Cryoballoon ablation of atrial fibrillation is effectively feasible without previous imaging of pulmonary vein anatomy: insights from the 1STOP project.

BACKGROUND: Pulmonary vein isolation by cryoablation (PVI-C) is a standard therapy for the treatment of atrial fibrillation (AF); however, PVI-C can become a challenging procedure due to the anatomy of the left atrium and pulmonary veins (PVs). Importantly, the utility of imaging before the procedure is still unknown regarding the long-term clinical outcomes following PVI-C. The aim of the analysis is to evaluate the impact of imaging before PVI-C on procedural data and AF recurrence. METHODS: Patients with paroxysmal AF underwent an index PVI-C. Data were collected prospectively in the framework of 1STOP ClinicalService® project. Patients were divided into two groups according to the utilization of pre-procedural imaging of PV anatomy (via CT or MRI) or the non-usage of pre-procedural imaging. RESULTS: Out of 912 patients, 461 (50.5%) were evaluated with CT or MRI before the PVI-C and denoted as the imaging group. Accordingly, 451 (49.5%) patients had no pre-procedural imaging and were categorized as the no imaging group. Patient baseline characteristics were comparable between the two cohorts, but the ablation centers that comprised the imaging group had fewer PVI-C cases per year than the no imaging group (p < 0.001). The procedure, fluoroscopy, and left atrial dwell times were significantly shorter in the no imaging cohort (p < 0.001). The rates of complications were significantly greater in the imaging group compared to the no imaging group (6.9% vs. 2.7%; p = 0.003); this difference was attributed to differences in transient diaphragmatic paralysis. The 12-month freedom from AF was 76.2% in the imaging group and 80.0% in the no imaging group (p = 0.390). CONCLUSIONS: In our analysis, PVI-C was effective regardless of the availability of imaging data on PV anatomy.

Psoriasis and the risk of acute coronary syndrome in the elderly.

BACKGROUND: Psoriasis has been associated with a higher prevalence of cardiovascular disease risk factors. However, there is inadequate quantification on the association between psoriasis and acute coronary syndrome (ACS), particularly in the elderly. Therefore, the aim of the present study was to assess the risk of ACS according to history of psoriasis in subjects aged 75 years and older. METHODS: We carried out a case control study based on 1455 cases and 1108 controls. Cases were all the patients admitted in the randomized Elderly ACS 2 trial. Controls were selected from subjects aged ≥75 years included in the Prevalence of Actinic Keratoses in the Italian Population Study (PraKtis), based on a representative sample of the general Italian population. Odds ratios (OR) of ACS according to history of psoriasis were obtained using a multiple logistic regression model including terms for age, sex and smoking. RESULTS: The prevalence of psoriasis was lower among cases (12/1455, 0.8%) than among controls (18/1108, 1.6%). The multivariate OR of ACS according to history of psoriasis was 0.51 (95% confidence interval: 0.23-1.09). CONCLUSIONS: Our data does not support an association between psoriasis and risk of ACS in the elderly.

Prediction of high on-treatment platelet reactivity in clopidogrel-treated patients with acute coronary syndromes.

BACKGROUND: About 40% of clopidogrel-treated patients display high platelet reactivity (HPR). Alternative treatments of HPR patients, identified by platelet function tests, failed to improve their clinical outcomes in large randomized clinical trials. A more appealing alternative would be to identify HPR patients a priori, based on the presence/absence of demographic, clinical and genetic factors that affect PR. Due to the complexity and multiplicity of these factors, traditional statistical methods (TSMs) fail to identify a priori HPR patients accurately. The objective was to test whether Artificial Neural Networks (ANNs) or other Machine Learning Systems (MLSs), which use algorithms to extract model-like 'structure' information from a given set of data, accurately predict platelet reactivity (PR) in clopidogrel-treated patients. METHODS: A complete set of fifty-nine demographic, clinical, genetic data was available of 603 patients with acute coronary syndromes enrolled in the prospective GEPRESS study, which showed that HPR after 1month of clopidogrel treatment independently predicted adverse cardiovascular events in patients with Syntax Score >14. Data were analysed by MLSs and TSMs. ANNs identified more variables associated PR at 1month, compared to TSMs. RESULTS: ANNs overall accuracy in predicting PR, although superior to other MLSs was 63% (95% CI 59-66). PR phenotype changed in both directions in 35% of patients across the 3 time points tested (before PCI, at hospital discharge and at 1month). CONCLUSIONS: Despite their ability to analyse very complex non-linear phenomena, ANNs or MLS were unable to predict PR accurately, likely because PR is a highly unstable phenotype.

A critical overview on ticagrelor in acute coronary syndromes.

Until a few years ago, the mainstay of anti-platelet therapy in patients with acute coronary syndrome (ACS) was the combination of aspirin and clopidogrel, a P2Y12 receptor inhibitor. However, current clinical practice has now changed with the introduction of ticagrelor, a more potent cardiovascular drug than clopidogrel, without the limitations related to clopidogrel therapy. In this review, we provide a critical overview of ticagrelor in ACS, highlight the results with ticagrelor in several subgroups of patients and discuss the future trials.

Management of patients with recently implanted coronary stents on dual antiplatelet therapy who need to undergo major surgery.

About 5% of patients undergoing coronary stenting need to undergo surgery within the next year. The risk of perioperative cardiac ischemic events, particularly stent thrombosis (ST), is high in these patients, because surgery has a prothrombotic effect and antiplatelet therapy is often withdrawn in order to avoid bleeding. The clinical and angiographic predictors of ST are well known, and the proximity to an acute coronary syndrome adds to the risk. The current guidelines recommend delaying non-urgent surgery for at least 6 weeks after the placement of a bare metal stent and for 6-12 months after the placement of a drug-eluting stent, when the risk of ST is reduced. However, in the absence of formal evidence, these recommendations provide little support with regard to managing urgent operations. When surgery cannot be postponed, stratifying the risk of surgical bleeding and cardiac ischemic events is crucial in order to manage perioperative antiplatelet therapy in individual cases. Dual antiplatelet therapy should not be withdrawn for minor surgery or most gastrointestinal endoscopic procedures. Aspirin can be safely continued perioperatively in the case of most major surgery, and provides coronary protection. In the case of interventions at high risk for both bleeding and ischemic events, when clopidogrel withdrawal is required in order to reduce perioperative bleeding, perioperative treatment with the short-acting intravenous glycoprotein IIb-IIIa inhibitor tirofiban is safe in terms of bleeding, and provides strong antithrombotic protection. Such surgical interventions should be performed at hospitals capable of performing an immediate percutaneous coronary intervention at any time in the case of acute myocardial ischemia.

Low-molecular-weight heparins vs. unfractionated heparin in the setting of percutaneous coronary intervention for ST-elevation myocardial infarction: a meta-analysis.

BACKGROUND: The aim of the current study was to perform two separate meta-analyses of available studies comparing low-molecular-weight heparins (LMWHs) vs. unfractionated heparin (UFH) in ST-elevation myocardial infarction (STEMI) patients treated (i) with primary percutaneous coronary intervention (pPCI) or (ii) with PCI after thrombolysis. METHODS: All-cause mortality was the pre-specified primary endpoint and major bleeding complications were recorded as the secondary endpoints. Relative risk (RR) with a 95% confidence interval (CI) and absolute risk reduction (ARR) were chosen as the effect measure. RESULTS: Ten studies comprising 16,286 patients were included. The median follow-up was 2 months for the primary endpoint. Among LMWHs, enoxaparin was the compound most frequently used. In the pPCI group, LMWHs were associated with a reduction in mortality [RR (95% CI) = 0.51 (0.41-0.64), P < 0.001, ARR = 3%] and major bleeding [RR (95% CI) = 0.68 (0.49-0.94), P = 0.02, ARR = 2.0%] as compared with UFH. Conversely, no clear evidence of benefits with LWMHs was observed in the PCI group after thrombolysis. Meta-regression showed that patients with a higher baseline risk had greater benefits from LMWHs (r = 0.72, P = 0.02). CONCLUSIONS: LMWHs were associated with greater efficacy and safety than UFH in STEMI patients treated with pPCI, with a significant relationship between risk profile and clinical benefits. Based on this meta-analysis, LMWHs may be considered as a preferred anticoagulant among STEMI patients undergoing pPCI.

Ischaemic and bleeding complications with new, compared to standard, ADP-antagonist regimens in acute coronary syndromes: a meta-analysis of randomized trials.

BACKGROUND: Platelets play a pivotal role in the pathogenesis of acute coronary syndromes (ACS) and their inhibition remains a mainstay therapy in this setting. We aimed to perform a meta-analysis of randomized trials to evaluate the benefits of new oral antiplatelet regimens to block platelet ADP-receptors compared to standard-dose clopidogrel (300 mg loading dose followed by 75 mg/daily). METHODS: We obtained results from all randomized trials enrolling patients with ACS. Primary endpoint was mortality. Secondary endpoints were myocardial infarction and definite in-stent thrombosis. Safety endpoint was the risk of major bleeding complications. We prespecified subanalyses according to new antiplatelet drugs (prasugrel/ticagrelor), high-dose clopidogrel (600 mg) and patients undergoing percutaneous coronary intervention. RESULTS: A total of seven randomized trials were finally included in the meta-analysis (n = 58 591). We observed a significant reduction in mortality (2.9% vs. 3.4%, OR = 0.87, 95% CI 0.79-0.95, P = 0.002), recurrent myocardial infarction (4.2% vs. 5.2%, OR = 0.80, 95% CI 0.74-0.87, P < 0.0001), definite in-stent thrombosis (0.9% vs. 1.7%, OR = 0.52, 95% CI 0.43-0.63, P < 0.0001). The benefits in mortality and reinfarction were driven by the treatment with prasugrel or ticagrelor, without a significant difference in terms of major bleeding complications as compared to standard-dose clopidogrel (5% vs. 4.7%, OR = 1.06 95% CI 0.96-1.17, P = 0.25). CONCLUSION: This meta-analysis showed that new oral antiplatelet regimens are associated with a significant reduction in mortality, reinfarction and in-stent thrombosis in ACS patients without an overall increase of major bleeding when treated with new antiplatelet drugs.

Early vs. delayed invasive strategy in patients with acute coronary syndromes without ST-segment elevation: a meta-analysis of randomized studies.

Although early percutaneous coronary intervention has been demonstrated to reduce the risk of mortality in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS), there are emerging conflicting data as to whether the catheterization needs to be done very early or whether it could be delayed while the patient receives medical therapy. The aim of the current study was to perform a meta-analysis of randomized controlled trials (RCTs) comparing early vs. delayed invasive strategies for NSTE-ACS patients. Medline/CENTRAL and the Web were searched for RCTs comparing early vs. delayed invasive strategies for NSTE-ACS patients. The primary endpoint was all cause mortality, whereas myocardial infarction (MI), coronary revascularizations and 30-day major bleeding complications were secondary end points. Fixed or random effects models were used based on statistical heterogeneity. As a sensitivity analysis, Bayesian random effects meta-analysis was performed in addition to the classical random effects meta-analysis. A total of 5 RCTs were finally included, enrolling 4155 patients. As compared with a delayed strategy, an early invasive approach did not significantly reduce the rates of death [odds ratio (OR) 95% confidence interval (95% CI) = 0.81 (95% CI 0.60-1.09), P = 0.17], MI [OR = 1.18 (95% CI 0.68-2.05), P = 0.55] or revascularizations [OR = 0.97 (0.77-1.24), P = 0.82]. There was a not significant trend toward fewer major bleeding complications for the early invasive approach [OR (95% CI) = 0.76 (0.55-1.04), P = 0.08]. The present meta-analysis shows that for NSTE-ACS patients a routine early invasive strategy does not significantly improve survival nor reduce MI and revascularization rates as compared with a delayed approach.

Urgent surgery in patients with a recently implanted coronary drug-eluting stent: a phase II study of 'bridging' antiplatelet therapy with tirofiban during temporary withdrawal of clopidogrel.

BACKGROUND: Patients with a recently implanted coronary drug-eluting stent (DES) who need urgent surgery are at increased risk of surgical bleeding unless clopidogrel is discontinued beforehand, but clopidogrel discontinuation has been associated with a high rate of adverse events due to stent thrombosis. This pilot study tested the hypothesis that the i.v. perioperative administration of the short-acting antiplatelet agent tirofiban allows the safe withdrawal of clopidogrel without increasing the rate of surgical bleeding. METHODS: Phase II study with a Simon two-stage design. RESULTS: Thirty patients with a recently implanted DES [median (range) 4 (1-12) months] and high-risk characteristics for stent thrombosis underwent urgent major surgery or eye surgery. Clopidogrel was to be withdrawn 5 days before surgery, and tirofiban started 24 h later, continued until 4 h before surgery, and resumed 2 h after surgery until oral clopidogrel was resumed. The use of aspirin was decided by the surgeon. There were no cases of death, myocardial infarction, stent thrombosis, or surgical re-exploration due to bleeding during the index admission, with a risk estimate of 0-11.6% (one-tail 97.5% CI). There was one case of thrombolysis in myocardial infarction (TIMI) major and one of TIMI minor bleeding in the postoperative phase; another four patients were transfused without meeting the TIMI criteria for major or minor bleeding. CONCLUSIONS: In patients with a recently implanted DES and high-risk characteristics for stent thrombosis needing urgent surgery, a 'bridging strategy' using i.v. tirofiban may allow temporary withdrawal of oral clopidogrel without increasing the risk of bleeding.

Impact of drug-eluting stent selection on long-term clinical outcomes in patients treated for unprotected left main coronary artery disease: the sirolimus vs paclitaxel drug-eluting stent for left main registry (SP-DELFT).

AIM: To compare the long-term relative efficacy and safety of SES and PES in patients undergoing percutaneous coronary intervention (PCI) for unprotected left main coronary artery (ULMCA) disease and to evaluate the role of lesion location and stenting technique in determining outcomes. METHODS AND RESULTS: From April 2002 to April 2004, 288 consecutive patients who underwent elective PCI with DES implantation for de novo lesions on ULMCA have been retrospectively selected and analyzed in seven European and US tertiary care centers. All patients had a minimum follow-up of 3 years. SES was used in 152 patients while 136 received PES. Isolated ostial-shaft disease was present in 27% of patients. Distal LM disease (73%) was treated with single and double stent approach in 29.5% and 43.4% of patients respectively. After 3 years, rates of survival free from any of the events investigated, were independent from lesion location and stenting approach and did not differ significantly between SES and PES groups. Freedom from MACE (SES vs. PES) was 76.3% vs. 83.1% in the ostial/shaft group, 80.3% vs. 72.8% in the distal-single stent group and 67.1% vs. 66.2% in the distal-double stent group. Definite stent thrombosis occurred only in 1(0.3%) patient at 439 days. CONCLUSIONS: In elective patients who underwent PCI for de novo lesions in the ostium, shaft or distal ULMCA, long-term clinical outcomes with SES and PES use were similar independently of lesion location and stenting technique.

[From the SIN Mailing List: the use of hemodialysis after radiocontrast media administration in patients with chronic renal failure]. / Dalla Mailing-List soci SIN (ML-SIN). Il ruolo della dialisi nella nefropatia da mezzo di contrasto: dubbi e certezze.

Over the last few years there has been a progressive increase in percutaneous endovascular procedures in patients with chronic renal disease, due to the high incidence of vascular disease, particularly coronary artery disease, in this population. The use of contrast medium may further worsen renal function in such patients, in some cases even accelerating the progression towards end-stage renal failure, and increase patients morbidity and mortality. In this review we discuss the role of dialysis in preventing contrast-induced nephropathy and indications to its use in patients already on dialysis treatment undergoing diagnostic or therapeutic procedures with contrast medium injection.

Complete or incomplete percutaneous coronary revascularization in patients with unstable angina in stent era: Are early and one-year results different?

The aim of our study was to evaluate the impact of a strategy of incomplete revascularization by PTCA, with or without stent implantation, on clinical outcome of 208 consecutive patients (171 men) with unstable angina and multivessel coronary artery disease. Mean age of the group was 63.8 +/- 10.3 years (range, 31-91). Complete and incomplete revascularization was achieved in 49 and 159 patients, respectively. A total of 226 stents were implanted in 172 patients (1.31 +/- 0.65 stent per patient), equally distributed between the two groups. Left ventricular ejection fraction < 40% and total chronic coronary occlusions were significantly more frequent in patients with incomplete revascularization than in those with complete (P = 0.014 and 0.001, respectively). In-hospital MACE occurred in 10% and 7.5% of patients with complete and incomplete revascularization, respectively (P = NS). By multivariate analysis, multiple stent implantation (OR, 5.44; 95% CI, 1.21-24.3), presence of thrombus in the treated lesion (OR, 6.3; 95% CI, 1.53-25.9), Braunwald class III (OR, 4.74; 95% CI, 1.08-20.8), and ad hoc PTCA (OR 4.51; 95% CI, 1.11-18.3) were significantly related to in-hospital outcome. At 1-year follow-up, 11.3% and 11.5% of patients with complete and incomplete revascularization, respectively, had MACE. In all patients, diabetes (OR, 3.40; 95% CI, 1.09-10.58) and presence of thrombus in the treated lesion (OR, 3.48; 95% CI, 1.12-10.84) were significant predictors of 1-year outcome by multivariate analysis. These results indicate that the strategy of incomplete revascularization in unstable angina patients with multivessel coronary disease does not expose them to a higher risk of death or other major ischemic events in comparison to those undergoing complete revascularization.

Increased concentrations of inflammatory mediators in unstable angina: correlation with serum troponin T.

OBJECTIVE: To measure plasma interferon gamma, monocyte chemotactic protein-1 (MCP-1), and interleukin 6 and to assess their correlation with cardiac troponin T in unstable angina. DESIGN: Blood sampling in patients undergoing coronary arteriography for known or suspected ischaemic heart disease. PATIENTS: 76 patients divided in three groups: 29 with unstable angina (group 1), 28 with stable angina (group 2), and 19 without ischaemic heart disease and with angiographically normal coronary arteries (group 3). MAIN OUTCOME MEASURES: Plasma interleukin 6, interferon gamma, MCP-1, and troponin T in the three groups of patients. RESULTS: Interleukin 6 was increased in group 1 (median 2.19 (range 0.53-50.84) pg/ml) compared with the control group (1.62 (0.79-3.98) pg/ml) (p < 0.005), whereas interferon gamma was higher in group 1 (range 0-5.51 pg/ml) than in the other two groups (range 0-0.74 pg/ml and 0-0.37 pg/ml; p < 0.005 and p < 0.001, respectively). Patients with unstable angina (group 1) and positive troponin T had higher concentrations of interferon gamma than those with negative troponin T (0-5.51 pg/ml v 0-0.60 pg/ml, p < 0.001). Plasma MCP-1 was also higher in group 1 (median 267 (range 6-8670) pg/ml) than in the other two groups (134 (19-890) pg/ml and 84.5 (5-325) pg/ml; p < 0.005 and p < 0.001, respectively), and among group 1 patients with a positive troponin T assay than in those with normal troponin T (531 (14.5-8670) pg/ml v 69 (6-3333) pg/ml; p < 0.01). There was no difference in plasma interleukin 6 in group 1 patients between those with and without raised troponin T. CONCLUSIONS: The inflammatory cytokines interferon gamma and MCP-1 are increased in patients with unstable angina, particularly in those with raised concentrations of troponin T, suggesting that they are probably related to myocardial cell damage or to plaque rupture and thrombus formation.

Coronary angioplasty in patients with unstable angina: clinical, electrocardiographic and angiographic predictors of in-hospital outcome. R.OS.A.I. Study Group.

BACKGROUND: In unstable angina early coronary arteriography is frequently performed, often followed by percutaneous revascularization with liberal use of stents. We intended to study the in-hospital outcome of patients receiving this treatment. METHODS: From April 1997 to April 1998, patients submitted to coronary arteriography due to unstable angina, and with no previous myocardial revascularization, were included in a multicenter registry. RESULTS: Out of 987 patients enrolled at 14 centers, 876 (89%) had percutaneous or surgical revascularization. Coronary angioplasty was performed in 571 patients (58%); 281 (49%) had Braunwald class IIIB or C angina. Refractory or prolonged chest pain, or both, were present in 133, 217 and 85 patients, respectively, and multivessel disease in 245 patients (43%). Stenting was performed in 486/571 cases (85%), abciximab was administered to 42 patients, and ticlopidine and/or aspirin to all. A procedural success was obtained in 96.9 % of cases. In-hospital major adverse cardiac events occurred in 29/571 patients (5.1%). Pain-related ST segment depression (44% of cases) was not predictive of outcome after coronary angioplasty. In multivariate analysis prolonged plus refractory angina (p = 0.02), an ejection fraction < 0.4 (p = 0.04), multivessel disease (p = 0.01) and--with the strongest predictive value--ad hoc angioplasty (p = 0.007) and use of > 1 stent (p = 0.0008) were all independent predictors of in-hospital adverse outcome. CONCLUSIONS: Coronary angioplasty with a liberal use of stents yields a high rate of procedural success, with few in-hospital major cardiac events also in "high risk" patients.

One-year outcome in multivessel coronary disease patients undergoing coronary stenting.

The purpose of this study was to assess 1-year clinical outcome of patients with multivessel coronary artery disease (CAD) who underwent coronary stenting and were prospectively enrolled in the Registro Impianto Stent Endocoronarico (RISE). Of 939 consecutive patients included in the registry, 377 patients with angiographic evidence of multivessel CAD had a 1-year clinical follow-up. All patients underwent PTCA and single or multiple stenting in at least one vessel. Angiographic optimization was usually performed by using high-pressure balloon dilation. After the procedure, continuation of aspirin (at least 250 mg/day) was recommended, whereas the use of anticoagulation or ticlopidine was determined by the physician in charge of the patient in the various centers. Major adverse cardiac events were defined as death, Q-wave or non-Q-wave myocardial infarction and target vessel revascularization. Mean age of patients (311 men, 66 women) was 60 +/- 10 years. Globally, there were 596 stents implanted (72% Palmaz-Schatz stents) in 434 vessels. In about 75% of the procedures, an inflation pressure > 12 atm was used. Angiographic success rate was 98.5%. After stenting, 77% of patients received antiplatelet treatment with ticlopidine and aspirin. During hospitalization, there were 34 major adverse cardiac events in 24 patients. At 1-year follow-up, 309 patients were alive and event-free; cumulative incidence of death, myocardial infarction, and repeat revascularization were 2.9%, 4.7%, and 10.8%, respectively. By Cox regression analysis, multiple stents implantation (HR 1.72, 95% CI 1-2.97), left anterior descending artery revascularization (HR 1.86, 95% CI 1.01-3.42), use of inflation pressure > 12 atm (HR 0.93, 95% CI 0.89-0.97), ticlopidine therapy (HR 0.41, 95% CI 0.23-0.74), and stent length (HR 1.03, 95% CI 1.01-1.05) were associated with 1-year major cardiac events. In patients with multivessel CAD undergoing stent implantation in at least one vessel, 1-year follow-up is favorable and the need for repeat revascularization procedures, based on clinical data, is lower than previously reported for conventional PTCA. Cathet. Cardiovasc. Intervent. 48:343-349, 1999.

Plasma levels of interleukin 2, 6, 10 and phenotypic characterization of circulating T lymphocytes in ischemic heart disease.

The purpose of this study was to assess lymphocyte receptors expression in patients with ischemic heart diseases, as well as to measure the plasma levels of interleukin (IL) 2, 6 and 10. T Lymphocytes are found in large numbers in human atherosclerotic plaques, indicating that immune and inflammatory mechanisms are important factors in the pathogenesis of atherosclerosis. Recent data have also implicated T lymphocytes in the pathogenetic mechanism of unstable angina and ischemic heart disease. Three groups of patients were studied: 42 with an acute ischemic syndrome (AIS), 36 with stable angina (SA) and 39 healthy controls. To characterize lymphocyte phenotype, flow cytometry was performed in whole-blood samples. IL-2, IL-6 and IL-10 were measured using the ELISA method. Double fluorescence evaluation showed an increase in CD8+/CD11b+ cells (cytotoxic T lymphocytes) and in CD11b+/CD16+CD56+ cells (NK lymphocytes) in the AIS group and in SA group as compared to the control group (P < 0.05 and P < 0.001, respectively). IL-2 was increased in the AIS and SA groups compared to the control group (AIS 4.5 +/- 0.5 pg/ml; SA 6.3 +/- 0.6 pg/ml; controls 2.4 +/- 0.8 pg/ml, P < 0.05), whereas IL-6 was higher in the AIS group than in the other two groups (AIS 10.8 +/- 1.8 pg/ml; SA 1.8 +/- 0.8 pg/ml; controls 1.2 +/- 0.6 pg/ml, P < 0.0001). These data show that patients with ischemic heart disease have an increase in circulating cytotoxic T lymphocytes and in IL-2 plasma levels, irrespective of their clinical presentation, compared to normal control subjects, whereas IL-6 is elevated only in patients with AIS.

Stent thrombosis: incidence and related factors in the R.I.S.E. Registry(Registro Impianto Stent Endocoronarico)

Although stent thrombosis has been greatly reduced by adequate stent expansion with high-pressure balloon inflations and by the use of antiplatelet drugs, this event is still frightening, as it may lead to acute myocardial ischemia resulting in acute myocardial infarction or sudden death. Therefore, the definition of factors associated with stent thrombosis may provide a better understanding of the mechanisms underlying this phenomenon and may permit us to define therapeutic strategies to further reduce its occurrence. The purpose of this study was to assess factors responsible for the occurrence of stent thrombosis after coronary stent implantation in 939 consecutive patients enrolled in the Registro Impianto Stent Endocoronarico (R.I.S.E. Study Group). Consecutive patients undergoing coronary stent implantation at 16 medical centers in Italy were prospectively enrolled in the registry. Clinical data, and qualitative and quantitative angiographic findings were obtained from data collected in case report forms at each investigator site. The study group consisted of 781 men and 158 women with a mean age of 59 yr: 1,392 stents were implanted in 1,006 lesions and expanded at a maximal inflation pressure of 14.7 +/- 3 atm. The great majority of patients (92%) received only antiplatelet drugs after coronary stenting. During hospitalization there were 45 major ischemic complications in 39 patients (4.2%): 13 events were related to acute or subacute thrombosis (1.4%). Another stent thrombotic event occurred in the first month of follow-up. On multivariate logistic regression analysis, stent thrombosis was related to the following factors: unplanned stenting (OR 3.46, 95% CI 1.65-7.23), unstable angina (OR 3.37, 95% CI 1.11-10.14) and maximal inflation pressure (OR 0.83, 95% CI 0.75-0.93). In conclusion, this registry shows that in an unselected population of patients undergoing coronary stenting, stent thrombosis occurs in less than 2% of patients and is significantly related to unplanned stent implantation, unstable angina, and maximal inflation pressure. The incidence of this phenomenon is likely to be further reduced by the use of new potent antiplatelet drugs, such as platelet glycoprotein IIb/IIIa antagonists.