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Background: Prompt reperfusion in patients with ST-segment elevation myocardial infarction (STEMI) reduces infarct size and improves survival. However, the intuitive link between infarct size and prognosis has not been convincingly demonstrated in the contemporary era.Objectives: This study sought to determine the strength of the relationship between infarct size assessed early after primary percutaneous coronary intervention (PCI) in STEMI and subsequent all-cause mortality, reinfarction, and hospitalization for heart failure.Methods: We performed a pooled patient-level analysis from 10 randomized primary PCI trials (total 2,632 patients) in which infarct size was assessed within 1 month after randomization by either cardiac magnetic resonance (CMR) imaging or technetium-99m sestamibi single-photon emission computed tomography (SPECT), with clinical follow-up for ≥ 6 months.Results: Infarct size was assessed by CMR in 1,889 patients (71.8%) and by SPECT in 743 patients (28.2%). Median (25th, 75th percentile) time to infarct size measurement was 4 days (3, 10 days) after STEMI. Median infarct size (% left ventricular myocardial mass) was 17.9% (8.0%, 29.8%), and median duration of clinical follow-up was 352 days (185, 371 days). The Kaplan-Meier estimated 1-year rates of all-cause mortality, reinfarction, and HF hospitalization were 2.2%, 2.5%, and 2.6%, respectively. A strong graded response was present between infarct size (per 5% increase) and subsequent mortality (Cox-adjusted hazard ratio: 1.19 [95% confidence interval: 1.18 to 1.20]; p < 0.0001) and hospitalization for heart failure (adjusted hazard ratio: 1.20 [95% confidence interval: 1.19 to 1.21]; p < 0.0001), independent of age, sex, diabetes, hypertension, hyperlipidemia, current smoking, left anterior descending versus non-left anterior descending infarct vessel, symptom-to-first device time, and baseline TIMI (Thrombolysis In Myocardial Infarction) flow 0/1 versus 2/3. Infarct size was not significantly related to subsequent reinfarction.Conclusions: Infarct size, measured by CMR or technetium-99m sestamibi SPECT within 1 month after primary PCI, is strongly associated with all-cause mortality and hospitalization for HF within 1 year. Infarct size may, therefore, be useful as an endpoint in clinical trials and as an important prognostic measure when caring for patients with STEMI. [ABSTRACT FROM AUTHOR]

The article focuses on study related to analysis of bypass angioplasty revascularization investigation trials outcomes using multistate model of clinical outcomes. Topics discussed include use of cardiovascular clinical trials in detection of treatment effect and composite outcomes, diagnosis of nonfatal Q-wave myocardial infarction in patients and use of regression analysis during the study.

Background In the HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction) trial, 3,602 patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) treated with bivalirudin had lower bleeding and mortality rates, but higher acute stent thrombosis rates compared with heparin + a glycoprotein IIb/IIIa inhibitor (GPI). Subsequent changes in primary PCI, including the use of potent P2Y 12 inhibitors, frequent radial intervention, and pre-hospital medication administration, were incorporated into the EUROMAX (European Ambulance Acute Coronary Syndrome Angiography) trial, which assigned 2,218 patients to bivalirudin versus heparin ± GPI before primary PCI. Objectives The goal of this study was to examine the outcomes of procedural anticoagulation with bivalirudin versus heparin ± GPI for primary PCI, given the evolution in primary PCI. Methods Databases from HORIZONS-AMI and EUROMAX were pooled for patient-level analysis. The Breslow-Day test evaluated heterogeneity between trials. Results A total of 5,800 patients were randomized to bivalirudin (n = 2,889) or heparin ± GPI (n = 2,911). The radial approach was used in 21.3% of patients, prasugrel/ticagrelor was used in 18.1% of patients, and GPI was used in 84.8% of the control group. Bivalirudin compared with heparin ± GPI resulted in reduced 30-day rates of major bleeding (4.2% vs. 7.8%; relative risk [RR]: 0.53; 95% confidence interval [CI]: 0.43 to 0.66; p < 0.0001), thrombocytopenia (1.4% vs. 2.9%, RR: 0.48; 95% CI: 0.33 to 0.71; p = 0.0002), and cardiac mortality (2.0% vs. 2.9%; RR: 0.70; 95% CI: 0.50 to 0.97; p = 0.03), with nonsignificantly different rates of reinfarction, ischemia-driven revascularization, stroke, and all-cause mortality. Bivalirudin resulted in increased acute (<24 h) stent thrombosis rates (1.2% vs. 0.2%; RR: 6.04; 95% CI: 2.55 to 14.31; p < 0.0001), with nonsignificantly different rates of subacute stent thrombosis. Composite net adverse clinical events were lower with bivalirudin (8.8% vs. 11.9%; RR: 0.74; 95% CI: 0.63 to 0.86; p < 0.0001). There was no significant heterogeneity between the 2 trials for these outcomes, and results were consistent across major subgroups. Conclusions Despite increased acute stent thrombosis, primary PCI with bivalirudin improved 30-day net clinical outcomes, with significant reductions in major bleeding, thrombocytopenia, and transfusions compared with heparin ± GPI, results that were consistent with evolution in PCI technique and pharmacotherapy. (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction [HORIZONS-AMI]; NCT00433966 ) (European Ambulance Acute Coronary Syndrome Angiography [EUROMAX]; NCT01087723 ) [ABSTRACT FROM AUTHOR]

Ischaemia−reperfusion (IR) injury is an important cause of myocardial damage during percutaneous coronary intervention (PCI). There are few therapies in widespread clinical use which impact on IR injury and it remains an important and underutilized target for treatment in acute myocardial infarction. This review will examine the translational scientific evidence for ischaemic conditioning and pharmacological agents including conditioning mimetics such as cyclosporine, anti-inflammatory agents, and those which modify myocardial glucose metabolism. We will address the reasons why many trials have failed to demonstrate clinical benefit and emphasize the need to deliver the right therapy to the right patient, at the right time to achieve successful translation of cardioprotection from bench-to-bedside. We critique trial design and offer advice for future translational trials in the field to ensure that effective treatments can be demonstrated clinically to improve patient outcomes during PCI. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of this study was to determine whether, in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), the reduction in cardiac mortality in those taking bivalirudin compared with unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (UFH+GPI) can be fully attributed to reduced bleeding. Background: The association between hemorrhagic complications and mortality may explain the survival benefit with bivalirudin. Methods: A total of 3,602 STEMI patients undergoing primary PCI were randomized to bivalirudin versus UFH+GPI. Three-year cardiac mortality was analyzed in patients with and without major bleeding. Results: When compared with UFH+GPI, bivalirudin resulted in lower 3-year rates of major bleeding (6.9% vs. 10.5%, hazard ratio [HR]: 0.64 [95% confidence interval (CI): 0.51 to 0.80], p < 0.0001) and cardiac mortality (2.9% vs. 5.1%, HR: 0.56 [95% CI: 0.40 to 0.80], p = 0.001). Three-year cardiac mortality was reduced in bivalirudin-treated patients with major bleeding (20 fewer deaths with bivalirudin; 5.8% vs. 14.6%, p = 0.025) and without major bleeding (18 fewer deaths with bivalirudin; 2.6% vs. 3.8%, p = 0.048). In a fully-adjusted multivariable model accounting for major bleeding and other adverse events, bivalirudin was still associated with a 43% reduction in 3-year cardiac mortality (adjusted HR: 0.57 [95% CI: 0.39 to 0.83], p = 0.003). Conclusions: Bivalirudin reduces cardiac mortality in patients with STEMI undergoing primary PCI, an effect that can only partly be attributed to prevention of bleeding. Further studies are required to identify the nonhematologic benefits of bivalirudin. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction; NCT00433966) [Copyright &y& Elsevier]

Registry Experience at the Washington Hospital Center, DES - Taxus Liberte Versus Xience V (REWARDS TLX) is a physician-initiated, retrospective, real-world, multicenter, observational study for all patients >18 years of age subjected to percutaneous coronary intervention with everolimus-eluting stents (EESs) or paclitaxel-eluting stents (PESs). Outcomes of patients receiving a TAXUS Liberté or XIENCE V drug-eluting stent were compared. Baseline clinical, procedural, and follow-up data at 12 months were collected from 10 clinical centers by an electronic data capture system. The study''s primary end point was major adverse cardiac events: a composite of all-cause death, Q-wave myocardial infarction, target vessel revascularization, and stent thrombosis. The trial is registered with http://www.clinicaltrials.gov (NCT01134159). Data were entered for 1,195 patients (PES, n = 595; EES, n = 600). Baseline clinical characteristics were similar except for higher dyslipidemia, systemic hypertension, and family history of coronary artery disease in the EES group. In-hospital outcome was similar between groups, with an overall in-hospital stent thrombosis rate of 0.2%. The primary end point at 12 months was similar (EES 7.8% vs 10.8%, p = 0.082). Overall stent thrombosis rate was lower in the EES group (0.3% vs 1.2%, respectively, p = 0.107); however, target lesion revascularization was similar (PES, hazard ratio 1.46, 95% confidence interval 0.98 to 2.19, p = 0.064). There was no difference in overall mortality between groups. In conclusion, second-generation EESs and PESs demonstrated similar efficacy and safety profiles for broadened patient and lesion subsets compared to a selected population from the pivotal trials. However, for composite efficacy and safety end points, EESs outperformed second-generation PESs. [Copyright &y& Elsevier]

Abstract: Background: Early abciximab administration in patients requiring transportation to undergo primary percutaneous coronary intervention (PPCI) has been reported to improve clinical outcome. We aimed to verify whether early administration leads to reduced infarct size (IS), assessed by delayed-enhancement magnetic resonance imaging (DE-MRI). Methods: We randomized 110 patients with acute myocardial infarction with symptom-to-diagnosis time <6h to either early (55 patients) or late (55 patients) abciximab administration. DE-MRI was performed at 4days and 6months. The primary end point was IS at 6months. Secondary end points were the rate of ST-segment elevation resolution ≥50% (STR) at 60min after PPCI, the extent of microvascular obstruction at 4days, and the change in IS and transmurality at 6months vs. 4days. Results: DE-MRI was performed in 103 patients after 4days, and in 87 at 6months. The mean IS at 6months was 13.8±9.0% in the early vs. 13.0±9.9% in the Late group (P >0.2). Similarly, microvascular obstruction and the change in IS were not significantly different. The Early group showed a significantly higher STR (94.5% vs. 80.0%, P =0.04) and a larger reduction in infarct transmurality (−9.2±7.0% vs. −5.9±6.4%; P =0.03), while a larger reduction in IS was observed only in patients with ECG-to-Cath Lab time >60min. Conclusions: Early abciximab administration did not lead to a smaller IS at 6-month DE-MRI, and was associated with a significant reduction in IS and transmurality only in patients with longer transportation time, warranting further investigation in this patient subset. [Copyright &y& Elsevier]

Objectives: We sought to compare long-term outcomes after coronary bypass surgery with and without an internal thoracic artery graft. Methods: We analyzed clinical outcomes over a median follow-up of 6.7 years among 3,087 patients who received coronary bypass surgery as participants in one of 8 clinical trials comparing surgical intervention with angioplasty. We used 2 statistical methods (covariate adjustment and propensity score matching) to adjust for the nonrandomized selection of internal thoracic artery grafts. Results: Internal thoracic artery grafting was associated with lower mortality, with hazard ratios of 0.77 (confidence interval, 0.62–0.97; P = .02) for covariate adjustment and 0.77 (confidence interval, 0.57–1.05; P = .10) for propensity score matching. The composite end point of death or myocardial infarction was reduced to a similar extent, with hazard ratios of 0.83 (confidence interval, 0.69–1.00; P = .05) for covariate adjustment to 0.78 (confidence interval, 0.61–1.00; P = .05) for propensity score matching. There was a trend toward less angina at 1 year, with odds ratios of 0.81 (confidence interval, 0.61–1.09; P = .16) in the covariate-adjusted model and 0.81 (confidence interval, 0.55–1.19; P = .28) in the propensity score–adjusted model. Conclusions: Use of an internal thoracic artery graft during coronary bypass surgery seems to improve long-term clinical outcomes. [Copyright &y& Elsevier]

Objectives: This study sought to evaluate the impact of SYNTAX score (SXscore), and compare its performance in isolation and combination with the PAMI (The Primary Angioplasty in Myocardial Infarction Study) score, for the prediction of 1-year clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. Background: Patients with STEMI were excluded from the original SYNTAX score (SXscore) algorithm. Therefore, the utility of using the SXscore in this patient group remains undefined. Methods: SXscore was calculated retrospectively in 807 patients with STEMI enrolled in the randomized STRATEGY (Single High-Dose Bolus Tirofiban and Sirolimus-Eluting Stent Versus Abciximab and Bare-Metal Stent in Acute Myocardial Infarction) and MULTISTRATEGY (Multicenter Evaluation of Single High-Dose Bolus Tirofiban Versus Abciximab With Sirolimus-Eluting Stent or Bare-Metal Stent in Acute Myocardial Infarction Study) clinical trials. Clinical outcomes of all-cause death, reinfarction, and clinically driven target vessel revascularization were subsequently stratified according to SXscore tertiles: SXLOW ≤9 (n = 311), 9 < SXMID ≤16 (n = 234), SXHIGH >16 (n = 262). Results: At 1-year follow-up, all clinical outcomes including mortality, mortality/reinfarction, major adverse cardiac events (MACE) (a composite of all-cause death, reinfarction and target vessel revascularization), and definite, definite/probable, and any stent thrombosis were all significantly higher in patients in the highest SXscore tertile. SXscore was identified as an independent predictor of mortality, MACE, and stent thrombosis out to 1-year follow-up. The combination SYNTAX-PAMI score led to a net reclassification improvement of 15.7% and 4.6% for mortality and MACE, respectively. The C-statistics for the SXscore, PAMI score, and the combined SYNTAX-PAMI score were 0.65, 0.81, and 0.73 for 1-year mortality, and 0.68, 0.64, and 0.69 for 1-year MACE, respectively. Conclusions: SXscore does have a role in the risk stratification of patients with STEMI having primary percutaneous coronary intervention; however, this ability can be improved through a combination with clinical variables. (Multicentre 2×2 Factorial Randomised Study Comparing Tirofiban Versus Abciximab and SES Versus BMS in AMI; NCT00229515) [Copyright &y& Elsevier]

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 p <0.001). 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, p <0.001), 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. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of this study was to investigate long-term 3-year clinical outcomes of an everolimus-eluting stent (EES) versus a paclitaxel-eluting stent (PES). Background: Compared with PES, EES reduced target vessel failure and major adverse cardiac events at 2 years. Whether the benefits of EES are sustained at 3 years has not been reported. Methods: In the SPIRIT II (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) and SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) trials, 1,302 patients were randomly assigned to EES (n = 892) or PES (n = 410). We report the 3-year clinical follow-up of this patient-level pooled analysis. Results: At 3 years, EES compared with PES resulted in a significant reduction in myocardial infarction (3.8% vs. 6.7%; relative risk [RR]: 0.56; 95% confidence interval [CI]: 0.34 to 0.94; p = 0.04), and target lesion revascularization (6.8% vs. 12.7%; RR: 0.53; 95% CI: 0.37 to 0.77; p = 0.001). Everolimus-eluting stents resulted in a significant reduction in target vessel failure (13.7% vs. 19.5%; RR: 0.70; 95% CI: 0.54 to 0.92; p = 0.01), and major adverse cardiac events (9.1% vs. 16.3%; RR: 0.56; 95% CI: 0.41 to 0.76; p = 0.0004). The cumulative rates of Academic Research Consortium–defined definite or probable stent thrombosis were 1.2% in EES patients and 1.9% in PES patients (RR: 0.64; 95% CI: 0.25 to 1.68; p = 0.43). Conclusions: In this patient-level pooled analysis, EES compared with PES resulted in a significant and persistent reduction in target vessel failure and major adverse cardiac events at 3 years due to fewer myocardial infarction and ischemic target lesion revascularization events, which is consistent with superior safety and efficacy of the EES platform. (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions [SPIRIT II]; NCT00180310) (SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions [SPIRIT III]; NCT00180479) [Copyright &y& Elsevier]

Objectives: The aim of this study was to evaluate outcomes of patients with moderate- and high-risk acute coronary syndromes (ACS) and multivessel coronary artery disease managed with percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). Background: There is uncertainty about the preferred revascularization strategy for high-risk patients with multivessel disease. Methods: Among 13,819 moderate- and high-risk ACS patients enrolled in the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial, 5,627 had multivessel disease (including left anterior descending artery involvement) and were managed by PCI (n = 4,412) or CABG (n = 1,215). Propensity score matching was applied to adjust for differences in baseline clinical and angiographic characteristics, yielding a total of 1,056 patients (528 managed by PCI, and 528 managed by CABG). Results: Propensity-matched patients undergoing CABG had higher 1-month rates of stroke (1.1% vs. 0.0%, p = 0.03) and myocardial infarction (13.3% vs. 8.8%, p = 0.03), received more blood transfusions (40.3% vs. 6.3%, p < 0.0001) and more frequently developed acute renal injury (31.7% vs. 14.2%, p < 0.0001), whereas PCI was associated with higher rates of unplanned revascularization at both 1 month and at 1 year (0.8% vs. 5.2%, p < 0.0001; and 3.8% vs. 16.5%, p < 0.0001, respectively). There were no significant differences between the CABG and PCI groups in 1-month or 1-year mortality (2.5% vs. 2.1%, p = 0.69; and 4.4% vs. 5.7%, p = 0.58, respectively). Conclusions: In this propensity-matched comparison from the ACUITY trial, moderate- and high-risk patients with ACS and multivessel disease treated with PCI rather than CABG had lower rates of peri-procedural stroke, myocardial infarction, major bleeding, and renal injury, with comparable 1-month and 1-year rates of mortality, but more frequently developed recurrent ischemia requiring repeat revascularization procedures during follow-up. (Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes [ACS]; NCT00093158) [Copyright &y& Elsevier]

Objectives: The purpose of this study was to summarize the evidence of pre-procedural statin therapy to reduce periprocedure cardiovascular events. Background: Invasive procedures can result in adverse cardiovascular events, such as myocardial infarction (MI) and death. We hypothesized that statins might improve clinical outcomes when used before invasive procedures. Methods: We searched the MEDLINE, Cochrane, and clinicaltrials.gov databases from inception to February 2010 for randomized, controlled trials that examined statin therapy before invasive procedures. Invasive procedures were defined as percutaneous coronary intervention, coronary artery bypass grafting (CABG), and noncardiac surgery. We required that studies initiated statins before the procedure and reported clinical outcomes. A DerSimonian-Laird model was used to construct random-effects summary risk ratios. Results: Eight percent of the screened trials (21 of 270) met our selection criteria, which included 4,805 patients. The use of pre-procedural statins significantly reduced post-procedural MI (risk ratio [RR]: 0.57, 95% confidence interval [CI]: 0.46 to 0.70, p < 0.0001). This benefit was seen after both percutaneous coronary intervention (p < 0.0001) and noncardiac surgical procedures (p = 0.004), but not CABG (p = 0.40). All-cause mortality was nonsignificantly reduced by statin therapy (RR: 0.66, 95% CI: 0.37 to 1.17, p = 0.15). Pre-procedural statins also reduced post-CABG atrial fibrillation (RR: 0.54, 95% CI: 0.43 to 0.68, p < 0.0001). Conclusions: Statins administered before invasive procedures significantly reduce the hazard of post-procedural MI. Additionally, statins reduce the risk of atrial fibrillation after CABG. The routine use of statins before invasive procedures should be considered. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to examine the use of and outcomes associated with antithrombotic strategies in patients with non–ST-segment elevation myocardial infarction (NSTEMI) who undergo percutaneous coronary intervention (PCI). Background: A variety of antithrombotic strategies have been tested in clinical trials for NSTEMI patients treated with PCI. Methods: Antithrombotic strategies for NSTEMI patients undergoing PCI at 217 ACTION (Acute Coronary Treatment and Intervention Outcomes Network) hospitals from January 1, 2007, to December 31, 2007, (n = 11,085) were classified into commonly observed antithrombotic groups: heparin alone (Hep alone; low-molecular-weight heparin or unfractionated heparin), bivalirudin alone (Bival alone), heparin with glycoprotein IIb/IIIa inhibitors (Hep/GPI), and bivalirudin with GPI (Bival/GPI). Baseline characteristics are shown across treatment groups. In addition, unadjusted and adjusted rates of in-hospital major bleeding and death are shown. Results: The standard strategy used was Hep/GPI (64%), followed by Hep or Bival alone (28%), and Bival/GPI (8%). Patients who received Hep or Bival alone were older with more comorbidities, higher baseline bleeding and mortality risk, and lower peak troponin. Compared with patients who received Hep/GPI , those who received Hep alone and Bival alone had lower rates of major bleeding (adjusted odds ratio [OR]: 0.52; 95% confidence interval [CI]: 0.42 to 0.65; adjusted OR: 0.48; 95% CI: 0.39 to 0.60; respectively), yet only patients who received Bival alone had lower mortality (adjusted OR: 0.39; 95% CI: 0.21 to 0.71). Conclusions: NSTEMI patients undergoing PCI are more likely to receive Bival or Hep alone when at higher baseline bleeding risk than when at lower baseline bleeding risk. Despite higher baseline risk, those receiving Bival or Hep alone had less bleeding. [Copyright &y& Elsevier]

Objectives: The goal of this analysis was to determine whether intensive statin therapy, compared with moderate-dose statin therapy, leads to a reduction in major adverse cardiovascular events (MACE) among patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS). Background: When compared with moderate-dose statins, intensive statin therapy reduces MACE among patients with ACS. The role of intensive statin therapy specifically among patients who undergo PCI for ACS is unknown. Methods: Outcomes were compared in 2,868 patients who underwent PCI for ACS just prior to enrollment in the PROVE IT–TIMI 22 (Pravastatin or Atorvastatin Evaluation and Infection Therapy–Thrombolysis In Myocardial Infarction 22) trial, which randomized patients to either atorvastatin 80 mg or pravastatin 40 mg daily. The incidence of the primary composite end point of all-cause mortality, myocardial infarction, unstable angina leading to hospitalization, and revascularization after 30 days and stroke was evaluated, as was the incidence of target vessel revascularization (TVR) and non-TVR during follow-up. Results: Treatment with 80 mg atorvastatin reduced the incidence of the composite end point (21.5% vs. 26.5%, hazard ratio: 0.78, 95% confidence interval: 0.67 to 0.91, p = 0.002) and lowered the incidence of both TVR (11.4% vs. 15.4%, p = 0.001) and non-TVR (8.0% vs. 10.5%, p = 0.017) compared with 40 mg pravastatin. After adjusting for on-treatment serum low-density lipoprotein cholesterol and C-reactive protein concentrations, the odds of TVR with high-dose statin therapy remained significant (odds ratio: 0.74, p = 0.015) while the odds of non-TVR did not (odds ratio: 0.92, p = 0.55). Conclusions: Among patients with ACS who undergo PCI, intensive statin therapy reduces MACE compared with moderate-dose statin therapy. The reduction in the incidence of TVR was independent of low-density lipoprotein cholesterol and C-reactive protein lowering and may therefore be due, at least in part, to a pleiotropic effect of high-dose statin therapy. (PROVE IT–TIMI 22; NCT00382460) [Copyright &y& Elsevier]

We explored the safety and quality-of-life consequences of treating patients with stable coronary disease and high-risk features initially with optimal medical therapy (OMT) alone compared to OMT plus percutaneous coronary intervention. This was a post hoc analysis of Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial patients. We defined high risk as the onset of Canadian Cardiovascular Society class III angina within 2 months or stabilized acute coronary syndrome within 2 weeks of enrollment. The primary end point was death or myocardial infarction after 4.6 years. Of the 2,287 patients enrolled in the COURAGE trial, 264 (12%) were high risk and had a relative risk of 1.56 for death or myocardial infarction (p = 0.0008) compared to those with non–high-risk features. A total of 35 primary events occurred in the OMT group and 32 in the percutaneous coronary intervention plus OMT group (hazard ratio 1.11, 95% confidence interval 0.69 to 1.79; p = 0.68). No significant difference was found in the prevalence of angina between the 2 groups at 1 year. During the first year of follow-up, 30% of the OMT patients crossed over to the revascularization group. In conclusion, an initial strategy of OMT alone for high-risk patients in the COURAGE trial did not result in increased death or myocardial infarction at 4.6 years or worse angina at 1 year, but it was associated with a high rate of crossover to revascularization. [Copyright &y& Elsevier]

Objectives: The aim of this report was to evaluate 12-month outcomes of facilitated percutaneous coronary intervention (PCI) in the FINESSE (Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events) trial. Background: Treatment delays remain common for patients with primary PCI leading to studies evaluating possible benefit of “facilitated” PCI. In the FINESSE trial, no reduction in the 90-day primary ischemic end point and an increase in bleeding were observed with both facilitated approaches, although modest favorable trends were seen for some patient subgroups. Methods: A total of 2,452 patients with ST-segment elevation myocardial infarction (MI) and anticipated 1 to 4 h delay until catheterization were randomized to reduced-dose reteplase + abciximab, abciximab alone, or placebo, followed by expedited primary PCI. Placebo-treated patients received abciximab in the cath lab. One-year mortality was a pre-specified secondary end point. Results: One-year mortalities in the 3 groups noted in the preceding text were 6.3%, 7.4%, and 7.0%, respectively (p = NS), representing 1.1%, 1.9%, and 2.5% increments since the 90-day outcome (p = 0.053 for combination treatment vs. primary PCI). A favorable trend with combination treatment was seen for patients with anterior MI (p = 0.09), but no other specified groups benefited or tended to benefit. Independent baseline correlates of 1-year mortality were systolic blood pressure <100 mm Hg, prior MI, age, Killip class >1, anterior MI, body mass index ≤25 kg/m2, heart rate >100 beats/min, and no statin use. Conclusions: These results suggest that widespread utilization of the facilitated approaches tested cannot be justified, but that high-risk patient groups such as patients with anterior MI may deserve further study. (The FINESSE trial; NCT00046228) [Copyright &y& Elsevier]

We evaluated the use and outcomes of drug-eluting stents (DESs) and bare metal stents (BMSs) in a large primary percutaneous coronary intervention (PCI) acute ST-elevation myocardial infarction (MI) trial. Recently concerns have been raised with “off-label” use of DESs for short- and long-term clinical outcomes. Limited randomized data exist evaluating DESs versus BMSs in ST-elevation MI. Patients (n = 5,745) in the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial were categorized by stent type used. Baseline variables and clinical outcomes were collected at 90 days and 6 months. Outcomes by stent type were adjusted for using conventional multivariable predictors of 90-day mortality (age, anterior location, total ST-segment deviation, and Killip class), time to PCI, and Thrombolysis In Myocardial Infarction grade flow. Stents were deployed (at the investigator''s discretion) in 5,124 patients (89.2%) with acute MI, with DES use in 2,221 (43.3%) and BMS use in 2,903 (56.7%). Patients receiving DESs were younger (median 59 vs 63 years of age, p <0.001), had left anterior descending coronary artery PCI (57.9% vs 48.1%, p <0.001), and often were treated in the United States (58.2%). DES-treated patients had a lower adjusted mortality at 90 days (hazard ratio 0.73, 95% confidence interval [CI] 0.54 to 0.99, p = 0.046) and trended toward lower mortality (hazard ratio 0.77, 95% CI 0.58 to 1.03, p = 0.084) and recurrent MI (hazard ratio 0.81, 95% CI 0.59 to 1.11, p = 0.186) at 6 months compared with BMSs. In conclusion, in this observational analysis of stent use from a large primary percutaneous intervention for acute MI trial, DESs appear as safe as BMSs with similar 6-month clinical outcomes with regard to death and recurrent MI. [Copyright &y& Elsevier]

Abstract: Objectives: Estimation of long-term outcome for patients suffering from acute myocardial infarction treated with primary angioplasty in an alsatian public center. Patients and methods: Two-hundred and ninety-eight patients who underwent an urgent coronarography in a non-university center, with a view to immediate angioplasty, between January 1999 and December 2001. Results: Two-hundred and sixty-four patients (88.6%) were actually treated with urgent angioplasty, which has been successful in 87.1% of cases. Hospital mortality was of 7.7%. The population was composed of 16.4% patients older than 75 and of 11.7% patients with Killip 3 or 4 at admission. Mean follow-up was 34 months, lost to follow-up rate was of 4.7%. The global survival rate was of 78.9% and eventless survival rate of 41.9%. Conclusion: Our results confirm the efficiency of angioplasty in real-life conditions as well at short-term as at long-term. [Copyright &y& Elsevier]

Abstract: Background: Bifurcation lesions at the time of emergent PCI for STEMI are relatively common. However, there are little data regarding their significance. The objective of this study is to evaluate the impact of bifurcation lesions in the setting of emergent percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). Methods: In 391 patients who underwent primary and rescue PCI, the clinical characteristics, procedural success, and in-hospital cardiac events were compared retrospectively between the patients with and without bifurcation lesions. The PCI strategy was at the discretion of the operator. Results: The culprit artery involved a bifurcation lesion in 54/391 (14%) patients. The baseline clinical characteristics between the groups with and without bifurcation lesions were similar. The majority of bifurcation lesions (81%) were seen in the left anterior ascending (LAD) artery. All lesions were treated with the provisional stenting approach, and only 2 (3%) patients required 2 stents. There were no difference in the procedural success and the final TIMI-3 flow, but PCI of bifurcation lesion required higher amount of contrast use. There was no in-hospital MACE in the bifurcation group. The peak cardiac enzyme, left ventricular function, and length of stay were similar in these 2 groups. Conclusions: Bifurcation lesions are relatively common in emergent PCI for STEMI involving the LAD. It can be safely treated with a provisional stenting approach, and the immediate outcome is similar to non-bifurcation lesions. [Copyright &y& Elsevier]