Long-Term Mortality Comparison of Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock and Treated With Culprit-Only or Multivessel Percutaneous Coronary Intervention.

OBJECTIVES: We sought to determine whether, in a real word context of patients with Acute Myocardial Infarction (AMI), multivessel disease (MVD) and cardiogenic shock (CS), the successful treatment with primary percutaneous coronary intervention (p-PCI) of only culprit lesions (OC-PCI) is associated with better long-term mortality rates than multivessel PCI (MV-PCI) of all significant lesions. METHODS: From our registry of all consecutive patients admitted for AMI between January 1995 and December 2016 we selected those presenting with CS and MVD successfully treated with p-PCI, and compared those who underwent OC-PCI against MV-PCI, either during the p-PCI (MV-pPCI) or by staged revascularization (Staged-PCI) during hospitalization. The primary endpoint was 2-year all-cause death. RESULTS: Among 4210 patients with AMI, 406 (9.6%) presented CS (Killip class IV). A total of 292 patients had MVD. Of them, 252 (86.3%) were successfully treated with p-PCI, 159 patients with OC-PCI and 93 with MV-PCI, either in the same (n = 29) or staged procedure (n = 64). At 2-year follow-up the overall mortality was 47.6%, lower in MV-PCI group (37.6% vs 53.5% in OC-PCI, p = 0.019). Diabetes (HR = 1.50, 1.01-2.22), three vessel disease (HR = 1.49, 1.02-2.17) and basal left ventricular ejection fraction <15% (HR = 3.39, 2.41-6.27) were independent predictors of mortality, while MV-PCI was the only variable associated with improved survival (HR = 0.54, 0.36-0.81). CONCLUSIONS: In this real world registry of AMI patients with MVD presenting CS, MV-PCI was associated with better long-term survival.

Impact of complete percutaneous revascularization in elderly patients with chronic total occlusion.

OBJECTIVE: The aim of the study was to assess the prognostic impact of successful chronic total occlusion (CTO) percutaneous coronary intervention (PCI) and completeness of revascularization in the elderly. BACKGROUND: Successful CTO-PCI is associated with clinical benefit. Notwithstanding elderly patients are currently underrepresented in CTO-PCI randomized controlled trials and registries. METHODS: From the Florence CTO-PCI registry 1,405 patients underwent CTO-PCI between 2004 and 2015; out of these, 460 consecutive patients were ≥75 years. End point of the study was long-term cardiac survival. The prognostic impact of successful CTO-PCI and complete revascularization on survival was assessed by Kaplan-Meier estimation and by Cox multivariable regression analysis. RESULTS: Patients were stratified according to success (72%) or failure of CTO-PCI. Completeness of revascularization was achieved in 57% of patients. Five-year cardiac survival was significantly higher in the successful CTO-PCI group (84 ± 3% vs. 72 ± 6%; p = .006) and it was further improved if complete coronary revascularization was achieved (90 ± 3% vs. 68 ± 5%; p < .001). At multivariable analysis, increasing age (hazard ratio [HR] 1.08; p = .001), diabetes (HR 1.55; p = .033), chronic kidney disease (HR 1.96, p = .002), left ventricular ejection fraction <0.40 (HR 2.10; p < .001), and completeness of revascularization (HR 0.58; p < .005) resulted independently associated with long-term cardiac survival. CONCLUSIONS: In the elderly successful CTO-PCI is associated with a long-term survival benefit. The results of this study suggest that, even in the elderly, a CTO-PCI attempt should be considered to achieve complete coronary revascularization.

Five-year clinical outcome of multicenter randomized trial comparing amphilimus - with paclitaxel-eluting stents in de novo native coronary artery lesions.

OBJECTIVES: Long-term data from randomized studies on polymer-free stents are scarce. Long-term data of Cre8 amphilimus eluting stent are still not available. We sought to investigate contribution of a polymer-free design versus a permanent-polymer one on the long-term. METHODS AND RESULTS: Patients undergoing percutaneous coronary intervention for de novo lesions were randomized 1:1 to Cre8 or Taxus Liberté (323 overall, 126 Cre8). Original primary endpoint (6-month angiographic in-stent late lumen loss) already demonstrated the superiority of Cre8 vs Taxus (0.14 + 0.36 mm vs. 0.34 + 0.40 mm; p < 0.001). Secondary endpoints were the device oriented composite endpoint (DOCE), patient oriented composite endpoint (POCE) up to 5-year. Long-term follow-up data confirmed the superiority shown by Cre8 in the analysis of the angiographic endpoint at 6-month, especially in the diabetic patients, where the device strongly reduced the clinical difference with non-diabetic. Landmark analysis demonstrated that the incidence of DOCE after 1-year and up to 5-year follow up was significantly lower in patients implanted with Cre8 AES (2.1% Cre8 vs. 9.3% Taxus, p = 0.009). While no differences were found in terms of DOCE rate among diabetic and non-diabetic patients treated with the Cre8 AES (HR 1.039; 95%CI 0.320-3.374), this was not true for Taxus (HR 2.64; 95%CI 1.112-6.278). CONCLUSIONS: Cre8 showed favourable safety and efficacy results versus Taxus at 5-years follow-up, with a superior clinical performance for the DOCE endpoint from 1 to 5 years. Cre8, differently from Taxus, has been able to strongly reduce the differences in clinical outcome between diabetic and non-diabetic up to 5 years, suggesting the higher efficacy of Cre8 in the treatment of diabetic patients.

Ticagrelor or Prasugrel in Patients with Acute Coronary Syndromes.

BACKGROUND: The relative merits of ticagrelor as compared with prasugrel in patients with acute coronary syndromes for whom invasive evaluation is planned are uncertain. METHODS: In this multicenter, randomized, open-label trial, we randomly assigned patients who presented with acute coronary syndromes and for whom invasive evaluation was planned to receive either ticagrelor or prasugrel. The primary end point was the composite of death, myocardial infarction, or stroke at 1 year. A major secondary end point (the safety end point) was bleeding. RESULTS: A total of 4018 patients underwent randomization. A primary end-point event occurred in 184 of 2012 patients (9.3%) in the ticagrelor group and in 137 of 2006 patients (6.9%) in the prasugrel group (hazard ratio, 1.36; 95% confidence interval [CI], 1.09 to 1.70; P = 0.006). The respective incidences of the individual components of the primary end point in the ticagrelor group and the prasugrel group were as follows: death, 4.5% and 3.7%; myocardial infarction, 4.8% and 3.0%; and stroke, 1.1% and 1.0%. Definite or probable stent thrombosis occurred in 1.3% of patients assigned to ticagrelor and 1.0% of patients assigned to prasugrel, and definite stent thrombosis occurred in 1.1% and 0.6%, respectively. Major bleeding (as defined by the Bleeding Academic Research Consortium scale) was observed in 5.4% of patients in the ticagrelor group and in 4.8% of patients in the prasugrel group (hazard ratio, 1.12; 95% CI, 0.83 to 1.51; P = 0.46). CONCLUSIONS: Among patients who presented with acute coronary syndromes with or without ST-segment elevation, the incidence of death, myocardial infarction, or stroke was significantly lower among those who received prasugrel than among those who received ticagrelor, and the incidence of major bleeding was not significantly different between the two groups. (Funded by the German Center for Cardiovascular Research and Deutsches Herzzentrum München; ISAR-REACT 5 ClinicalTrials.gov number, NCT01944800.).

One-Year Follow-Up Results From the Observational, Multicenter, Prospective, and Controlled Registry: The WALTZ All-Comers Study.

The aim of this study was to evaluate 1-year follow-up results in an all "comers" population treated with a new cobalt chromium bare-metal stent (BMS) design. Since August 2016 to March 2017, 201 (9.7% of screening population) consecutive patients undergoing coronary stent implantation in 11 centers in Argentina were prospectively included in our registry. The inclusion criteria were multiple-vessel disease and/or unprotected left main disease, acute coronary syndromes (ACS) with at least one severe (⩾70%) stenosis in any of major epicardial vessel. In-stent restenosis, protected left main stenosis, or impossibility to receive dual-antiplatelet therapy was an exclusion criterion. Major adverse cardiac events (MACE) were the primary endpoint and included cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR); also, all components of the primary endpoint were separately analyzed. Completeness of revascularization was analyzed as post hoc data using residual SYNTAX or ERACI risk scores. Demographic characteristics showed that 6.5% of patients were very elderly, 22.5% have diabetes, 47% have multiple-vessel disease, 67% have ACS, and 32% have ST elevation MI. At a mean of 376 ± 18.1 days of follow-up, MACE was observed in 10.4% of patients: death + MI + cardiovascular accident (CVA) in 3% (6 of 201) and cardiac death + MI + CVA in 1.5% (3 of 201). Residual ERACI score ⩽5 was associated with 98% of event-free survival (P < .04). In conclusion, this prospective, multicenter, and observational all-comers registry with this novel BMS design showed a low incidence of adverse events at 1 year mainly due to coronary restenosis.

Patterns and Impact of Dual Antiplatelet Cessation on Cardiovascular Risk After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndromes.

The aim of this study was to examine the patterns and clinical impact of differing modes of dual-antiplatelet therapy (DAPT) cessation after percutaneous coronary intervention (PCI) in patients presenting with and without acute coronary syndromes (ACS). The PARIS (patterns of nonadherence to antiplatelet regimens in stented patients) registry was a multicenter study of 5,018 patients who underwent PCI. DAPT cessation was categorized as physician-recommended discontinuation, interruption, or disruption. Overall rates of 2-year DAPT discontinuation did not differ between non-ACS and ACS patients (38.8% vs 37.2%, p = 0.252). ACS patients were less likely to interrupt DAPT (8.5% vs 10.7% p<0.001), but were more likely to disrupt DAPT (16.4% vs 11.9%, p<0001). Adverse events after DAPT cessation were highest after disruption, intermediate with discontinuation, and lowest with interruption across both groups. Disruption of DAPT predicted MACE in both ACS patients (hazard ratio [HR] 2.89 [1.88 to 4.45; p<0.001]) and non-ACS patients (HR 2.08 [1.29 to 3.35; p = 0.002]). Interruption of DAPT predicated MACE in ACS patients (HR 2.72 [1.35 to 5.48]) but not in non-ACS patients (HR 0.44 [0.14 to 1.40]; pinteraction≤0.01). In conclusion, the incidence of DAPT cessation mode differs by presentation with or without ACS. Physician guided DAPT discontinuation was the most common mode of DAPT cessation and appears to be safe across both groups. There were higher rates of adverse events associated with the interruption of DAPT in ACS patients.

Randomised evaluation of a novel biodegradable polymer-based sirolimus-eluting stent in ST-segment elevation myocardial infarction: the MASTER study.

AIMS: The MASTER study was designed to compare the performance of a new biodegradable polymer sirolimus-eluting stent (BP-SES) with a bare metal stent (BMS) in patients with ST-segment elevation myocardial infarction (STEMI). METHODS AND RESULTS: The study was a prospective, randomised (3:1), controlled, single-blind multicentre trial that enrolled 500 STEMI patients within 24 hours of symptom onset during 2013-2015. Three hundred and seventy-five patients were treated with BP-SES and 125 with BMS. One hundred and four (104) randomised patients underwent angiographic follow-up at six months. The primary clinical endpoint was target vessel failure (TVF), defined as cardiac death, MI not clearly attributable to a non-target vessel, or clinically driven target vessel revascularisation (TVR) at 12 months. The primary angiographic endpoint was in-stent late lumen loss (LLL) at six months in the angiographic cohort. The major secondary endpoint for safety was a composite of all-cause death, recurrent MI, unplanned infarct-related artery revascularisation, stroke, definite stent thrombosis (ST) or major bleeding at one month. At 12 months, TVF had occurred in 6.1% of BP-SES and 14.4% of BMS patients (pnon-inferiority=0.0004), mainly driven by a higher rate of repeat revascularisation in BMS patients. The safety endpoint occurred in 3.5% of BP-SES and 7.2% of BMS patients (p=0.127). In-stent LLL demonstrated the superiority (p=0.0125) of BP-SES (0.09±0.43 mm) over BMS (0.79±0.67 mm). CONCLUSIONS: The study showed clinical non-inferiority and angiographic superiority of BP-SES versus a comparator BMS, suggesting that this novel DES may be a potential treatment option in STEMI.

Clinical and Angiographic Outcomes Comparison of Patients With Left Main Vs Non-Left Main Bifurcation Lesions Treated With Percutaneous Coronary Intervention With Second-Generation Drug-Eluting Stents.

INTRODUCTION: It is not clear if differences exist about treating left main bifurcation (LMB) and non-left main bifurcation (non-LMB) lesions by means of percutaneous coronary intervention (PCI). METHODS: We prospectively analyzed all consecutive patients treated at our center for bifurcation lesions from January 1, 2011 to December 31, 2015, including acute myocardial infarction (MI) and cardiogenic shock, and compared the angiographic and clinical outcomes of patients with LMB and non-LMB lesions treated with PCI and second-generation drug-eluting stent (2G-DES) implantation. The primary endpoint was the major adverse cardiac event (MACE) composite, including MI, clinically indicated target-vessel revascularization (TVR), and cardiac death (CD) at 2-year follow-up. We also compared the angiographic patency of the vessel, which was a composite of the restenosis-reocclusion (RR) rate. RESULTS: Out of 1081 patients (1368 bifurcations), a total of 320 patients had LMB (29%). Overall, procedural success was 98.4%. Clinical follow-up rate was 100%. Angiographic follow-up rate was 83.7%. No differences were seen regarding the primary endpoint of all MACE (17.8% in LMB vs 18.0% in non-LMB; P>.99), MI rate (4.3% in LMB vs 2.9% in non-LMB; P=.20), and CD (8.7% in LMB vs 5.8% in non-LMB; P=.08). The overall RR rate was 11.8%, with 5% RR rate in the LMB group (16/320 lesions) and 9.7% RR rate in the non-LMB group (102/1048 lesions); P<.01. The LMB group had a better TVR rate (5.0% vs 9.4% in the non-LMB group; P=.01). CONCLUSION: PCI with 2G-DES for LMB has better target-vessel patency and TVR rates when compared with non-LMB lesions, without clinical differences in terms of 2-year clinical outcomes.

Timing of invasive septal reduction therapies and outcome of patients with obstructive hypertrophic cardiomyopathy.

BACKGROUND: Whether early vs. delayed referral to septal reduction therapies (SRT, alcohol septal ablation or surgical myectomy) bears prognostic relevance in hypertrophic obstructive cardiomyopathy (HOCM) is unresolved. We analyzed the impact of SRT timing on the outcome of HOCM patients. METHODS: We followed 126 patients for 5 ±â€¯4 years after SRT (mean age 53 ±â€¯15 years; 55 post-ASA and 71 post-SM). Based on time-to-treatment (TTT; from HOCM diagnosis to SRT), patients were divided into three groups: "<3" years, N = 50; "3-5" years, N = 25; ">5" years, N = 51. RESULTS: Patients with TTT > 5 years were younger at diagnosis and more often had atrial fibrillation (AF). Left ventricular outflow tract (LVOT) gradients were comparable in the 3 TTT groups. Two patients died peri-operatively, all with TTT > 5. Long-term, 8 patients died (3 suddenly and 5 due to heart failure). Mortality increased progressively with TTT (2% vs. 4% vs. 12% for TTT "<3", "3-5", and ">5" years, p for trend = 0.039). Independent predictors of disease progression (new-onset AF, worsening to NYHA III/IV symptoms, re-intervention or death) were TTT ("3-5" vs. "<3" years: HR: 4.988, 95%CI: 1.394-17.843; ">5" vs. "<3" years: HR: 3.420, 95%CI: 1.258-9.293, overall p-value = 0.025), AF at baseline (HR: 1.896, 95%CI: 1.002-3.589, p = 0.036) and LVOT gradient (HR per mm Hg increase: 1.022, 95%CI: 1.007-1.024, p = 0.023). CONCLUSIONS: Delay in SRT referral has significant impact on long-term outcome of patients with HOCM, particularly when >5 years from first detection of gradient, even when successful relief of symptoms and gradient is achieved. Earlier interventions are associated with lower complication rates and better prognosis, suggesting the importance of timely SRT to maximize treatment benefit and prevent late HOCM-related complications.

On-Treatment Platelet Reactivity is a Predictor of Adverse Events in Peripheral Artery Disease Patients Undergoing Percutaneous Angioplasty.

OBJECTIVES: Few data are available on the association between a different entity of platelet inhibition on antiplatelet treatment and clinical outcomes in patients with peripheral artery disease (PAD). The aim of this study was to evaluate the degree of on-treatment platelet reactivity, and its association with ischaemic and haemorrhagic adverse events at follow up in PAD patients undergoing percutaneous transluminal angioplasty (PTA). METHODS: In this observational, prospective, single centre study, 177 consecutive patients with PAD undergoing PTA were enrolled, and treated with dual antiplatelet therapy with aspirin and a P2Y12 inhibitor. Platelet function was assessed on blood samples obtained within 24 h from PTA by light transmission aggregometry (LTA) using arachidonic acid (AA) and adenosine diphosphate (ADP) as agonists of platelet aggregation. High on-treatment platelet reactivity (HPR) was defined by LTA ≥ 20% if induced by AA, and LTA ≥ 70% if induced by ADP. Follow up was performed to record outcomes (death, major amputation, target vessel re-intervention, acute myocardial infarction and/or myocardial revascularisation, stroke/TIA, and bleeding). RESULTS: HPR by AA and HPR by ADP were found in 45% and 32% of patients, respectively. During follow up (median duration 23 months) 23 deaths (13%) were recorded; 27 patients (17.5%) underwent target limb revascularisation (TLR), two (1.3%) amputation, and six (3.9%) myocardial revascularisation. Twenty-four patients (15.6%) experienced minor bleeding. On multivariable analysis, HPR by AA and HPR by ADP were independent predictors of death [HR 3.8 (1.2-11.7), p = .023 and HR 4.8 (1.6-14.5), p = .006, respectively]. The median value of LTA by ADP was significantly lower in patients with bleeding complications than in those without [26.5% (22-39.2) vs. 62% (44.5-74), p < .001). LTA by ADP ≤ 41% was independently associated with bleeding HR 14.6 (2.6-24.0), p = .001] on multivariable analysis. CONCLUSIONS: In this study a high prevalence of on-clopidogrel and aspirin high platelet reactivity was found, which was significantly associated with the risk of death. Conversely, a low on-clopidogrel platelet reactivity was associated with a higher risk of bleeding. These results document that the entity of platelet inhibition is associated with both thrombotic and bleeding complications in PAD patients.

Relationship between CHA2DS2-VASc score, coronary artery disease severity, residual platelet reactivity and long-term clinical outcomes in patients with acute coronary syndrome.

BACKGROUND: The CHA2DS2-VASc score predicts stroke risk in patients with atrial fibrillation, but recently has been reported to have a prognostic role even in patients with ACS. We sought to assess the ability of the CHA2DS2-VASc score to predict the severity of coronary artery disease, high residual platelet reactivity and long-term outcomes in patients with acute coronary syndrome (ACS). METHODS: Overall, 1729 consecutive patients with ACS undergoing invasive management were included in this prospective registry. We assessed platelet reactivity via light transmittance aggregometry after clopidogrel loading. Patients were divided according to the CHA2DS2-VASc score: group A = 0, B = 1, C = 2, D = 3, E = 4 and F ≥ 5. RESULTS: Patients with higher CHA2DS2-VASc score were more likely to have a higher rate of multivessel CAD (37%, 47%, 55%, 62%, 67 and 75% in Group A, B, C, D, E and F; p < 0.001); moreover, CHA2DS2-VASc score correlated linearly with residual platelet reactivity (R = 0.77; p < 0.001). At long-term follow-up, estimated adverse event rates (MACCE: cardiac death, MI, stroke or any urgent coronary revascularization) were 3%, 8%, 10%, 14%, 19% and 24% in group A, B, C, D, E and F; p < 0.001. Multivariable analysis demonstrated CHA2DS2-VASc to be an independent predictor of severity of coronary artery disease, of high residual platelet reactivity and of MACCE. CONCLUSIONS: In a cohort of patients with ACS, CHA2DS2-VASc score correlated with coronary disease severity and residual platelet reactivity, and therefore it predicted the risk of long-term adverse events.

Lowering risk score profile during PCI in multiple vessel disease is associated with low adverse events: The ERACI risk score.

In recent years angiographic risk scores have been introduced in clinical practice to stratify different levels of risk after percutaneous coronary interventions (PCI). The SYNTAX score included all intermediate lesions in vessels ≥1.5 mm, consequently, multiple stent implantation was required. Four years ago, we built a new angiographic score in order to guide PCI strategy avoiding stent deployment both in intermediate stenosis as in small vessels, therefore these were not scored (ERACI risk score). The purpose of this mini review is to validate the strategy of PCI guided by this scoring, taking into account long term follow up outcomes of two observational and prospective registries where this policy was used. With this new risk score we have modified risk profile of our patient's candidates for PCI or coronary artery bypass surgery lowering the risk and <20% of them are now included anatomically as high risk for PCI. The simple exclusion of small vessels and intermediate stenosis from the revascularization approach resulted in clinical outcome comparable with the one of fractional flow reserve guided revascularization. Low events rate at late follow up observed in both studies was also in agreement with guided PCI by functional lesion assessment observed by Syntax II registry, where investigators found lower events rate in spite of a few number of stents implanted per patient. In conclusion: use of ERACI risk scores may significantly reclassify patients into a lower risk category and be associated with low adverse events rate.

Angiographic and clinical outcome after crush of everolimus-eluting stent for distal unprotected left main disease.

Obiectives: Angiographic and clinical outcomes after crushing of everolimus-eluting stent (EES) for distal unprotected left main disease (ULMD). BACKGROUND: Few data exist about crushing of EES for distal ULMD. METHODS: From the Florence ULMD Percutaneous Coronary Interevention Registry consecutive patients with distal ULMD treated with EES were included in the analysis. Patients treated with provisional stenting were compared with patients treated with crush stenting. ENDPOINTS: angiographic in-segment restenosis rate, and 1-year clinical outcome. RESULTS: From 2008 to 2015, 405 patients with distal ULMD were treated with EES: 278 (69%) were treated with provisional stenting while 127 (31%) with crush stenting. Provisional stenting group compared to crush stenting group had higher incidence of acute coronary syndrome on admission (63% vs. 52%; P = 0.033) and of left ventricular ejection fraction ≤ 40% (36% vs. 23%; p= 0.008), while patients treated with crush stenting had more frequently diabetes mellitus (35% vs. 21%; P = 0.003) and 3-vessel coronary artery disease (46% vs. 29%; P < 0.001). Angiographic follow rate was 95%. Restenosis rates were similar: 7.1% in the crush stenting group and 5.8% in the provisional stenting group. There were no differences in 1-year clinical outcome between crush stenting group and provisional stenting group: major adverse cardiac events 11.1% and 11.2%, stent thrombosis 0.8% and 1.4%, respectively. CONCLUSION: Crush stenting using EES in patients with complex distal ULMD is associated with low rates of restenosis and adverse clinical events and could be considered as a valid double stenting technique in all patients with complex ULMD bifurcation lesions. © 2017 Wiley Periodicals, Inc.

APpropriateness Assessment in Antiplatelet THerapY (APATHY) registry: Insight from current clinical practice.

BACKGROUND: In clinical practice there is a gap between guidelines recommendation and antiplatelet strategies used for acute coronary syndrome (ACS). We sought to evaluate appropriateness of antiplatelet strategies employed in a tertiary center. METHODS AND RESULTS: From January to June 2014, 430 ACS were treated with percutaneous coronary intervention by 3 groups of interventional cardiologists. Aspirin and clopidogrel (52%) were the most commonly used antiplatelet therapies, being prasugrel associated with aspirin in 110 (25.5%) and ticagrelor in 97 (22.5%) ACS. Inappropriate use of prasugrel (Tia/Ictus) was found in 2 (1.8%) patients and not recommended use (>75years, without diabetes or previous myocardial infarction) in 11 (10%). Not recommended use of ticagrelor (plus warfarin) was found in 4 (4.4%). Switching from clopidogrel to prasugrel occurred in 29% [28 showing high residual platelet reactivity (HRPR: ADP 10µmol>70%), and 4 left main stenting], while from clopidogrel to ticagrelor occurred in 13.4% (all showing HRPR, but 1). The most powerful predictor for prescription of 3rd generation P2Y12 inhibitors was the HRPR (OR 5.473, 95%CI 2.41-12.43, p<0.0001), whereas the behavior of attending cardiologist (HR 0.674, 95%CI 0.573-0.847, p=0.001) and the older age reduced the probability of receiving it (OR0.963, 95%CI 0.943-0.984, p=0.001). CONCLUSIONS: Clopidogrel remained the most common P2Y12 inhibitor employed for ACS. Third generation P2Y12 inhibitor prescription was lower than the one expected by guidelines recommendations, and the switching was largely based on clopidogrel HRPR. These findings suggest the need for a greater effort to improve adherence of cardiology community to current guidelines.

Early changes of left ventricular filling pattern after reperfused ST-elevation myocardial infarction and doxycycline therapy: Insights from the TIPTOP trial.

AIM: Metalloproteinases inhibition by doxycycline reduces cardiac protein degradation at extracellular and intracellular level in the experimental model ischemia/reperfusion injury. Since both extracellular cardiac matrix and titin filaments inside the cardiomyocyte are responsible for the myocardial stiffness, we hypothesized that doxycycline could favorably act on left ventricular (LV) filling pressures in patients after reperfused acute ST-elevation myocardial infarction (STEMI). METHODS AND RESULTS: Seventy-three of 110 patients of the TIPTOP trial underwent a 2D-Echo-Doppler on admission, and at pre-discharge and at 6-month after a primary PCI for STEMI and LV dysfunction. From admission to pre-discharge, LV filling changed from a high filling pressure (HFP) to a normal filling pressure (NFP) pattern in 91% of the doxycycline-group, and in 67% of the control-group. Conversely, 1% of the doxycycline-group, and 37% of the control-group changed the LV filling from NFP to HFP pattern. Overall, a pre-discharge HFP pattern was present in 4 patients (11%) of the doxycycline-group and in 13 patients (36%) of the control-group (p=0.025). The evaluation of metalloproteinases and their tissue inhibitors plasma concentrations provide possible favorable action of doxycycline. On the multivariate analyses, troponine I peak (p=0.026), doxycycline (p=0.033), and on admission to pre-discharge LVEF changes (p=0.044) were found to be associated with pre-discharge HFP pattern. Independently of their baseline LV filling behavior, the 6-month remodeling was less in patients with pre-discharge NFP pattern than in patients with HFP pattern. CONCLUSIONS: In patients with STEMI and LV dysfunction doxycycline can favorably modulate the LV filling pattern early after primary PCI.

Clinical events beyond one year after an acute coronary syndrome: insights from the RECLOSE 2-ACS study.

AIMS: The optimal duration of dual antiplatelet therapy after an acute coronary syndrome (ACS) is still unknown and debated. We sought to assess the incidence of adverse clinical events beyond 12 months after an ACS in patients treated by percutaneous coronary intervention (PCI) and clopidogrel. METHODS AND RESULTS: Among 1,592 consecutive ACS patients treated by PCI enrolled in the RECLOSE 2-ACS study and without event within one year, 1,310 (82%) patients presented at least one risk factor such as age ≥65 years, diabetes, prior myocardial infarction (MI), chronic kidney disease and multivessel coronary disease. The primary endpoint rate (the composite of cardiac death, MI, stroke and any urgent coronary revascularisation) was 3.7% per year after the first 12 months. The adverse event rate beyond 12 months was higher in patients with at least one risk factor as compared with patients without (8.1% vs. 1.8%, p<0.001). Each additional risk factor was associated with a relative risk for long-term adverse events of 1.66 (95% CI: 1.41-1.96; p=0.0001). Independent predictors of late events were age ≥65 years (OR 2.11, 95% CI: 1.38-3.37, p=0.002), insulin-treated diabetes mellitus (OR 2.29, 95% CI: 1.41-3.71, p=0.001), chronic kidney disease (OR 1.93, 95% CI: 1.21-3.09, p=0.006), prior MI (OR 2.71, 95% CI: 1.85-3.97, p=0.0001), and multivessel coronary disease (OR 1.53, 95% CI: 1.18-1.97, p=0.01). CONCLUSIONS: Patients at risk of adverse events beyond 12 months after an ACS may be identified by simple clinical and angiographic characteristics such as age, diabetes, chronic kidney disease, prior MI and multivessel CAD. The risk of adverse events progressively increases with the number of these high-risk features.

Long-Term Primary Patency Rate After Nitinol Self-Expandable Stents Implantation in Long, Totally Occluded Femoropopliteal (TASC II C & D) Lesions.

BACKGROUND: Endovascular therapy for long femoropopliteal lesions using percutaneous transluminal balloon angioplasty or first-generation of peripheral stents has been associated with unacceptable one-year restenosis rates. However, with recent advances in equipment and techniques, a better primary patency rate is expected. This study was conducted to detect the long-term primary patency rate of nitinol self-expandable stents implanted in long, totally occluded femoropopliteal lesions TransAtlantic Inter-Society Census (TASC II type C & D), and determine the predictors of reocclusion or restenosis in the stented segments. METHODS: The demographics, clinical, anatomical, and procedural data of 213 patients with 240 de novo totally occluded femoropopliteal (TASC II type C & D) lesions treated with nitinol self-expandable stents were retrospectively analysed. Of these limbs, 159 (66.2%) presented with intermittent claudication, while 81 (33.8%) presented with critical limb ischaemia. The mean-time of follow-up was 36±22.6 months, (range: 6.3-106.2 months). Outcomes evaluated were, primary patency rate and predictors of reocclusion or restenosis in the stented segments. RESULTS: The mean age of the patients was 70.9±9.3 years, with male gender 66.2%. Mean pre-procedural ABI was 0.45±0.53. One-hundred-and-seventy-five (73%) lesions were TASC II type C, while 65 (27%) were type D lesions. The mean length of the lesions was 17.9±11.3mm. Procedure related complications occurred in 10 (4.1%) limbs. There was no periprocedural mortality. Reocclusion and restenosis were detected during follow-up in 45 and 30 limbs respectively, and all were re-treated by endovascular approach. None of the patients required major amputation. Primary patency rates were 81.4±1.1%, 77.7±1.9% and 74.4±2.8% at 12, 24, and 36 months respectively. Male gender, severe calcification, and TASC II D lesion were independent predictors for reocclusion, while predictors of restenosis were DM, smoking and TASC II D lesions. CONCLUSIONS: Treatment of long, totally occluded femoropopliteal (TASC II C & D) lesions with nitinol self-expandable stents is safe and is associated with highly acceptable long-term primary patency rates.

Second vs. First generation drug eluting stents in multiple vessel disease and left main stenosis: Two-year follow-up of the observational, prospective, controlled, and multicenter ERACI IV registry.

OBJECTIVE: To compare second generation drug eluting stents (2DES) with first generation (1DES) for the treatment of patients (pts) with multiple coronary vessel disease (MVD). BACKGROUND: Although 2DES improved safety and efficacy compared to 1DES, MVD remains a challenge for percutaneous coronary interventions. METHODS: ERACI IV was a prospective, observational, and controlled study in pts with MVD including left main and treated with 2DES (Firebird 2, Microport). We included 225 pts in 15 sites from Argentina. Primary endpoint was the incidence of major adverse cardiovascular events (MACCE) defined as death, myocardial infarction (MI), cerebrovascular accident (CVA) and unplanned revascularization; and to compare with 225 pts from ERACI III study (1DES). PCI strategy was planned to treat lesions ≥70% in vessels ≥ 2.00 mm, introducing a modified Syntax score (SS) where severe lesions in vessels < 2.0 mm and intermediate lesions were not scored. RESULTS: Baseline characteristics showed that compared to ERACI III, ERACI IV pts had higher number of diabetics (P = 0.02), previous revascularization (P = 0.007), unstable angina IIb/IIIc (P < 0.001) and three vessels/left main disease (P = 0.003). Modified SS was 22.2 ± 11. At 2 years of follow-up ERACI IV group had significantly lower incidence of death+ MI + CVA, (P = 0.01) and MACCE (P = 0.001). MACCE rate was similar in diabetics, (5.8%) and nondiabetics (7.0%). After performing a matched propensity score, MACCE remain significantly lower in ERACI IV (P = 0.005). CONCLUSION: This registry showed that 2DES in MVD has a remarkable low incidence of MACCE in unadjusted and adjusted analysis. © 2016 Wiley Periodicals, Inc.

A New Risk Score to Predict Long-Term Cardiac Mortality in Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock and Treated With Primary Percutaneous Intervention.

Poor data exist about predictors of long-term cardiac mortality in patients presenting acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) treated with primary percutaneous coronary intervention (p-PCI), and current risk-adjustment models in this setting are not adequate. We retrospectively analyzed our registry of patients with AMI treated with p-PCI. The aim of this study was to identify the independent predictors of 2-year cardiac mortality in patients presenting CS. A Risk Score was created assigning at any independent variable a value directly correlated with its power to increase mortality. From 1995 to 2013, 4,078 consecutive patients underwent primary PCI for AMI. Of these, 388 patients (10.5%) had CS on admission. The p-PCI procedural success was 85%. At 2-year follow-up, the overall cardiac mortality rate was 48%. The independent predictors related with mortality were: out of hospital cardiac arrest (OHCA) (hazard ratio [HR] 1.51; p = 0.04), age >75 years (HR 2.09; p ≤0.001), and failure p-PCI (HR 2.30; p <0.001). On the basis of the HR obtained, we assigned an incremental value to each independent variable identified (OHCA: 0.5 points, age>75 years: 1 point, failed p-PCI: 1.5 points). The mortality rates among different score risk level were highly significant (p <0.001): 32% score risk 1 (points 0), 58% score risk 2 (points 0.5-2), and 83% score risk 3 (points >2), respectively. In conclusion, OHCA, age >75 years, and failed p-PCI are strong predictors of 2-year cardiac mortality. On the basis of this, a rapid score tool could be useful to identify patients at major risk of death.

Bleeding events and maintenance dose of prasugrel: BLESS pilot study.

OBJECTIVE: To evaluate changes in residual platelet reactivity (RPR) over time, and bleeding and ischaemic events rate using 5 vs 10 mg maintenance dose (MD) regimens of prasugrel 1 month after acute coronary syndrome (ACS). BACKGROUND: The optimal level of RPR with prasugrel may change over time after an ACS. METHODS: After 60 mg loading dose of prasugrel (T0) followed by 10 mg/day for 1 month, patients were randomised to receive prasugrel 10 mg/day (n=95, group A) or 5 mg/day MD (n=98, group B) up to 1 year. RPR was assessed at T0, 37 (T1) and 180 days (T2). The primary end point was Bleeding Academic Research Consortium (BARC) bleeding events ≥2 between 1 and 12 months, and the secondary composite end point was cardiac death, myocardial infarction, stroke and definite/probable stent thrombosis. RESULTS: From T0 to T1, RPR significantly increased in both groups A and B and the increase was higher for group B (δ ADP 10 µmol: 13.8%±14.7% vs 23.5%±19.2%, p=0.001). At T2 a lower rate of high RPR patients were found in group A (2.6% vs13.3%; p=0.014). The BARC type ≥2 bleeding occurred in 12.6% of group A versus 4.1% of group B (OR 0.29, 95% CI 0.09 to 0.94) and secondary end point in 2.1% vs 1.0% (p=0.542), respectively, without stent thrombosis. CONCLUSIONS: RPR increases shifting from 60 mg loading dose to 10 mg/day prasugrel MD with a further increase of RPR reducing prasugrel MD to 5 mg 1 month after ACS. Clinical value of these pharmacodynamic findings should be proved in larger clinical trials. TRIAL REGISTRATION NUMBER: NCT01790854.