Dual antiplatelet therapy prolongation in high-risk patients with prior myocardial infarction: insights from the post-PCI registry.

BACKGROUND: Patients surviving a myocardial infarction (MI) are at a heightened risk for recurrent ischemic events that can be reduced with the long-term addition of a second antithrombotic drug to aspirin. However, data about real prescription of this therapy are lacking and sometimes controversial. METHODS: We aimed to describe the incidence and the determinants of a dual antiplatelet therapy (DAPT) prolongation beyond 12 months in a cohort of consecutive patients undergoing percutaneous coronary intervention (PCI) with prior MI undergoing PCI and features of high ischemic risk intended as age more than 65 years, second MI, type 2 diabetes mellitus, multivessel coronary artery disease (MVCAD) and chronic kidney disease (CKD). We analysed patients enrolled in the prospective 'Post-PCI' registry that included patients treated with PCI for stable coronary artery disease (CAD) or acute coronary syndromes. At 12 months' follow-up, we collected data about DAPT prolongation in patients with prior MI and at least one of the previous features of high risk who did not experience ischemic and bleeding events during the follow-up. RESULTS: Among 1113 patients included in the registry, 778 (72%) presented the inclusion criteria for the present study: 434 (66%) were more than 65 years old, 245 (37%) had a second MI, 189 (29%) diabetes mellitus, 480 (73%) MVCAD and 216 (33%) CKD. Despite a DAPT being prescribed for 1 year in 86% of the patients, it was prolonged for over 12 months in 105 (16%) of them. At multivariable analysis, only second MI and MVCAD were independent predictors of DAPT prolongation in a model including age more than 65 years, diabetes mellitus, CKD and PCI on left main/left anterior descending coronary artery. We found no significant difference in DAPT prolongation according to a DAPT-score value at least 2 or based on the physician who actually performed the follow-up (clinical cardiologist, interventional cardiologist or other). CONCLUSION: In patients with prior MI and features of high ischemic risk undergoing PCI, the rate of DAPT prolongation beyond 12 months was low; recurrent MI and MVCAD appeared as its main determinants.

Management and Long-Term Prognosis of Spontaneous Coronary Artery Dissection.

The optimal management and short- and long-term prognoses of spontaneous coronary artery dissection (SCAD) remain not well defined. The aim of this observational multicenter study was to assess long-term clinical outcomes in patients with SCAD. In-hospital and long-term outcomes were assessed in 134 patients with documented SCAD, as well as the clinical impact and predictors of a conservative rather than a revascularization strategy of treatment. The mean age was 52 ± 11, years and 81% of patients were female. SCAD presented as an acute coronary syndromes in 93% of patients. A conservative strategy was performed in 58% of patients and revascularization in 42%. On multivariate analysis, distal versus proximal or mid location of dissection (odds ratio 9.27) and basal Thrombolysis In Myocardial Infarction (TIMI) flow grade 2 or 3 versus 0 or 1 (odds ratio 0.20) were independent predictors of conservative versus revascularization strategy. A conservative strategy was associated with better in-hospital outcomes compared with revascularization (rates of major adverse cardiac events 3.8% and 16.1%, respectively, p = 0.028); however, no significant differences were observed in the long-term outcomes. In conclusion, in this large observational study of patients with SCAD, angiographic features significantly influenced the treatment strategy, providing an excellent short- and long-term prognosis.

[Acute coronary syndrome and cancer: which therapeutic option first?]. / Sindrome coronarica acuta e neoplasia: quale iter scegliere?

Cardiovascular disease and cancer are the leading causes of mortality worldwide. We report our experience in a cancer patient with acute coronary syndrome successfully treated by hybrid revascularization, i.e. off-pump coronary artery bypass grafting, followed by surgical removal of the tumor and percutaneous coronary intervention. The concomitant presence of cancer and acute coronary syndrome is not rare, ranging from 1.9% to 4.2%. Usually, the most life-threatening disease should be treated first, more frequently coronary artery disease. There are several therapeutic approaches to patients with cancer and coronary artery disease and cancer, including percutaneous coronary intervention, surgical treatment of cancer, or coronary artery bypass grafting. Each of these options should consider the severity of cardiac disease, the stage of malignancy and the clinical conditions of the patient.

Defining high-risk patients with ST-segment elevation acute myocardial infarction undergoing primary percutaneous coronary intervention: a comparison among different scoring systems and clinical definitions.

BACKGROUND: Identification of high-risk patients with ST-segment elevation acute myocardial infarction (STEMI) is of the utmost importance for adequate patient stratification and evaluation of additive treatments. However, there is no consensus on the optimal definition of high-risk patients. METHODS: We therefore compared 5 scoring systems in the assessment of the risk of 30-day mortality in 3214 patients with STEMI treated with primary percutaneous coronary intervention (PCI). RESULTS: Clinical scores showed a large variability in risk stratifying patients. Identification of high-risk patients ranged from 15% (PAMI score ≥ 9) to 66% (McNamara definition). McNamara, Antoniucci and Brodie definitions had the best sensitivity (0.87-0.88 and 95% confidence intervals (CI) ranging from 0.82-0.93) while PAMI ≥ 9 had the best specificity (0.87 with 95% CI of 0.86-0.88), while its sensitivity was quite low (0.42). In a sample size simulation of a trial aimed at demonstrating a 33% difference in 30-day mortality between two hypothetical treatments, the number of STEMI patients needed to be screened varied from 4712 for the Brodie definition to 9038 for the PAMI ≥ 9 score. CONCLUSIONS: There is a large variability in risk stratification, sensitivity, specificity and predictive values among different scoring systems. These considerations should be taken into account when designing randomised trials.

Impact of primary PCI volume on hospital mortality in STEMI patients: does time-to-presentation matter?

The exact relationship between primary percutaneous coronary intervention (PCI) volume and mortality remains unclear. No data are available on how this relationship could be affected by time-to-presentation. The primary aim of this study was to evaluate the impact of hospital primary PCI volume on in-hospital mortality in ST-elevation myocardial infarction (STEMI) patients depending on time-to-presentation. The impact of primary PCI volume on in-hospital mortality was investigated in a prospective registry of the Lombardy region in Northern Italy, deriving data on mortality rates and number of primary PCIs from a cohort of 2,558 patients. We also explored this relationship at different times-to-presentation (≤90 min, >90 min-180 min, >180 min) and risk profiles assessed with the TIMI Risk Index. A strong inverse relationship was found between primary PCI hospital volume and risk-adjusted mortality (r = -0.9; P < 0.001). High primary PCI volumes best predicted the improvement of survival when the time-to-presentation was ≤90 min (area under the curve = 0.73, P < 0.0001). At this time, the best primary PCI threshold to provide benefit was >66 primary PCIs/year (OR = 0.21 [95% CI 0.10-0.47], P < 0.001) and those with high TIMI Risk Index achieved the greatest benefit (P < 0.001). At >90 min-180 min, the model was less significant (P = 0.02) with a higher threshold of procedures (>145 primary PCIs/year) required to provide benefits. The model was not predictive of survival for time-to-presentation >180 min (P = 0.30). The reduction of mortality of STEMI patients treated at high-volume primary PCI centers is time-dependent and affected by risk profile. The greatest benefit was observed in high-risk patients presenting within 90 min from symptoms onset.

Importance and limits of pre-hospital electrocardiogram in patients with ST elevation myocardial infarction undergoing percutaneous coronary angioplasty.

BACKGROUND: The purpose of this study is to present data on the effects of pre-hospital electrocardiogram (PH-ECG) on the outcome of ST elevation myocardial infarction (STEMI) patients treated with percutaneous coronary angioplasty (PCI) included in a registry undertaken in the Italian region of Lombardy. Pre-hospital 12-lead electrocardiogram is recommended by current guidelines in order to achieve faster times to reperfusion in patients with STEMI. METHODS: The registry includes 3901 STEMI patients who underwent primary PCI over an 18-month period. RESULTS: Mean age was 63 ± 12 years. Admission through the emergency medical system (EMS) occurred in 1603 patients (40%): they were older, more frequently had previous MI, TIMI flow = 0 at entry and were more frequently in Killip class >1 than patients who were not admitted through the EMS. Among the patients admitted through the EMS, PH-ECG was obtained in 475 patients (12%). These patients had less frequently an anterior MI, but more frequently had absence of TIMI flow at entry than patients whose ECG was not teletransmitted. Moreover, they had a significantly shorter first medical contact-to-balloon time and a trend toward a lower 30-day death rate (5.3% vs 7.9 %, p = 0.06). However, only patients in Killip class 2-3 had a significantly lower mortality when the diagnostic ECG was transmitted, whereas no difference was found in Killip class 1 or Killip class 4 patients. CONCLUSIONS: In this registry, PH-ECG significantly decreased first medical contact-to-balloon time. Attempts to achieve faster reperfusion times should be undertaken, as this may result in improved outcome, particularly in patients with mild to moderate symptoms of heart failure.

LombardIMA: a regional registry for coronary angioplasty in ST-elevation myocardial infarction.

BACKGROUND: Percutaneous coronary intervention (PCI) has been shown to be the best reperfusion therapy for acute myocardial infarction with ST-elevation (STEMI), but data from registries show differences in patient populations and outcomes between randomized trials and real life. OBJECTIVES: We sought to provide information about the current status of this treatment with a registry collecting data in Lombardy, the most densely populated region in Italy, with widespread availability of cathlabs and a well-established network for the treatment of STEMI. METHODS AND RESULTS: Patient enrollment was performed by 32 hub centres recruiting 3901 STEMI patients who underwent PCI procedures within 12 h of the onset of symptoms, of whom 3317 patients underwent primary PCI, 376 'facilitated' PCI, and 208 rescue PCI in cathlabs located, in 77% of cases, in the same hospital of admission. In-hospital and 30-day total death were 4.4 and 6.6%, respectively. At multivariate analysis independent negative predictors of 30-day mortality were Killip class 3-4, number of involved ECG leads, chronic renal failure and age, whereas positive predictors were ST resolution more than 50% and postprocedural grade 3 thrombolysis in myocardial infarction flow. CONCLUSIONS: LombardIMA PCI registry enrolled STEMI patients representing a real-world population treated with PCI. Findings presented in this study may provide a benchmark for similar registries undertaken in other Italian regions and may be helpful to assess future possible developments of care for STEMI patients.

Prognostic implications of ST-segment elevation resolution in patients with ST-segment elevation acute myocardial infarction treated with primary or facilitated percutaneous coronary intervention.

Scant data are available on the relation between ST-segment elevation (STE) resolution and 30-day mortality in patients with STE acute myocardial infarction treated with percutaneous coronary intervention in contemporary, real world, clinical practice. Furthermore, whether the prognostic value of STE resolution is influenced by the patient clinical risk profile or postprocedural Thrombolysis In Myocardial Infarction (TIMI) flow has never been investigated. Lombardima was an observational registry implemented in Lombardy, a Northern Italian region. The clinical characteristics, electorcardiographic parameters, and procedural data were prospectively entered into a Web-based database. In the present study, we enrolled 3,403 patients. STE resolution occurred in 2,452 patients (group 1) and did not in 951 patients (group 2). The mortality rate was 2.4% in group 1 and 11.3% in group 2 (p <0.001). After stratifying patients according to their TIMI risk index, we observed that STE resolution was an independent predictor of 30-day mortality across all spectrum of clinical risk. Furthermore, in patients with TIMI 3 flow, STE resolution remained an independent predictor of 30-day mortality (p <0.0001). In conclusion, STE resolution was a strong and independent predictor of 30-day mortality in patients with STE acute myocardial infarction undergoing percutaneous coronary intervention across all spectrum of clinical risk.

[Role of prehospital electrocardiogram in the early diagnosis of ST-elevation myocardial infarction]. / L'importanza della diagnosi precoce nell'infarto miocardico con sopraslivellamento del tratto ST: l'elettrocardiogramma preospedaliero.

In patients with ST-elevation myocardial infarction (STEMI), fast reperfusion is associated with reduced morbidity and mortality. Many patients, however, do not meet the recommended standard times. Among the strategies considered to accomplish this task, prehospital ECG (PH-ECG) is advocated by international guidelines. International and Italian regional registries demonstrate the efficacy of PH-ECG to reduce both ischemic and first medical contact-to-balloon times in STEMI patients treated with primary angioplasty. Despite the available evidence, PH-ECG is still underused in the real world, without showing any significant increase in recent years. According to the LombardIMA registry, only 12% of the total population had a PH-ECG; in these patients median ischemic time was 154 vs 208 min when PH-ECG was not available. Median first medical contact-to-balloon time was 50 and 85 min, respectively. The use of PH-ECG showed also a trend for lower 30-day mortality, though not statistically significant. PH-ECG can also lead to early antithrombotic therapy (aspirin, clopidogrel or IIb/IIIa inhibitors), which is associated with better angiographic outcome. Data from the LombardIMA registry show that PH-ECG may play a relevant role in the management of STEMI networks, with less patients admitted to hospital without on-site cath-lab and reduced reperfusion delays in patients transferred from spoke to hub hospitals.

[Treatment of neoplastic pericardial effusions]. / Trattamento dei versamenti pericardici neoplastici.

Pericardial effusion is a known complication of many advanced malignancies, with strong impact both on quality of life and prognosis. The initial and easier relief can be obtained through percutaneous pericardiocentesis, echo- or fluoro-guided. However, effusion recurrences can be observed in up to 40% of cases. Effective management can be obtained by more invasive approaches like percutaneous or surgical creation of pericardial windows but the more cost-effective procedure is pericardiocentesis followed by intrapericardial instillation of sclerosing or cytostatic agents like tetracyclines, bleomycin, cisplatin and thiotepa. No significant local or systemic side effects are reported, except for chest pain during tetracyclines instillation. No recurrences at 30 days are observed in 80%-90% of patients, according to different series and, particularly, to different malignancies. No evidence-based data are in fact available to assess the "gold standard" and the best therapeutical approach for the single patient.

Early reduction in left ventricular contractile reserve detected by dobutamine stress echo predicts high-dose chemotherapy-induced cardiac toxicity.

BACKGROUND: High-dose chemotherapy (HDC) is utilized in high-risk cancer patients. This type of treatment may induce cardiac toxicity which becomes clinically evident weeks or months after HDC. Hence, the possibility of early identification of patients who will develop cardiac impairment is strategic for its clinical implications. The aim of this study was to identify possible early changes of left ventricular contractile reserve (LVCR) in cancer patients undergoing HDC, as well as to evaluate the relevance of such changes as predictors of chemotherapy-induced cardiotoxicity. METHODS: In forty-nine female patients scheduled for HDC, due to poor-prognosis breast cancer, dobutamine stress echocardiography (DSE) was performed, before each of the three HDC cycles (C1, C2, C3), and 1, 4, and 7 months after the end of chemotherapy. According to rest left ventricular ejection fraction (LVEF) evaluated within 18 months after HDC (f-LVEF), patients were allocated to Group A (LVEF < 50% and >10 absolute units reduction) and to Group B (LVEF > or = 50%). RESULTS: Rest LVEF didn't show any significant difference between the two groups except at f-LVEF. Peak LVEF and LVCR significantly decreased in Group A only, starting from C3. At C3, a > or = 5 units fall in LVCR was found to be predictive for f-LVEF drop below 50%. CONCLUSIONS: In patients undergoing HDC, low-dose DSE allows the early identification of patients at a high risk of developing cardiac dysfunction.

Long-term results of intrapericardial chemotherapeutic treatment of malignant pericardial effusions with thiotepa.

OBJECTIVE: Pericardial involvement is a common feature in different neoplastic diseases, having a strong influence on the natural history of the disease and on the quality of life of the patients. This study was performed in order to investigate the long-term effects of intracavitary treatment with thiotepa in the reduction of pericardial effusion (PE) recurrences. DESIGN: Prospective controlled intervention study. SETTING: European Institute of Oncology, Milan, Italy. PATIENTS: We studied 33 patients, 15 men and 18 women, with malignant PE, who were affected by breast cancer (11 patients), lung cancer (16 patients), microcytoma (4 patients), endometrial cancer (1 patients), and melanoma (1 patient). INTERVENTION: All patients with large PE, with or without cardiac tamponade, underwent percutaneous pericardiocentesis (PC) under echocardiographic monitoring. Patients with neoplastic cells in drained fluid were considered to be eligible for treatment. After drainage, the catheter was maintained in the pericardial sac for the instillation of a sclerosing, alkylating antiblastic agent (thiotepa) on days 1, 3, and 5 after the PC (15 mg at each step). RESULTS: No procedure-related complications or side effects were observed. Two patients died because of disease progression, without PE evidence. No PE occurred in the remaining patients during the first month. Three recurrences occurred (9.1%), requiring additional PC and intrapericardial treatment. The median survival time was 115 days (range, 22 to 1,108 days) in the overall population, and 272 days in patients with breast cancer. CONCLUSIONS: Intrapericardial treatment with thiotepa carries a minimal risk and is a repeatable procedure that can dramatically increase quality of life, or even can improve survival and the natural history of disease in cancer patients.

Impact of limited pulmonary function on the management of resectable lung cancer.

AIMS: Limited pulmonary function (LPF) related to obstructive disease and emphysema or due to significant lung toxicity resulting from chemotherapy regimens are frequent co-morbidity factors in lung cancer patients. Purpose of this study was to investigate the frequency of LPF in lung cancer and its impact of on surgical eligibility and postoperative outcome. MATERIALS AND METHODS: We analyzed a series of 255 consecutive patients with otherwise resectable lung cancer, admitted to our department between January 1998 and December 1999. Patients were considered affected by LPF if their forced expiratory volume in one second (FEV1%) and/or diffusing lung capacity for carbon monoxide (DLCO%) was less than 50% of predicted normal values. Perioperative mortality, major and minor complications were analysed according to lung function status. RESULTS: A total of 42 (16.5%) patients presented with significant limitations of the pulmonary function (LPF). Of these, 11 (26%) cases were excluded from surgery because of the severity of pulmonary disease. In the group of 244 patients who underwent surgery, the 31 LPF cases showed a slightly higher frequency of preoperative induction therapies (42 vs. 30%) and sublobar resections (33 vs. 8%) in comparison with the other 213 resected cases. However, no difference was observed in median hospital stay (7 days in both groups), major morbidity (13 vs. 11%) or mortality (0 vs. 1.4%). CONCLUSIONS: A strict and careful selection of patients, guided by concurrent analysis of different functional tests, allowed to offer surgery with a very low complication rate to the majority of patients with limited pulmonary function. A volume reduction effect was evident in selected patients with severe emphysema.

Minor increases in plasma troponin I predict decreased left ventricular ejection fraction after high-dose chemotherapy.

BACKGROUND: Increased cardiac troponin I (cTnI) in patients treated with high-dose chemotherapy (HDCT) for aggressive malignancy has been proposed as an early marker of late HDCT-induced cardiac dysfunction. We investigated whether cTnI measured by the Stratus CS (Dade Behring) would allow detection of minimal cTnI increases in patients treated with HDCT. METHODS: Plasma cTnI concentrations were determined in 179 consecutive patients before HDCT, at the end of the treatment, and after 12, 24, 36, and 72 h. Cardiac function was explored by echocardiography, and left ventricular ejection fraction (LVEF) was recorded during follow-up. The greatest variation in LVEF from the baseline value was used as a measure of cardiac damage. RESULTS: In 99 healthy volunteers, the 99th percentile was at 0.07 microg/L. On the basis of ROC curve analysis (area under the curve, 0.89), a cutoff of 0.08 microg/L was chosen (sensitivity, 82%; specificity, 77%). cTnI > or =0.08 microg/L occurred in 57 patients (32%) with echocardiographic monitoring revealing a mean decrease in LVEF of 18%. In comparison, the group of cTnI-negative patients had a mean decrease in LVEF of 2.5% (P <0.001). CONCLUSIONS: Plasma cTnI, as measured with the Stratus CS, can detect minor myocardial injury in patients treated with HDCT.