Contemporary balloon aortic valvuloplasty: Changing indications and refined technique.

Even if un to improve long-term prognosis, balloon aortic valvuloplasty (BAV) may be useful in selected patients with symptomatic severe aortic stenosis either as a bridge to surgical or transcatheter valve replacement (aortic valve replacement [AVR] or transcatheter aortic valve implantation [TAVI]) or as a triage strategy for patients with uncertain indications. International guidelines recommend BAV as: a "bridge" to AVR/TAVI, a "trial" in patients with undetermined symptoms, or a "bridge-to-decision" in case of comorbidities. However, in clinical practice, BAV is also used as a palliative measure to improve hemodynamics and quality of life in many patients who are excluded from AVR/TAVI. Finally, BAV is often performed during TAVI to facilitate prosthesis delivery, optimize frame expansion, or for bioprosthetic valve fracture in selected valve-in-valve procedures. Technical innovations, which allow for a mini-invasive approach via transradial access and pacing delivered through the wire, have led to a decrease in complications over time. This review focuses on contemporary BAV with a specific emphasis on new indications, innovative techniques, and specific complex patient subgroups.

Safety, efficacy and impact on frailty of mini-invasive radial balloon aortic valvuloplasty.

OBJECTIVE: The study was designed to: (1) confirm safety and feasibility of mini-invasive radial balloon aortic valvuloplasty (BAV); (2) assess its impact in terms of quality of life and frailty; and (3) evaluate whether changes in frailty after BAV are associated with death in patients undergoing transcatheter aortic valve implantation (TAVI). METHODS: 330 patients undergoing BAV in 16 Italian centres were prospectively included. The primary endpoint was the occurrence of major and minor Valve Academic Research Consortium (VARC)-2 bleeding. Secondary endpoints were scales of quality of life, frailty, evaluated at baseline and 30 days, and their relationship with the occurrence of all-cause death. RESULTS: BAV was performed by radial access in 314 (95%) patients. No VARC-2 major and six (1.8%) VARC-2 minor bleedings occurred in the study population. Quality of life, as well as frailty status, significantly improved 30 days after BAV. At 1 year, patients undergoing TAVI with baseline essential frailty toolset (EFT) <3 or achieving an EFT <3 after BAV had a comparable occurrence of all-cause death (15% vs 19%, p=0.58). On the contrary, patients with EFT ≥3 at 30 days despite BAV showed the worst prognosis (all-cause death: 40% vs 15% and 19%, p=0.006 and p=0.05, respectively). CONCLUSIONS: Mini-invasive radial BAV is safe, feasible and associated with a low rate of vascular complications. Patients improving EFT 30 days after BAV showed a favourable outcome after TAVI. TRIAL REGISTRATION NUMBER: NCT03087552.

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.

Impact of the COVID-19 pandemic on coronary invasive procedures at two Italian high-volume referral centers.

AIMS: The purpose of this study was to verify the impact on the number and characteristics of coronary invasive procedures for acute coronary syndrome (ACS) of two hub centers with cardiac catheterization facilities, during the first month of lockdown following the COVID-19 pandemic. MATERIALS AND METHODS: Procedural data of ACS patients admitted between 10 March and 10 April 2020 were compared with those of the same period of 2019. RESULTS: We observed a 23.4% reduction in ACS admissions during 2020, with a decrease for both ST-elevation myocardial infarction (STEMI) (-5.6%) and non-ST-elevation myocardial infarction (-34.5%), albeit not statistically significant (P = 0.2). During the first 15 days of the examined periods, the reduction in ACS admissions reached 52.5% (-25% for STEMI and -70.3% for non-ST-elevation myocardial infarction, P = 0.04). Among STEMI patients, the rate of those with a time delay from symptoms onset longer than 180 min was significantly higher during the lockdown period (P = 0.01). Radiograph exposure (P = 0.01) was higher in STEMI patients treated in 2020 with a slightly higher amount of contrast medium (P = 0.1) and number of stents implanted (P = 0.1), whereas the number of treated vessels was reduced (P = 0.03). Percutaneous coronary intervention procedural success and in-hospital mortality were not different between the two groups and in STEMI patients (P NS for all). CONCLUSION: During the early phase, the COVID-19 outbreak was associated with a lower rate of admissions for ACS, with a substantial impact on the time delay presentation of STEMI patients, but apparently without affecting the in-hospital outcomes.

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.

Percutaneous coronary interventions in octogenarians: Acute and 12 month results in a large single-centre experience.

OBJECTIVES: To review the results of PCI in patients aged >or=80 years. BACKGROUND: Octogenarians represent a growing proportion of patients treated with PCI; in this subset of high-risk patients, the role of complete revascularization is still controversial. METHODS: We examined in-hospital, 30 days, and 12-month events in 356 patients aged >or=80 years submitted to PCI from 2004 to 2006 and 754 patients aged <80 years treated in 2006. RESULTS: Octogenarians had a higher risk profile. A complete revascularization was obtained in 48% of them and in 65% of younger patients (P < 0.001); glycoprotein IIb/IIIa inhibitors (GPI) use was common in both groups (43 vs. 46.5%). In-hospital mortality was higher in octogenarians (3.9 vs. 1.3%, P = 0.01) as well as vascular complications (2.8 vs. 1%, P = 0.058). Mortality resulted 5.9 vs. 1.2% at 30 days (P < 0.001), and 16.3 vs. 3.9% at 12 months (P <0.001) in the two groups whereas repeat revascularization procedures did not differ (9.3 vs. 8.4%, respectively). In patients aged >or=80, there was no difference in 12 months total events (20 vs. 28%, P = 0.07) and repeat revascularizations (8 vs. 10%, P = 0.498) in completely or uncompletely revascularized subjects. At multivariate analysis age (P = 0.002), diabetes (P = 0.002), three vessel disease (P = 0.020) and procedural success (P = 0.002) were independent predictors of total events at 12 months. CONCLUSIONS: In our experience, frequent GPI use and multivessel PCI in 41% of >or=80 years-old patients resulted in good immediate and mid-term clinical outcomes, irrespective of the completeness of revascularization achieved.

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.

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.

[Bioresorbable vascular scaffolds: clinical experience of the Emilia-Romagna Region, Italy]. / Scaffold bioriassorbibile: l'esperienza clinica della Regione Emilia-Romagna.

BACKGROUND: The bioresorbable vascular scaffold (BRS) technology constitutes the new revolution of the coronary artery disease interventional treatment. Currently, three distinct types of BRSs are available but only one, the Absorb BVS, was on the market in 2013 when the Regional Commission for Medical Devices and the Cardiology and Cardiac Surgery Commission of the Emilia-Romagna Region drew up a technical and scientific essay to provide guidance for the introduction of BRS in public and affiliated health facilities. Five preferential indications were given for use: long coronary lesions (>28 mm), ostial lesions (left main stem excluded), complete revascularization in patients aged <50 years, diffuse disease (>40 mm) or involving the mid/distal left anterior descending (LAD) branch in patients <70 years, spontaneous coronary artery dissection. METHODS: This survey analyzed data from all the catheterization laboratories in the Emilia-Romagna Region, merged in a unified database. RESULTS: In a 3-year study period, 546 BRS were implanted in 328 patients, corresponding to 1.5% of the drug-eluting stents (DES) used, with a trend towards a progressive increase over time. Initial indications were followed in 200/328 (61.0%) patients (about one third fitting more indications), mainly for treatment of long lesions in vessels >2.5 mm (67%), young patients (31.5%) and mid/distal LAD (28%). In 22.6% of cases the clinical scenario was a ST-segment elevation myocardial infarction, in 39.3% a non-ST-segment elevation acute coronary syndrome. Intracoronary imaging was infrequently used (intravascular ultrasound in 24.7% of cases). In 85 patients (25.9%) a hybrid procedure (BVS/DES) was performed. CONCLUSIONS: BRS use has resulted lower than expected, with discrete variability among centers, but according to the initial indications of the Emilia-Romagna Region in the majority of cases. The underuse might have been due to operators' caution in their initial experience. However, the increasing trend may reveal a greater confidence in the implantation technique and the whole amount of safety and efficacy data.

Left main percutaneous coronary intervention in ACS or stable coronary artery disease: acute and long-term results.

BACKGROUND: The aim of this study was to assess in-hospital and long-term results of the novo unprotected left main (UPLM) percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS) or stable coronary artery disease (CAD), in an unselected population admitted to a single high- volume cath-lab without on-site cardiac surgery. METHODS: From 2008 to 2011, among 317 PCI performed in patients with the novo UPLM stenosis, 49 patients presented ST-elevation myocardial infarction (STEMI), 152 non ST-elevation MI/unstable angina (NSTEMI/UA), 116 stable CAD. RESULTS: In-hospital mortality was 20% in STEMI, 5.3% in NSTEMI/UA and 1.7% in stable CAD patients (P<0.001). Two-year total mortality was 24.5%, 25.6% and 6% in the 3 groups, and cardiac death was 20%, 13.8% and 3.4% (P=0.002). Left main target lesion revascularization (TLR) was similar in the 3 groups, as the clinically-driven TLR (10% vs. 11% vs. 7.7%, P=0.642), with neither definite nor probable stent thrombosis. Multivariate analysis showed the following independent predictors of 2-year mortality: bare-metal stent use (OR 4.53, P<0.001), Syntax Score >32 (OR 3.53, P=0.012), ACS as the indication (OR 3.24, P=0.012), peripheral artery disease (OR 2.20, P=0.042), and age >75 years (OR 2.09, P=0.05). CONCLUSIONS: Our experience showed acceptable results of UPLM PCI in STEMI patients, where short-term prognosis was related to hemodynamic conditions, good results in NSTEMI/UA patients where mortality increased in the follow-up due to comorbidities, and very good results in patients with stable CAD.

Percutaneous treatment of the left main coronary artery ostial obstruction following aortic valve replacement.

Iatrogenic left main coronary artery ostial stenosis is a rare and late life-threatening complication of aortic valve replacement. The exact causes of this critical condition, despite being still nowadays elusive, are possibly related to the insertion of perfusion catheters into the left coronary system for cardioplegia delivery. We describe the case of a 69-year-old man, with normal coronary arteries documented by preoperative coronary angiography before surgery, who developed 1 year after aortic valve replacement worsening effort angina. A second coronary angiography revealed a severe left main ostial stem stenosis, which was successfully treated by sirolimus-eluting stent deployment. This case demonstrates a new percutaneous approach of this poorly understood, yet potentially fatal complication following aortic valve replacement.

Cost of single-vessel and multivessel coronary drug-eluting stenting: comparison to the DRG funding level.

BACKGROUND: Large-scale utilization of drug-eluting stents (DES) presents significant economic limitations, related to the current high cost of the device and the absence of adequate reimbursement from the health care system. The aim of the study was to evaluate the cost of single-vessel and multivessel drug-eluting stenting and to compare it with the DRG funding level. METHODS: Between November 2003 and May 2004, we studied 100 consecutive patients who underwent a percutaneous coronary intervention (PCI) with DES, 50 single-vessel and 50 multivessel procedures, in order to evaluate the real procedure costs of DES. The cost fields calculated in the analysis included: costs for the materials and drugs used in each procedure, costs related to medical personnel and staff, costs for equipment depreciations, and costs for total hospitalization based on the length of stay in the coronary care unit and/or in the cardiology ward. RESULTS: With regard to the 50 patients with single-vessel disease, 63 lesions were treated with 58 DES. With regard to the 50 patients with multivessel disease, the average number of treated vessels was 2.3 and of lesions 2.8. An average of 2.7 DES per patient was implanted; glycoprotein Ilb/IIIa inhibitors were used in 70% of cases. The multivessel procedure necessitated an average of 1.62 guide catheters, 1.86 guides, 1.36 balloons, and 475 +/- 124 ml of contrast medium; the average endoscopy time was 16 +/- 8 min while the total procedural time was 106 +/- 37 min. The procedural success rate was 100% for both groups. The post-PCI hospital stay was 2.1 +/- 1.7 days for patients with single-vessel disease and 2.8 +/- 2.6 days for patients with multivessel disease; the total was 4.7 +/- 2.8 and 6 +/- 3.2 days respectively. The mean total cost of hospital stay for PCI and DES was 6390 +/- 2274 Euro for single-vessel PCI and 9828 +/- 3026 Euro for multivessel PCI, split as follows: materials 2915 +/- 963 Euro and 5294 +/- 1177 Euro, procedural costs 404 +/- 55 and 446 +/- 99 Euro, costs of hospital stay 3070 +/- 2024 Euro and 4089 +/- 2517 Euro respectively for single-vessel and multivessel PCI. CONCLUSIONS: The mean total cost of a single-vessel PCI with DES falls within the DRG 112 reimbursement level for coronary angioplasty of 7006 Euro, while that of multivessel PCI with multiple DES is about 40% above the same reimbursement level. Interestingly, the multivessel PCI cost with multiple DES does fall within the reimbursement amount related to DRG 107 for bypass surgery procedures (14,322 Euro).

Spontaneous coronary dissection of all three coronary arteries: a case description with medium-term angiographic follow-up.

Spontaneous coronary artery dissection is a rare cause of ischemic heart disease, often related with a poor prognosis. We report the case of a 38-year-old woman without cardiovascular risk factors, admitted to our coronary care unit for unstable angina with ECG findings of inferior ischemia. The day after, an acute anterior myocardial infarction occurred and was treated with intravenous thrombolysis. Again, there were ECG signs of transient inferior ischemia. Coronary angiography showed widespread spontaneous coronary dissection involving the terminal left main stem, both the left anterior descending and circumflex artery, and the right coronary artery even peripherally, rendering any type of revascularization procedure inappropriate. The patient was placed on beta-blockers, acetylsalicylic acid and nitrates and her symptoms resolved; the 17-month angiographic follow-up showed almost complete healing of spontaneous coronary artery dissection. The peculiarities of the case are discussed and a review of the literature is provided.

[Ad-hoc coronary angioplasty: organizational model, clinical results and costs]. / L'angioplastica coronarica ad hoc: modello organizzativo, risultati clinici e costi.

BACKGROUND: Our center routinely employs the strategy of ad hoc percutaneous coronary intervention (PCI) after diagnostic catheterization in previously informed and prepared patients with anatomical and clinical indications for some years. The aim of this study was to evaluate clinical results and resource consumption of the ad hoc PCI strategy in our center. METHODS: We evaluated the results and resource consumption of 783 PCIs performed between January 1, 1999 and June 30, 2001, divided into 642 (82%) ad hoc and 141 (18%) deferred PCIs. We analyzed the patients' in-hospital clinical and procedural characteristics, the 1 and 6-month outcomes and resource consumption (costs of materials, quantity of contrast medium, fluoroscopic time and duration of procedures) in the two groups. RESULTS: Patients in the ad hoc group had more frequently previous PCI, hypertension, diabetes, acute coronary syndrome, single vessel disease, single lesion and single vessel PCI, stent use and direct stenting, use of glycoprotein IIb/IIIa inhibitors and hemostatic devices; those in the deferred PCI group had more frequently previous myocardial infarction, stable angina, elective programmed hospital admission for PCI and multilesion single vessel PCI. The clinical results were good: clinical success in 97% of cases, in-hospital major adverse clinical events occurred in 2%, non-Q wave myocardial infarction in 3.4% (creatine-kinase-MB > 3 times higher than the upper normal limit in serial routine controls), major vascular complications in 0.4%, 1-month and 6-month major adverse clinical events in 4 and 9% respectively, without any difference between the two groups. Ad hoc PCI resulted in less contrast medium use, a shorter procedure duration, lower costs and shorter fluoroscopy times with respect to deferred PCI plus diagnostic catheterization, although not statistically significant. CONCLUSIONS: In our experience, ad hoc PCI was safe and effective. Costs were lower and less resources were required. Patients were satisfactorily assisted and the logistics and organization of the procedure were optimal.

Coronary thrombus in patients undergoing primary PCI for STEMI: Prognostic significance and management.

Acute ST-elevation myocardial infarction (STEMI) usually results from coronary atherosclerotic plaque disruption with superimposed thrombus formation. Detection of coronary thrombi is a poor prognostic indicator, which is mostly proportional to their size and composition. Particularly, intracoronary thrombi impair both epicardial blood flow and myocardial perfusion, by occluding major coronary arteries and causing distal embolization, respectively. Thus, although primary percutaneous coronary intervention is the preferred treatement strategy in STEMI setting, the associated use of adjunctive antithrombotic drugs and/or percutaneous thrombectomy is crucial to optimize therapy of STEMI patients, by improving either angiographical and clinical outcomes. This review article will focus on the prognostic significance of intracoronary thrombi and on current antithrombotic pharmacological and interventional strategies used in the setting of STEMI to manage thrombotic lesions.

Off-hour primary percutaneous coronary angioplasty does not affect outcome of patients with ST-Segment elevation acute myocardial infarction treated within a regional network for reperfusion: The REAL (Registro Regionale Angioplastiche dell'Emilia-Romagna) registry.

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 < 0.0001) were longer for off-hours pPCI. However, unadjusted in-hospital (5.8% off-hours vs. 7.2% regular-hours, p = 0.11) and 1-year cardiac mortality (8.4% off-hours vs. 10.3% regular-hours, p = 0.08) were comparable. At multivariate analysis, off-hours pPCI did not predict an adverse outcome either for the overall population (odds ratio [OR]: 0.70, 95% confidence interval [CI]: 0.49 to 1.01) or for patients directly admitted to the interventional center (OR: 0.79, 95% CI: 0.52 to 1.20). 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.

Long-term clinical outcomes after drug eluting stent implantation in women with de novo coronary lesions. Results from the REAL (REgistro Regionale AngiopLastiche Emilia-Romagna) multicenter registry.

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 6 months 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.

A European multicentre, randomised study of the MAR-Tyn cobalt chromium tin-coated stent in patients with de novo coronary artery lesions: study design and protocol.

AIMS: The aim of this randomised study is to evaluate the efficacy and safety of a new bare metal stents (BMS) with thin struts and a novel passive coating as compared to current standard BMS. METHODS AND RESULTS: We designed an international, multicentre, randomised trial planned to include 160 patients assigned to receive either the titanium-nitride coated MAR-tyn stent (International Biomedical Systems, Trieste, Italy) or the Vision stent (Abbott Vascular, Abbott Laboratories, Abbott Park, IL, USA). Patients with left main or bypass graft disease, complex coronary lesions, needing treatment of multiple lesions, with recent myocardial infarction, prior BMS in or within 5 mm of the target lesion, left ventricular ejection fraction < or =25% and at increased bleeding risk are excluded. All patients are treated with dual antiplatelet therapy for two months. The primary endpoint is in-stent late luminal loss (LL) at 6-month follow-up angiography. Secondary endpoints are the incidence of major adverse cardiovascular events (MACE) and stent thrombosis over 12 months after randomisation. Patients' enrolment is open in all centres. CONCLUSIONS: This study will address the important question of safety and efficacy of a novel, inert and highly compatible passive coating on a thin-strut BMS with a great potential to be superior to a non-coated widely used BMS.

Long-term clinical outcomes and cost-effectiveness analysis in multivessel percutaneous coronary interventions: comparison of drug-eluting stents, bare-metal stents and a mixed approach in patients at high and low risk of repeat revascularisation.

AIMS: To evaluate the long-term effectiveness and cost-efficacy of drug-eluting stents (DES) in a real world setting of multivessel percutaneous coronary intervention (PCI). METHODS AND RESULTS: We evaluated the 2-year outcome of all multivessel PCI in de novo lesions enrolled in a prospective web-based multicentre registry from July 2003 to December 2006. Among the 2,898 eligible patients, 1,315 were treated with bare-metal stent (BMS) alone, 657 with DES alone, and 926 with both. At 2-years, use of DES was associated with a lower propensity score adjusted incidence of major adverse cardiac events (MACE), death and myocardial infarction, and target vessel revascularisation (TVR) compared with BMS but only in patients at high risk of TVR. No difference was apparent between "pure" DES and the mixed approach. The matched cost-effectiveness analysis revealed DES to be more costly and more effective with a reasonable incremental cost-efficacy ratio for any MACE avoided only in patients with a high risk of TVR and only in comparison with "pure" BMS patients. CONCLUSIONS: In this real-world multivessel PCI registry, the use of DES and a mixed approach were associated with a 2-year reduction of adverse clinical outcomes in comparison with BMS especially in patients with a high risk of TVR. DES were cost-effective only in patients at high risk of TVR.