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Background and objectives: Recent data have established non-inferiority of drug-coated balloons (DCB) compared to drug-eluting stents (DES) for treatment of small-vessel coronary artery disease. Since coronary vessels in women might have anatomical and pathophysiological particularities, the safety of the DCB strategy among women compared to men needs to be assessed in more detail. Methods: In BASKET-SMALL 2, patients with de novo lesions in coronary vessels < 3 mm and an indication for percutaneous coronary intervention were randomly allocated (1:1) to DCB vs. DES after successful lesion preparation. The primary objective of the randomized trial was to establish non-inferiority of DCB vs. DES regarding major adverse cardiac events (MACE; i.e., cardiac death, non-fatal myocardial infarction, and target vessel revascularization) after 12 months. The aim of the current sub-analysis is to evaluate whether the DCB strategy is equally safe among women and men after 12 and 36 months. Results: Among 758 randomized patients, 382 were assigned to DCB (23% women) and 376 to DES (30% women). In general, women were older, had more often diabetes mellitus and renal insufficiency, and presented more often with an acute coronary syndrome, whereas men were more often smokers, had multivessel disease and a previous history of acute myocardial infarction, and received a treatment with a statin. After 3 years, the primary clinical end point was not significantly different between groups (13% women vs. 16% men, HR 0.82; 95% CI 0.52−1.30; p = 0.40). There was no interaction between sex and coronary intervention strategy regarding MACE at 36 months (10% women vs. 16% men in DCB, 16% women vs. 15% men in DES; pinteraction = 0.31). Conclusion: In small native coronary artery disease, there was no statistically significant effect of sex on the difference between DCB and DES regarding MACE up to 36 months. Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01574534. [ABSTRACT FROM AUTHOR]

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Background: Data on the safety and efficacy of drug-coated balloon (DCB) compared to drug-eluting stent (DES) in patients with chronic kidney disease (CKD) are scarce, particularly at long term. This pre-specified analysis aimed to investigate the 3-year efficacy and safety of DCB versus DES for small coronary artery disease (< 3 mm) according to renal function at baseline. Methods: BASKET-SMALL-2 was a large multi-center, randomized, controlled trial that tested the efficacy and safety of DCBs (n = 382) against DESs (n = 376) in small vessel disease. CKD was defined as eGFR < 60 ml/min/1.73m2. The primary endpoint was the composite of cardiac death, non-fatal myocardial infarction, and target vessel revascularization (MACE) during 3 years. Results: A total of 174/758 (23%) patients had CKD, out of which 91 were randomized to DCB and 83 to DES implantation. The primary efficacy outcome during 3 years was similar in both, DCB and DES patients (HR 0.98; 95%-CI 0.67–1.44; p = 0.937) and patients with and without CKD (HR 1.18; 95%-CI 0.76–1.83; p = 0.462), respectively. Rates of cardiac death and all-cause death were significantly higher among patients with CKD but not affected by treatment with DCB or DES. Major bleeding events were lower in the DCB when compared to the DES group (12 vs. 3, HR 0.26; 95%-CI 0.07–0.92; p = 0.037) and not influenced by presence of CKD. Conclusions: The long-term efficacy and safety of DCB was similar in patients with and without CKD. The use of DCB was associated with significantly fewer major bleeding events (NCT 01574534). [ABSTRACT FROM AUTHOR]

We present the case of a 78-year-old woman suffering from coronary artery disease and secondary severe mitral valve regurgitation due to left ventricular and annular distention. The interdisciplinary heart team recommended a simultaneous hybrid procedure consisting of minimally invasive direct coronary artery bypass grafting with subsequent transapical mitral valve replacement using the Tendyne prosthesis via the same small anterolateral thoracotomy. The operation was performed using a heart-team approach with close collaboration between heart surgeons and cardiologists in the hybrid operating theatre. The intra- and postoperative courses were uneventful. Predischarge transthoracic echocardiography on postoperative day 8 revealed the immaculate functioning of the implanted valve without para- or transvalvular insufficiency, a mean gradient of 2 mmHg, no left ventricular outflow tract obstruction and a stable ejection fraction of 50%. The combination of minimally invasive direct coronary artery bypass grafting revascularization with concomitant transapical mitral valve replacement is feasible and enables a further step towards minimally invasive therapy, even in complex situations. It shows that the modern heart-team approach exceeds mere decision making and expands towards a hybrid treatment for patients. [ABSTRACT FROM AUTHOR]

Background: Dual antiplatelet therapy (DAPT) prevents thrombotic events after coronary stent implantation but may induce bleedings, specifically in elderly patients. However, a competitive risk analysis is lacking. Objectives: To assess the determinants of major bleeding and the balance between the competing risks of major bleeding and thrombotic events during prasugrel-based DAPT after stent implantation. Methods: Overall, 2,291 patients randomized to drug-eluting or bare metal stents and treated with prasugrel 10mg/day for 1 year were followed over 2 years for major bleeding (BARC 3/5) and thrombotic events (cardiac death, myocardial infarction, definitive/probable stent thrombosis). Prasugrel dose was reduced to 5mg in patients >75 years and/or <60kg. Predictors of major bleeding and competing risks of major bleeding and thrombotic events were assessed. Results: Two-year rates of major bleeding and thrombotic events were 2.9% and 9.0%, respectively. The only independent predictor of major bleeding was age (hazard ratio per year increase 1.05 [1.02,1.07], p<0.001). The relationship between major bleeding and age was non-linear, with lowest hazard ratios at 57 years and an exponential increase only above 65 years. In contrast, the relationship between thrombotic events and age was linear and continuously increasing with older age. While the competing risk of thrombotic events was higher than that of major bleeding in younger patients, the two risks were similar in older patients. After discontinuation of prasugrel, bleeding events leveled off in all patients, while thrombotic events continued to increase. Conclusions: In prasugrel-based DAPT, age is the strongest risk factor for major bleeding, increasing exponentially >65 years. In younger patients, thrombotic events represent a higher risk than bleeding, while thrombotic and bleeding risks were similar in older patients. Important clinical implications relate to prasugrel dose in the elderly, duration of DAPT and the competing risk balance necessitating individualized treatment decisions. [ABSTRACT FROM AUTHOR]

Background: Drug-coated balloons (DCB) are a novel therapeutic strategy for small native coronary artery disease. However, their safety and efficacy is poorly defined in comparison with drug-eluting stents (DES).Methods: BASKET-SMALL 2 was a multicentre, open-label, randomised non-inferiority trial. 758 patients with de-novo lesions (<3 mm in diameter) in coronary vessels and an indication for percutaneous coronary intervention were randomly allocated (1:1) to receive angioplasty with DCB versus implantation of a second-generation DES after successful predilatation via an interactive internet-based response system. Dual antiplatelet therapy was given according to current guidelines. The primary objective was to show non-inferiority of DCB versus DES regarding major adverse cardiac events (MACE; ie, cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation) after 12 months. The non-inferiority margin was an absolute difference of 4% in MACE. This trial is registered with ClinicalTrials.gov, number NCT01574534.Findings: Between April 10, 2012, and February 1, 2017, 382 patients were randomly assigned to the DCB group and 376 to DES group. Non-inferiority of DCB versus DES was shown because the 95% CI of the absolute difference in MACE in the per-protocol population was below the predefined margin (-3·83 to 3·93%, p=0·0217). After 12 months, the proportions of MACE were similar in both groups of the full-analysis population (MACE was 7·5% for the DCB group vs 7·3% for the DES group; hazard ratio [HR] 0·97 [95% CI 0·58-1·64], p=0·9180). There were five (1·3%) cardiac-related deaths in the DES group and 12 (3·1%) in the DCB group (full analysis population). Probable or definite stent thrombosis (three [0·8%] in the DCB group vs four [1·1%] in the DES group; HR 0·73 [0·16-3·26]) and major bleeding (four [1·1%] in the DCB group vs nine [2·4%] in the DES group; HR 0·45 [0·14-1·46]) were the most common adverse events.Interpretation: In small native coronary artery disease, DCB was non-inferior to DES regarding MACE up to 12 months, with similar event rates for both treatment groups.Funding: Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung, Basel Cardiovascular Research Foundation, and B Braun Medical AG. [ABSTRACT FROM AUTHOR]

Objectives: To assess independent predictors of stent thrombosis (ST) in an all-comer trial. Methods: This is an observational case-control study based on a retrospective analysis of the Basel Stent Kosten Effektivitäts Trial (BASKET) (n = 826). Patients with ST were compared to controls with regard to baseline parameters. Multivariate models were performed to identify independent predictors of ST. Results: At 36 months, there were 53 (6.4%) patients with ST, 17 (32%) of whom had early ST and 36 (68%) of whom had late/very late ST. Patients with ST were at a higher cardiovascular risk but received lower doses of statins than the controls (n = 212). Stents in ST patients were longer, had more overlap and were not as well expanded, with significantly more remaining stenoses than the stents in the controls. Multivariable analysis revealed interventions in saphenous vein grafts, malapposed stents, an overlap >3 mm, complex coronary anatomy and treatment with low-dose/no statins as risk factors for ST, while interventions in saphenous vein grafts, underexpanded or malapposed stents, a history of myocardial infarction and treatment with low-dose/no statins were risk factors for late ST. Conclusions: The use of statins might have a protective effect against ST. This observation is new, hypothesis-generating and should be evaluated in an adequately powered randomized trial. Copyright © 2013 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Background: A pooled analysis in cardiogenic shock due to acute coronary syndromes is desirable to assess the effect of early revascularization (ERV) across all ages and a wide spectrum of disease severity. Methods: Only two randomized controlled trials (RCT), i.e. SMASH and SHOCK, met the inclusion criteria and were combined for a pooled analysis using individual patient data ( n == 348). Results: SMASH patients ( n == 54, 16%) had more severe disease than SHOCK patients ( n == 294, 84%). After adjustment for age, anoxic brain damage, non-inferior myocardial infarction, prior coronary artery bypass graft surgery, renal failure, systolic blood pressure, and selection for coronary angiography, one-year mortality was similar (relative risk SHOCK versus SMASH 0.87, 95% CI: 0.61--1.25). Relative risk of one-year death for ERV versus initial medical stabilization was 0.82 (95% CI: 0.70--0.96). There was no significant difference in the treatment effect by age (≤≤75 years relative risk at one year 0.79, 95% CI: 0.63--0.99; > 75 years relative risk at one year 0.93, 95% CI: 0.56--1.53; interaction P == 0.10). Conclusions: Only two RCT have been published emphasizing the difficulty of enrolling critically ill patients. Despite large differences in shock severity, ERV benefit is similar across all ages and not significantly different for the elderly. [ABSTRACT FROM AUTHOR]

Background: Few studies describe recent changes in the incidence, treatment, and outcomes of cardiogenic shock.Objective: To examine temporal trends in the incidence, therapeutic management, and mortality rates of patients with the acute coronary syndrome (ACS) and cardiogenic shock, and to assess associations of therapeutic management with death and cardiogenic shock developing during hospitalization.Design: Analysis of registry data collected among patients admitted to hospitals between 1997 and 2006.Setting: 70 of the 106 acute cardiac care hospitals in Switzerland.Patients: 23 696 adults with ACS enrolled in the AMIS (Acute Myocardial Infarction in Switzerland) Plus Registry.Measurements: Cardiogenic shock incidence; treatment, including rates of percutaneous coronary intervention; and in-hospital mortality rates.Results: Rates of overall cardiogenic shock (8.3% of patients with ACS) and cardiogenic shock developing during hospitalization (6.0% of patients with ACS and 71.5% of patients with cardiogenic shock) decreased during the past decade (P < 0.001 for temporal trend), whereas rates of cardiogenic shock on admission remained constant (2.3% of patients with ACS and 28.5% of patients with cardiogenic shock). Rates of percutaneous coronary intervention increased among patients with cardiogenic shock (7.6% to 65.9%; P = 0.010), whereas in-hospital mortality decreased (62.8% to 47.7%; P = 0.010). Percutaneous coronary intervention was independently associated with lower risk for both in-hospital mortality in all patients with ACS (odds ratio, 0.47 [95% CI, 0.30 to 0.73]; P = 0.001) and cardiogenic shock development during hospitalization in patients with ACS but without cardiogenic shock on admission (odds ratio, 0.59 [CI, 0.39 to 0.89]; P = 0.012).Limitations: There was no central review of cardiogenic shock diagnoses, and follow-up duration was confined to the hospital stay. Unmeasured or inaccurately measured characteristics may have confounded observed associations of treatment with outcomes.Conclusion: Over the past decade, rates of cardiogenic shock developing during hospitalization and in-hospital mortality decreased among patients with ACS. Increased percutaneous coronary intervention rates were associated with decreased mortality among patients with cardiogenic shock and with decreased development of cardiogenic shock during hospitalization. [ABSTRACT FROM AUTHOR]

Background: Few studies describe recent changes in the incidence, treatment, and outcomes of cardiogenic shock. Objective: To examine temporal trends in the incidence, therapeutic management, and mortality rates of patients with the acute coronary syndrome (ACS) and cardiogenic shock, and to assess associations of therapeutic management with death and cardiogenic shock developing during hospitalization. Design: Analysis of registry data collected among patients admitted to hospitals between 1997 and 2006. Setting: 70 of the 106 acute cardiac care hospitals in Switzerland. Patients: 23 696 adults with ACS enrolled in the AMIS (Acute Myocardial Infarction in Switzerland) Plus Registry. Measurements: Cardiogenic shock incidence; treatment, including rates of percutaneous coronary intervention; and in-hospital mortality rates. Results: Rates of overall cardiogenic shock (8.3% of patients with ACS) and cardiogenic shock developing during hospitalization (6.0% of patients with ACS and 71.5% of patients with cardiogenic shock) decreased during the past decade (P < 0.001 for temporal trend), whereas rates of cardiogenic shock on admission remained constant (2.3% of patients with ACS and 28.5% of patients with cardiogenic shock). Rates of percutaneous coronary intervention increased among patients with cardiogenic shock (7.6% to 65.9%; P = 0.010), whereas in-hospital mortality decreased (62.8% to 47.7%; P = 0.010). Percutaneous coronary intervention was independently associated with lower risk for both in-hospital mortality in all patients with ACS (odds ratio, 0.47 [95% CI, 0.30 to 0.73]; P = 0.001) and cardiogenic shock development during hospitalization in patients with ACS but without cardiogenic shock on admission (odds ratio, 0.59 [CI, 0.39 to 0.89]; P = 0.012). Limitations: There was no central review of cardiogenic shock diagnoses, and follow-up duration was confined to the hospital stay. Unmeasured or inaccurately measured characteristics may have confounded observed associations of treatment with outcomes. Conclusion: Over the past decade, rates of cardiogenic shock developing during hospitalization and in-hospital mortality decreased among patients with ACS. Increased percutaneous coronary intervention rates were associated with decreased mortality among patients with cardiogenic shock and with decreased development of cardiogenic shock during hospitalization. [ABSTRACT FROM AUTHOR]

Objectives: To define long-term efficacy of different stent types in saphenous vein graft (SVG) interventions. Methods: In BASKET (Basel Stent Cost Effectiveness Trial), major adverse cardiac events (MACE), i.e. cardiac death, myocardial infarction and symptom-driven target vessel revascularization (TVR) were assessed after 18 months comparing drug-eluting stents (DES) versus bare metal stents (BMS), and SVG and large native vessels (≥3.0 mm). Results: Large vessel interventions were performed in 605 patients. Patients with SVG interventions (n = 47, 8%) were older and had more often hypertension, prior myocardial infarction, prior revascularization and multivessel disease and less frequent ST-elevation myocardial infarction than patients with large native vessel interventions (n = 558, 92%). Stent number and length were higher in SVG than in large native vessel interventions. Baseline characteristics were similar for DES and BMS. In SVG stenting, long-term outcome was better in DES- than in BMS-treated patients (MACE 21 vs. 62%, p = 0.007, mainly due to TVR 18 vs. 46%, p = 0.045), but for large native vessel stenting, no significant difference was noted (MACE: 13 vs. 16%, p = 0.40). Conclusions: Among patients with SVG disease, treatment with DES resulted in a better long-term outcome than treatment with BMS. In contrast, no DES benefit was found in similarly sized native vessels regarding MACE. Copyright © 2008 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

The article discusses the study on the importance of hemodynamic parameters in cardiogenic shock (CS). It shows that stroke volume index (SVI) and stroke work index (SWI) are the most powerful hemodynamic predictors of 30-day mortality in CS patients. It also notes that the early hemodynamic stability after initial medical stabilization should not delay revascularization since long term outcomes are superior with early vascularization.

Background: Diabetes mellitus (DM), particularly if insulin-dependent, is a predictor of increased perioperative risk, whereas stringent metabolic control with insulin is beneficial in the critically ill. Methods: The impact of oral hypoglycemics (OH) vs. insulin on outcome was determined as a secondary retrospective analysis of a cohort study in patients with coronary artery disease (CAD) and DM undergoing major non-cardiac surgery. Primary end-point was 2-year all-cause mortality; secondary endpoints were perioperative myocardial ischemia and 2-year cardiac mortality. Results: Of 173 patients, DM was diagnosed in 42 (24%) based on pre-existing treatment with OH (15%) or insulin (9%). During follow-up, 40/173 (23%) patients died. All-cause mortality was similar in the non-diabetic (20%) and insulin groups (19%) but significantly higher in the OH group (42%; p = 0.025). Cardiac mortality tended to be higher in the OH group compared with the insulin and non-diabetic groups (27 vs. 19% and 11%, respectively; p = 0.066). Multivariate analysis revealed renal failure (odds ratio [OR] = 4.9, 95% confidence interval [CI] = 1.8–13.0), treatment with OH (OR = 3.3, 95% CI = 1.2–9.0), peripheral vascular surgery (OR = 2.7, 95% CI = 1.2–6.0), and prior diuretic therapy (OR = 2.6, 95% CI = 1.1–5.7) being independently associated with 2-year all-cause death. No difference existed in postoperative ischemia among the different groups. Conclusions: Long-term mortality after major non-cardiac surgery is elevated in patients with CAD and diabetes mellitus only if they are treated with OH, but not if they are treated with insulin. Further evaluation of the impact of perioperative anti-diabetic treatment on morbidity and mortality in CAD is warranted. Copyright © 2007 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Background: In cardiogenic shock, causes of death usually are cardiac. However, a systemic inflammatory response syndrome may influence outcome. Methods: Should we emergently revascularize Occluded Coronaries in cardiogenic shocK? (SHOCK) Trial patients (n = 302) were analyzed regarding cause of death and re-hospitalization. Results: Deaths (n = 180) occurred ≤30 days in 86% and >30 days in 14%. Known causes of death ≤30 days were cardiac in 88% (37% arrhythmic) and non-cardiac in 12% (29% septic). Non-cardiac deaths ≤30 days occurred later (206 [91,394] versus 41 [15,156] h, P<0. 01) and were more frequently associated with signs of inflammation (43 versus 12%, P = 0. 01) than cardiac deaths ≤30 days. Known causes of in-hospital death >30 days (n = 19) were cardiac in 58% and non-cardiac in 42%. Among deaths ≤30 days systemic vascular resistance index was higher (2,666±1,063 versus 2,090±731 dynes·sec·cm-5 m2, P = 0. 05) than among deaths >30 days. Among the 116 survivors of the initial hospitalization with data available, 52 (45%) were readmitted, most of which due to heart failure (n = 22, 42%) and myocardial ischemia (n = 16, 31%). Conclusions: In CS, early deaths ≤30 days are mainly cardiac. Non-cardiac deaths are associated with signs of inflammation. In survivors of the initial hospitalization, re-hospitalizations are due to heart failure and myocardial ischemia. [ABSTRACT FROM AUTHOR]

Aims To determine clinical correlates and optimal treatment strategy in patients with cardiogenic shock (CS) on admission. [ABSTRACT FROM PUBLISHER]

Study objectives: To define the prognostic value of stress testing (STRT) in patients ≥75 years of age. Design: Multicenter prospective randomized trial. Setting: Tertiary care centers. Patients: Two hundred ninety-two patients of the Trial of Invasive vs Medical Treatment of Elderly Patients aged ≥75 years with chronic angina despite receiving two or more antianginal drugs were prospectively observed for 1 year. Intervention: STRT (88% exercise ECG; 12% pharmacologic stress imaging) was performed if possible, and ischemia was diagnosed using current guidelines. Death for any reason and nonfatal myocardial infarction were outcome events. Results: Patients who could perform STRT (148 patients) were younger, had a lower risk profile, received less medication, and had less severe angina than patients who could not perform STRT (144 patients). The 1-year mortality rate was only 1.4% in patients with negative STRT results (72 patients) compared to 5.3% in patients with positive STRT results (76 patients) and 13.7% in patients who had not undergone STRT due to unstable symptoms (95 patients). The corresponding 1-year rates of death/infarction were 2.8%, 15.8%, and 26.3%, respectively. After adjustment for baseline differences, mortality rates were no longer significantly different. However, compared to patients with negative STRT results, infarction and death/infarction rates remained higher in patients with provocable ischemia (hazard ratio [HR], 8.9 [p = 0.04]; HR, 6.1 [p = 0.02], respectively) and in patients without STRT due to unstable angina (HR, 11.8 [p = 0.02]; HR, 8.6 [p = .004], respectively). Conclusions: STRT in elderly patients is feasible and provides important prognostic information for their future management. Patients with negative STRT results after receiving therapy have a good prognosis, and their conditions may be managed conservatively. [ABSTRACT FROM AUTHOR]