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Dual antiplatelet therapy (DAPT) cessation increases the risk of adverse events after percutaneous coronary intervention (PCI). Whether risk changes over time, depends on the underlying reason for DAPT cessation, or both is unknown. We assessed associations between different modes of DAPT cessation and cardiovascular risk after PCI. The PARIS (patterns of non-adherence to anti-platelet regimens in stented patients) registry is a prospective observational study of patients undergoing PCI with stent implantation in 15 clinical sites in the USA and Europe between July 1, 2009, and Dec 2, 2010. Adult patients (aged 18 years or older) undergoing successful stent implantation in one or more native coronary artery and discharged on DAPT were eligible for enrolment. Patients were followed up at months 1, 6, 12, and 24 after implantation. Prespecified categories for DAPT cessation included physician-recommended discontinuation, brief interruption (for surgery), or disruption (non-compliance or because of bleeding). All adverse events and episodes of DAPT cessation were independently adjudicated. Using Cox models with time-varying covariates, we examined the effect of DAPT cessation on major adverse events (MACE [composite of cardiac death, definite or probable stent thrombosis, myocardial infarction, or target-lesion revascularisation]). Incidence rates for DAPT cessation and adverse events were calculated as Kaplan-Meier estimates of time to the first event. This study is registered with ClinicalTrials.gov, number NCT00998127. We enrolled 5031 patients undergoing PCI, including 5018 in the final study population. Over 2 years, the overall incidence of any DAPT cessation was 57·3%. Rate of any discontinuation was 40·8%, of interruption was 10·5%, and of disruption was 14·4%. The corresponding overall 2 year MACE rate was 11·5%, most of which (74%) occurred while patients were taking DAPT. Compared with those on DAPT, the adjusted hazard ratio (HR) for MACE due to interruption was 1·41 (95% CI 0·94–2·12; p=0·10) and to disruption was 1·50 (1·14–1.97; p=0·004). Within 7 days, 8–30 days, and more than 30 days after disruption, adjusted HRs were 7·04 (3·31–14·95), 2·17 (0·97–4·88), and 1·3 (0·97–1·76), respectively. By contrast with patients who remained on DAPT, those who discontinued had lower MACE risk (0·63 [0·46–0·86]). Results were similar after excluding patients receiving bare metal stents and using an alternative MACE definition that did not include target lesion revascularisation. In a real-world setting, for patients undergoing PCI and discharged on DAPT, cardiac events after DAPT cessation depend on the clinical circumstance and reason for cessation and attenuates over time. While most events after PCI occur in patients on DAPT, early risk for events due to disruption is substantial irrespective of stent type. Bristol-Myers Squibb and Sanofi-Aventis.

Conflicting results have been reported about the prognostic impact of left bundle branch block (LBBB) after transcatheter aortic valve implantation (TAVI). The aim of this study was to evaluate the impact of LBBB after TAVI on left ventricular (LV) function and remodeling and on 1-year outcomes. Of 101 TAVI patients, 9 were excluded. All complications were evaluated according to the Valve Academic Research Consortium 2 definition. Of 92 patients, 34 developed LBBB without more advanced myocardial damage or inflammation biomarkers in comparison with patients without LBBB. The only predictor of new LBBB was larger baseline LV end-diastolic volume. LBBB plus advanced atrioventricular block was strongly correlated with permanent pacemaker implantation (p <0.0001). Patients with LBBB had a higher rate of permanent pacemaker implantation at 30 days (59% vs 19%, p <0.0001) and less recovery of LV systolic function and a trend toward a lower rate of LV reverse remodeling at 1 year. The development of acute kidney injury and the logistic European System for Cardiac Operative Risk Evaluation score were associated with poor outcomes (all-cause mortality and heart failure) (hazard ratio 6.86, 95% confidence interval 2.51 to 18.74, p <0.0001, and hazard ratio 1.04, 95% confidence interval 1.01 to 1.08, p = 0.021, respectively), but not LBBB. In conclusion, after TAVI, 37% of patients developed new LBBB without more advanced myocardial damage or inflammation biomarkers. LBBB was associated with a higher rate of permanent pacemaker implantation, which negatively affected the recovery of LV systolic function. The development of acute kidney injury, rather than LBBB, increases the 1-year risk for mortality and hospitalization for heart failure.

Although transcatheter aortic valve implantation (TAVI) for severe aortic stenosis is becoming an established technique, the effect of gender-related differences is poorly described. We performed a gender-based comparison of high-risk patients undergoing TAVI with the self-expandable CoreValve Revalving System for severe aortic stenosis to evaluate early and mid-term clinical outcomes. From the Italian prospective CoreValve registry, 659 consecutive patients (55.8% women) who underwent TAVI were included in the present study. We analyzed the gender-based differences in terms of clinical, angiographic, and procedural features and the differences in the rate of early and mid-term major adverse cardiac and cerebrovascular events. The men were younger, presented more often with severe left ventricular dysfunction, and had a greater rate of previous myocardial infarction, coronary revascularization, peripheral artery disease, renal failure, and heart conduction disorders than the women. The logistic European System for Cardiac Operative Risk Evaluation score did not differ between the 2 groups. The overall unadjusted and adjusted analyses failed to show significant differences between genders in terms of major adverse cardiac and cerebrovascular events at a median follow-up of 13 months (range 8 to 18). At late follow-up (landmark analysis >12 months), a survival benefit was observed in women (hazard ratio 0.27, 95% confidence interval 0.09 to 0.84, p = 0.02). In conclusion, in this multicenter registry, the gender-based comparison of TAVI patients showed that men, despite the younger age, had more extensive atherosclerotic burden compared to women. Overall, the early and mid-term outcomes were similar between genders, although women might have a survival benefit with longer follow-up.

The benefits of adjunctive mechanical devices to prevent distal embolization in patients with acute myocardial infarction (AMI) are still a matter of debate. The aim of this meta-analysis was to combine data from all randomized trials conducted with adjunctive mechanical devices to prevent distal embolization in AMI. The literature was scanned by formal searches of electronic databases (MEDLINE and Central) from January 1990 to October 2006, scientific session abstracts (from January 1990 to October 2006), and oral presentation and/or expert slide presentations (from January 2002 to October 2006) (on the Transcatheter Cardiovascular Therapeutics, American Heart Association, European Society of Cardiology, American College of Cardiology, and European Percutaneous Revascularization Web sites). We examined all randomized trials on adjunctive mechanical devices to prevent distal embolization in AMI. The following key words were used: randomized trial, myocardial infarction, reperfusion, primary angioplasty, rescue angioplasty, thrombectomy, thrombus aspiration, proximal or distal protection device, X-sizer, Diver, Export Catheter, Angiojet, Rescue catheter, Pronto catheter, PercuSurge, GuardWire, FilterWire, and SpideRX. Disagreements were resolved by consensus. A total of 21 trials with 3721 patients were included (1877 patients [50.4%] in the adjunctive mechanical device group and 1844 [49.6%] in the control group); 1502 patients (40.3%) were randomized in trials with distal protection devices, and 2219 patients (59.7%) were randomized in trials with thrombectomy devices. Adjunctive mechanical devices were associated with a higher rate of postprocedural TIMI 3 flow (89.4% vs 87.1%, P = .03), a significantly higher rate of postprocedural myocardial blush grade 3 (48.8% vs 36.5%, P < .0001), and less distal embolization (6.0% vs 9.3%, P = .008), without any benefit in terms of 30-day mortality (2.5% vs 2.6%, P = .88). No difference was observed in terms of coronary perforations (0.27% vs 0.07%, P = .24). This meta-analysis demonstrates that, among patients with AMI treated with percutaneous coronary intervention, the use of adjunctive mechanical devices to prevent distal embolization is associated with better myocardial perfusion and less distal embolization, but without an apparent improvement in survival.

In ST-elevation myocardial infarction (STEMI) patients, residual platelet reactivity soon after a loading dose (LD) of prasugrel or ticagrelor is higher than that reported for healthy volunteers or subjects with stable coronary artery disease; and the majority of primary percutaneous coronary intervention (PPCI) procedures with bivalirudin monotherapy are performed without proper platelet inhibition. However, ticagrelor LD is just the daily dose, whereas prasugrel LD is 6-fold the long-term daily dose. We hypothesized that an increased ticagrelor LD may result in a faster and more effective platelet inhibition as compared with the standard prasugrel LD. Fifty patients with STEMI, pretreated with intravenous aspirin, undergoing PPCI were randomized to receive prasugrel 60-mg LD (n = 25) or ticagrelor 360-mg LD (n = 25). Residual platelet reactivity was assessed by VerifyNow at baseline and 1, 2, 4, and 12 hours after drug LD. At the time of LD, 90% of enrolled patients had an aspirin reactivity unit value <550. P2Y12 reaction units 1 hour after the LD (study primary end point) were 236 (129-289) and 248 (115-304) in the prasugrel and ticagrelor group, respectively (P = .899). High residual platelet reactivity (P2Y12 reaction units ≥240) was found in 43% and 56% of patients (P = .386) at 1 hour and in 30% and 32% of patients (P = .907) at 2 hours, respectively. There was no significant difference in bleeding, arrhythmias, or dyspnea episodes in the 2 groups. In patients with STEMI undergoing PPCI, double (360 mg) ticagrelor LD failed to achieve a faster and more intense platelet inhibition as compared with the standard prasugrel LD. Intravenously administered aspirin allowed to achieve a very early inhibition of acid arachidonic pathway.

There is a lack of clarity concerning the clinical implications of myocardial injury occurring after transcatheter aortic valve implantation (TAVI) procedures. The aim of this study was to determine the incidence, degree, and timing of myocardial injury associated with TAVI procedures and to evaluate its 1-year prognostic value. Among 68 consecutive patients (mean age 80.9 ± 6.4 years) treated with TAVI, 3 patients who died within 24 hours, precluding cardiac biomarker measurements, and 3 patients with major procedural complications were excluded. Cardiac troponin I, creatine kinase-MB, and creatinine levels were determined at baseline and 6, 12, 24, 48, and 72 hours after TAVI. All complications were defined according to the Valve Academic Research Consortium. Myocardial injury was observed in all patients (n = 62), as determined by an increase in cardiac troponin I (median peak at 12 hours 3.8 μg/L, interquartile range 1.8 to 25.67), and a higher degree of myocardial injury was observed in patients (n = 9) who developed acute kidney injury (AKI) (p = 0.026). Periprocedural myocardial infarction was not found. At 1-year follow-up, 5 patients had died, and 7 patients had been hospitalized for heart failure. The development of AKI, not the degree of peak cardiac troponin I (p = 0.348), was identified as the only strong independent predictor of 1-year mortality from any cause (including heart failure) after TAVI (hazard ratio 4.74, 95% confidence interval 1.12 to 20.03, p = 0.034). In conclusion, TAVI was systematically associated with myocardial injury, occurring with a higher degree in patients who developed AKI. However, the simultaneous development of AKI occurring after TAVI is the strongest predictor of 1-year mortality.

Coronary chronic total occlusion (CTO) carries a poor outcome in patients with acute myocardial infarction (AMI) treated with primary percutaneous coronary intervention (PCI). We sought to investigate the prognostic impact of a staged successful CTO-PCI in patients with AMI treated with primary PCI. Outcome analysis included consecutive patients treated by successful primary PCI with coexisting non–infarct-related artery CTO who survived after 1 week from AMI. A comparison between patients with successful CTO-PCI and patients with failed or nonattempted CTO-PCI was performed. The primary end points of the study were 1-year and 3-year cardiac survival. Of 1,911 patients who underwent successful primary PCI for AMI from 2003 to 2012, 169 (10%) had non–infarct-related artery CTO of a major branch. A staged CTO-PCI attempt was performed in 74 patients (44%) and was successful in 58 (success rate 78%). All patients with successful CTO-PCI received drug-eluting stents. In the successful CTO-PCI group, a complete coronary revascularization was achieved in 88% of the patients. The 1-year cardiac mortality rate was 1.7% in the successful CTO-PCI group and 12% in nonattempted or failed CTO-PCI group (p = 0.025). Successful CTO-PCI was an independent predictor of 3-year cardiac survival (hazard ratio 0.20, 95% confidence interval 0.05 to 0.92, p = 0.038). In conclusion, successful CTO-PCI in survivors after primary PCI is associated with improved long-term cardiac survival. •Chronic total occlusion (CTO) carries a poor outcome in patients with acute myocardial infarction (AMI) treated by primary percutaneous coronary intervention (PCI).•Prognostic impact assessment of staged successful CTO-PCI in patients with AMI.•Successful CTO-PCI in patients with AMI is associated with improved long-term survival.

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.

Cardiac surgery is the standard treatment for unprotected left main disease (ULM). Drug-eluting stent (DES) implantation has been recently reported in patients with ULM but with unclear results. We systematically reviewed outcomes of percutaneous DES implantation in ULM. Several databases were searched for clinical studies reporting on ≥20 patients and ≥6-month follow-up. The primary end point was major adverse cardiovascular events (MACEs; ie, death, myocardial infarction, or target vessel revascularization [TVR]) at the longest follow-up. Incidence and adjusted risk estimates were pooled with generic inverse variance random-effect methods (95% CIs). From 823 initial citations, 16 studies were included (1278 patients, median follow-up 10 months). Eight were uncontrolled registries, 5 nonrandomized comparisons between DES and bare-metal stents and 3 nonrandomized comparisons between DES and CABG, with no properly randomized trial. Meta-analysis for DES-based PCI showed, at the longest follow-up, rates of 16.5% (11.7%-21.3%) MACE, 5.5% (3.4%-7.7%) death, and 6.5% (3.7%-9.2%) TVR. Comparison of DES versus bare-metal stent disclosed adjusted odds ratios for MACE of 0.34 (0.16-0.71), and DES versus CABG showed adjusted odds ratios for MACE plus stroke of 0.46 (0.24-0.90). Meta-regression showed that disease location predicted MACE ( P = .001) and TVR ( P = .020), whereas high-risk features predicted death ( P = .027). Clinical studies report apparently favorable early and midterm results in selected patients with ULM. However, given their limitations in validity and the inherent risk for DES thrombosis, results from randomized trials are still needed to definitely establish the role of DES implantation instead of the reference treatment, surgery.

Left ventricular (LV) remodeling has been shown to occur in a relevant proportion of patients with acute myocardial infarction successfully treated with primary percutaneous coronary intervention. The development of LV remodeling after primary percutaneous coronary intervention is associated with increased mortality and with shorter event-free survival. Therapy to prevent or limit LV remodeling is of paramount importance, and it should be started in the early phase of reperfusion. Early identification of patients at risk for LV remodeling may have important prognostic and therapeutic implications. The pathophysiology, time course, and predictors of LV remodeling, as well as the relevant diagnostic techniques and therapeutic interventions evaluated to date, will be discussed.