Early and late ventricular arrhythmias complicating ST-segment elevation myocardial infarction.

BACKGROUND: Ventricular arrhythmias can be life-threatening complications of ST-segment elevation myocardial infarction (STEMI). AIMS: To describe the incidence, predictors and in-hospital impact of early ventricular arrhythmia (EVA, occurring

Pharmacoinvasive Strategy Versus Primary Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction in Patients ≥70 Years of Age.

The benefit-risk ratio of a pharmacoinvasive strategy (PI) in patients ≥70 years of age with ST-segment elevation myocardial infarction (STEMI) remains uncertain resulting in its limited use in this population. This study compared efficacy and safety of PI with primary percutaneous coronary intervention (pPCI). Data from 2,841 patients (mean age: 78.1 ± 5.6 years, female: 36.1%) included in a prospective multicenter registry, and who underwent either PI (n = 269) or pPCI (n = 2,572), were analyzed. The primary end point was in-hospital major adverse cardiovascular events (MACE) defined as the composite of all-cause mortality, nonfatal MI, stroke, and definite stent thrombosis. Secondary end points included all-cause death, major bleeding, net adverse clinical events, and the development of in-hospital Killip class III or IV heart failure. Propensity-score matching and conditional logistic regression were used to adjust for confounders. Within the matched cohort, rates of MACE was not statistically different between the PI (n = 247) and pPCI (n = 958) groups, (11.3% vs 9.0%, respectively, odds ratio 1.25, 95% confidence interval 0.81 to 1.94; p = 0.31). Secondary end points were comparable between groups at the exception of a lower rate of development of Killip class III or IV heart failure after PI. The rate of intracranial hemorrhage was significantly higher in the PI group (2.3% vs 0.0%, p = 0.03). In conclusion, the present study demonstrated no difference regarding in-hospital MACE following PI or pPCI in STEMI patients ≥70 years of age. An adequately-powered randomized trial is needed to precisely define the role of PI in this high-risk subgroup.

Immediate complete revascularization in patients with ST-segment elevation myocardial infarction and multivessel disease treated by primary percutaneous coronary intervention: Insights from the ORBI registry.

BACKGROUND: Recent studies demonstrated the superiority of complete revascularization (CR) in patients treated by primary percutaneous coronary intervention (pPCI) in ST-elevation myocardial infarction (STEMI). AIM: To evaluate whether immediate CR improves in-hospital outcomes in patients with STEMI with multivessel disease. METHODS: Data from a prospective multicentre registry including 9365 patients with STEMI were analysed. Patients with multivessel disease and treated with pPCI (n=3412) were included and separated into two groups according to whether immediate CR was performed during the index procedure. The primary endpoint was in-hospital major adverse cardiovascular events (MACE), defined as a composite of all-cause death, non-fatal myocardial infarction, stroke and definite stent thrombosis. Secondary endpoints were individual components of MACE and major bleeding. Multivariable Cox regression and propensity-score adjustment were performed to account for confounders. RESULTS: Immediate CR was performed in 98 patients (2.9%), whereas 3314 patients (97.1%) were incompletely revascularized. The prevalence of severe heart failure (Killip class III or IV) and significant lesions of the left main coronary artery were higher in the immediate CR group (21.6% vs. 13.5% and 24.5% vs. 6.7%, respectively; P<0.001 for both). After adjustment, immediate CR was not associated with reduced rates of MACE (hazard ratio [HR] 0.64, 95% confidence interval [CI]: 0.31-1.35; P=0.24) or all-cause death (HR: 0.52, 95% CI: 0.23-1.16; P=0.11), but with increased risks of definite stent thrombosis (HR: 3.93, 95% CI: 1.12-13.75; P=0.03) and major bleeding (HR: 17.46, 95% CI: 2.29-133.17; P=0.006). CONCLUSION: Immediate CR did not improve in-hospital outcomes of patients with STEMI with multivessel disease in this analysis. Randomized studies are warranted to elucidate the optimal timing of CR in patients with STEMI.

6- Versus 24-Month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents in Patients Nonresistant to Aspirin: Final Results of the ITALIC Trial (Is There a Life for DES After Discontinuation of Clopidogrel).

OBJECTIVES: The aim of this study was to test the hypothesis that 6-month dual antiplatelet therapy (DAPT) is noninferior to 24-month DAPT in aspirin-sensitive patients. BACKGROUND: The ITALIC (Is There a Life for DES After Discontinuation of Clopidogrel) trial showed that rates of bleeding and thrombotic events at 1 year were much the same with 6 versus 12 months of DAPT after percutaneous coronary intervention with second-generation drug-eluting stents. In this report, 2-year follow-up is presented. METHODS: In a multicenter randomized study, patients with confirmed nonresistance to aspirin undergoing drug-eluting stent implantation were allocated to 6 or 24 months of DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post-percutaneous coronary intervention. The secondary endpoints comprised the same composite endpoint at 24 months and each individual component. RESULTS: Overall, 2,031 patients from 70 centers were screened; 926 were randomized to 6-month and 924 to 24-month DAPT. Noninferiority was demonstrated for 6- versus 12-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: -1.04% to 1.26%; p = 0.0002). At 2 years, the composite endpoint was unchanged, at 3.5% for 6 months and 3.7% for 24 months (p = 0.79), and rates of myocardial infarction (1.3% vs. 1.0%; p = 0.51), stroke (0.6% vs. 0.8%; p = 0.77), and target vessel revascularization (1.0% vs. 0.3%; p = 0.09) were likewise similar. There was a trend toward higher mortality with longer DAPT (2.2% vs. 1.2%; p = 0.11). Four patients (0.4%) in the 24-month group and none in the 6-month group had major bleeding. CONCLUSIONS: Two-year outcomes in the ITALIC trial confirmed the 1-year results and showed that patients receiving 6-month DAPT after percutaneous coronary intervention with second-generation drug-eluting stent have similar outcomes to those receiving 24-month DAPT.

Efficacy and safety of prehospital administration of unfractionated heparin, enoxaparin or bivalirudin in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: Insights from the ORBI registry.

BACKGROUND: Despite numerous studies in recent years, the best anticoagulant option for primary percutaneous coronary intervention (PCI) remains a matter of debate. AIMS: To compare in-hospital outcomes after prehospital administration of low-dose unfractionated heparin (UFH)±glycoprotein IIb/IIIa inhibitors (GPIs), enoxaparin±GPIs, or bivalirudin in patients undergoing primary PCI for ST-segment elevation myocardial infarction (STEMI). METHODS: A total of 1720 patients (median age 62.0 years, 79.2% male) who had been enrolled in a prospective registry and received an injectable anticoagulant in physician-staffed mobile intensive care units before primary PCI were included in the study. The main outcomes were in-hospital major adverse cardiovascular events (MACE) (a composite of all-cause mortality, non-fatal myocardial infarction, stroke or definite stent thrombosis) and in-hospital major bleeding (Bleeding academic research consortium type 3 or 5). RESULTS: UFH was administered in 420 (24.4%) patients, enoxaparin in 1163 (67.6%) patients and bivalirudin in 137 patients (8.0%). Rates of in-hospital MACE were 7.4% with UFH, 6.0% with enoxaparin and 6.6% with bivalirudin, with no significant differences between groups (P=0.628). In-hospital major bleeding occurred in 1.7% of patients on UFH, 1.4% on enoxaparin and 1.5% on bivalirudin (P=0.851). By multivariable analysis, the prehospital anticoagulant used was not an independent predictor of MACE or major bleeding. CONCLUSION: In this prospective registry, there were no significant differences in the rates of in-hospital MACE or major bleeding after prehospital initiation of UFH, enoxaparin or bivalirudin in patients treated by primary PCI for STEMI.

Incidence, timing, predictors and impact of acute heart failure complicating ST-segment elevation myocardial infarction in patients treated by primary percutaneous coronary intervention.

BACKGROUND: Acute heart failure (AHF) complicating ST-segment elevation myocardial infarction (STEMI) is recognized as an ominous complication. Previous studies mostly reported outcomes of heterogeneous, non-contemporary population. Moreover, few studies assessed the prognosis of AHF according to its timing. This study evaluated incidence, predictors and impact of AHF according to its timing in a homogeneous STEMI patients population treated by primary percutaneous coronary intervention (pPCI). METHODS: Data from 6282 patients included in a prospective multicenter registry were analyzed. Patients with AHF (Killip class>I) were compared to patients without AHF and patients with admission AHF were compared to patients who developed in-hospital AHF. In-hospital mortality was the primary endpoint of the study. Propensity-score matching and multivariable regression were used to adjust for confounders. RESULTS: A total of 1328 patients (21.1%) presented AHF: 739 on admission and 589 during hospitalization. AHF was associated with a markedly increased in-hospital mortality rate (19.9% vs. 0.8%, p<0.001). There was a gradual excess risk with each Killip class and admission AHF patients displayed the highest crude mortality rate (24.1%). By multivariable analysis, AHF was the strongest independent predictor of in-hospital mortality (HR=3.852 (2.303-6.442), p<0.001) without evidence of any difference according to its timing (HR=0.947 (0.638-1.372), p=0.767). These results were consistent after extensive adjustment on baseline characteristics in the matched cohorts. Among other predictors, pPCI beyond guidelines-recommended delays and stent thrombosis were independently associated with AHF. CONCLUSION: AHF regardless of its timing remains a common and dreadful complication of STEMI in the contemporary era.

Safety of prasugrel in real-world patients with ST-segment elevation myocardial infarction: 1-year results from a prospective observational study (Bleeding and Myocardial Infarction Study).

BACKGROUND: Antiplatelet therapies, including prasugrel, are a cornerstone in the treatment of ST-segment elevation myocardial infarction (STEMI), but are associated with a bleeding risk. This risk has been evaluated in randomized trials, but few data on real-world patients are available. AIM: To evaluate prasugrel safety in real-world patients with STEMI. METHODS: Consecutive patients with STEMI were recruited over 1 year. Follow-up was done at 3 months and 1 year to evaluate prasugrel safety from hospital discharge to the STEMI anniversary date. The primary outcome was occurrence of any major bleeding according to the Bleeding Academic Research Consortium (BARC) 3 or 5 definitions, or minor bleeding according to the BARC 2 definition. RESULTS: Overall, 1083 patients were recruited. Compared to patients treated with aspirin+clopidogrel, patients treated with aspirin+prasugrel had fewer BARC 3 or 5 bleedings (two [0.4%] patients vs. nine [1.8%] patients; P=0.04), but more BARC 2 bleedings (45 [9.3%] patients vs. 20 [4.0%] patients; P<0.001). The baseline characteristics of prasugrel- and clopidogrel-treated patients differed because the former were carefully selected (younger, higher body mass index, less frequent history of stroke). In the overall population, rates of in-hospital and out-of-hospital major bleeding were 2.6% (n=28) and 1.3% (n=13), respectively. CONCLUSION: The rate of major bleeding, particularly out-of-hospital bleeding, in patients treated with prasugrel is low within 1 year after a STEMI. Accurate selection of patient candidates for prasugrel is likely to have reduced the risk of bleeding.

High-degree atrioventricular block complicating ST segment elevation myocardial infarction in the contemporary era.

BACKGROUND: High-degree atrioventricular block (HAVB) is a common complication of ST segment elevation myocardial infarction (STEMI). HAVB in STEMI is historically considered as a marker of worse outcome but overall data about HAVB in the contemporary era of mechanical reperfusion and potent antiplatelet therapies are scarce. AIM: Analysing incidence, clinical correlates and impact on inhospital outcomes of HAVB in a large prospective registry (Observatoire Régional Breton sur l'Infarctus, ORBI) of modern management of STEMI with a special focus on potential differences between patients with HAVB on admission and those who developed HAVB during hospitalisation. METHODS: All patients enrolled in ORBI between June 2006 and December 2013 were included in the present analysis and were divided into 3 groups: patients without HAVB at any time, patients with HAVB on admission and those who developed HAVB during hospitalisation. RESULTS: A total of 6662 patients (age: 62.0 (52.0-74.0) years; male: 76.3%) were included in the present analysis. HAVB was documented in 3.5% of patients, present on admission in 63.7% of patients and occurring during hospitalisation in 36.3%. Patients with HAVB on admission or occurring during the first 24 h of hospitalisation had higher inhospital mortality rates (18.1% and 28.6%, respectively) than patients without (4.5%) or with HAVB occurring beyond the first 24 h of hospitalisation (8.0%). However by multivariable analysis, HAVB was not independently associated with inhospital mortality contrarily to age, presentation as cardiac arrest, anterior STEMI location, reperfusion therapy, cardiogenic shock, mechanical ventilation and occurrence of sustained ventricular tachyarrhythmias or mechanical complication. CONCLUSIONS: Patients with HAVB had a higher mortality rate than patients without. However HAVB is not an independent predictor of inhospital mortality.

6- versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin: the randomized, multicenter ITALIC trial.

BACKGROUND: The currently recommended duration of dual antiplatelet therapy (DAPT) in drug-eluting stent (DES) recipients is 12 months to reduce the risk of late stent thrombosis, particularly in those with acute coronary syndrome (ACS). OBJECTIVES: This study hypothesized that antiplatelet treatment with DAPT for 6 months may be noninferior to 24-month DAPT in aspirin-sensitive patients. METHODS: A multicenter, randomized study assigned patients undergoing implantation of everolimus-eluting stents with confirmed nonresistance to aspirin to receive 6- or 24-month DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post-stenting. RESULTS: A total of 2,031 patients were enrolled in 70 European and Middle Eastern centers. The trial was prematurely terminated due to recruitment problems, leaving 941 patients randomized to 24-month DAPT and 953 to 6-month DAPT. The 2 treatment groups had similar baseline and procedural characteristics. There was no significant difference in the primary endpoint (24-month: 1.5% vs. 6-month: 1.6%; p = 0.85). Noninferiority was demonstrated for 6- versus 24-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: -1.04% to 1.26%; p for noninferiority = 0.0002). There were no significant differences in stent thrombosis or bleeding complications. In the 792 (44%) high-risk patients with ACS, primary and secondary endpoints did not significantly differ (hazard ratio: 1.7 [95% confidence interval: 0.519 to 6.057; p = 0.361]). CONCLUSIONS: Rates of bleeding and thrombotic events were not significantly different according to 6- versus 24-month DAPT after PCI with new-generation DES in good aspirin responders. (Is There A LIfe for DES After Discontinuation of Clopidogrel [ITALICplus]; NCT01476020).

Efficacy of pre-hospital use of glycoprotein IIb/IIIa inhibitors in ST-segment elevation myocardial infarction before mechanical reperfusion in a rapid-transfer network (from the Acute Myocardial Infarction Registry of Brittany).

Previous studies investigating prehospital use of glycoprotein IIb/IIIa inhibitors (GPIs) in patients with ST-segment elevation myocardial infarction reached conflicting conclusions. The benefit of this strategy in addition to in-ambulance loading of dual-antiplatelet therapy remains controversial. The aim of this study was to analyze data from a prospective registry of patients with ST-segment elevation myocardial infarctions admitted <24 hours after symptom onset (July 2006 to May 2012). A total of 2,052 patients managed in a physician-staffed mobile intensive care unit (MICU)<12 hours after symptom onset and scheduled for primary percutaneous coronary intervention (PPCI) were retrospectively included. Patients who received GPIs in the MICU were compared with those who did not. The primary end point was infarct-related artery patency, defined as pre-PPCI Thrombolysis In Myocardial Infarction (TIMI) flow grade 3. GPIs were administered in the MICU to 737 patients (36%), including 430<2 hours after symptom onset, and 1,315 patients (64%) did not received prehospital GPIs. Pre-PPCI TIMI flow grade 3 rate was lower in patients treated in the MICU (17.2% vs 21.3%, p=0.03) because of patients treated >2 hours after symptom onset, of whom only 12.7% reached the primary end point. There was no significant difference between groups in the rate of in-hospital major adverse cardiac events. In conclusion, prehospital GPI use in patients with ST-segment elevation myocardial infarctions<12 hours after symptom onset scheduled for PPCI neither improved pre-PPCI infarct-related artery patency nor reduced in-hospital major adverse cardiac events.

Gender differences in presentation, management and inhospital outcome in patients with ST-segment elevation myocardial infarction: data from 5000 patients included in the ORBI prospective French regional registry.

BACKGROUND: Gender differences in presentation, management and outcome in patients with ST-segment elevation myocardial infarction (STEMI) have been reported. AIM: To determine whether female gender is associated with higher inhospital mortality. METHODS: Data from ORBI, a regional STEMI registry of 5 years' standing, were analysed. The main data on presentation, management, inhospital outcome and prescription at discharge were compared between genders. Various adjusted hazard ratios were then calculated for inhospital mortality (women versus men). RESULTS: The analysis included 5000 patients (mean age 62.6±13 years), with 1174 women (23.5%). Women were on average 8 years older than men, with more frequent co-morbidities. Median ischaemia time was 215 minutes (26 minutes longer in women; P<0.05). Reperfusion strategies in women less frequently involved fibrinolysis, coronary angiography, radial access and thrombo-aspiration. Female gender, especially in patients aged<60 years, was associated with poorer inhospital prognosis (including higher inhospital mortality: 9% vs. 4% in men; P<0.0001), and underutilization of recommended treatments at discharge. Moreover, excess female inhospital mortality was independent of presentation, revascularization time and reperfusion strategy (hazard ratio for women 1.33, 95% confidence interval 1.01-1.76; P=0.04). CONCLUSIONS: One in four patients admitted for STEMI was female, with significant differences in presentation. Female gender was associated with less-optimal treatment, both in the acute-phase and at discharge. Efforts should be made to reduce these differences, especially as female gender was independently associated with an elevated risk of inhospital mortality.

Door-to-balloon delays before primary angioplasty in the Regional Acute Myocardial Infarction Registry of Brittany. An analysis of the Observatoire Régional Breton sur l'Infarctus du myocarde (ORBI).

BACKGROUND: Minimizing delays to coronary reperfusion is critical in the management of acute myocardial infarction (AMI). AIMS: To determine delays in in-hospital management and factors associated with delays of over 45min. METHODS: We analysed data from the Observatoire Régional Breton sur l'Infarctus, a registry of AMI patients admitted within 24h of symptom onset (July 2007 to December 2008) to an interventional cardiology centre in Brittany. Prehospital delay was defined as time between first responder arrival at the patient and patient arrival at an interventional cardiovascular centre. In-hospital delay was defined as time between admission to the interventional cardiovascular centre and first balloon inflation. Patients were grouped according to duration of in-hospital delay (>45 vs