Strike early-strike strong lipid-lowering strategy with PCSK9i in ACS patients. Real-world evidence from AT-TARGET-IT registry.

AIMS: No data are available on early initiation of proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) in patients with acute coronary syndrome (ACS) in real-world. This study investigates the effects of PCSK9i started at time of ACS hospitalization on lipid control and major CV events in real-world. METHODS: The lipid control outcome was the percentage of patients reaching the LDL-C target of < 55 mg/dL at first lipid control. The clinical outcome was the incidence of composite major CV events (all cause death, non-fatal MI, non-fatal stroke, and ischemia-driven revascularization) during follow-up in relation to quartiles of LDL-C at first lipid control. RESULTS: We included 771 patients with ACS from AT-TARGET-IT registry, receiving PCSK9i prescription during hospitalization or at discharge. Median LDL-C was 137 mg/dL and decreased to 43 mg/dL at first lipid control. 527 (68.3%) patients achieved LDL-C target at the first lipid control at a median time of 37 days from hospitalization; of them, 404 (76.8%) were discharged on statin plus ezetimibe background therapy. Event curves through a median follow-up of 11 months across quartiles of LDL-C showed a stepwise lower risk of 4P-MACE, 3P-MACE, all-cause mortality, and ischemia-driven revascularization in lower quartile of LDL-C values at first lipid control (<23 mg/dL) and in patients reaching LDL-C <55 mg/dL. CONCLUSIONS: Intensive and early lipid-lowering therapy using PCSK9i in patients with ACS (strike early strike strong strategy) is safe and effective in clinical practice and associated with a reduction of residual CV risk.

This study, from AT-TARGET-IT registry, investigates the effects of PCSK9i started at time of ACS hospitalization on lipid control and major CV events in real-world. Intensive and early PCSK9i therapy reduce composite major cardiovascular (CV) events in patients in reaching LDL-C target values. A strike early-strike strong strategy is safe and effective.

Efficacy, safety, adherence and persistence of PCSK9 inhibitors in clinical practice: A single country, multicenter, observational study (AT-TARGET-IT).

BACKGROUND AND AIMS: Proprotein Convertase Subtilisin/Kexin type 9 inhibitors (PCSK9i) are recommended in patients at high and very-high cardiovascular (CV) risk, with documented atherosclerotic CV disease (ASCVD), and for very-high risk patients with familial hypercholesterolaemia not achieving LDL-cholesterol (LDL-C) goal while receiving maximally tolerated dose of lipid-lowering therapy (LLT). However, single country real-life data, reporting the use of PCSK9i in clinical practice, are limited. Therefore, we designed AT-TARGET-IT, an Italian, multicenter, observational registry on the use of PCSK9i in clinical practice. METHODS: All data were recorded at the time of the first prescription and at the latest observation preceding inclusion in the study. RESULTS: 798 patients were enrolled. The median reduction in LDL-C levels was 64.9%. After stratification for CV risk, 63.8% achieved LDL-C target; of them, 83.3% took LLTs at PCSK9i initiation and 16.7% did not. 760 patients (95.2%) showed high adherence to therapy, 13 (1.6%) partial adherence, and 25 (3.1%) poor adherence. At 6 months, 99.7% of patients enrolled in the study remained on therapy; there were 519 and 423 patients in the study with a follow-up of at least 12 and 18 months, respectively. Persistence in these groups was 98.1% and 97.5%, respectively. Overall, 3.5% of patients discontinued therapy. No differences in efficacy, adherence, and persistence were found between alirocumab and evolocumab. CONCLUSIONS: PCSK9i are safe and effective in clinical practice, leading to very high adherence and persistence to therapy, and achievement of recommended LDL-C target in most patients, especially when used as combination therapy.

Management of aspirin intolerance in patients undergoing percutaneous coronary intervention. The role of mono-antiplatelet therapy: a retrospective, multicenter, study.

BACKGROUND: The optimal management of patients with aspirin intolerance undergoing stent implantation represents a challenge for physicians. The aim of this study was to assess the overall number of patients discharged with mono antiplatelet therapy after percutaneous coronary intervention (PCI). The most frequent aspirin intolerance symptoms in this population and the overall incidence of patient-oriented composite endpoints (POCE). METHODS: From January 2006 to June 2016 all patients discharged with mono-antiplatelet therapy because of aspirin intolerance/hypersensitivity/allergy and treated by means of PCI were included. Data about percutaneous treatments and aspirin intolerance were collected. POCE were evaluated at a twelve-month clinical follow-up comparing safety and efficacy of clopidogrel monotherapy versus new P2Y12 inhibitors. RESULTS: We collected 70 patients, that is 0.3% of the total amount of PCI in the considered period, 25 (35%) of them were women and the remaining 45 (65%) were men. An acute coronary syndrome (ACS) was the clinical presentation in 47 (67.1%) patients, with NSTEMI in 19 (27.1%) of them. Forty-six patients (65.7%) were treated with clopidogrel and 24 (34.3%) with new P2Y12 inhibitors. At one-year follow-up, 18 (25.7%) patients suffered a new clinically relevant adverse event, 5 (7.1%) died, 3 (4.3%) required a target vessel revascularization and 10 (14.3%) patients a target lesion revascularization. CONCLUSIONS: Our study evaluated patients with ACS or stable coronary artery disease undergoing PCI and treated with mono-antiplatelet therapy with P2Y12 inhibitors due to aspirin intolerance shows a 25% incidence of POCE at one year. Further studies with adequate sample size are required to evaluate the efficacy and safety of mono antiplatelet therapy in this clinical scenario.

Interventional catheterization after total cavopulmonary connection: experience in 68 patients.

BACKGROUND: Total cavopulmonary connection (TCPC) is performed in patients having a single ventricle to allow the passive flow of systemic venous blood to the lungs. Interventional catheterization is needed to treat residual defects or complications. AIMS: We discuss our results concerning 68 patients who had had TCPC from January 1995 to December 2010. METHODS: Initial and follow-up catheterization data were reviewed retrospectively. Mid-term results were evaluated by means of angiography and/or CT scan. RESULTS: Mean age at TCPC was 5 years (2.5-18); mean interval between TCPC and catheterization was 5.6 years (1.5-15). Sixty-nine catheterizations were performed in 53 patients. Eleven patients (21%) had low venous pressure, did not display a right-to-left shunt, and did not need any intervention. Fifteen patients (28%) had low venous pressure and only needed the closure of the fenestration. The remaining 27 patients (51%) needed the following interventions: embolization of venous vessels prompting right-to-left shunt (n = 15), stenting or reconnection of pulmonary arteries (n = 5), stenting or recanalization of systemic veins (n = 11), other procedures (n = 5). In 3 patients the fenestration could not be closed due to high venous pressure. After the interventions oxygen saturation increased from 90.5%± 4.8% to 94.7% ± 3.6% (P = 0.002). CONCLUSIONS: Our data show that 49% of patients with TCPC are in good condition late after surgery. However, half of these patients continue to need interventions generally aimed at suppressing stenoses at various levels of TCPC or at occluding vessels prompting right-to-left shunt. This population should enter a multicenter program aimed at identifying patients at risk.

Visualization of multiple catheters with electroanatomical mapping reduces X-ray exposure during atrial fibrillation ablation.

AIMS: Atrial fibrillation (AF) ablation still requires long procedural time and high radiation exposure with its related risk for the patient and the operators. This study was designed to compare three different approaches of AF ablation to verify the hypothesis that image integration with electroanatomic mapping allows minimal use of fluoroscopy. Therefore, we evaluated the procedure and fluoroscopy times of ablation using three imaging modalities: conventional fluoroscopy, image integration electroanatomic mapping, and a new electroanatomic mapping system that provides visualization of multiple catheters. METHODS AND RESULTS: One hundred and twenty patients with symptomatic refractory AF were enrolled in the study. Patients were randomly assigned to fluoroscopy alone (Group A, 40 patients), electroanatomic integration (Cartomerge®, Group B, 40 patients), and electroanatomic integration plus catheters visualization (Carto® 3 System, Group C, 40 patients) guided procedures. The ablation procedure aimed at isolating the pulmonary veins and creating lesion lines at the left atrial roof and left isthmus. Procedure and fluoroscopy parameters were recorded in all patients. Total procedure time and skin to catheter positioning time did not significantly differ between the groups. Total fluoroscopy time was statistically different between all three groups (Group A, 18'09″±5'00″; Group B, 9'48″±3'41″; Group C, 2'28″±1'40″; P<0.001). A significant difference was noted in ablation fluoroscopy time between all groups (P<0.001), mainly due to shortened fluoroscopy time in Group B (7'34″±3'15″) and Group C (0'21″±0'31″) when compared with Group A (16'07″±5'04″). CONCLUSION: Image integration and, to a larger extent, visualization of multiple catheters allowed a minimal use of fluoroscopy in transcatheter AF ablation.

Ablation of atrial fibrillation: does the addition of three-dimensional magnetic resonance imaging of the left atrium to electroanatomic mapping improve the clinical outcome?: a randomized comparison of Carto-Merge vs. Carto-XP three-dimensional mapping ablation in patients with paroxysmal and persistent atrial fibrillation.

AIMS: To compare in a randomized and prospective fashion the outcome of atrial fibrillation (AF) ablation either after one procedure or after two procedures using the Carto-XP vs. the Carto-Merge mapping system in two different AF populations. METHODS AND RESULTS: Two hundred and ninety-nine patients with paroxysmal and persistent AF were enrolled in the study. One hundred and fifty patients with paroxysmal or persistent AF were randomly assigned to the Carto-Merge group and 149 patients to the Carto-XP group. The Carto-Merge patients underwent magnetic resonance imaging (MRI) of left atrium (LA) the day before the ablation. The ablation scheme included electrical disconnection of the pulmonary veins plus linear lesions. In the Carto-Merge patients, the three-dimensional MRI of the LA reconstruction merged with the electroanatomical map, and in the Carto-XP patients, the electroanatomical map guided the procedure. Considering the overall population with paroxysmal AF, 54% maintained sinus rhythm (SR), whereas in the persistent AF population, SR was present in 43% of the patients at the 12-month follow-up. In patients with paroxysmal AF, 52% in the Carto-XP group and 55% in the Carto-Merge group maintained SR without drugs. Procedure durations and exposure to X-ray in the Carto-XP group were 94.6 +/- 17.5 and 40.4 +/- 13.5 min, respectively. In the Carto-Merge group, duration and X-ray exposure were 89 +/- 41.6 and 22.1 +/- 11.4 min, respectively. Considering the patients with persistent AF at the12-month follow-up, 44% in the Carto-XP group and 42% in the Carto-Merge group maintained SR without drugs. Procedure durations and X-ray exposure in the Carto-XP group were 102.9 +/- 22.9 and 58 +/- 8.7 min, respectively. In the Carto-Merge group, both duration and X-ray exposure were 114.4 +/- 50.9 and 28.8 +/- 14.3 min, respectively. CONCLUSION: Image integration using Carto-Merge in patients undergoing catheter ablation for paroxysmal and persistent AF does not significantly improve the clinical outcome, but shortens the X-ray exposure.

Long-term clinical results of 2 different ablation strategies in patients with paroxysmal and persistent atrial fibrillation.

BACKGROUND: Data regarding the long-term efficacy of atrial fibrillation (AF) ablation are still lacking. METHODS AND RESULTS: Two hundred four consecutive patients symptomatic for paroxysmal or persistent/permanent AF were randomly assigned to 2 different ablation schemes: pulmonary vein isolation (PVI) and PVI plus left linear lesions (LL). Primary end point was to assess the maintenance of sinus rhythm (SR) after procedures 1 and 2 in the absence of antiarrhythmic drugs in a long-term follow-up of at least 3 years. Paroxysmal AF- With a single procedure at 12-month follow-up, 46% of patients treated with PVI maintained SR, whereas at 3-year follow-up, 29% were in SR; using the "PVI plus LL" at the 12-month follow-up, 57% of patients were in SR, whereas at the 3-year follow-up, 53% remained in SR. After a second procedure, the long-term overall success rate without antiarrhythmic drugs was 62% with PVI and 85% with PVI plus LL. Persistent/Permanent AF- With a single procedure at the 12-month follow-up, 27% of patients treated with PVI were in SR, whereas at the 3-year follow-up, 19% maintained SR; using the PVI plus LL with a single procedure at the 12-month follow-up 45% of patients were in SR, whereas at the 3-year follow-up, 41% remained in SR. After a second procedure, the long-term overall success rate without antiarrhythmic drugs was 39% with PVI and 75% with PVI plus LL. CONCLUSIONS: A long-term follow-up of AF ablation shows that short-term results cannot be considered permanent because AF recurrences are still present after the first year especially in patients who have had "PVI" strategy. PVI isolation plus LL is superior to the PVI strategy in maintaining SR without antiarrhythmic drugs after procedures 1 and 2 both in paroxysmal and persistent AF.