Impact of around-the-clock in-house cardiology fellow coverage on door-to-balloon time in an academic medical center.

OBJECTIVES: To assess if a change in our cardiology fellowship program impacted our ST elevation myocardial infarction (STEMI) program. BACKGROUND: Fellows covering the cardiac care unit were spending excessive hours in the hospital while on call, resulting in increased duty hours violations. A night float fellow system was started on July 1, 2012, allowing the cardiac care unit fellow to sign out to a night float fellow at 5:30 pm. The night float fellow remained in-house until the morning. METHODS: We performed a retrospective study assessing symptom onset to arrival, arterial access to first device, and door-to-balloon (D2B) times, in consecutive STEMI patients presenting to our emergency department before and after initiation of the night float fellow system. RESULTS: From 2009 to 2013, 208 STEMI patients presented to our emergency department and underwent primary percutaneous coronary intervention. There was no difference in symptom onset to arrival (150±102 minutes vs 154±122 minutes, p=0.758), arterial access to first device (12±8 minutes vs 11±7 minutes, p=0.230), or D2B times (50±32 minutes vs 52±34 minutes, p=0.681) during regular working hours. However, there was a significant decrease in D2B times seen during off-hours (72±33 minutes vs 49±15 minutes, p=0.007). There was no difference in in-hospital mortality (11% vs 8%, p=0.484) or need for intra-aortic balloon pump placement (7% vs 8%, p=0.793). CONCLUSION: In academic medical centers, in-house cardiology fellow coverage during off-hours may expedite care of STEMI patients.

Impact of call-to-balloon time on 30-day mortality in contemporary practice.

OBJECTIVE: Studies reporting an association between treatment delay and outcome for patients with ST segment elevation myocardial infarction (STEMI) have generally not included patients treated by a primary percutaneous coronary intervention (PPCI) service that systematically delivers reperfusion therapy to all eligible patients. We set out to determine the association of call-to-balloon (CTB) time with 30-day mortality after PPCI in a contemporary series of patients treated within a national reperfusion service. METHODS: We analysed data on 16 907 consecutive patients with STEMI treated by PPCI in England and Wales in 2011 with CTB time of ≤6 hours. RESULTS: The median CTB and door-to-balloon times were 111 and 41 min, respectively, with 80.9% of patients treated within 150 min of the call for help. An out-of-hours call time (58.2% of patients) was associated with a 10 min increase in CTB time, whereas inter-hospital transfer for PPCI (18.5% of patients) was associated with a 49 min increase in CTB time. CTB time was independently associated with 30-day mortality (p<0.0001) with a HR of 1.95 (95% CI 1.54 to 2.47) for a CTB time of >180-240 min compared with ≤90 min. The relationship between CTB time and 30-day mortality was influenced by patient risk profile with a greater absolute impact of increasing CTB time on mortality in high-risk patients. CONCLUSION: CTB time is a useful metric to assess the overall performance of a PPCI service. Delays to reperfusion remain important even in the era of organised national PPCI services with rapid treatment times and efforts should continue to minimise treatment delays.

Ethnicity and revascularisation following acute coronary syndromes: a 5-year cohort study (ANZACS-QI-3).

BACKGROUND: Prior studies have reported higher rates of coronary revascularisation in European compared with Maori and Pacific patients. Our aim was to define the current variation by ethnicity in investigation, revascularisation and pharmacotherapy after admission with an acute coronary syndrome (ACS). METHODS: Data from consecutive New Zealand residents <80 years of age admitted to the Middlemore Hospital coronary care unit with ACS (2007 to 2012) were collected prospectively. RESULTS: Of 2666 ACS patients <80y, 51.5% were European/Other, 14.2% Maori, 16.0% Pacific, 14.8% Indian, and 3.5% Asian. Cardiac risk factors and comorbidity varied markedly by ethnicity. The overall coronary angiography rate was high (89%). After adjustment for clinical factors which influence the decision to perform angiography, European/Other patients were about 5% more likely than Maori and Pacific patients to have angiography. Overall revascularisation was highest in Asian, Indian and European/Other (76.1%, 69.1% and 68.6%), and lower in Maori and Pacific patients (58.2% and 52.9%). Non-obstructive coronary disease was more common in Maori and Pacific (20.6 and 18.6%, respectively), than in European/Other, Indian and Asian patients (13.3%, 8.7% and 6.1%). After adjustment, Maori, Indian and Asian patients were as likely to receive revascularisation as European/Others, but revascularisation in Pacific patients was 13% lower. Discharge prescribing of triple preventive therapy was uniformly high across ethnic groups (overall 91%). CONCLUSIONS: There is a small unexplained variation in angiography rates across ethnic groups. Much of the observed variation in revascularisation may be due to differences in the coronary artery disease phenotype.

Implementation of primary angioplasty in Europe: stent for life initiative progress report.

AIMS: Primary percutaneous coronary intervention (PPCI) is the recommended treatment for patients with acute ST-segment elevation myocardial infarction (STEMI). Despite substantial evidence of its effectiveness, a 2007 study reported that only 40-45% of European STEMI patients were treated with PPCI, with large variations in treatment availability between countries. In 2008, the Stent for Life (SFL) initiative was launched by the European Association of Percutaneous Cardiovascular Interventions and EuroPCR in partnership with the European Society of Cardiology (ESC) Working Group on Acute Cardiac Care and country-specific national cardiac societies. The aim is to promote the prioritisation of percutaneous coronary intervention treatment towards those who will benefit most, namely STEMI patients. The following countries are currently participating: Bulgaria, Egypt, France, Greece, Italy, Portugal, Romania, Serbia, Spain and Turkey. METHODS AND RESULTS: Since SFL was launched, several activities have been initiated in the participating countries. Preliminary reports suggest that major increases have been seen in the numbers of PPCI performed, with some countries reporting very significant increases in PPCI use from 2008-2010. Improvements in STEMI mortality rates have also been observed. CONCLUSIONS: This report summarises the progress of the SFL initiative in the 10 target countries.

Prevalence and the long-term coronary risks of patients with Kawasaki disease in a general population <40 years: a national database study.

BACKGROUND: Patients with Kawasaki disease (kDa) may develop coronary arterial lesions and subsequent coronary events. The first reported case in Taiwan was in 1976, and the annual incidence from 2003 to 2006 was 69/100 000 children < 5 years. A population study from Taiwan, a country with a high incidence of kDa, national health insurance, and easily accessible medical care, would adequately reflect the long-term risk. METHODS AND RESULTS: We retrieved the data of kDa patients from a national health insurance 2000 to 2010 database of Taiwan, a country with a child health index similar to those in the United States. The occurrence of coronary complications and interventions was identified by the respective International Classification of Diseases, Ninth Revision, codes. The prevalence of kDa in the population < 40 years was 34.9/100 000 (male/female ratio, 1.47). Coronary complications occurred in 1254 patients (5.37%; male/female ratio, 2.19), with an average annual risk of 2.4% (2.7% for males and 2.0% for females). An acute myocardial infarction occurred in 19 patients (0.08%; 18 males and 1 female), of whom one third were aged between 10 and 15 years (median, 15.7 years; range, 0.7-36.7 years). A coronary intervention was performed by catheterization in 18 patients (all males) at a median age of 24.5 years and by surgery in 10 patients (male/female ratio, 4.0) at a median age of 21.7 years, with mortality at discharge being 0% and 25%, respectively. CONCLUSIONS: This study estimated the overall prevalence of kDa (≈1/2940) in a population < 40 years. They, particularly the males, carry long-term coronary risks from a young age. Risk stratification for a timely coronary intervention and risk modification are mandatory.

Transfer times and outcomes in patients with ST-segment-elevation myocardial infarction undergoing interhospital transfer for primary percutaneous coronary intervention: APEX-AMI insights.

BACKGROUND: Transfer delays for primary percutaneous coronary intervention may increase mortality in patients with ST-segment-elevation myocardial infarction. We examined the association between door 1-to-door 2 (D1D2) time, a measure capturing the entire transfer process, and outcomes in patients undergoing interhospital transfer for primary percutaneous coronary intervention. METHODS AND RESULTS: We evaluated the relationship between D1D2 time and the 90-day incidence of death, shock, and heart failure in the subset of 2075 (36.1%) of 5745 patients who underwent interhospital transfer for primary percutaneous coronary intervention in the Assessment of Pexelizumab in Acute Myocardial Infarction trial. There was no significant difference in the 90-day incidence of death, shock, and heart failure between the transferred and the nontransferred groups (10.3% versus 10.2%; P = 0.89). The median difference in symptom-to-balloon time between the 2 groups was 45 minutes (229 versus 184; P<0.001). The primary outcome per 30-minute delay was higher for patients with a D1D2 time ≤150 minutes (hazard ratio, 1.19: 95% confidence interval, 1.06 to 1.33; P = 0.004) but not for D1D2 times >150 minutes (hazard ratio, 0.99: 95% confidence interval, 0.96 to 1.02; P = 0.496). The association between longer D1D2 time and worsening outcome was no longer statistically significant after multivariable adjustment. CONCLUSIONS: Longer transfer times were associated with higher rate of death, shock, and heart failure among patients undergoing interhospital transfer from primary percutaneous coronary intervention, although this difference did not persist after adjusting for baseline characteristics.

Analysis on outcome of 5284 patients with coronary artery disease: the role of integrative medicine.

ETHNOPHARMACOLOGICAL RELEVANCE: Traditional Chinese Medicine (TCM) has a history of thousands of years and has made great contributions to the health and well-being of the people. Integrative medicine (IM) treatment, combing TCM and conventional medicine, has been the most representative characteristic for coronary artery disease (CAD) patients in China, especially those in IM hospitals. However, the secondary prevention status of CAD and the potential benefit of IM therapy in improving CAD prognosis remains unclear. MATERIALS AND METHODS: By means of a unified clinical and research information platform, we collected clinical information of hospitalized patients with CAD in cardiovascular department of 9 IM hospitals in Beijing and Tianjin from January 2003 to September 2006. The primary endpoints were major adverse cardiac events (MACEs) which include all-cause death in hospital and during one-year follow-up, acute myocardial infarction (AMI), percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). The diagnostic and therapeutic status of CAD patients was evaluated based on the latest available clinical guidelines. Meanwhile, a logistic stepwise regression analysis was also used to identify independent prognostic factors. RESULTS: 5284 hospitalized patients with CAD were registered. The top five TCM patterns were in turn blood stasis 79.3%, Qi deficiency 56.5%, phlegm-turbidness 41.1%, Yin deficiency 24.8%, Yang deficiency 11.3%. The standard-reaching rate of CAD patients with hyperlipidemia was 85.6% for total cholesterol, 31.2% for triglyceride, 21.4% for low-density lipoprotein cholesterol, 52.5% for high-density lipoprotein cholesterol, while it was 61.9% and 80.9% in systolic and diastolic blood pressure of CAD with hypertension respectively. The top five commonly used herbs by functions were Qi-tonifying agents 89.25%, blood-activating agents 86.04%, Qi-regulating agents 77.60%, heat-clearing agents 67.50%, dampness-draining agents 65.95%. The herbs commonly used were Salvia miltiorrhiza Bunge 63.10%, Poria 59.99%, Raidx Astragali 49.67%, Radix Paeoniae Rubra 48.71%, peach seed 47.32%, angelica 46.82%, Radix Ligustici Chuanxiong 46.36%, safflower 45.40%, Pinellia 45.30%, glycyrrhiza 41.36%. 90 patients (1.7%) died in hospital, and the overall incidence of endpoints was 6.1% (322/5284). The logistic stepwise regress analysis showed that AMI (OR, 5.62, 95% CI=2.56-12.33), heart failure (OR, 2.68, 95% CI=1.67-4.29), age≥60 years (OR, 2.01, 95% CI=1.22-3.30), and medication of phosphodiesterase inhibitors (OR, 1.67, 95% CI=1.15-2.42) were independent risk factors for in-hospital mortality and one-year follow-up MACEs, while statins (OR, 0.23, 95% CI=0.06-0.91) and IM therapy (OR, 0.69, 95% CI=0.49-0.97) were protective factors. CONCLUSION: There was still certain gap between the usage of conventional medicine and clinical guideline in IM hospitals of China. Integrative Medicine might have potential benefit for CAD patients in reducing MACEs. However, the scheme of IM intervention and the mechanism of action are still needed to be further determined.

Higher efficacy of pre-hospital tirofiban with longer pre-treatment time to primary PCI: protection for the negative impact of time delay.

AIMS: To evaluate the impact of longer duration of pre-hospital initiated antiplatelet and antithrombotic therapy on outcome in patients with ST-segment elevation myocardial infarction (STEMI). METHODS AND RESULTS: In this sub-analysis of the Ongoing Tirofiban in Myocardial Evaluation (On-TIME) 2 trial, we studied, in 1,370 patients, the effect of pre-treatment time (time from administering study medication to time of angiography) on complete ST-segment resolution (STR), initial patency and 30-day mortality. Study medication consisted of high dose tirofiban (HDT) or control (placebo or no HDT) on top of high dose clopidogrel, aspirin and unfractionated heparin. Median pre-treatment time was 55 min (44-70). Longer pre-treatment was associated with longer transportation times, longer in-hospital delay, longer total ischaemic time (all p<0.001) and higher 30-day mortality (3.6% vs. 1.8%, p=0.046). Longer HDT pre-treatment time was independently associated with increased complete STR both before (odds ratio [OR] 1.51, 95%; confidence interval [CI] 0.98-2.32; p=0.06) and after PCI (OR 1.43, 95%; CI 1.02-2.02; p=0.039) and with a significantly improved initial TIMI 2 or 3 flow (51.4% vs. 43.4%, p=0.042) and reduced 30-day mortality (2.1% vs. 5.0%, p=0.047) as compared to longer control pre-treatment. CONCLUSIONS: Longer time delay before primary PCI is associated with increased mortality. Pre-treatment with high dose tirofiban, however, may compensate for this negative effect by improving ST-segment resolution and initial patency and by reducing mortality. Further studies should be performed to confirm that this is an attractive therapy for patients with longer delays to reperfusion.

Pre-hospital ECG in patients undergoing primary percutaneous interventions within an integrated system of care: reperfusion times and long-term survival benefits.

AIMS: Treatment delay is a powerful predictor of survival in STEMI patients undergoing primary PCI. We investigated the effectiveness of pre-hospital triage with direct referral to PCI, alongside more conventional referral strategies. METHODS AND RESULTS: From January 2003 to December 2007, 1,619 STEMI patients were referred for primary PCI at our cathlab through two main triage groups: i.e., 1) following pre-hospital triage (n=524), 2) via more conventional triages (n=1,095) represented by the S. Orsola-Malpighi hospital emergency department triage (hub hospital) and local hospital triage. Pre-hospital diagnosis was associated with a 76 minute reduction in pain-to-balloon time (143 [107-216] vs. 219 [149-343], p=0.001) allowing mechanical revascularisation within 90 minutes from the first medical contact in the vast majority of the patients (>80%). Clinically, pre-hospital triage showed no significant reductions in terms of adjusted long-term mortality (HR 0.81, 95% CI 0.61-1.08; p=0.16) in the overall population. However, significant adjusted survival benefits were observed in high-risk groups (i.e., cardiogenic shock, TIMI risk score >30, diabetes mellitus). CONCLUSIONS: This study shows that pre-hospital diagnosis allows for significant reductions in primary PCI treatment delays and suggests the hypothesis that this referral strategy might provide long-term survival benefits especially in high-risk patients.

Impact of N-acetylcysteine on contrast-induced nephropathy defined by cystatin C in patients with ST-elevation myocardial infarction undergoing primary angioplasty.

BACKGROUND: The aim of this study was to assess the effects of N-acetylcysteine (N-ACC) on contrast-induced nephropathy (CIN) defined by Cystatin C (Cys-C) serum levels and to evaluate the influence of Cys-C on clinical outcome in patients with ST-elevation myocardial infarction (STEMI). METHODS: In total, 251 patients with STEMI undergoing primary percutaneous coronary intervention (PCI) were randomized to either high-dose N-ACC (2 × 1200 mg/d for 48 h) with optimal hydration or placebo plus optimal hydration. Serum Cys-C was measured at baseline, immediately, 24, 48 and 72 h after PCI. CIN was defined as an increase in serum Cys-C levels of 25% or more from baseline within 72 h after PCI. Major adverse cardiac events (MACE)--defined as death, recurrent infarction and congestive heart failure--within 6 months were recorded. RESULTS: Baseline Cys-C was 1294 ± 611 and 1352 ± 811 ng/mL (p = 0.54) for the N-ACC and placebo group, respectively. There was a steady increase in Cys-C in both groups within the first 72 h after randomization. CIN occurred in 74.6 and in 70.4% of patients in the N-ACC and placebo group, respectively (p = 0.46). The magnitude of increase in the serum concentration of Cys-C was an independent predictor for MACE after 6 months of follow-up. CONCLUSIONS: High-dose N-ACC does not provide additional benefit over placebo with respect to Cys-C defined CIN in STEMI patients undergoing primary PCI. The magnitude of increase in Cys-C serum levels in the early course after STEMI is a predictor of medium-term MACE.

Health and cost consequences of early versus late invasive strategy after thrombolysis for acute myocardial infarction.

UNLABELLED: The NORwegian study on DIstrict treatment of ST-Elevation Myocardial Infarction showed an improved clinical outcome with early transfer for percutaneous coronary intervention (PCI) compared to a more conservative approach after thrombolysis. The aim of this substudy was to compare the 12-month quality-adjusted life years (QALYs) and costs of these alternative strategies. METHODS: Patients with ST-elevation myocardial infarction <6 h duration and >90 min expected delay to PCI, received full-dose tenecteplase and were randomized to either early or late invasive strategy (n = 266). Detailed quality of life and resource use data were registered prospectively for a period of 12 months. Health outcomes were measured as quality of life using a generic instrument (15D). Quality of life scores were translated into QALYs. Unit costs were based on hospital accounts, fee schedules, and market prices. RESULTS: After 12 months of follow-up, patients in the early invasive group had 0.008 (95% CI -0.027 to 0.043) more QALYs compared to the late invasive group. The mean total costs were €18,201 in the early versus €17,643 in the late invasive group, with a mean difference of €558 (95% CI -2258 to 3484). Cost/QALY was €69,750 while cost/avoided clinical endpoint was €5636. CONCLUSION: Early and late invasive strategies after thrombolysis resulted in similar quality of life and similar costs in ST-elevation myocardial infarction patients living far from a PCI centre (NCT00161005).

Off-hour primary percutaneous coronary angioplasty does not affect outcome of patients with ST-Segment elevation acute myocardial infarction treated within a regional network for reperfusion: The REAL (Registro Regionale Angioplastiche dell'Emilia-Romagna) registry.

OBJECTIVES: This study aims to evaluate whether results of "off-hours" and "regular-hours" primary angioplasty (primary percutaneous coronary intervention [pPCI]) are comparable in an unselected population of patients with ST-segment elevation acute myocardial infarction treated within a regional network organization. BACKGROUND: Conflicting results exist on the outcome of off-hours pPCI. METHODS: We analyzed in-hospital and 1-year cardiac mortality among 3,072 consecutive ST-segment elevation myocardial infarction (STEMI) patients treated with pPCI between January 1, 2004, and June 30, 2006, during regular-hours (weekdays 8:00 AM to 8:00 PM) and off-hours (weekdays 8:01 PM to 7:59 AM, weekends, and holidays) within the STEMI Network of the Italian Region Emilia-Romagna (28 hospitals: 19 spoke and 9 hub interventional centers). RESULTS: Fifty-three percent of patients were treated off-hours. Baseline findings were comparable, although regular-hours patients were older and had more incidences of multivessel disease. Median pain-to-balloon (195 min, interquartile range [IQR]: 140 to 285 vs. 186 min, IQR: 130 to 280 min; p = 0.03) and door-to-balloon time (88 min, IQR: 60 to 122 vs. 77 min, IQR: 48 to 116 min; p < 0.0001) were longer for off-hours pPCI. However, unadjusted in-hospital (5.8% off-hours vs. 7.2% regular-hours, p = 0.11) and 1-year cardiac mortality (8.4% off-hours vs. 10.3% regular-hours, p = 0.08) were comparable. At multivariate analysis, off-hours pPCI did not predict an adverse outcome either for the overall population (odds ratio [OR]: 0.70, 95% confidence interval [CI]: 0.49 to 1.01) or for patients directly admitted to the interventional center (OR: 0.79, 95% CI: 0.52 to 1.20). CONCLUSIONS: When pPCI is performed within an efficient STEMI network focused on reperfusion, the clinical effectiveness of either off-hours or regular-hours pPCI is comparable.

Persistent coronary no flow after wire insertion is an early and readily available mortality risk factor despite successful mechanical intervention in acute myocardial infarction: a pooled analysis from the 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) trials.

OBJECTIVES: These studies sought to investigate the impact on mortality of coronary flow after passage of the wire through the culprit vessel in patients with ST-segment elevation myocardial infarction (STEMI) undergoing mechanical reperfusion. BACKGROUND: Reduced spontaneous coronary flow before percutaneous coronary intervention influences mortality in patients with STEMI. Response to vessel wiring in patients with an occluded coronary artery before intervention might further discriminate outcomes irrespective of pre- and post-intervention coronary flow. METHODS: Data from the 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) trials were pooled: of 919 index procedures, 902 films (98%) were technically adequate for core laboratory TIMI (Thrombolysis In Myocardial Infarction) flow determination. RESULTS: TIMI flow grade 0 was present before percutaneous coronary intervention in 59% of infarct vessels, TIMI flow grade 1 to 2 was found in 21%, whereas the remainder of infarct arteries presented with TIMI flow grade 3. In 49% of patients who showed persistent TIMI flow grade 0 after wire insertion (AWI), mortality was higher at 30 days (5.3%) and 1 year (9.4%) compared with patients in whom TIMI flow grade before percutaneous coronary intervention was either >0 (0.8%; p < 0.003 and 3.6%, p < 0.008) or improved from 0 AWI (1.5%, p < 0.04 and 3.6%, p < 0.02). After correcting for multiple imbalances, including baseline and final flow, persistent TIMI flow grade 0 AWI remained associated at 30 days to 2-fold (risk ratio [RR]: 2.1, 95% confidence interval [CI]: 1.08 to 5.00; p = 0.038) and at 1 year to almost 3-fold increases of mortality (RR: 2.7, 95% CI: 1.3 to 5.6; p = 0.008). CONCLUSIONS: STEMI patients displaying persistent no-flow AWI have a lower survival rate despite an apparently successful mechanical intervention. As an early marker for high residual mortality risk, persistent no-flow AWI may qualify STEMI patients for dedicated pharmacomechanical treatment strategies.

Prediction of 1-year clinical outcomes using the SYNTAX score in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: a substudy of the 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) trials.

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: SX(LOW) ≤ 9 (n = 311), 9 < SX(MID) ≤ 16 (n = 234), SX(HIGH) >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).

Effects of loading dose of atorvastatin before percutaneous coronary intervention on periprocedural myocardial injury.

OBJECTIVES: To investigate the effects of loading dose of atorvastatin on periprocedural myocardial injury and inflammatory reaction in patients with non-ST segment elevation (NSTE) acute coronary syndromes (unstable angina or NSTE acute myocardial infarction). METHODS: A total of 81 patients with NSTE-acute coronary syndromes were randomly divided into the pretreatment with atorvastatin group [80 mg 12 h before percutaneous coronary intervention (PCI), with a further 40 mg preprocedure dose] (n=41) or the placebo group (n=40). The main end point was a 30-day incidence of major adverse cardiac events (cardiac death, nonfatal acute myocardial infarction, or revascularization with either PCI or coronary artery bypass grafting). Creatine kinase-MB, cardiac troponin I, and high-sensitivity C-reactive protein levels were measured at the baseline and at 8 and 24 h after the procedure. RESULTS: Major adverse cardiac events occurred in 2.4% of patients in the atorvastatin group and 22.5% of those in the placebo group (P=0.0161). This difference was mostly because of reduction in the incidence of myocardial infarction (2.4 vs. 20.0%; P=0.0307). Markers of the two groups were elevated after PCI; however, the higher values of creatine kinase-MB, cardiac troponin I, and high-sensitivity C-reactive protein in the atorvastatin treatment group were significantly lower than those in the placebo group (P<0.01). CONCLUSION: Short-term pretreatment with a high dose of atorvastatin significantly reduces procedural myocardial injury in early PCI.

Effect of early, pre-hospital initiation of high bolus dose tirofiban in patients with ST-segment elevation myocardial infarction on short- and long-term clinical outcome.

OBJECTIVES: The purpose of this trial was to study the effect of a high bolus dose (HBD) of tirofiban on clinical outcome in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI). BACKGROUND: The On-TIME 2 (Ongoing Tirofiban In Myocardial infarction Evaluation 2) placebo-controlled, double-blind, randomized trial showed that early administration of HBD tirofiban in the ambulance improves ST-segment resolution in patients with STEMI undergoing primary percutaneous coronary intervention. The effect of early tirofiban treatment on clinical outcome is unclear. METHODS: The On-TIME 2 trial consisted of 2 phases: an open-label phase, followed by a double-blind, placebo-controlled phase. STEMI patients were randomized to either HBD tirofiban or no tirofiban (phase 1) or placebo (phase 2) in addition to aspirin, heparin, and high-dose clopidogrel. The protocol pre-specified a pooled analysis of the 2 study phases to assess the incidence of major adverse cardiac events at the 30-day follow-up and on total mortality at the 1-year follow-up. RESULTS: During a 3-year period, 1,398 patients were randomized, 414 in phase 1 and 984 in phase 2. Major adverse cardiac events at 30 days were significantly reduced (5.8% vs. 8.6%, p = 0.043). There was a strong trend toward a decrease in mortality (2.2% vs. 4.1%, p = 0.051) in patients who were randomized to tirofiban pre-treatment, which was maintained during the 1-year follow-up (3.7% vs. 5.8%, p = 0.08). No clinically relevant difference in bleeding was observed. CONCLUSIONS: Early, pre-hospital initiation of HBD tirofiban, in addition to high-dose clopidogrel, improves the clinical outcome after primary percutaneous coronary intervention in patients with STEMI. (Ongoing 2b/3a inhibition In Myocardial infarction Evaluation; ISRCTN06195297).

Contemporary treatment of unstable angina and non-ST-segment-elevation myocardial infarction (part 2).

In Part 1 of this review, we discussed how plaque rupture is the most common underlying cause of most cases of unstable angina/non-ST-segment-elevation myocardial infarction (UA/NSTEMI) and how early risk stratification is vital for the timely diagnosis and treatment of acute coronary syndromes (ACS). Now, in Part 2, we focus on the medical therapies and treatment strategies (early conservative vs early invasive) used for UA/NSTEMI. We also discuss results from various large randomized controlled trials that have led to the contemporary standards of practice for, and reduced morbidity and death from, UA/NSTEMI. In summary, ACS involving UA/NSTEMI is associated with high rates of adverse cardiovascular events, despite recent therapeutic advances. Plaque composition and inflammation are more important in the pathogenesis of ACS than is the actual degree of arterial stenosis. As results from new trials challenge our current practices and help us develop the optimal treatment strategy for UA/NSTEMI patients, the cornerstones of contemporary treatment remain early risk stratification and aggressive medical therapy, supplemented by coronary angiography in appropriately selected patients. An early-invasive-treatment strategy is of most benefit to high-risk patients, whereas an early-conservative strategy is recommended for low-risk patients. Adjunctive medical therapy with acetylsalicylic acid, clopidogrel or another adenosine diphosphate antagonist, glycoprotein IIb/IIIa inhibitors, and either low-molecular-weight heparin or unfractionated heparin, in the appropriate setting, further reduces the risk of ischemic events secondary to thrombosis. Short- and long-term inhibition of platelet aggregation should be achieved by appropriately evaluating the risk of bleeding complications in these patients.

Efficacy of high-dose atorvastatin loading before primary percutaneous coronary intervention in ST-segment elevation myocardial infarction: the STATIN STEMI trial.

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