[SICI-GISE/SICOA Consensus document: Clinical follow-up of patients after acute coronary syndrome or percutaneous coronary intervention]. / Documento di consenso SICI-GISE/SICOA: La gestione del follow-up del paziente dopo sindrome coronarica acuta e/o angioplastica coronarica.

In the last decades, advances in percutaneous coronary intervention (PCI) strategies have significantly reduced the risk of procedural complications and in-hospital mortality of patients with acute coronary syndromes (ACS), thus increasing the population of stable post-ACS patients. This novel epidemiological scenario emphasizes the importance of implementing secondary preventive and follow-up strategies. The follow-up of patients after ACS or elective PCI should be based on common pathways and on the close collaboration between hospital cardiologists and primary care physicians. However, the follow-up strategies of these patients are still poorly standardized. This SICI-GISE/SICOA consensus document was conceived as a proposal for the long-term management of post-ACS or post-PCI patients based on their individual residual risk of cardiovascular adverse events. We defined five patient risk classes and five follow-up strategies including medical visits and examinations according to a specific time schedule. We also provided a short guidance for the selection of the appropriate imaging technique for the assessment of left ventricular ejection fraction and of non-invasive anatomical or functional tests for the detection of obstructive coronary artery disease. Physical and pharmacological stress echocardiography was identified as the first-line imaging technique in most of cases, while cardiovascular magnetic resonance should be preferred when an accurate evaluation of left ventricular ejection fraction is needed. The standardization of the follow-up pathways of patients with a history of ACS or elective PCI, shared between hospital doctors and primary care physicians, could result in a more cost-effective use of resources and potentially improve patient's long-term outcome.

Current Use of Oral Anticoagulation Therapy in Elderly Patients with Atrial Fibrillation: Results from an Italian Multicenter Prospective Study-The ISNEP Study.

Background: Atrial fibrillation (AF) is the most common heart arrhythmia, and its prevalence increases with age. Oral Anticoagulant Therapy (OAT) with non-vitamin K antagonist oral anticoagulants (NOACs) or vitamin K antagonists (VKAs) is essential to avoid thromboembolic events in AF. However, this treatment is associated with a high risk of bleeding and low adherence in elderly patients. Aim: The aim was to evaluate the real-world use of OAT in a population of patients aged ≥80 years in twenty-three Italian centers and to investigate the tolerance of and patient satisfaction with this therapy. Methods: The ISNEP Study is a multicenter cross-sectional study enrolling patients with AF and aged ≥80 years and treated with either NOACs or VKAs. A written questionnaire was administered to each patient to evaluate the adherence to and patient satisfaction with this therapy. Results: The study included 641 patients with a mean age of 85 (82−87) years. The use of NOACs was reported in 93.0% of cases, with the remaining 7.0% treated with VKAs. A history of stroke events was reported in five (11.1%) and one (0.2%) patients in the VKA and NOAC groups, respectively. The rate of referred ecchymosis/epistaxis was significantly higher in the VKA group compared to the NOAC group (p < 0.001). Patients receiving NOACs reported a substantial improvement in their quality of life compared to the VKA group. Conclusions: A small, but not negligible, proportion of elderly AF patients is still treated with VKAs. Patients treated with NOAC have a higher level of satisfaction with the therapy and complete adherence.

One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in diabetic patients: Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry).

BACKGROUND: The ULISSE registry evaluated the real-world performance of the Ultimaster® biodegradable polymer sirolimus-eluting stent (BP-SES) in a multicenter-independent cohort of patients undergoing percutaneous coronary intervention, including a large proportion of diabetes mellitus (DM) patients. METHODS: In this subgroup analysis, 1,660 consecutive patients, 2,422 lesions, treated with BP-SES enrolled in the ULISSE registry were divided in two groups: DM (485 patients, 728 lesions) and non-DM (1,175 patients, 1,694 lesions). Primary endpoint was target lesion failure (TLF), a composite endpoint of cardiac-death, target-vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR) at 1-year. Secondary endpoint was TLR at 1-year. RESULTS: At 1-year follow-up TLF occurred in 5% overall patients and was significantly higher in DM patients (8 vs. 3.7%; p = .001), due to more cardiac deaths (3.4 vs. 1.1%; p = .002). TLR occurred in 3.2% overall patients, and it was not significantly higher in DM compared to non-DM patients (4.4 vs. 2.8%; p = .114). The incidence of stent thrombosis was low and similar between groups (0.4 vs. 0.9%; p = .526). Insulin-treated DM (ITDM) patients showed higher rate of TLF as compared to non-ITDM patients (13 vs. 6.5%; p = .041), but similar rate of TLR (6 vs. 4%; p = .405). After adjustment for relevant comorbidities, DM was not significantly associated with TLF or cardiac death in patients undergoing BP-SES implantation. CONCLUSIONS: This study is the first all-comers evaluation of BP-SES in DM patients. Our findings show that DM patients, mostly those with ITDM, still represent a vulnerable population and experience significantly higher rate of TLF. Overall BP-SES efficacy is considerable, although not statistically significant higher rate of TLR is still present in DM compared to non-DM patients.

One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in patients presenting with acute myocardial infarction: Insight from the ULISSE registry.

BACKGROUND: The ULISSE registry has demonstrated the real-world performance of the Ultimaster biodegradable polymer sirolimus-eluting stent (BP-SES) in a large cohort of patients undergoing percutaneous coronary intervention, including a large proportion of patients presenting with acute myocardial infarction (AMI). METHODS: We performed a subgroup analysis of the ULISSE registry in AMI patients and compared the outcomes of this vulnerable cohort with that of patients presenting without AMI (non-AMI). The primary end point was the incidence of 1-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically indicated target lesion revascularization (TLR). RESULTS: Of 1,660 patients included in the ULISSE registry, 381(23%) presented with AMI, 207(54.3%) non-ST elevation myocardial infarction, and 174(45.7%) ST-elevation myocardial infarction. Compared with non-AMI patients, those with AMI were more frequently female and smokers, with lower left ventricular ejection fraction (LVEF) and chronic kidney disease requiring dialysis. At 1 year, TLF rate was significantly higher in AMI than non-AMI patients (7.9 vs. 4.1%; HR 1.98, CI 95% 1.22-3.23; p = .005) driven by higher rate of cardiac death (4.0 vs. 1.1%; HR 3.59, CI 95% 1.64-7.88; p = .01) and TV-MI (2.8 vs 0.9%; HR 2.99,CI 95% 1.22-7.37; p = .01), without differences in TLR rate (4.3 vs. 2.9%,HR 0.66, CI95% 0.35-1.25; p = .2). At multivariate Cox regression analysis, eGFR <40 mL/min (HR: 2.868) and LVEF <40% (HR: 2.394) were the only independent predictors of TLF. CONCLUSIONS: In AMI patients, Ultimaster BP-SES implantation was associated with higher rate of TLF and definite stent thrombosis compared with non-AMI patients. The high incidence of adverse events was mainly driven by the unfavorable baseline risk profile.

One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in patients needing short dual antiplatelet therapy. Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry).

BACKGROUND: This study aimed to evaluate real-world clinical outcome of patients needing short dual antiplatelet therapy (S-DAPT) following PCI with Ultimaster® thin-strut, biodegradable polymer sirolimus-eluting stent (BP-SES), which was supposed to induce faster stent endothelialization and reduce device thrombogenicity. METHODS: In this sub-group analysis of patients enrolled in the ULISSE registry, two groups were identified: 1) patients discharged with S-DAPT (≤3-month) due to high bleeding risk or need for urgent major non-cardiac surgery and 2) patients discharged with recommended DAPT (R-DAPT) duration (≥6-month). The primary ischemic-safety and bleeding-safety endpoints were TLF (composite of cardiac-death, target vessel MI, and clinically driven target lesion revascularization), and BARC major bleedings (≥type-3a) at 1-year follow-up. To account for events occurring before DAPT discontinuation we performed 3-month landmark analysis. RESULTS: 82 patients (5%) were discharged with ≤3-month DAPT (57 ±â€¯27 days), and 1558 patients (94%) were discharged with ≥6-month DAPT (318 ±â€¯75 days). No significant differences between S-DAPT and R-DAPT group were observed in TLF at 1-year (7.9% vs. 4.6%). The rate of BARC major bleeding resulted significantly higher in S-DAPT group (3.9% vs. 0.3%; p = 0.001), with the majority of bleeding events occurring within 3 months. The landmark analysis showed no significant differences in BARC major bleedings between groups (1.4% vs. 0.3%; p = 0.142). CONCLUSIONS: As compared to those treated with R-DAPT (≥6-month), patients needing -S-DAPT (≤3-month) after PCI with Ultimaster® BP-SES had similar rates of 1-year TLF and BARC major bleedings following early DAPT discontinuation.

[Updated SICI-GISE position paper on institutional and operator requirements for transcatheter aortic valve implantation]. / Update del documento di posizione della Società Italiana di Cardiologia Interventistica (SICI-GISE) sui requisiti minimi per ospedali ed operatori che eseguono procedure di impianto transcatetere di protesi valvolare aortica.

Transcatheter aortic valve implantation (TAVI) has revolutionized the management of patients with symptomatic severe aortic stenosis and has become the standard of care for inoperable patients and the preferred therapy for those at increased surgical risk with peculiar clinical and anatomic features. Technology advances, growing experience and accumulating data prompted the update of the 2011 Italian Society of Interventional Cardiology (SICI-GISE) position paper on institutional and operator requirements to perform TAVI. The main objective of this document is to provide a guidance to assess the potential of institutions and operators to initiate and maintain an efficient TAVI program.

One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in all-comers population. Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry).

BACKGROUND: This study was designed to confirm in a large population of unselected patients the promising results of Ultimaster® biodegradable polymer sirolimus-eluting stent (BP-SES) already shown in previous trial. METHODS: ULISSE is an observational, multicenter, national registry evaluating all patients undergoing PCI with the Ultimaster® BP-SES. Incidence of 1-year TLF (cardiac death or target vessel MI or clinically indicated TLR) was the primary endpoint. Pre-specified subgroup analysis was performed for diabetic patients and for those with lesion longer than 25 mm, bifurcation and CTO lesions. RESULTS: 1660 patients were enrolled in 9 Italian cardiology centers, 82% were males, mean age of 68 ±â€¯10 years, and 29% were diabetics. Overall 2422 lesions were treated, 65% type B2/C lesions, 7% CTOs, 17% bifurcations and 38% long lesions. The incidence of 1-year TLF was 5%, with 3.2% of clinically indicated TLR. TLF occurred in 8% of the patients with diabetes mellitus, and 7% in bifurcation, 6.7% in CTO and 6.2% in long lesions. Definite overall ST was 0.9%, and 1.2% in patients treated for type B2/C lesions. Multivariate logistic regression analysis identified stenting on unprotected LMT (OR = 4.80), stenting on ISR lesion (OR = 3.19) and need for rotational atherectomy (OR = 6.24) as the strongest independent predictors of TLF. CONCLUSIONS: The results of this national all-comers registry show that the Ultimaster® BP-SES real-world performance was comparable with that observed in the clinical trial, with low rate of primary endpoint and TLR. Long term follow-up will be necessary to prove the theoretical advantage of the BP-SES over time.

Early and long-term outlook of percutaneous coronary intervention for bifurcation lesions in young patients.

BACKGROUND: Coronary artery disease is most common in older patients, but may occur in younger subjects. The outlook of young patients after percutaneous coronary intervention (PCI) of challenging lesion subsets such as coronary bifurcations, is not established. We thus aimed to appraise the early and long-term results of PCI for bifurcations in young patients. METHODS: A multicenter, retrospective study was conducted enrolling consecutive patients undergoing bifurcation PCI between 2002 and 2006 in 22 Italian centers. Patients were divided in 2 groups: age ≤ 45 years, and age > 45 years. The primary end-point was long-term rate of major adverse cardiac events (MACE). RESULTS: 4,314 patients were included: 195 (4.5%) in the younger group, and 4119 (95.5%) in the older group. 30-day outcomes did not show significant differences in MACE rates, with 1.0% in the ≤ 45 years group and 2.1% in the >45 years group (p=0.439), with death in 0.5% and 1.2% (p=0.388). At long-term follow-up (24.4 ± 15.1 months), younger patients showed similar rates of MACE, (12.8% vs. 16.6%, p=0.161), myocardial infarction (3.1% vs. 3.7%, p=0.633), target lesion revascularization (11.3% vs. 12.5%, p=0.627), or stent thrombosis (1.5% vs. 2.8%, p=0.294), despite an increased risk of death in older patients (1.0% vs. 5.0%, p=0.012). Even at extensive multivariable analysis, younger patients still faced a similar risk of MACE (HR=0.78 [0.48-1.27], p=0.318). CONCLUSIONS: Despite their low age, young patients undergoing PCI for bifurcation face a significant risk of early and late non-fatal adverse events. Thus, they should not be denied careful medical management and follow-up.

Simplifying clinical risk prediction for percutaneous coronary intervention of bifurcation lesions: the case for the ACEF (age, creatinine, ejection fraction) score.

AIMS: We aimed to appraise the predictive accuracy of a novel and user-friendly risk score, the ACEF (age, creatinine, ejection fraction), in patients undergoing PCI for coronary bifurcations. METHODS AND RESULTS: A multicentre, retrospective study was conducted enrolling consecutive patients undergoing bifurcation PCI between January 2002 and December 2006 in 22 Italian centres. Patients with complete data to enable computation of the ACEF score were divided into three groups according to tertiles of ACEF score. The primary endpoint was 30-day mortality. The discrimination of the ACEF score as a continuous variable was also appraised with area under the curve (AUC) of the receiver-operating characteristic. A total of 3,535 patients were included: 1,119 in the lowest tertile of ACEF score, 1,190 in the mid tertile, and 1,153 in the highest tertile. Increased ACEF score was associated with significantly different rates of 30-day mortality (0.1% in the lowest tertile vs. 0.5% in the mid tertile and 3.0% in the highest tertile, p<0.001), with similar differences in myocardial infarction (0.3% vs. 0.7% and 1.8%, p<0.001) and major adverse cardiac events (MACE, 0.5% vs. 1.2% and 4.3%, p<0.001). After an average follow-up of 24.4±15.1 months, increased ACEF score was still associated with a higher rate of all-cause death (1.3% vs. 2.4% and 11.0%, p<0.001), cardiac death (0.9% vs. 1.4% and 7.2%, p<0.001), myocardial infarction (3.4% vs. 2.7% and 5.7%, p<0.001), MACE (13.6% vs. 15.9% and 22.3%, p<0.001), and stent thrombosis (2.3% vs. 1.8% and 5.0%, p<0.001). Discrimination of ACEF score was satisfactory for 30-day mortality (AUC=0.82 [0.77-0.87], p<0.001), 30-day MACE (AUC=0.73 [0.67-0.78], p<0.001), long-term mortality (AUC=0.77 [0.74-0.81], p<0.001), and moderate for long-term MACE (AUC=0.60 [0.57-0.62], p<0.001). CONCLUSIONS: The simple and extremely user-friendly ACEF score can accurately identify patients undergoing PCI for coronary bifurcation lesions at high risk of early fatal or non-fatal complications, as well as long-term fatality.

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.

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

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

Impact of drug-eluting stents and diabetes mellitus in patients with coronary bifurcation lesions: a survey from the Italian Society of Invasive Cardiology.

BACKGROUND: We investigated the long-term impact of different stent types and diabetes mellitus (DM) in patients undergoing percutaneous coronary intervention (PCI) of bifurcation lesions, based on a large multicenter survey endorsed by the Italian Society of Invasive Cardiology. METHODS AND RESULTS: Relative benefits of drug eluting stent (DES) over bare metal stent (BMS) in patients with (n=1049) and without (n=3020) DM were analyzed with extensive multivariable adjustment. At 3 years, stenting with DES was associated with lower adjusted risk of major adverse cardiac events (MACE, adjusted hazard ratio [HR] 0.27, 95% confidence interval [CI] 0.15 to 0.49, P<0.001), cardiac death, and target lesion revascularization in DM patients but failed to demonstrate any significant benefit in patients without DM. CONCLUSIONS: In a large observational registry with admitted potential for selection bias and residual confounding, DES in DM patients with coronary bifurcation lesions were associated with improved outcomes in terms of MACE, cardiac death, and repeat revascularization at long-term follow up. These figures were not replicated in non-DM subjects.

Appraising the impact of left ventricular ejection fraction on outcomes of percutaneous drug-eluting stenting for unprotected left main disease: insights from a multicenter registry of 975 patients.

BACKGROUND: Despite the well-known prognostic impact of systolic dysfunction in unselected patients undergoing percutaneous coronary intervention (PCI), limited data are available on its current predictive role after PCI for unprotected left main disease (ULM). We thus appraised the prognostic role of left ventricular ejection fraction (LVEF) in patients undergoing PCI for ULM with drug-eluting stents (DES). METHODS: Consecutive eligible subjects were retrospectively enrolled in a national registry. Patients were divided into three groups: LVEF < 30%, LVEF 30-45%, and LVEF > 45%. Relevant baseline and outcome data were compared with bivariate and multivariable tests. RESULTS: A total of 975 subjects was included (LVEF < 30%: 46, LVEF 30-45%: 208, LVEF > 45%: 721). Patients with LVEF < 30% had several other unfavorable clinical features, including older age and higher EuroSCORE. Adverse event rates were different already at 7 days (p = 0.012 for all-cause death and p = 0.015 for major adverse cardiac events [MACE]), with even more significant trends up to 30 days and at long-term (p < 0.001 for death, and p < 0.001 for MACE). After a median of 18 months, risk of death totaled 39 versus 13 versus 8% (p < 0.001) and risk of MACE 44 versus 24 versus 22% (p = 0.003). Multivariable analyses showed however that reduced LVEF was not an independent predictor of adverse events at any time-point. CONCLUSIONS: Whereas reduced LVEF is apparently a significant predictor of adverse events after PCI with DES for ULM, its prognostic impact is mostly due to clustering with other adverse features.

Real-world outcome of coronary bifurcation lesions in the drug-eluting stent era: results from the 4,314-patient Italian Society of Invasive Cardiology (SICI-GISE) Italian Multicenter Registry on Bifurcations (I-BIGIS).

BACKGROUND: Drug-eluting stents (DESs) introduction has somewhat renewed the issues of strategy and stenting technique for treatment of bifurcation lesions. In particular, concerns remain on extensive use of DESs, especially in the side branch, and on time of dual antiplatelet therapy (DAT) discontinuation, reflecting lack of pertinent long-term data. This study aimed to evaluate clinical safety and efficacy of different strategies for bifurcations treatment in a large observational real-world registry. METHODS: A multicenter, retrospective Italian study of consecutive patients undergoing bifurcation percutaneous coronary intervention between January 2002 and December 2006 was performed. The primary end point was the long-term rate of major adverse cardiac events (MACEs). The role of DAT length on outcome was also analyzed. RESULTS: A total of 4,314 patients (4,487 lesions) were enrolled at 22 independent centers. In-hospital procedural success rate was 98.7%. After median follow-up of 24 months, MACEs occurred in 17.7%, with cardiac death in 3.4%, myocardial infarction in 4.0%, target lesion revascularization in 13.2%, and stent thrombosis in 2.9%. Extensive multivariable analysis showed that MACEs were independently predicted by age, diabetes, renal failure, systolic dysfunction, multivessel disease, myocardial infarction at admission, restenotic lesion, bare-metal stent implantation, complex stenting strategy, and short duration of DAT. CONCLUSIONS: This large study based on current clinical practice in an unselected patient population presenting with bifurcation disease and submitted to percutaneous coronary intervention demonstrated favorable long-term clinical results in this challenging patient setting, especially when DESs, simple stenting strategy, and DAT for at least 6 months are used.

Sex-related differences in patients undergoing percutaneous unprotected left main stenting.

AIMS: Percutaneous coronary intervention (PCI) is increasingly being used for unprotected left main (ULM) disease. Limited data are available on sex-related differences in this setting. We investigated gender-associated differences in patients undergoing stent-based PCI for ULM. METHODS AND RESULTS: We analysed baseline, procedural and long-term data of patients with ULM undergoing stent-based PCI at participating centres. The primary end-point was the long-term rate of major cardiovascular events rate (MACE, i.e., the composite of death, myocardial infarction, or target lesion revascularisation). The study population included 1,452 cases, with 27.8% females and 72.2% males. Women were older, more frequently diabetic, hypertensive or presenting with an acute coronary syndrome, and thus with a higher EuroSCORE, but were less commonly treated with drug-eluting stents (DES), in comparison to men (all p<0.01). After a median follow-up of 18 months, women showed an unadjusted higher risk of death (p=0.040), cardiac death (p=0.033), and the death/myocardial infarction (p=0.012). However, after multivariable adjustment, gender was no longer an independent predictor of death (hazard ratio=1.119 [0.804-1.558]), cardiac death (hazard ratio=1.045 [0.697-1.567]), or death/myocardial infarction (hazard ratio=0.531 [0.192-1.465]), given the predominant role of age, diabetes and EuroSCORE as independent predictors and confounders of the gender-based comparison. CONCLUSIONS: Women undergoing PCI for ULM present more often with an acute coronary syndrome, are treated less frequently with DES, and have more adverse events, but these gender biases are not confirmed after adjusting for confounders. Thus, stent-based PCI for ULM offers similarly favourable clinical results in women as well as in men.

Impact of acute coronary syndromes on two-year clinical outcomes in patients with unprotected left main coronary artery stenosis treated with drug-eluting stents.

In this study we investigated the impact of acute coronary syndromes (ACSs) on clinical outcomes in patients with unprotected left main coronary artery (ULMCA) stenosis treated with drug-eluting stents (DESs). In this multicenter, retrospective, observational study we enrolled 1,101 patients with ULMCA stenosis treated with DESs. Six hundred eleven patients presented with ACS and 490 had stable coronary artery disease. ACS was defined as the presence of unstable angina or non-ST-segment elevation myocardial infarction (MI). During 2-year follow-up, the adjusted hazard ratio of cardiac mortality and MI of patients with ACS versus stable patients was 2.42 (95% confidence interval 1.37 to 4.28, p = 0.002). We observed a stepwise risk increase, namely patients with stable coronary disease had the lowest risk, patients with unstable angina an intermediate risk, and patients with non-ST-segment elevation MI the highest risk. The increased risk of cardiac mortality and MI of patients with ACS was concentrated in the first year after DES implantation. In conclusion, patients with ULMCA stenosis and ACS treated with DESs have an increased risk of cardiac mortality and MI during the first year after the intervention compared to stable 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.

Patient selection to enhance the long-term benefit of first generation drug-eluting stents for coronary revascularisation procedures. Insights from a large multicentre registry.

AIMS: To evaluate the long-term clinical outcome after drug-eluting stents (DES) implantation, and to test if patient selection could enhance their net clinical benefit. METHODS AND RESULTS: We assessed the incidence of major adverse cardiac events (MACE=death, acute myocardial infarction, and target vessel revascularisation, TVR) and angiographic stent thrombosis (ST) during 3-year follow-up in a prospective multicentre registry. Propensity-score analysis to adjust for different clinical, angiographic and procedural characteristics was performed. Overall, 14,115 patients enrolled in the registry received solely BMS (n=9,565) or DES (n=4,550). The incidence of definite ST was 0.6% for BMS and 1.3% for DES (p=0.003). The propensity-score adjusted incidence of cardiac death and myocardial infarction was similar between the two groups (DES 11.9% vs. BMS 12.1%, HR 0.90, 95% CI 0.77-1.04), whereas DES were associated with lower rates of TVR (DES 11.6% vs. BMS 15.2%, HR 0.67, 95% CI 0.59-0.76). The efficacy of DES in reducing TVR increased with increasing likelihood of TVR at baseline. CONCLUSIONS: The beneficial effect of DES in reducing new revascularisations compared to BMS extends out to three years without a significantly worse overall safety profile. The benefit seems more evident in patients with the highest baseline risk of clinical restenosis.

Ostial and midshaft lesions vs. bifurcation lesions in 1111 patients with unprotected left main coronary artery stenosis treated with drug-eluting stents: results of the survey from the Italian Society of Invasive Cardiology.

AIMS: In this study, we compared the cumulative risk of major adverse cardiac events (MACE) of patients with distal unprotected left main coronary artery (ULMCA) stenosis with those of patients with ostial and midshaft lesions treated with drug-eluting stent (DES). METHODS AND RESULTS: The survey promoted by the Italian Society of Invasive Cardiology on ULMCA stenosis was an observational study involving 19 high-volume Italian centres. We enrolled 1111 patients with ULMCA stenosis treated with DES. Major adverse cardiac events were defined as death, myocardial infarction, and target lesion revascularization. Three hundred and thirty-four patients had ostial or midshaft lesions (group 1) and 777 bifurcations (group 2). The adjusted hazards ratio of the risk of 2 year MACE of patients in group 2 vs. patients in group 1 was 1.50 (P = 0.024). However, we observed that there was a significant difference between patients with bifurcations treated with two stents and those in group 1 (P = 0.001), but not between patients with bifurcations treated with one stent and those in group 1 (P = 0.38). CONCLUSION: Patients with bifurcations have a worse outcome than patients with ostial and midshaft lesions. However, the technique used to treat bifurcations has a significant impact on clinical outcomes.

Temporal pattern of ischemic events in relation to dual antiplatelet therapy in patients with unprotected left main coronary artery stenosis undergoing percutaneous coronary intervention.

OBJECTIVES: The aim of this study was to investigate whether there is a temporal pattern of ischemic events in relation to dual antiplatelet therapy in patients with unprotected left main coronary artery (ULMCA) stenosis treated with percutaneous coronary intervention (PCI). BACKGROUND: Identifying which periods during follow-up of patients with ULMCA stenosis treated with PCI are associated with higher risk of clinical events might help to improve therapeutic strategies. METHODS: We analyzed data from 15 centers involved in an observational study conducted by the Italian Society of Invasive Cardiology on patients with ULMCA stenosis treated with PCI. Eight hundred ninety-four patients were enrolled. RESULTS: At 30-day follow-up, the rate of cardiac mortality and myocardial infarction (MI) was 5.4%. In patients still taking dual antiplatelet therapy, the adjusted incidence rate ratio/10,000 patient-days of the combination of cardiac mortality and MI in the 31- to 180-day interval compared with the 181- to 360-day interval after PCI was 3.64 (p = 0.035). This risk was particularly high in patients with acute coronary syndromes. After stopping clopidogrel, the adjusted incidence rate ratio of cardiac mortality and MI in the 0- to 90-day interval compared with the 91- to 180-day interval was 4.20 (p = 0.009). CONCLUSIONS: In patients with ULMCA stenosis taking dual antiplatelet therapy there is an increased hazard of cardiac mortality and MI between 31 and 180 days compared with 181 to 360 days. Furthermore, there is an increased hazard of cardiac mortality and MI in the first 90 days after stopping clopidogrel.