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Objectives To assess the quality of coronary reperfusion and long-term clinical outcomes of patients enrolled in the HORIZONS-AMI trial according to the use of thrombus aspiration (TA). Background The impact of manual TA on microvascular perfusion and clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI) is unsettled. Methods In this retrospective, nonrandomized, subgroup analysis, the authors evaluated thrombolysis in myocardial infarction (TIMI) flow, tissue myocardial perfusion grade (TMPG), ST-segment resolution (STR), net adverse clinical events (NACE), and major adverse cardiac events (MACE) in patients undergoing pPCI with or without manual TA. Results A total of 318 patients had pPCI with upfront TA, and 2,917 patients had pPCI without TA. Patients who had TA were more likely to have TIMI 0/1 flow at baseline (75.1% vs. 63.7%, P < 0.0001). There was no difference in the rates of final TIMI 3 flow (90.2% vs. 92.3%, P = 0.19) or dynamic TMPG 2-3 (77.4% vs. 76.4%, P = 0.68). STR ≥70% was similar in both groups at 60 minutes but higher in the TA group at discharge (71.8% vs. 64.6%, P = 0.02). After multivariable adjustment, TA did not predict MACE at 30 days (HR 0.96 [0.51–1.80], P = 0.90), 1 year (HR 1.03 [0.68–1.55], P = 0.89), or 3 years (HR 1.13 [0.86–1.48], P = 0.39). Stent thrombosis did not differ at 1 year or 3 years. Conclusions In STEMI patients undergoing pPCI, the use of manual TA was associated with improved STR at discharge, but not with any difference in final TIMI flow, TMPG, or MACE. © 2012 Wiley Periodicals, Inc.

Objective To compare outcomes between US and non-US (OUS) sites in patients with non ST-elevation acute coronary syndromes (NSTEACS) and to evaluate potential reasons for differences in outcomes. Background There are little data comparing outcomes at US versus OUS sites in patients with NSTEACS managed with an invasive strategy. Methods The ACUITY trial randomized 13,819 patients with NSTEACS in 17 countries to an invasive approach with one of three strategies: (1) heparin plus glycoprotein platelet inhibitors (GPI), (2) bivalirudin plus GPI, or (3) bivalirudin alone. Results US patients were more often female, were younger, heavier, and had more diabetes, prior myocardial infarction (MI), and prior bypass surgery. US patients were less often treated with percutaneous coronary intervention but had more frequent drug-eluting stent use. US patients had lower mortality and higher MI rates at 30 days and 1 year and higher composite ischemic outcome at 30 days. After adjusting for differences in baseline variables, US patients had higher rates of MI and composite ischemic outcome at 30 days and higher rates of MI at 1 year {HR [95% confidence interval (CI)] = 1.36 [1.18–1.56], P < 0.0001} with no differences in mortality. There were no differences in treatment effects comparing bivalirudin with the other strategies between US and OUS sites. Conclusions US versus OUS patients with NSTEACS had higher adjusted rates of MI and ischemia. The reasons for these differences are not clear but may be due to unmeasured confounders, different thresholds for event reporting, or valid differences in systems of care which may impact outcomes. © 2012 Wiley Periodicals, Inc.

AIMS To examine outcomes in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI) at US sites versus sites outside the US (OUS). METHODS AND RESULTS In the HORIZONS-AMI trial 3,602 STEMI patients in 11 countries were randomised to primary PCI with bivalirudin versus heparin + glycoprotein IIb/IIIa inhibitors. US patients (n=814) had more diabetes, prior infarction, prior bypass surgery, and renal insufficiency. OUS patients (n=2,788) had longer door-to-balloon times, more radial access, fewer bypass surgeries, and were discharged more often on beta-blockers and statins. At three years US patients had higher mortality (9.7% vs. 6.0%, p=0.0003), reinfarction (10.2% vs. 6.4%, p=0.001), major adverse cardiac events (MACE; 28.2% vs. 20.1%, p

The objective of this study is to compare the long-term safety of new generation drug-eluting stents (DES) with early generation DES and bare metal stents (BMS) for ST-segment elevation myocardial infarction (STEMI).Early generation DES for STEMI have reduced target vessel revascularization, but have more very late ST compared with BMS raising concerns about their safety. New compared with early generation DES have lower rates of ST, but there are limited data in STEMI patients.From 2003 to 2011, 3,464 STEMI patients were treated with BMS (n = 1,187), early generation DES (n = 1,525), or new generation DES (n = 752) and were followed for 1-9 years.Patients with new generation DES were younger, had less cardiogenic shock, and less prior infarction versus BMS, and more hypertension versus early generation DES. At 2 years, new generation DES had lower mortality (4.0% vs. 12.4%, P 0.001), similar reinfarction (4.4% vs. 5.1%, P = 0.35), and less ST (1.4% vs. 3.8%, P = 0.031) versus BMS; and similar mortality (4.0% vs. 5.8%, P = 0.23), similar reinfarction (4.4% vs. 5.2%, P = 0.64), and trends for less ST (1.4% vs. 3.3%, P = 0.17) versus early generation DES. By Cox multivariable analyses, BMS had more ST than new generation DES (HR [95% CI] = 1.93 [1.01-3.66], P = 0.045).New generation DES in STEMI patients have less ST compared to BMS and trends for less ST compared to early generation DES. These data suggest a new safety paradigm and should encourage the use of new generation DES in most STEMI patients treated with primary percutaneous coronary intervention (PCI).

AIMS The predictors of TIMI flow

Background Stent thrombosis remains among the most feared complications of percutaneous coronary intervention (PCI) with stenting. However, data on its incidence and predictors are sparse and conflicting. We thus aimed to perform a collaborative systematic review on incidence and predictors of stent thrombosis. Methods PubMed was systematically searched for eligible studies from the drug-eluting stent (DES) era (1/2002–12/2010). Studies were selected if including ≥2000 patients undergoing stenting or reporting on ≥25 thromboses. Study features, patient characteristics, and incidence of stent thrombosis were abstracted and pooled, when appropriate, with random-effect methods (point estimate [95% confidence intervals]), and consistency of predictors was formally appraised. Results A total of 30 studies were identified (221,066 patients, 4276 thromboses), with DES used in 87%. After a median of 22months, definite, probable, or possible stent thrombosis had occurred in 2.4% (2.0%; 2.9%), with acute in 0.4% (0.2%; 0.6%), subacute in 1.1% (1.0%; 1.3%), late in 0.5% (0.4%; 0.6%), and very late in 0.6% (0.4%; 0.8%). Similar figures were computed for studies reporting only on DES. From a total of 47 candidate variables, definite/probable stent thrombosis was more commonly and consistently predicted by early antiplatelet therapy discontinuation, extent of coronary disease, and stent number/length, with acute coronary syndrome at admission, diabetes, smoking status, and bifurcation/ostial disease also proving frequent predictors, but less consistently. Conclusions Despite numerous possible risk factors, the most common and consistent predictors of stent thrombosis are early antiplatelet therapy discontinuation, extent of coronary disease, and stent number/length.

Aims Using the database from the large-scale, prospective, randomised HORIZONS-AMI trial, the authors sought to assess the impact of bifurcation target lesions (BTL) on angiographic, electrocardiographic, and clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI). Methods and results In HORIZONS-AMI, bifurcation lesions in which a provisional approach was planned were eligible for enrolment. By angiographic core laboratory assessment of 3,306 patients with STEMI undergoing primary PCI, 333 patients (10%) had ≥1 BTL, and 2,973 patients had no BTL. There were no significant differences in baseline characteristics between the groups, except for lower left ventricular ejection fraction and more frequent left anterior descending infarct artery in the BTL group. BTLs required longer procedural and fluoroscopy times and higher contrast loads, but rates of TIMI 3 flow post PCI were similar in both groups (with vs. without BTL 99% vs. 87%, p=0.25). ST-segment resolution ≥70% by core laboratory analysis was similar in both groups (48% vs. 50%, p=0.47). Importantly, there was no difference between groups in the rate of death (6.1% vs. 6.7%, p=0.72), definite or probable stent thrombosis (4.2% vs. 5.2%, p=0.42), and ischaemic target vessel revascularisation (14.3% vs. 14.0%, p=0.86) during three-year follow-up. Conclusions Although the PCI procedure involving BTL was more complex, the acute results and late outcomes in patients with BTLs were comparable to those in patients without BTLs.

Objectives.The purpose of this study was to evaluate the importance of late infarct-related artery patency for recovery of left ventricular function and late survival after primary angioplasty for acute myocardial infarction.Background.Infarct-related artery patency is thought to improve late survival by its effect on preservation of left ventricular function. Patency may also enhance late survival by preventing left ventricular dilation and reducing arrhythmias, independent of myocardial salvage. However, most studies have not shown patency to be an independent predictor of survival when late left ventricular function is taken into account.Methods.We followed up 576 hospital survivors of acute myocardial infarction treated with primary angioplasty for 5.3 years. Ejection fraction and infarct-related artery patency were determined at follow-up catheterization at 6 months. Predictors of late cardiac survival were determined using Cox regression models.Results.Patients with patent arteries had more improvement and a better late ejection fraction than patients with occluded arteries (56.3% vs. 47.9%, p = 0.001). In patients with acute ejection fraction

Mechanical reperfusion was introduced as a reperfusion strategy for ST-segment elevation acute myocardial infarction (AMI) in the mid- and late 1980s and offered advantages over thrombolytic therapy in achieving higher infarct artery patency rates with less re-occlusion. With the publication of the

ObjectivesThis study sought to describe the economic outcomes from a prospective multicenter registry of primary coronary angioplasty.BackgroundInterest in coronary angioplasty without preceding thrombolytic therapy as a primary reperfusion strategy has increased as a result of three recent randomized trials showing outcomes equivalent to or better than standard thrombolytic therapy.MethodsThe Primary Angioplasty Registry enrolled 270 patients with acute myocardial infarction at six private tertiary care medical centers. Baseline and follow-up medical costs and counts of resources consumed were collected from enrollment to the 6-month follow-up visit. Correlates and predictors of cost were identified with multivariable linear regression modeling.ResultsNinety-five percent of patients had a revascularization procedure during the baseline hospital period: 85% had coronary angioplasty only; 4% had coronary bypass surgery only; 6% had both procedures. The total mean baseline hospital cost (not charge) was $13,113, with mean physician fees of $5,694. During the follow-up period, repeat coronary angiography was performed in 21% of patients, whereas 13% had repeat angioplasty and 3% bypass surgery. Mean hospital follow-up costs were $3,174, with mean physician fees of $1,443. Independent correlates of higher baseline hospital costs included older age (p = 0.049), anterior infarction (p = 0.03), initial Killip class (p < 0.0001), more severe coronary disease (p = 0.0015), need for bypass surgery alone or in addition to angioplasty (p < 0.0001) and recurrent ischemia (p < 0.0001).ConclusionsCosts of primary angioplasty for patients with acute myocardial infarction eligible for thrombolysis were strongly influenced by infarction- and procedure-related complications but only modestly influenced by patient selection factors.

Background— Contrast-induced acute kidney injury (CI-AKI) after percutaneous coronary intervention is associated with adverse short- and long-term outcomes. However, identification of patients at risk for CI-AKI is challenging. Using a large contemporary randomized trial database of patients with ST-segment–elevation myocardial infarction, we therefore sought to examine whether admission B-type natriuretic peptide (BNP) levels predict the development of CI-AKI. Methods and Results— A total of 979 ST-segment–elevation myocardial infarction patients enrolled in the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial had BNP levels measured in the emergency room prior to primary percutaneous coronary intervention as part of the study protocol. CI-AKI was defined as a relative increase in serum creatinine of ≥25%, or an absolute increase of ≥0.5 mg/dL, occurring within 48 hours after contrast administration. Logistic regression analysis was used to estimate the association of admission BNP with development of CI-AKI. CI-AKI occurred in 131 patients (13.3%). Baseline BNP was a significant univariable correlate of CI-AKI (odds ratio 1.31, 95% confidence interval, 1.14–1.51; P =0.0001). After multivariable adjustment for clinical, laboratory, and angiographic variables, BNP remained a significant independent predictor of CI-AKI (1.29 [1.10, 1.51]; P P P =0.015). Conclusions— Measurement of serum BNP at hospital admission may help identify patients who are at risk for developing CI-AKI after primary percutaneous coronary intervention in ST-segment–elevation myocardial infarction. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00433966.

Previous IVUS studies examining correlates of drug-eluting stent (DES) thrombosis were retrospective and in small patient cohorts. ADAPT-DES was a prospective, multicenter, real-world registry of 8,575 consecutive pts at 11 international centers treated with percutaneous coronary intervention (PCI

Objectives To assess the impact of age on safety and efficacy of paclitaxel-eluting stent (PES) implantation during primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI). Background The benefits of paclitaxel-eluting stent (PES) implantation during primary PCI were confirmed by the long-term results of the HORIZONS-AMI trial. Whether the effects of PES are independent of age has not been reported. Methods Data on 3,006 patients from the HORIZONS-AMI study randomized in a 3:1 ratio to PES or bare-metal stent (BMS) in whom at least one stent was implanted were assessed. There were 2,302 (76.6%) patients

To assess the quality of coronary reperfusion and long-term clinical outcomes of patients enrolled in the HORIZONS-AMI trial according to the use of thrombus aspiration (TA).The impact of manual TA on microvascular perfusion and clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI) is unsettled.In this retrospective, nonrandomized, subgroup analysis, the authors evaluated thrombolysis in myocardial infarction (TIMI) flow, tissue myocardial perfusion grade (TMPG), ST-segment resolution (STR), net adverse clinical events (NACE), and major adverse cardiac events (MACE) in patients undergoing pPCI with or without manual TA.A total of 318 patients had pPCI with upfront TA, and 2,917 patients had pPCI without TA. Patients who had TA were more likely to have TIMI 0/1 flow at baseline (75.1% vs. 63.7%, P0.0001). There was no difference in the rates of final TIMI 3 flow (90.2% vs. 92.3%, P = 0.19) or dynamic TMPG 2-3 (77.4% vs. 76.4%, P = 0.68). STR ≥70% was similar in both groups at 60 minutes but higher in the TA group at discharge (71.8% vs. 64.6%, P = 0.02). After multivariable adjustment, TA did not predict MACE at 30 days (HR 0.96 [0.51-1.80], P = 0.90), 1 year (HR 1.03 [0.68-1.55], P = 0.89), or 3 years (HR 1.13 [0.86-1.48], P = 0.39). Stent thrombosis did not differ at 1 year or 3 years.In STEMI patients undergoing pPCI, the use of manual TA was associated with improved STR at discharge, but not with any difference in final TIMI flow, TMPG, or MACE.

To compare outcomes between US and non-US (OUS) sites in patients with non ST-elevation acute coronary syndromes (NSTEACS) and to evaluate potential reasons for differences in outcomes.There are little data comparing outcomes at US versus OUS sites in patients with NSTEACS managed with an invasive strategy.The ACUITY trial randomized 13,819 patients with NSTEACS in 17 countries to an invasive approach with one of three strategies: (1) heparin plus glycoprotein platelet inhibitors (GPI), (2) bivalirudin plus GPI, or (3) bivalirudin alone.US patients were more often female, were younger, heavier, and had more diabetes, prior myocardial infarction (MI), and prior bypass surgery. US patients were less often treated with percutaneous coronary intervention but had more frequent drug-eluting stent use. US patients had lower mortality and higher MI rates at 30 days and 1 year and higher composite ischemic outcome at 30 days. After adjusting for differences in baseline variables, US patients had higher rates of MI and composite ischemic outcome at 30 days and higher rates of MI at 1 year {HR [95% confidence interval (CI)] = 1.36 [1.18-1.56], P0.0001} with no differences in mortality. There were no differences in treatment effects comparing bivalirudin with the other strategies between US and OUS sites.US versus OUS patients with NSTEACS had higher adjusted rates of MI and ischemia. The reasons for these differences are not clear but may be due to unmeasured confounders, different thresholds for event reporting, or valid differences in systems of care which may impact outcomes.

Few studies have examined the association between hyperglycemia and adverse outcomes in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI). We therefore evaluated the prognostic utility of admission hyperglycemia in the HORIZONS-AMI trial.Admission glucose levels were available in 3405 of 3602 (94.5%) enrolled patients, of which 566 patients (16.6%) were known to have diabetes. Outcomes were assessed at 30 days and 3 years, stratified by baseline glucose level and diabetes status. Median [IQR] admission glucose level in the entire study cohort was 138.0 [115.4, 171.0] mg/dl. Multivariable adjusted 30-day mortality was significantly increased in all patients with admission glucose in the highest glucose tertile vs. the lower two-thirds (HR [95%CI]=3.53 [1.89, 6.60], p0.0001); in patients with diabetes (4.40 [2.04, 9.50], p=0.0002); and in patients without diabetes (3.33 [1.16, 9.55], p=0.03). By ROC analysis, the best cut-off values for 30-day mortality were 169 mg/dl for all patients (AUC=0.76), 149 mg/dl for patients without diabetes (AUC=0.77), and 231 mg/dl for patients with diabetes (AUC=0.69). Baseline hyperglycemia was also an independent predictor of 3-year mortality in all patients (HR [95%CI]=1.93 [1.35, 2.76], P=0.0003), patients with diabetes (2.65 [1.28, 5.47], P=0.008), and patients without diabetes (1.58 [1.05, 2.36], P=0.03).In patients with STEMI undergoing primary PCI, admission hyperglycemia is an independent predictor of early and late mortality in both patients with and without known diabetes.

Absrac Caegor: 7. CI - Adjuc harmacologyreseao Number: 2536-627Auhors: Ajay J. Kirtane, Thomas Stuckey, Helen Parise, Bernhard Witzenbichler, Giora Weisz, Michael Rinaldi, Franz-Josef Neumann, David Metzger, Timothy Henry, David Cox, Peter Duffy, Bruce Brodie, Ernest Mazzaferri, Ecaterina Cristea, Roxana Mehran, Gregg Stone, Columbia University Medical Center / New York-Presbyterian Hospital, New York, NY, USA, Cardiovascular Research Foundation, New York, NY, USABackground: aes wh dabees mellus (M) udergog se mlaao have creased o-reame laele reacv (H), whch ma corbue o a greaer rs o os-rocedural hromboc eves.Objectives and Methods: AAT-E was a 8,575 ae rosecve, mulceer observaoal sud o useleced aes udergog drug-elug se mlaao; roue laele uco esg was erormed wh he VerNow 212 o-o-care assa ollowg clodogrel loadg. We sough o exame he assocao bewee H ad se hromboss (T) accordg o dabec saus.Results: A oal o 2,778 erolled aes (32.%) had M. aes wh M had hgher laele reacv us (U) comared o o-M aes (mea U 219.1 vs. 175.7, 208: 56.8% vs. 37.2%, 208 = 2.83 (95% CI 0.87-9.20), =0.08) ad o-M aes (H or U>208 = 3.63 (95% CI 1.28-10.26), =0.02), alhough he secic was low boh aes wh ad whou M (3.3% each grou).Conclusions: aes wh M have more reue H ad hgher 30-da raes o T ha aes whou M, ad H was assocaed wh a ~3-old creased haard o 30-da T deede o dabec saus. However, due ar o low overall eve raes, he redcve caac o H or 30-da T s modes boh aes wh ad whou M.

Objectives The study sought to determine whether rapid access to medical care and reperfusion results in a better prognosis in patients with in-hospital compared with out-of-hospital stent thrombosis (ST) in patients with ST-segment elevation myocardial infarction (STEMI) in the HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trial. Background Whether the prognosis of in-hospital and out-of-hospital ST are similar is uncertain, with conflicting data reported from prior studies. Methods A total of 3,602 STEMI patients undergoing primary percutaneous coronary intervention (PCI) were randomized to bivalirudin (n = 1,800) versus unfractionated heparin (UFH) plus a glycoprotein IIb/IIIa inhibitor (GPI) (UFH + GPI; n = 1,802). Stents were implanted in 3,202 patients, 156 (4.9%) of whom developed Academic Research Consortium definite/probable ST during 3-year follow-up. We investigated the 1-year clinical outcomes after ST in 54 patients with in-hospital ST compared with 102 patients with out-of-hospital ST. Results One year after the ST event, patients with in-hospital compared with out-of-hospital ST had significantly greater mortality (27.8% vs. 10.8%, p

During a 14-month period, 6 experienced centers prospectively enrolled 271 patients into a registry in which percutaneous transluminal coronary angioplasty was the primary treatment for acute myocardial infarction. Patients age18 years who presented with ST-segment elevation on the 12-lead electrocardiogram were enrolled if symptom duration was12 hours and there was no proclivity for bleeding. An independent core angiographic laboratory processed the angiographic data. Of 271 patients giving informed consent, 245 (90%) were deemed anatomically suitable and underwent angioplasty therapy. Upon leaving the catheterization laboratory 98% of patients had achieved reperfusion; 92% had a residual visual stenosisor = 50%. Emergency bypass surgery was required in 14 patients (5%) for either failed angioplasty (n = 3) or presumed life-threatening anatomy (n = 11). The in-hospital mortality rate was 4%, whereas the reinfarction rate was 3% and the stroke rate was 1%, with 1 intracranial hemorrhage and 2 embolic events. Bleeding requiringor = 2 units of blood occurred in 46 patients (18%); 14 of these transfusions were related to coronary artery bypass surgery. Primary angioplasty is associated with a high reperfusion rate, low in-hospital mortality and few recurrent myocardial ischemic events. These results point to the need for a large-scale trial comparing angioplasty with thrombolytic therapy in the setting of acute myocardial infarction.

We sought to determine whether a transradial (TR) approach compared with a transfemoral (TF) approach was associated with improved clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) in a post hoc analysis of the HORIZONS-AMI trial. There is a paucity of data comparing the TR approach with the TF approach in patients with STEMI treated with primary PCI and contemporary anticoagulant regimens.In HORIZONS-AMI, primary PCI for STEMI was performed in 3,340 patients, either by the TR (n=200) or TF approach (n=3,134). Endpoints included the 30-day and one-year rates of major adverse cardiovascular events (MACE: death, reinfarction, stroke or target vessel revascularisation), non CABG-related major bleeding, and net adverse clinical events (NACE: MACE or major bleeding). TR compared to TF access was associated with significantly lower 30-day rates of composite death or reinfarction (1.0% vs. 4.3%, OR 0.23, 95% CI [0.06,0.94], p=0.02), non CABG-related major bleeding (3.5% vs. 7.6%, OR 0.45, 95% CI [0.21,0.95], p=0.03), MACE (2.0% vs. 5.6%, OR 0.35, 95% CI [0.13,0.95], p=0.02), and NACE (5.0% vs. 11.6%,OR 0.42, 95% CI [0.22,0.78], p0.01). At one year, the TR group still had significantly reduced rates of death or reinfarction (4.0% vs. 7.8%, OR 0.51, 95% CI [0.25,1.02], p=0.05), non CABG-related major bleeding (3.5% vs. 8.1%, OR 0.42, 95% CI [0.20,0.89], p=0.02), MACE (6.0% vs. 12.4%, OR 0.47, 95% CI [0.26,0.83], p0.01) and NACE (8.5% vs. 17.8%, OR 0.45, 95% CI [0.28,0.74], p0.001). By multivariable analysis, TR access was an independent predictor of freedom from MACE and NACE at 30 days and one year.In patients with STEMI undergoing primary PCI with contemporary anticoagulation regimens in the HORIZONS-AMI trial, a TR compared with a TF approach was associated with reduced major bleeding and improved event-free survival.

The study sought to determine whether rapid access to medical care and reperfusion results in a better prognosis in patients with in-hospital compared with out-of-hospital stent thrombosis (ST) in patients with ST-segment elevation myocardial infarction (STEMI) in the HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trial.Whether the prognosis of in-hospital and out-of-hospital ST are similar is uncertain, with conflicting data reported from prior studies.A total of 3,602 STEMI patients undergoing primary percutaneous coronary intervention (PCI) were randomized to bivalirudin (n = 1,800) versus unfractionated heparin (UFH) plus a glycoprotein IIb/IIIa inhibitor (GPI) (UFH+GPI; n = 1,802). Stents were implanted in 3,202 patients, 156 (4.9%) of whom developed Academic Research Consortium definite/probable ST during 3-year follow-up. We investigated the 1-year clinical outcomes after ST in 54 patients with in-hospital ST compared with 102 patients with out-of-hospital ST.One year after the ST event, patients with in-hospital compared with out-of-hospital ST had significantly greater mortality (27.8% vs. 10.8%, p0.01); most deaths in both groups occurred within 1 week of the ST event. Patients with in-hospital ST also had higher rates of major bleeding (21.2% vs. 6.0%, p0.01), but a lower rate of myocardial infarction (56.6% vs. 77.5%, p0.01). Subgroup analysis within both in-hospital and out-of-hospital ST groups indicated that subacute ST had the highest mortality. By multivariable analysis, 1-year mortality was significantly increased in patients with in-hospital compared with out-of-hospital ST (adjusted hazard ratio: 4.62, 95% confidence interval: 1.98 to 10.77, p0.01). Additional correlates of increased mortality after an ST event included diabetes and randomization to UFH+GPI (vs. bivalirudin).Following primary PCI for STEMI, more than one-third of all ST events during 3-year follow-up occurred during the index hospital phase. Mortality and major bleeding were significantly higher after in-hospital ST compared with out-of-hospital ST. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction; NCT00433966).

Primary results of the HORIZONS-AMI trial have been previously reported. In this final report, we aimed to assess 3-year outcomes.HORIZONS-AMI was a prospective, open-label, randomised trial undertaken at 123 institutions in 11 countries. Patients aged 18 years or older were eligible for enrolment if they had ST-segment elevation myocardial infarction (STEMI), presented within 12 h after onset of symptoms, and were undergoing primary percutaneous coronary intervention. By use of a computerised interactive voice response system, we randomly allocated patients 1:1 to receive bivalirudin or heparin plus a glycoprotein IIb/IIIa inhibitor (GPI; pharmacological randomisation; stratified by previous and expected drug use and study site) and, if eligible, randomly allocated 3:1 to receive a paclitaxel-eluting stent or a bare metal stent (stent randomisation; stratified by pharmacological group assignment, diabetes mellitus status, lesion length, and study site). We produced Kaplan-Meier estimates of major adverse cardiovascular events at 3 years by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00433966.Compared with 1802 patients allocated to receive heparin plus a GPI, 1800 patients allocated to bivalirudin monotherapy had lower rates of all-cause mortality (5·9%vs 7·7%, difference -1·9% [-3·5 to -0·2], HR 0·75 [0·58-0·97]; p=0·03), cardiac mortality (2·9%vs 5·1%, -2·2% [-3·5 to -0·9], 0·56 [0·40-0·80]; p=0·001), reinfarction (6·2%vs 8·2%, -1·9% [-3·7 to -0·2], 0·76 [0·59-0·99]; p=0·04), and major bleeding not related to bypass graft surgery (6·9%vs 10·5%, -3·6% [-5·5 to -1·7], 0·64 [0·51-0·80]; p=0·0001) at 3 years, with no significant differences in ischaemia-driven target vessel revascularisation, stent thrombosis, or composite adverse events. Compared with 749 patients who received a bare-metal stent, 2257 patients who received a paclitaxel-eluting stent had lower rates of ischaemia-driven target lesion revascularisation (9·4%vs 15·1%, -5·7% [-8·6 to -2·7], 0·60 [0·48-0·76]; p0·0001) after 3 years, with no significant differences in the rates of death, reinfarction, stroke or stent thrombosis. Stent thrombosis was high (≥4·5%) in both groups.The effectiveness and safety of bivalirudin monotherapy and paclitaxel-eluting stenting are sustained at 3 years for patients with STEMI undergoing primary percutaneous coronary intervention.Boston Scientific and The Medicines Company.

Background— Small stent area and residual inflow/outflow disease have been reported as the strongest intravascular ultrasound (IVUS) predictors of early stent thrombosis (ST) in patients with stable angina. IVUS predictors of early ST in patients with acute myocardial infarction have not been studied. Methods and Results— In the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) study, a formal substudy included poststent and 13-month follow-up IVUS at 36 centers. Twelve patients with baseline IVUS who had definite/probable early ST ≤30 days after enrollment were compared with 389 patients without early ST. Significant residual stenosis was a lumen area 2 with ≥70% plaque burden ≤10 mm from each stent edge. Significant edge dissection was more than medial dissection with lumen area 2 or dissection angle ≥60°. Randomization to bivalirudin ( P =0.29) or paclitaxel-eluting stent ( P =0.74) was not related to early ST. Minimum lumen area was smaller in patients with versus without early ST (4.4 mm 2 [3.6, 6.9] versus 6.7 mm 2 [5.3, 8.0], respectively, P =0.014). Minimum lumen area 2 , significant residual stenosis, significant stent edge dissection, and significant tissue (plaque/thrombus) protrusion (more than the median that narrowed the lumen to 2 ) were more prevalent in patients with early ST, but significant acute malapposition (more than the median) was not. Overall, 100% of patients with early ST had at least 1 of these significant features: minimum lumen area 2 , edge dissection, residual stenosis, or tissue protrusion versus 23% in patients without early ST ( P Conclusions— Smaller final lumen area and inflow/outflow disease (residual stenosis or dissection) but not acute malapposition were related to early ST after acute myocardial infarction intervention. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00433966.

Pre-percutaneous coronary intervention (PCI) Thrombolysis In Myocardial Infarction (TIMI) grade 3 flow has been identified as a predictor of final TIMI grade 3 flow and better survival. Yet pharmacologic strategies increasing the rates of pre-PCI TIMI grade 3 flow resulted in more bleeding, without a benefit in survival. The aim of this study was to identify the predictors and implications of spontaneous reperfusion before primary PCI in patients with ST-segment elevation myocardial infarction. The Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) and Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trials were combined, and the predictors of core laboratory-determined baseline TIMI grade 3 flow and 1-year outcomes were analyzed according to baseline TIMI flow. Baseline TIMI grade 3 flow was present in 932 of 5,332 patients (17.5%). The independent predictors of baseline TIMI grade 3 flow were diabetes, longer delay to PCI, smoking, and more extensive coronary disease. Patients with compared to those without baseline TIMI grade 3 flow had significantly higher rates of post-PCI TIMI grade 3 flow (99.1% vs 91.4%, p

Measurement of left ventricular end-diastolic pressure (LVEDP) is readily obtainable in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). However, the prognostic utility of LVEDP during primary PCI has never been studied. LVEDP was measured in 2,797 patients during primary PCI in the Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial. Outcomes were assessed at 30 days and 2 years stratified by medians of LVEDP. Multivariable analysis was performed to determine whether LVEDP was an independent determinate of adverse outcomes. The median (interquartile range) for LVEDP was 18 mm Hg (12 to 24). For patients with LVEDP >18 mm Hg versus those with ≤18 mm Hg, hazard ratios (95% confidence intervals) for death and death or reinfarction at 30 days were 2.00 (1.20 to 3.33, p = 0.007) and 1.84 (1.24 to 2.73, p = 0.002), respectively, and at 2 years were 1.57 (1.12 to 2.21, p = 0.009) and 1.45 (1.14 to 1.85, p = 0.002), respectively. Patients in the highest quartile of LVEDP (≥24 mm Hg) were at the greatest risk of mortality. Only a weak correlation was present between LVEDP and left ventricular ejection fraction (LVEF; R(2) = 0.03, p

Aims: Previous risk models predicting in-hospital major adverse cardiac or cerebrovascular events (MACCE) after percutaneous coronary interventions (PCI) may underestimate actual short-term post-procedure complications due to the trend toward early discharge of patients. Methods and results: Using a subset (N=10,679) from the STENT Group registry, a logistic regression model was developed to predict 30-day MACCE which includes death, myocardial infarction, target vessel revascularisation and stroke. An integer-based risk score was created from the model and validated in another subset (N=3,099). In the study subset, there was significant difference between in-hospital and 30-day MACCE N=443 (2.0%) vs. 131 (4.2), p

Background— In the prospective, randomized Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, implantation of paclitaxel-eluting stents (PES) safely reduced the rates of ischemic target lesion revascularization (TLR) compared with bare metal stents (BMS) in patients with ST-segment–elevation myocardial infarction (STEMI) undergoing primary percutaneous intervention. Diabetes mellitus is a known predictor of adverse outcomes after percutaneous intervention in STEMI. We therefore sought to assess the impact of PES in diabetic patients with STEMI from the HORIZONS-AMI trial. Methods and Results— A total of 478 patients with diabetes and 2527 without diabetes were randomly assigned to receive PES versus BMS. The 12-month rates of ischemic TLR were significantly reduced by PES compared with BMS in both diabetic (11.2% versus 5.2%; hazard ratio [95% confidence interval]=0.45 [0.21 to 0.93]; P =0.03) and nondiabetic (6.8% versus 4.3%, hazard ratio [95% confidence interval]=0.63 [0.44 to 0.92]; P =0.02) patients. In patients with insulin-treated diabetes, PES compared with BMS reduced the 12-month TLR rate from 21.4% to 7.3% (hazard ratio [95% confidence interval]=0.35 [0.12 to 1.03]; P =0.046). Angiographic late loss and binary restenosis at 13 months were also significantly reduced in PES-treated diabetic patients. There were no significant differences between the BMS and PES groups in the 12-month rates of death, reinfarction, stroke, or stent thrombosis in either diabetic or nondiabetic patients. Conclusions— In the large-scale, prospective, randomized HORIZONS-AMI trial, implantation of PES compared with BMS in patients with STEMI and diabetes mellitus resulted in significant reductions in ischemia-driven TLR and angiographic restenosis at 1 year, with comparable safety outcomes, including stent thrombosis. These results suggest that PES can safely be used to reduce restenosis in high-risk diabetic patients presenting with STEMI. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00433966.

Background— Concerns persist regarding the risk of stent thrombosis in the setting of primary percutaneous coronary intervention for ST-segment elevation myocardial infarction. Methods and Results— The Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial included 3602 patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention who were randomized to heparin plus a glycoprotein IIb/IIIa inhibitor (GPI) (n=1802) versus bivalirudin monotherapy (n=1800). Stents were implanted in 3202 patients, including 2261 who received drug-eluting stents and 861 who received only bare metal stents. Definite or probable stent thrombosis within 2 years occurred in 137 patients (4.4%), including 28 acute events (0.9%), 49 subacute events (1.6%), 32 late events (1.0%), and 33 very late events (1.1%). The 2-year cumulative rates of stent thrombosis were 4.4% with both drug-eluting stents and bare metal stents ( P =0.98) and 4.3% versus 4.6% in patients randomized to bivalirudin monotherapy versus heparin plus a GPI, respectively ( P =0.73). Acute stent thrombosis occurred more frequently in patients assigned to bivalirudin compared with heparin plus a GPI (1.4% versus 0.3%; P P =0.02). Prerandomization heparin and a 600-mg clopidogrel loading dose were independent predictors of reduced acute and subacute stent thrombosis, respectively. Conclusions— Stent thrombosis is not uncommon within the first 2 years after primary percutaneous coronary intervention in ST-segment elevation myocardial infarction, and occurs with similar frequency in patients receiving drug-eluting stents versus bare metal stents and bivalirudin alone versus heparin plus a GPI. Optimizing adjunct pharmacology including early antithrombin therapy preloading with a potent antiplatelet therapy may further reduce stent thrombosis in ST-segment elevation myocardial infarction. Clinical Trial Registration:— http://www.clinicaltrials.gov . Unique identifier: NCT00433966.

The presence of visible thrombus at the time of primary PCI for STEMI is associated with poor procedural and clinical outcomes. Aspiration thrombectomy has been used with primary PCI in an attempt to improve these outcomes. The TAPAS (Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction) Trial found that aspiration improved myocardial blush scores and ST-segment resolution (STR), and also was associated with lower mortality at 1 year. Four meta-analyses have shown improved measures of myocardial reperfusion (TIMI flow, myocardial blush, and STR) and improved procedural outcomes (reduced no-reflow and distal embolization), and three of four trials have shown reduced mortality. Aspiration thrombectomy has received a Class IIa indication with primary PCI in the recent ACC/AHA and ESC Guidelines. Unanswered questions include whether there is truly a mortality benefit with aspiration, which subgroups may and may not benefit from aspiration, and whether patients with large thrombus burden are better treated with mechanical thrombectomy.

We investigated the outcomes of switching to bivalirudin after initial administration of heparin in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.Unfractionated heparin (UFH) is frequently administered early in ST-segment elevation myocardial infarction. Whether the benefits of bivalirudin documented in the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial persist in patients previously administered UFH is unknown.We analyzed the outcomes of the 2,357 patients from HORIZONS-AMI treated with UFH before enrollment according to their subsequent randomization to bivalirudin (switch group, n = 1,178) or UFH plus a glycoprotein IIb/IIIa inhibitor (control group, n = 1,179).At 30 days, major bleeding occurred in 7.6% of the switch group versus 12.3% of the control group (p = 0.0001). Switch patients had lower 30-day rates of cardiac mortality (1.6% vs. 2.9%, p = 0.04). At 2-year follow-up, switch patients experienced lower rates of major bleeding (8.4% vs. 13.0%, p = 0.0003), cardiac mortality (2.3% vs. 3.8%, p = 0.04), and reinfarction (4.0% vs. 7.1%, p = 0.0002). Two-year rates of definite/probable stent thrombosis were similar in switch and control patients (3.1% vs. 4.3%, p = 0.17).In ST-segment elevation myocardial infarction patients who receive early treatment with UFH, switching to bivalirudin before primary percutaneous coronary intervention results in reduced rates of major bleeding and improved early and late cardiac survival.

We sought to identify patients with ST-segment elevation myocardial infarction most likely to benefit from drug-eluting stents (DES), and to evaluate the impact of routine angiographic follow-up on the apparent differences between stent types.DES might have greatest utility in patients who would benefit most from their antirestenotic properties.We randomly assigned 3,006 patients with ST-segment elevation myocardial infarction to paclitaxel-eluting stents (PES) or to bare-metal stents (BMS). Events were assessed at 12 months and 24 months, with a subset undergoing routine angiographic follow-up at 13 months. Using well-known risk factors for restenosis and target lesion revascularization (TLR), risk groups were formed to examine the absolute differences between PES and BMS.Compared with BMS, PES reduced TLR at 12 months from 7.4% to 4.5% (p = 0.003). Insulin-treated diabetes mellitus (hazard ratio: 3.12), reference vessel diameter ≤3.0 mm (hazard ratio: 2.89), and lesion length ≥30 mm (hazard ratio: 2.49) were independent predictors of 12-month TLR after BMS. In patients with 2 or 3 of these baseline risk factors, PES compared with BMS markedly reduced 12-month TLR (19.8% vs. 8.1%, p = 0.003). In patients with 1 of these risk factors, the 12-month rates of TLR were modestly reduced by PES (7.3% vs. 4.3%, p = 0.02). The 12-month TLR rates were low and similar for both stents in patients with 0 risk factors (3.3% vs. 3.2%, p = 0.93). Routine 13-month angiographic follow-up resulted in a marked increase in TLR procedures (more so with BMS) so that the absolute incremental benefit of PES compared with BMS doubled from 2.9% at 12 months to 6.0% at 24 months, a difference evident in all risk strata.Patients at high risk for TLR after BMS in ST-segment elevation myocardial infarction for whom DES are of greatest benefit may be identified. Conversely, DES may be of less clinical benefit for patients at lower risk for TLR after BMS. Routine angiographic follow-up increases the perceived clinical benefits of DES, and must be avoided to accurately estimate absolute treatment effects. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI]; NCT00433966).

Primary percutaneous coronary intervention (PCI) is the optimal method of reperfusion when performed expeditiously. Factors contributing to delays in PCI for ST-segment elevation myocardial infarction (STEMI) have not been thoroughly characterized or quantified. We sought to identify the factors associated with the delays to reperfusion in patients with STEMI undergoing primary PCI. Primary PCI was performed in 3,340 patients with STEMI in the international, multicenter Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trial. Multivariate analysis was used to identify independent predictors of delay in achieving reperfusion from 38 baseline and procedural variables. A total of 905 patients (27.1%) presented to non-PCI hospitals and were subsequently transferred; the remainder presented to PCI hospitals. The most powerful independent predictor of the interval from symptom onset to arrival at the PCI hospital and the first door-to-balloon time was an initial presentation at a non-PCI hospital (median incremental 58- and 54-minute delay, respectively, both p0.001). Other independent predictors of prolonged door-to-balloon times included presentation with respiratory failure (42-minute incremental delay, p = 0.003), presentation during off-work hours (11-minute incremental delay, p0.001), and co-morbid conditions such as diabetes and heart failure. In conclusion, among patients undergoing primary PCI, presentation to a non-PCI hospital was the variable associated with the greatest delay to reperfusion. Systems of care that encourage ambulance diagnosis and direct delivery of patients with STEMI to a PCI hospital might shorten the overall door-to-balloon times and improve the clinical outcomes.

We compared intravascular ultrasound (IVUS) findings of fractures of sirolimus-eluting stents (SESs) versus paclitaxel-eluting stents (PESs). IVUS findings in 6 PES fractures (all in the right coronary artery) in 6 patients from a clinical trial cohort were compared to 14 SES fractures (8 in the right coronary artery, 2 in the left anterior descending coronary artery, and 4 in the left circumflex coronary artery) in 13 patients from our institutional cohort. Comparing PES fractures to SES fractures, IVUS analysis showed (1) similar frequency of complete stent fracture (1 of 6, 17%, vs 3 of 14, 21%, p >0.99), (2) similar frequency of fracture adjacent to calcified plaque or stent metal overlap (5 of 6, 86%, vs 14 of 14, 100%, p = 0.99), (3) more frequent complete malalignment of proximal and distal fragments in PES strut fractures compared to SES fractures (5 of 6, 83%, vs 1 of 14, 7%, p = 0.002), (4) similar stent lengths (45.2 mm, 23.8 to 50.7, vs 39.3 mm, 22.6 to 73.4, p >0.99), (5) similar fracture lengths (0.5 mm, 0.4 to 0.7, vs 0.7 mm, 0.6 to 1.0, p = 0.14), and (6) larger reference external elastic membrane area (15.0 mm 2 , 13.5 to 18.0, vs 10.4 mm 2 , 6.8 to 13.6, p = 0.01). In conclusion, malalignment of proximal and distal stent fragments more often occurred in PES fractures compared to SES fractures; otherwise the IVUS features of PES and SES fractures were similar.

Methods: We assessed outcomes of pts who underwent PCI for STEMI using RA vs. FA in the HORIZONS-AMI trial. Of 3,334 pts randomized to bivalirudin vs. to UFH + a GPIIb/IIIa inhibitor (GPI), PCI by operator choice was performed by the FA and RA in 3134 (94.0%) and 200 (6.0%) pts, respectively. Results: Pts treated by FA vs. RA tended to be older, with higher rates of smoking, hyperlipidemia, prior CABG, and lower baseline creatinine clearance and platelet count. RA was associated with signiicant reduction in 30-day major and minor bleeding due to reductions in both major hemorrhagic events and large hematomas. By multivariable analysis, RA (vs. FA) was an independent predictor of freedom from non-CABG major bleeding at 30 days (HR 0.40; 95% CI [0.18, 0.90]; p=0.03). Conclusions: In the large-scale, international HORIZONS-AMI trial, performance of primary PCI by the RA rather than the FA was infrequent, and was selected in younger STEMI pts with fewer comorbidities. Primary PCI using the RA was associated with reduced hemorrhagic complications compared to the FA. A randomized trial is required to determine the generalizability and advantages of this approach. 30 day events, % Radial (N=200)

The importance of a patent infarct-related artery (IRA) for hospital and late survival was examined in 383 patients with acute myocardial infarction treated with direct coronary angioplasty. At hospital discharge, 317 of 348 patients (91%) had a patent IRA and mean follow-up left ventricular (LV) ejection fraction (EF) was 58%. Cardiac survival after hospital discharge at 1, 3 and 6 years was 99, 95 and 90%. Patency of the IRA was the most important determinant of hospital mortality: patent versus occluded IRA, 5 vs 39% mortality, p less than 0.001. Follow-up LVEF was the most important determinant of late cardiac mortality: follow-up LVEF greater than or equal to 45 versus less than 45%, 2 versus 24% mortality, p less than 0.001. Patency of the IRA was not a significant predictor of late cardiac mortality in the group as a whole: patent versus occluded IRA, 4.7 versus 6.5% mortality, p = 0.67. In the subgroup of patients with depressed initial LVEF less than 45%, patency was a significant predictor of late cardiac mortality: patent versus occluded IRA, 9.2 versus 40% mortality, p = 0.03. Patients with a patent IRA had better recovery of LV function than patients with an occluded IRA (follow-up LVEF 58.5 versus 47.6%, p less than 0.001). When late cardiac mortality was adjusted for differences in follow-up LVEF, patency was no longer a significant predictor of late mortality. Our results indicate patency of the IRA is the most important determinant of hospital survival, and LV function (measured after recovery) is the most important determinant of late cardiac survival.(ABSTRACT TRUNCATED AT 250 WORDS)

Our objective was to evaluate the impact of door-to-balloon time (DBT) on mortality depending on clinical risk and time to presentation.DBT affects the mortality rate in ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention, but the impact may vary across subgroups.The CADILLAC (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications) and HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trials evaluated stent and antithrombotic therapy in patients undergoing primary percutaneous coronary intervention. We studied the impact of DBT on mortality in 4,548 patients based on time to presentation and clinical risk.The 1-year mortality rate was lower in patients with short versus long DBT (or = 90 min vs.90 min, 3.1% vs. 4.3%, p = 0.045). Short DBTs were associated with a lower mortality rate in patients with early presentation (or = 90 min: 1.9% vs. 3.8%, p = 0.029) but not those with later presentation (90 min: 4.0% vs. 4.6%, p = 0.47). Short DBTs showed similar trends for a lower mortality rate in high-risk (5.7% vs. 7.4%, p = 0.12) and low-risk (1.1% vs. 1.6%, p = 0.25) patients. Short DBTs had similar relative risk reductions in patients with early presentation in high-risk (3.7% vs. 7.0%, p = 0.08) and low-risk (0.8% vs. 1.5%, p = 0.32) patients, although the absolute benefit was greatest in high-risk patients.Short DBTs (or = 90 min) are associated with a lower mortality rate in patients with early presentation but have less impact on the mortality rate in patients presenting later. The absolute mortality rate reduction with short DBT is greatest in high-risk patients presenting early. These data may be helpful in designing triage strategies for reperfusion therapy in patients presenting to non-percutaneous coronary intervention hospitals.

Background— Vascular responses to drug-eluting stents in ST-segment elevation myocardial infarction are unknown. In the prospective, multicenter Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, patients with ST-segment elevation myocardial infarction within 12 hours of symptom onset were randomized 3:1 to TAXUS EXPRESS paclitaxel-eluting stents (PES) or EXPRESS bare metal stents (BMS). Methods and Results— A formal intravascular ultrasound substudy enrolled 464 patients with baseline and 13-month follow-up imaging at 36 centers. Overall, 446 lesions in 402 patients were suitable for standard qualitative and quantitative analyses, which were performed at an independent blinded core laboratory. The primary prespecified end point was the in-stent percent net volume obstruction at follow-up. Median stent length measured 23.4 mm (first and third quartiles, 18.5 and 31.9 mm). PES compared with BMS significantly reduced 13-month percent net volume obstruction (6.5% [first and third quartiles, 2.2% and 10.8%] versus 15.6% [first and third quartiles, 7.2% and 28.8%]; P P =0.0005) resulting from positive vessel remodeling. Plaque and/or thrombus protrusion through stent struts was initially present in 70.4% of PES and 64.8% of BMS; all resolved during follow-up. New aneurysm formation, stent fracture, and subclinical thrombus were uncommon, although seen only in PES. Conclusions— PES compared with BMS significantly reduce neointimal hyperplasia in patients with ST-segment elevation myocardial infarction but also result in a high frequency of late-acquired stent malapposition as a result of positive vessel remodeling. Ongoing long-term follow-up is required to establish the clinical significance of these findings. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00433966.

AIMS We compared epicardial and microvascular reperfusion, infarct size, and clinical outcomes after primary and rescue PCI with and without GuardWire distal protection in patients with LAD vs. non-LAD acute myocardial infarction (AMI). In the general AMI population undergoing primary PCI, the use of GuardWire did not yield higher reperfusion success, reduced infarct size, or enhanced event-free survival. Whether GuardWire is beneficial in patients with AMI in certain territories of the coronary circulation is unknown. METHODS AND RESULTS In the EMERALD trial, 501 patients with AMI were randomised to PCI with vs. without distal protection. The outcomes were analysed as a function of culprit vessel (LAD vs. non-LAD) and the use of GuardWire. Patients with LAD vs. non-LAD infarcts had significantly (P< or =0.0001) lower rates of final TIMI flow grade 3 (85.2% vs. 94.4%), myocardial blush grade 3 (40.1% vs. 67.6%), and complete ST-segment resolution (35.1% vs. 79.6%). Patients with LAD infarcts also had larger infarct size (25.8+/-21.8% vs. 11.3_13.7%, p