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Objectives The aim of this study was to compare long-term clinical outcomes in patients treated with new-generation drug-eluting stent (DES) or early-generation DES in a real-world registry. Background New-generation DESs have proved to be more effective and safer than early-generation DES in randomized trials. However, the effects of new-generation DES versus early-generation DES in everyday clinical practice deserve further verification. Methods A propensity-score and inverse-probability weighted analysis of 5,332 patients undergoing DES implantation (2,557 new-generation and 2,775 early-generation) between January 1, 2007 and June 30, 2011 was performed, with a median follow-up of 3 years. We assessed the incidence of major adverse cardiovascular events (MACE: all-cause death, nonfatal myocardial infarction [MI], and target vessel revascularization [TVR]), and angiographic stent thrombosis (ST) during follow-up. Results At 3-years, new-generation DES in comparison with early-generation DES were associated with a reduced risk of MI (5% versus 7.4%, hazard ratio [HR] = 0.65, 95% confidence interval [CI] = 0.51–0.82, P = 0.0004) and angiographic ST (0.5% vs. 1.1%, HR = 0.35, 95% CI 0.17–0.72, P = 0.004), whereas, the risk of TVR (10.9% vs. 13.5%; HR 0.99, 95% CI 0.84–1.16, P = 0.99) and overall MACE was not significantly different (19.2% vs. 22.4%, HR = 0.94, 95% CI = 0.83–1.07, P = 0.35). Conclusions Our data from a large all-comers multicenter registry confirm that, in comparison with early-generation DES, the use of new-generation DES is associated with similar efficacy and increased long-term safety, because of a reduced risk of ST and MI. © 2014 Wiley Periodicals, Inc.

Background The aim of this study was to compare 7-year rates of all-cause death, cardiac death, myocardial infarction, target vessel revascularization, and stroke in a large cohort of octogenarians with left main coronary artery or multivessel disease, treated with coronary artery bypass grafting or percutaneous coronary intervention. Methods Two propensity score-matched cohorts of patients undergoing revascularization procedures at regional public and private centers of Emilia-Romagna, Italy, from July 2002 to December 2008 were used to compare long-term outcomes of percutaneous coronary intervention (947 patients) and coronary artery bypass grafting (441 patients). Results There were no significant differences between groups in 30-day mortality. In the follow-up the overall and the matched percutaneous coronary intervention population experienced significantly worse outcomes in terms of cardiac mortality, myocardial infarction, and target vessel revascularization. No difference was found for stroke between treatment groups. Percutaneous coronary intervention was an independent predictor of increased death at long-term follow-up. The subgroups in which coronary artery bypass grafting reduced more clearly the risk of death were age 80 to 85 years, previous myocardial infarction, history of cardiac heart failure, chronic renal failure, peripheral vascular disease, and patients with three-vessel disease associated with the left main coronary artery. Conclusions In this real-world setting, surgical coronary revascularization remains the standard of care for patients with left main or multivessel disease. The long-term outcomes of current percutaneous coronary intervention technology in octogenarians are yet to be determined with adequately powered prospective randomized studies. © 2015 The Society of Thoracic Surgeons.

larization), compared with 29% (23% revascularization) in the IC group. The primary outcome occurred in 43 patients (27.9%) in the EA group and 55 (34.6%) in the IC group (hazard ratio [HR]: 0.80; 95% confidence interval [CI]: 0.53 to 1.19; p 0.26). The rates of mortality (HR: 0.87; 95% CI: 0.49 to 1.56), myocardial infarction (HR: 0.67; 95% CI: 0.33 to 1.36), and repeat hospital stay (HR: 0.81; 95% CI: 0.45 to 1.46) did not differ between groups. The primary endpoint was significantly reduced in patients with elevated troponin on admission (HR: 0.43; 95% CI: 0.23 to 0.80), but not in those with normal troponin (HR: 1.67; 95% CI: 0.75 to 3.70; p for interaction 0.03). Conclusions The present study does not allow a definite conclusion about the benefit of an EA approach when applied systematically among elderly patients with NSTEACS. The finding of a significant interaction for the treatment effect according to troponin status at baseline should be confirmed in a larger size trial. (Italian Elderly ACS Study; NCT00510185) (J Am Coll Cardiol Intv 2012;5: 906 –16) © 2012 by the American College of Cardiology Foundation

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.

Background The long-term effectiveness of drug eluting stents (DESs) in a real-world setting of female patients is currently unclear. Methods and results We analyzed long-term follow-up (up to 3 years) data from all female patients with de novo lesions enrolled in a prospective web-based multicenter registry (REAL Registry; study period, July 2002–June 2006) including all 15 hospitals performing PCI in the Emilia-Romagna region of Italy. Among the 3549 women without ST elevation myocardial infarction, 2434 were treated with BMSs alone and 1115 with DESs alone. At 3 years, use of DESs was associated with a lower propensity score adjusted incidence of MACE [cardiac mortality, non-fatal myocardial infarction and target vessel revascularization (TVR); 19.5% vs. 24.4%; HR 0.75, p =0.006)] and TVR (11.6% vs. 15.6%; HR 0.68, p =0.004) compared with BMSs. No difference was apparent in terms of adjusted 3-year cardiac mortality or myocardial infarction. Nevertheless, after the first 6months of follow-up, a non significantly increased risk of myocardial infarction and stent thrombosis was found in the DES group. Conclusions In this real-world female registry, the use of DESs was associated with a 3-year reduction of TVR and MACE in comparison with the use of BMSs. However, the observed (non-significant) increment of late AMI makes performing larger studies to clarify the long-term safety of DESs mandatory.

Objectives This study aims to evaluate whether results of “off-hours” and “regular-hours” primary angioplasty (primary percutaneous coronary intervention [pPCI]) are comparable in an unselected population of patients with ST-segment elevation acute myocardial infarction treated within a regional network organization. Background Conflicting results exist on the outcome of off-hours pPCI. Methods We analyzed in-hospital and 1-year cardiac mortality among 3,072 consecutive ST-segment elevation myocardial infarction (STEMI) patients treated with pPCI between January 1, 2004, and June 30, 2006, during regular-hours (weekdays 8:00 am to 8:00 pm ) and off-hours (weekdays 8:01 pm to 7:59 am , weekends, and holidays) within the STEMI Network of the Italian Region Emilia-Romagna (28 hospitals: 19 spoke and 9 hub interventional centers). Results Fifty-three percent of patients were treated off-hours. Baseline findings were comparable, although regular-hours patients were older and had more incidences of multivessel disease. Median pain-to-balloon (195 min, interquartile range [IQR]: 140 to 285 vs. 186 min, IQR: 130 to 280 min; p = 0.03) and door-to-balloon time (88 min, IQR: 60 to 122 vs. 77 min, IQR: 48 to 116 min; p Conclusions When pPCI is performed within an efficient STEMI network focused on reperfusion, the clinical effectiveness of either off-hours or regular-hours pPCI is comparable.

OBJECTIVE To compare the long-term efficacy of cobalt-chromium bare-metal stents (CCSs) with that of first-generation drug-eluting stents (DESs) in patients within a large real-world multicentre registry. METHODS The incidence of major adverse cardiac events [death, acute myocardial infarction, and target-vessel revascularization (TVR)] and angiographic stent thrombosis were assessed in consecutive patients undergoing percutaneous coronary intervention with CCS (n = 1103) or DES (n = 5195) during 2-year follow-up. Propensity score-adjusted outcomes, overall and in patients with low (≤ 10%), intermediate (10-15%), and high (>15%) 1-year restenosis risk, were estimated. RESULTS DES-treated patients had significantly higher rates of diabetes, longer lesions, and smaller vessel diameters than CCS-treated patients (all P < 0.0001). However, CCS patients were older and presented a higher rate of hypertension, previous myocardial infarction, and heart failure (all P < 0.01). At 2 years, adjusted rates of myocardial infarction, death, and cumulative-stent thrombosis were similar for DES and CCS. DES provided statistically significant (P < 0.01) reductions in TVR and adjusted major adverse cardiac event rates (9.7 and 17.2%, respectively) compared with CCS (13.2 and 21.2%, respectively). In patients at highest and intermediate risk of restenosis, adjusted TVR rates were significantly (P < 0.01) lower with DES (12.2 and 8.9%, respectively) than CCS (19.9 and 17.1%, respectively), but rates were similar in low-risk patients. CONCLUSION DESs were more effective than CCSs in lowering TVR rates in patients with an intermediate-high baseline restenosis risk.

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 p 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.

Background— This article reports the 2-year clinical, angiographic, and intravascular ultrasound outcomes of the everolimus-eluting stent (EES) compared with the paclitaxel-eluting stent (PES) in the randomized SPIRIT II trial. Methods and Results— This was a prospective, single-blind clinical trial in which a total of 300 patients with de novo native coronary artery lesions were randomized to either EES or PES in a 3:1 fashion. Clinical follow-up was planned at 2 years in all patients. A subset of 152 patients underwent serial angiographic and intravascular ultrasound analyses at 6 months and 2 years. After 2 years, target lesion failure (cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization) rates were 6.6% and 11% in EES and PES, respectively ( P =0.31). At 6 months, a significant reduction in angiographic in-stent late loss and percentage volume obstruction measured by intravascular ultrasound was observed in the EES group. However, at 2-year follow-up, a late increased intimal hyperplasia growth after implantation of an EES was observed. There were no significant differences between EES and PES for in-stent late loss (EES, 0.33�0.37 mm versus PES, 0.34�0.34 mm; P =0.84) and percentage volume obstruction (EES, 5.18�6.22% versus PES, 5.80�6.31%; P =0.65) at 2 years. The incidence of stent thrombosis was low and comparable in both groups (EES, 0.9%; PES, 1.4%). Conclusions— Although the previously reported angiographic and clinical superiority of the EES has vanished over time, this report confirms and extends the previously demonstrated noninferiority in terms of in-stent late loss of the EES when compared with the PES up to 2-year follow-up. There were no significant differences between EES and PES in clinical, angiographic and intravascular ultrasound outcomes at 2 years.

To evaluate the impact of symptom-onset-to-balloon delay on ST-segment resolution (STR) in patients with acute myocardial infarction transferred from community hospitals for angioplasty after pharmacological treatment. The study design was prospective, single centre registry.Between October 2000 and December 2003, 330 consecutive patients agedor =75 years with high-risk myocardial infarction were considered; 193 patients underwent primary percutaneous coronary intervention (PCI) (group P), whereas 137 patients were given pharmacological therapy and were immediately transferred to the hospital with PCI facilities (group F).Compared with group P, group F showed a longer time to treatment (253 +/- 136 vs. 195 +/- 141 min; P0.0001) and a higher percentage of Thrombolysis In Myocardial Infarction flow grade 2-3 at pre-PCI angiography (107 [78.1%] vs. 48 [24.8%]; P0.0001). The rate of STRor =70% was similar in groups P and F (121 [62.7%] vs. 94 [68.6%]; P = 0.41). Even after accounting for baseline variables, STR70% was not significantly related to the transfer strategy (adjusted hazard ratio 0.94, 95% confidence interval 0.94-1.77; P = 0.8). Patients with incomplete STR showed a higher six-month mortality compared with patients with complete STR (10 [8.85%] vs. 6 [2.76%]; P = 0.027).The STR index predicts survival in patients with ST-elevation myocardial infarction treated with angioplasty either directly or after pharmacological treatment and hospital transfer. Pharmacological facilitation seems to be able to counterbalance the negative consequences of the transfer-related time delay on myocardial reperfusion as evaluated by the STR index.

Background— The long-term safety and efficacy of drug-eluting stents (DES) have been questioned recently. Methods and Results— Between July 2002 and June 2005, 10 629 patients undergoing elective percutaneous coronary intervention with either DES (n=3064) or bare-metal stents (BMS, n=7565) were enrolled in a prospective registry comprising 13 hospitals. We assessed the cumulative incidence of major adverse cardiac events (death, acute myocardial infarction, and target-vessel revascularization) and angiographic stent thrombosis during 2-year follow-up. A propensity score analysis to adjust for different baseline clinical, angiographic, and procedural characteristics was performed. The 2-year unadjusted cumulative incidence of major adverse cardiac events was 17.8% in the DES group and 21.0% in the BMS group ( P =0.003 by log-rank test). Angiographic stent thrombosis was 1.0% in the DES group and 0.6% in the BMS group ( P =0.09). After adjustment, the 2-year cumulative incidence of death was 6.8% in the DES group and 7.4% in the BMS group ( P =0.35), whereas the rates were 5.3% in DES and 5.8% in BMS for acute myocardial infarction ( P =0.46), 9.1% in DES and 12.9% in BMS for target-vessel revascularization ( P P Conclusions— In this large real-world population, the beneficial effect of DES in reducing the need for new revascularization compared with BMS extends to 2 years without evidence of a worse safety profile.

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.

Background: The study compares five-year clinical outcomes of CABG vs PCI in a real world population of diabetic patients with multivessel coronary disease since it is not clear whether to prefer surgical or percutaneous revascularization. Methods: Between July 2002 and December 2008, 2885 multivessel coronary diabetic patients underwent revascularization (1466 CABG and 1419 PCI) at hospitals in Emilia-Romagna Region, Italy and were followed for 1827±617 days by record linkage of two clinical registries with the regional administrative database of hospital admissions and the mortality registry. Five-year incidences of MACCE (mortality, acute myocardial infarction [AMI], stroke, and repeat revascularization [TVR]) were assessed with Kaplan-Meier estimates, Cox proportional hazards regression and cumulative incidence functions of death and TVR, to evaluate the competing risk of AMI on death and TVR. The same analyses were applied to the propensity score matched subgroup of patients undergoing CABG or PCI with DES and with complete revascularization. Results: PCI had higher mortality for all causes (HR: 1.8, 95% CI 1.4-2.2 p

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.

We evaluated the clinical effect of selective use of sirolimus-eluting stents (SESs) in real-world, high-risk patients. A total of 4,237 consecutive patients who underwent percutaneous coronary intervention (SES, n = 872, bare metal stents [BMSs], n = 3,365) was enrolled in a prospective regional survey. A prespecified high-risk subset of patients was selected on the basis of clinical and angiographic characteristics. A propensity score analysis was performed to compare patients who received SESs with those who received BMSs. Patients in the SES group more often had diabetes and more frequently had previous myocardial infarction or coronary revascularization, type C lesions, and multivessel procedures. Patients who presented with acute myocardial infarction were treated more often with BMSs. At 9 months, the use of SESs was associated with fewer major adverse cardiac events (death, myocardial infarction, or target lesion revascularization; hazard ratio 0.56, 95% confidence interval 0.37 to 0.85) and target lesion revascularizations (hazard ratio 0.43, 95% confidence interval 0.20 to 0.91). This decrease was more evident in a prespecified high-risk subgroup of patients (major adverse cardiac events, 8.0% SES vs 15.6% BMS, hazard ratio 0.45, 95% confidence interval 0.29 to 0.72). We conclude that selective SES use in real-world patients who have high-risk clinical and angiographic characteristics is associated with significant decreases in major adverse cardiac events and repeat revascularizations compared with BMS use.

Objectives: Early angioplasty after thrombolysis is now recommended for ST-elevation myocardial infarction, but the current guidelines propose a wide time-window ranging between 3 and 24 h after lytic administration. To identify the optimal timing for PCI after thrombolysis, we analyzed frequency and time course of the adverse events in patients randomized in the multicenter CARESS-in-AMI trial. Methods: 598 high-risk patients with STEMI recruited in the CARESS-in-AMI study, were divided into the Immediate PCI group (IMM, n=298), Rescue PCI group (RES, n=107) and Standard Treatment Arm without rescue PCI (STA, n=193). Results: RES patients had worse pre-procedural TIMI flow and post-procedural blush grade. At 30 days, there were 23 deaths: 11 (10.3%) in RES, 9 (3%) in IMM and 3 (1.6%) in STA (pb0.001). There were 22 episodes of refractory ischemia or re-infarction: 17 (8.8%) in the STA group, 4 (1.6%) in IMM and 1 (0.9%) in RES (pb0.001). In the RES group 10/11 (90.9%) deaths occurred before day 5. In the STA group, all deaths and the majority of ischemic events occurred after day 3. A reduction of risk of de Conclusions: The mortality benefit of immediate referral to PCI after pharmacological treatment for STEMI derives from a reduction in the time to reperfusion of patients with failed thrombolysis in need of rescue PCI. In patients with evidence of successful reperfusion, "elective" PCI within 3 days may be sufficient to reduce the recurrent ischemic events. (C) 2010 Elsevier Ireland Ltd. All rights reserved.

Background Most patients with acute myocardial infarction (AMI) are admitted to hospitals without percutaneous transluminal coronary angioplasty (PTCA) facilities or are initially managed in a prehospital mobile unit. Thrombolysis remains the most readily available reperfusion treatment in those settings, but the optimal subsequent strategy in those patients is unclear. If a mechanical recanalization is likely to be performed in an emergency, it is probably desirable that the patient receives abciximab, the glycoprotein IIb/IIIa antagonist with the strongest evidence of benefit for angioplasty in AMI. Objective The aim of this trial is to compare the effects on clinical outcome and cost-effectiveness of 2 strategies after immediate treatment with abciximab and half-dose reteplase for ST-elevation AMI: to manage the patients conservatively (referring them for rescue PTCA only if needed) or to immediately send all patients for emergency coronary angioplasty. Methods The Combined Abciximab RE-teplase Stent Study in Acute Myocardial Infarction (CARESS in AMI) is an open, prospective, randomized, multicenter clinical trial conducted in patients with high-risk ST-segment elevation AMI treated within 12 hours from symptom onset in hospitals without PTCA facilities or in a prehospital mobile intensive care unit. Apart from contraindications to thrombolysis, the main exclusion criteria are age ≥75 years and a past history of CABG surgery or a percutaneous coronary intervention procedure involving the infarct-related artery. Enrollment will be performed in hospitals without PTCA facilities or directly in the ambulance if a dedicated system is in place for prehospital diagnosis and treatment of AMI. Patients will receive half-dose reteplase and full-dose abciximab and will subsequently be randomized to conventional medical therapy (with referral for emergency rescue PTCA allowed in selected cases) or emergency angioplasty. The primary end point is the 30-day combined incidence of mortality, reinfarction, and refractory ischemia. In order to obtain a 95% power (2-sided) to detect a 42% reduction in the primary end point, 900 patients are required in each arm of the study. Secondary end points include the 1-year composite end point of mortality, reinfarction, refractory ischemia, and hospital readmission because of heart failure; resource use at 30 days and 1 year; and the incidence of inhospital stroke and bleeding complications in the 2 groups. Results Seventy-four patients have been randomized (as of March 10, 2004); results are expected in June 2005. Conclusion This study will establish whether angioplasty must be started as soon as possible in all patients who receive combined pharmacologic reperfusion with the glycoprotein IIb/IIIa inhibitor abciximab and half-dose thrombolysis or whether it can be postponed or skipped in patients with signs of successful reperfusion, with obvious organizational advantages.

Prospective randomized, multicentre study.Recanalisation of the culprit lesion is the main goal of primary angioplasty for acute myocardial infarction. With the exception of cardiogenic shock, staged procedures are performed in the presence of multivessel disease. The study hypothesis is that with modern non-thrombogenic stents (heparin coated) complete revascularization with multivessel treatment can be safely achieved during the primary angioplasty procedure with a lower need of subsequent revascularization procedures and at a lower cost.PRIMARY: 12-month incidence of repeat revascularization (any revascularization, infarct related artery as well as non-infarct-related artery). SECONDARY: (1) in hospital repeat revascularization, reinfarction and death; (2) total hospital cost (including a 12 months follow-up period).69 patients with ST elevation Acute Myocardial Infarction (AMI),12 hours after symptoms onset, undergoing primary angioplasty, with documented multivessel disease and both culprit lesion and 1 to 3 other lesions suitable for stent implantation. Unbalanced randomization between culprit lesion treatment only (n = 17) and complete multivessel treatment (n = 52, with 71 additional lesions treated).The two groups were well balanced in terms of clinical characteristics, number of diseased vessels and angiographic characteristics of the culprit lesion. In the complete multivessel treatment group 2.36 +/- 0.64 lesions per patient were treated using 2.73 +/- 0.78 heparin coated stents (1.00 lesions and 1.29 +/- 0.61 stents in the culprit treatment group, both p0.001). The duration of the procedure increased from 53 +/- 21 min (culprit treatment group) to 69 +/- 32 min (p = 0.032) and the amount of contrast used from 242 +/- 102 ml (culprit treatment group) to 341 +/- 163 ml (multivessel complete treatment), p = 0.025. A similar low incidence of in-hospital major adverse cardiac events was observed in the 2 groups (0 and 3.8% in culprit and multivessel treatment groups, p = 0.164). The increase in the incidence of new revascularisation in the culprit treatment group at 12 month follow-up was not significant (35 vs 17%, p = 0.247) but was sufficient to compensate the initial higher in-hospital cost, with a similar 12 month hospital cost in the 2 groups (Euro 22,330 +/- Euro 13,653 vs Euro 20,382 +/- Euro 11,671, p = 0.231).Multivessel treatment during primary PTCA was safe in this controlled trial. However, when only the culprit lesion was initially treated, the need for subsequent clinically driven revascularization remained low and no clinical or economical advantages were obtainable with a more aggressive initial approach. In clinical practice, a staged approach to multivessel treatment during primary angioplasty avoids to treat unnecessarily non clinically relevant lesions.

Aims We evaluated the effect of different dose hydration protocols, with normal saline or bicarbonate, on the incidence of contrast-induced acute kidney injury (CI-AKI) in patients with ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PPCI). Methods We considered 592 STEMI patients treated with PPCI in 5 Italian centers. Patients were randomized to receive standard or high-dose infusions of normal saline or sodium bicarbonate started immediately before contrast medium administration and continued for the following 12 h. Results The cumulative incidence of CI-AKI was 18.1% without any difference among treatment groups. Shock, age, ejection fraction 35% or less, and basal serum creatinine were significantly associated with an increased risk of CI-AKI. Follow-up at 12 months was complete in 573 patients. Overall, 25 out of 573 patients died (4.3%). We observed higher short-term mortality rates in patients receiving high-volume hydration. Otherwise, only age, shock and CI-AKI were significantly associated with 1-year mortality. Conclusion In patients with STEMI undergoing PPCI, high-volume hydration with normal saline or sodium bicarbonate administrated at the time of contrast media administration was not associated with any significant advantage in terms of CI-AKI prevention.

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 (≥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 (Δ −3.4%, 95% confidence interval −10.35 to +3.56), which falls beyond the predefined Δ ± 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.

Abciximab therapy during primary percutaneous coronary intervention (PCI) has shown to ameliorate left ventricular (LV) function recovery in patients with ST elevated myocardial infarction. High-dose bolus tirofiban has similar effect on platelet inhibition. Whether this is associated with comparable efficacy on LV function recovery remains unclear. We sought to evaluate the impact on LV function of high-dose bolus tirofiban or abciximab in patients undergoing primary PCI with the predictors of favorable (or = 50%) LV ejection fraction (EF) and LV function recovery at 30 days. We studied 314 patients (abciximab n = 154; tirofiban n = 160) undergoing primary PCI in the randomized Facilitated Angioplasty with Tirofiban or Abciximab (FATA) Trial. LVEF was assessed within 48 hours and at 30 days after primary PCI. In patients with systolic dysfunction at baseline, LV function recovery was defined by either increase of LVEFor = 10% compared with baseline or LVEFor = 50%. Similar LVEF was observed in the 2 groups postprocedure (abciximab 49.7 +/- 10.1% vs tirofiban 49.3 +/- 10.1%, p = 0.9) and at 30 days (abciximab 53.1 +/- 9.8% vs tirofiban 52.5 +/- 10.2%, p = 0.6). Independent predictors of 30-day LVEFor = 50% were preprocedure Thrombolysis In Myocardial Infarction flow class0 (odds ratio = 2.4, 95% confidence interval 1.32 to 4.34), anterior location (odds ratio = 0.25, 95% confidence interval 0.15 to 0.42), and age (odds ratio = 0.97, 95% confidence interval 0.95 to 0.99). Preprocedure Thrombolysis In Myocardial Infarction flow grade0 was the only predictor of LV function recovery (odds ratio = 6.73, 95% confidence interval 2.69 to 16.88). In conclusion, this study showed no difference in LV function recovery in patients undergoing primary PCI treated either with abciximab or high-dose bolus tirofiban. Preprocedure Thrombolysis In Myocardial Infarction flow grade0 seems to be the most important predictor of favorable LVEF and LV function recovery at 30 days.

Objectives To examine the differences in cardiac outcomes for patients with ST-elevation myocardial infarction (STEMI) and multivessel disease (MVD) as a function of whether they underwent culprit-only primary percutaneous coronary intervention (PPCI) or multivessel PCI, either during PPCI or as a staged procedure. Background MVD occurs in about 40% of patients presenting with STEMI, and it has been associated with a worse outcome compared to single-vessel disease. The most favorable PCI strategy for dealing with significant nonculprit lesions has to be established. Methods A total of 2061 STEMI patients with MVD undergoing PPCI, prospectively enrolled in the REAL Registry between July 2002 and December 2010, were considered: 706 underwent culprit-only PPCI; 367 multivessel PCI during the index procedure; 988 had a staged PCI within 60 days. Mortality and outcomes were calculated at 30 days and 2 years. Results At multivariate analysis, culprit-only PPCI was associated with higher rates of cardiac outcomes as compared to staged multivessel PCI, taken as reference [Hazard Ratio (HR): 2.81, 95% confidence interval (CI): 1.34–5.89, P = 0.006 for 30-day mortality, and HR: 1.93, 95% CI: 1.35–2.74, P = 0.0002 for 2-year mortality, respectively]. Short-term mortality rates were higher in multivessel PCI group as compared to staged PCI group (HR: 2.58, 95% CI: 1.06–6.26, P = 0.03); no differences were observed at 2-year follow-up (HR: 1.08, 95% CI: 0.64–1.82, P = 0.76). Conclusions Our findings support the current guidelines recommendation to perform culprit-only PPCI in STEMI patients with MVD without hemodynamic compromise, followed by a staged PCI of noninfarct-related significant lesions. © 2014 Wiley Periodicals, Inc.

OBJECTIVES: Most studies comparing coronary artery bypass grafting (CABG) and percutaneous coronary interventions (PCI) showed that fewer patients who had undergone CABG required repeat revascularizations , but no difference in survival, with the exception of some subgroups of patients. However, long-term real-world evidence on patients in whom both procedures are technically feasible is yet not available. The aim of this study was to compare 5-year rates of death, myocardial infarction (MI), target vessel revascularization (TVR) and stroke in a large cohort of patients with left main coronary artery (LMCA) or multivessel disease, treated with CABG or PCI (with or without DES) or PCI with DES only. METHODS: Two propensity score (PS)-matched cohorts of patients undergoing revascularization procedures at the regional public and private centres of Emilia-Romagna over the period July 2002–December 2008 were used to compare long-term outcomes of PCI (6246 patients) and CABG (5504 patients). RESULTS: PCI was associated with higher risk of death (HR = 1.6; 95% CI 1.4–1.8, P< 0.0001), MI (HR = 3.3; 95% CI 2.7–4.0, P< 0.0001) and TVR (HR = 4.5; 95% CI 3.8–5.2, P< 0.0001) at 5 years. No significant difference was shown for stroke (HR = 1.1; 95% CI 0.9–1.4, P= 0.43). CABG benefit was more evident in the risk of death in patients with two-vessel disease plus LMCA and in those with threevessel disease, LVEF

AIMS To evaluate whether gender differences in terms of up to 4-year outcome still persist within patients with acute myocardial infarction (AMI) who uniformly underwent coronary revascularization, we performed a gender comparison in a large contemporary multicentre percutaneous intervention (PCI) registry. MATERIALS AND METHODS We retrospectively analyzed data from 18,351 patients with AMI, who underwent percutaneous coronary interventions (5093 women and 13,258 men) in the Emilia Romagna region of Italy between July 2002 and December 2007. Median follow-up was 1174 days. RESULTS After propensity score adjustment, differences in gender-related mortality were not temporarily homogeneous: 30-day adjusted mortality was higher in women than in men [hazard ratio (HR): 1.40, P < 0.0001], whereas thereafter female gender showed a significantly lower mortality risk (HR: 0.84, P = 0.01). Notably, younger women (

This study sought to determine the risk versus benefit ratio of an early aggressive (EA) approach in elderly patients with non-ST-segment elevation acute coronary syndromes (NSTEACS).Elderly patients have been scarcely represented in trials comparing treatment strategies in NSTEACS.A total of 313 patients ≥ 75 years of age (mean 82 years) with NSTEACS within 48 h from qualifying symptoms were randomly allocated to an EA strategy (coronary angiography and, when indicated, revascularization within 72 h) or an initially conservative (IC) strategy (angiography and revascularization only for recurrent ischemia). The primary endpoint was the composite of death, myocardial infarction, disabling stroke, and repeat hospital stay for cardiovascular causes or severe bleeding within 1 year.During admission, 88% of the patients in the EA group underwent angiography (55% revascularization), compared with 29% (23% revascularization) in the IC group. The primary outcome occurred in 43 patients (27.9%) in the EA group and 55 (34.6%) in the IC group (hazard ratio [HR]: 0.80; 95% confidence interval [CI]: 0.53 to 1.19; p = 0.26). The rates of mortality (HR: 0.87; 95% CI: 0.49 to 1.56), myocardial infarction (HR: 0.67; 95% CI: 0.33 to 1.36), and repeat hospital stay (HR: 0.81; 95% CI: 0.45 to 1.46) did not differ between groups. The primary endpoint was significantly reduced in patients with elevated troponin on admission (HR: 0.43; 95% CI: 0.23 to 0.80), but not in those with normal troponin (HR: 1.67; 95% CI: 0.75 to 3.70; p for interaction = 0.03).The present study does not allow a definite conclusion about the benefit of an EA approach when applied systematically among elderly patients with NSTEACS. The finding of a significant interaction for the treatment effect according to troponin status at baseline should be confirmed in a larger size trial. (Italian Elderly ACS Study; NCT00510185).

Item does not contain fulltext BACKGROUND: The effect of intensified platelet inhibition for patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization has not been delineated. METHODS: In this double-blind, randomized trial, in a primary analysis involving 7243 patients under the age of 75 years receiving aspirin, we evaluated up to 30 months of treatment with prasugrel (10 mg daily) versus clopidogrel (75 mg daily). In a secondary analysis involving 2083 patients 75 years of age or older, we evaluated 5 mg of prasugrel versus 75 mg of clopidogrel. RESULTS: At a median follow-up of 17 months, the primary end point of death from cardiovascular causes, myocardial infarction, or stroke among patients under the age of 75 years occurred in 13.9% of the prasugrel group and 16.0% of the clopidogrel group (hazard ratio in the prasugrel group, 0.91; 95% confidence interval [CI], 0.79 to 1.05; P=0.21). Similar results were observed in the overall population. The prespecified analysis of multiple recurrent ischemic events (all components of the primary end point) suggested a lower risk for prasugrel among patients under the age of 75 years (hazard ratio, 0.85; 95% CI, 0.72 to 1.00; P=0.04). Rates of severe and intracranial bleeding were similar in the two groups in all age groups. There was no significant between-group difference in the frequency of nonhemorrhagic serious adverse events, except for a higher frequency of heart failure in the clopidogrel group. CONCLUSIONS: Among patients with unstable angina or myocardial infarction without ST-segment elevation, prasugrel did not significantly reduce the frequency of the primary end point, as compared with clopidogrel, and similar risks of bleeding were observed. (Funded by Eli Lilly and Daiichi Sankyo; TRILOGY ACS ClinicalTrials.gov number, NCT00699998.).