patients admitted to the emergency department with suspected acute coronary syndromes. We used logistic regression synergistically with classification and regression tree (CART) analysis to define a multimarker strategy and the cut-off values and sequencing needed to optimize risk stratification in a low to moderate risk population of the emergency department. Methods 432 unselected patients (59.7 ± 14.5 y, 60.4% male) admitted to the emergency department (ED) with acute coronary syndromes (ACS) were enrolled. Cardiac troponin I (cTnI), N-terminal pro-B-Type natriuretic peptide (NT-proBNP), high sensitivity C-reactive protein (hsCRP), placental growth factor (PlGF), lipoprotein-associated phospholipase A 2 (Lp-PLA 2) and D-dimers were measured by immunoassay and whole blood choline (WBCHO) and plasma choline (PLCHO) were measured using LC/MS from baseline samples. Logistic regression and CART analysis were used to define the importance of the various biomarkers tested and to define their hierarchy with respect to the prediction of major adverse cardiac events (MACE; cardiac death, non-fatal MI, unstable angina, CHF requiring admission, urgent PCI and CABG) over the 42-day follow-up period. Results A combination of NT-proBNP, WBCHO and Lp-PLA2 with cutoffs identified by CART-analysis was optimal for risk-stratification and superior to all other possible combinations of markers. Increased concentrations of both NT-proBNP (> 1400 ng/l) and WBCHO (> 21 μmol/l) identified patients with very high risk (RR = 2.4, 39% primary endpoint) while low concentrations of NT-proBNP (≤ 1400 ng/l), WBCHO (≤ 17 μmol/l) and LP-PLA2 (≤ 210 μg/l) indicated very low risk (0% primary endpoint). WBCHO > 17 μmol/l additionally identified a subgroup with intermediate risk (RR = 3.0, 13.5% primary endpoint) in patients with NT-proBNP concentrations ≤ 1400 ng/l. Troponin when increased was highly prognostic but was not often positive in this early cohort. Conclusions A multimarker strategy defined synergistically by logistic regression and by classification and regression tree (CART) analysis can stratify patients into risk groups ranging from very low risk (0% MACE) to very high risk (39.5% MACE) based on admission values.

Effectiveness and cost-effectiveness of facilitated percutaneous coronary intervention compared with primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction transferred from community hospitals

Background: Primary percutaneous coronary intervention ([PCI], percutaneous transluminal coronary angioplasty+stenting) for ST-segment elevation myocardial infarction (STEMI) is regarded as superior to fibrinolysis even if it means that patients need to be transferred from one center to another to undergo the procedure. However, this inevitable delay between symptom onset and PCI, caused by the time required to travel, might increase the occurrence of cardiac events. A hybrid method called facilitated PCI uses fibrinolysis and/or glycoprotein (GP) IIb/IIIa inhibitors before transfer to a tertiary medical center where urgent PCI might be performed. This approach, however, has not been systematically evaluated. Objective: The purpose of this study was to compare the effectiveness (combined end point of in-hospital mortality, reinfarction, stroke, or emergency revascularization) and cost-effectiveness of utilizing a bolus thrombolytic agent with GP IIb/IIIa inhibitor followed by transfer to a tertiary institution for facilitated PCI or standard of care transfer without primary PCI drugs among patients presenting to a community hospital with STEMI. Methods: This was a prospective, single-center, cohort study comprising data from STEMI patients transferred from community hospitals to Hartford Hospital, Hartford, Connecticut, from the years 2000 to 2003. At the time of analysis, patients receiving primary PCI were matched (1:1) with those receiving facilitated PCI, utilizing propensity scores to assure similar demographics. The combined incidence of major adverse cardiac end points (MACE) and total hospital costs was compared between groups. Non-parametric bootstrapping was conducted to calculate CIs for the incremental cost-effectiveness ratio and generate a quadrant analysis. Results: Based on 254 propensity score-matched patients (127 facilitated PCI and 127 primary PCI), in-hospital MACE and total hospital costs were reduced by 61.3% and US $4563 (2005), respectively, in patients receiving facilitated compared with primary PCI ( P=0.021 and P=NS, respectively). Patients receiving facilitated PCI were more likely to have target lesion Thrombolysis in Myocardial Infarction (TIMI) III (normal) blood flow on cardiac catheterization than those receiving primary PCI (49.6% vs 30.7%; P=0.002). However, the rate of TIMI bleeding was similar in both groups (21.3% in the facilitated PCI group vs 18.9% in the primary PCI group). Nonsignificant reductions were observed in both intensive care unit (ICU) and total length of stay (LOS) (0.8 day and 1.0 day, respectively) compared with the primary PCI group. Bootstrap analysis revealed that of 25,000 samplings, facilitated PCI would likely be both more effective and less costly 94.6% of the time. Conclusions: The use of facilitated PCI in STEMI patients who initially presented to community hospitals and were transferred for PCI appeared to significantly reduce the incidence of MACE, and increase the likelihood of having baseline TIMI III blood flow at time of catheterization. Nonsignificant reductions were observed in total ICU and hospital LOS. However, there did not appear to be a significant effect on the incidence of bleeding in patients receiving facilitated PCI. Bootstrap analysis confirmed that facilitated PCI would be both a more effective and less costly strategy.

Angiographic evaluation of the effect of intracoronary abciximab administration in patients undergoing urgent PCI

Background Recent data suggest that the intracoronary (IC) administration of a systemic bolus dose of abciximab during PCI may increase the efficacy of this antiplatelet drug. However, the effect of IC abciximab on coronary angiographic flow has been not clarified. Methods We studied 37 consecutive patients with acute coronary syndromes (ACS) who underwent successful urgent PCI on the target vessel and were treated by an IC abciximab bolus (0.25 mg/kg) prior to the first balloon inflation (Group IC), and 37 matched controls who were treated by intravenous (IV) abciximab bolus at the same dose (Group IV). Corrected TIMI frame count (CTFC) in the culprit and in a non-culprit coronary artery branch was assessed before treatment, immediately after intracoronary administration of abciximab bolus and at the end of the procedure. Results After administration of abciximab, CTFC significantly decreased from 48 + 37 to 33 + 30 ( P = 0.001) in the culprit vessel while in the non-culprit vessel it remained unchanged (16 + 7 pre-treatment and 16 + 7 post-treatment, P = 0.68). Final CTFC was 12 + 4 in Group IC and 14 + 5 in Group IV ( P = 0.069). Post-treatment mean peak of the cardiac enzymes showed a trend toward reduction in Group IC compared with Group IV. Conclusions The IC administration of abciximab bolus acutely decreases CTFC through culprit vessels of patients with ACS undergoing urgent PCI. Further studies evaluating the potential clinical benefits associated with IC abciximab administration are warranted.

The Influence of Prior Oral Anticoagulation Therapy on the Anticoagulant Effect of Low Molecular Weight Heparin.

Low Molecular Weight Heparins (LMWHs) have been suggested by the ACCP as an alternative to UFH for the anticoagulation of patients on chronic oral anticoagulation therapy (OAT) with warfarin. However, the optimal way to manage these patients remains to be established particularly for high-risk patients who require any type of general surgery or urgent invasive PCI procedures.The purpose of this study is to evaluate the LMWH point-of-care (POC) HEMONOXTM assay (Edison, NJ) in patients on chronic OAT. This clot-based test uses rTF reagents and the Hemochron Jr. Signature+ system. The Hemonox clotting time (CT) was analyzed at baseline and at peak response post enoxaparin treatment.Following IRB approval, blood samples from patients on chronic OAT (5 to 20 years, n=13) were evaluated with the Hemonox assay within 12– 18 hours of their last warfarin dose, patients were evaluated weekly for 4 –12 consecutive weeks. In vitro enoxaparin dose response was evaluated by adding 1 U/ml to blood samples obtained from the OAT patients. In supplemental clinical evaluation, 2 PCI cases on OAT were performed at Newark Beth Israel Medical Center, Newark, NJ. Patients were anticoagulated during their PCI procedure with enoxaparin at a final IV dose of 0.5 mg/kgHemonox CT baseline response was patient specific and the same response profile was obtained for each patient on OAT who underwent consecutive weekly testing. The majority of patients on OAT (9/13; 69%) exhibited elevated Hemonox baseline CT (150–350 secs) when compared to the previously reported range for PCI patients without prior OAT (baseline CT < 100 secs in 100% of cases, Mean = 71.2 ± 9.0, n= 39). Three patients on OAT (23%) showed CT≤150 secs, and only one patient (8%) yielded a baseline < 100 secs. When the blood of the patient with baseline < 100 sec (baseline value = 70 secs) was spiked in vitro with 1 U/ml enoxaparin, the Hemonox CT was 339 secs which was comparable with the peak response (386 and 308 secs; anti-Xa activity = 0.70 ± 0.01 U/ml; concentration of enoxaparin in the circulation = 0.77± 0.13) observed in the PCI patients receiving enoxaparin (0.5 mg/kg IV) and with a prior OAT who showed similar baseline values. Spiked samples from clinic patients with Hemonox baseline > 150 secs were > 700 secs.Our results demonstrate that prior to administration of LMWH, baseline monitoring may be helpful in patients on OAT to alert clinicians to appropriate alterations of enoxaparin dosing and target anticoagulation times due to the influence of warfarin.