Elisabetta Varani

Long-term safety and efficacy of drug-eluting stents: two-year results of the REAL (REgistro AngiopLastiche dell'Emilia Romagna) multicenter registry.

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<0.00001), and 16.9% in DES and 21.8% in BMS for major adverse cardiac events (P<0.0001). Independent predictors of target-vessel revascularization in the DES group were diabetes mellitus (hazard ratio 1.36, 95% confidence interval 1.06 to 1.76), renal failure (hazard ratio 1.69, 95% confidence interval 1.06 to 2.69), and reference vessel diameter (hazard ratio 0.64, 95% confidence interval 0.45 to 0.93). 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.

Single or Multivessel Percutaneous Coronary Intervention in ST-Elevation Myocardial Infarction Patients

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

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.

Clinical impact of an inter-hospital transfer strategy in patients with ST-elevation myocardial infarction undergoing primary angioplasty: the Emilia-Romagna ST-segment elevation acute myocardial infarction network

AIMS This study sought to evaluate the impact of an inter-hospital transfer strategy on treatment times and in-hospital and 1 year cardiac mortality of patients with ST-segment elevation acute myocardial infarction (STEMI) undergoing primary percutaneous intervention (p-PCI) in the Italian region of Emilia-Romagna, where an efficient region-wide system for reperfusion has been established. METHODS AND RESULTS 3296 patients with STEMI, undergoing on-site p-PCI (2444 patients) (OS group) or p-PCI after inter-hospital transfer (852 patients) (T group) between 1 January 2004 and 30 June 2006 in the Italian region of Emilia-Romagna, were considered. During the study period, the number of patients undergoing p-PCI increased both for patients admitted to interventional centres and for those admitted to peripheral hospitals. At the same time, the proportion of patients with STEMI initially admitted to peripheral hospitals and not transferred and the door-to-balloon time delays of transfer patients decreased. In spite of longer door-to-balloon delay in the transfer group [112 min (86-147) vs. 71 min (46-104)], in-hospital cardiac mortality (OS 7.0 vs. T 5.4%, P = 0.10) did not significantly differ between the two groups. After multivariable adjustment, the transfer strategy was not associated with increased risk of in-hospital [odds ratio 0.956; 95% confidence interval (CI) 0.633-1.442] and 1 year (hazard ratio 0.817; 95% CI 0.617-1.085) cardiac mortality. CONCLUSION This study, concerning an established STEMI regional network, suggests that a strategy of inter-hospital transfer for p-PCI, when supported by an organized system of care, may be applied with rapid reperfusion times and favourable short- and long-term clinical outcomes.

Long-Term Outcomes With Drug-Eluting Stents Versus Bare Metal Stents in the Treatment of Saphenous Vein Graft Disease (Results from the REgistro Regionale AngiopLastiche Emilia-Romagna Registry)

Percutaneous revascularization of saphenous vein grafts (SVGs) remains a challenging task. Drug-eluting stents (DESs) have been shown to decrease the incidence of restenosis in de novo native coronary artery lesions. However, their clinical value in SVGs remains to be established. We compared long-term clinical outcomes of percutaneous coronary intervention with DESs and bare metal stents (BMSs) for de novo lesions in SVGs. In a large prospective, multicenter registry, 360 patients underwent stenting of a de novo lesion in SVGs using BMSs (288 patients) or DESs (72 patients). Incidence of major adverse cardiac events (MACEs), including all-cause mortality, reinfarction, and target vessel revascularization, was recorded at a 12-month follow-up. Compared with the DES group, patients receiving BMSs were more likely to be men, to have chronic renal insufficiency or higher Charlson scores, but less likely to have undergone previous percutaneous coronary intervention. Incidence of MACEs at 12-month follow-up was similar in the 2 groups (17.8% in DES group vs 20.3% in BMS group, respectively, p = 0.460). Cox regression analysis identified age, chronic renal failure, cardiogenic shock at presentation, and ostial location of stenosis as independent predictors of long-term MACEs. In conclusion, our data suggest that rates of 12-month MACEs associated with the use of DESs and BMSs are similar in patients undergoing treatment of de novo lesions in SVGs.

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.

Prognostic Impact of Hospital Readmissions After Primary Percutaneous Coronary Intervention

The implementation of primary percutaneous coronary intervention (PCI) has significantly improved the clinical outcome of patients admitted for ST-segment elevation myocardial infarction (STEMI).1 However, some patients still develop recurrent adverse events, with a negative impact on survival. Accordingly, we analyzed the data from the REAL (Registro Angioplastiche dell’Emilia-Romagna) registry in order to evaluate the 3-year readmission rate for cardiovascular causes and their influence on death. Methods For all patients with STEMI (from January 2003 to June 2009) undergoing primary PCI enrolled in the REAL registry,2-4 we evaluated the incidence of death and hospital readmission due to cardiovascular causes up to 3 years. Particularly, myocardial infarction (MI), coronary revascularization (CR), acute or congestive heart failure (HF), and serious bleeding events […]

Long-term outcome in patients with ST segment elevation myocardial infarction and multivessel disease treated with culprit-only, immediate, or staged multivessel percutaneous revascularization strategies: Insights from the REAL registry.

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.

Antithrombotic Management and 1-Year Outcome of Patients on Oral Anticoagulation Undergoing Coronary Stent Implantation (from the Registro Regionale Angioplastiche Emilia-Romagna Registry)

Current recommendations for the antithrombotic management of patients receiving oral anticoagulation (OAC) who undergo percutaneous coronary intervention with stent implantation (PCI-S) are based on limited and relatively weak data. To broaden and strengthen available evidence, the management and 1-year outcomes of OAC patients who underwent PCI-S and were included in a prospective, multicenter registry from 2003 to 2007 were evaluated. Among the 632 patients receiving OAC, mostly because of atrial fibrillation (58%), who underwent PCI-S, mostly because of acute coronary syndromes (63%), dual-antiplatelet therapy with aspirin and clopidogrel was the most frequently prescribed at discharge (48%), followed by triple therapy with OAC, aspirin, and clopidogrel (32%) and OAC plus aspirin (18%). The choice of antithrombotic therapy largely matched the thromboembolic risk profiles of patients, with the prescription of regimens including OAC predicted by the presence of non-low-risk features. The cumulative 1-year occurrence of major adverse cardiovascular events was as high as 27% and was not significantly different among the 3 treatment groups. Stroke and stent thrombosis were limited to 2% and 3%, respectively, and although no significant differences were found among the 3 groups, stroke was 4 times less frequent when OAC, with either 1 or 2 antiplatelet agents, was administered. Major bleeding was also limited to 3%, with no significant differences among the 3 groups. In conclusion, these findings suggest overall real-world management of OAC patients who undergo PCI-S that is in accordance with their clinical risk profiles and give further support to the reported efficacy and safety of triple therapy for the optimal treatment of these patients.

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.