One-Year Clinical Outcomes of Forty-Eight Millimeter Everolimus-Eluting Stent Implanted in Very Long Lesions: A Propensity-Matched Comparison (The FREIUS Study).

BACKGROUND: Long coronary lesions still remain a challenge, with poor immediate results and suboptimal outcomes when compared to class A/B1 lesions. The presence of overlapped segments of metal struts and polymer might trigger an abnormal inflammatory reaction, resulting in a higher restenosis rate. The aim of our study was to evaluate the safety, feasibility, and cost effectiveness of a 48 mm everolimus-eluting stent (EES) during treatment of very long coronary lesions. METHODS AND RESULTS: The FREIUS study is a prospective data collection of consecutive patients undergoing 48 mm EES implantation in six high-volume European centers. Each patient was matched through a propensity score to a comparable patient treated with two or more second-generation overlapped drug-eluting stents. The primary endpoint was the combined incidence of cardiac death, target-vessel myocardial infarction, and target-lesion revascularization (device-oriented composite endpoint [DOCE]). The secondary endpoints were all-cause death, each individual component of the primary endpoint, and definite/probable stent thrombosis. From January 2014 to April 2015, a total of 218 patients were treated with at least one 48 mm EES and were compared with 218 matched controls. Overall, 9% of patients reached the primary endpoint. Cumulative survival free from DOCE incidence did not differ between the two groups (7% in the cases vs 10.5% in the controls; P=.10). After multivariable analysis, only clinical presentation with myocardial infarction (hazard ratio [HR], 1.8; 95% confidence interval [CI], 1.5-2.1; P=.01) and stent number (HR, 1.4; 95% CI, 1.1-1.8; P=.02) emerged as independent predictors of DOCE. CONCLUSION: The use of 48 mm EES offers a safe and effective strategy for the treatment of very long coronary lesions.

Complete versus culprit-only revascularization in ST-elevation myocardial infarction and multivessel disease.

In 30-60 % of patients presenting with ST-segment elevation myocardial infarction (STEMI), significant stenoses are present in one or more non-infarct-related arteries (IRA). This correlates with an increased risk of major adverse cardiac events (MACE). Current guidelines, do not recommend revascularization of non-culprit lesions unless complicated by cardiogenic shock or persistent ischemia after primary percutaneous coronary intervention (PCI). Prior observational and small randomized controlled trials (RCTs) have demonstrated conflicting results regarding the optimal revascularization strategy in STEMI patients with multivessel disease. Recently, randomized studies (PRAMI, CvLPRIT, and DANAMI 3-PRIMULTI) provide encouraging data that suggest potential benefit with complete revascularization in STEMI patients with obstructive non-culprit lesions. Differently, in the PRAGUE-13 trial there were no differences in MACE between complete revascularization and culprit-only PCI. Several meta-analyses were recently published including randomized and non-randomized clinical trials, showing different results depending on the included trials. In conclusion, the current available evidence from the randomized clinical trials, with a total sample size of only 2000 patients, is not robust enough to firmly recommend complete revascularization in STEMI patients. This uncertainty lends support to the continuation of the COMPLETE trial. This ongoing trial is anticipated to enroll 3900 patients with STEMI from across the world, and will be powered for the hard outcomes of death and myocardial infarction. Until the results of the COMPLETE trial are reported, physicians need to individualize care regarding the opportunity and the timing of the non-IRA PCI.

Combining therapeutic hypothermia and emergent coronary angiography in out-of-hospital cardiac arrest survivors: Optimal post-arrest care for the best patient.

BACKGROUND: Aggressive post-resuscitation care, in particular combining mild therapeutic hypothermia (MTH) with early coronary angiography (CAG) and percutaneous coronary intervention (PCI), may improve prognosis after out-of-hospital cardiac arrest (OHCA). OBJECTIVES: The study aims to assess the value of immediate CAG or PCI in comatose survivors after OHCA treated with MTH and their association with outcomes. METHODS: Observational, prospective analysis of all comatose, resuscitated patients treated with MTH at a tertiary centre and undergoing CAG or PCI ≤6 hours after OHCA, or non-invasively managed. Primary outcomes were 30-day and 1-year survival. RESULTS: From March 2004-December 2012, 141 (51%) out of 278 comatose patients after cardiac OHCA were treated with MTH (median age: 64.5 (interquartile range 55-73) years, males: 67%, first shockable rhythm: 70%, witnessed OHCA: 94%, interval OHCA-resuscitation ≤20 min: 81%). Ninety-seven patients (69%) underwent early CAG, and 45 (32%) of them PCI. Patients undergoing CAG or PCI had a more favourable risk profile than subjects non-invasively managed. PCI treated patients had more bleedings, but no stent thrombosis occurred. Thirty-day and one-year unadjusted total mortality rates were 50% and 72% for non-invasively managed patients, 26% and 38.7% for patients submitted only to CAG and 32% and 36.6% for patients treated with PCI (p=0.0435 for early death, and p<0.0001 for one-year mortality, respectively). However, a propensity-matched score analysis did not confirm the survival advantage of invasive management (p=0.093). At multivariable analysis, clinical and OHCA-related variables as well as CAG, but not PCI, were associated with outcomes. CONCLUSIONS: Comatose patients cooled after OHCA and submitted to emergency CAG or PCI are a favourable outcome population that receives optimal post-arrest care.

A clinical and angiographic study of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with multivessel coronary artery disease: the EXECUTIVE trial (EXecutive RCT: evaluating XIENCE V in a multi vessel disease).

OBJECTIVES: This study sought to investigate the efficacy and performance of the XIENCE V everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in the treatment of de novo coronary lesions in patients with 2- to 3-vessel multivessel coronary artery disease (MV-CAD). BACKGROUND: Drug-eluting stents (DES) have emerged as an alternative to conventional coronary artery bypass surgery in patients with MV-CAD although first-generation DES yielded inferior efficacy and safety compared with surgery. METHODS: Prospective, randomized (1:1), multicenter feasibility trial was designed to assess angiographic efficacy of EES compared with the TAXUS paclitaxel-eluting stent (PES) in 200 patients, and a prospective, open-label, single-arm, controlled registry was designed to analyze the clinical outcome of EES at 1-year follow-up in 400 MV-CAD patients. For the randomized trial, the primary endpoint was in-stent late loss at 9 months. For the registry, the primary endpoint was a composite of all-cause death, myocardial infarction, and ischemia-driven target vessel revascularization at 12 months. RESULTS: The primary endpoint per single lesion was significantly lower in the EES group compared with the PES group (-0.03 ± 0.49 mm vs. 0.23 ± 0.51 mm, p = 0.001). Similar results were observed when analyzing all lesions (0.05 ± 0.51 mm vs. 0.24 ± 0.50 mm, p < 0.001). Clinical outcome at 1 year yielded a composite of major adverse cardiac events of 9.2% in the single-arm registry, and 11.1% and 16.5% in the EES and PES randomized groups, respectively (p = 0.30). CONCLUSIONS: The EXECUTIVE trial was a randomized pilot trial dedicated to the comparison of the efficacy of 2 different DES among patients with 2- to 3-vessel MV-CAD. The study shows lower in-stent late loss at 9 months with the EES XIENCE V compared with the PES TAXUS Libertè, and a low major adverse cardiac event rate at 1 year in patients with 2-to 3-vessel MV-CAD. (EXECUTIVE [EXecutive RCT: Evaluating XIENCE V in a Multi Vessel Disease]; NCT00531011).

Incidence and outcome of high on-treatment platelet reactivity in patients with non-ST elevation acute coronary syndromes undergoing percutaneous coronary intervention (from the VIP [VerifyNow and Inhibition of Platelet Reactivity] study).

High residual platelet reactivity (RPR) on clopidogrel treatment has been associated with increased risk for ischemic events during follow-up in patients with acute coronary syndromes. The aim of this study was to assess the incidence, predictors, and clinical consequences of high RPR in a large population of patients with non-ST-segment elevation acute coronary syndromes who underwent percutaneous coronary intervention and stenting. Overall, 833 patients received point-of-care testing of platelet inhibition 30 days after percutaneous coronary intervention. High RPR was diagnosed on the basis of P2Y12 reaction units >230. The incidence and predictors of death, myocardial infarction, stroke, and serious bleeding events were assessed up to 1 year from the day of testing. P2Y12 reaction units were normally distributed, and 264 patients were classified as poor responders (31.7%). Independent predictors of response to clopidogrel were male gender (odds ratio [OR] 1.51), age (OR 0.96), diabetes mellitus (OR 0.51), and use of proton pump inhibitors (OR 0.59). At 1 year, poor responders showed higher rates of death (4.6% vs 1.9%, p = 0.032) and serious bleeding events (4.9% vs 1.8%, p = 0.009) compared with good responders. After adjustment for confounders, high RPR did not emerge as an independent predictor of mortality (OR 0.57, 95% confidence interval [CI] 0.23 to 1.42, p = 0.23) or serious bleeding events (OR 0.61, 95% CI 0.25 to 1.52, p = 0.29). The results did not change using the a cut-off value for P2Y12 reaction units of 208. In conclusion, 1/3 of patients with acute coronary syndromes who underwent percutaneous coronary intervention and stenting showed high on-treatment RPR on bedside monitoring. They had a worse prognosis, but the level of platelet inhibition was not independently associated with the incidence of ischemic or bleeding events.

Impact of COPD on long-term outcome after ST-segment elevation myocardial infarction receiving primary percutaneous coronary intervention.

BACKGROUND: There are limited data describing the long-term outcome of patients with concomitant COPD who develop ST-segment elevation myocardial infarction (STEMI). METHODS: A total of 11,118 consecutive patients with STEMI enrolled in the web-based Registro Regionale Angioplastiche Emilia-Romagna (REAL) registry were followed-up and stratified according to COPD presence or not. At 3-year follow-up, mortality and hospital readmissions due to myocardial infarction (MI), heart failure (HF), coronary revascularization (CR), serious bleeding, and COPD were assessed. RESULTS: According to our criteria, 2,032 patients (18.2%) had a diagnosis of COPD. Overall, 1,829 patients (16.5%) died. COPD was an independent predictor of mortality (hazard ratio [HR], 1.4; 95% CI, 1.2-1.6). Hospital readmissions for recurrent MI (10% vs 6.9%, P < .01), CR (22% vs 19%, P < .01), HF (10% vs 6.9%, P < .01), and SB (10% vs 6%, P < .01) were significantly more frequent in patients with COPD as compared with those without. Also, hospital readmissions for COPD were more frequent in patients with a previous history of COPD as compared with those without (19% vs 3%; P < .01, respectively). Patients with a hospital readmission for COPD showed a fourfold increased risk of death (HR, 4.2; 95% CI, 3.4-5.2). Finally, hospital readmissions for COPD emerged as a strong independent risk factor for recurrence of MI (HR, 2.1; 95% CI, 1.4-3.3), HF (HR, 5.8; 95% CI, 4.6-7.5), and SB (HR, 3; 95% CI, 2.1-4.4). CONCLUSIONS: Patients with STEMI and concomitant COPD are at greater risk for death and hospital readmissions due to cardiovascular causes (eg, recurrent MI, HF, bleedings) than patients without COPD.

Transradial versus transfemoral intervention for acute myocardial infarction: a propensity score-adjusted and -matched analysis from the REAL (REgistro regionale AngiopLastiche dell'Emilia-Romagna) multicenter registry.

OBJECTIVES: This study sought to assess whether transradial intervention, by minimizing access-site bleeding and vascular events, improves outcomes in patients with ST-segment elevation myocardial infarction compared with the transfemoral approach. BACKGROUND: Bleeding and consequent blood product transfusions have been causally associated with a higher mortality rate in patients with myocardial infarction undergoing coronary angioplasty. METHODS: We identified all adults undergoing percutaneous intervention for acute myocardial infarction in Emilia-Romagna, a region in the north of Italy of 4 million residents, between January 1, 2003, and July 30, 2009, at 12 referral hospitals using a region-mandated database of percutaneous coronary intervention procedures. Differences in the risk of death at 2 years between patients undergoing transfemoral versus transradial intervention, assessed on an intention-to-treat basis, were determined from vital statistics records and compared based on propensity score adjustment and matching. RESULTS: A total of 11,068 patients were treated for acute myocardial infarction (8,000 via transfemoral and 3,068 via transradial route). According to analysis of matched pairs, the 2-year, risk-adjusted mortality rates were lower for the transradial than for the transfemoral group (8.8% vs. 11.4%; p = 0.0250). The rate of vascular complications requiring surgery or need for blood transfusion were also significantly decreased in the transradial group (1.1% vs. 2.5%, p = 0.0052). CONCLUSIONS: In patients undergoing angioplasty for acute myocardial infarction, transradial treatment is associated with decreased 2-year mortality rates and a reduction in the need for vascular surgery and/or blood transfusion compared with transfemoral intervention.

[Restraints and psychiatric emergencies in the metropolitan area of Rome]. / Contenzioni ed emergenze psichiatriche a Roma.

This research, sponsored by the coordination center for the Psychiatric, Diagnosis, and Cure Services (SPDC), would verify if, and in which measure, the mechanical restraint is still today a mean necessary for the management of the states of agitation in the psychiatric emergencies. The perspective in which the search is developed has been that to consider the restraint a point of synthesis of the matters of ethic, of quality and safety, and not only and exclusively a moral matter. The results of the search have showed a conspicuous and diffused use the mechanical restraint as routine mean in the management of the serious agitation and the incisive influence of endogenous (SPDC) factors of risk and exogenous (catchment's area and mental health department) in to determine a recourse to it. In conclusion, he sustains that a effectiveness and winner action to limit and to eliminate, in perspective, the mechanical restraint in the current routine of SPDC cannot put aside at the most from an appointment level both type professional (leadership, staff training, guide lines, yearly audit) both type normative (the restraint as discriminating for the accreditation and for the evaluation of the executives, and business procedures for prevention of risk in the safety's optics for patients and operators).

A clinical and angiographic study of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with multivessel coronary artery disease. Study design and rationale of the EXECUTIVE trial.

BACKGROUND: Myocardial revascularization with drug-eluting stents (DESs) is emerging as an alternative to conventional coronary artery bypass surgery in patients with multivessel coronary artery disease (MV-CAD). First-generation DESs have yielded equivalent safety results at mid-term compared with surgery, but inferior efficacy in preventing the recurrence of ischemic symptoms. The outcome of percutaneous coronary intervention with a second-generation everolimus DES as compared with a paclitaxel DES in patients with MV-CAD has not been established. AIM OF THE STUDY: The aim of the study is the assessment of the efficacy and performance of the XIENCE V everolimus-eluting stent in the treatment of de-novo coronary artery lesions in patients with MV-CAD. STUDY DESIGN: The study is composed of two parts: a prospective, double arm, randomized multicenter trial to assess the angiographic efficacy of the XIENCE V everolimus-eluting coronary stent system (EECSS) compared with the Taxus Liberté Paclitaxel Eluting Coronary Stent System (Taxus Liberté Stent) and a prospective, open-label, single arm, controlled registry to analyze the clinical efficacy and safety of XIENCE V EECSS at mid-term and long-term follow-up in patients treated for MV-CAD. ENDPOINTS: For the EXECUTIVE randomized trial, the primary endpoint is in-stent late lumen loss at 9 months. For the EXECUTIVE registry, the primary endpoint is a composite of all death, myocardial infarction (Q-wave and non-Q-wave), and ischemia-driven target vessel revascularization at 12 months. The study will be conducted at 30 study centers in Italy and 600 patients will be enrolled in total: 200 patients will be enrolled (1: 1) in the randomized trial and 400 patients will enter the registry. SAMPLE SIZE: It was calculated that, assuming a mean in-stent late lumen loss of 0.20 +/- 0.41 mm in the XIENCE V EECSS arm and 0.30 +/- 0.53 mm in the Taxus Liberté stent arm, and a noninferiority margin delta of 0.12 (according to the SPIRIT III results), the analysis of 81 lesions per arm would provide over 90% power. Therefore, 200 patients will be enrolled to account for dropouts. CONCLUSION: The present study is expected to provide as yet unavailable information about the performance of second-generation stents in the specific setting of patients with MV-CAD.

Comparison of 2-year clinical outcomes with sirolimus and paclitaxel-eluting stents for patients with diabetes: results of the Registro Regionale AngiopLastiche Emilia-Romagna Registry.

BACKGROUND: Long-term outcomes of percutaneous coronary interventions (PCI) with sirolimus-eluting stents (SES) compared to paclitaxel-eluting-stents (PES) in unselected diabetics in routine practice is still debated. OBJECTIVE: This study compared the 2-year incidence of MACE (all-cause mortality, nonfatal myocardial infarction and target vessel revascularization) of SES and PES in a real-world setting of patients with diabetes. DESIGN: Observational, multicenter, nonrandomized study. SETTING: Prospective web-based registry (REAL Registry; study period, 2002-2005) comprising all 13 hospitals performing PCI. PATIENTS: Among the 945 eligible patients treated with either SES alone (n = 606) or PES alone (n = 339), 29% were insulin-requiring, 72% had multivessel coronary disease, 26% had prior myocardial infarction and 10% had poor left ventricular function. MEASUREMENTS: Unadjusted and propensity score-adjusted 2-year clinical outcome. RESULTS: After propensity score adjustment, 2-year MACE incidence in the SES and PES groups was equivalent (23.3% vs. 23.7%, HR 1.01, 95%CI 0.72-1.42, P = 0.96). Adjusted 2-year angiographic stent thrombosis occurred in 1.1% of the SES patients versus 2.6% of the PES patients (P = 0.15). In this large, real-world, diabetic population treated with DES, there was no difference in outcome between SES and PES. Further studies are needed to demonstrate the long-term safety of different types of DES in patients with diabetes.

Long-term outcome after drug eluting stenting in patients with ST-segment elevation myocardial infarction: data from the REAL registry.

BACKGROUND: The long-term safety and efficacy of drug eluting stents (DES) implanted during primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) is unclear. The purpose of this study was to compare the long-term outcome of STEMI patients undergoing primary PCI with DES vs. bare metal stent (BMS) implantation. METHODS: In the present analysis 4764 patients were enrolled (706, 15%, received DES). We assessed the cumulative incidence of major adverse cardiac events (MACE) and stent thrombosis (ST). RESULTS: Overall, no significant difference emerged for the rates of death and reinfarction. DES implantation was associated to a reduction of target vessel revascularization (TVR) (HR 0.65, 95%CI 0.47-0.91; p=0.01), leading to a MACE reduction (HR 0.7, 95%CI 0.56-0.86; p<0.01). In particular, during the first 2 years we observed less adverse events in the DES group, mainly because of a lower TVR rate (TVR: HR 0.56, 95%CI 0.37-0.83, p<0.01; MACE: HR 0.71, 95%CI 0.54-0.94, p=0.01). On the contrary, during the third year, adverse events tended to be higher in the DES group. ST did not differ between DES and BMS groups (p=0.6). No differences were observed between sirolimus eluting stents and paclitaxel eluting stents. CONCLUSIONS: DES implantation during primary PCI is safe and associated with a significant TVR and MACE reduction in the first two years, whereas a trend to have more adverse events in the third year is observed. More data about long-term follow-up are needed to better evaluate both safety and efficacy of DES in the setting of STEMI.

Randomized comparison between tirofiban and abciximab to promote complete ST-resolution in primary angioplasty: results of the facilitated angioplasty with tirofiban or abciximab (FATA) in ST-elevation myocardial infarction trial.

AIMS: To test the equivalence of high-dose bolus (HDB) tirofiban vs. abciximab during primary percutaneous coronary intervention (PPCI) in terms of ST-segment resolution (STR). METHODS AND RESULTS: The FATA trial (Facilitated Angioplasty with Tirofiban or Abciximab) was a prospective, multicentre, open-label trial that enrolled 692 patients with ST-segment elevation myocardial infarction (STEMI) undergoing PPCI. Patients were randomized 1:1 to receive abciximab (n = 341) or HDB tirofiban (n = 351). Primary endpoint was the rate of complete (> or =70%) STR 90 min after first balloon inflation. Thirty-day incidence of major bleedings, death, re-infarction and new revascularizations was also evaluated. Baseline characteristics of the two groups were well-balanced, with the exception of previous MI rates (tirofiban 6% vs. abciximab 2.6%, P = 0.03). The procedure was successful in 96.7% of the abciximab and in 96.6% of the tirofiban cohort (P = 0.94). Complete STR was obtained in 67.05% of the tirofiban and 70.45% of the abciximab group (Delta -3.4%, 95% confidence interval -10.35 to +3.56), which falls beyond the predefined Delta +/- 10% equivalence boundaries. Rates of secondary endpoints were similar between the two groups. CONCLUSION: This study failed to show the equivalence of HBD of tirofiban and abciximab as adjunctive therapy to PPCI.

Comparison of effectiveness and safety of sirolimus-eluting stents versus bare-metal stents in patients with diabetes mellitus (from the Italian Multicenter Randomized DESSERT Study).

Few studies directly compared drug-eluting stents and bare-metal stents (BMSs) in diabetic patients. DESSERT was an Italian multicenter randomized trial to show the efficacy of sirolimus-eluting stents (SESs) compared with BMSs in de novo lesions of diabetic patients treated with insulin and/or oral antidiabetics for > or =3 months on top of glycoprotein IIb/IIIa inhibitors. The primary end point was in-stent late lumen loss, assessed using centralized quantitative coronary angiography at 8-month follow-up. Centrally adjudicated composite major adverse cardiac events (MACEs) and target-vessel failure (TVF; death, treated vessel-related acute myocardial infarction, and target-vessel revascularization) at 30 days and 9 and 12 months were secondary end points. Seventy-five patients were randomly assigned to an SES (109 lesions), and 75 (109 lesions), to a BMS. The 2 groups were well balanced for clinical, anatomic, and procedural characteristics. In-stent late lumen loss decreased from 0.96 +/- 0.61 mm for BMSs to 0.14 +/- 0.33 for SESs (p <0.001), and in-segment binary restenosis was 38.8% versus 3.6%, respectively (p <0.001). Twelve-month clinical events were significantly lower in the sirolimus group: MACEs 22.1% versus 40% (p = 0.023), target-lesion revascularization 5.9% versus 30% (p <0.001), and TVF 14.7% versus 34.3% (p = 0.008). At multivariate analysis, stent type was confirmed as an independent predictor of in-segment late loss (p <0.001), binary restenosis (p <0.001), 12-month TVF (p = 0.010), and 12-month MACEs (p = 0.037). In conclusion, the randomized DESSERT showed SESs to be safe and effective in decreasing both angiographic parameters of restenosis and incidence of MACEs compared with BMSs in diabetic patients with de novo 1- or 2-vessel coronary stenoses.

Two-year clinical outcomes with drug-eluting stents for diabetic patients with de novo coronary lesions: results from a real-world multicenter registry.

BACKGROUND: The long-term effectiveness of drug-eluting stents (DES) in unselected diabetics in routine practice is currently unclear. METHODS AND RESULTS: To evaluate the long-term effectiveness of bare metal stents and DES in a real-world setting of diabetic patients, we analyzed 2-year follow-up data from all diabetic patients with de novo lesions enrolled in a prospective Web-based multicenter registry (Registro Regionale Angioplastiche dell'Emilia-Romagna; study period, 2002 to 2004) comprising all 13 hospitals performing percutaneous coronary interventions in the Emilia-Romagna region of Italy. Among the 1648 eligible patients treated with either bare metal stents alone (n=1089) or DES alone (n=559), 27% were insulin dependent and 83% had multivessel coronary disease. At 2 years, use of DES was associated with lower crude incidence of major adverse cardiac advents (all-cause mortality, nonfatal myocardial infarction, and target vessel revascularization) compared with bare metal stents (22.5% versus 28.1%; P=0.01). After propensity score adjustment, only target vessel revascularization appeared significantly lower in the DES group (11.6% versus 15.0%; hazard ratio, 0.66; 95% confidence interval, 0.46 to 0.96; P=0.041). Two-year angiographic stent thrombosis occurred in 1.5% DES patients and 0.7% of the bare-metal-stents patients (P=0.18). At Cox regression analysis, predictors of 2-year major adverse cardiac advents were left ventricular ejection fraction <35%, Charlson comorbidity index, insulin-dependent diabetes, and total lesion length. CONCLUSIONS: In this large, real-world, diabetic population, the use of DES was associated with a moderate reduction in the 2-year risk of target vessel revascularization, a benefit that was limited to non-insulin-dependent diabetic patients. Larger long-term studies are needed to clarify the long-term effectiveness and safety of such devices in diabetic patients.

Comparison of two antiplatelet regimens (aspirin alone versus aspirin + ticlopidine or clopidogrel) after intracoronary implantation of a carbofilm-coated stent.

Stent thrombosis (ST) is an infrequent (0.5% to 1.5%) complication of intracoronary stenting, with severe clinical consequences. This multicenter, randomized study evaluated the clinical outcome in 479 patients (598 lesions treated) who underwent elective coronary stenting with a Carbofilm-coated stent (CarboStent) who met prespecified eligibility criteria and were randomly assigned to receive aspirin alone (n = 235) or aspirin plus a thienopyridine antiplatelet regimen (n = 244). Clinical, angiographic, and procedural characteristics were similar between groups. The primary end point was the incidence of 30-day ST; secondary end points included major vascular or bleeding complications within 30 days and death, acute myocardial infarction, and target vessel revascularization at 6 months. ST occurred in 4 patients (1.4%) in the aspirin-only group and in 1 patient (0.3%) in the aspirin-plus-thienopyridine group (relative risk 0.23, 95% confidence interval 0.03 to 2.08, p = NS). After careful review of cases, 89 patients (19%) with protocol deviations were identified. When they were excluded from the analysis, no ST was observed in either group. Secondary end points were reached by 4% of the aspirin-alone group and 8% of the aspirin-plus-thienopyridine group (relative risk 2.35, 95% confidence interval 0.94 to 5.85, p = NS). In conclusion, after optimal intracoronary implantation of the CarboStent, antiplatelet therapy with aspirin alone was safe and provided efficacy comparable to aspirin plus a thienopyridine in the prevention of ST.

Periprocedural and medium-term antithrombotic strategies in patients with an indication for long-term anticoagulation undergoing coronary angiography and intervention.

OBJECTIVES: The optimal antithrombotic treatment for patients on long-term anticoagulation undergoing invasive coronary procedures is currently undefined. The strategies adopted periprocedurally and medium-term after coronary stenting (percutaneous coronary intervention with stent implantation) at our Institution, were reviewed, and the safety and efficacy of the various regimens evaluated. METHODS: All patients undergoing invasive coronary procedures between January 2002 and December 2004 were retrospectively identified. RESULTS: Out of 3709 patients overall, 104 (2.8%; 95% confidence interval 2.3-3.4) were on warfarin (because of atrial fibrillation in >50% of cases), whereas this was the case for 49 (3.1%; 95% confidence interval 2.3-4.1) of 1584 undergoing percutaneous coronary intervention with stent implantation. The antithrombotic strategies were highly variable, both periprocedurally (i.e. warfarin withdrawal or substitution by heparin, followed by aspirin with or without a thienopyridine) and medium-term after percutaneous coronary intervention with stent implantation (i.e. combination of warfarin and single or dual antiplatelet agents or pure dual antiplatelet treatment). Overall, periprocedural hemorrhages occurred in five patients (4.8%; 95% confidence interval 1.56-11.22). No thromboembolic events were observed, whereas one subacute stent thrombosis occurred (2%; 95% confidence interval 0.05-11) during warfarin and aspirin treatment. Among patients undergoing percutaneous coronary intervention with stent implantation, 1-month hemorrhagic rate was 10% (95% confidence interval, 3.3-23.8); most hemorrhages (major bleeds in three-quarters of cases) occurred during triple therapy with warfarin (or low-molecular-weight heparin), aspirin and a thienopyridine. CONCLUSIONS: At our Institution (where standardized protocols are currently not in use), periprocedural and medium-term antithrombotic treatment in patients on long-term anticoagulation undergoing percutaneous coronary intervention with stent implantation showed substantial variability. As a result of the relevant 1-month complication rate, further properly sized and designed studies are warranted to identify the optimal strategies for this patient subset, which is foreseen to progressively increase over the next years.

Percutaneous treatment of multivessel coronary disease in the drug eluting stent era: comparison of bare-metal stents, drug-eluting stents and a mixed approach in a large multicentre registry.

BACKGROUND: Restenosis and a high incidence of new revascularisations reduce the long-term efficacy of percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease. AIMS: To determine the modality of utilisation and the clinical efficacy of drug eluting stents (DES) in a real world multivessel PCI scenario. METHODS: From July 2002 to December 2004, 1726 consecutive patients enrolled in the REAL Registry (Registro REgionale AngiopLastiche Emilia-Romagna) underwent elective multivessel PCI with multiple stents in at least two different vessels; among them, 939 (54%) received only bare-metal stents (BMS group), 288 (17%) only DES (DES group) and 499 (29%) were treated with BMS and DES in different vessels (MIX group). The incidence of major adverse cardiac events (MACE= death, myocardial infarction and target vessel revascularisation) during follow-up was assessed. RESULTS: Patients in the BMS group were older, diabetes was more frequent in the DES and MIX groups, while more lesions and more often a three vessel treatment was performed in the MIX group. In the DES group, lesions were longer, in smaller vessels and more often in the left main compared with BMS and MIX groups. In the MIX group too, lesions treated with DES were at higher risk for restenosis than those treated with BMS. Procedural success was similar in the three groups (98.9%). Notwithstanding the different risk profile, 12-month follow up did not show differences in clinical end points among the three groups. Multivariate analysis indicated that age, a modified Charlson's comorbidity index and diabetes were independent predictors of death or AMI; total lesion length, use of only DES or MIX approach and treatment of left main were predictors of TVR, while left main treatment along with only DES use, modified Charlson's index and reference vessel diameter independently affected the incidence of MACE. Use of at least one DES reduced the risk of TVR by 37% and MACE by 29%, while DES in every lesion treated reduced TVR risk by 37% and MACE by 39%. CONCLUSIONS: In this large multicentre registry, DES were utilised in only half of the multivessel PCI procedures, mainly to treat high-risk patients and lesions. However, this selective use of DES was independently associated with a lower incidence of 1-year TVR and MACE. Whether increasing the rate of DES utilisation would further improve the clinical outcome remains to be investigated.

Clinical outcomes for sirolimus-eluting stents and polymer-coated paclitaxel-eluting stents in daily practice: results from a large multicenter registry.

OBJECTIVES: We compared the clinical outcome of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in a real-world scenario. BACKGROUND: In selected patients, SES has been associated with lower late luminal loss than PES. Whether this emerging biological difference could translate into different clinical efficacy in daily practice is presently unknown. METHODS: This analysis included 1,676 consecutive patients with de novo coronary lesions treated solely with drug-eluting stents (SES = 992; PES = 684). All patients were enrolled in a dynamic prospective registry comprising 13 hospitals. We assessed the cumulative incidence of major adverse cardiac events (MACE), defined as death, myocardial infarction (MI), and target vessel revascularization (TVR) during follow-up. RESULTS: Overall, 29% of the patients had diabetes, 23% had prior MI, and 9% had poor left ventricular function. ST-segment elevation MI was diagnosed at admission in 12%. Multivessel intervention was performed in 16%. At 1-year follow-up, SES was associated with a reduced incidence of MACE (9.2% SES vs. 14.1% PES; p = 0.007) and TVR (5.0% SES vs. 10.0% PES; p = 0.0008) compared to PES. A propensity analysis with many clinical and angiographic variables was carried out to adjust for baseline differences. In this analysis, SES was associated with a 44% risk reduction of MACE (hazard ratio 0.56, 95% confidence interval 0.39 to 0.78) and a 55% reduction of TVR (hazard ratio 0.45, 95% confidence interval 0.29 to 0.70). This result was consistent across most subgroups tested. Similar rates of death and MI were observed in the 2 treatment groups. CONCLUSIONS: In this large real-world population, SES improved 1-year clinical results as compared to PES.