Effect of Abciximab Therapy in Patients Undergoing Coronary Angioplasty for Acute ST-Elevation Myocardial Infarction Complicated by Cardiogenic Shock.

BACKGROUND: The effect of abciximab on survival in patients with ST-elevation myocardial infarction (STEMI) complicated by cardiogenic shock (CS) undergoing primary percutaneous coronary intervention (PCI) is not clear. METHODS AND RESULTS: We evaluated outcome in 410 consecutive patients with STEMI and CS who underwent PCI treated without (n=123) or with (n=287) abciximab. The endpoint was survival at 1-year follow-up. The predictors of death at 1 year were also investigated. The groups with and without abciximab had similar survival at 1-year follow-up. Propensity score-adjusted Cox proportional hazards model identified age (adjusted hazard ratio [HR], 1.02; 95% confidence interval [95% CI]: 1.01-1.03, P=0.001), oro-tracheal intubation (HR, 1.49; 95% CI: 1.12-1.96, P=0.05), post-PCI TIMI flow grade 0-1 (HR, 2.08; 95% CI: 1.52-2.83, P=0.0001) but not abciximab use (HR, 1.08; 95% CI: 0.70-1.60, P=0.60) as independent predictors of death at 1-year follow-up. Cox adjusted 1-year survival rates were 42.8% and 51.6%, (P=0.56) in patients treated without vs. with abciximab, respectively. CONCLUSIONS: Patients with STEMI complicated by CS undergoing PCI treated with or without abciximab have similar 1-year survival rates; age, final TIMI 0-1 and oro-tracheal intubation are predictors of death.

Head-to-head comparison of sirolimus-eluting stent versus bare metal stent evaluation of the coronary endothelial dysfunction in the same patient presenting with multiple coronary artery lesions: the CREDENTIAL study.

OBJECTIVES: To assess the endothelial dysfunction (ED) after bare metal stents (BMS) and sirolimus eluting stents (SES) implantation in the same patient, overcoming the confounding role of individual variables. BACKGROUND: SES reduce restenosis rate compared to BMS but causes more ED. ED is a potentially unsafe phenomenon, since it is the first step in the cascade of atherosclerosis. Studies showing more pronounced ED with drug eluting stents than BMS involved different series of patients, making the comparison difficult because endothelial function (EF) is responsive to many risk factors. METHODS: we designed a prospective comparison of 6 months post-deployment EF of SES versus BMS implanted in the same patient, but in different coronary segments. Forty-eight lesions were randomly assigned on a 1:1 allocation using block sizing of 4 according to a computer-generated sequence (SAS System, Version 9.1) basis to treatment with SES or BMS. The EF was evaluated by measuring vessel diameter variation in the stented segment, before and after selective intracoronary infusion of acetylcholine (iiAch). RESULTS: In eligible patients, the relative magnitudes of major vasoconstriction were 2.6, 2.9, 4.6, and 3.1 at 5 mm proximal and 5, 10 and 20 mm distal to the stent edge. Overall, a 3.5-fold major distal vasoconstriction after iiAch of SES vs. BMS was calculated. CONCLUSIONS: in the same patients, but treating different coronary segments, SES implantation induces a higher rate of vasoconstriction compared to BMS. The increased vasoconstriction after iiAch is an indicator of ED.

Comparison between the new Gore septal and Amplatzer devices for transcatheter closure of patent foramen ovale. Short- and mid-term clinical and echocardiographic outcomes.

BACKGROUND: The ideal device for percutaneous patent foramen ovale (PFO) occlusion should provide effective closure with long-term biocompatibility and it should have a low profile without interfering with adjacent cardiac structures. Long-term data regarding safety and efficacy of the GORE Septal Occluder (GSO) are lacking. The aim of this study was to investigate the short- and mid-term clinical and echocardiographic outcomes of this device. METHODS AND RESULTS: Forty-five consecutive patients with clinically significant PFO were treated with GSO and their results were compared with those of 45 consecutive patients treated with Amplatzer PFO device (APO). Primary endpoint was the incidence of 6-month residual right-to-left shunting (rRLS). The procedural results and the recurrence of embolic events (REE) at 1 year were also investigated. No differences in terms of embolic risk profile and echocardiographic parameters were observed between the 2 groups. GSO was successfully implanted in all patients without device-related complication. In 2 patients for whom device position was not optimal, the GSO was easily retrieved and a new GSO was successfully repositioned. Immediate moderate-severe rRLS was similar in 2 groups. No cases of severe 6-month rRLS were registered. Two patients (4%) and 1 patient (2%) had moderate 6-month rRLS in the GSO and APO group, respectively (P=NS). No cases of REE were registered at 1-year follow-up. CONCLUSIONS: GSO appears a valuable alternative to Amplatzer device for PFO occlusion.

Early and mid-term clinical outcome of emergency PCI in patients with STEMI due to unprotected left main coronary artery disease.

OBJECTIVES: Evaluation of acute and mid-term outcomes of patients with ST-elevation myocardial infarction (STEMI) undergoing emergency PCI due to unprotected left main coronary artery (ULMCA) disease. BACKGROUND: STEMI patients due to ULMCA disease represent a rare, high risk group. Percutaneous coronary intervention (PCI) may be the preferred strategy of myocardial revascularization but there are few data about this topic. METHODS: We analyzed 30-day and mid-term mortality of 58 patients with STEMI and ULMCA disease as culprit lesion treated in our centre by emergency PCI between 2000 to 2010. RESULTS: Mean age was 67.3 ± 11.5 years. Thirty (51.7%) patients had cardiogenic shock on admission. PCI success was achieved in 54 patients (93.1%). Mean follow-up was 15.8 ± 10.9 months (median 14, range 6-45). Thirty-day and mid-term mortality rates were 39.7% and 44%. Backward binary logistic regression model identified cardiogenic shock at presentation (OR 12.6, 95% CI 2.97-53.6, P < 0.001), age ≥75 years (OR 5.9, 95% CI 1.3-26.5, P = 0.019) and post-PCI TIMI flow grade <3 (OR 2.9, 95% CI 1.8-5.7 P = 0.02) as independent predictors of 30-day mortality. Cox proportional hazard ratio (HR) identified shock at presentation (HR 5.2, 95% CI 1.8-14.3, P < 0.002), age ≥75 years (HR 3.9, 95% CI 1.8-8.7, P < 0.001), post-PCI TIMI flow grade <3 (HR 4.9, 95% CI 1.6-14.6; P < 0.005) as independent predictors of mid-term mortality. CONCLUSIONS: In patients with STEMI and ULMCA as culprit lesion, emergency PCI is a valuable therapeutic strategy. Early and mid-term survival depends on cardiogenic shock, advanced age, and PCI failure. Patients surviving the first month have good mid-term prognosis.

Angiographic and clinical outcome of invasively managed patients with thrombosed coronary bare metal or drug-eluting stents: the OPTIMIST study.

AIMS: Stent thrombosis (ST) is a major complication of percutaneous coronary interventions (PCIs). An invasive management by re-PCI is the commonly adopted treatment for ST, but data on outcome are limited. METHODS AND RESULTS: We performed a 2-year multicentre registry enrolling consecutive patients with angiographically confirmed ST undergoing PCI. The primary angiographic endpoint was optimal angiographic reperfusion (TIMI 3 + blush grade 2 or 3). The primary clinical endpoints were death and major adverse coronary and cerebrovascular events (MACCEs) at 6 months. A total of 110 patients underwent 117 urgent PCI during the study. Patients with drug-eluting stent (DES) thrombosis, compared with those with bare metal stent (BMS) thrombosis, exhibited a higher rate of late or very late presentation and of anti-platelet therapy withdrawal. Optimal angiographic reperfusion was obtained in 64% of the patients. Death and MACCE rates at 6 months were 17 and 30%, respectively. Clinical outcome was similar for BMS and DES thrombosis. Very late ST, implantation of stent during PCI for ST, and failure to achieve optimal angiographic reperfusion were the independent predictors of 6-month mortality. CONCLUSION: DES and BMS thromboses have different clinical features, but a similar poor outcome. Indeed, PCI for ST is associated with a low rate of reperfusion and to a high rate of death and MACCE, calling for action in order to prevent its occurrence and to improve its management.

The Outcome of PCI for stent-ThrombosIs MultIcentre Study (OPTIMIST): rationale and design of a multicenter registry.

BACKGROUND: Stent thrombosis (ST) is a recognized complication limiting the clinical efficacy of percutaneous coronary interventions (PCI). Because of the increasing number of stent-based PCI, the absolute number of patients experiencing ST is expected to expand. Re-PCI is the commonly adopted treatment for patients with ST; however, the prognostic variables as well as the angiographic and clinical results have not been systematically assessed. Moreover, the possible benefit associated with the use of adjunctive devices (AD) with theoretical antiembolic property has not been systematically analyzed in this high-risk population. METHODS: We present the design of a prospective and retrospective multicenter registry to assess the contemporary angiographic and clinical outcome of PCI in patients with ST. Moreover, we sought to assess if the use of thrombectomy or distal protection AD is associated with any improvement in the PCI's angiographic results. All patients with angiographically confirmed ST undergoing attempt of PCI in the enrolling centers during a fixed 2-year study period will enter the study. Clinical outcome during hospitalization, at 30 days and 6 months will be assessed. Percutaneous coronary intervention with or without AD will be performed according to physician's discretion. All PCI cine-film will undergo blind core laboratory analysis to assess a series of key angiographic data (TIMI flow, TIMI frame count, thrombus score, myocardial blush grade, distal embolization). CONCLUSIONS: The OPTIMIST study is designed to provide a detailed description of the angiographic and clinical outcome achieved in the real world with contemporary PCI for ST. Moreover, it will provide observational data regarding the role of AD in this high-risk scenario.

The extent of late in-stent neointima formation is modified by treatment with pravastatin: a preliminary study with intravascular ultrasound.

BACKGROUND: The aim of the present comparative, non-randomized intravascular ultrasound (IVUS) study was to test the effect of pravastatin on late neointima formation in stented de novo lesions. METHODS: The treatment group consisted of 28 consecutive patients in whom 31 stents were deployed; all patients were prescribed 40 mg daily of pravastatin for a mean follow-up period of 14 +/- 3 months (group 1). The control group consisted of 27 consecutive patients in whom 30 stents were deployed; lipid-lowering treatment was not prescribed; the mean follow-up period for this group of patients was 13 +/- 3 months (group 2). At follow-up IVUS images were acquired at a continuous 0.5 mm/s speed. IVUS measurements of the lumen area, stent area and neointima area were calculated within the stent at 0.5 mm intervals. RESULTS: The stent dimensions and technique of implantation were similar in the two groups. At follow-up the minimal lumen diameter at quantitative coronary angiography was slightly larger in group 1 than in group 2 (2.43 +/- 0.58 vs 2.17 +/- 0.59 mm, p = NS), while the late loss tended to be lower in group 1 than in group 2 (0.28 +/- 0.39 vs 0.63 +/- 0.37 mm, p = NS). At IVUS evaluation, the lumen and stent areas were similar in the two groups whereas the percent neointima area was significantly lower in group 1 than in group 2 (21 +/- 11 vs 29 +/- 11% respectively, p < 0.03). CONCLUSIONS: Pravastatin treatment was associated with a significantly reduced late in-stent neointima formation as assessed at IVUS.

Primary coronary angioplasty in ST-elevation myocardial infarction: prediction of the thirty-day mortality risk in an unselected population of patients.

BACKGROUND: The 30-day mortality in catheter-based reperfusion therapy in patients with acute myocardial infarction varies widely in the literature and only some factors, such as cardiogenic shock, are clearly associated with the risk. This non-randomized, single center study investigates the potential factors influencing the 30-day mortality in 586 consecutive patients with ST-elevation myocardial infarction, treated with primary coronary angioplasty (PTCA). METHODS: In the whole series and in two subgroups (with and without cardiogenic shock) the clinical, angiographic and procedural variables were used to develop multivariate statistical models for the prediction of the endpoint. RESULTS: The overall 30-day mortality was 7.3%: 35.8 and 4.5% in patients with and without cardiogenic shock, respectively (p < 0.001). Independent predictors of the 30-day mortality included: a) in the entire series: shock, PTCA angiographic success, time to treatment, age, and coronary artery disease extension; b) in patients with cardiogenic shock: PTCA angiographic success, time to treatment, coronary artery disease extension, and use of abciximab; c) in patients without cardiogenic shock: time to treatment, age, and coronary artery disease extension. CONCLUSIONS: In patients with ST-elevation myocardial infarction submitted to primary PTCA, the 30-day mortality rate is a highly predictable endpoint. The role of abciximab therapy and of other independent predictors varies according to the presence or otherwise of cardiogenic shock.

One-year clinical outcome of elderly patients undergoing angioplasty for ST-elevation myocardial infarction complicated by cardiogenic shock: the importance of 3-vessel disease and final TIMI-3 flow grade.

BACKGROUND: The influence of age on clinical results of primary percutaneous coronary intervention (PCI) in patients with ST-elevation myocardial infarctions (STEMI) complicated by cardiogenic shock (CS) is poorly investigated. METHODS: In this study, we evaluated the outcome of 216 consecutive all-comer patients with STEMI and CS undergoing PCI who were divided into 2 groups according to age: <75 years (n = 131) or ≥75 years (n = 81). The study endpoint was the incidence of death at 1-year follow-up. The predictors of mortality at 1 year were also investigated. RESULTS: The group <75 years had a significantly lower incidence of death compared with the group ≥75 years at 30 days (39% vs 69%; P=.01) and 1 year (51% vs 79%; P<.001). Cox proportional hazards model identified: age (adjusted hazard ratio [HR] = 1.02; 95% confidence interval [CI], 1.00-1.03; P=.02), 3-vessel disease (HR = 1.47; 95% CI, 1.00-2.17; P=.05), post-PCI TIMI flow grade 0-1 (HR = 2.48; 95% CI, 1.66-3.70; P=.01) and grade 2 (HR = 1.68; 95% CI, 1.01-2.80; P=.05) after PCI as independent predictors of death at 1-year follow-up. CONCLUSIONS: Patients ≥75 years with STEMI complicated by CS and treated by PCI have higher 1-year mortality compared with younger counterparts. Final TIMI 0-2 and 3-vessel disease are strong predictors of death. This finding may be valuable in risk stratification of these patients.

One-year clinical outcome of patients treated with or without abciximab in rescue coronary angioplasty.

BACKGROUND: The clinical results of abciximab administration during rescue angioplasty (PCI) are poorly investigated. METHODS: We evaluated the outcome of 406 consecutive patients undergoing rescue PCI treated with (n=218) or without (n=188) abciximab and a clopidogrel loading dose of 300 mg. The end point was the incidence of major cardiac adverse events (MACE) defined as death, recurrent acute myocardial infarction (AMI) and target vessel revascularization at 30 days and 1 year. The predictors of MACE were also investigated. RESULTS: No differences were found in MACE between the groups treated with or without abciximab at 30 days (15 and 20, p=0.67) and 1 year (23 and 29, p=0.85). Stepwise logistic regression analysis identified: cardiogenic shock (Odds Ratio [OR]=17.8, 95% confidence interval [CI] 5-99, p=0.0001), age (OR=1.099, 95% CI 1.04-1.15, p=0.0001), TIMI flow 0-1 after procedure (OR=5.51, 95% CI 1.72-17.6, p=0.004) as independent predictors of MACE at 30 days. Cox proportional hazards model identified: cardiogenic shock (adjusted hazard ratio [HR]=3.83, 95% confidence interval [CI] 1.76-8.35, p=0.01), age (HR=3.7, 95% CI 1.75-8.3, p=0.01), TIMI flow 0-1 after procedure (HR=1.04, 95% CI 1.01-1.07, p=0.001 as predictors of MACE at 1 year). After propensity score adjustments the predictors of MACE did not change. CONCLUSION: There were no differences in MACE at 30 days and 1 year in patients treated with or without abciximab during rescue PCI after a clopidogrel loading dose of 300 mg. Cardiogenic shock, age and TIMI flow 0 and 1 after PCI were predictors of MACE.

Five-year outcomes in patients with chronic total coronary occlusion treated with drug-eluting vs bare-metal stents: a case-control study.

BACKGROUND: Limited data exist on long-term safety and effectiveness of drug-eluting stents (DESs) in true chronic total coronary occlusion (CTO) settings. We evaluated 5-year clinical outcomes of patients with CTO treated successfully with DES vs bare-metal stent (BMS). METHODS: We compared the 5-year clinical outcomes of 156 patients treated with DES implantation with outcomes of a historical cohort of 159 patients treated with BMS. Primary end point was freedom from major adverse cardiac events (MACEs; defined as death, myocardial infarction [MI], and target lesion revascularization [TLR]); secondary end points were freedom from target vessel failure (TVF; combination of target vessel revascularization, MI, and cardiac death) and TLR at 5 years. RESULTS: After 5 years, the DES group had significantly superior event-free survival from MACE (84% vs 69%; log rank P < 0.001), TVF (71% vs 84%; P = 0.002), and TLR (77% vs 92%; P = 0.0001), compared with the BMS group. The Cox proportional hazards model identified BMS vs DES (adjusted hazard ratio [HR] = 3.37; 95% confidence interval [CI], 1.85-6.17; P = 0.001), final minimal lumen diameter (HR, 0.27; 95% CI, 0.14-0.52; P = 0.0001), and stent length (HR, 1.01; 95% CI, 1.00-1.03; P = 0.03) as independent predictors of MACE at 5-year follow-up. Twelve (7%) and 7 (4%) stent thromboses occurred in the DES and BMS groups (P = 0.23), respectively. CONCLUSIONS: After 5 years, DESs were superior to BMSs in reducing MACE, TVF, and TLR in patients with CTO and should be the preferred strategy.

Effect of multivessel coronary artery disease with or without a concomitant chronic total occlusion on 1-year survival in patients treated with rescue angioplasty.

BACKGROUND: The effect of multivessel disease (MVD) with or without a concomitant chronic total occlusion (CTO) has never been investigated in patients treated with rescue percutaneous coronary intervention (PCI). OBJECTIVES: This study evaluates whether there is an increased rate of death at 1-year follow-up in patients undergoing rescue PCI with angiographic pattern of MVD and a concurrent CTO in comparison with single-vessel disease (SVD) and MVD without CTO. METHODS: Among 551 consecutive patients undergoing rescue PCI, we compared the 1-year survival rates of 361 patients with SVD, 137 with MVD without a CTO, and 53 with MVD and a CTO. RESULTS: The 1-year mortality rates of patients with SVD, MVD without CTO, and MVD with CTO were 5%, 13%, and 27%, respectively (P<.001). The Cox proportional hazard model identified the presence of MVD with CTO as a strong predictor of death at 1-year follow-up (hazard ratio [HR], 3.4; 95% confidence interval [CI], 1.6-7.1; P=.001), while MVD alone did not result as a predictor of outcome (HR, 1.9; 95% CI, 0.9-3.8; P=.064). Adjusted 1-year overall survival rates were 96%, 91.4%, and 83.4% (P=.001) in the groups with SVD, MVD without CTO, and MVD with CTO, respectively. CONCLUSION: Patients with MVD and concurrent CTO have higher mortality rates than those with SVD or MVD without CTO at 1-year follow-up after rescue PCI. MVD with CTO and not MVD alone is a predictor of death at 1-year follow-up.

Gore Helex septal occluder for percutaneous closure of patent foramen ovale associated with atrial septal aneurysm: short- and mid-term clinical and echocardiographic outcomes.

OBJECTIVES: To evaluate the short- and mid-term clinical and echocardiographic outcome of HELEX Septal Occluder (HSO) implantation in patients with patent foramen ovale (PFO) and atrial septal aneurysm (ASA). BACKGROUND: Percutaneous closure of PFO and ASA with HSO device has not been systematically studied. METHODS: We studied 90 patients with PFO and ASA with documented paradoxical embolic events. The procedural and clinical results of 30 consecutive patients treated with HSO were compared with those obtained in 30 consecutive patients treated with the Amplatzer PFO (APO) and with those of a further 30 consecutive patients treated with the Amplatzer Cribriform (AMF). Primary endpoint was the persistence of moderate to severe residual right-to-left shunting (rRLS) at 6-month follow-up. The incidence of death or recurrent embolic events (REE) at 1-year follow-up were also investigated. RESULTS: The procedure was successfully completed in all patients. There was one HSO device embolization. Immediate moderate RLS was significantly higher in the HSO group compared to APO and AMF groups (20% vs 3% vs 0%, respectively; P=.008). The incidence of moderate rRLS decreased but was still significant at 6-month follow-up (17% in the HSO group vs 3% in the APO group; P=.02). At 1-year follow-up, moderate rRLS persisted only in the HSO group (7%). No deaths or REE were observed during hospitalization or at 1-year follow-up. CONCLUSION: HSO device seems to be a second-line device as compared to Amplatzer occluders for the treatment of PFO and ASA.

Comparison of one-year cardiac events with drug-eluting versus bare metal stent implantation in rescue coronary angioplasty.

Rescue percutaneous coronary intervention (PCI) with bare metal stent (BMS) implantation is useful in patients with acute myocardial infarction (AMI) and failed thrombolysis. Drug-eluting stent (DESs) are more effective in reducing restenosis compared to BMS. No data are available comparing the clinical outcomes between the 2 types of stents nor has information ever been provided about the predictors of events in patients treated with rescue PCI in the current era. The aims of the present study were to evaluate the outcomes of patients undergoing rescue PCI with DES implantation compared to BMS implantation and to determine the independent predictors of events during 1 year of follow-up. The study population consisted of 311 consecutive patients with ST-segment elevation AMI and evidence of failed fibrinolysis undergoing successful revascularization with DES (n = 134) or BMS (n = 177) implantation. The end point of the present study was the incidence of major adverse cardiac events (MACE) defined as death, recurrent AMI, and target vessel revascularization. No differences were found in the number of MACE at 1 year of follow-up between the DES and BMS groups (n = 10 and 19, respectively, p = 0.29). The Cox proportional hazards model identified cardiogenic shock (adjusted hazard ratio 7.05, 95% confidence interval 2.08 to 23.9, p = 0.001), age (hazard ratio 1.51, 95% CI 1.09 to 2.08, p = 0.011), and final minimal lumen diameter (hazard ratio 0.42, 95% confidence interval 0.21 to 0.83, p = 0.013) as independent predictors of MACE at 1 year of follow-up. After propensity score adjustments, the predictors did not change. In conclusion, we found no differences between DESs and BMSs with respect to MACE at 1 year of follow-up in patients with AMI treated with rescue PCI. Cardiogenic shock, age, and final minimal luminal diameter were identified as predictors of MACE.

Comparison of one-year outcome of patients aged <75 years versus ≥75 years undergoing "rescue" percutaneous coronary intervention.

The influence of age on the clinical results after rescue angioplasty (percutaneous coronary intervention [PCI]) has been poorly investigated. In the present study, we evaluated the outcome of 514 consecutive patients undergoing rescue PCI who were divided into 2 groups according to age: <75 years (n = 469) and ≥75 years (n = 45). The primary end point of the study was the incidence of death at 1 year of follow-up. The secondary end point was the 1-year incidence of major cardiac adverse events (MACE) defined as a composite of death, recurrent acute myocardial infarction, and target vessel revascularization. The predictors of death and MACE at 1 year were also investigated. At 1 year of follow-up, the <75-year-old group had a significantly lower incidence of death (7% vs 24%, p = 0.0001) and MACE (14% vs 28%, p = 0.01) compared to the ≥75-year-old group. The Cox proportional hazards model identified age (adjusted hazard ratio 0.2665, 95% confidence interval 0.1285 to 0.5524, p = 0.0004), cardiogenic shock (hazard ratio 0.1057, 95% confidence interval 0.0528 to 0.2117, p <0.000001), Thrombolysis In Myocardial Infarction flow grade 2 to 3 after PCI versus 0 to 1 (hazard ratio 3.8380, 95% confidence interval 1.7781 to 8.2843, p = 0.0006), multi- versus single-vessel disease (hazard ratio 0.3716, 95% confidence interval 0.1896 to 0.7284, p = 0.0039) as independent predictors of survival at 1 year of follow-up. In conclusion, at 1 year of follow-up after rescue PCI, the patients aged ≥75 years had a greater incidence of death and MACE compared to patients aged <75 years. Age, cardiogenic shock, Thrombolysis In Myocardial Infarction flow grade 0-1 after PCI, and multivessel coronary disease were predictors of survival and freedom from MACE at 1 year of follow-up.

Long-term outcome of transcatheter patent foramen ovale closure in patients with paradoxical embolism.

BACKGROUND: Optimal management of patients with PFO and paradoxical embolic events is still debated. Moreover, data from long-term studies on large patient populations are lacking. Aim of the study is to assess immediate and long-term clinical outcome of patients with PFO and paradoxical thrombo-embolic events submitted to transcatheter PFO closure. METHODS: Only patients with PFO-related transient ischemic attack or stroke underwent PFO closure. Patients were evaluated clinically and echocardiographically at 1, 6 and 12 months after the procedure and yearly thereafter. Primary endpoints were death, recurrent stroke or TIA. Residual right-to left shunt (RLS) was monitored by transthoracic echocardiography (TTE) or transcranial Doppler (TCD) at 6 months'follow-up. RESULTS: 202 consecutive patients underwent percutaneous PFO closure for secondary prevention of TE. Device migration was observed in one patient 24 h after the procedure. No cases of procedure-related death or stroke occurred during a median follow-up of 3+/-1.3 years. Three recurrent TIAs were observed within the first 6 months of follow-up. The cumulative estimated probability of recurrent TE-free survival rate after PFO closure was 99% in patients 55 years (p<0.05) and 94% and 100% in patients with PFO, with or without atrial septal aneurysm (ASA), respectively (p<0.05). Of the 188 (93%) patients submitted to TTE or TCD at 6 months' follow-up, 8 (4%) presented a small RLS. CONCLUSION: Transcatheter PFO closure is associated with low incidence of in-hospital complications and low frequency of recurrent TE at long-term follow-up.

Angiographic predictors of recurrent stent thrombosis (from the Outcome of PCI for stent-ThrombosIs MultIcentre STudy [OPTIMIST]).

Stent thrombosis is a catastrophic occurrence burdened by a high mortality rate and a tendency to recur. We sought to evaluate the angiographic risk factors for recurrent stent thrombosis (rST) in a subpopulation of 91 Outcome of PCI for stent-ThrombosIs Multicenter STudy (OPTIMIST) patients who underwent quantitative angiographic evaluation by an independent core laboratory. The Academic Research Consortium criteria were used for rST adjudication. A multivariate Cox proportional hazards model was applied to estimate the hazard ratios and the corresponding 95% confidence intervals for the occurrence of Academic Research Consortium-defined, definite rST (primary end point), definite or probable rST (secondary end point), and definite or probable or possible rST (secondary end point). A total of 8 definite rST events occurred during a median follow-up of 244 days (range 165 to 396), of which 5 were early and 3 were late. In the multivariate model, a residual thrombus score of > or =3 (hazard ratio 6.5, 95% confidence interval 1.4 to 30.7, p = 0.017) and a larger postprocedural reference vessel diameter (hazard ratio 4.5, 95% confidence interval 1.5 to 13.3, p = 0.006) were significantly associated with the primary end point. When the same model was applied to the 15 definite and probable rST events, only a residual thrombus score of > or =3 (hazard ratio 7.8, 95% confidence interval 2.5 to 24.5, p <0.001) was significantly associated with rST. Finally, when possible rST events were included (18 patients), a residual thrombus score of > or =3 remained associated with the dependent variable (hazard ratio 6.1, 95% confidence interval 2.0 to 18.2, p = 0.001), along with a larger postprocedural reference vessel diameter. In conclusion, when performing percutaneous coronary intervention for stent thrombosis, the residual thrombus burden and larger reference vessel were potent risk factors for rST.

3-year clinical outcome of patients with chronic total occlusion treated with drug-eluting stents.

OBJECTIVES: The aim of this study was to evaluate whether percutaneous coronary intervention (PCI) with drug-eluting stent (DES) reduces major adverse cardiac events (MACE) in patients with chronic coronary total occlusions (CTO) compared with bare-metal stent (BMS) during 3-year follow-up. BACKGROUND: The long-term prognosis of patients with CTO treated with PCI and DES implantation is poorly investigated. METHODS: We compared the 3-year clinical outcome of 124 patients with CTO after successful PCI with DES implantation with that of 159 patients with CTO previously treated with BMS. MACE were defined as death, myocardial infarction, and target lesion revascularization (repeat PCI or coronary artery bypass surgery) and were considered as combined primary end point. RESULTS: After 3 years, the composite end point was significantly lower in the DES than in the BMS group: 18% versus 28%, respectively, (p < 0.05). The difference was due to the reduction of target lesion revascularization with DES compared with BMS-8% versus 21%, respectively, (p < 0.004). The Cox proportional hazards model identified: DES versus BMS (adjusted hazard ratio [HR]: 0.338, 95% confidence interval [CI]: 0.19 to 0.60, p = 0.0001), lesion length (HR: 1.033, 95% CI: 1.008 to 1.058, p = 0.012), and final minimal lumen diameter (HR: 0.456, 95% CI: 0.232 to 0.898, p = 0.023) as independent predictors of MACE at 3-year follow-up. CONCLUSIONS: After 3 years, DES were superior to BMS in reducing MACE in patients with CTO and should be considered the preferred treatment strategy.

Clinical outcome of patients with chronic total occlusion treated with drug-eluting stents.

BACKGROUND: There is limited evidence on the medium-term prognosis of patients with chronic total occlusion successfully treated with drug-eluting stent (DES) implantation. METHODS: We compared the medium-term outcome of 111 patients with chronic total occlusion (CTO) successfully treated with implantation of sirolimus-or paclitaxel-eluting stents versus 112 patients treated with bare metal stents. RESULTS: During an overall follow-up period of 18 months, the composite endpoint of death, myocardial infarction or target lesion revascularization was significantly lower in the drug-eluting stent than in the bare metal stent group: 8.1% vs. 21.6%, respectively (p=0.005). The difference was due to the reduction of target lesion revascularization with DES compared to bare metal stents: 3.6% vs. 18.9%, respectively (p<0.001). The Cox proportional hazards model identified DES as an independent predictor of adverse cardiac events (adjusted hazard ratio, 0.16; 95% confidence interval 0.05 to 0.52, p=0.002). CONCLUSIONS: During medium-term follow-up use of DES is associated with improved outcome compared to use of bare metal stents in patients with CTO.