Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial.

AIM: Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes. METHODS AND RESULTS: We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR): 0.65, 95% confidence interval (CI): 0.44-0.96; Pnon-inferiority < 0.001; Psuperiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs. 11.1%, HR: 0.67, 95% CI: 0.46-0.99; P = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups. CONCLUSION: In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT03321032.

Electrocardiographic changes announcing the rapid development of apical hypertrophic cardiomyopathy in an adult male.

We presented the case of an adult male without structural heart disease, who in the period of 3 years developed apical hypertrophic cardiomyopathy. ECG changes preceded the development of ventricular hypertrophy. We discussed the appearance of ventricular enlargement during adulthood, in some cases of hypertrophic cardiomyopathy (HC), and how the ECG abnormalities may precede the onset of ventricular hypertrophy.

Incidence and prognosis of late readmission after percutaneous coronary intervention.

BACKGROUND: Early readmission (< 30 days) after percutaneous coronary intervention (PCI) is associated with a worse prognosis, but little is known regarding the causes and consequences of late readmission. The aim of the present study was to determine the incidence, causes, and prognosis of patients readmitted > 1 < 12-months after PCI (late readmission). METHODS: Single-center retrospective cohort study of 743 consecutive post-PCI patients. Patient characteristics and follow-up data were collected by reviewing their electronic medical records and from standardized telephone interviews performed at 1 year and at the end of follow-up. RESULTS: Of the 743 patients, 224 (30.14%) were readmitted 1-12 months after PCI, 109 due to chest pain (48.66%), and 115 for other reasons (51.34%). Hospital readmission was associated with lower survival rates of 77.6% vs. 98.3% at 24 months and 73.5% vs. 97.6% at 36 months (p < 0.001). Univariate predictors for late readmission were hypertension, older age, chronic kidney disease, lower left ventricular ejection fraction, and lower baseline hemoglobin concentration. Only baseline hemoglobin concentration was an independent predictor of late readmission (odds ratio: 0.867, 95% confidence interval: 0.778-0.966, p = 0.01). Readmission for chest pain portrayed a lower mortality rate compared to other causes, with survival rates of 90.2% vs. 50% at 36 months (p < 0.001). CONCLUSIONS: Late hospital readmission after PCI is associated with a worse prognosis and is related to patient comorbidities. Readmission for chest pain is common and portrayed a more favorable prognosis, similar to patients not readmitted. A readily available parameter, baseline anemia, was the main predictor of late readmission.

Accuracy of the angiography-based quantitative flow ratio in intermediate left main coronary artery lesions and comparison with visual estimation.

BACKGROUND: Revascularization of left main coronary artery (LMCA) stenosis is mostly based on angiography. Indices based on angiography might increase accuracy of the decision, although they have been scarcely used in LMCA. The objective of this study is to study the diagnostic agreement of QFR (quantitative flow ratio) with wire-based fractional flow reserve (FFR) in LMCA lesions and to compare with visual severity assessment. METHODS: In a series of patients with invasive FFR assessment of intermediate LMCA stenoses we retrospectively compared the measured value of QFR with that of FFR and the estimate of significance from angiography. RESULTS: 107 QFR studies were included. The QFR intra-observer and inter-observer agreement was 87% and 82% respectively. The mean QFR-FFR difference was 0.047 ± 0.05 with a concordance of 90.7%, sensitivity 88.1%, specificity 92.3%, positive predictive value 88.1% and negative predictive value 92.3%. All these values were superior to those observed with the visual estimation which showed an intra- and inter-observer agreement of 73% and 72% respectively, besides 78% with the FFR value. The low diagnostic performance of the visual estimation and the acceptable performance of the QFR index measurement were observed in all subgroups analysed. CONCLUSIONS: QFR allows an acceptable estimate of the FFR obtained with intracoronary pressure guidewire in intermediate LMCA lesions, and clearly superior to the assessment based on angiography alone. The decision to revascularize patients with moderate LMCA lesions should not be based solely on the degree of angiographic stenosis.

Long-term prognostic value of quantitative-flow-ratio-concordant revascularization in stable coronary artery disease.

OBJECTIVES: Confirming the prognostic value of global QFR and evaluating the long-term prognosis of QFR-concordant therapy in stable coronary artery disease. BACKGROUND: Wire-based functional evaluation of coronary disease is linked to patient's prognosis. Quantitative Flow Ratio (QFR) is a newer index of computational physiology, linked to clinical outcomes and prognosis at 1 year follow-up. Long-term prognosis of QFR-concordant revascularization in stable coronary artery disease is however unknown hitherto. METHODS: Consecutive patients with stable coronary disease undergoing coronary angiography were included. Centralized and blinded QFR analysis of three coronary territories was performed. Three vessel QFR (3vQFR) was defined as the sum of the basal QFR of each coronary territory. QFR-concordant revascularization was met if all significant lesions (QFR ≤ 0.80) were revascularized and all non-significant lesions (QFR > 0.80) were not; otherwise, the case was defined as QFR-discordant revascularization. Patient-oriented composite end-point (POCE) of cardiac death, myocardial infarction and unscheduled revascularization was the primary endpoint. RESULTS: A total of 803 patients from six high-volume centers were included. Canadian Cardiovascular Society (CCS) class II angina was the most frequent (48.9%) clinical presentation. Median of follow-up was 68.8 months. 3vQFR was an independent predictor of POCE (HR 1.79 CI95% 1.01-3.18), with 2.75 as optimal cut-off value, irrespective of the therapy received. QFR-discordant revascularization (QFR+/Revascularization- or QFR-/Revascularization+) was an independent predictor of POCE in multivariate analysis (HR 1.65, CI 95% 1.03-2.64). CONCLUSION: Global burden of epicardial coronary atherosclerosis, as evaluated by 3vQFR, as well as QFR-discordant therapy are independent predictors of adverse clinical outcome at long-term follow-up in stable coronary artery disease.

A simple score to select patients for manual thrombectomy in emergent percutaneous coronary interventions: the DDTA score.

BACKGROUND: The objective of manual thrombectomy is the removal of occlusive thrombus to improve the results of primary angioplasty. The better understanding of the factors associated with successful manual thrombectomy may provide relevant information regarding thrombus formation and resolution. METHODS: Observational study of all consecutive patients remitted for emergent percutaneous coronary intervention (PCI) in a single centre. Successful manual thrombectomy was considered when TIMI 3 was achieved after using the device and a score to predict successful manual thrombectomy was designed. RESULTS: We included 618 patients, 65.1% treated with manual thrombectomy. No relevant differences in clinical features or time delays were observed between patients treated with vs. without manual thrombectomy, but manual thrombectomy treated patients received more often dual antiplatelet treatment (DAPT) before PCI. Final TIMI flow 3 was achieved in most patients and more frequently in manual thrombectomy treated patients (94.8 vs. 86.6%; P < 0.01). The successful manual thrombectomy rate was 81.3% and it was higher in patients pretreated with DAPT (89.0 vs. 73.3%; P < 0.01). The time delay to first medical contact was not related to the final TIMI 3, but it was significantly and negatively related to successful manual thrombectomy. According to the multivariate analysis, we designed the DDTA score: DAPT pretreatment (2), delay less than 2 h (3) or 2-4 h (2), TIMI flow improvement after wiring the lesion (2) and age less than 55 years (3). Patients with DDTA score at least 4 had lower no-reflow, mortality and major cardiovascular complications incidence. CONCLUSION: The DDTA score (DAPT pretreatment, time delays, TIMI flow improvement after wiring the lesion and age) identifies patients who benefit mostly from manual thrombectomy.

Prevalence and prognosis of percutaneous coronary intervention-associated nephropathy in patients with acute coronary syndrome and normal kidney function.

INTRODUCTION AND OBJECTIVES: The aim of this study was to analyze the prevalence, risk factors, and short- and long-term prognosis of patients with acute coronary syndrome and normal renal function who developed percutaneous coronary intervention-associated nephropathy. METHODS: This was an observational, retrospective, single-center study with a prospective follow-up of 470 consecutive patients hospitalized for acute coronary syndrome (not in cardiogenic shock) who underwent percutaneous coronary intervention, with no preexisting renal failure (admission creatinine ≤ 1.3mg/dL). Percutaneous coronary intervention-associated was defined as an increase in baseline creatinine ≥ 0.5 mg/dL or ≥ 25% baseline. The mean follow-up was 26.7 (14) months. RESULTS: Of the 470 patients, 30 (6.4%) developed percutaneous coronary intervention-associated nepfhropathy. The independent predictors for acute renal failure were admission hemoglobin level (odds ratio = 0.71) and maximum troponin I level prior to the procedure (odds ratio = 1.02). During the long-term follow-up, the patients whose renal function deteriorated had a higher incidence of total mortality (5 [16.7%] vs 27 [6.1%]; P = .027). In the Cox regression analysis, percutaneous coronary intervention-associated nepfhropathy was not an independent predictor for total mortality, but could be a predictor for cardiac mortality (hazard ratio=5.4; 95% confidence interval 1.35-21.3; P = .017). CONCLUSIONS: Percutaneous coronary intervention-associated nephropathy in patients with acute coronary syndrome and normal preexisting renal function is not uncommon and influences long-term survival.