Ticagrelor vs Clopidogrel in Clopidogrel-Naive Patients With Chronic Coronary Syndrome.

BACKGROUND: Whether ticagrelor may reduce periprocedural myocardial necrosis after elective percutaneous coronary intervention (PCI) in patients with and without chronic clopidogrel therapy is unclear. OBJECTIVES: This study sought to compare ticagrelor vs clopidogrel in patients with and without chronic clopidogrel therapy before undergoing elective PCI. METHODS: In this prespecified analysis of the ALPHEUS (Assessment of Loading With the P2Y12 Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting) trial, patients were defined as clopidogrel(+) and clopidogrel(-) according to the presence and absence of clopidogrel treatment for ≥7 days before PCI, respectively. The primary endpoint was the composite of PCI-related myocardial infarction and major injury as defined by the third and fourth universal definition 48 hours after PCI. RESULTS: A total of 1,882 patients were included, 805 (42.7%) of whom were clopidogrel(+). These patients were older, had more comorbidities, and had more frequent features of complex PCI. The primary endpoint was less frequently present in clopidogrel(-) compared to clopidogrel(+) patients (32.8% vs 40.0%; OR: 0.73; 95% CI: 0.60-0.88), but no significant differences were reported for the risk of death, myocardial infarction, stroke, or transient ischemic attack at 48 hours or 30 days. Ticagrelor did not reduce periprocedural myocardial necrosis or the risk of adverse outcomes, and there was no significant interaction regarding the presence of chronic clopidogrel treatment. CONCLUSIONS: Clopidogrel-naive patients presented less periprocedural complications compared to clopidogrel(+) patients, a difference related to a lower risk profile and less complex PCI. The absence of clopidogrel at baseline did not affect the absence of a difference between ticagrelor and clopidogrel in terms of PCI-related complications supporting the use of clopidogrel as the standard of care in elective PCI in patients with or without chronic clopidogrel treatment.

Optimal Heart Failure Medical Therapy and Mortality in Survivors of Cardiogenic Shock: Insights From the FRENSHOCK Registry.

BACKGROUND: The effects of pharmacological therapy on cardiogenic shock (CS) survivors have not been extensively studied. Thus, this study investigated the association between guideline-directed heart failure (HF) medical therapy (GDMT) and one-year survival rate in patients who are post-CS. METHODS AND RESULTS: FRENSHOCK (French Observatory on the Management of Cardiogenic Shock in 2016) registry was a prospective multicenter observational survey, conducted in metropolitan French intensive care units and intensive cardiac care units. Of 772 patients, 535 patients were enrolled in the present analysis following the exclusion of 217 in-hospital deaths and 20 patients with missing medical records. Patients with triple GDMT (beta-blockers, renin-angiotensin system inhibitors, and mineralocorticoid receptor antagonists) at discharge (n=112) were likely to have lower left ventricular ejection fraction on admission and at discharge compared with those without triple GDMT (n=423) (22% versus 28%, P<0.001 and 29% versus 37%, P<0.001, respectively). In the overall cohort, the one-year mortality rate was 23%. Triple GDMT prescription was significantly associated with a lower one-year all-cause mortality compared with non-triple GDMT (adjusted hazard ratio 0.44 [95% CI, 0.19-0.80]; P=0.007). Similarly, 2:1 propensity score matching and inverse probability treatment weighting based on the propensity score demonstrated a lower incidence of one-year mortality in the triple GDMT group. As the number of HF drugs increased, a stepwise decrease in mortality was observed (log rank; P<0.001). CONCLUSIONS: In survivors of CS, the one-year mortality rate was significantly lower in those with triple GDMT. Therefore, this study suggests that intensive HF therapy should be considered in patients following CS.

Cardiogenic Shock in Idiopathic Dilated Cardiomyopathy Patients: Red Flag for Myocardial Decline.

Idiopathic dilated cardiomyopathy (IDCM) is one of the most common forms of nonischemic cardiomyopathy worldwide, possibly leading to cardiogenic shock (CS). Despite this heavy burden, the outcomes of CS in IDCM are poorly reported. Based on a large registry of unselected CS, our aim was to shed light on the 1-year outcomes after CS in patients with and without IDCM. FRENSHOCK was a prospective registry including 772 patients with CS from 49 centers. The 1-year outcomes (rehospitalizations, mortality, heart transplantation [HTx], ventricular assist devices [VAD]) were analyzed and adjusted on independent predictive factors. Within 772 CS included, 78 occurred in IDCM (10.1%). Patients with IDCM had more frequent history of chronic kidney failure and implantable cardioverter-defibrillator implantation. No difference was found in 1-month all-cause mortality between groups (28.2 vs 25.8%for IDCM and others, respectively; adjusted hazard ratio 1.14 [0.73 to 1.77], p = 0.57). Patients without IDCM were more frequently treated with noninvasive ventilation and intra-aortic balloon pump. At 1 year, IDCM led to higher rates of death or cardiovascular rehospitalizations (adjusted odds ratio 4.77 [95% confidence interval 1.13 to 20.1], p = 0.03) and higher rates of HTx or VAD for patients aged <65 years (adjusted odds ratio 2.68 [1.21 to 5.91], p = 0.02). In conclusion, CS in IDCM is a very common scenario and is associated with a higher rate of 1-year death or cardiovascular rehospitalizations and a more frequent recourse to HTx or VAD for patients aged <65 years, encouraging the consideration of it as a red flag for myocardial decline and urging for a closer follow-up and earlier evaluation for advanced heart failure therapies.

Intravenous enoxaparin or unfractionated heparin in primary percutaneous coronary intervention for ST-elevation myocardial infarction: the international randomised open-label ATOLL trial.

BACKGROUND: Primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction has traditionally been supported by unfractionated heparin, which has never been directly compared with a new anticoagulant using consistent anticoagulation and similar antiplatelet strategies in both groups. We compared traditional heparin treatment with intravenous enoxaparin in primary PCI. METHODS: In a randomised open-label trial, patients presenting with ST-elevation myocardial infarction were randomly assigned (1:1) to receive an intravenous bolus of 0·5 mg/kg of enoxaparin or unfractionated heparin before primary PCI. Wherever possible, medical teams travelling in mobile intensive care units (ambulances) selected, randomly assigned (using an interactive voice response system at the central randomisation centre), and treated patients. Patients who had received any anticoagulant before randomisation were excluded. Patients and caregivers were not masked to treatment allocation. The primary endpoint was 30-day incidence of death, complication of myocardial infarction, procedure failure, or major bleeding. The main secondary endpoint was the composite of death, recurrent acute coronary syndrome, or urgent revascularisation. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, number NCT00718471. FINDINGS: 910 patients were assigned to treatment with enoxaparin (n=450) or unfractionated heparin (n=460). The primary endpoint occurred in 126 (28%) patients after anticoagulation with enoxaparin versus 155 (34%) patients on unfractionated heparin (relative risk [RR] 0·83, 95% CI 0·68-1·01, p=0·06). The incidence of death (enoxaparin, 17 [4%] vs heparin, 29 [6%] patients; p=0·08), complication of myocardial infarction (20 [4%] vs 29 [6%]; p=0·21), procedure failure (100 [26%] vs 109 [28%]; p=0·61), and major bleeding (20 [5%] vs 22 [5%]; p=0·79) did not differ between groups. Enoxaparin resulted in a significantly reduced rate of the main secondary endpoint (30 [7%] vs 52 [11%] patients; RR 0·59, 95% CI 0·38-0·91, p=0·015). Death, complication of myocardial infarction, or major bleeding (46 [10%] vs 69 [15%] patients; p=0·03), death or complication of myocardial infarction (35 [8%] vs 57 [12%]; p=0·02), and death, recurrent myocardial infarction, or urgent revascularisation (23 [5%] vs 39 [8%]; p=0·04) were all reduced with enoxaparin. INTERPRETATION: Intravenous enoxaparin compared with unfractionated heparin significantly reduced clinical ischaemic outcomes without differences in bleeding and procedural success. Therefore, enoxaparin provided an improvement in net clinical benefit in patients undergoing primary PCI. FUNDING: Direction de la Recherche Clinique, Assistance Publique-Hôpitaux de Paris; Sanofi-Aventis.

Characteristics and Prognosis of Patients With Fibromuscular Dysplasia in a Population of Spontaneous Coronary Artery Dissections (from the French Registry of Spontaneous Coronary Artery Dissections "DISCO").

Spontaneous coronary artery dissection (SCAD) and fibromuscular dysplasia (FMD) are pathologies that appear to be closely related. This study compares the characteristics of the FMD population to the non-FMD population in a SCAD cohort. It thus assesses the involvement of the FMD phenotype in a SCAD population. From the data of the French DISCO registry, we included patients with a diagnosis of SCAD and in whom a search for FMD was performed. We collected the following characteristics of this population: the clinical and angiographic presentation, the data concerning the management, and the events occurring during the follow-up. In the 373 SCADs confirmed in the DISCO registry, we obtained imaging data for 340 of them. FMD was found in 45% of cases. The mean age was higher in the FMD group, 53.2 ± 8.8 years, versus 50.1 ± 11 years in the non-FMD group. High blood pressure and postmenopausal status were significantly higher in the FMD group. Clinical presentation, angiographic data, and management were comparable. The major adverse cardiac event rate and recurrence rate were not different between the 2 groups after 1 year of follow-up. In conclusion, we confirmed a 45% prevalence of FMD in the SCAD population. The median age was higher in the FMD group, suggesting that FMD may develop over time. The rate of major adverse cardiac events and recurrence were similar in the FMD group versus the non-FMD group after 1 year of follow-up.

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.

Current indications for the intra-aortic balloon pump: The CP-GARO registry.

BACKGROUND: Intra-aortic balloon pumps (IABPs) have been used routinely since the 1970s. Recently, large randomized trials failed to show that IABP therapy has meaningful benefit, and international recommendations downgraded its place, particularly in cardiogenic shock. AIMS: The aim of this registry was to describe the contemporary use of IABP therapy, in light of these new data. METHODS: This prospective multicentre registry included 172 patients implanted with an IABP in 19 French cardiac centres in 2015. Baseline characteristics, aetiologies leading to IABP use, and IABP-related and disease-related complications were assessed. In-hospital and 1-year mortality rates were studied. RESULTS: A total of 172 patients were included (mean age 65.5±12.0 years; 118 men [68.6%]). The reasons for IABP implantation were mainly haemodynamic (n=107; 62.2%), followed by bridge to revascularization (n=34; 19.8%) and four other "rare" aetiologies (n=29 patients; 16.8%). In-hospital and 1-year mortality rates were 40.7% and 45.8%, respectively. Fourteen patients (8.1%) experienced ischaemic or haemorrhagic complications, which were directly related to the IABP in seven patients (4.1%). CONCLUSIONS: Despite current international guidelines regarding the place of IABPs in ischaemic cardiogenic shock without mechanical complications, this aetiology remains the leading cause for its utilization 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.