Setting Of Primary Percutaneous Coronary Intervention Research Articles

Safety and Efficacy of Adjuvant Glycoprotein IIb/IIIa Inhibitors During Primary Percutaneous Coronary Intervention Performed From the Radial Approach for Acute ST Segment Elevation Myocardial Infarction

The use of glycoprotein IIb/IIIa receptor inhibitors (GPIs) in high-risk patients with acute coronary syndromes has been associated with reductions in ischemic events but increases in bleeding complications. The role of GPIs in patients who undergo primary percutaneous coronary intervention (PCI) by the transradial approach (TRA) is not well studied. The aim of this post hoc analysis from the randomized prospective Acute Myocardial Infarction Treated With Primary Angioplasty and Intravenous Enoxaparin or Unfractionated Heparin to Lower Ischemic and Bleeding Events at Short- and Long-Term Follow-Up (ATOLL) trial was to assess the safety and efficacy of GPIs in primary PCI performed using the TRA. A total of 910 patients were enrolled in ATOLL; 522 patients (67%) underwent PCI using the TRA. Two comparative analyses were performed. First, patients who underwent PCI using the TRA who received GPIs were compared with those who did not receive GPIs. Second, patients who underwent PCI using the TRA who received GPIs were compared with those who underwent PCI using a nonradial route and received GPIs. Composite end points of net clinical benefit, ischemic outcomes, and safety consisting of bleeding and transfusion at 1 month were analyzed. A propensity score was constructed, and weight adjustment were made for variables, including but not limited to age, weight, gender, renal function, concomitant use of other medications, Killip class, and medical history, when analyzing the end points. There was no significant difference in net clinical benefit or ischemic outcomes between either TRA patients with versus without GPIs or TRA patients with GPIs versus non-TRA patients with GPIs. Additionally, there were significantly fewer major bleeding events and blood transfusions in TRA patients with GPIs compared with non-TRA patients with GPIs. In conclusion, the addition of GPIs in the setting of primary PCI using the TRA was not associated with bleeding liability. The use of GPIs with TRA was associated with safer outcomes than using GPIs with a nontransradial approach. This study was limited in that it was a nonrandomized retrospective analysis.

Outcome of the HORIZONS-AMI trial: bivalirudin enhances long-term survival in patients with ST-elevation myocardial infarction undergoing angioplasty

Cardiovascular disease is the leading cause of death in the US. For patients with ST-elevation myocardial infarction (STEMI), urgent reperfusion of the culprit arterial occlusion, often achieved via primary percutaneous coronary intervention (PCI), reduces post-MI mortality and other major adverse cardiovascular events (MACE). Adjunctive antithrombotic and antiplatelet therapies are used during PCI to reduce MACE rates. Currently, a variety of antithrombotic options are available for peri-procedural use. The most commonly used agents include unfractionated heparin or low molecular weight heparin ± glycoprotein IIb/IIIa inhibitors (GPI). These agents reduce the rates of peri-procedural ischemic and thrombotic events, though these benefits come at the cost of an increase in bleeding complications. Bivalirudin is a direct thrombin inhibitor with a short half-life and linear pharmacokinetics, which results in predictable serum concentrations and anticoagulant effect. Bivalirudin has emerged as an efficacious and safe alternative to heparin plus GP IIb/IIIa inhibitors in both stable coronary artery disease and acute coronary syndrome patients. In the HORIZONS-AMI trial, monotherapy with bivalirudin was compared with the combination of heparin and a GPI in a large population of patients with STEMI who underwent primary PCI. Bivalirudin treatment was associated with improved event-free survival at 30 days and reduced rates of major bleeding. Based on the results of the trial, the American College of Cardiology/American Heart Association and European Society of Cardiology guidelines have incorporated recommendations for bivalirudin use in the setting of STEMI. Recently, 3-year follow-up data from the HORIZONS-AMI cohort were published, demonstrating sustained benefits in patients treated with bivalirudin, including reduced rates of mortality, cardiovascular mortality, reinfarction, and major bleeding events. These results further support the use of bivalirudin in the setting of primary PCI for STEMI given that its benefits are maintained through long-term follow-up.

Clopidogrel pre-treatment is associated with reduced in-hospital mortality in primary percutaneous coronary intervention for acute ST-elevation myocardial infarction

AIMS Pre-treatment with clopidogrel results in a reduction of ischaemic events in non-ST-elevation acute coronary syndromes. Data on upstream clopidogrel in the setting of primary percutaneous coronary intervention (PCI) are limited. The aim of this study was to investigate whether clopidogrel loading before arrival at the PCI centre may result in an improved outcome of primary PCI for ST-elevation myocardial infarction (STEMI). METHODS AND RESULTS In a multicentre registry of acute PCI, 5955 patients undergoing primary PCI in Austria between January 2005 and December 2009 were prospectively enrolled. The patients consisted of two groups, a clopidogrel pre-treatment group (n = 1635 patients) receiving clopidogrel before arrival at the PCI centre and a peri-interventional clopidogrel group (n = 4320 patients) receiving clopidogrel at a later stage. Multiple logistic regression analysis including major confounding factors stratified by the participating centres was applied to investigate the effect of pre-treatment with clopidogrel on the in-hospital mortality. Additionally, two subgroups, with or without the use of GP IIb/IIIa antagonist therapy in the catheterization laboratory, were analysed. On univariate analysis, clopidogrel pre-treatment was associated with a reduced in-hospital mortality (3.4 vs. 6.1%, P< 0.01) after primary PCI. On multivariate analysis, clopidogrel pre-treatment remained an independent predictor of in-hospital mortality [odds ratio (OR) = 0.60, 95% confidence interval (CI) 0.35-0.99; P =0.048], especially in patients receiving additional GP IIb/IIIa antagonist therapy in the catheterization laboratory (OR = 0.40, 95% CI 0.19-0.83; P =0.01). CONCLUSION Clopidogrel pre-treatment before arrival at the PCI centre is associated with reduced mortality in a real world setting of primary PCI. These results strongly support the recommendation of clopidogrel treatment 'as soon as possible' in patients with STEMI undergoing pimary PCI.

Plasma fibrinogen levels and restenosis after primary percutaneous coronary intervention

Plasma fibrinogen levels influence restenosis following elective percutaneous coronary intervention (PCI) for stable angina. It is unknown whether the same is true in the setting of primary PCI. The aim of the study was therefore to assess whether fibrinogen levels were associated to 6-month in-stent restenosis (ISR) in STEMI patients undergoing successful primary PCI. From January 2003 to October 2004, 267 patients were admitted to our Institution for STEMI and treated by primary PCI. Of these, 171 patients met the inclusion criteria and were enrolled in our study. Fibrinogen levels were assessed at admission, 12h, 24h, 48h, 72h following PCI and at discharge. Six-month angiographic follow-up was 100% complete. Subjects with 6-month ISR showed higher fibrinogen levels than patients without ISR. Patients in the upper fibrinogen tertile showed a higher 6-month incidence of symptoms and/or inducible myocardial ischemia (27.1% vs. 7.1%, P=0.006) and a larger late lumen loss (1.3±0.8 vs. 1.0±0.9mm, P=0.049). Logistic regression analysis demonstrated a significant and independent association between fibrinogen levels and ISR. Our study suggests that increased plasma fibrinogen levels are related to ISR in STEMI patients undergoing primary PCI. Larger studies are warranted to assess the prognostic value of fibrinogen over harder end-points.

Clinical Impact of Enhanced Inhibition of P2Y12-Mediated Platelet Aggregation in Patients with ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention

The combination of aspirin and clopidogrel at a loading dose of 300 mg followed by a maintenance dose of 75 mg daily is a well-established antiplatelet therapy for the secondary prevention of thrombotic complications in the settings of acute coronary syndrome and/or percutaneous coronary intervention (PCI). Despite the demonstrated clinical benefits associated with this antiplatelet therapy, there is accumulating evidence that a consistent proportion of patients persist in having high levels of platelet aggregation following standard clopidogrel dose. Importantly, the high platelet reactivity after clopidogrel treatment has been associated with higher risk for cardiovascular ischemic events, including stent thrombosis. This has warranted the need for alternative oral antiplatelet regimens that achieve a higher degree of platelet inhibition. Several functional studies have shown that a higher clopidogrel loading dose (600 mg) compared with standard dose, and novel oral adenosine diphosphate platelet receptor (P2Y12) antagonists compared with clopidogrel achieve a faster onset of action, increased platelet inhibition, and a more predictable drug response. These more favorable pharmacodynamic characteristics are of particular interest in the setting of primary PCI for ST-segment elevation myocardial infarction (STEMI), in which rapid and consistent inhibition of platelet activation and aggregation is desirable for therapeutic success. The present article reviews data on the clinical impact of enhanced P2Y12 inhibition with either higher clopidogrel dosing or new oral antiplatelet agents, including prasugrel and ticagrelor, in the setting of STEMI, focusing on results in the setting of primary PCI.

Use of antiplatelet therapies during primary percutaneous coronary intervention for acute myocardial infarction

Inhibition of platelet function is necessary to achieve successful and long-lasting primary percutaneous coronary intervention (PCI) for acute myocardial infarction. For many years, antiplatelet therapy in the setting of primary PCI consisted of two drugs that inhibit platelet activation (aspirin and clopidogrel) and an intravenous blocker of platelet aggregation (abciximab). The development of new, more potent oral antiplatelet drugs (prasugrel and ticagrelor) as well as new data on clopidogrel dosing regimens limited the use of abciximab after pretreatment with aspirin and clopidogrel. Thus, intracoronary administration of abciximab and the use of small molecule glycoprotein IIb/IIIa blockers (tirofiban or eptifibatide) challenge the contemporary schemes of antiplatelet treatment in primary PCI. We review recently published data with particular attention on patients and drug characteristics and propose an update of existing recommendations.

Effect on Bleeding, Time to Revascularization, and One-Year Clinical Outcomes of the Radial Approach During Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Myocardial Infarction

The radial approach during percutaneous coronary intervention (PCI) has been reported to reduce the incidence of bleeding complications. However, the radial approach still accounts for <10% of procedures worldwide and only 1% in the United States. Our objective was to compare the effect of radial versus femoral vascular access on the time to reperfusion, incidence of bleeding complications, and overall clinical outcomes in the setting of primary PCI. We prospectively collected data on all patients undergoing primary PCI at the Montreal Heart Institute from April 1, 2007 to March 30, 2008. The time to revascularization and major bleeding were prespecified as a co-primary end point, and major adverse cardiac events, including death, myocardial infarction, and target vessel revascularization within 12 months, were considered a secondary end point. A total of 489 patients were included in the present longitudinal cohort study, 234 in the femoral group and 254 in the radial group. In the propensity-adjusted model, the use of the femoral approach was a strong independent predictor of bleeding (odds ratio 4.22, 95% confidence interval 3.17 to 10.60). No significant difference between the radial and femoral groups was observed relative to the time to revascularization (21.4 +/- 11.8 minutes vs 22.8 +/- 10.3 minutes, respectively; p = 0.68). Moreover, the radial approach was associated with a decreased risk of major adverse cardiac events (odds ratio 0.31, 95% confidence interval 0.10 to 0.94). In conclusion, primary PCI using the radial approach was associated with a fourfold reduction in major bleeding, without compromising the time to revascularization. Moreover, the radial approach was associated with a significant reduction in major adverse cardiac events at 12 months.

Treatment of a large thrombus containing lesion with the MGuard™ protective net coronary stent system: optical coherence tomographic evidence of complete plaque sealing

Avoidance of distal embolization is the key of success in the percutaneous treatment of patients with ST elevation myocardial infarction. Embolization may lead to microvascular obstruction, and consequently impairment of myocardial perfusion with increased infarct size and mortality [1, 2]. Different types of devices have been proposed to avoid this issue. Prospective randomized clinical trials have shown the beneficial effect of thrombus aspiration devices in the setting of primary percutaneous coronary intervention (PCI) [3, 4]. Recently, the use of MGuard net coronary stent system (MGS, Inspire-MD, Tel Aviv, Israel) in the setting of primary PCI has shown high rate of myocardial reperfusion and angiographic procedural success [5]. MGS is a new stainless-steel closed-cell design stent concept. Other than conventional available bare-metal stents (BMS), it has an ultrathin flexible polyethylene terephthalate mesh sleeve that is anchored to the external surface of the struts. This biocompatible microfiber net (string diameter 10–22 lm) has minimal effects on stent crossing profile and deliverability (Fig. 1). During stent deployment, the net stretches and slides over the expanding stent struts, creating custom designed pores of &200 lm in diameter. The idea of this design is to entrap the thrombus burden between stent mesh and the wall of the artery, isolating the high-thrombogenic intima components and preventing the ‘‘snow plug effect’’. This is the first time, at our knowledge, that the optical coherence tomography (OCT) assessment of MGS implantation for the treatment of a large thrombus burden right coronary artery (RCA) lesion is being reported. A 78-year-old female with mild hypertension and dislipidemia, previously treated with dual chamber pacemaker implant, was admitted at our hospital for coronary angiography following an inferior ST elevation myocardial infarction treated with a partial effective systemic thrombolytic therapy with reteplase. At the time of coronary angiography, the patient was already on double antiplatelet therapy (600 mg loading dose of clopidogrel and 300 mg loading dose of acetylsalicylic acid). The angiography showed a significant mid-RCA lesion with large thrombus burden (Fig. 2a), while there were no lesions on the left coronary system. PCI was then performed using the standard approach. A bolus of 80 UI/kg of unfractioned heparin was given at the start of procedure. No glycoprotein IIb/IIIa inhibitors were given during the procedure to avoid bleeding complications related to the already administered anti-platelet therapy and patient’s age. After cannulation of the RCA with a 7 French side holes Judking right 4 guiding catheter, a BMW guide wire (Abbott Vascular, Redwood City, CA, USA) was advanced until the distal postero-lateral branch and an OCT scan using the C7XR OCT image system (LightLab Imaging Inc., Westford, MA, USA) was then performed using the nonocclusive flushing technique [6]. The OCT pullback showed a tight stenosis of RCA with a very large intraluminal stratified red thrombus (Fig. 2b). Subsequently, it was decided to perform a direct stenting with 4.0/24 mm MGS implantation, which was deployed at 16 atm. The OCT was repeated thereafter showing a malapposition at the mid part of the stent. Therefore, post-dilatation was A. La Manna S. D. Tomasello C. Tamburino Clinical Division of Cardiology, Department of Internal Medicine and Systemic Disease, Ferrarotto Hospital, University of Catania, Catania, Italy

Early Administration of Small-Molecule Glycoprotein IIb/IIIa Inhibitors Before Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction: Insights From Randomized Clinical Trials

Current guidelines recommend abciximab (ReoPro) as an adjunctive pharmacologic agent to primary percutaneous coronary intervention (PPCI) for patients with ST-segment elevation myocardial infarction (STEMI). However, small-molecule glycoprotein IIb/IIIa receptor inhibitors (smGPIs), such as tirofiban (aggrastat) and eptifibatide (integrilin), are more commonly used in clinical practice. We performed a meta-analysis to compare the safety and efficacy of early administration of smGPIs versus abciximab before PPCI. The literature was scanned by formal searches of electronic databases from January 1990 to April 2009. A total of 4 randomized trials meeting the prespecified criteria were analyzed, involving 2040 patients. Rates of initial Thrombolysis in Myocardial Infarction Study (TIMI) 3 flow before procedure as well as complete ST resolution after PPCI were not inferior in smGPIs group compared with abciximab group (odds ratio [OR] 1.12, P = .31; and OR 1.05, P = .66, respectively). There was no significant difference in the risk of 30-day (OR 0.83, P = .54) or 8-month mortality (OR 0.78, P = .43) between smGPI and abciximab group. With regard to the safety end points, neither the major nor the minor bleeding complications in smGPIs group differed significantly from those in abciximab group (OR 1.32, P = .43; and OR 0.82, P = .37, respectively). This meta-analysis shows that early administration of smGPIs is as effective as abciximab in the setting of PPCI for STEMI, without an increase in bleeding complications.

Efficacy of High-Dose Atorvastatin Loading Before Primary Percutaneous Coronary Intervention in ST-Segment Elevation Myocardial Infarction: The STATIN STEMI Trial

This study sought to determine the efficacy of high-dose atorvastatin in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Previous randomized trials have demonstrated that statin pre-treatment reduced major adverse cardiac events (MACEs) in patients with stable angina pectoris and acute coronary syndrome. However, no randomized studies have been carried out with STEMI patients in a primary PCI setting. A total 171 patients with STEMI were randomized to 80-mg atorvastatin (n = 86) or 10-mg atorvastatin (n = 85) arms for pre-treatment before PCI. All patients were prescribed clopidogrel (600 mg) before PCI. After PCI, both groups were treated with atorvastatin (10 mg). The primary end point was 30-day incidence of MACE including death, nonfatal MI, and target vessel revascularization. Secondary end points included corrected thrombolysis in myocardial infarction frame count, myocardial blush grade, and ST-segment resolution at 90 min after PCI. MACE occurred in 5 (5.8%) and 9 (10.6%) patients in the 80-mg and 10-mg atorvastatin pre-treatment arms, respectively (p = 0.26). Corrected thrombolysis in myocardial infarction frame count was lower in the 80-mg atorvastatin arm (26.9 +/- 12.3 vs. 34.1 +/- 19.0, p = 0.01). Myocardial blush grade and ST-segment resolution were also higher in the 80-mg atorvastatin arm (2.2 +/- 0.8 vs. 1.9 +/- 0.8, p = 0.02 and 61.8 +/- 26.2 vs. 50.6 +/- 25.8%, p = 0.01). High-dose atorvastatin pre-treatment before PCI did not show a significant reduction of MACEs compared with low-dose atorvastatin but did show improved immediate coronary flow after primary PCI. High-dose atorvastatin may produce an optimal result for STEMI patients undergoing PCI by improving microvascular myocardial perfusion. (Efficacy of High-Dose AtorvaSTATIN Loading Before Primary Percutaneous Coronary Intervention in ST-Elevation Myocardial Infarction [STATIN STEMI]; NCT00808717).

Impact of Thrombus Aspiration on Myocardial Tissue Reperfusion and Left Ventricular Functional Recovery and Remodeling After Primary Angioplasty

Failure to achieve myocardial reperfusion often occurs during percutaneous coronary intervention (PCI) in patients with myocardial infarction with ST-segment elevation. We hypothesized that manual thrombus aspiration during primary PCI would favorably influence tissue-level myocardial perfusion and left ventricular (LV) functional recovery and remodeling. We prospectively randomized 111 patients with ST-segment elevation myocardial infarction to either standard or thrombus-aspiration PCI. Primary end point of the study was postprocedural incidence of ST-segment resolution >or=70%. Secondary end points included Thrombolysis in Myocardial Infarction (TIMI) myocardial perfusion grade >or=2, the combination of TIMI myocardial perfusion grade >or=2 and ST-segment resolution >or=70%, post-PCI TIMI grade 3 flow, corrected TIMI frame count, myocardial contrast echocardiography score index, the absence of persistent ST-segment deviation, and time course of wall-motion score index, LV ejection fraction, and LV volume in the 2 groups. The incidence of ST-segment resolution >or=70% was 71% and 39% in the thrombus-aspiration and standard PCI groups, respectively (odds ratio, 3.7; 95% CI, 1.7 to 8.3; P=0.001). TIMI myocardial perfusion grade >or=2 was attained in 93% in the thrombus-aspiration group compared with 71% in the standard PCI group (P=0.006). The percentage of patients with ST-segment resolution >or=70% and TIMI myocardial perfusion grade >or=2 was significantly greater in the thrombus-aspiration group compared with the standard PCI group (69% versus 36%, P=0.0006). Myocardial contrast echocardiography score index was significantly higher in the thrombus-aspiration group compared with the standard PCI group (0.86+/-0.20 versus 0.65+/-0.31; P<0.0001). A significantly greater improvement in LV ejection fraction and in wall-motion score index from baseline to 6-month follow-up was observed in the thrombus-aspiration group compared with the standard PCI group (LV ejection fraction from 48+/-6% to 55+/-6% versus 48.7+/-7% to 49+/-8%, P<0.0001; wall-motion score index from 1.59+/-0.13 to 1.31+/-0.19 versus 1.64+/-0.20 to 1.51+/-0.26, P=0.008). Twelve patients (11%) developed LV remodeling at 6 months, 2 (4%) in the thrombus-aspiration group and 10 (18%) in the standard PCI group (P=0.02). Manual thrombus aspiration in the setting of primary PCI improves myocardial tissue-level perfusion as well as LV functional recovery and remodeling.

Influence of different antiplatelet treatment regimens for primary percutaneous coronary intervention on all-cause mortality

The aim of this analysis was to examine the influence of different in-cath-lab antiplatelet regimens for the primary percutaneous coronary intervention (PCI) on all-cause mortality. The study group consisted of 7193 patients (pts) undergoing primary PCI in 38 centres in 2003 in Poland. All patients received pretreatment with 300 mg of aspirin, 992 pts (14%) received glycoprotein (GP) IIb/IIIa inhibitors, 2690 pts (37%) were treated with 300 mg loading dose of clopidogrel, and 1566 (22%) received combined antiplatelet treatment with both GP IIb/IIIa inhibitors and clopidogrel. Remaining 1945 patients (27%) did not receive GP IIb/IIIa inhibitors or clopidogrel. Primary endpoint of the study was all-cause mortality up to 1 year from ST-segment elevation myocardial infarction (STEMI). One year mortality rates in the four groups were: 10.4%, 9.0%, 9.7%, and 15.3%, respectively. Propensity-adjusted survival analysis showed significant reduction of mortality for combination therapy with GP IIb/IIIa inhibitors and clopidogrel, clopidogrel alone, and GP IIb/IIIa inhibitors alone over aspirin alone. No additive effect on survival was seen for a combination therapy with GP IIb/IIIa inhibitors and clopidogrel in comparison to treatment with clopidogrel alone. In this large cohort, multicentre STEMI registry in-cath-lab use of GP IIb/IIIa inhibitors and clopidogrel alone or in combination was associated with the reduction of 1 year all-cause mortality in the setting of primary PCI in comparison with aspirin only. However, the use of GP IIb/IIIa inhibitors on top of 300 mg loading dose of clopidogrel did not further reduce mortality.

Clinical impact of sirolimus‐eluting stent in ST‐segment elevation myocardial infarction: A meta‐analysis of randomized clinical trials

To evaluate outcome of patients undergoing sirolimus-eluting stent (SES) as compared to bare-metal stent (BMS) implantation during primary angioplasty for ST-segment elevation myocardial infarction (STEMI). The role of SES in primary percutaneous coronary intervention setting is still debated. We searched Medline, EMBASE, CENTRAL, scientific session abstracts, and relevant Websites for studies in any language, from the inception of each database until October 2008. Only randomized clinical trials with a mean follow-up period >6 months and sample size >100 patients were included. Primary endpoint for efficacy was target-vessel revascularization (TVR) and primary endpoint for safety was stent thrombosis. Secondary endpoints were cardiac death and recurrent myocardial infarction (MI). Six trials were included in the meta-analysis, including 2,381 patients (1,192 randomized to SES and 1,189 to BMS). Up to 12-month follow-up, TVR was significantly lower in patients treated with SES as compared to patients treated with BMS (4.53% vs. 12.53%, respectively; odds ratio [OR] 0.33; 95% confidence interval [CI] 0.24-0.46; P < 0.00001). There were no significant differences in the incidence of stent thrombosis (3.02% vs. 3.70%, OR = 0.81 [95% CI, 0.52-1.27], P = 0.81), cardiac death (2.77% vs. 3.28%, OR = 0.84 [95% CI, 0.52-1.35], P = 0.47), and recurrent MI (2.94% vs. 4.04%, OR = 0.71 [95% CI, 0.45-1.11], P = 0.13) between the two groups. SES significantly reduces TVR rates as compared to BMS in STEMI patients up to 1 year follow-up. Further studies with larger population and longer follow-up time are needed to confirm our findings.

Acute heart failure in patients with acute myocardial infarction treated with primary percutaneous coronary intervention☆

Scanty data exist about the relation between acute heart failure (HF) and acute myocardial infarction (AMI). To assess the impact of HF on outcome in AMI patients treated with primary percutaneous coronary intervention (PCI). Out of 2,089 AMI patients, 82% did not present HF, 17% presented HF on admission and 1% developed HF after hospitalisation. Predictors of HF on admission were age, diabetes, prior MI, time delay to admission, anterior location, and TIMI grade 0-1 in the culprit vessel. Predictors of HF during hospitalisation were age and peak creatine kinase. The 1- and 6-month mortalities were 1.1% and 2.2%, 8% and 12%, 26% and 33% in patients without HF, with HF on admission and after hospitalisation, respectively. The risk of death was higher in patients with HF than in patients without HF (HR 3.47), as well as in patients with HF after admission (HR 5.19) than in patients with HF on admission (HR 2.44). In a primary PCI setting, the incidence of HF on hospital admission remains high, but mortality is lower when compared with historical patient series. Primary PCI may prevent the development of HF during hospitalisation; however, when HF develops, the prognosis remains severe.

Plasma levels of thromboxane A2 on admission are associated with no-reflow after primary percutaneous coronary intervention

Thromboxane A2 (TXA2) is a key mediator of platelet activation and aggregation, and an important mediator of platelet-induced coronary artery constriction. We sought to investigate whether baseline plasma levels of TXA2 are associated with coronary no-reflow after primary percutaneous coronary intervention (PPCI). A total of 47 consecutive patients (age, 62.5 +/- 12.7; male sex, 76.6%) admitted to our hospital for a first ST-segment elevation myocardial infarction and undergoing PPCI within 12 h of onset of symptoms were enrolled. Admission TXA2 plasma levels were measured by enzyme-linked immunosorbent assay (ELISA). Angiographic no-reflow was defined as a final TIMI flow of <or=2 or final TIMI flow of 3 with a myocardial blush grade of <2, whereas ST-segment resolution from baseline value of <or=50% was used as ECG index of no-reflow. At multivariable analysis TXA2 plasma levels, endothelin-1 (ET-1) plasma levels, and left anterior descending coronary artery (LAD) as culprit vessel were significant predictors of angiographic no-reflow (P = 0.04), whereas TXA2 and ET-1 plasma levels were the only independent predictors of lack of ST-segment resolution (P = 0.013 and 0.04, respectively). Of note, TXA2 tertiles were independent predictors of both angiographic no-reflow and lack of ST-segment resolution (OR, 3.5; 95% CI, 1.1-11; P = 0.03 and OR, 3; 95% CI, 1.3-7; P = 0.01, respectively). TXA2 is an independent indicator of no-reflow that occurs after PPCI. This observation may open new therapeutic opportunity in the setting of PPCI.

The Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial: Study design and rationale

Advances in coronary angioplasty and adjunct pharmacology have improved patient outcomes after primary percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI). However, several areas for improvement remain. Hemorrhagic complications, which are common in patients receiving intense anticoagulant and antiplatelet agents during primary PCI to suppress ischemia, have been strongly associated with early and late mortality. Moreover, restenosis after bare-metal stents (BMSs) frequently results in symptom recurrence and the need for repeat rehospitalization and revascularization procedures. Newer pharmacologic agents and drug-eluting stents may address both of these issues. In the HORIZONS-AMI trial, 3,602 patients with AMI undergoing primary PCI were prospectively randomized to unfractionated heparin plus routine use of glycoprotein (GP) IIb/IIIa inhibitors versus the direct thrombin inhibitor bivalirudin plus provisional use of GP IIb/IIIa inhibitors reserved for predefined thrombotic complications. In a second randomization, 3,011 eligible patients were randomly assigned to either a polymer-based paclitaxel-eluting stent or to an otherwise identical BMS. The study was powered for the assessment of sequential safety and efficacy end points for each specific randomization, with clinical end points assessed at 30 days, 1 year, and then annually for 5 years. The ongoing HORIZONS-AMI trial will determine whether bivalirudin monotherapy reduces bleeding complications and improves overall event-free survival compared with unfractionated heparin plus the routine use of GP IIb/IIIa inhibitors in patients undergoing primary PCI for AMI. Furthermore, this study will determine whether paclitaxel-eluting stents safely reduce rates of ischemic target lesion revascularization compared with BMSs in the setting of primary PCI.

The role of thrombectomy and distal protection devices during percutaneous coronary interventions

Achievement of the angiographic gold standard TIMI 3 flow (Thrombolysis in Myocardial Infarction) flow grade during PCI (percutaneous coronary intervention) in the setting of AMI (acute myocardial infarction) is insufficient for attainment of optimal prognostic benefit, as there is a poor prognosis for patients with evidence of inadequate flow at the tissue level despite patent coronary arteries. PCI in lesions containing thrombus are associated with an increased risk of complications occurring through dislodgement of thrombotic material resulting and distal embolisation leading to slow flow or even no-reflow. Devices which remove thrombus from coronary arteries (thrombectomy devices) or protect from distal embolisation of thrombus (distal protection devices) are increasingly used in PCI. We have performed a systematic review of the literature to investigate the role of these devices in PCI in the setting of AMI. Use of thrombectomy devices in randomised and multicentre trials in patients undergoing PCI during STEMI is associated with a significant benefit in a number of markers of myocardial perfusion including MBG (myocardial blush grade), ST segment resolution and improvement of distal embolisation, although no significant benefits in mortality have been observed. There does not appear to be strong evidence for the use of embolic protection devices and distal filter devices in the setting of primary PCI in native coronary arteries, although evidence from trials such as the SAFER trial would make a strong case for their use in SVG interventions.

Safety and effectiveness of drug eluting stent in patients with ST elevation myocardial infarction undergoing primary angioplasty

Drug eluting stents (DES) have recently been proven to further reduce restenosis and revascularization rate in comparison to bare metal stents in elective procedures. Most early DES trials did not include patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation MI, because these patients tend to have lower restenosis rates than other patient groups and delayed endothelization of these stents raises concern about a possible increase of thrombotic complications in the setting of STEMI. To confirm the safety and effectiveness of DES in patients with STEMI in a real-world scenario. From January 2004 to December 2006, clinical and angiographic data of 370 patients with STEMI treated with primary PCI have been analyzed. Patients were retrospectively followed for the occurrence of major adverse cardiac events (MACE): death, reinfarction and target vessel revascularization (TVR). Overall, 120 patients received DES (32%, DES group) and 250 received bare metal stents (68%, BMS group) in the infarct related artery. Compared with the BMS group, DES patients were younger, (mean age 56 +/- 12 vs. 65 +/- 10; P < 0.001) had more often diabetes mellitus (47% vs. 14% P < 0.001), anterior localization (65% vs. 45%; P < 0.0011) and less cardiogenic shock at admission (4% vs. 7%; P < 0.001). The angiographic characteristics in the DES group showed longer lesions (23 mm vs. 19 mm) and smaller diameter of vessels (2.5 mm vs. 3.0 mm). After a median follow-up of 24 +/- 9 months, there was no significant difference in the rate of stent thrombosis (1.6% in the DES group vs. 1.2% in the BMS group, P = ns). The incidence of MACE was significantly lower in the DES group compared with the BMS group (HR 0.56 [95% CI: 0.3-0.8]; P = 0.01), principally due to the lower rate of TVR (HR 0.41 [95% CI: 0.2-0.85]; P = 0.01). Utilization of DES in the setting of primary PCI for STEMI, in our "real world," was safe and improved the 3-year clinical outcome compared with BMS reducing the need of TVR.

Effect of Clopidogrel Pretreatment on Angiographic and Clinical Outcomes in Patients Undergoing Primary Percutaneous Coronary Intervention for ST-Elevation Acute Myocardial Infarction

Pretreatment with clopidogrel before elective primary percutaneous coronary intervention (PCI) has been shown to reduce ischemic complications. There are limited data about the value of clopidogrel pretreatment in the setting of PCI for ST-elevation myocardial infarction (STEMI). We aimed to examine the effect of clopidogrel preloading on angiographic and clinical outcomes in patients with STEMI who were treated with PCI. We conducted a prospective registry of all patients treated with primary PCI for STEMI from March 2003 to June 2006. Excluded were patients with cardiogenic shock. For the current analysis, patients (n = 292) were allocated into 2 groups. One group received clopidogrel loading dose before PCI (in the emergency department or coronary care unit, n = 165); the other,immediately after PCI (n = 127). TIMI myocardial perfusion (TMP) grade at the end of PCI and 30-day and 6-month clinical outcomes were assessed. Clinical characteristics were similar among the groups. However, patients pretreated with clopidogrel were more likely to receive aspirin and beta blockers before the current admission. TMP grade 3 occurred in a higher proportion of patients in the clopidogrel pretreatment group than in the no-pretreatment group (85% vs 71%, p = 0.01). Multivariate logistic regression analysis showed that clopidogrel pretreatment was associated with an odds ratio of 2.2 for TMP grade 3 (1.2 to 3.9, p = 0.01). Furthermore, the incidence of reinfarction at 30 days was lower in the pretreatment group (0% vs 3.2%, respectively, p = 0.04). In conclusion, these findings support the early use of clopidogrel in patients with STEMI who are treated with primary PCI.

Drug-Eluting Stent Update 2007

Randomized trials have largely demonstrated that percutaneous coronary intervention (PCI) with sirolimus-eluting (SES) and paclitaxel-eluting stents (PES) results in a significant reduction in the occurrence of angiographic restenosis and revascularization compared with bare metal stents (BMS).1–4 The benefit of drug-eluting stents (DES) also has been confirmed in “real-world” scenarios. In this setting, when the analysis was focused on high-risk patient and lesion subgroups, a benefit still existed despite the presence of restenosis.5–7 These expanded indications do not yet cover many other types of complex lesions for which only registries or randomized trials, not yet published, are available so far (Tables 1 through 7⇓⇓⇓⇓⇓⇓). This topic is discussed in detail in this review. An important clarification is that the lack of proof is most probably due to the difficulty in performing randomized trials in high-risk groups using BMS as controls. It will be no surprise to find that the field in which DES perform best compared with BMS is likely to be complex lesions and patients8 (Figure 1). View this table: TABLE 1. DES in Unprotected Left Main Stenosis View this table: TABLE 2. DES in Bifurcation Lesions View this table: TABLE 3. DES in Chronic Total Occlusions View this table: TABLE 4. DES in Small-Vessel Disease and Long Lesions View this table: TABLE 5. DES in SVGs View this table: TABLE 6. DES in Acute MI View this table: TABLE 7. DES in Multivessel Disease Figure 1. Lesion complexity and stent performance in the BMS and DES eras. Adapted from Edelman et al.8 Current American Heart Association/American College of Cardiology (AHA/ACC) and European Society of Cardiology (ESC) guidelines consider the presence of a stenosis in the unprotected left main coronary artery (LMCA) a class IIa or IIb indication, respectively, for PCI if coronary artery bypass grafting (CABG) is not a viable option.9,10 Moreover, according to the AHA/ACC 2005 guidelines, in …