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Aims: To evaluate crude cardiovascular risk in patients with acute coronary syndrome (ACS) who are on oral anticoagulants (OAC) after percutaneous coronary intervention with stents (PCI-S) and also to evaluate if the patients on OAC after PCI-S benefit from clopidogrel., Methods and Results: Data from RIKS-HIA and SCAAR on patients admitted to coronary care units 1997 to 2005, undergoing PCI-S (n=27,972), were evaluated. OAC were prescribed to 4.2% (n=1,183) of the patients and they had higher crude 1-year mortality than the non-OAC group, (3.6% [n=42] vs. 1.5% [n= 413], p=0.008), but after adjusting for pre-treatment patient characteristics there were no significant difference in 1-year mortality (adjusted risk ratio [adj. RR] 0.82 [95% CI 0.58-1.16]). Of patients on OAC, 56% (n=659) were also on clopidogrel at discharge. Incidence of death or myocardial infarction (MI) within one year did not differ between the clopidogrel and non-clopidogrel group, adj. RR 0.93 (95% CI 0.65-1.34). Triple therapy (OAC, clopidogrel plus aspirin) was associated with four times higher risk of any bleeding than OAC plus aspirin, adj. RR 4.27 (95% CI 1.2-15.1) but a lower incidence of death or MI than OAC plus clopidogrel adj. RR 0.63 (95% CI 0.40-0.99)., Conclusions: Patients discharged on OAC after PCI-S in ACS have higher crude 1-year mortality than patients not on OAC, largely explained by age and comorbidities. Adding clopidogrel is not associated with lower incidence of death or MI at one year. Triple therapy is associated with higher risk of any bleeding than OAC plus aspirin but lower risk of death or MI than OAC plus clopidogrel.

Objective: To evaluate if female gender is associated with renal insufficiency in patients with ST-elevation myocardial infarction (STEMI) and if there is a gender difference in the prognostic importance of renal insufficiency in STEMI., Design: Single-centre observational study., Setting: One tertiary cardiac centre., Patients: All consecutive patients with STEMI planned for primary percutaneous coronary intervention in one Swedish county in 2005 (98 women and 176 men)., Main Outcome Measures: Logistic regression analyses were conducted to evaluate the predictors of renal insufficiency, associations between estimated glomerular filtration rate (eGFR) and outcome in each gender and a possible interaction between gender and eGFR regarding outcome., Results: Renal insufficiency was defined as eGFR less than 60 ml/min per 1.73 m(2). 67% of women had renal insufficiency compared with 26% of men, OR 5.06 (95% CI 2.66 to 9.59) after multivariable adjustment. In women each 10 ml/min per 1.73 m(2) increment of eGFR was associated with a 63% risk reduction for 1-year mortality, OR 0.37 (95% CI 0.15 to 0.89). No such association was found in men, OR 1.05 (95% CI 0.63 to 1.76). A trend towards a significant interaction between gender and eGFR regarding 1-year mortality was found, OR 2.05 (95% CI 0.93 to 4.50)., Conclusions: A considerable gender difference in the prevalence of renal insufficiency in STEMI was found and renal insufficiency seemed to be a more important prognostic marker in women. These results are important as previous STEMI studies have shown higher multivariable adjusted mortality in women than in men but renal function has seldom been taken into consideration.

Objectives: The aim of this study was to test the noninferiority of eptifibatide relative to abciximab in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI)., Background: Glycoprotein IIb/IIIa inhibitors are recommended by international guidelines in patients with acute coronary syndromes undergoing PCI. Abciximab is recommended with a higher level of evidence than eptifibatide in patients with STEMI. No large, prospective, randomized trial comparing abciximab and eptifibatide has been published., Methods: All (n = 11,479) STEMI patients in Sweden who underwent primary PCI and received either eptifibatide or abciximab from 2004 to 2007 were derived from the SCAAR (Swedish Coronary Angiography and Angioplasty Registry). The primary end point was death or myocardial infarction (MI) during 1-year follow-up, with adjustment for baseline differences with a multivariate logistic regression analysis including propensity score. The pre-specified noninferiority margin was set to 1.29., Results: The combined end point occurred in 353 of 2,355 patients (15.0%) treated with eptifibatide and in 1,432 of 9,124 patients (15.7%) treated with abciximab. The unadjusted odds ratio (OR) for eptifibatide versus abciximab was 0.95 (95% confidence interval [CI]: 0.84 to 1.08). Multivariate adjustment (n = 11,317) confirmed noninferiority, with an OR of 0.94 (95% CI: 0.82 to 1.09). The adjusted secondary end points of death and MI separately also showed noninferiority, with ORs of 0.99 (95% CI: 0.82 to 1.19) and 0.88 (95% CI: 0.73 to 1.05), respectively., Conclusions: This large registry study suggests that eptifibatide is noninferior to abciximab in patients with STEMI undergoing primary PCI with respect to death or MI during 1 year, thereby supporting the use of either drug in clinical practice., (Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Unlabelled: There is debate whether early treatment with GpIIb/IIIa inhibitors is of clinical benefit in primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). This study explored the effects of early given abciximab on coronary blood flow and major adverse cardiac events (MACE) in patients with STEMI treated with primary PCI and adjunctive abciximab. We studied all consecutive patients from our catchment area with STEMI undergoing acute angiography with the intention of primary PCI during 2005. Abciximab was given as early pre-treatment before, (n = 133) or at the cath. lab. after a diagnostic angiography (n = 109). Pre-procedural TIMI 2-3 flow was observed in 45.9 % of patients in the early group versus 20.2 % in the cath. lab. group, P = 0.0001. Mortality rates were 3.8 % versus 3.7% inhospital and 8.3 % versus 7.3% at one year in the early respectively the cath. lab. group, both P = NS. The MACE rate (death, non fatal myocardial infarction, unplanned revascularization) at one year was 19.5 % (early group) and 26.6 % (cath. lab. group), P = 0.19., Conclusion: In this single centre registry study of unselected patients with STEMI early given abciximab was associated with a significantly higher rate of TIMI 2-3 flow compared to abciximab given after the acute angiography.

Aims: Percutaneous coronary interventions (PCI) are used to treat acute and chronic forms of coronary artery disease. While in chronic forms the main goal of PCI is to improve the quality of life, in acute coronary syndromes (ACS) timely PCI is a life-saving procedure - especially in the setting of ST-elevation myocardial infarction (STEMI). The aim of this study was to describe the experience of countries with successful nationwide implementation of PCI in STEMI, and to provide general recommendations for other countries., Methods and Results: The European Association of Percutaneous Cardiovascular Interventions (EAPCI) recenty launched the Stent For Life Initiative (SFLI). The initial phase of this pan-European project was focused on the positive experience of five countries to provide the best practice examples. The Netherlands, the Czech Republic, Sweden, Denmark and Austria were visited and the logistics of ACS treatment was studied. Public campaigns improved patient access to acute PCI. Regional networks involving emergency medical services (EMS), non-PCI hospitals and PCI centres are useful in providing access to acute PCI for most patients. Direct transfer from the first medical contact site to the cathlab is essential to minimise the time delays. Cathlab staff work is organised to provide acute PCI services 24 hours a day / seven days a week (24/7). Even in those regions where thrombolysis is still used due to long transfer distances to PCI, patients should still be transferred to a PCI centre (after thrombolysis). The highest risk non-ST elevation acute myocardial infarction patients should undergo emergency coronary angiography within two hours of hospital admission, i.e. similar to STEMI patients., Conclusions: Three realistic goals for other countries were defined based on these experiences: 1) primary PCI should be used for >70% of all STEMI patients, 2) primary PCI rates should reach >600 per million inhabitants per year and 3) existing PCI centres should treat all their STEMI patients by primary PCI, i.e. should offer a 24/7 service.

Objectives: The aim of this study was to investigate the outcome of bare-metal stents (BMS) versus drug-eluting stents (DES) after on-label as well as off-label use., Background: DES lower restenosis rates while not influencing the risk for death and myocardial infarction when used in Federal Food and Drug Administration (FDA)-approved indications. It is debated whether the clinical results of this so-called on-label use might be extrapolated to off-label situations., Methods: The SCAAR (Swedish Coronary Angiography and Angioplasty Registry) was used to investigate the outcomes in 17,198 patients who underwent stenting with an on-label indication (10,431 BMS and 6,767 DES patients) and 16,355 patients in the context of an off-label indication (9,907 BMS and 6,448 DES patients). The patients were included from 2003 to 2005 with a minimum follow-up of 1 year and a maximum of 4 years. The analysis was adjusted for differences in baseline characteristics., Results: There were not significant differences between on-label DES and BMS (adjusted hazard ratio: 1.02; 95% confidence interval: 0.92 to 1.13) or between off-label DES and BMS (adjusted hazard ratio: 0.95; 95% confidence interval: 0.87 to 1.04) use with regard to the incidence of myocardial infarction and death. Off-label use of DES did not lead to significant differences in the combined risk of death and myocardial infarction compared with BMS throughout the whole spectrum of clinical indications., Conclusions: In contemporary Swedish practice, neither on- nor off-label use of DES is associated with worse outcome than use of BMS.

Context: Whether the superior results of percutaneous coronary intervention (PCI) reported in clinical trials in which patients with ST-segment elevation myocardial infarction (STEMI) received reperfusion treatment can be replicated in daily practice has been questioned, especially whether it is superior to prehospital thrombolysis (PHT)., Objective: To evaluate the outcome of different reperfusion strategies in consecutive STEMI patients., Design, Setting, and Patients: A prospective observational cohort study of 26 205 consecutive STEMI patients in the Register of Information and Knowledge about Swedish Heart Intensive Care Admissions (RIKS-HIA) who received reperfusion therapy within 15 hours of symptom onset. The registry includes more than 95% of all Swedish patients, of all ages, who were treated in a coronary intensive care unit between 1999 and 2004., Interventions: Seven thousand eighty-four patients underwent primary PCI; 3078, PHT; and 16 043, in-hospital thrombolysis (IHT)., Main Outcome Measures: Mortality, reinfarction, and readmissions as reported in the National Health Registries through December 31, 2005., Results: After adjusting for younger age and less comorbidity, primary PCI was associated with lower mortality than IHT at 30 days (344 [4.9%] vs 1834 [11.4%]; hazard ratio [HR], 0.61; 95% confidence interval [CI], 0.53-0.71) and at 1 year (541 [7.6%] vs 2555 [15.9%]; HR, 0.68; 95% CI, 0.60-0.76). Also primary PCI correlated with lower mortality than PHT at 30 days (344 [4.9%] vs 234 [7.6%]; HR, 0.70; 95% CI, 0.58-0.85) and 1 year (541 [7.6%] vs 317 [10.3%]; HR, 0.81; 95% CI, 0.69-0.94). Prehospital thrombolysis predicted a lower mortality than IHT at 30 days (HR, 0.87; 95% CI, 0.76-1.01) and at 1 year (HR, 0.84; CI 0.74-0.95). Beyond 2 hours' treatment delay, the observed mortality reductions with PHT tended to decrease while the benefits with primary PCI seemed to remain regardless of time delay. Primary PCI was also associated with shorter hospital stay and less reinfarction than either PHT or IHT., Conclusions: In unselected patients with STEMI, primary PCI, which compared favorably with IHT and PHT, was associated with reduced duration of hospital stay, readmission, reinfarction, and mortality.

Background: The Percutaneous Coronary Intervention-Clopidogrel in Unstable Angina to Prevent Recurrent Events (PCI-CURE) study, which examined the effect of adding clopidogrel to aspirin versus aspirin alone in patients with unstable coronary artery disease (CAD) undergoing PCI, found a relative risk reduction in cardiovascular deaths and myocardial infarction among those treated with clopidogrel. In addition, a within-trial cost-effectiveness analysis showed favorable costs per event avoided. However, to estimate the long-term effects, a modeling approach is necessary., Objectives: The purpose of this study was to estimate the long-term cost-effectiveness of treating patients undergoing PCI with clopidogrel plus aspirin in Sweden., Methods: A Markov model was developed. Transition probabilities were estimated based on a register of patients treated in the coronary care units at 74 (out of 78) hospitals throughout Sweden. Patients were assumed to be treated for 1 year with an effect based on data from the PCI-CURE study. Costs were collected from published sources and recalculated to year-2004 Euros (Euro 1.00 = USD 1.24). Life-years gained were used as the measure of effectiveness. The perspective was that of the Swedish society, with a separate analysis using a health care cost perspective., Results: After inclusion and exclusion criteria were applied, 3474 patients were included in the model analysis. The model predicted a net gain in survival of 0.04 year per patient when adding clopidogrel. This yielded a net increase of Euros 449 if only direct costs were included; with indirect costs, the net increase was Euros 332. The resulting cost-effectiveness ratios were Euros 10,993 and Euros 8127 per life-year gained., Conclusions: The predicted cost-effectiveness ratios were well below the threshold values generally considered cost-effective. Adding clopidogrel to aspirin appeared to be cost-effective in this model analysis of patients with unstable CAD undergoing PCI in Sweden.