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Myocardial infarction with non-obstructive coronary arteries (MINOCA) represents about 6-8% of patients presenting with myocardial infarction (MI), and it is associated with a significant risk of mortality, rehospitalisation, and angina burden, with high associated socioeconomic costs. It is important to note that multiple mechanisms may be responsible for MINOCA. However, to date, there are few prospective clinical trials on MINOCA and the treatment of these patients is still not defined, most likely because of the multiple underlying pathogenic mechanisms. The PROMISE trial is a randomised, multicentre, prospective, superiority, phase IV trial that will include 180 MINOCA patients randomised 1:1 to a "precision-medicine approach", consisting of a comprehensive diagnostic workup and pharmacological treatment specific for the underlying cause, versus a "standard of care" approach, consisting of routine diagnostic workup and standard medical treatment for acute coronary syndrome. The aim of this study is to evaluate if the "precision-medicine approach" will improve the angina status, evaluated using the Seattle Angina Questionnaire summary score, at 12 months (primary endpoint). Secondary endpoints include the rate of major adverse cardiovascular events at 12-month follow-up, the related primary and secondary healthcare costs, and the ability of cardiac magnetic resonance to evaluate the different mechanisms of MINOCA. Of importance, the results derived from this trial may pave the way for a new pathophysiology-driven approach with cause-target therapies personalised for the mechanisms of MINOCA (ClinicalTrials.gov: NCT05122780).

Objectives: The management of severe aortic stenosis has been revolutionized by the introduction of transcatheter aortic valve implantation (TAVI), especially in patients at intermediate, high, or prohibitive surgical risk. There is uncertainty, however, regarding the comparative effectiveness and safety of contemporary TAVI devices., Methods: We queried detailed data from the ongoing national Italian TAVI registry and compared baseline features, procedural details, and 12-month outcomes of Acurate Neo (Boston Scientific), Evolut Pro/R (Medtronic), Lotus (Boston Scientific), Portico (Abbott Vascular), and Sapien/ Sapien S3 Ultra (Edward Lifesciences) transcatheter aortic valves. Several endpoints were collected and appraised, including the composite of death, stroke, myocardial infarction (MI), major bleeding, major vascular complication, surgical aortic valve replacement and transcatheter aortic valve reimplantation, which were deemed major adverse events (MAEs)., Results: A total of 1976 patients were included, with 234 treated with Acurate, 703 with Evolut, 151 with Lotus, 347 with Portico, and 541 with Sapien. Twelve-month events were not significantly different among the 5 devices, including death (P=.29) and MAE (P=.21), with the notable exception of major vascular complications, which were more common with Acurate and Sapien (P<.001) and permanent pacemaker implantation, which was more frequent with Lotus and Evolut (P<.001). Differences in MAE were more pronounced in women and subjects with prior cardiac surgery, with the lowest event rates in the Evolut group. Propensity-score adjusted analysis suggested that Acurate, Evolut, Portico, and Sapien were all associated with similarly favorable results, whereas adverse events were more evident with Lotus (P<.05)., Conclusion: Leading current-generation TAVI devices offer similarly favorable results at mid-term follow-up.

Background: Acute myocardial infarction (AMI) patients are at increased risk of death and recurrent ischemic events. We aimed to elaborate a risk score, based on the PEGASUS-TIMI 54 criteria, to predict mortality and non-fatal AMI in AMI patients., Methods: We retrospectively analyzed two prospectively collected AMI cohorts. We calculated a cut-off for the developed score and investigated its 1-year prognostic power in the derivation cohort (n = 1257). We externally validated our score in 913 AMI patients with a longer follow-up., Results: In the derivation cohort, the area under the curve of the score for the primary endpoint (1-year death and non-fatal AMI) was 0.70 (95% CI 0.65-0.76; P < 0.0001) and a cut-off of 6 was identified. The primary endpoint incidence in patients with a score above and below the cut-off was 12% and 3% (P < 0.001) in the derivation cohort and 16% and 6% in the validation cohort (P < 0.001). At multivariate analysis, the HR for the primary endpoint associated with a score ≥ 6 was 4.45 (P < 0.0001) in the derivation cohort and 2.86 (P < 0.0001) in the validation cohort. One-year major bleeding rate was low (<0.2% overall) and similar between risk groups. The prognostic performance of the score cut-off persisted beyond the first year after AMI in the validation cohort, maintaining a similar risk for death and non-fatal AMI (HR 3) at every following year., Conclusions: Our score, based on the PEGASUS-TIMI 54 criteria, may identify AMI patients at high risk of recurrent ischemic events, who might benefit from thorough preventive strategies., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Objective: Acute hyperglycemia is a powerful predictor of poor prognosis in acute myocardial infarction (AMI), particularly in patients without diabetes. This emphasizes the importance of an acute glycemic rise rather than glycemia level at admission alone. We investigated in AMI whether the combined evaluation of acute and chronic glycemic levels, as compared with admission glycemia alone, may have a better prognostic value., Research Design and Methods: We prospectively measured admission glycemia and estimated average chronic glucose levels (mg/dL) by the following formula: [(28.7 × glycosylated hemoglobin %) - 46.7], and calculated the acute-to-chronic (A/C) glycemic ratio in 1,553 consecutive AMI patients (mean ± SD age 67 ± 13 years). The primary end point was the combination of in-hospital mortality, acute pulmonary edema, and cardiogenic shock., Results: The primary end point rate increased in parallel with A/C glycemic ratio tertiles (5%, 8%, and 20%, respectively; P for trend <0.0001). A parallel increase was observed in troponin I peak value (15 ± 34 ng/mL, 34 ± 66 ng/mL, and 68 ± 131 ng/mL; P < 0.0001). At multivariable analysis, A/C glycemic ratio remained an independent predictor of the primary end point and of troponin I peak value, even after adjustment for major confounders. At reclassification analyses, A/C glycemic ratio showed the best prognostic power in predicting the primary end point as compared with glycemia at admission in the entire population (net reclassification improvement 12% [95% CI 4-20]; P = 0.003) and, particularly, in patients with diabetes (27% [95% CI 14-40]; P < 0.0001)., Conclusions: In AMI patients with diabetes, A/C glycemic ratio is a better predictor of in-hospital morbidity and mortality than glycemia at admission., (© 2018 by the American Diabetes Association.)

Aims: Recent studies suggested that even non-obstructive coronary artery disease (CAD) increases major cardiovascular adverse events (MACE) rate. Aim of this study was to evaluate whether coronary computed tomography angiography (CCTA) may detect specific plaque characteristics that may affect prognosis in patients with non-obstructive CAD., Methods: We enrolled 245 patients who underwent CCTA between April 2004 and April 2007 for suspected CAD and were found to have non-obstructive CAD. Positive remodelling index (PRI), low-attenuation plaque (LAP), plaque burden (PB), spotty calcification (SC), and napkin-ring sign (NRS) have been evaluated for each coronary plaque detected. Acute coronary syndrome, all-cause/cardiac death, and very late elective revascularization (vl-ER) were the endpoints of the study., Results: A total of 28 events were recorded (2 STEMI, 4 NSTEMI, 6 UA, 2 cardiac deaths, 4 non-cardiac death, and 10 vl-ERs) at long-term follow-up (98 ± 20 months). When adjusted for significant clinical variables PRI > 1.4 (HR 3.31 CI 95% 1.11-9.91, P = 0.0392), LAP (HR 8.45 CI 95% 2.22-32.21, P = 0.0019), PB > 0.7 (HR 5.25 CI 95% 1.45-19.03, P = 0.0120), and NRS (HR 12.52 CI 95% 1.51-103.90, P = 0.0198) were still significantly associated with higher rate of hard cardiac events at follow-up. The Kaplan-Meyer curves confirmed lower cumulative hard cardiac events-free survival in patients presenting at least one coronary plaque with two or more high-risk characteristics when compared with patients with no lesion with more than one high-risk plaque characteristics (log-rank P < 0.0001)., Conclusions: High-risk plaque characteristics at CCTA (PRI > 1.4, PB > 0.7, LAP, and NRS) seem to be promising for risk stratification of patients with non-obstructive CAD., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)

Aims: The present multicentre prospective study, IT-DISAPPEARS, was designed with the aim of evaluating early and long-term clinical outcomes of the Absorb BVS in patients with long coronary lesions and/or multivessel coronary artery disease. The aim of this article is to present the one-year clinical results of this study., Methods and Results: Between November 2014 and January 2016, we enrolled 1,002 patients undergoing BVS implantation (long lesion [≥ 24 mm] of a single vessel in 80.4%, at least two BVS in two or three coronary vessels in 8.6% and both criteria in 11%). Clinical presentation was an acute coronary syndrome in 59.8% of patients, including ST-elevation myocardial infarction in 21.8%. The primary endpoint was the device-oriented composite endpoint (DOCE) of cardiac death, target vessel MI, and ischaemia-driven TLR at one year. We implanted 2,040 BVS according to a pre-specified technique. One-year follow-up was available in 956 patients (95.4%). The rate of DOCE was 9.9% (95 patients). Cardiac death occurred in five patients (0.5%), while target vessel MI and TLR each occurred in 45 (4.7%) patients. The one-year rates of all-cause death, non-fatal MI, and any revascularisation were 1.2%, 5.4%, and 10.9%, respectively. The rate of definite/probable scaffold thrombosis was 0.9%., Conclusions: This is the first study specifically investigating the Absorb technology in patients with a high atherosclerotic burden and multivessel disease. The mandatory adherence to a pre-specified implantation technique led to minimising the risk of device failure reported by other studies, in particular with respect to the rate of DOCE and scaffold thrombosis.

Rationale: In contrast to cardiomyocyte necrosis, which can be quantified by cardiac troponin, functional cardiomyocyte impairment, including mitochondrial dysfunction, has escaped clinical recognition in acute myocardial infarction (AMI) patients., Objective: To investigate the diagnostic accuracy for AMI and prognostic prediction of in-hospital mortality of cytochrome c., Methods and Results: We prospectively assessed cytochrome c serum levels at hospital presentation in 2 cohorts: a diagnostic cohort of patients presenting with suspected AMI and a prognostic cohort of definite AMI patients. Diagnostic accuracy for AMI was the primary diagnostic end point, and prognostic prediction of in-hospital mortality was the primary prognostic end point. Serum cytochrome c had no diagnostic utility for AMI (area under the receiver-operating characteristics curve 0.51; 95% confidence intervals 0.44-0.58; P=0.76). Among 753 AMI patients in the prognostic cohort, cytochrome c was detectable in 280 (37%) patients. These patients had higher in-hospital mortality than patients with nondetectable cytochrome c (6% versus 1%; P<0.001). This result was mainly driven by the high mortality rate observed in ST-segment-elevation AMI patients with detectable cytochrome c, as compared with those with nondetectable cytochrome c (11% versus 1%; P<0.001). At multivariable analysis, cytochrome c remained a significant independent predictor of in-hospital mortality (odds ratio 3.0; 95% confidence interval 1.9-5.7; P<0.001), even after adjustment for major clinical confounders (odds ratio 4.01; 95% confidence interval 1.20-13.38; P=0.02)., Conclusions: Cytochrome c serum concentrations do not have diagnostic but substantial prognostic utility in AMI., (© 2016 The Authors.)

Aims: We sought to compare the outcomes of low/moderate complexity patients treated with the Absorb BVS from the ABSORB EXTEND trial with patients treated with the XIENCE everolimus-eluting stent (EES), using propensity score (PS) matching of pooled data from the SPIRIT trials (SPIRIT II, SPIRIT III, SPIRIT IV) and the XIENCE V USA trial., Methods and Results: ABSORB EXTEND was a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and with a reference vessel diameter of 2.0-3.8 mm (as assessed by online QCA). The propensity score was obtained by fitting a logistic regression model with the cohort indicator as the binary outcome and other variables as the predictor variables. At one-year clinical follow-up, there was no statistical difference between groups with regard to MACE (5.0% vs. 4.8%, p=0.83), target lesion failure (5.0% vs. 4.7%, p=0.74), ischaemia-driven target vessel revascularisation (2.3% vs. 3.0%, p=0.38) and device thrombosis (1.0% vs. 0.3%, p=0.11). Myocardial infarction was higher with Absorb (3.3% vs. 1.5%, p=0.02), at the expense of periprocedural CK-MB elevation. Independent predictors of MACE among patients receiving Absorb BVS were treatment of multivessel disease, insulin-dependent diabetes and performance of post-dilation., Conclusions: At one-year follow-up, propensity score-matched analysis demonstrated that the clinical safety and effectiveness of Absorb are comparable to those of XIENCE EES among non-complex patients treated with PCI.

Objectives: Dipyridamole stress cardiac magnetic resonance (CMR) evaluates the key phases (perfusion and wall motion) of the ischemic cascade. We sought to determine the prognostic value of dipyridamole stress-CMR in consecutive patients symptomatic for chest pain., Methods: Seven hundred and ninety-three consecutive patients symptomatic for chest pain underwent dipyridamole stress-CMR and were followed up for 810 ± 665 days. Patients were classified in group 1 (no- reversible ischemia), group 2 (stress perfusion defect alone), and group 3 [stress perfusion defect plus abnormal wall motion (AWM)]. End points were "all cardiac events" (myocardial infarction, cardiac death and revascularization) and "hard cardiac events" (all cardiac events excluding revascularization)., Results: One hundred and ninety-five (24 %) all cardiac events and 53 (7 %) hard cardiac events were observed. All and hard cardiac event rates in groups 1, 2, and 3 were 11 %, 49 %, 69 % and 4 %, 8 %, 21 %, respectively, with a higher rate in group 2 vs. group 1 (p<0.01) and group 3 vs. groups 1 and 2 (p<0.01). Multivariate analysis showed the presence of late gadolinium enhancement and stress perfusion defect plus AWM as independent predictors of all and hard cardiac events., Conclusions: Dipyridamole stress-CMR improves prognostic stratification of patients through differentiation between the different components of the ischemic cascade., Key Points: • Dipyridamole stress cardiac magnetic resonance helps to assess coronary artery disease. • Novel technique to study the key phases of myocardial ischemia. • Combined assessment of perfusion and motion defects. • Dipyridamole stress imaging has additional value for predicting cardiac events.

Objectives: To investigate the characteristics and one-year outcomes following sirolimus-eluting CYPHER Select Plus stent (SES) implantation in small (SmVD) and non-small vessel disease (NSmVD) in the international e-SELECT registry., Background: Large-scale registry data are lacking on DES outcomes in SmVD treatment., Methods: There were 4,700 SmVD (at least one vessel with estimated reference vessel diameter [RVD] < 2.5 mm, excluding 283 patients with unknown RVD vessels) and 10,139 NSmVD only patients., Results: The SmVD population was older, with more women, diabetics, and vessels treated, higher mean Charlson Comorbidity Index score (CCI), shorter lesions, and less STEMI presentation. The 1-year stent thrombosis (ST) rate (primary end-point), was significantly higher (1.3% vs. 0.7%) in SmVD versus NSmVD, mainly driven by early events. One-year major adverse cardiac event (MACE), myocardial infarction (MI), and clinically indicated target-lesion revascularization (TLR) rates were significantly higher in SmVD although death and major bleeding rates were similar in both groups. Complication rates were similar between pure (3,188 patients; only RVD < 2.5 mm) and mixed (1,795 patients; some RVD < 2.5 mm or unknown RVD) SmVD. Multivariate predictors for 1-year MACE in SmVD included saphenous vein graft or bifurcation lesions, major bleeding, any antiplatelet therapy discontinuation within 1 month, age, number of stents implanted, CCI, acute coronary syndrome, and insulin-dependent diabetes mellitus., Conclusion: SES implantation for SmVD occurs more frequently in women, diabetics, and those with multivessel disease and comorbidities. One-year ST, MACE, MI, and clinically indicated TLR rates are higher, although low overall, in SmVD or mixed SmVD patients while death rates are similar to NSmVD., (©2012, Wiley Periodicals, Inc.)

Background: Acute hyperglycemia and contrast-induced nephropathy (CIN) are frequently observed in ST-elevation acute myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI), and both are associated with an increased mortality rate. We investigated the possible association between acute hyperglycemia and CIN in patients undergoing primary PCI., Methods: We prospectively enrolled 780 STEMI patients undergoing primary PCI. For each patient, plasma glucose levels were assessed at hospital admission. Acute hyperglycemia was defined as glucose levels>198 mg/dL (11 mmol/L). Contrast-induced nephropathy was defined as an increase in serum creatinine>25% from baseline in the first 72 hours., Results: Overall, 148 (19%) patients had acute hyperglycemia; and 113 (14.5%) patients developed CIN. Patients with acute hyperglycemia had a 2-fold higher incidence of CIN than those without acute hyperglycemia (27% vs 12%, P<.001). In-hospital mortality was higher in patients with acute hyperglycemia than in those without acute hyperglycemia (12% vs 3%, P<.001). Mortality rate was also higher in patients developing CIN than in those without this renal complication (27% vs 0.9%, P<.001). Patients with acute hyperglycemia that developed CIN had the highest mortality rate (38%). Acute hyperglycemia was an independent predictor of CIN and in-hospital mortality., Conclusions: In STEMI patients undergoing primary PCI, acute hyperglycemia is associated with an increased risk for CIN and with increased in-hospital mortality., (Copyright © 2010 Mosby, Inc. All rights reserved.)

In patients with ST-segment elevation acute myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI), abrupt reperfusion can induce myocardial injury and apoptotic cell death. Reperfusion-induced myocardial damage, however, cannot be easily evaluated in clinical practice because of the lack of specific biomarkers. Cytochrome c, a mitochondrial protein, is released on reperfusion into the cytosol, where it triggers the apoptotic process. It can reach the external fluid and circulating blood when cell rupture occurs. We measured the cytochrome c circulating levels in patients with STEMI undergoing pPCI, and correlated them with the clinical signs of myocardial necrosis and reperfusion. The plasma creatine kinase-MB mass and serum cytochrome c (enzyme-linked immunosorbent assay method) were serially measured in 55 patients with STEMI undergoing pPCI. The angiographic and electrocardiographic signs of myocardial reperfusion were also assessed. Cytochrome c transiently increased in all patients with STEMI, with a curve that paralleled that of creatine kinase-MB. A significant relation was found between the peak values of the 2 biomarkers (R = 0.35, p = 0.01) and between the areas under the 2 curves (R = 0.33, p = 0.02). The creatine kinase-MB peak value correlated significantly with the clinical features of infarct extension. In contrast, the cytochrome c peak value correlated inversely with the myocardial blush grade. Patients with clinical signs of myocardial reperfusion injury had a significantly greater cytochrome c peak value than patients without reperfusion injury (median 1.65 ng/ml, interquartile range 1.20 to 2.20, vs 1.1 ng/ml, interquartile range 0.65 to 1.55; p = 0.04). In conclusion, serum cytochrome c is detectable in the early phase of STEMI treated with pPCI and is associated with clinical signs of impaired myocardial reperfusion., (Copyright © 2010 Elsevier Inc. All rights reserved.)

Objective: To evaluate the clinical and prognostic relevance of acute kidney injury (AKI) in the setting of ST-elevation acute myocardial infarction (STEMI) complicated by cardiogenic shock (CS)., Design: Prospective study., Setting: Single-center study, 13-bed intensive cardiac care unit at a University Cardiological Center., Patients: Ninety-seven consecutive STEMI patients with CS at admission, undergoing intra-aortic balloon pump (IABP) support and primary percutaneous coronary intervention (PCI)., Interventions: None., Measurements and Main Results: We measured serum creatinine at baseline and each day for the following 3 days. Acute kidney injury was defined as a rise in creatinine >25% from baseline. Overall, AKI occurred in 52 (55%) patients, and in 12 of these patients, a renal replacement therapy was required. In multivariate analysis, age >75 yrs (p = .005), left ventricular ejection fraction < or = 40% (p = .009), and use of mechanical ventilation (p = .01) were independent predictors of AKI. Patients developing AKI had a longer hospital stay, a more complicated clinical course, and significantly higher mortality rate (50% vs. 2.2%; p <.001) than patients without AKI. In our population, AKI was the strongest independent predictor of in-hospital mortality (relative risk 12.3, 95% confidence intervals 1.78 to 84.9; p <.001)., Conclusions: In patients with STEMI complicated by CS, AKI represents a frequent clinical complication associated with a poor prognosis.

Background: Contrast-induced nephropathy (CIN) frequently occurs in patients with acute ST-segment elevation myocardial infarction (STEMI) who are undergoing primary percutaneous coronary intervention, and CIN is associated with a more complicated clinical course and increased mortality., Objective: To investigate the association between absolute and weight- and creatinine-adjusted contrast volume, CIN incidence, and clinical outcome in the era of mechanical reperfusion of STEMI., Design: Prospective, observational study., Setting: A university cardiology center in Milan, Italy., Patients: 561 consecutive patients with STEMI who were undergoing primary percutaneous coronary intervention., Measurements: For each patient, the maximum contrast dose was calculated, according to the formula (5 x body weight [kg])/serum creatinine, and the contrast ratio, defined as the ratio between the contrast volume administered and the maximum dose calculated, was assessed. An increase in serum creatinine of more than 25% from baseline was defined as CIN., Results: 115 (20.5%) patients developed CIN. In-hospital mortality was higher among patients with CIN than those without CIN (21.4% vs. 0.9%; P < 0.001). The maximum contrast dose was exceeded in 130 (23%) patients. Patients who received more than the maximum contrast dose (contrast ratio >1) had a more complicated in-hospital clinical course and higher mortality rate (13% vs. 2.8%; P < 0.001) than did patients with a contrast ratio less than 1. Development of CIN was associated with both contrast volume and contrast ratio., Limitation: The association between contrast volume and outcomes was observed in a single center and could be due to comorbid conditions, disease severity, or an unknown factor., Conclusion: During primary percutaneous coronary intervention for STEMI, higher contrast volume is associated with higher rates of CIN and mortality; however, further study is needed to determine whether limiting contrast volume would improve patient outcome., Funding: Centro Cardiologico Monzino, Institute of Cardiology, University of Milan.

Objectives: This study sought to determine whether hyperoxemic reperfusion with aqueous oxygen (AO) improves recovery of ventricular function after percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI)., Background: Hyperbaric oxygen reduces myocardial injury and improves ventricular function when administered during ischemia-reperfusion., Methods: In a prospective, multicenter study, 269 patients with acute anterior or large inferior AMI undergoing primary or rescue PCI (<24 h from symptom onset) were randomly assigned after successful PCI to receive hyperoxemic reperfusion (treatment group) or normoxemic blood autoreperfusion (control group). Hyperoxemic reperfusion was performed for 90 min using intracoronary AO. The primary end points were final infarct size at 14 days, ST-segment resolution, and delta regional wall motion score index of the infarct zone at 3 months., Results: At 30 days, the incidence of major adverse cardiac events was similar between the control and AO groups (5.2% vs. 6.7%, p = 0.62). There was no significant difference in the incidence of the primary end points between the study groups. In post-hoc analysis, anterior AMI patients reperfused <6 h who were treated with AO had a greater improvement in regional wall motion (delta wall motion score index = 0.54 in control group vs. 0.75 in AO group, p = 0.03), smaller infarct size (23% of left ventricle in control group vs. 9% of left ventricle in AO group, p = 0.04), and improved ST-segment resolution compared with normoxemic controls., Conclusions: Intracoronary hyperoxemic reperfusion was safe and well tolerated after PCI for AMI, but did not improve regional wall motion, ST-segment resolution, or final infarct size. A possible treatment effect was observed in anterior AMI patients reperfused <6 h of symptom onset.

Background: Risk stratification of patients with ST-elevation myocardial infarction (STEMI) undergoing primary angioplasty is important in order to predict outcomes and to delineate targeted therapeutic strategies. Although the prognostic implications of reduced left ventricular ejection fraction (LVEF) and creatinine clearance (CrCl) have been recognized, the clinical and prognostic impact of their combination has never been prospectively evaluated., Methods: We stratified 467 patients with STEMI undergoing primary angioplasty according to LVEF and CrCl values at admission: CrCl > 60 mL/min and LVEF > 40% (group 1, n = 261); CrCl < or = 60 mL/min and LVEF > 40% (group 2, n = 113); CrCl > 60 mL/min and LVEF < or = 40% (group 3, n = 60); CrCl < or = 60 mL/min and LVEF < or = 40% (group 4, n = 33)., Results: Inhospital mortality was different in the 4 groups (1% in group 1, 3% in group 2, 15% in group 3, 30% in group 4) (P < .001). The incidence of combined end point of death, acute pulmonary edema, cardiogenic shock, and acute renal failure requiring mechanical support increased progressively from group 1 to group 4 (5%, 17%, 33%, and 48%, respectively) (P < .001). We found a significant gradient of risk in terms of inhospital mortality and combined end point when patients outcome was evaluated according to the presence of both normal LVEF and CrCl (group 1), impairment in only 1 of these 2 parameters (group 2 and 3 pooled together), and combined LVEF and CrCl reductions (group 4)., Conclusions: Reduced LVEF and CrCl are strong independent predictors of increased inhospital morbidity and mortality, and their combined evaluation provides a simple tool for early risk stratification in patients with STEMI treated with primary angioplasty.

Objectives: To assess left ventricle function recovery, ST-segment changes, and enzyme kinetic in ST-elevation myocardial infarction patients treated with intracoronary hyperoxemic perfusion (IHP) after primary percutaneous coronary intervention and compare them with the results obtained in control patients., Background: IHP has been shown to attenuate microvascular reperfusion injury, which may result in poor LV function recovery despite successful primary percutaneous coronary intervention., Methods: Twenty seven anterior ST-elevation myocardial infarction patients treated < or = 12 hr after symptom onset by primary percutaneous coronary intervention were subjected to selective IHP into the left anterior descending coronary artery for 90 min. They were compared with 24 anterior ST-elevation myocardial infarction control patients matched in clinical and angiographic characteristics and treated with conventional primary percutaneous coronary intervention. Left ventricular function recovery was evaluated by serial 2D contrast echocardiography., Results: Left anterior descending coronary artery recanalization was successful in all patients. After IHP (100% successful, duration 90 +/- 5.4 min), patients showed a 4.8 +/- 2.2 hr shorter time-to-peak creatine kinase release (P = 0.001), a shorter creatine kinase half-life period (23.4 +/- 8.9 hr vs. 30.5 +/- 5.8 hr, P = 0.006), and a higher rate of complete ST-segment resolution (78% vs. 42%, P = 0.01). A significant improvement of mean left ventricular ejection fraction (from (44 +/- 9)% to (55 +/- 11)%, P < 0.001) and wall motion score index (from 1.77 +/- 0.2 to 1.39 +/- 0.4, P < 0.001) was observed at 3 months in IHP patients only., Conclusion: After successful primary coronary intervention, IHP is associated with significant left ventricular function recovery when compared to conventional treatment. Enzyme kinetic and ST-segment changes suggest faster and more complete microvascular reperfusion and may explain the salutary effects of this new therapy on left ventricular function., (Copyright 2006 Wiley-Liss., Inc.)

Objectives: The aim of this research was to assess the incidence, clinical predictors, and outcome of contrast-induced nephropathy (CIN) after primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI)., Background: Contrast-induced nephropathy is associated with significant morbidity and mortality after PCI. Patients undergoing primary PCI may be at higher risk of CIN because of hemodynamic instability and unfeasibility of adequate prophylaxis., Methods: In 208 consecutive AMI patients undergoing primary PCI, we measured serum creatinine concentration (Cr) at baseline and each day for the following three days. Contrast-induced nephropathy was defined as a rise in Cr >0.5 mg/dl., Results: Overall, CIN occurred in 40 (19%) patients. Of the 160 patients with baseline Cr clearance >/=60 ml/min, only 21 (13%) developed CIN, whereas it occurred in 19 (40%) of those with Cr clearance <60 ml/min (p < 0.0001). In multivariate analysis, age >75 years (odds ratio [OR] 5.28, 95% confidence interval [CI] 1.98 to 14.05; p = 0.0009), anterior infarction (OR 2.17, 95% CI 0.88 to 5.34; p = 0.09), time-to-reperfusion >6 h (OR 2.51, 95% CI 1.01 to 6.16; p = 0.04), contrast agent volume >300 ml (OR 2.80, 95% CI 1.17 to 6.68; p = 0.02) and use of intraaortic balloon (OR 15.51, 95% CI 4.65 to 51.64; p < 0.0001) were independent correlates of CIN. Patients developing CIN had longer hospital stay (13 +/- 7 days vs. 8 +/- 3 days; p < 0.001), more complicated clinical course, and significantly higher mortality rate (31% vs. 0.6%; p < 0.001)., Conclusions: Contrast-induced nephropathy frequently complicates primary PCI, even in patients with normal renal function. It is associated with higher in-hospital complication rate and mortality. Thus, preventive strategies are needed, particularly in high-risk patients.

In patients with acute myocardial infarction (AMI) primary angioplasty and stent placement is a more effective and better tolerated treatment than thrombolysis, and therefore, when logistics allow, this treatment is preferred and routinely used. However, successful reopening of an occluded coronary artery does not necessarily lead to recovery of left ventricular (LV) function. Post-AMI reduction in contractile function and ventricular remodeling may result in heart failure. There is evidence that reduced contractile function in the infarct zone is related to poor microvascular perfusion even after normalization of large-vessel flow by angiographic criteria following coronary recanalization. Failure to re-establish adequate tissue perfusion may be because of reperfusion injury, ischemia-induced microvascular damage, and plugging of the microcirculation by thrombus and plaque during mechanical recanalization. Experimental data support the hypothesis that reperfusion microvascular ischemia contributes to myocardial tissue injury over a prolonged time period. Hyperbaric oxygen therapy (HBO) attenuates microvascular dysfunction and reperfusion microvascular ischemia, as demonstrated in both experimental models and patients with AMI. However, treating patients in an HBO chamber or with a conventional oxygenator is impractical and difficult. Aqueous oxygen (AO) is a newly developed solution containing extremely high oxygen concentrations (1-3 ml O(2)/mL saline). The AO system mixes AO solution with a patient's blood from an arterial puncture and delivers the hyperoxemic blood to targeted ischemic myocardium via an infusion catheter for regional correction of hypoxemia and production of hyperoxemia. The system precisely controls the level of pO(2) without clinically significant microbubble formation. Hyperoxemic coronary infusion of AO in experimental models of AMI improved LV function and reduced infarct size compared with normoxemic controls,very likely as a result of microvascular blood flow improvement. The first clinical experiences with intracoronary infusion of AO solution demonstrated the therapy to be a safe and well tolerated in the setting of AMI after successful primary percutaneous transluminal coronary angioplasty. Its use was associated with significant progressive improvement in LV function as measured by ejection fraction and wall motion score index. Interestingly, such improvement was primarily due to functional recovery of infarct zone contractility. A larger randomized trial is currently underway to define the role of hyperoxemic coronary infusion in patients with AMI.

Although most patients with coronary artery aneurysms are asymptomatic, manifestations of myocardial ischemia may occur. However, the role that a coronary aneurysm may play in impairing arterial flow of an otherwise normal coronary circulation is not completely known. A 64-year-old woman with previous anteroseptal myocardial infarction was found to have a large aneurysm of the proximal left anterior descending (LAD) coronary artery without angiographic evidence of atherosclerotic disease. IVUS evaluation revealed an 18 mm long and 12.2 x 10.8 mm wide aneurysm without atherosclerosis, thrombus or calcification. Pulsed wave Doppler showed significant reduction of LAD flow reserve, which normalized after successful obliteration of the aneurysm with polytetrafluoroethylene (PTFE)-covered stent implantation. Severe in-stent graft restenosis was found at 7-month angiographic and intravascular ultrasound follow-up, which was managed successfully with minimally invasive direct coronary bypass surgery. The patient did well, without symptoms over the following year.

Objectives: The purpose of this study was to evaluate the feasibility and safety of intracoronary hyperoxemic reperfusion after primary angioplasty for acute myocardial infarction (MI)., Background: Hyperoxemic therapy with aqueous oxygen (AO) attenuates reperfusion injury and preserves left ventricular (LV) function in experimental models of MI., Methods: In a multi-center study of patients with acute MI undergoing primary angioplasty (PTCA), hyperoxemic blood (pO(2): 600 to 800 mm Hg) was infused into the infarct-related artery for 60 to 90 min after intervention. The primary end points were clinical, electrical and hemodynamic stability during hyperoxemic reperfusion and in-hospital major adverse cardiac events. Global and regional LV function was evaluated by serial echocardiography after PTCA, after AO infusion, at 24 h and at one and three months., Results: Twenty-nine patients were enrolled (mean age: 58.9+/-12.6 years). Hyperoxemic reperfusion was performed successfully in all cases (mean infusion time: 80.8+/-18.2 min; mean coronary perfusate pO(2): 631+/-235 mm Hg). There were no adverse events during hyperoxemic reperfusion or the in-hospital period. Compared with baseline, a significant improvement in global wall motion score index was observed at 24 h (1.68+/-0.24 vs. 1.48+/-0.24, p < 0.001) with a trend toward an increase in ejection fraction (48.6+/-7.3% vs. 51.8+/-6.8%, p = 0.08). Progressive improvement in LV function was observed at one and three months, primarily due to recovery of infarct zone function., Conclusions: Intracoronary hyperoxemic reperfusion is safe and well tolerated after primary PTCA. These preliminary data support the need for a randomized controlled trial to determine if hyperoxemic reperfusion enhances myocardial salvage or improves long-term outcome.

Effective treatment of patients with acute myocardial infarction and cardiogenic shock depends on restoring persistent patency of the infarct-related artery. Coronary stenting, reducing abrupt or delayed closure related to dissection and suboptimal result, may improve PTCA results in cardiogenic shock. Eighteen patients (14 males and 4 females, mean age 59 +/- 7 years), referred to catheterization laboratory for acute myocardial infarction and shock, had elective stent implantation during 14 primary and 4 rescue PTCA. Time delay between shock onset and PTCA was 4.1 +/- 3 hr (range, 30 min to 12 hr). The IRA was LAD in seven patients (38%), LCx in two (11%), and RCA in eight (45%). One patient (5.%) had distal LMCA occlusion. Stent deployment was successful in 100% of patients and resulted in TIMI 3 flow in 13 (72%) patients. In 13 (72%) cases, cardiogenic shock gradually resolved and the patients were discharged alive. Five patients (28%) died because of irreversible hemodynamic deterioration without evidence of reinfarction. At 6-month follow-up, all the discharged patients were alive and no patient had reinfarction or recurrent angina. Heart transplant was required in one patient 5 months after stenting because of refractory congestive heart failure. Angiography demonstrated patency of all the coronary arteries treated, with TIMI 3 flow in all patients. Stent restenosis rate was 30%, and target lesion revascularization with CABG or re-PTCA was not required in any case. LV function improved from 39% +/- 15% to 51% +/- 15% (P < 0.01). Elective coronary stenting is an effective treatment for acute myocardial infarction complicated by cardiogenic shock and may improve acute and long-term survival.

Background: Local delivery of pharmacologic agents or genes at the site of angioplasty is a promising approach to reduce restenosis. However, there are unresolved questions concerning the safety and feasibility of local vascular delivery in clinical practice as well as the efficacy of delivered drug. To this end, the safety, feasibility, and efficacy of local delivery of heparin were evaluated in the Heparin Infusion Prior to Stenting (HIPS) trial., Methods and Results: A total of 179 patients were enrolled in this multicenter, randomized, prospective, core laboratory-evaluated trial. Patients were randomly assigned to 5000 U heparin either administered to the coronary artery lumen or infused into the arterial wall immediately after angioplasty and before stent placement. End points included procedural events and clinical, angiographic, and intravascular ultrasound events at 6 months. Patient groups were evenly matched. There was no difference in the incidence of arterial injury, defined as an increase in arterial dissection, acute closure, or decrease in Thrombolysis In Myocardial Infarction grade blood flow in the group receiving local delivery. At follow-up there was no difference in the major adverse event rate between intraluminal (22.7%) and local groups (24.7%). There was no difference between intraluminal and local therapy in the angiographic in-stent restenosis rate (12.5%, 12.7%) or the in-stent volumetric analysis by intravascular ultrasound (IVUS) (37.19 +/- 20. 86 mm(3) vs 43.79 +/- 25.52 mm(3))., Conclusions: Local delivery of 5000 U heparin into the arterial wall before stent implantation is safe and feasible. There was not a favorable effect of locally delivered heparin on clinical, angiographic, or IVUS end points of restenosis. The use of IVUS to measure volume of intimal hyperplasia in a multicenter, core laboratory-controlled trial is feasible.

We report a case of emergency stenting for acute occlusion of the left main coronary artery in the setting of acute myocardial infarction. Although stent implantation allowed prompt revascularization and successful immediate management of this life-threatening condition, subacute stent thrombosis occurred, requiring re-PTCA followed by surgical revascularization. This case suggests that stenting of an acutely occluded left main coronary artery may be a life-saving procedure but should only be used as a bridge to surgery rather than a definitive treatment modality.

We describe a patient with acute myocardial infarction due to thrombotic occlusion of the left anterior descending coronary artery. Following thrombolytic therapy, five episodes of ventricular fibrillation recurred despite the absence of profibrillatory factors other than myocardial ischemia. Because of thrombolysis failure, rescue angioplasty associated with coronary stent implantation was performed. After successful mechanical artery recanalization, no recurrences of the malignant arrhythmia were observed. This case supports the concept, recently demonstrated in animals, that the process of intracoronary thrombosis itself may have arrhythmogenic effects above and beyond the impact of myocardial ischemia induced by coronary occlusion per se.

Recent evidence suggests that higher restenosis rate is observed after coronary angioplasty of an infarct-related artery. Furthermore, angiographic restenosis seems associated with a deterioration of left ventricular function at follow-up. The aim of this study was to assess the acute results and angiographic restenosis following coronary artery stenting of infarct-related (Group 1) and non infarct-related coronary arteries (Group 2). We retrospectively analyzed the results of 381 consecutive patients treated with Palmaz-Schatz coronary stent implantation between May 1992 and January 1996. Stenting of the infarct-related artery was performed in 154 patients (Group 1), while 227 patients (Group 2) received stenting of the non infarct-related artery. Both groups had similar age, gender, clinical conditions and coronary angiographic pattern. There were no significant differences between groups, concerning type of stented coronary vessel (left anterior descending-LAD 52.4% vs non-LAD 47.6%, Group 1, LAD 59.5% vs non-LAD 40.5%, Group 2) and number of stents per patient (1.31 +/- 0.48 in Group 1, 1.18 +/- 0.56 in Group 2) and per coronary vessel (1.17 +/- 0.54 in Group 1, 1.09 +/- 0.46 in Group 2). The procedure was performed using similar maximal inflation pressures in both groups (13.3 +/- 2.9 atm in Group 1, 13.40 +/- 3.17 atm in Group 2). Technical success was achieved in 96.8% of Group 1 and in 96% of Group 2 patients. Acute coronary stenting success and major adverse events (acute myocardial infarction, emergency bypass, death) were similar in both groups of patients. No difference was found in restenosis rate at 6-month angiographic follow-up (Group 1 = 29.8%, Group 2 = 27%). In conclusion, this study indicates that stenting of infarct and non infarct-related coronary arteries has similar success and 6-month restenosis rates.