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Study objectives: To test the short- and long-term performance of a simple algorithm to detect or rule out acute coronary artery disease (CAD) in patients referred with acute chest pain (CP). Design: Prospective, multicenter study with 30-day and 1-year follow-ups. Setting: Emergency and coronary care units of two university hospitals and four affiliated teaching hospitals in a suburban region of northern Switzerland. Patients: One hundred sixty-one consecutive patients referred with acute CP with a high CAD risk profile underwent exercise testing (ET) within 24 h if results of two troponin tests and ECG remained normal within 6 h. The patients were discharged if ET results were negative or underwent angiography if the results were positive. Measurements and results: The primary end point was survival free of death, myocardial infarction (MI), and acute coronary syndrome, as well as the correct diagnosis of CAD in need of revascularization. Failure of the algorithm included events not predicted and false-positive ET results. Symptom-limited ET was performed in 142 patients, and stress imaging was performed in 17 patients. Discharge within 24 h was possible in 76%. Angiography in 21 patients showed no CAD in 4 patients, whereas revascularization was necessary in 17 patients. During follow-up, three patients had an MI (one fatal) and two patients had unstable angina, for an event rate of 3.1%/yr. Overall sensitivity of the algorithm to detect CAD was 71%, whereby six of seven false-positive ET results were due to exercise-induced CP without ECG changes. More importantly, the negative predictive value was 96.4%, indicating that this simple algorithm failed to identify only 3.6% of patients at risk for future events. Conclusions: Discharge within 24 h after onset of acute CP in high-risk CAD patients is safe, irrespective of CAD history, if ECG findings remain unchanged and troponin test results are normal within 6 h, and if results of adequate ET are negative. [ABSTRACT FROM AUTHOR]

Background: Chronic angina is a common and disabling disorder in the elderly. Combined antianginal drug treatment represents the mainstay of therapy in this population. However, there is a paucity of data regarding the effect of this strategy on long-term outcome in the elderly.Methods: To assess the long-term effect of combined antianginal drug therapy in elderly individuals, we performed a long-term follow-up analysis of all 148 patients of the Trial of Invasive versus Medical therapy in Elderly (TIME) patients with chronic symptomatic coronary-artery disease assigned to an optimized medical therapy strategy. Angina severity, measures of quality of life (QOL), and survival were assessed after a median of 3.7 (0.1-6.9) years.Results: At baseline, patients were 79.8 +/- 3.5 years old with Canadian Cardiovascular Society (CCS) class angina 3.0 +/- 0.7 despite the use of 2.4 +/- 0.6 antianginal drugs. Although antianginal drugs were increased to 2.8 +/- 0.9 (P < .01), 63 (43%) patients needed revascularization for refractory symptoms during the first year of observation (REVASC). At baseline, REVASC patients had more frequently CCS class 4 angina (37% vs 20%, P < 0.05) but reported less prior heart failure (5% vs 20%, P < 0.01), fewer prior cerebral events (3% vs 13%, P < .05) and a lower rate of two or more comorbidities (10% vs 33%, P < .01) than patients on continued drug therapy (DRUG). At long-term follow-up, angina severity was still higher in DRUG compared to REVASC patients (CCS class, 1.8 +/- 1.6 vs 1.0 +/- 1.4, P < .05) despite more antianginal drugs (2.1 +/- 1.1 vs 1.5 +/- 1.0, P < .01), whereas measures of QOL had improved similarly in both groups. In addition, long-term mortality was significantly higher in DRUG than in REVASC patients (38% vs 13%, P < .01).Conclusion: Combined antianginal drug therapy successfully relieved symptoms in most elderly patients with chronic angina but failed to do so in 43%. Patients who needed revascularization for refractory symptoms reported less angina, despite lower drug use during long-term follow-up and had a better long-term survival. Thus, the widely used strategy to increase antianginal drug therapy in elderly patients instead of evaluating them for revascularization should be reconsidered. [ABSTRACT FROM AUTHOR]

Summary Background No prospective trial-based data are available for incremental cost-effectiveness of drug-eluting stents (DES) compared with bare-metal stents (BMS) in unselected patients, as treated in everyday practice. Methods The Basel stent cost-effectiveness trial (BASKET) included 826 consecutive patients treated with angioplasty and stenting for 1281 de-novo lesions, irrespective of indication for angioplasty. Patients were randomised to one of two DES (Cypher, n=264; Taxus, n=281) or to a cobalt-chromium-based BMS (Vision, n=281) and followed up for 6 months for occurrence of major adverse cardiac events and costs. Analysis was by intention-to-treat. The primary endpoint was cost-effectiveness after 6 months, with effectiveness defined as reduction of major adverse cardiac events. Findings Cardiac death, myocardial infarction, or target vessel revascularisation occurred in 39 of 544 (7·2%) patients with DES and 34 of 280 (12·1%) with BMS (odds ratio 0·56, 95% CI 0·35-0·91; p=0·02), without significant differences between the two DES. Total costs at 6 months were higher with DES (mean &z.euro;10 544, SD 6849) than with BMS (&z.euro;9639, 9067; p<0·0001); higher stent costs of DES were not compensated for by lower follow-up costs. Incremental cost-effectiveness ratio of DES compared with BMS to avoid one major event was &z.euro;18 311, and costs per quality-adjusted life-year gained were more than &z.euro;50 000. Subgroup analyses showed that DES were more cost-effective for elderly patients in specific high-risk groups. Interpretation In a real-world setting, use of DES in all patients is less cost effective than in studies with selected patients. Use of these stents could be restricted to patients in high-risk groups. [ABSTRACT FROM AUTHOR]

Background: B-type natriuretic peptide levels are higher in patients with congestive heart failure than in patients with dyspnea from other causes. Methods: We conducted a prospective, randomized, controlled study of 452 patients who presented to the emergency department with acute dyspnea: 225 patients were randomly assigned to a diagnostic strategy involving the measurement of B-type natriuretic peptide levels with the use of a rapid bedside assay, and 227 were assessed in a standard manner. The time to discharge and the total cost of treatment were the primary end points. Results: Base-line demographic and clinical characteristics were well matched between the two groups. The use of B-type natriuretic peptide levels reduced the need for hospitalization and intensive care; 75 percent of patients in the B-type natriuretic peptide group were hospitalized, as compared with 85 percent of patients in the control group (P=0.008), and 15 percent of those in the B-type natriuretic peptide group required intensive care, as compared with 24 percent of those in the control group (P=0.01). The median time to discharge was 8.0 days in the B-type natriuretic peptide group and 11.0 days in the control group (P=0.001). The mean total cost of treatment was $5,410 (95 percent confidence interval, $4,516 to $6,304) in the B-type natriuretic peptide group, as compared with $7,264 (95 percent confidence interval, $6,301 to $8,227) in the control group (P=0.006). The respective 30-day mortality rates were 10 percent and 12 percent (P=0.45). Conclusions: Used in conjunction with other clinical information, rapid measurement of B-type natriuretic peptide in the emergency department improved the evaluation and treatment of patients with acute dyspnea and thereby reduced the time to discharge and the total cost of treatment. N Engl J Med 2004;350:647-54. [ABSTRACT FROM AUTHOR]

Background: The randomized BASKET-PROVE study showed no significant differences between sirolimus-eluting stents (SES), everolimus-eluting stents (EES), and bare-metal stents (BMS) with respect to the primary end point, rates of death from cardiac causes, or myocardial infarction (MI) at 2 years of follow-up, in patients requiring stenting of a large coronary artery. Clinical risk factors may affect clinical outcomes after percutaneous coronary interventions. We present a retrospective analysis of the BASKET-PROVE data addressing the question as to whether the optimal type of stent can be predicted based on a cumulative clinical risk score., Methods: A total of 2,314 patients (mean age 66 years) who underwent coronary angioplasty and implantation of ≥1 stents that were ≥3.0 mm in diameter were randomly assigned to receive SES, EES, or BMS. A cumulative clinical risk score was derived using a Cox model that included age, gender, cardiovascular risk factors (hypercholesterolemia, hypertension, family history of cardiovascular disease, diabetes, smoking), presence of ≥2 comorbidities (stroke, peripheral artery disease, chronic kidney disease, chronic rheumatic disease), a history of MI or coronary revascularization, and clinical presentation (stable angina, unstable angina, ST-segment elevation MI)., Results: An aggregate drug-eluting stent (DES) group (n = 1,549) comprising 775 patients receiving SES and 774 patients receiving EES was compared to 765 patients receiving BMS. Rates of death from cardiac causes or nonfatal MI at 2 years of follow-up were significantly increased in patients who were in the high tertile of risk stratification for the clinical risk score compared to those who were in the aggregate low-mid tertiles. In patients with a high clinical risk score, rates of death from cardiac causes or nonfatal MI were lower in patients receiving DES (2.4 per 100 person-years, 95% CI 1.6-3.6) compared with BMS (5.5 per 100 person-years, 95% CI 3.7-8.2, hazard ratio 0.45, 95% CI 0.26-0.80, P = .007). However, they were not significantly different between receivers of DES and BMS in patients in the low-mid risk tertiles., Conclusions: This exploratory analysis suggests that, in patients who require stenting of a large coronary artery, use of a clinical risk score may identify those patients for whom DES use may confer a clinical advantage over BMS, beyond lower restenosis rates., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objective: This study sought to evaluate the prognostic value of routine stress myocardial perfusion scintigraphy (MPS) 5 years after percutaneous coronary intervention (PCI)., Background: Current appropriate use criteria define routine cardiac stress imaging <2 years after PCI as inappropriate and >2 years as uncertain in asymptomatic patients., Methods: All 339 of 683 BASKET (Basel Stent Kosteneffektivitäts Trial) 5-year survivors (55%) consenting to undergo protocol-mandated MPS and subsequent evaluation irrespective of symptoms were followed for major adverse cardiac events (MACE) (cardiac death, myocardial infarction [MI], or revascularization). For MPS, summed perfusion scores were calculated and perfusion defects were related to treated-vessel or remote myocardial areas., Results: Patients were 72 ± 10 years of age, 18% were female, and 90% were free of angina. MPS findings were abnormal in 205 of 339 patients (60%) with complete follow-up. During 3.7 ± 0.3 years, there were 7 cardiac deaths, 18 MIs, and 47 revascularizations, resulting in a MACE rate of 4.4% and a cardiac mortality rate of 0.6% per year. Patients with abnormal MPS findings had higher hazard ratios (HR) for MACE (HR: 1.95; 95% confidence interval [CI]: 1.06 to 3.59; p = 0.032), and cardiac death/MI (HR: 2.50; 95% CI: 0.93 to 6.69; p = 0.066) than patients with normal MPS finding. MACE rates were similar in patients with symptomatic and silent ischemia (p = 0.61) but higher than in patients with normal MPS findings (p < 0.05 for both comparisons). MACE rates were independently predicted by remote ischemia but not by treated-vessel ischemia or scar., Conclusions: Abnormal MPS findings 5 years after PCI are frequent irrespective of symptoms. The predictive power of abnormal MPS lies more in the detection of persistent or progressing coronary artery disease in remote vessel areas than in the diagnosis of late intervention-related problems in treated vessels., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Incidence, predictors, and prognostic impact of worsening renal function (WRF) in elderly patients with chronic heart failure (HF) undergoing intensive contemporary medical therapy are unknown., Methods and Results: In 566 patients (age 77 ± 8 years) included in the TIME-CHF, serum creatinine (sCr) was repeatedly measured up to 6 months. Worsening renal function was classified as increase in sCr by 0.2 to 0.3 (WRFI), 0.3 to 0.5 (WRFII), or ≥0.5 mg/dL (WRFIII) within the first 6 months. Outcome events were assessed for 18 months., Results: The incidence of WRF I, II, and III was 12%, 19%, and 22%, respectively. Worsening renal function III was associated with increased mortality (hazard ratio 1.98 [95% CI 1.27-3.07, P = .002] vs no WRF), whereas WRF I/II was not. History of renal failure, spironolactone treatment, higher baseline dose, and higher maximal increase in loop diuretic dose were independently associated with the occurrence of WRF III, whereas angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, and β-blocker use and allocation to N-terminal pro-B-type natriuretic peptide-guided management were not. Worsening renal function III was an independent predictor of death, death or hospitalization, and death or HF hospitalization also after adjusting for baseline characteristics., Conclusions: One fifth of elderly patients with chronic HF experienced WRF III on 6-month intensive HF treatment. These patients had higher mortality, whereas patients with smaller sCr rises did not. Occurrence of WRF III was associated with high doses of loop diuretics and spironolactone use but not with other treatments., (Copyright © 2012 Mosby, Inc. All rights reserved.)

Objectives: This study sought to define the importance of 5-year coronary artery disease (CAD) progression after successful stenting., Background: Safety concerns regarding first-generation drug-eluting stents mandate 5-year follow-up studies. However, only limited data exist on the long-term importance of CAD progression relative to late stent-related problems., Methods: This study followed for 5 years, 428 consecutive patients randomized to drug-eluting versus bare-metal stents with successful stenting documented by freedom from symptoms/events and no ischemic perfusion defects (PDs) after 6 months. Rest/stress scintigraphic scans were repeated after 60 months. Late events and new PDs in areas remote from stented vessels indicated CAD progression., Results: During follow-up, 110 of 428 (25.7%) patients had 150 clinical events: 43 patients (10%) died, 36 (8.4%) suffered a myocardial infarction, and 71 (16.6%) needed repeat revascularization. Event rates were lower in remote versus target-vessel areas (9.8% vs. 14.3%, p = 0.019). Remote myocardial infarction and repeat revascularization accounted for 46 of 124 (37.1%) nonfatal events and were similar for both stent types. Five-year scintigraphic studies in patients without follow-up events showed 23.3% new PDs, 71% of which were asymptomatic. Remote defects accounted for 37.5% PDs and were similar for both stent types., Conclusions: Even 5 years after stenting, target-vessel events and/or new PDs remained more frequent than CAD progression assessed by remote events and/or new PDs. Still, remote events accounted for almost 40% of all events with a similar rate of additional new PDs, often silent, and independent of stent type. This documents the importance of CAD progression and stresses the need to differentiate remote from target-vessel events/PDs in long-term stent safety studies. (Basel Stent Kosten-Effektivitäts Trial [BASKET]; ISRCTN75663024)., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

In this review of the BAsel Stent Kosten-Effektivitäts Trial (BASKET) the trials and their impact on coronary stenting practice were examined, basing the clinical questions of each study on the findings of the previous study. Are the new drug-eluting stents (DES) cost-effective compared to standard bare-metal stents (BMS) if used in all patients? No. Are there specific subgroups of patients with a particular benefit? Yes. A "targeted stent use" was proposed for daily practice. What is the long-term safety of DES? Unexpected safety problems were observed. Was this a chance finding? No. However, with improved stenting techniques, newer stents and intensified antiplatelet regimens late problems were minimised as shown in the BASKET-PROspective Validation Examination (BASKET-PROVE). Further stent developments? Wait and see! - Many additional questions were raised and answered or are still under investigation. Obviously, answers were not always simple and needed a closer look and this is discussed. The BASKET trials proceeded not only from one question to the other, but also in size and methodology. From the restricted single-centre "local" BASKET study to multicentre international long-term trials, all prospective, randomized and investigator-driven. Their relevance was acknowledged by publications in major medical journals as well as by their impact on US and European practice guidelines and on DES research. These aspects are summarised in the present review, highlighting lessons learned from each study and commenting on the possibilities and difficulties of performing such clinical research in Switzerland.

The occurrence of sudden cardiac death (SCD) in patients with silent ischemia after myocardial infarction (MI) and the factors facilitating SCD are unknown. This study aimed to determine the factors facilitating SCD in patients with silent ischemia after MI. In the Swiss Interventional Study on Silent Ischemia Type II (SWISSI II), 201 patients with silent ischemia after MI were randomized to percutaneous coronary intervention (PCI) or medical management. The main end point of the present analysis was SCD. Multivariable regression models were used to detect potential associations between baseline or follow-up variables and SCD. During a mean follow-up of 10.3 +/- 2.6 years, 12 SCDs occurred, corresponding to an average annual event rate of 0.6%. On multivariate regression analysis, the decline in the left ventricular ejection fraction (LVEF) during follow-up was the only independent predictor of SCD (p = 0.011), other than age; however, the baseline LVEF was not. The decline in LVEF was greater in patients receiving medical management than in those who had received PCI (p <0.001), as well as in patients with residual myocardial ischemia or recurrent MI compared with patients without these findings (p = 0.038 and p <0.001, respectively). Compared with medical management, PCI reduced the rate of residual myocardial ischemia (p <0.001) and recurrent MI (p = 0.001) during follow-up. In conclusion, patients with silent ischemia after MI are at a substantial risk of SCD. The prevention of residual myocardial ischemia and recurrent MI using PCI resulted in better long-term LVEF and a reduced SCD incidence.

Context: It is uncertain whether intensified heart failure therapy guided by N-terminal brain natriuretic peptide (BNP) is superior to symptom-guided therapy., Objective: To compare 18-month outcomes of N-terminal BNP-guided vs symptom-guided heart failure therapy., Design, Setting, and Patients: Randomized controlled multicenter Trial of Intensified vs Standard Medical Therapy in Elderly Patients With Congestive Heart Failure (TIME-CHF) of 499 patients aged 60 years or older with systolic heart failure (ejection fraction < or = 45%), New York Heart Association (NYHA) class of II or greater, prior hospitalization for heart failure within 1 year, and N-terminal BNP level of 2 or more times the upper limit of normal. The study had an 18-month follow-up and it was conducted at 15 outpatient centers in Switzerland and Germany between January 2003 and June 2008., Intervention: Uptitration of guideline-based treatments to reduce symptoms to NYHA class of II or less (symptom-guided therapy) and BNP level of 2 times or less the upper limit of normal and symptoms to NYHA class of II or less (BNP-guided therapy)., Main Outcome Measures: Primary outcomes were 18-month survival free of all-cause hospitalizations and quality of life as assessed by structured validated questionnaires., Results: Heart failure therapy guided by N-terminal BNP and symptom-guided therapy resulted in similar rates of survival free of all-cause hospitalizations (41% vs 40%, respectively; hazard ratio [HR], 0.91 [95% CI, 0.72-1.14]; P = .39). Patients' quality-of-life metrics improved over 18 months of follow-up but these improvements were similar in both the N-terminal BNP-guided and symptom-guided strategies. Compared with the symptom-guided group, survival free of hospitalization for heart failure, a secondary end point, was higher among those in the N-terminal BNP-guided group (72% vs 62%, respectively; HR, 0.68 [95% CI, 0.50-0.92]; P = .01). Heart failure therapy guided by N-terminal BNP improved outcomes in patients aged 60 to 75 years but not in those aged 75 years or older (P < .02 for interaction), Conclusion: Heart failure therapy guided by N-terminal BNP did not improve overall clinical outcomes or quality of life compared with symptom-guided treatment., Trial Registration: isrctn.org Identifier: ISRCTN43596477.

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.

Background: There are no prospective trial data on long-term outcomes in 80-year-old patients with chronic angina with regard to antiischemic therapy., Methods and Results: To assess long-term survival and quality of life (QoL) in patients from the Trial of Invasive versus Medical Therapy in the Elderly (TIME), all 276 1-year survivors (of a total 301 patients) were contacted after a median of 3.1 years (range, 1.1 to 5.9 years). At baseline, patients were 80+/-4 years old, 42% were women, and they were designated as being in angina class 3.2+/-0.7, despite their taking 2.5+/-0.7 antiischemic drugs. Patients were randomized to an invasive (n=153) or an optimized medical (n=148) strategy. Survival of invasive-strategy versus medical-strategy patients was 91.5% versus 95.9% after 6 months, 89.5% versus 93.9% after 1 year, and 70.6% versus 73.0% after 4.1 years (P=NS). Mortality was independently increased in patients >or=80 years of age, with prior heart failure, ejection fraction or=2 comorbidities, and without revascularization within the first year. Revascularization within the first year improved survival in invasive-strategy (P=0.07) and medical-strategy (P<0.001) patients. The early benefit of both treatments in angina relief and QoL was maintained long term, but freedom from major events remained higher in invasive-strategy versus medical-strategy patients (39% versus 20%, P<0.0001)., Conclusions: Long-term survival was similar for patients assigned to invasive and medical treatment. The benefits of both treatments in angina relief and improvement in QoL were maintained, but nonfatal events occurred more frequently in patients assigned to medical treatment. Irrespective of whether patients were catheterized initially or only after drug therapy failure, their survival rates were better if they were revascularized within the first year.