Antiplatelet therapy in patients with conservatively managed spontaneous coronary artery dissection from the multicentre DISCO registry.

AIMS: The role of antiplatelet therapy in patients with spontaneous coronary artery dissection (SCAD) undergoing initial conservative management is still a matter of debate, with theoretical arguments in favour and against its use. The aims of this article are to assess the use of antiplatelet drugs in medically treated SCAD patients and to investigate the relationship between single (SAPT) and dual (DAPT) antiplatelet regimens and 1-year patient outcomes. METHODS AND RESULTS: We investigated the 1-year outcome of patients with SCAD managed with initial conservative treatment included in the DIssezioni Spontanee COronariche (DISCO) multicentre international registry. Patients were divided into two groups according to SAPT or DAPT prescription. Primary endpoint was 12-month incidence of major adverse cardiovascular events (MACE) defined as the composite of all-cause death, non-fatal myocardial infarction (MI), and any unplanned percutaneous coronary intervention (PCI). Out of 314 patients included in the DISCO registry, we investigated 199 patients in whom SCAD was managed conservatively. Most patients were female (89%), presented with acute coronary syndrome (92%) and mean age was 52.3 ± 9.3 years. Sixty-seven (33.7%) were given SAPT whereas 132 (66.3%) with DAPT. Aspirin plus either clopidogrel or ticagrelor were prescribed in 62.9% and 36.4% of DAPT patients, respectively. Overall, a 14.6% MACE rate was observed at 12 months of follow-up. Patients treated with DAPT had a significantly higher MACE rate than those with SAPT [18.9% vs. 6.0% hazard ratios (HR) 2.62; 95% confidence intervals (CI) 1.22-5.61; P = 0.013], driven by an early excess of non-fatal MI or unplanned PCI. At multiple regression analysis, type 2a SCAD (OR: 3.69; 95% CI 1.41-9.61; P = 0.007) and DAPT regimen (OR: 4.54; 95% CI 1.31-14.28; P = 0.016) resulted independently associated with a higher risk of 12-month MACE. CONCLUSIONS: In this European registry, most patients with SCAD undergoing initial conservative management received DAPT. Yet, at 1-year follow-up, DAPT, as compared with SAPT, was independently associated with a higher rate of adverse cardiovascular events (ClinicalTrial.gov id: NCT04415762).

Real-world reasons and outcomes for 1-month versus longer dual antiplatelet therapy strategies with a polymer-free BIOLIMUS A9-coated stent.

BACKGROUND: A large trial established the favorable profile of a new polymer-free biolimus A9-eluting stent (PF-BES) with a 1-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients. This is the first study comparing outcomes for a 1-month versus longer DAPT strategies following PF-BES-percutaneous coronary intervention (PCI). METHODS: All patients undergoing PF-BES-PCI (January 2016 to July 2018) were included in the multicenter CHANCE registry. Patients were stratified according to DAPT strategy at discharge (planned 1-month vs. planned >1-month). Primary outcomes were the 390-day estimates of a patient-oriented and of a device-oriented composite endpoints (POCE: death, myocardial infarction [MI] or target vessel revascularization; DOCE: cardiac death, target vessel-MI or ischemia-driven target lesion revascularization). Landmark analyses from 1-month post-PCI were carried. RESULTS: Following PF-BES-PCI, 328(40.3%) and 485(59.6%) patients were discharged with 1-month and longer DAPT (12 months [6-12]), respectively. Patients with a previous or index MI were less likely to be discharged on 1-month DAPT. Patients prescribed with 1-month DAPT were more likely to be at HBR than those with longer DAPT (90.2% vs. 69.9%, p = .001). No between-groups differences in the primary outcomes (planned 1-month vs. planned >1-month DAPT: POCE 11.9% vs. 13.2%, p = .747; DOCE: 4.8% vs. 8.1%, p = .500) were observed, also after adjusting for confoundings (POCE: adjusted-hazard ratio [adj-HR] 1.26, 95%CI 0.74-2.13; DOCE: adj-HR 1.00, 95%CI 0.49-1.99). Landmark analyses showed similar results. CONCLUSIONS: In a large all-comers registry of PF-BES PCI, no interaction of planned DAPT strategy (1-month vs. >1-month) with outcomes was found. This observation warrants investigation in adequately powered randomized studies (ClinicalTrials.gov NCT03622203).

Safety and efficacy of polymer-free biolimus-eluting stents versus ultrathin stents in unprotected left main or coronary bifurcation: A propensity score analysis from the RAIN and CHANCE registries.

OBJECTIVES: Evaluate safety and efficacy of polymer-free biolimus-eluting stents (PF-BESs) versus ultrathin stents in unprotected left main (ULM) or bifurcation. BACKGROUND: PF-BESs due to reduced length of dual antiplatelet therapy (DAPT) are increasingly used. However, there are limited data about safety and efficacy for ULM or bifurcation. METHODS: We selected all-patients treated for ULM or bifurcation from two multicenter real life registries (RAIN [NCT03544294] evaluating ultrathin stents, CHANCE [NCT03622203] appraising PF-BES). After propensity score with matching, the primary endpoint was major adverse cardiac events (MACE; a composite of all-cause death, myocardial infarction, target lesion revascularization [TLR], and stent thrombosis [ST]), while its components along with target vessel revascularization (TVR) secondary endpoints. RESULTS: Three thousand and three patients treated with ultrathin stents and 446 with PF-BESs, resulting respectively in 562 and 281 after propensity score with matching (33 and 22%, respectively, with ULM disease). After 12 (8-20) months, rates of MACE were similar (9 vs. 8%, p = 0.56) without difference in TLR and ST (3.0 vs. 1.7%, p = .19 and 1.8 vs. 1.1%, p = .42). These results were consistent for ULM group (3 vs. 1.7% and 1.8 vs. 1.1%, p = .49 and .76), for non-ULM group (2.1 vs. 3.4%, p = .56 and 1.2 vs. 1.7%, p = .78) and for two-stent strategy (8.7 vs. 4.5% and 4.3 vs. 3.2%, p = .75 and .91). Among patients treated with 1 month of DAPT in both groups, those with ultrathin stents experienced higher rates of MACE related to all-cause death (22 vs. 12%, p = .04) with higher although not significant rates of ST (3 vs. 0%, p = .45). CONCLUSIONS: PF-BES implanted on ULM or BiF offered freedom from TLR and ST comparable to ultrathin stents. PF-BESs patients assuming DAPT for 1 month experienced a lower despite not significant incidence of ST.

Spontaneous coronary artery dissection (SCAD) with cardiac arrest at presentation: A subanalysis from the DISCO registry.

INTRODUCTION: Spontaneous coronary artery dissection (SCAD) is a rare cause of acute myocardial infarction (AMI), which primarily affects young women without traditional cardiovascular risk factors, often presenting as sudden cardiac death. This study aims to investigate the prevalence, characteristics, predictors, and outcomes of cardiac arrest in SCAD patients. METHODS: The DISCO IT/SPA registry, an international retrospective multicenter study, enrolled 375 SCAD patients from 26 centers in Italy and Spain. Patients were categorized based on the presence or absence of cardiac arrest at admission. Data on demographics, clinical presentation, treatment, angiographic findings, and outcomes were collected. Angiograms were independently reviewed, and outcomes included major adverse cardiovascular events (MACE) and in-hospital bleeding. RESULTS: Among 375 SCAD patients, 20 (5.3%) presented with cardiac arrest. Both groups were similar in age, gender distribution, and conventional risk factors, except for a lower prevalence of dyslipidemia in the cardiac arrest group. ST-segment elevation myocardial infarction (STEMI) presentation and angiographic type 2b were independent predictors of cardiac arrest. Revascularization was more frequent in the cardiac arrest group. In-hospital outcomes, except for longer hospitalization, did not differ. On follow-up (average 21 months), MACE rates were similar between groups. CONCLUSIONS: Cardiac arrest is a notable complication in SCAD, mostly presenting with ventricular fibrillation. The prognosis of SCAD patients presenting with cardiac arrest did not differ from those without, reporting a similar rate of events both in-hospital and during long-term follow-up. STEMI presentation and angiographic type 2b were identified as independent predictors of cardiac arrest in SCAD.

OCT guided vs. COmplete pci in patieNts with sT segment elevation myocArdial infarCtion and mulTivessel disease: OCT-CONTACT RCT.

BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) of the culprit lesion significantly reduces the risk of cardiovascular death. However, the management of non-culprit lesions in patients with the multivessel disease remains a matter of debate in this setting. It's still unclear if a morphological OCT-guided approach, identifying coronary plaque instability, may provide a more specific treatment compared with a standard angiographic/functional approach. METHODS: OCT-Contact is a prospective, multicenter, open-label, non-inferiority randomized controlled trial. Patients with STEMI with successful primary PCI of the culprit lesion will be enrolled after the index PCI. Patients will be deemed eligible if a critical coronary lesion other than the culprit (associated with a diameter of stenosis ≥50%) will be identified during the index angiography. Patients will be randomized in a 1:1 fashion to OCT-guided PCI of non-culprit lesions (Group A) vs. complete PCI (Group B). PCI in group A will be undertaken according to criteria of plaque vulnerability, while in group B the use of fractional flow reserve will be left at the operators' discretion. Major-adverse cardiovascular events (MACE) are a composite of all-cause mortality, non-fatal myocardial infarction (MI) (excluding peri-procedural MI), unplanned revascularization, and NYHA IV heart failure) will be the primary efficacy outcome. Single components of MACE along with cardiovascular mortality will be the secondary endpoints. . Safety endpoints will embrace worsening of renal failure, procedural complications, and bleedings. Patients will be followed for 24 months after randomization. RESULTS: A sample size of 406 patients (203 per group) is required to provide the analysis an 80% power to detect a non-inferiority in the primary endpoint with an alpha error set at 0.05 and a non-inferiority limit of 4%. CONCLUSIONS: A morphological OCT-guided approach may be a more specific treatment compared with the standard angiographic/functional approach in non-culprit lesions of STEMI patients.

Percutaneous left main coronary disease treatment without on-site surgery back-up in patients with acute coronary syndromes: immediate and 2-year outcomes.

BACKGROUND: Best revascularization strategy in patients with acute coronary syndromes (ACS) and unprotected left main (ULM) coronary disease is still debate reflecting lack of convincing data. OBJECTIVES: To assess clinical feasibility and efficacy of ULM percutaneous coronary intervention (PCI) in patients with ACS and describe the practice of a center without on-site surgical back-up over a 7-year period. METHODS: Data on high-risk patients with ACSs undergoing percutaneous ULM treatment were prospectively collected in an independent registry. Primary end-points of this study were immediate and long-term outcomes expressed as target lesion failure (TLF, composite of cardiac death, myocardial infarction (MI), and target lesion revascularization). RESULTS: Between January 2003 and January 2010, 200 consecutive patients were included in this study. Angiographic success was obtained in 95% of patients but procedural success was 87% primarily affected by an 11% of in-hospital cardiac mortality. At median follow-up of 26 months (IQ 10-47), the overall TLF rate was 28.5%, with 16.0% of cardiac death, 7.0% of MI, and 10.5% of clinically driven target lesion revascularization rates. Cumulative definite/probable stent thrombosis was 3.5%. Elevated EuroSCORE value and pre-procedural hemodynamic instability were the strongest predictors of TLF. Temporal trend analysis showed progressive but not significant improvement for both immediate (P = 0.110) and long-term (P = 0.073) outcomes over the study period. CONCLUSIONS: This single-center study based on current clinical practice in patient with ULM disease and ACS confirmed PCI as feasible revascularization strategy in absence of on-site cardio-thoracic support. Nevertheless, the outcome of these high-risk patients is still hampered by a sensible in-hospital mortality rate.

Polymer-Free Biolimus-Eluting Stents or Polymer-Based Zotarolimus-Eluting Stents for Coronary Bifurcation Lesions.

BACKGROUND: A polymer-free biolimus-eluting stent (PF-BES) and a zotarolimus-eluting stent (ZES) recently showed similar clinical profiles and appear to be competing options in specific clinical settings of patients undergoing percutaneous coronary intervention (PCI). Whether they perform similarly also in complex procedural settings as coronary bifurcation lesions remains unaddressed. METHODS: All consecutive patients undergoing coronary bifurcation PCI with PF-BES or the new iteration of the ZES from three large multicenter real-world registries were included. The primary outcome was major adverse cardiovascular events (MACE), a composite of all-cause death, myocardial infarction (MI), target lesion revascularization (TLR) and stent thrombosis (ST). Multiple analyses to adjust for baseline differences were carried out including propensity-score matching, propensity-score stratification and inverse-probability-weighting. Outcomes are reported according to Cox proportional hazard models censored at 400-day follow-up. RESULTS: 1169 patients treated with PF-BES (n = 440) or ZES (n = 729) on the main branch of a coronary bifurcation lesion were included (mean age 69 ± 11 years, 75.4% male, 53.8% acute coronary syndrome at presentation, 26.6% left main bifurcation, median dual antiplatelet therapy duration 12 [range 12-12] months). MACE, all-cause death, TLR and ST tended towards non-statistically higher rates with the PF-BES as compared to the ZES. Higher MI and target vessel revascularization occurrence was observed with PF-BES. CONCLUSIONS: In this large contemporary cohort of patients undergoing coronary bifurcation PCI, the occurrence of MACE was non-statistically different with the use of PF-BES and ZES devices. However, differences favoring the ZES device that may entail clinical relevance were observed. Further studies are needed to confirm these findings and explore whether they remain valid when a short dual antiplatelet therapy is adopted.

Cardiogenic shock complicating acute myocardial infarction in the elderly: predictors of long-term survival.

BACKGROUND: Cardiogenic shock (CS) is a severe complication of acute myocardial infarction (AMI), associated with a high mortality. A significant improvement in survival has been reported with immediate coronary revascularization. However, there is no clear evidence of such an improvement amongst older patients. The aim of our work was to evaluate in-hospital and long-term outcomes in the group of elderly AMI patients with CS (≥75 years old). METHODS: We collected data of 157 consecutive AMI patients with CS who underwent percutaneous coronary intervention (PCI) and compared clinical and procedural characteristics and in-hospital and long-term outcomes between patients <75 years and patients ≥75 years old. RESULTS: There were 58 patients (36.9%) with age ≥75 years and 99 patients (63.1%) with age <75 years. Patients were followed up for an average period of 34 months (range 5-69). In-hospital and long-term mortality was significantly higher in the older group (55 vs. 25%, P < 0.0001; and 62.1 vs. 37.3%, P = 0.005, respectively). Multivariate predictors of in-hospital mortality were age ≥75 years (hazard ratio 1.81, 95% CI 1.006-3.27, P = 0.04) and PCI failure (hazard ratio 2.67, 95% CI 1.34-5.307, P = 0.005), whereas, the only multivariate predictor of long-term mortality was PCI failure (hazard ratio 2.88, 95% CI 1.52-5.46, P = 0.001). Age ≥75 years showed only a trend toward statistical significance (hazard ratio 1.62, 95% CI 0.96-2.76, P = 0.07). CONCLUSIONS: In elderly AMI patients with CS, PCI can be performed with an acceptable risk that seems lower than that reported in most previous studies.

Real-World Experience With a Tapered Biodegradable Polymer-Coated Sirolimus-Eluting Stent in Patients With Long Coronary Artery Stenoses.

BACKGROUND: Treatment of long coronary stenoses (LCS) with long tapered drug-eluting stents (LT-DES) would offer clinical and economic benefits. However, the feasibility of an interventional strategy based upon the systematic LCS treatment with an LT-DES has not been evaluated so far. METHODS: We performed a multicenter prospective study including consecutive patients with: 1) An LCS > 25 mm at coronary angiography; 2) An attempt to fix the LCS with a single BioMime Morph™ stent, a novel LT-DES available from 30 to 60 mm long. The primary efficacy endpoint was procedural success. The secondary safety endpoints were post-procedural TIMI3 flow, stent detachment during delivery, acute stent thrombosis and in-hospital mortality. RESULTS: From February 2017 to March 2018, we recorded 272 patients with an LCS and an attempt to deploy an LT-DES during percutaneous coronary intervention (PCI) (69.3 ± 11.4 years, 75.7% males, 25.7% diabetic and 43.8% with acute coronary syndromes, mean LCS length 48.8 ± 9.5 mm). LT-DES deployment was successful in 262 patients (96.3%), and failure occurred without stent detachment or other complications. Final TIMI3 flow was present in 270 (99.3%) patients. In-hospital death occurred in five patients (1.8%), with no case of acute stent thrombosis, recurrent myocardial infarction or repeated revascularization. CONCLUSION: In this real-world study, a strategy of fixing LCS with a single LT-DES was feasible and safe, with a high rate of procedural success and a low rate of in-hospital complications. More extensive randomized studies are warranted to assess the potential clinical and economic benefits of LT-DES.

Dual antiplatelet therapy strategies and clinical outcomes in patients treated with polymer-free biolimus A9-coated stents.

AIMS: A large trial established the favourable clinical profile of a new polymer-free biolimus A9-eluting stent (PF-BES) with a one-month dual antiplatelet therapy (DAPT) regimen in patients at high bleeding risk (HBR). We aimed to evaluate the real-world patterns of indications, DAPT strategies and outcomes for the PF-BES following this evidence. METHODS AND RESULTS: CHANCE is a multicentre registry including all patients who underwent percutaneous coronary intervention (PCI) with at least one PF-BES. The reasons for the PF-BES PCI and planned antithrombotic regimens were collected. Primary outcomes were the 390-day Kaplan-Meier estimates of patient-oriented and device-oriented composite endpoints (POCE: death, myocardial infarction [MI] or target vessel revascularisation [TVR]; DOCE: cardiac death, target vessel MI or ischaemia-driven target lesion revascularisation [ID-TLR]). Between January 2016 and July 2018, 858 patients (age 74±10 years, 64.6% male, 58.7% acute coronary syndrome presentation) underwent PF-BES PCI. The main reasons for the physicians' choice of PF-BES reflected a perceived HBR in 77.7% of patients. One-month DAPT was planned in 40.3% of patients. At 390-day follow-up (median 340 days, interquartile range: 187-390 days), the estimated incidence of POCE was 13.1% (any MI 3.7%, any TVR 3.4%) and of DOCE was 7.1% (TV-MI 3.6%, ID-TLR 1.4%), while the 390-day estimate of any bleeding event was 11.1% (BARC 3-5 bleeding 3.0%). CONCLUSIONS: In a large all-comers registry, PF-BES was used mostly in HBR patients, frequently followed by a very short DAPT regimen. The reported outcomes suggest a favourable safety and efficacy profile for the PF-BES in a real-world clinical setting. ClinicalTrials.gov identifier: NCT03622203.

Gender differences in acute coronary syndromes patterns during the COVID-19 outbreak.

BACKGROUND: Mortality from acute coronary syndromes (ACS) is strictly related to early management. As female patients usually experience longer delays before diagnosis and treatment, we assessed whether women were more affected by the dramatic drop in hospital admissions for ACS during the Covid-19 pandemic. METHODS: We performed a retrospective analysis of clinical and angiographic characteristics of consecutive patients who were admitted for ACS at 15 hospitals in Northern Italy comparing men and women data. The study period was defined as the time between the first confirmed case of Covid-19 in Italy (February 20, 2020) and March 31, 2020. We compared hospitalization rates between the study period and two control periods: the corresponding period during the previous year (February 20 to March 31, 2019) and the earlier period during the same year (January 1 to February 19, 2020). Incidence rate ratios comparing the study period with each of the control periods were calculated with the use of Poisson regression. RESULTS: Of the 547 patients who were hospitalized for ACS during the study period, only 127 (23%) were females, accounting for a mean of 3.1 admissions per day, while ACS hospitalized males were 420, with a mean of 10.2 admissions per day. There was a significant decrease driven by a similar reduction in ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI) diagnosis in both sexes compared to the control periods. A trend toward a greater reduction in admitted females was shown in the intra-year control period (46% admission reduction in females vs 37% in males, with females accounting for 26% of ACS, P=0.10) and a significant reduction when compared to the previous year control period (40% admission reduction in females vs 23% in males, with females accounting for 28% of ACS, P=0.03), mainly related to Unstable Angina diagnosis. CONCLUSION: The Covid-19 pandemic period closed the gap between men and women in ACS, with similar rates of reduction of hospitalized STEMI and NSTEMI and a trend toward greater reduction in UA admission among women. Furthermore, many typical differences between males and females regarding ischemic heart disease presentations and vessel distribution were leveled.

Buddy balloon to deliver a percutaneous aortic valve device: a percutaneous shoehorn?

Percutaneous aortic valve replacement is performed with increasing frequency in patients with severe aortic stenosis at prohibitive surgical risk. Currently available devices are however in their early development stage, and are thus quite bulky with a large profile, with ensuing difficulties in delivery of the device through a stenotic aortic valve. We report hereby a case in which we employed a buddy wire and balloon technique as a "shoehorn" to enable accurate delivery of a balloon-expandable aortic valve prosthesis from the transfemoral route.

Very long-term results comparing a simple versus a complex stenting strategy in the treatment of coronary bifurcation lesions.

BACKGROUND: The optimal stenting strategy for coronary bifurcation lesions has not yet been defined, especially given the lack of very long-term data (>24 months). We compared our long-term results of a simple vs complex stenting strategy in patients with bifurcation lesions. METHODS: We retrospectively selected subjects undergoing percutaneous coronary intervention (PCI) with stenting in a bifurcation lesion between June 2002 and December 2005, comparing those treated with a simple technique vs those treated with a complex one. The primary end-point was the rate of major adverse cardiac events (MACE) at >24 months of follow-up. RESULTS: A total of 326 patients were included, 64.7% treated with a simple technique (Group A) and 35.3% with a complex strategy (Group B). Drug-eluting stents were used in 82.0% and 73.0%, respectively (P = 0.059), final kissing balloon in 47.9% and 53.0% (P = 0.37), and procedural success obtained in 99.5% and 99.1% (P = 0.66). After a median of 34 months, MACE occurred in 52 (26.5%) in Group A and in 32 (31.4%) in Group B (P = 0.37), cardiac death in six (3.1%) vs four (3.9%, P = 0.70), myocardial infarction in 13 (6.6%) vs 6 (5.9%, P = 0.80), target vessel revascularization in 36 (18.4%) vs 29 (28.4%, P = 0.04), and bypass in five (2.6%) vs two (2%, P = 0.74). Definite stent thrombosis was adjudicated in two (1%) vs one (0.9%, P = 0.98). CONCLUSIONS: This study, comparing simple and complex stenting strategies for the treatment of coronary bifurcation lesions, shows that both techniques are associated with favorable clinical results and low adverse events rates at long-term follow-up.

A long-term comparison of drug-eluting versus bare metal stents for the percutaneous treatment of coronary bifurcation lesions.

BACKGROUND: After the first exciting results on drug-eluting stents (DES), many concerns have been raised on their potential risk for late stent thrombosis. Whereas DES appear beneficial at early and mid-term for coronary bifurcation lesions, no data are available on their long-term safety in this setting in comparison to bare metal stents (BMS). We thus aimed to appraise the long-term (> 2 years) outcomes of patients with bifurcation lesions treated with DES vs. BMS. METHODS: We abstracted baseline, procedural and follow-up data on all patients with bifurcation coronary lesions (both branches with reference vessel diameter > 2.0 mm) treated with stent implantation at our centre. The primary end-point was the long-term (> 2 years) rate of major adverse cardiac events (MACE, i.e. cardiac death, myocardial infarction, coronary artery bypass grafting and target vessel revascularization). RESULTS: A total of 315 patients and 334 lesions were included, 84.4% treated with DES, and 15.6% treated with BMS. The side branch was stented in 108 cases, according to a provisional T in 76 (22.7%), crushing in 15 (4.5%),V in 14 (4.2%), and culottes in 1 (0.3%). In-hospital MACE occurred in 4 (1.5%) patients of the DES group and 2 (4.1%) of the BMS group (P = 0.22). After 35.8 +/- 12.9 months, MACE were 72 (27.1%) vs. 24 (49%), respectively (P = 0.002), with cardiac death in 7 (2.6%) patients vs. 3 (6.1%, P = 0.20), myocardial infarction in 12 (4.5%) vs. 6 (12.2%, P = 0.42), coronary artery bypass grafting in 5 (1.9%) vs. 1 (2%, P = 0.93), target lesion revascularization in 30 (11.3%) vs. 13 (26.5%, P = 0.0042), and target vessel revascularization in 48 (18%) vs. 13 (26.5%, P = 0.16). Definite stent thrombosis occurred in 2 (0.75%) patients in the DES group vs. 1 (2%, P = 0.93) in the BMS group, whereas probable stent thrombosis was adjudicated in 5 (1.9%) vs. 2 (4%, P = 0.93). CONCLUSION: This cohort study, reporting for the first time on the long-term outlook of patients treated with DES vs. BMS for coronary bifurcation lesions, supports the overall safety and efficacy of DES in comparison to BMS. Specifically, even after several years of follow-up, repeat revascularizations appeared significantly lower with DES, and stent thromboses occurred with equivalent frequency in both DES and BMS groups.

[MGuard Dacron mesh-covered stent implantation in patients with ST-elevation myocardial infarction and high thrombotic burden: in-hospital and long-term outcome in a single high-volume center]. / MGuard "Dacron mesh covered" stent per il trattamento della sindrome coronarica acuta con sopraslivellamento del tratto ST in presenza di elevato carico trombotico: outcome intraospedaliero e a lungo termine in un singolo centro ad alto volume.

BACKGROUND: The MGuard (MG) is a stainless-steel closed cell stent covered with an ultra-thin polymer mesh sleeve, which has the purpose of ensuring reduced distal embolization of thrombotic material, thus lowering the risk of no-reflow/slow-flow phenomena. Only few data are available that evaluated the usefulness of the MG stent in patients with ST-elevation myocardial infarction (STEMI) with a high thrombotic burden. METHODS: We prospectively collected data of patients presenting with STEMI and high thrombotic burden (thrombus burden grade 4 or 5 according to the TIMI score) who underwent primary percutaneous coronary intervention (PCI) with MG stent implantation in our center. Lesions involving a bifurcation or very calcified and tortuous vessels were not included. Final TIMI 3 flow, normal myocardial blush grade (MBG), and complete ST-segment resolution were defined as short-term endpoints, whereas major adverse cardiovascular events were evaluated during follow-up. RESULTS: From August 2008 to June 2013, the MG stent was implanted in 104 (9.3%) of 1108 patients who underwent primary PCI. Cardiogenic shock on admission was present in 4 patients (3.8%). Final TIMI 3 flow was achieved in 97.1% of patients, MBG 3 in 56.7%, and regression of ST-segment elevation ≥70% within 90 min was recorded in 64.4% of patients. In-hospital mortality was 2.9% (n=3), and at a mean follow-up of 455±430 days overall major adverse cardiovascular events were 11 (10.6%). Cardiac death occurred in 5 patients (4.9%) and stent thrombosis in 2 (1.9%). CONCLUSIONS: In selected patients with STEMI undergoing primary PCI, the use of the mesh-covered MG stent in vessels with high thrombotic burden despite thrombus aspiration was effective and safe both immediately and at mid-term follow-up.

Impact of transcatheter closure of patent foramen ovale in the evolution of migraine and role of residual shunt.

OBJECTIVES: To retrospectively evaluate the impact on daily activities of transcatheter closure of patent foramen ovale (PFO) versus medical therapy in patients with migraine and to analyze the role of the residual shunt after PFO closure. BACKGROUND: While non-controlled observational studies reported an improvement of migraine after PFO closure, a randomized trial has shown no benefit of such an intervention. The role of residual shunt after PFO closure is also poorly known. METHODS: Out of 217 patients with migraine and echocardiographic evidence of PFO, 89 were managed with percutaneous PFO closure (Group A) while 128 were medically treated (Group B). All MIDAS questionnaires were obtained at the first evaluation and repeated at least 6 months after the index evaluation or after the PFO closure. All the patients were also asked to give a subjective estimate of their migraine status. A postprocedural transcranial Doppler study was available in 70 patients in Group A. RESULTS: The mean basal MIDAS score did not differ between the two groups (p = 0.859). After a mean follow-up (FU) of 1399 ± 982 days the MIDAS score decreased significantly in both groups (Group A baseline vs FU, p < 0.001; Group B baseline vs FU, p < 0.001), but no differences were observed between groups (p = 0.204). However a significantly higher number of Group A patients reported a perceived clinical benefit or the disappearance of migraine compared to Group B (p < 0.001). Patients with moderate or severe residual right to left shunt were no more likely to have an higher MIDAS score or to complain of migraine than those with mild or no shunt. CONCLUSIONS: Although the overall evolution of migraine is not significantly different, the abolition of migraine occurs in a larger proportion after PFO closure.

Primary percutaneous coronary intervention without on-site cardiac surgery backup in unselected patients with ST-segment-elevation myocardial infarction: the Rivoli ST-segment elevation myocardial infarction (RISTEMI) registry.

BACKGROUND: Primary percutaneous coronary intervention (PCI) is the preferred reperfusion strategy for patients with ST-segment-elevation myocardial infarction (STEMI), but some concerns remain about its safety and efficacy in centers without on-site cardiac surgery (OCS). METHODS: The Infermi Hospital in Rivoli, Italy, is a community hospital without OCS with a high volume catheterization laboratory (>800 PCI and >150 primary PCI per year), which provides a 24-hour primary PCI service to a population of 583.000 and is only 14 km far from the nearest OCS hospital. We analyzed clinical and procedural data, as well as 30-day outcome, of all STEMI patients treated by primary PCI within 12 hours from symptom onset. RESULTS: From September 2001 to June 2010, 1302 patients with a suspect of STEMI underwent urgent coronary angiography. Of these, 1251 (96.1%), underwent primary PCI. A successful myocardial revascularization was achieved in 1172 patients (93.7%). Thirty-day mortality occurred in 7.1%. Multivariate predictors of 30-day mortality were: age ≥75 years (OR 3.96, p=0.0003), left ventricular ejection fraction ≤40% (OR 35.0, p=0.02), cardiogenic shock at presentation (OR 33.4, p<0.0001), anterior STEMI (OR 1.82, p=0.036) and total ischemic time ≤3 hours (OR 0.55, p=0.05). CONCLUSIONS: Primary PCI is a reperfusion strategy feasible and effective in unselected high-risk STEMI patients even in hospitals without OCS with a high volume of routine and emergency interventional procedures.

Is percutaneous coronary intervention of unprotected left main coronary artery via transradial approach feasible for skilled transfemoral operators? Initial experience in an unselected population.

BACKGROUND: The feasibility and efficacy of percutaneous coronary intervention (PCI) of unprotected left main coronary artery (ULMCA) via transradial access (TRA) is still a matter of concern, mainly in an unselected population. METHODS: We collected data about all PCI performed in patients with ULMCA stenosis by a TRA-dedicated operator and analyzed clinical and procedural characteristics as well as in-hospital and long-term outcomes. RESULTS: From January 2008 to December 2011, 49 PCIs were performed; 27 (55%) via TRA and 22 (45%) via transfemoral access (TFA). Most patients in both groups underwent PCI for acute coronary syndrome (66.7% in the TRA group vs 77.3% in the TFA group, p=0.73). Patients in the TRA group were more hypertensive (81.5% vs 40.9%, p=0.008) and had a higher left ventricular ejection fraction (54.6±10.3 vs 46.1±12.8, p=0.01). There were no significant differences in procedural success (100% in the TRA group vs 90.9% in the TFA group, p=0.38), as well as in procedural time, in fluoroscopic time and in contrast volume. Bleeding complications occurred in 1 patient in the TFA group (4.5%) vs none in the TRA group (p=0.91). In-hospital major adverse cardiac events (MACE) occurred in 1 patient (3.7%) in the TRA group vs 3 (13.6%) in the TFA group (p=0.48). At a follow-up of 32±13 months, MACE occurred in 4 cases (14.8%) in the TRA group vs 7 cases (31.8%) in the TFA group (p=0.28). CONCLUSIONS: The PCI of ULMCA via TRA is feasible with good results, provided that a rigorous learning curve was followed and a TRA volume caseload was maintained.