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Background: In patients with ST-segment-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention, reperfusion injury accounts for a significant fraction of the final infarct size, which is directly related to patient prognosis. In animal studies, brief periods of ischemia in noninfarct-related (nonculprit) coronary arteries protect the culprit myocardium via remote ischemic preconditioning. Positive fractional flow reserve (FFR) documents functional significant coronary nonculprit stenosis, which may offer remote ischemic preconditioning of the culprit myocardium. The aim of the study was to investigate the association between functional significant, multivessel disease (MVD) and reduced culprit final infarct size or increased myocardial salvage (myocardial salvage index [MSI]) in a large contemporary cohort of STEMI patients., Methods: Cardiac magnetic resonance was performed in 610 patients with STEMI at day 1 and 3 months after primary percutaneous coronary intervention. Patients were stratified into 3 groups according to FFR measurements in nonculprit stenosis (if any): angiographic single vessel disease (SVD), FFR nonsignificant MVD (functional SVD), or FFR-significant, functional MVD., Results: A total of 431 (71%) patients had SVD, 35 (6%) had functional SVD, and 144 (23%) had functional MVD. There was no difference in final infarct size (mean infarct size [%left ventricular mass] SVD, 9±3%; functional SVD, 9±3%; and functional MVD, 9±3% [ P =0.82]) or in MSI between groups (mean MSI [%left] SVD, 66±23%; functional SVD, 68±19%; and functional MVD, 69±19% [ P =0.62]). In multivariable analyses, functional MVD was not associated with larger MSI ( P =0.56) or smaller infarct size ( P =0.55)., Conclusions: Functional MVD in nonculprit myocardium was not associated with reduced culprit final infarct size or increased MSI following STEMI. This is important knowledge for future studies examining a cardioprotective treatment in patients with STEMI, as a possible confounding effect of FFR-significant, functional MVD can be discarded. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01435408 (DANAMI 3-iPOST and DANAMI 3-DEFER) and NCT01960933 (DANAMI 3-PRIMULTI).

Aims: The aim of this substudy was to investigate the correlation between fractional flow reserve (FFR) and diameter stenosis in patients with STEMI with and without left ventricular hypertrophy (LVH), and the influence of LVH on complete FFR-guided revascularisation versus culprit only, in terms of risk of clinical outcome., Methods and Results: In this DANAMI-3-PRIMULTI substudy, 279 patients with STEMI had cardiac magnetic resonance (CMR) imaging for assessment of left ventricular mass index. Ninety-six patients had FFR evaluation of a non-culprit lesion. Diameter stenosis of the non-culprit lesion was determined with two-dimensional quantitative coronary analysis. The diameter stenosis (56.9% vs 54.3%, p=0.38) and FFR value (0.83 vs 0.85, p=0.34) were significantly correlated in both groups (Spearman's ρ=-0.40 and -0.41 without LVH and with LVH, respectively; p<0.001) but were not different between patients without and with LVH (p for interaction=0.87). FFR-guided complete revascularisation was associated with reduced risk of death, myocardial infarction or ischaemia-driven revascularisation both for patients without LVH (HR 0.42, 95% CI: 0.20-0.85) and for patients with LVH (HR 0.50, 95% CI: 0.17-1.47), with no interaction between the FFR-guided complete revascularisation and LVH (p for interaction=0.82)., Conclusions: LVH did not interact with the correlation between diameter stenosis and FFR and did not modify the impact of complete revascularisation on the occurrence of subsequent clinical events.

Background: Treatment with newer direct-acting anti-platelet drugs (Ticagrelor and Prasugrel) prior to primary percutaneous coronary intervention (PCI) is associated with improved outcome in patients with ST-segment elevation myocardial infarction (STEMI) when compared with Clopidogrel. We compared infarct size following treatment with Ticagrelor/Prasugrel versus Clopidogrel in the DANish trial in Acute Myocardial Infarction (DANAMI-3) population of STEMI patients treated with primary PCI., Methods and Results: Patients were loaded with Clopidogrel, Ticagrelor or Prasugrel in the ambulance before primary PCI. Infarct size and myocardial salvage index were calculated using cardiac magnetic resonance (CMR) during index admission and at three-month follow-up. Six-hundred-and-ninety-three patients were included in this analysis. Clopidogrel was given to 351 patients and Ticagrelor/Prasugrel to 342 patients. The groups were generally comparable in terms of baseline and procedural characteristics. Median infarct size at three-month follow-up was 12.9% vs 10.0%, in patients treated with Clopidogrel and Ticagrelor/ Prasugrel respectively (p < 0.001), and myocardial salvage index was 66% vs 71% (p < 0.001). Results remained significant in a multiple regression model (p < 0.001)., Conclusions: Pre-hospital loading with Ticagrelor or Prasugrel compared to Clopidogrel, was associated with smaller infarct size and larger myocardial salvage index at three-month follow-up in patients with STEMI treated with primary PCI., Competing Interests: Declaration of competing interest The authors have no conflicts of interest to declare., (Copyright © 2020. Published by Elsevier B.V.)

Objectives: The aim of this study was to evaluate the effect of fractional flow reserve (FFR)-guided revascularization compared with culprit-only percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) on infarct size, left ventricular (LV), function, LV remodeling, and the presence of nonculprit infarctions., Background: Patients with STEMI with multivessel disease might have improved clinical outcomes after complete revascularization compared with PCI of the infarct-related artery only, but the impact on infarct size, LV function, and remodeling as well as the risk for periprocedural infarction are unknown., Methods: In this substudy of the DANAMI-3 (Third Danish Trial in Acute Myocardial Infarction)-PRIMULTI (Primary PCI in Patients With ST-Elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization) randomized trial, patients with STEMI with multivessel disease were randomized to receive either complete FFR-guided revascularization or PCI of the culprit vessel only. The patients underwent cardiac magnetic resonance imaging during index admission and at 3-month follow-up., Results: A total of 280 patients (136 patients with infarct-related and 144 with complete FFR-guided revascularization) were included. There were no differences in final infarct size (median 12% [interquartile range: 5% to 19%] vs. 11% [interquartile range: 4% to 18%]; p = 0.62), myocardial salvage index (median 0.71 [interquartile range: 0.54 to 0.89] vs. 0.66 [interquartile range: 0.55 to 0.87]; p = 0.49), LV ejection fraction (mean 58 ± 9% vs. 59 ± 9%; p = 0.39), and LV end-systolic volume remodeling (mean 7 ± 22 ml vs. 7 ± 19 ml; p = 0.63). New nonculprit infarction occurring after the nonculprit intervention was numerically more frequent among patients treated with complete revascularization (6 [4.5%] vs. 1 [0.8%]; p = 0.12)., Conclusions: Complete FFR-guided revascularization in patients with STEMI and multivessel disease did not affect final infarct size, LV function, or remodeling compared with culprit-only PCI., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The aim of this study was to examine the patterns and clinical impact of differing modes of dual-antiplatelet therapy (DAPT) cessation after percutaneous coronary intervention (PCI) in patients presenting with and without acute coronary syndromes (ACS). The PARIS (patterns of nonadherence to antiplatelet regimens in stented patients) registry was a multicenter study of 5,018 patients who underwent PCI. DAPT cessation was categorized as physician-recommended discontinuation, interruption, or disruption. Overall rates of 2-year DAPT discontinuation did not differ between non-ACS and ACS patients (38.8% vs 37.2%, p = 0.252). ACS patients were less likely to interrupt DAPT (8.5% vs 10.7% p<0.001), but were more likely to disrupt DAPT (16.4% vs 11.9%, p<0001). Adverse events after DAPT cessation were highest after disruption, intermediate with discontinuation, and lowest with interruption across both groups. Disruption of DAPT predicted MACE in both ACS patients (hazard ratio [HR] 2.89 [1.88 to 4.45; p<0.001]) and non-ACS patients (HR 2.08 [1.29 to 3.35; p = 0.002]). Interruption of DAPT predicated MACE in ACS patients (HR 2.72 [1.35 to 5.48]) but not in non-ACS patients (HR 0.44 [0.14 to 1.40]; p interaction ≤0.01). In conclusion, the incidence of DAPT cessation mode differs by presentation with or without ACS. Physician guided DAPT discontinuation was the most common mode of DAPT cessation and appears to be safe across both groups. There were higher rates of adverse events associated with the interruption of DAPT in ACS patients., (Copyright © 2018. Published by Elsevier Inc.)

Background: Midregional proadrenomedullin (MR-proADM) has demonstrated prognostic potential after myocardial infarction (MI). Yet, the prognostic value of MR-proADM at admission has not been examined in patients with ST-segment-elevation MI (STEMI)., Methods and Results: The aim of this substudy, DANAMI-3 (The Danish Study of Optimal Acute Treatment of Patients with ST-segment-elevation myocardial infarction), was to examine the associations of admission concentrations of MR-proADM with short- and long-term mortality and hospital admission for heart failure in patients with ST-segment-elevation myocardial infarction. Outcomes were assessed using Cox proportional hazard models and area under the curve using receiver operating characteristics. In total, 1122 patients were included. The median concentration of MR-proADM was 0.64 nmol/L (25th-75th percentiles, 0.53-0.79). Within 30 days 23 patients (2.0%) died and during a 3-year follow-up 80 (7.1%) died and 38 (3.4%) were admitted for heart failure. A doubling of MR-proADM was, in adjusted models, associated with an increased risk of 30-day mortality (hazard ratio, 2.67; 95% confidence interval, 1.01-7.11; P =0.049), long-term mortality (hazard ratio, 3.23; 95% confidence interval, 1.97-5.29; P <0.0001), and heart failure (hazard ratio, 2.71; 95% confidence interval, 1.32-5.58; P =0.007). For 30-day and 3-year mortality, the area under the curve for MR-proADM was 0.77 and 0.78, respectively. For 3-year mortality, area under the curve (0.84) of the adjusted model marginally changed (0.85; P =0.02) after addition of MR-proADM., Conclusions: Elevation of admission MR-proADM was associated with long-term mortality and heart failure, whereas the association with short-term mortality was borderline significant. MR-proADM may be a marker of prognosis after ST-segment-elevation myocardial infarction but does not seem to add substantial prognostic information to established clinical models., Clinical Trial Registration: URL: http:/www.ClinicalTrials.gov/. Unique identifiers: NCT01435408 and NCT01960933., (© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Background: Terminal "QRS distortion" on the electrocardiogram (ECG) (based on Sclarovsky-Birnbaum's Grades of Ischemia Score) is a sign of severe ischemia, associated with adverse cardiovascular outcome in ST-segment elevation myocardial infarction (STEMI). In addition, ECG indices of the acuteness of ischemia (based on Anderson-Wilkins Acuteness Score) indicate myocardial salvage potential. We assessed whether severe ischemia with or without acute ischemia is predictive of infarct size (IS), myocardial salvage index (MSI) and left ventricular ejection fraction (LVEF) in anterior versus inferior infarct locations., Methods: In STEMI patients, the severity and acuteness scores were obtained from the admission ECG. Based on the ECG patients were assigned with severe or non-severe ischemia and acute or non-acute ischemia. Cardiac magnetic resonance (CMR) was performed 2-6days after primary percutaneous coronary intervention (pPCI). LVEF was measured by echocardiography 30days after pPCI., Results: ECG analysis of 85 patients with available CMR resulted in 20 (23%) cases with severe and non-acute ischemia, 43 (51%) with non-severe and non-acute ischemia, 17 (20%) with non-severe and acute ischemia, and 5 (6%) patients with severe and acute ischemia. In patients with anterior STEMI (n=35), ECG measures of severity and acuteness of ischemia identified significant and stepwise differences in myocardial damage and function. Patients with severe and non-acute ischemia had the largest IS, smallest MSI and lowest LVEF. In contrast, no difference was observed in patients with inferior STEMI (n=50)., Conclusions: The applicability of ECG indices of severity and acuteness of myocardial ischemia to estimate myocardial damage and salvage potential in STEMI patients treated with pPCI, is confined to anterior myocardial infarction., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Temporary interruption of dual antiplatelet therapy (DAPT) is not infrequently required in patients undergoing percutaneous coronary intervention (PCI). We sought to describe the procedures and outcomes associated with DAPT interruption in patients treated with DAPT following successful PCI from the Patterns of non-adherence to anti-platelet regimens in stented patients registry (n = 5018). DAPT interruption was prespecified as physician recommended cessation for <14 days. Of the study cohort, 490 patients (9.8%) experienced 594 DAPT interruptions over 2 years following PCI. Only 1 antiplatelet agent was interrupted in 57.2% cases and interruption was frequently recommended by noncardiologists (51.3%). Where type of surgery was reported, majority of DAPT interruptions occurred for minor surgery (68.4% vs 31.6%) and a similar cessation pattern of single versus dual antiplatelet cessation was observed regardless of minor or major surgery. Subsequent to DAPT interruption, 12 patients (2.4%) experienced 1 thrombotic event each, of which 5 (1.0%) occurred during the interruption period. All events occurred in patients who either stopped both agents (8 of 12) or clopidogrel-only (4 of 12), with no events occurring due to aspirin cessation alone. In conclusion, in the Patterns of Non-adherence to Anti-platelet Regiments in Stented Patients registry, 1 in 10 patients were recommended DAPT interruption for surgery within 2 years of PCI. Interruption was more common for a single agent rather than both antiplatelet agents regardless of severity of surgery, and was frequently recommended by noncardiologists. Only 1% of patients with DAPT interruption experienced a subsequent thrombotic event during the interruption period, which mainly occurred in patients stopping both antiplatelet agents., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Although some studies found improved coronary flow and myocardial salvage when stent implantation was deferred, the DANAMI-3-DEFER (Third DANish Study of Optimal Acute Treatment of Patients With ST-elevation Myocardial Infarction) did not show any improvement in clinical outcome in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI) and deferred stenting., Objectives: This study sought to evaluate the effect of deferred stent implantation on infarct size, myocardial salvage, and microvascular obstruction (MVO) in patients with STEMI., Methods: In the present DANAMI-3 substudy, a total of 510 patients with STEMI were randomized to PCI with deferred versus immediate stent implantation. The patients underwent a cardiac magnetic resonance examination before discharge after the index procedure and again 3 months later. The primary endpoint was final infarct size., Results: Deferred stenting did not reduce final infarct size (9% left ventricle [LV]; interquartile range [IQR]: 3% to 18% vs. 10% LV; IQR: 3% to 18%; p = 0.67). Similarly, deferred stenting was not associated with myocardial salvage index (66%; IQR: 50% to 89% vs. 67%; IQR: 49% to 88%; p = 0.80) or presence of MVO (43% vs. 42%; p = 0.78). In a post hoc analysis, stent length was the only subgroup of 7 that had an effect on outcome. In patients with a stent length ≥24 mm, deferred stenting reduced the final infarct size (6% LV; IQR: 2% to 18% vs. 13% LV; IQR: 7% to 23%; p = 0.006; and p for interaction = 0.005)., Conclusions: In the DANAMI-3-DEFER cardiac magnetic resonance substudy, routine deferred stenting did not reduce infarct size or MVO and did not increase myocardial salvage. These results do not support the use of routine deferred stenting in STEMI patients treated with primary PCI. (DANish Study of Optimal Acute Treatment of Patients With ST-elevation Myocardial Infarction [DANAMI-3]; NCT01435408)., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Pathological early Q waves (QW) are associated with adverse outcomes in patients with ST-segment-elevation myocardial infarction (STEMI). Primary percutaneous coronary intervention (PCI) may therefore be less beneficial in patients with QW than in patients without QW. Myocardial salvage index and microvascular obstruction (MVO) are markers for reperfusion success. Thus, to clarify the benefit from primary PCI in STEMI patients with QW, we examined the association between baseline QW and myocardial salvage index and MVO in STEMI patients treated with primary PCI., Methods and Results: The ECG was assessed before primary PCI for the presence of QW (early) in 515 STEMI patients. The patients underwent a cardiac magnetic resonance imaging scan at day 1 (interquartile range [IQR], 1-1) and again at day 92 (IQR, 89-96). Early QW was observed in 108 (21%) patients and was related to smaller final myocardial salvage index (0.59 [IQR, 0.39-0.69] versus 0.65 [IQR, 0.46-0.84]; P <0.001) and larger MVO (1.4 [IQR, 0.0-5.4] versus 0.0 [IQR, 0.0-2.4]; P <0.001) compared with non-QW. QW remained associated with both final myocardial salvage index (β=-0.12; P =0.03) and MVO (β=0.18; P =0.001) after adjusting for potential confounders., Conclusions: Patients presenting with their first STEMI and early QW in the ECG had smaller myocardial salvage index and more extensive MVO than non-QW despite treatment within 12 hours after symptom onset. However, final myocardial salvage index in patients with QW was substantial, and patients with QW still benefit from primary PCI., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01435408., (© 2017 American Heart Association, Inc.)

Background: Approximately one third of patients with ST-segment elevation myocardial infarction (STEMI) have left ventricular hypertrophy (LVH), which is associated with impaired outcome. However, the causal association between LVH and outcome in STEMI is unknown. We evaluated the association between LVH and: myocardial infarct size, area at risk, myocardial salvage, microvascular obstruction, left ventricular (LV) function (all determined by cardiac magnetic resonance [CMR]), and all-cause mortality and readmission for heart failure in STEMI patients treated with primary percutaneous coronary intervention., Methods and Results: In this substudy of the DANAMI-3 trial, 764 patients underwent CMR. LVH was defined by CMR and considered present if LV mass exceeded 77 (men) and 67 g/m 2 (women). One hundred seventy-eight patients (24%) had LVH. LVH was associated with a larger final infarct size (15% [interquartile range {IQR}, 10-21] vs 9% [IQR, 3-17]; P<0.001) and smaller final myocardial salvage index (0.6 [IQR, 0.5-0.7] vs 0.7 [IQR, 0.5-0.9]; P<0.001). The LVH group had a higher incidence of microvascular obstruction (66% vs 45%; P<0.001) and lower final LV ejection fraction (LVEF; 53% [IQR, 47-60] vs 61% [IQR, 55-65]; P<0.001). In a Cox regression analysis, LVH was associated with a higher risk of all-cause mortality and readmission for heart failure (hazard ratio 2.59 [95% CI, 1.38-4.90], P=0.003). The results remained statistically significant in multivariable models., Conclusions: LVH is independently associated with larger infarct size, less myocardial salvage, higher incidence of microvascular obstruction, lower LVEF, and a higher risk of all-cause mortality and incidence of heart failure in STEMI patients treated with primary percutaneous coronary intervention., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01435408., (© 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Women are frequently reported to have increased morbidity after presentation with acute coronary syndromes and myocardial infarction; however, whether a greater thrombotic tendency contributes to gender differences in clinical outcomes of urgent percutaneous coronary intervention is unknown. Intraprocedural Thrombotic Events (IPTEs) are defined as new or increasing thrombus, abrupt vessel closure, no reflow or slow reflow, or distal embolization at any time during percutaneous coronary intervention. IPTEs were evaluated in this pooled analysis of 6,591 patients with stent implantation and blinded quantitative coronary angiography (QCA) analysis, from the ACUITY and HORIZONS-AMI trials. We compared major adverse cardiac events (MACE) at in-hospital, 30-day, and 1-year follow-up and major bleeding at 30 days according to gender and the presence or absence of IPTE. IPTE was identified in 507 patients (7.7%), with 119 of 1,744 (6.8%) occurring in women and 388 of 4,847 (8.0%) in men (p = 0.12). IPTE, but not gender, was independently associated with MACE at in-hospital and 30-day follow-up. At 1-year follow-up, the adjusted hazard of MACE was higher in women and in patients with IPTE; however, the risk of MACE associated with IPTE was similar among women and men. There was no significant interaction between IPTE and gender for 1-year MACE or 30-day bleeding. IPTE predicted major bleeding only in women. In conclusion, in acute coronary syndromes, women have increased risk of adverse outcome at 1 year. IPTEs are common, occur at similar frequency, and are associated with similar degree of increased MACE in both genders at short- and long-term follow-up. Higher thrombotic propensity does not offer a mechanistic explanation for the worse outcomes noted in women., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Aims: In the HORIZONS-AMI trial, bivalirudin compared to unfractionated heparin (UFH) plus a glycoprotein IIb/IIIa inhibitor (GPI) improved net clinical outcomes in patients undergoing primary percutaneous coronary intervention (PCI) at the cost of an increased rate of acute stent thrombosis. We sought to examine whether these effects are dependent on time to treatment., Methods and Results: The interaction between anticoagulation regimen and symptom onset to first balloon inflation time (SBT) on the 30-day and three-year rates of major adverse cardiac events (MACE) was examined in 3,199 randomised patients according to SBT ≤3 hours versus >3 hours. Among patients with an SBT ≤3 hours, bivalirudin resulted in higher 30-day rates of MACE compared to UFH plus a GPI. Non-significant differences were observed in patients with an SBT >3 hours. Similar results were found for MACE at three years and stent thrombosis and reinfarction at 30 days and three years. By multivariable analysis, bivalirudin was an independent predictor of MACE at 30 days and three years in patients with an SBT ≤3 hours, but not in patients with SBT >3 hours., Conclusions: Bivalirudin compared to UFH plus a GPI is associated with an increased rate of stent thrombosis and MACE in patients with short SBTs, but not in those with longer SBTs.

An increasing hemoglobin A1c (HbA1c) level portends an adverse cardiovascular prognosis; however, the association between glycemic control, platelet reactivity, and outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is unknown. We sought to investigate whether HbA1c levels are associated with high platelet reactivity (HPR) in patients loaded with clopidogrel and aspirin, thereby constituting an argument for intensified antiplatelet therapy in patients with poor glycemic control. In the prospective, multicenter Assessment of Dual Antiplatelet Therapy With Drug Eluting Stents registry, HbA1c levels were measured as clinically indicated in 1,145 of 8,582 patients, stratified by HbA1c <6.5% (n = 551, 48.12%), 6.5% to 8.5% (n = 423, 36.9%), and >8.5% (n = 171, 14.9%). HPR on clopidogrel and aspirin was defined after PCI as P2Y12 reaction units (PRU) >208 and aspirin reaction units >550, respectively. HPR on clopidogrel was frequent (48.3%), whereas HPR on aspirin was not (3.9%). Patients with HbA1c >8.5% were younger, more likely non-Caucasian, had a greater body mass index, and more insulin-treated diabetes and acute coronary syndromes. Proportions of PRU >208 (42.5%, 50.2%, and 62.3%, p <0.001) and rates of definite or probable stent thrombosis (ST; 0.9%, 2.7%, and 4.2%, p = 0.02) increased progressively with HbA1c groups. Clinically relevant bleeding was greatest in the intermediate HbA1c group (8.2% vs 13.1% vs 9.5%, p = 0.04). In adjusted models that included PRU, high HbA1c levels (>8.5) remained associated with ST (hazard ratio 3.92, 95% CI 1.29 to 12.66, p = 0.02) and cardiac death (hazard ratio 4.24, 95% CI 1.41 to 12.70) but not bleeding at 2-year follow-up. There was no association between aspirin reaction units >550 and HbA1c levels. In conclusion, in this large-scale study, HbA1c and HPR were positively associated, but the clinical effect on adverse outcome was driven by poor glycemic control, which predicted ST and cardiac death after PCI regardless of PRU levels, warranting efforts to improve glycemic control after DES implantation in patients with diabetes mellitus., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: In the era of novel antithrombotic therapy, the optimal treatment for patients with nonvalvular atrial fibrillation (AF) or flutter undergoing percutaneous coronary intervention (PCI) is undetermined., Study Design: The AVIATOR 2 study is a multicenter prospective observational registry that will enroll approximately 2,500 patients with nonvalvular AF or flutter undergoing PCI starting March 2015 over an 18-month enrollment period. Antithrombotic therapy selection will be at the discretion of the treating physician. An integral feature of this study is the use of a smartphone-based survey to capture physician and patient perspectives regarding antithrombotic therapies after PCI. Survey-derived patient treatment concerns, perceived need, and affordability will be used to calculate the risk of non-adherence. Subjective risk for ischemic or bleeding events will be correlated with previously validated risk scores as well as observed event rates at 1, 6, or 12 months post-PCI., Endpoints: The primary efficacy end point will be major adverse cardiac and cerebrovascular events, a composite occurrence of death, nonfatal myocardial infarction, stroke, stent thrombosis, and clinically driven target lesion revascularization at 1 year. The primary safety end point will be major bleeding as per Bleeding Academic Research Consortium criteria types 2, 3, or 5. The secondary end points will include (i) net adverse clinical events, a composite occurrence of all major adverse cardiac and cerebrovascular events, and major bleeding at 1 year; (ii) correlation between estimated subjective and objective (CHADS2, CHA2DS2-VASc, stent thrombosis score, HAS-BLED, and ATRIA scores) ischemic and bleeding risks; (iii) modes of antithrombotic therapy cessation and their impact on outcomes; and (iv) correlation between observed and expected non-adherence to treatment., Summary: AVIATOR 2 is a real-world registry designed to evaluate ischemic and bleeding outcomes according to conventional and novel antithrombotic regimens in patients with nonvalvular AF or flutter undergoing PCI. The study will also provide insights in to physician- and patient-centered factors affecting treatment selection and adherence and their overall impact on clinical outcomes. The study is registered on clinicaltrials.gov NCT02362659., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Aims: The currently stated optimal catchment population for a pPCI centre is 300,000-1,100,000, resulting in 200-800 procedures/year. pPCI centres are increasing in number even within small geographic areas. We describe the organisation and quality of care after merging two high-volume centres, creating one mega centre serving 2.5 million inhabitants, and performing ~1,000 procedures/year., Methods and Results: In this descriptive cohort study, we linked individual-level data from the national Central Population Register holding survival status with our in-hospital dedicated PCI database of baseline, organisational and procedural characteristics. Quality measures were treatment delays and 30-day all-cause mortality. In the three-year study period, 2,066 consecutive pPCIs were performed. After the fusion of the two centres, pPCI procedures increased by 102%, while door-to-balloon remained stable at 32 minutes. Up to 75.1% of patients were directly transferred by pre-hospital triage, of whom 82.7% had ECG-to-balloon <120 min, 92.6% had door-to-balloon <60 min. Thirty-day all-cause mortality remained low at 6.3%., Conclusions: This study challenges the stated maximal pPCI centre volume. The quality of a centre reflects governance, training, resources and pre-hospital triage, rather than catchment population and STEMI incidence, as long as a minimum volume is guaranteed. Resources can be utilised better by merging neighbouring centres, without negative effects on quality of care.

Patients with atrial fibrillation (AF) who underwent percutaneous coronary intervention (PCI) are at elevated risk for bleeding and thromboembolic ischemic events. Currently, guidelines on antithrombotic treatment for these patients are based on weak consensus. We describe patterns and determinants of antithrombotic prescriptions in this population. The Antithrombotic Strategy Variability in Atrial Fibrillation and Obstructive Coronary Disease Revascularized with PCI Registry was an international observational study of 859 consecutive patients with AF who underwent PCI from 2009 to 2011. Patients were stratified by treatment at discharge with either dual antiplatelet therapy (DAPT; aspirin plus clopidogrel) or triple therapy (TT; warfarin plus DAPT). Bleeding and thromboembolism risks were assessed by the HAS-BLED and CHADS2 scores, respectively, and predictors of TT prescription at discharge were identified. Major adverse cardiovascular events and clinically relevant bleeding (Bleeding Academic Research Consortium score ≥2) at 1-year follow-up were compared across antithrombotic regimens. Compared with patients on DAPT (n = 488; 57%), those given TT (n = 371; 43%) were older, with higher CHADS2 scores, lower left ventricular ejection fraction, and more often had permanent AF, single-vessel coronary artery disease, and bare-metal stents. In multivariate analysis, increasing thromboembolic risk (CHADS2) was associated with a higher rate of TT prescription at discharge (intermediate vs low CHADS2: odds ratio 2.2, 95% confidence interval [CI] 2.0 to 3.3, p <0.01; high vs low CHADS2: odds ratio 1.6, 95% CI 2.6 to 4.3, p <0.01 for TT). However, there was no significant association between bleeding risk and TT prescription in the overall cohort or within each CHADS2 risk stratum. The rates of major adverse cardiovascular events were similar for patients discharged on TT or DAPT (20% vs 17%, adjusted hazard ratio 0.8, 95% CI 0.5 to 1.1, p = 0.19), whereas the rate of Bleeding Academic Research Consortium ≥2 bleeding was higher in patients discharged on TT (11.5% vs 6.4%, adjusted hazard ratio 1.8, 95% CI 1.1 to 2.9, p = 0.02). In conclusion, the choice of the intensity of antithrombotic therapy correlated more closely with the risk of ischemic rather than bleeding events in this cohort of patients with AF who underwent PCI., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: The prospective, randomized FREEDOM (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes) trial found coronary artery bypass graft surgery (CABG) was associated with better clinical outcomes than percutaneous coronary intervention (PCI) in patients with diabetes and multivessel disease, managed with or without insulin., Objectives: In this subgroup analysis of the FREEDOM trial, we examined the association of long-term clinical outcomes after revascularization in patients with insulin-treated diabetes mellitus (ITDM) compared with patients not treated with insulin., Methods: A total of 1,850 FREEDOM subjects had an index revascularization procedure performed: 956 underwent PCI with drug-eluting stents (DES), and 894 underwent CABG. A total of 602 patients (32.5%) had ITDM (PCI/DES n = 325, 34%; CABG n = 277, 31%). Subjects were classified according to ITDM versus non-ITDM, with comparison of PCI/DES versus CABG for each group. Interaction analyses were performed for treatment by diabetes mellitus (DM) status alone and for treatment by DM status by coronary lesion complexity. Analyses were performed for the primary outcome composite of death/stroke/myocardial infarction (MI) using all available follow-up data., Results: The overall 5-year event rate of death/stroke/MI was significantly higher in ITDM versus non-ITDM patients (28.7% vs. 19.5%, p < 0.001), which persisted even after adjustment for multiple baseline factors, angiographic complexity, and revascularization treatment group (death/stroke/MI hazard ratio [HR]: 1.35, 95% confidence interval [CI]: 1.06 to 1.73, p = 0.014). With respect to the primary composite endpoint, CABG was superior to PCI/DES in both DM types and the magnitude of treatment effect was similar (interaction p = 0.40) for ITDM (PCI vs., Cabg Hr: 1.21; 95% CI: 0.87 to 1.69) and non-ITDM patients (PCI vs., Cabg Hr: 1.46; 95% CI 1.10 to 1.94), even after adjusting for the angiographic SYNTAX score level. Based on 5-year event rates, the number needed to treat with CABG versus PCI to prevent 1 event is 12.7 in ITDM and 13.2 in non-ITDM., Conclusions: In patients with diabetes and multivessel coronary artery disease, the rate of major adverse cardiovascular events (death, MI, or stroke) is higher in patients treated with insulin than in those not treated with insulin. Furthermore, we did not detect a significant difference in the magnitude of PCI versus CABG treatment effect for patients treated with insulin and those not treated with insulin. (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes [FREEDOM]; NCT00086450)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)