Ten-year survival of patients undergoing coronary angioplasty with first-generation sirolimus-eluting stents and bare-metal stents.

INTRODUCTION: Compared to bare-metal stents (BMS), drug-eluting stents reduce stent restenosis and improve subsequent revascularization rates. The impact on patients' survival has been the subject of debate. OBJECTIVE: To assess the long-term (10-year) survival of patients undergoing percutaneous coronary intervention (PCI) with first-generation sirolimus-eluting stents (SES) in comparison with BMS. METHODS: In a single-center registry, 600 consecutive patients who underwent successful PCI with SES between April 2002 and February 2003 were compared to 594 patients who underwent PCI with BMS between January 2002 and April 2002, just before the introduction of SES. Clinical and procedural data were collected at the time of intervention and 10-year survival status was assessed via the national life status database. RESULTS: All baseline characteristics were similar between groups except for smaller stent diameter (2.84±0.38 vs. 3.19±0.49 mm; p<0.001), greater stent length (18.50±8.2 vs. 15.96±6.10 mm; p<0.001) and higher number of stents per patient (1.95 vs. 1.46, p<0.001) in the SES group. Overall five- and 10-year all-cause mortality was 9.6% (n=110) and 22.7% (n=272), respectively. The adjusted HR for 10-year mortality in patients undergoing PCI with SES was 0.74 (95% CI 0.58-0.94; p=0.013), corresponding to a relative risk reduction of 19.8%. Other than PCI with BMS, older age, chronic kidney disease, chronic obstructive pulmonary disease and lower ejection fraction were independent predictors of 10-year mortality. CONCLUSION: To date, this is the longest follow-up study ever showing a potential survival benefit of first-generation sirolimus-eluting stents versus bare-metal stents, supporting prior observations on their sustained efficacy and safety relative to contemporary BMS.

Transcatheter tricuspid valve-in-valve replacement: one-year results : Alternative to surgery in high-risk patients.

Although rheumatic heart disease is becoming uncommon in industrialized countries, its global burden is still significant. We report the case of a 70-year-old male with rheumatic heart disease, who underwent 4 previous heart valve replacement surgeries, and presented to our hospital with refractory heart failure (NYHA functional class IV) due to severe stenosis of a previously implanted tricuspid bioprosthesis. The Heart Team deemed the patient as inoperable/high-risk for surgery. As an alternative, a transcatheter tricuspid valve-in-valve replacement was decided upon and later executed through the right femoral vein, with the insertion of an Edwards SAPIEN XT 29 no. (Edwards Lifesciences, Irvine, CA, USA) through the inferior vena cava, towards the RV, followed by direct implantation in the tricuspid bioprosthesis (valve-in-valve), under rapid pacing, without complications. A substantial clinical and echocardiographic improvement was noted after the procedure and the patient was subsequently discharged in NYHA functional class II. These favourable outcomes persisted through the 1-year follow-up period. This case report adds to the current body of evidence that tricuspid valve implantation stands as a viable and reliable alternative in the treatment of degenerated bioprosthesis in high-surgical-risk patients.

Late results (>10 years) of intracoronary beta brachytherapy for diffuse in-stent restenosis.

INTRODUCTION: Until the development of drug-eluting stents (DES), diffuse in-stent restenosis (ISR) was the main limitation of bare-metal stents in percutaneous coronary intervention (PCI). Among the different treatments available, intracoronary brachytherapy (BT) emerged as one of the most promising, although it was almost abandoned with the increasing use of DES. OBJECTIVE: To assess the Portuguese experience with 90Sr/90Y beta brachytherapy for the treatment of diffuse ISR regarding long-term (>10 years) major adverse cardiac events (MACE) and angiographic restenosis. METHODS: This single-center, retrospective, observational study included 12 consecutive patients treated between January and June 2001, mean age 58.6±9.9 years (range 43-77 years), 11 male. All had chronic stable angina, 75% had dyslipidemia, 58% had hypertension, 50% had peripheral arterial disease, 42% had diabetes and 50% had multivessel disease. Recurrent ISR was present in half of the patients and 11 had normal left ventricular function. After balloon dilatation, BT was performed using an Sr90/Y90 (Novoste Beta-CathTM) beta radiation source. All patients remained under dual antiplatelet therapy until scheduled nine-month follow-up angiography. Patients were followed for the occurrence of death (all-cause and cardiovascular), non-fatal myocardial infarction (MI), revascularization, stent thrombosis and angiographic restenosis. MACE were defined as the combined incidence of cardiac death, MI and urgent target vessel revascularization. RESULTS: In all cases there was both clinical and angiographic success. In a mean follow-up of 10.9±2.5 years, 19 events occurred in seven patients: death in three (25%), only one cardiac (8.3%); ST-elevation MI in one (related to a non-target vessel) (8.3%); and 15 revascularizations in five (42%), of which nine were of the target vessel (mainly in the first two years). There was only one case of probable stent thrombosis. Angiographic restenosis at nine months was 27% (three out of 11 patients), of which two were total occlusions. Ten-year MACE-free survival was 42% (5 patients). CONCLUSIONS: Intracoronary beta brachytherapy for the treatment of diffuse ISR in this small cohort of patients proved to be safe and efficacious, with no late adverse events related to intracoronary radiation.

Use and impact of intra-aortic balloon pump on mortality in patients with acute myocardial infarction complicated by cardiogenic shock: results of the Euro Heart Survey on PCI.

AIMS: The intra-aortic balloon pump (IABP) is recommended by current guidelines as adjunct in patients with cardiogenic shock, despite the lack of larger clinical trials. We sought to investigate the use and impact on mortality of IABP in current practice of percutaneous coronary interventions in Europe. METHODS AND RESULTS: Between May 2005 and April 2008 a total of 47,407 consecutive patients undergoing percutaneous coronary intervention (PCI) in 176 centres in 33 countries in Europe and the Mediterranean basin were enrolled into the registry. From these, 8,102 had ST-elevation myocardial infarction and 7,999 non-ST elevation myocardial infarction and cardiogenic shock was observed in 7.9% and 2.1%, respectively. Of the 653 patients with cardiogenic shock 25% were treated with an IABP. In-hospital mortality, with and without IABP, was 56.9% and 36.1%. In the multivariate analysis the use of IABP was not associated with an improved survival (odds ratio 1.47; 95% CI 0.97-2.21, p=0.07). CONCLUSIONS: In current clinical practice in Europe, IABP is used only in one quarter of patients with cardiogenic shock treated with primary PCI. However, there was no hint of a beneficial effect of IABP on outcome. Therefore, a large randomised clinical trial is urgently needed to define the role of IABP in patients with PCI for shock.

EuroHeart score for the evaluation of in-hospital mortality in patients undergoing percutaneous coronary intervention.

AIMS: The applicability of currently available risk prediction models for patients undergoing percutaneous coronary interventions (PCIs) is limited. We aimed to develop a model for the prediction of in-hospital mortality after PCI that is based on contemporary and representative data from a European perspective. METHODS AND RESULTS: Our analyses are based on the Euro Heart Survey of PCIs, which contains information on 46 064 consecutive patients who underwent PCI for different indications in 176 participating European centres during 2005-08. Patients were randomly divided into a training (n = 23 032) and a validation (n = 23 032) set with similar characteristics. In these sets, 339 (1.5%) and 305 (1.3%) patients died during hospitalization, respectively. On the basis of the training set, a logistic model was constructed that related 16 independent patient or lesion characteristics with mortality, including PCI indication, advanced age, haemodynamic instability, multivessel disease, and proximal LAD disease. In both the training and validation data sets, the model had a good performance in terms of discrimination (C-index 0.91 and 0.90, respectively) and calibration (Hosmer-Lemeshow P-value 0.39 and 0.18, respectively). CONCLUSION: In-hospital mortality in PCI patients was well predicted by a risk score that contains 16 factors. The score has strong applicability for European practices.

Evaluation of the functional status questionnaire in heart failure: a sub-study of the second cardiac insufficiency bisoprolol survival study (CIBIS-II).

AIMS: We evaluated a generic quality of life (QoL) Functional Status Questionnaire (FSQ), in patients with chronic heart failure (CHF). The FSQ assesses the 3 main dimensions of QoL: physical functioning, mental health and social role. It also includes 6 single item questions about: work status, frequency of social interactions, satisfaction with sexual relationships, days in bed, days with restricted activity and overall satisfaction with health status. The FSQ was compared to the Minnesota Living with Heart Failure questionnaire (MLwHF). METHODS AND RESULTS: The FSQ was evaluated in a substudy (n = 340) of the second Cardiac Insufficiency Bisoprolol Survival study (CIBIS-II), a placebo-controlled mortality trial. 265 patients (75%) patients completed both questionnaires at 6 months of follow-up. Both questionnaires indicated substantially impaired QoL. The FSQ demonstrated high internal consistency (Cronbach's α > 0.7 for all items except "social activity" = 0.66) and construct and concurrent validity. After 6 months, the only item on either questionnaire to show a difference between the placebo- and bisoprolol-treatment groups was the single item FSQ question about "days in bed" (p = 0.018 in favour of bisoprolol). CONCLUSIONS: The FSQ performed well in this study, provided additional information to the MLwHF questionnaire and allowed interesting comparisons with other chronic medical conditions. The FSQ may be a useful general QoL instrument for studies in CHF.

Impact of diabetes mellitus status on coronary pathoanatomy and interventional treatment: insights from the Euro heart survey PCI registry.

OBJECTIVES: The present analysis was performed to evaluate the impact of diabetes mellitus (DM) status on the severity of coronary artery disease (CAD) and current approaches in interventional treatment. BACKGROUND: Little is known about the effect of DM treated with diet, oral agents, or insulin on lesion characteristics and anatomical pattern of CAD and their interventional treatment. METHODS AND RESULTS: Patients (n = 46,779) of the contemporary Euro Heart Survey PCI registry with known DM status were included in this analysis. Nondiabetics (n = 35,280, 75.4%) were compared with diabetics treated with diet (n = 1,533, 3.3%), oral agents (n = 7,222, 15.4%), and insulin (n = 2,744, 5.8%). Diabetic patients were older, suffered more frequently from comorbidities and presented more often with cardiogenic shock. The number of severely stenosed (≥ 70%) segments incrementally increased from nondiabetics to insulin-requiring diabetics. The location of lesions did not differ between patients with and without DM. The ratio stenosed/treated segments progressively rose among the four patient cohorts. The severity of DM negatively correlated with the extent of complete revascularization. After adjustment for confounding variables no significant differences in hospital mortality could be observed between patients without DM and diabetics treated with diet, but a significantly higher rate of death was seen in diabetic patients with oral medication and insulin therapy. CONCLUSIONS: Although CAD was more severe in patients with DM the percentage of treated segments with ≥ 70% stenosis was lower. Adjusted hospital mortality was increased among diabetics treated with oral medication or insulin, but not among those treated with diet.

Predictors of hospital mortality in the elderly undergoing percutaneous coronary intervention for acute coronary syndromes and stable angina.

BACKGROUND: The percentage of elderly treated with percutaneous coronary intervention (PCI) has been increasing year by year. Little is known about predictors of hospital mortality in elderly undergoing PCI for acute coronary syndromes (ACS) and stable angina. METHODS: Between 2005 and 2008 a total of 47,407 consecutive patients undergoing PCI were prospectively enrolled into the PCI-Registry of the EHS Programme. For the present analysis patients were divided into four categories: ACS patients ≥ 75 (n=4,943) and < 75 years (n=19,446), and patients with stable angina ≥ 75 (n=3,393) and < 75 years (n=19,625). A multiple logistic regression analysis was conducted to detect independent predictors of mortality in patients ≥ 75 years undergoing PCI. In addition, differences in clinical characteristics, procedural details and in-hospital outcomes between the subgroups were evaluated. RESULTS: Patients ≥ 75 years had more co-morbidities, and more severe coronary pathology. The use of guideline-recommended adjunctive therapy and procedural success was high in all groups. The incidence of in-hospital death was highest in ACS patients ≥ 75 years (5.2%) and < 75 years (1.7%), followed by patients with stable angina ≥ 75 (0.5%) and < 75 years (0.2%). Haemodynamic instability and acute ST-elevation myocardial infarction were the strongest determinants of hospital mortality among patients ≥ 75 years with ACS, whereas interventional complications were the most meaningful predictors of death in older patients undergoing elective PCI. CONCLUSIONS: Patients ≥ 75 years undergoing PCI face a relatively low risk of hospital death. However, complication rates were significantly higher compared to younger patients, strongly influenced by clinical, angiographic and interventional variables.

A model for predicting mortality in acute ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention: results from the Assessment of Pexelizumab in Acute Myocardial Infarction Trial.

BACKGROUND: Accurate models to predict mortality are needed for risk stratification in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). METHODS AND RESULTS: We examined 5745 patients with STEMI undergoing primary PCI in the Assessment of Pexelizumab in Acute Myocardial Infarction Trial within 6 hours of symptom onset. A Cox proportional hazards model incorporating regression splines to accommodate nonlinearity in the log hazard ratio (HR) scale was used to determine baseline independent predictors of 90-day mortality. At 90 days, 271 (4.7%) of 5745 patients died. Independent correlates of 90-day mortality were (in descending order of statistical significance) age (HR, 2.03/10-y increments; 95% CI, 1.80 to 2.29), systolic blood pressure (HR, 0.86/10-mm Hg increments; 95% CI, 0.82 to 0.90), Killip class (class 3 or 4 versus 1 or 2) (HR, 4.24; 95% CI, 2.97 to 6.08), heart rate (>70 beats per minute) (HR, 1.45/10-beat increments; 95% CI, 1.31 to 1.59), creatinine (HR, 1.23/10-µmol/L increments >90 µmol/L; 95% CI, 1.13 to 1.34), sum of ST-segment deviations (HR, 1.25/10-mm increments; 95% CI, 1.11 to 1.40), and anterior STEMI location (HR, 1.47; 95% CI, 1.12 to 1.93) (c-index, 0.82). Internal validation with bootstrapping confirmed minimal overoptimism (c-index, 0.81). CONCLUSIONS: Our study provides a practical method to assess intermediate-term prognosis of patients with STEMI undergoing primary PCI, using baseline clinical and ECG variables. This model identifies key factors affecting prognosis and enables quantitative risk stratification that may be helpful in guiding clinical care and for risk adjustment for observational analyses.

Characterization of an ambulatory population with stable coronary artery disease and importance of heart rate: the PULSAR registry.

AIMS: To characterize a population with stable coronary artery disease (CAD) in an outpatient setting and to evaluate the importance of resting heart rate (HR), a recently recognized prognostic risk factor. TYPE OF STUDY: A prospective and observational registry of patients with stable CAD followed mainly by cardiologists in private outpatient clinics. METHODS: Patients were selected by at least one of the following inclusion criteria: coronary angiography with at least one significant stenosis; positive stress test; previous myocardial infarction; or revascularization by angioplasty or surgery. Demographics, concomitant diseases, HR, blood pressure (BP), presence of angina and medical therapy were all recorded. Data compilation and statistical analysis were performed by a CRO independent of the sponsor and the investigators. RESULTS: Between May and October 2009, 3477 consecutive patients were included by 186 doctors. Mean age was 66.6 +/- 10.1 years and 26.3% were female, 76% had arterial hypertension, 34% diabetes, 47% previous infarction, 42% angioplasty and 25% coronary surgery. Of concomitant diseases, 13% of patients had peripheral vascular disease or erectile dysfunction. Medical therapy included antiplatelet agents (97%), lipid-lowering agents (92%), beta-blockers (72%), ACEIs (54%), nitrates (39%), calcium blockers (36%), ARBs (28%), ivabradine (24%) and trimetazidine (17%). Mean HR was 67 +/- 12 bpm and 67% of patients had HR > 60 bpm. Mean systolic BP was 134 +/- 18 mmHg and mean diastolic BP was 76 +/- 10 mmHg. Angina was present in 31.3% of patients and 53.4% had class II angina. The population with angina was more severe, 74% had HR > 60 bpm and 68% were taking beta-blockers. In patients with angina and HR > 60 bpm, beta-blocker use was only 64%. CONCLUSION: In an outpatient population with stable CAD of whom a third had angina, there was an increased number of patients with HR > 60 bpm and decreased use of beta-blockers with increasing disease severity. These findings support increased use of newly developed drugs for the treatment of stable CAD and angina.

Improved survival with bisoprolol in patients with heart failure and renal impairment: an analysis of the cardiac insufficiency bisoprolol study II (CIBIS-II) trial.

AIMS: Information on the effectiveness of beta-blockade in patients with heart failure (HF) and concomitant renal impairment is scarce and beta-blockers are underutilized in these patients. METHODS AND RESULTS: The Cockcroft-Gault formula normalized for body surface-area was used to estimate renal function (eGFR(BSA)) in 2622 patients with HF, left ventricular ejection fraction < or =35%, New York Heart Association class III/IV and serum creatinine <300 micromol/L (3.4 mg/dL) in the second Cardiac Insufficiency Bisoprolol Study II. Patients were divided into four sub-groups according to baseline eGFR(BSA) (<45, 45-60, 60-75 and > or =75 mL/min per 1.73 m(2)). Cox proportional-hazards models adjusted for pre-specified confounders were used to assess the effect of bisoprolol and potential heterogeneity of effect across the eGFR(BSA) sub-groups. Older age, female-sex, diabetes and ischaemic-aetiology were more common in those with reduced eGFR(BSA). The hazard associated with bisoprolol use for all-cause mortality, the composite of all-cause mortality or HF-hospitalization and HF-hospitalization alone was consistently <1.0 across eGFR(BSA) categories with no treatment by renal-function interaction (P = 0.81, P = 0.66, P = 0.71, respectively). The rate of bisoprolol discontinuation was higher in patients with eGFR(BSA) < 45 mL/min per 1.73 m(2). Nevertheless the absolute benefit of bisoprolol was greater for patients with chronic kidney disease compared with those without. CONCLUSION: The beneficial effects of bisoprolol on mortality and hospitalization for worsening heart-failure were not modified by baseline eGFR(BSA). Renal impairment should not prevent the use of bisoprolol in patients with HF.

Use of platelet glycoprotein IIb/IIIa inhibitors in diabetics undergoing PCI for non-ST-segment elevation acute coronary syndromes: impact of clinical status and procedural characteristics.

BACKGROUND: The most recent ESC guidelines for percutaneous coronary intervention (PCI) recommend the use of glycoprotein IIb/IIIa inhibitors (GPI) in high risk patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS), particularly in diabetics. Little is known about the adherence to these guidelines within Europe. METHODS AND RESULTS: Between May 2005 and April 2008 a total of 47,407 consecutive patients undergoing PCI were prospectively enrolled into the PCI-Registry of the Euro Heart Survey Programme. In the present analysis we examined the use of GPI in 2,922 diabetics who underwent PCI for NSTE-ACS. In this high risk population only 22.2% received a GPI; 8.9% upstream and 13.4% during PCI. The strategy of the individual institution had a major impact on the usage of GPI. In the multiple regression analysis clinical instability and complex lesion characteristics were strong independent determinants for the use of GPI, whereas renal insufficiency was negatively associated with its use. After adjustment for confounding variables no significant differences in hospital mortality could be observed between the cohorts, but a significantly higher rate of non-fatal postprocedural myocardial infarction was observed among patients receiving GPI upstream. CONCLUSIONS: Despite the recommendation for its use in the current ESC guidelines, only a minority of the diabetics in Europe undergoing PCI for NSTE-ACS received a GPI. The use of GPI was mainly triggered by high-risk interventional scenarios.