Field and Temperature Shaping for Microwave Hyperthermia: Recent Treatment Planning Tools to Enhance SAR-Based Procedures.

The aim of the article is to provide a summary of the work carried out in the framework of a research project funded by the Italian Ministry of Research. The main goal of the activity was to introduce multiple tools for reliable, affordable, and high-performance microwave hyperthermia for cancer therapy. The proposed methodologies and approaches target microwave diagnostics, accurate in vivo electromagnetic parameters estimation, and improvement in treatment planning using a single device. This article provides an overview of the proposed and tested techniques and shows their complementarity and interconnection. To highlight the approach, we also present a novel combination of specific absorption rate optimization via convex programming with a temperature-based refinement method implemented to mitigate the effect of thermal boundary conditions on the final temperature map. To this purpose, numerical tests were carried out for both simple and anatomically detailed 3D scenarios for the head and neck region. These preliminary results show the potential of the combined technique and improvements in the temperature coverage of the tumor target with respect to the case wherein no refinement is adopted.

Ostial and midshaft lesions vs. bifurcation lesions in 1111 patients with unprotected left main coronary artery stenosis treated with drug-eluting stents: results of the survey from the Italian Society of Invasive Cardiology.

AIMS: In this study, we compared the cumulative risk of major adverse cardiac events (MACE) of patients with distal unprotected left main coronary artery (ULMCA) stenosis with those of patients with ostial and midshaft lesions treated with drug-eluting stent (DES). METHODS AND RESULTS: The survey promoted by the Italian Society of Invasive Cardiology on ULMCA stenosis was an observational study involving 19 high-volume Italian centres. We enrolled 1111 patients with ULMCA stenosis treated with DES. Major adverse cardiac events were defined as death, myocardial infarction, and target lesion revascularization. Three hundred and thirty-four patients had ostial or midshaft lesions (group 1) and 777 bifurcations (group 2). The adjusted hazards ratio of the risk of 2 year MACE of patients in group 2 vs. patients in group 1 was 1.50 (P = 0.024). However, we observed that there was a significant difference between patients with bifurcations treated with two stents and those in group 1 (P = 0.001), but not between patients with bifurcations treated with one stent and those in group 1 (P = 0.38). CONCLUSION: Patients with bifurcations have a worse outcome than patients with ostial and midshaft lesions. However, the technique used to treat bifurcations has a significant impact on clinical outcomes.

First demonstration of machine-designed ultra-flat, low-cost directive antenna.

In this paper, we present a fully automated procedure for the direct design of a novel class of single-feed flat antennas with patterning of a conductive surface. We introduce a convenient surface discretization, based on hexagonal cells, and define an appropriate objective function, including both gain and input matching requirements. The reference geometry is constituted by a very thin, single feed-point square panel. It features a backing metal plate ("ground") and a top conductive layer, which is automatically patterned to achieve the desired radiation and input matching properties. The process employs an evolutionary algorithm combined with a boundary element electromagnetic solver. By applying this method, we designed an antenna tailored to the 2.4 GHz ISM frequency band, with a size of [Formula: see text], i.e., [Formula: see text] wavelengths and an height of 4 mm, or 0.03 wavelengths. Measured data confirmed the expected high gain (13 dBi), with a remarkable aperture efficiency (higher than 50%, including losses), thus validating the proposed approach.

Percutaneous coronary interventions in octogenarians: Acute and 12 month results in a large single-centre experience.

OBJECTIVES: To review the results of PCI in patients aged >or=80 years. BACKGROUND: Octogenarians represent a growing proportion of patients treated with PCI; in this subset of high-risk patients, the role of complete revascularization is still controversial. METHODS: We examined in-hospital, 30 days, and 12-month events in 356 patients aged >or=80 years submitted to PCI from 2004 to 2006 and 754 patients aged <80 years treated in 2006. RESULTS: Octogenarians had a higher risk profile. A complete revascularization was obtained in 48% of them and in 65% of younger patients (P < 0.001); glycoprotein IIb/IIIa inhibitors (GPI) use was common in both groups (43 vs. 46.5%). In-hospital mortality was higher in octogenarians (3.9 vs. 1.3%, P = 0.01) as well as vascular complications (2.8 vs. 1%, P = 0.058). Mortality resulted 5.9 vs. 1.2% at 30 days (P < 0.001), and 16.3 vs. 3.9% at 12 months (P <0.001) in the two groups whereas repeat revascularization procedures did not differ (9.3 vs. 8.4%, respectively). In patients aged >or=80, there was no difference in 12 months total events (20 vs. 28%, P = 0.07) and repeat revascularizations (8 vs. 10%, P = 0.498) in completely or uncompletely revascularized subjects. At multivariate analysis age (P = 0.002), diabetes (P = 0.002), three vessel disease (P = 0.020) and procedural success (P = 0.002) were independent predictors of total events at 12 months. CONCLUSIONS: In our experience, frequent GPI use and multivessel PCI in 41% of >or=80 years-old patients resulted in good immediate and mid-term clinical outcomes, irrespective of the completeness of revascularization achieved.

Long-term clinical benefit of drug-eluting stents over bare-metal stents in diabetic patients with de novo left main coronary artery disease: results from a real-world multicenter registry.

BACKGROUND: Few data are available on diabetic patients undergoing percutaneous coronary intervention (PCI) in the context of unprotected left main coronary artery (ULMCA) disease. The main goal of this study was to present the long-term relative benefits of using drug-eluting stent (DES) instead of bare-metal stent (BMS) for diabetic patients submitted to percutaneous ULMCA treatment in a large real world multicenter registry. METHODS: The GISE-SICI registry is a retrospective, observational multicenter registry promoted by the Italian Society of Invasive Cardiology in which 19 high-volume participating centers enrolled 1,453 consecutive patients who underwent PCI on ULMCA between January 2002 and December 2006. From the registry, a total of 398 consecutive patients with diabetes mellitus who underwent DES (n = 321) or BMS (n = 77) implantation were analyzed, with extensive multivariable adjustments. RESULTS: At 3-years, use of DES in diabetic patients resulted in no significant differences with respect to death (HR 0.56, 95% CIs 0.24-1.28), myocardial infarction (HR 0.82, 95% CIs 0.21-3.26), and the composite end-point of death or myocardial infarction (HR 0.56, 95% CIs 0.27-1.20). Conversely, DES were associated with significant reduction of target lesion revascularization (TLR, HR 0.33; 95% CIs 0.14-0.80, P = 0.001) rates. CONCLUSIONS: Patients presenting with ULMCA disease in the context of diabetes mellitus who are treated with stent-supported PCI have a significant reduction in the rate of TLR with no increased risk of death or myocardial infarction.

Single or multivessel percutaneous coronary intervention in ST-elevation myocardial infarction patients.

OBJECTIVES: To evaluate clinical results of percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI) in patients with multivessel disease (MVD), in relation to single or multivessel (MV)-PCI and to patients with single vessel disease (SVD). METHODS: Patients treated with PCI in the setting of <24 hr STEMI in the years 2004-2007 were considered. RESULTS: Seven hundred forty-five primary PCI, 346 (46%) in patients with SVD and 399 (54%) in patients with MVD were performed. Among MVD patients, 156 (39%) had infarct related artery (IRA)-only treatment and 243 had MV-PCI: 147 (37%) in a single session, 48 (12%) within 24 hr, and 48 (12%) predischarge. Revascularization was complete in 46% of MVD patients. At a median follow-up of 597 days, mortality was 6.3% in SVD and 12% in MVD (P = 0.007), new revascularization 2.9% and 9%, respectively (P < 0.001). Thirty-day mortality was 2.4% in SVD and 6.7% in MVD (P = 0.006). After exclusion of patients with cardiogenic shock or pulmonary oedema, more frequent in the MV-PCI in single session group (P = 0.006), 30-day mortality was SVD 1.3%, IRA-only 6.3%, MV-PCI 2.8% (P = 0.023), without differences if in a single (3.3%) or in staged session (2.2%). By multivariate analysis, female sex, anterior STEMI, cardiogenic shock, MVD, and procedural failure were independent predictors of 30-day mortality. CONCLUSIONS: STEMI patients with MVD have a worse prognosis than those with SVD. MV-PCI in patients without hemodynamic compromise yields good short-term results, even if performed very early, with a 30-day mortality in between that of SVD patients and that of MVD patients with IRA-only treatment.

Left main percutaneous coronary intervention in ACS or stable coronary artery disease: acute and long-term results.

BACKGROUND: The aim of this study was to assess in-hospital and long-term results of the novo unprotected left main (UPLM) percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS) or stable coronary artery disease (CAD), in an unselected population admitted to a single high- volume cath-lab without on-site cardiac surgery. METHODS: From 2008 to 2011, among 317 PCI performed in patients with the novo UPLM stenosis, 49 patients presented ST-elevation myocardial infarction (STEMI), 152 non ST-elevation MI/unstable angina (NSTEMI/UA), 116 stable CAD. RESULTS: In-hospital mortality was 20% in STEMI, 5.3% in NSTEMI/UA and 1.7% in stable CAD patients (P<0.001). Two-year total mortality was 24.5%, 25.6% and 6% in the 3 groups, and cardiac death was 20%, 13.8% and 3.4% (P=0.002). Left main target lesion revascularization (TLR) was similar in the 3 groups, as the clinically-driven TLR (10% vs. 11% vs. 7.7%, P=0.642), with neither definite nor probable stent thrombosis. Multivariate analysis showed the following independent predictors of 2-year mortality: bare-metal stent use (OR 4.53, P<0.001), Syntax Score >32 (OR 3.53, P=0.012), ACS as the indication (OR 3.24, P=0.012), peripheral artery disease (OR 2.20, P=0.042), and age >75 years (OR 2.09, P=0.05). CONCLUSIONS: Our experience showed acceptable results of UPLM PCI in STEMI patients, where short-term prognosis was related to hemodynamic conditions, good results in NSTEMI/UA patients where mortality increased in the follow-up due to comorbidities, and very good results in patients with stable CAD.

Cost of single-vessel and multivessel coronary drug-eluting stenting: comparison to the DRG funding level.

BACKGROUND: Large-scale utilization of drug-eluting stents (DES) presents significant economic limitations, related to the current high cost of the device and the absence of adequate reimbursement from the health care system. The aim of the study was to evaluate the cost of single-vessel and multivessel drug-eluting stenting and to compare it with the DRG funding level. METHODS: Between November 2003 and May 2004, we studied 100 consecutive patients who underwent a percutaneous coronary intervention (PCI) with DES, 50 single-vessel and 50 multivessel procedures, in order to evaluate the real procedure costs of DES. The cost fields calculated in the analysis included: costs for the materials and drugs used in each procedure, costs related to medical personnel and staff, costs for equipment depreciations, and costs for total hospitalization based on the length of stay in the coronary care unit and/or in the cardiology ward. RESULTS: With regard to the 50 patients with single-vessel disease, 63 lesions were treated with 58 DES. With regard to the 50 patients with multivessel disease, the average number of treated vessels was 2.3 and of lesions 2.8. An average of 2.7 DES per patient was implanted; glycoprotein Ilb/IIIa inhibitors were used in 70% of cases. The multivessel procedure necessitated an average of 1.62 guide catheters, 1.86 guides, 1.36 balloons, and 475 +/- 124 ml of contrast medium; the average endoscopy time was 16 +/- 8 min while the total procedural time was 106 +/- 37 min. The procedural success rate was 100% for both groups. The post-PCI hospital stay was 2.1 +/- 1.7 days for patients with single-vessel disease and 2.8 +/- 2.6 days for patients with multivessel disease; the total was 4.7 +/- 2.8 and 6 +/- 3.2 days respectively. The mean total cost of hospital stay for PCI and DES was 6390 +/- 2274 Euro for single-vessel PCI and 9828 +/- 3026 Euro for multivessel PCI, split as follows: materials 2915 +/- 963 Euro and 5294 +/- 1177 Euro, procedural costs 404 +/- 55 and 446 +/- 99 Euro, costs of hospital stay 3070 +/- 2024 Euro and 4089 +/- 2517 Euro respectively for single-vessel and multivessel PCI. CONCLUSIONS: The mean total cost of a single-vessel PCI with DES falls within the DRG 112 reimbursement level for coronary angioplasty of 7006 Euro, while that of multivessel PCI with multiple DES is about 40% above the same reimbursement level. Interestingly, the multivessel PCI cost with multiple DES does fall within the reimbursement amount related to DRG 107 for bypass surgery procedures (14,322 Euro).

Diffuse cystic lung diseases: correlation between radiologic and functional status.

BACKGROUND: High-resolution CT (HRCT) scanning plays an important role in the diagnosis of diffuse cystic lung diseases (DCLDs). However, its role in the clinical evaluation of patients affected by DCLD has not yet been well-clarified. At present, pulmonary function tests are the only methods available for the evaluation of lung impairment due to these diseases, but their sensitivity and reliability are still limited. PURPOSE: The aim of this study was to correlate the quantitative score of cystic-aerial lesions obtained by a HRCT density mask (DM) software with pulmonary function data in DCLDs. METHODS: Spirometry, lung volumes, diffusion capacity, arterial blood gas (ABG) analysis, 6-min walking test (6-MWT), and HRCT with DM quantitative evaluation were performed in a cohort of 25 patients (lymphangioleiomyomatosis [LAM], 13 patients; Langerhans cells histiocytosis [LCH], 12 patients). Linear regression was used for the statistical analysis. The sum and mean of the air-trapping percentages at three different levels of DM study (ie, aortic arch, left lower lobe bronchus origin, and 2 cm from the diaphragmatic muscle), and various functional parameters and exercise performance values were matched for the analysis. RESULTS: An obstructive pattern was present in 13 patients (52%; LCH group, 8 patients; LAM group, 5 patients). A predominant restrictive pattern was detected only in three patients (12%; LCH group, two patients; LAM group, one patient). Nine patients (36%) walked < 350 m, and 14 of 23 patients (61%) had a significant decrease in arterial oxygen saturation during exercise (> 4 U). The results of DM quantitative study (sum and mean) significantly correlated with FVC (r = - 0.56; p < 0.001), FEV(1)/vital capacity (r = - 0.94; p < 0.002), midexpiratory phase of forced expiratory flow (r = - 0.84; p < 0.05), FEV(1) (r = - 0.82; p < 0.05), and diffusing capacity of the lung for carbon monoxide (r = - 0.82; p < 0.05), bronchial airway resistance (r = 0.79; p < 0.05), and distance walked on the 6-MWT (r = - 0.53; p < 0.05). No significant correlation was found with the results of ABG analysis. CONCLUSIONS: In DCLDs, HRCT scans with quantitative assessment performed by a DM software showed a very good correlation with functional parameters. Therefore, DM could be considered, in combination with a complete functional assessment, in the initial evaluation of patients affected by DCLDs. However, further studies are needed to assess its usefulness in the follow-up of these patients.

Spontaneous coronary dissection of all three coronary arteries: a case description with medium-term angiographic follow-up.

Spontaneous coronary artery dissection is a rare cause of ischemic heart disease, often related with a poor prognosis. We report the case of a 38-year-old woman without cardiovascular risk factors, admitted to our coronary care unit for unstable angina with ECG findings of inferior ischemia. The day after, an acute anterior myocardial infarction occurred and was treated with intravenous thrombolysis. Again, there were ECG signs of transient inferior ischemia. Coronary angiography showed widespread spontaneous coronary dissection involving the terminal left main stem, both the left anterior descending and circumflex artery, and the right coronary artery even peripherally, rendering any type of revascularization procedure inappropriate. The patient was placed on beta-blockers, acetylsalicylic acid and nitrates and her symptoms resolved; the 17-month angiographic follow-up showed almost complete healing of spontaneous coronary artery dissection. The peculiarities of the case are discussed and a review of the literature is provided.

[Ad-hoc coronary angioplasty: organizational model, clinical results and costs]. / L'angioplastica coronarica ad hoc: modello organizzativo, risultati clinici e costi.

BACKGROUND: Our center routinely employs the strategy of ad hoc percutaneous coronary intervention (PCI) after diagnostic catheterization in previously informed and prepared patients with anatomical and clinical indications for some years. The aim of this study was to evaluate clinical results and resource consumption of the ad hoc PCI strategy in our center. METHODS: We evaluated the results and resource consumption of 783 PCIs performed between January 1, 1999 and June 30, 2001, divided into 642 (82%) ad hoc and 141 (18%) deferred PCIs. We analyzed the patients' in-hospital clinical and procedural characteristics, the 1 and 6-month outcomes and resource consumption (costs of materials, quantity of contrast medium, fluoroscopic time and duration of procedures) in the two groups. RESULTS: Patients in the ad hoc group had more frequently previous PCI, hypertension, diabetes, acute coronary syndrome, single vessel disease, single lesion and single vessel PCI, stent use and direct stenting, use of glycoprotein IIb/IIIa inhibitors and hemostatic devices; those in the deferred PCI group had more frequently previous myocardial infarction, stable angina, elective programmed hospital admission for PCI and multilesion single vessel PCI. The clinical results were good: clinical success in 97% of cases, in-hospital major adverse clinical events occurred in 2%, non-Q wave myocardial infarction in 3.4% (creatine-kinase-MB > 3 times higher than the upper normal limit in serial routine controls), major vascular complications in 0.4%, 1-month and 6-month major adverse clinical events in 4 and 9% respectively, without any difference between the two groups. Ad hoc PCI resulted in less contrast medium use, a shorter procedure duration, lower costs and shorter fluoroscopy times with respect to deferred PCI plus diagnostic catheterization, although not statistically significant. CONCLUSIONS: In our experience, ad hoc PCI was safe and effective. Costs were lower and less resources were required. Patients were satisfactorily assisted and the logistics and organization of the procedure were optimal.

Coronary thrombus in patients undergoing primary PCI for STEMI: Prognostic significance and management.

Acute ST-elevation myocardial infarction (STEMI) usually results from coronary atherosclerotic plaque disruption with superimposed thrombus formation. Detection of coronary thrombi is a poor prognostic indicator, which is mostly proportional to their size and composition. Particularly, intracoronary thrombi impair both epicardial blood flow and myocardial perfusion, by occluding major coronary arteries and causing distal embolization, respectively. Thus, although primary percutaneous coronary intervention is the preferred treatement strategy in STEMI setting, the associated use of adjunctive antithrombotic drugs and/or percutaneous thrombectomy is crucial to optimize therapy of STEMI patients, by improving either angiographical and clinical outcomes. This review article will focus on the prognostic significance of intracoronary thrombi and on current antithrombotic pharmacological and interventional strategies used in the setting of STEMI to manage thrombotic lesions.

Appraising the impact of left ventricular ejection fraction on outcomes of percutaneous drug-eluting stenting for unprotected left main disease: insights from a multicenter registry of 975 patients.

BACKGROUND: Despite the well-known prognostic impact of systolic dysfunction in unselected patients undergoing percutaneous coronary intervention (PCI), limited data are available on its current predictive role after PCI for unprotected left main disease (ULM). We thus appraised the prognostic role of left ventricular ejection fraction (LVEF) in patients undergoing PCI for ULM with drug-eluting stents (DES). METHODS: Consecutive eligible subjects were retrospectively enrolled in a national registry. Patients were divided into three groups: LVEF < 30%, LVEF 30-45%, and LVEF > 45%. Relevant baseline and outcome data were compared with bivariate and multivariable tests. RESULTS: A total of 975 subjects was included (LVEF < 30%: 46, LVEF 30-45%: 208, LVEF > 45%: 721). Patients with LVEF < 30% had several other unfavorable clinical features, including older age and higher EuroSCORE. Adverse event rates were different already at 7 days (p = 0.012 for all-cause death and p = 0.015 for major adverse cardiac events [MACE]), with even more significant trends up to 30 days and at long-term (p < 0.001 for death, and p < 0.001 for MACE). After a median of 18 months, risk of death totaled 39 versus 13 versus 8% (p < 0.001) and risk of MACE 44 versus 24 versus 22% (p = 0.003). Multivariable analyses showed however that reduced LVEF was not an independent predictor of adverse events at any time-point. CONCLUSIONS: Whereas reduced LVEF is apparently a significant predictor of adverse events after PCI with DES for ULM, its prognostic impact is mostly due to clustering with other adverse features.

Impact of acute coronary syndromes on two-year clinical outcomes in patients with unprotected left main coronary artery stenosis treated with drug-eluting stents.

In this study we investigated the impact of acute coronary syndromes (ACSs) on clinical outcomes in patients with unprotected left main coronary artery (ULMCA) stenosis treated with drug-eluting stents (DESs). In this multicenter, retrospective, observational study we enrolled 1,101 patients with ULMCA stenosis treated with DESs. Six hundred eleven patients presented with ACS and 490 had stable coronary artery disease. ACS was defined as the presence of unstable angina or non-ST-segment elevation myocardial infarction (MI). During 2-year follow-up, the adjusted hazard ratio of cardiac mortality and MI of patients with ACS versus stable patients was 2.42 (95% confidence interval 1.37 to 4.28, p = 0.002). We observed a stepwise risk increase, namely patients with stable coronary disease had the lowest risk, patients with unstable angina an intermediate risk, and patients with non-ST-segment elevation MI the highest risk. The increased risk of cardiac mortality and MI of patients with ACS was concentrated in the first year after DES implantation. In conclusion, patients with ULMCA stenosis and ACS treated with DESs have an increased risk of cardiac mortality and MI during the first year after the intervention compared to stable patients.

Sex-related differences in patients undergoing percutaneous unprotected left main stenting.

AIMS: Percutaneous coronary intervention (PCI) is increasingly being used for unprotected left main (ULM) disease. Limited data are available on sex-related differences in this setting. We investigated gender-associated differences in patients undergoing stent-based PCI for ULM. METHODS AND RESULTS: We analysed baseline, procedural and long-term data of patients with ULM undergoing stent-based PCI at participating centres. The primary end-point was the long-term rate of major cardiovascular events rate (MACE, i.e., the composite of death, myocardial infarction, or target lesion revascularisation). The study population included 1,452 cases, with 27.8% females and 72.2% males. Women were older, more frequently diabetic, hypertensive or presenting with an acute coronary syndrome, and thus with a higher EuroSCORE, but were less commonly treated with drug-eluting stents (DES), in comparison to men (all p<0.01). After a median follow-up of 18 months, women showed an unadjusted higher risk of death (p=0.040), cardiac death (p=0.033), and the death/myocardial infarction (p=0.012). However, after multivariable adjustment, gender was no longer an independent predictor of death (hazard ratio=1.119 [0.804-1.558]), cardiac death (hazard ratio=1.045 [0.697-1.567]), or death/myocardial infarction (hazard ratio=0.531 [0.192-1.465]), given the predominant role of age, diabetes and EuroSCORE as independent predictors and confounders of the gender-based comparison. CONCLUSIONS: Women undergoing PCI for ULM present more often with an acute coronary syndrome, are treated less frequently with DES, and have more adverse events, but these gender biases are not confirmed after adjusting for confounders. Thus, stent-based PCI for ULM offers similarly favourable clinical results in women as well as in men.

Administration of eptifibatide during transfer for primary PCI in patients with STEMI: effect on Pre-PCI TIMI flow and its correlation with pain-to-therapy time.

BACKGROUND: Facilitation therapy in ST-elevation myocardial infarction (STEMI) is still controversial and no relationship between timing of treatment and efficacy has been reported to date. METHODS: In order to evaluate the effect of pre-catheterization laboratory (cath lab) administration of eptifibatide on pre-percutaneous coronary intervention (PCI) thrombolysis in myocardial infarction (TIMI) flow and its correlation with ischemia duration, we studied all 438 STEMI patients treated with primary PCI from January 2006 to December 2007: 310 patients were pretreated with eptifibatide (Group P), while 128 patients received either no glycoprotein IIb/IIIa inhibitors or were only given them in the cath lab (Group C). All ischemia times (chest pain onset, diagnostic electrocardiogram, eptifibatide administration, cath lab arrival, first balloon inflation) were recorded. Group P was divided into early (E:159 patients with symptoms duration or= 2 flow on multivariable analysis. Thirtyday mortality was 1.9% in Group P and 9.5% in Group C (p < 0.001). CONCLUSIONS: In our experience, very early (< 90 minutes) eptifibatide therapy prior to primary PCI achieves a higher rate of pre-PCI TIMI flow >or= 2 with respect to late administration.

Comparison of drug-eluting stents and bare-metal stents for the treatment of unprotected left main coronary artery disease in acute coronary syndromes.

The aim of this study was to compare long term clinical outcome after left main stenting in a large real world population of patients treated with drug-eluting stents (DES) or bare-metal stents (BMS) in the setting of acute coronary syndromes. The advent of DES decreased the risk of unprotected left main coronary artery restenosis as compared with BMS, but safety concerns still exist, especially when high-risk patients presenting with acute coronary syndromes are considered. The Gruppo Italiano Studi Emodinamici-Societa' Italiana di Cardiologia Invasiva (GISE-SICI) registry is a retrospective, observational multicenter registry promoted by the Italian Society of Invasive Cardiology in which 19 high-volume participating centers enrolled 1,453 consecutive patients who underwent percutaneous coronary intervention on unprotected left main coronary artery between January 2002 and December 2006. From the registry, a total of 849 consecutive patients presenting with unstable angina or non-ST-segment elevation myocardial infarction who underwent DES (n=611) or BMS (n=238) implantation were analyzed with extensive multivariable and propensity-score adjustments. At 3-year follow-up, the adjusted hazard ratio for the risk of mortality after DES implantation relative to BMS implantation was 0.90 (95% confidence intervals [CI] 0.59 to 1.38, p=0.617), and the adjusted hazard ratio for the risk of cardiac mortality was 0.75 (95% CI 0.45 to 1.27, p=0.287). DES were associated with significant reduction of myocardial infarction (hazard ratio 0.37, 95% CI 0.17 to 0.81, p=0.009) and target lesion revascularization rates (hazard ratio 0.38, 95% CI 0.21 to 0.69, p=0.001). Younger age, low ejection fraction, an increase in the cardiac biomarkers, absence of diabetes, and bifurcations showed a significant interaction with assigned treatment regarding myocardial infarction. The treatment effects on target lesion revascularization were consistent across multiple subgroups, with the possible exception of patients with nonbifurcational lesions. In conclusion, in a large population of patients with acute coronary syndromes and unprotected left main coronary artery disease DES were more effective than BMS in reducing myocardial infarction and target lesion revascularization. There was no evidence of a significant reduction in mortality with DES versus BMS.

Temporal pattern of ischemic events in relation to dual antiplatelet therapy in patients with unprotected left main coronary artery stenosis undergoing percutaneous coronary intervention.

OBJECTIVES: The aim of this study was to investigate whether there is a temporal pattern of ischemic events in relation to dual antiplatelet therapy in patients with unprotected left main coronary artery (ULMCA) stenosis treated with percutaneous coronary intervention (PCI). BACKGROUND: Identifying which periods during follow-up of patients with ULMCA stenosis treated with PCI are associated with higher risk of clinical events might help to improve therapeutic strategies. METHODS: We analyzed data from 15 centers involved in an observational study conducted by the Italian Society of Invasive Cardiology on patients with ULMCA stenosis treated with PCI. Eight hundred ninety-four patients were enrolled. RESULTS: At 30-day follow-up, the rate of cardiac mortality and myocardial infarction (MI) was 5.4%. In patients still taking dual antiplatelet therapy, the adjusted incidence rate ratio/10,000 patient-days of the combination of cardiac mortality and MI in the 31- to 180-day interval compared with the 181- to 360-day interval after PCI was 3.64 (p = 0.035). This risk was particularly high in patients with acute coronary syndromes. After stopping clopidogrel, the adjusted incidence rate ratio of cardiac mortality and MI in the 0- to 90-day interval compared with the 91- to 180-day interval was 4.20 (p = 0.009). CONCLUSIONS: In patients with ULMCA stenosis taking dual antiplatelet therapy there is an increased hazard of cardiac mortality and MI between 31 and 180 days compared with 181 to 360 days. Furthermore, there is an increased hazard of cardiac mortality and MI in the first 90 days after stopping clopidogrel.

Two-year clinical outcome with drug-eluting stents versus bare-metal stents in a real-world registry of unprotected left main coronary artery stenosis from the Italian Society of Invasive Cardiology.

Data are limited about the relative efficacy of drug-eluting stents (DESs) versus bare-metal stents (BMSs) for the treatment of unprotected left main coronary artery (ULMCA) stenosis. The survey promoted by the Italian Society of Invasive Cardiology on ULMCA stenosis was an observational study involving 19 high-volume Italian centers of patients with ULMCA stenosis treated using percutaneous coronary intervention (PCI). From January 2002 to December 2006, of 1,453 patients identified with ULMCA stenosis treated with PCI, 1,111 were treated with DESs and 342 were treated with BMSs. During a 2-year follow-up, risk-adjusted survival free from cardiac death was significantly higher in patients treated with DESs than in those treated with BMSs. The propensity-adjusted hazard ratio for risk of 2-year cardiac mortality after DES versus BMS implantation was 0.49 (95% confidence interval 0.32 to 0.77). The benefit of DESs in reducing cardiac mortality was obtained in the period from 3 to 6 months and maintained up to 2 years. In conclusion, for patients with ULMCA stenosis undergoing PCI, DES implantation was associated with higher adjusted rates of 2-year survival free from cardiac death. The benefit of DESs in reducing cardiac mortality was obtained in the period in which clinical manifestations of restenosis usually peak.

Impact of bifurcation technique on 2-year clinical outcomes in 773 patients with distal unprotected left main coronary artery stenosis treated with drug-eluting stents.

BACKGROUND: Distal unprotected left main coronary artery (ULMCA) stenosis represents a technical challenge for interventional cardiologists. In this study, we compared 2-year clinical outcomes of different stenting strategies in patients with distal ULMCA stenosis treated with drug-eluting stents. METHODS AND RESULTS: The survey promoted by the Italian Society of Invasive Cardiology on ULMCA stenosis was an observational study on patients with ULMCA stenosis treated with percutaneous coronary intervention. In this study, we selected patients with distal ULMCA stenosis treated with drug-eluting stents. Seven hundred seventy-three patients were eligible for this study: 456 were treated with 1 stent (group 1) and 317 with 2 stents (group 2). The primary end point of the study was the incidence of major adverse cardiac events (MACEs), defined as the occurrence of mortality, myocardial infarction, and target lesion revascularization. During a 2-year follow-up, risk-adjusted survival free from MACE was significantly higher in patients in group 1 than in patients in group 2. The propensity-adjusted hazard ratio for the risk of 2-year MACE in patients in group 1 versus group 2 was 0.53 (95% CI, 0.37 to 0.76). The propensity-adjusted hazard ratio for the risk of 2-year cardiac mortality and myocardial infarction in patients in group 1 versus group 2 was 0.38 (95% CI, 0.17 to 0.85). CONCLUSIONS: Compared with the 2-stent technique, the 1-stent technique is associated with a better 2-year MACE-free survival. The stenting strategy is a prognostic factor that should be taken into account when deciding the optimal revascularization treatment.