Percutaneous Coronary Intervention For Acute Coronary Syndrome Research Articles

Prasugrel use and clinical outcomes by age among patients undergoing PCI for acute coronary syndrome: from the PROMETHEUS study.

Prasugrel is a potent thienopyridine that may be preferentially used in younger patients with lower bleeding risk. We compared prasugrel use and outcomes by age from the PROMETHEUS study. We also assessed age-related trends in treatment effects with prasugrel versus clopidogrel. PROMETHEUS was a multicenter acute coronary syndrome (ACS) percutaneous coronary intervention (PCI) registry. We compared patients in age tertiles (T1 < 60 years, T2 60-70years, T3 > 70years). Major adverse cardiac events (MACE) were a composite of death, myocardial infarction, stroke or unplanned revascularization. Data were adjusted using multivariable Cox regression for age-related risks and propensity score stratification for thienopyridine effects. The study included 19,914 patients: 7045 (35.0%) in T1, 6489 (33.0%) in T2 and 6380 (32.0%) in T3. Prasugrel use decreased from T1 to T3 (29.2% vs. 23.5% vs. 7.5%, p < 0.001). Crude 1-year MACE rates were highest in T3 (17.4% vs. 16.8% vs. 22.7%, p < 0.001), but adjusted risk was similar between the groups (p-trend 0.52). Conversely, crude incidence (2.8% vs. 3.8% vs. 6.9%, p < 0.001) and adjusted bleeding risk were highest in T3 (HR 1.24, 95% CI 0.99-1.55 in T2; HR 1.83, 95% CI 1.46-2.30 in T3; p-trend < 0.001; reference = T1). Treatment effects with prasugrel versus clopidogrel did not demonstrate age-related trends for MACE (p-trend = 0.91) or bleeding (p-trend = 0.28). Age is a strong determinant of clinical risk as well as prasugrel prescription in ACS PCI with much lower use among older patients. Prasugrel did not have a differential treatment effect by age for MACE or bleeding. Frequency of prasugrel use and age-related temporal risks of all-cause death and bleeding after ACS PCI.

714 Adherence to Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention

Current cardiac guidelines recommend dual antiplatelet therapy (DAPT) for 12 months to prevent stent thrombosis after a percutaneous coronary intervention (PCI). Non-adherence to DAPT increases the risk of stent thrombosis, especially within 6 months post-PCI. To characterise non-adherence to DAPT in patients who underwent PCI for acute coronary syndrome. Local participants were identified from the Victorian Cardiac Outcomes Registry who had been using DAPT or triple therapy for 4-6 or 8-10 months (groups 1 and 2, respectively) post-PCI. A structured phone interview was conducted using validated adherence tools (MMAS-4). Non-responders were sent a paper questionnaire. Ethics approval was obtained. 149 participants were enrolled (n=66 in group 1; n=83 in group 2, mean (standard deviation) age 65.4±10.7 years; 75.8% male), from which 117 (78.5%) participants were still taking the DAPT they were discharged on. The remaining 32 participants had stopped the discharged DAPT. Most patients stopped due to switching to another antiplatelet therapy (nine). Only three patients stopped due to non-adherence, from which two claimed that DAPT had been stopped in hospital. Other reasons to stop included side effects, after cardiology or general practitioner review and unknown. Patient discontinuation of DAPT is low at 4-6 and 8-10 month in this patient cohort. Most patients who stopped or changed DAPT did this in consultation with their medical practitioner. Clarifying a patient’s understanding of DAPT at the point of discharge is an important consideration in reducing the risk of non-adherence and thus avoiding early stent thrombosis.

Outcomes of acute coronary syndrome patients with concurrent extra-cardiac vascular disease in the era of transradial coronary intervention: A retrospective multicenter cohort study.

Extra-cardiac vascular diseases (ECVDs), such as cerebrovascular disease (CVD) or peripheral arterial disease (PAD), are frequently observed among patients with acute coronary syndrome (ACS). However, it is not clear how these conditions affect patient outcomes in the era of transradial coronary intervention (TRI). Among 7,980 patients with ACS whose data were extracted from the multicenter Japanese percutaneous coronary intervention (PCI) registry between August 2008 and March 2017, 888 (11.1%) had one concurrent ECVD (either PAD [345 patients: 4.3%] or CVD [543 patients; 6.8%]), while 87 patients (1.1%) had both PAD and CVD. Overall, the presence of ECVD was associated with a higher risk of mortality (odds ratio [OR]: 1.728; 95% confidence interval [CI]: 1.183-2.524) and bleeding complications (OR: 1.430; 95% CI: 1.028-2.004). There was evidence of interaction between ECVD severity and procedural access site on bleeding complication on the additive scale (relative excess risk due to interaction: 0.669, 95% CI: -0.563-1.900) and on the multiplicative scale (OR: 2.105; 95% CI: 1.075-4.122). While the incidence of death among patients with ECVD remained constant during the study period, bleeding complications among patients with ECVD rapidly decreased from 2015 to 2017, in association with the increasing number of TRI. Overall, the presence of ECVD was a risk factor for adverse outcomes after PCI for ACS, both mortality and bleeding complications. In the most recent years, the incidence of bleeding complications among patients with ECVD decreased significantly coinciding with the rapid increase of TRI.

P5536Comparison of safety and effectiveness between right and left radial artery approach in percutaneous coronary intervention for acute coronary syndrome. Propensity score analysis of data from the ORPKI

Abstract Introduction The use of the radial approach (RA) for percutaneous coronary intervention (PCI) has gradually increased. Several studies demonstrated that radial artery is associated with significant reduction in major adverse cardiac events for both coronary angiography and PCI in acute coronary syndrome (ACS). However, it is still unclear if the side of RA has influence on clinical outcomes in an all-comer population in ACS settings. Purpose We sought to evaluate safety, feasibility, and clinical outcomes of right radial approach (RRA) compared to left radial approach (LRA) during PCI in “real-world” patients with ACS. Methods A total of 234,087 consecutive patients with ACS treated with PCI and stent implantation via radial approach between 2014 and 2017 in 151 invasive cardiology centers on the Polish territory. Data was based on the ORPKI Polish National Registry. Patients treated with RRA and LRA were compared using a propensity score analysis to avoid possible selection bias. The analysis was done in an “as-treated” manner. Results Procedure was conducted using RRA and LRA in 180,378 (77.1%) and 53,709 (22.9%) patients, respectively. After propensity score matching higher total amount of contrast (174.28 (±75.56) vs. 166.95 (±70.57) [ml]; P=0.001) and radiation doses were reported in PCI with left radial artery utilization (1210.21 (±1003.53) vs. 1054.07 (±1024.17) [mGy]; p=0.001). No differences were observed between RRA and LRA in rate of periprocedural adverse events such as myocardial infarction (0.08% vs. 0.08%; p=0.9) stroke (0.02% vs. 0.01%; p=0.1), no-reflow phenomenon (0.64%vs. 0.56%; p=0.1) and death (0.25% vs. 0.24%; p=0.7). A trend towards a lower rate of access-site-related bleeding during PCI was observed in RRA group (0.08% vs. 0.05%; p=0.066). Coronary artery perforation (0.21% vs. 0.16%; p=0.05) and cardiac arrest (0.56% vs 0.42%; p=0.01) were reported more often during PCI conducted with LRA. Conclusions Both radial approaches seems to be equally effective in the setting of PCI in ACS. However, utilization of left radial artery was associated with trend toward increased risk of access-site bleeding and higher rate of periprocedural complications as compared to RRA. Higher amount of contrast and radiation doses used in LRA procedures might be equivalent of generally lower experience with this access site. Acknowledgement/Funding None

258Use of low-dose prasugrel vs. clopidogrel in elderly patients undergoing complex or non-complex PCI for acute coronary syndromes: insights from the Elderly ACS 2 study

Abstract Background Prasugrel was superior to clopidogrel in the setting of acute coronary syndromes (ACS) and recent data highlighted its possible role in the setting of complex percutaneous coronary intervention (PCI). Nonetheless, evidence supporting its use in high bleeding risk population are lacking. Purpose The aim of this post-hoc subgroup analysis was to evaluate the impact of prasugrel administration in elderly patients undergoing complex PCI for ACS. A primary composite endpoint of composite of mortality, myocardial infarction, disabling stroke and re-hospitalization for cardiovascular causes or bleeding within one year and secondary endpoints of all-cause mortality and any bleeding at 1 year were analyzed. Methods In the multicenter Elderly ACS 2 Study 1,443 patients aged &gt;74 y were randomly assigned to receive low-dose prasugrel (5 mg) or clopidogrel (75 mg) and were prospectively followed for 1 year (Table 1). Complex PCI was defined if ≥3 lesions were treated, if ≥3 stents were deployed, or if any bifurcation, trifurcation, chronic total obstruction or moderate-to-severe calcified lesions were treated. Results Patients undergoing complex PCI (n=607) did not experience worse outcome, as compared to those with simpler PCI, in terms of primary endpoint (p=0.21, Figure 1A). Furthermore, in this subgroup, no significant difference was observed with prasugrel vs clopidogrel with regard to the primary endpoint (HR 1.17; CI 0.819–1.67; p=0.39, Figure 1A), all-cause death and bleeding (Figure 1C and 1D). No significant interaction was observed between treatment and PCI complexity (interaction p=0.34). Table 1 Overall Non-complex PCI Complex PCI p value Age (y) 80.60±4.46 80.00 [77.00, 84.00] 80.00 [77.00, 83.00] 0.215 STE-ACS 595 (41.2) 272 (32.5) 323 (53.4) &lt;0.001 Diabetes mellitus 253 (17.5) 159 (19.0) 94 (15.5) 0.104 LVEF 48.27±9.59 49.08±9.55 47.26±9.54 0.002 Total number of diseased vessels 2.29±1.06 2.22±1.06 2.38±1.05 0.005 Previous Myocardial Infarction 274 (19.0) 171 (20.4) 103 (17.0) 0.122 Randomized to prasugrel 713 (49.4) 404 (48.2) 404 (48.2) 0.307 Data are expressed as mean ± SD or [IQR] and count/valid %). Figure 1 Conclusions In elderly patients presenting with ACS low-dose prasugrel was comparable to clopidogrel in terms of all-cause mortality and any bleeding at 1 year. Acknowledgement/Funding None

P1760Incidence and effects of stroke, MI and bleeding on mortality among patients with ACS undergoing PCI: a comparative analysis from the PROMETHEUS registry

Abstract Background Stroke represents a potentially calamitous complication among patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) even though its rates are relatively low. Data on the distribution of stroke occurrence over time and its overlap with myocardial infarction (MI) and bleeding after PCI is scarce. Purpose We sought to compare the occurrence and impacts of stroke, MI and bleeding on subsequent mortality in ACS patients undergoing PCI in contemporary clinical practice. Methods A total of 19,914 ACS patients who underwent PCI in the PROMETHEUS multi-center observational study were analyzed. We calculated the cumulative stroke incidence at 30 days and 1 year using Kaplan Meier (KM) method. We also compared the distribution of stroke, myocardial infarction (MI) and bleeding across time and evaluated the overlap between their occurrences. Predictors of 1 year stroke occurrence were identified through multivariable Cox-regression and stroke, MI and bleeding were entered as time-updated covariates to estimate their individual effects on subsequent mortality. Results Of the total number of patients, 244 patients (1.5%) had a stroke within 1 year. 48 of these patients also experienced an MI while another 48 patients experienced a bleeding event. Furthermore, 14 of these overlapping patients experienced a stroke, MI and bleeding event, all within the 1-year follow-up. Patients who sustained a stroke were more likely to have a prior history of cerebrovascular disease, peripheral artery disease, MI and heart failure compared to those who did not have a stroke. Mortality risk was significantly higher among those with stroke versus those without stroke (adjusted HR 4.84, p&lt;0.0001). However, the association attenuated over time with a much larger effect in the first 30 days of its occurrence (adjusted HR 17.7, p&lt;0.0001) versus beyond 30 days (adjusted HR 1.22; 95% CI: 0.6–2.46, p=0.58). Although the effects of MI and bleeding on subsequent mortality within 30 days of occurrence were significantly lower than stroke (adjusted HR 6.22, p&lt;0.0001; adjusted HR 7.30, p&lt;0.0001, respectively), their effects were more sustained on mortality beyond 30 days (adjusted HR 2.89, p&lt;0.0001; adjusted HR 3.05, p&lt;0.0001, respectively). Conclusion When compared with MI and bleeding, stroke had a substantially stronger impact on mortality that attenuated rapidly over time among ACS patients undergoing PCI. Optimization of modifiable risk factors and medication adherence are essential parts of management of stroke following PCI for ACS.

P4634Acute-phase high platelet reactivity with prasugrel loading is correlated with clinical outcomes during hospitalization in acute coronary syndrome

Abstract Background/Introduction Although high platelet reactivity (HPR) seems to be associated with adverse cardiovascular events after percutaneous coronary intervention (PCI), the relationship between post-procedure HPR with prasugrel loading and clinical outcomes in acute coronary syndrome (ACS) is still unclear. Moreover, factors contributing to HPR in ACS with prasugrel loading are also unknown. Purpose This study aimed to assess the impact of post-procedure HPR with prasugrel loading on clinical outcomes in ACS during hospitalization, as well as to define appropriate cut-off values and identify factors contributing to HPR. Methods We performed a single-centre, retrospective observational study that enrolled 132 patients who underwent emergent PCI for ACS with prasugrel loading. The P2Y12 reaction unit (PRU) value was measured immediately after PCI with the VerifyNowR System. The primary endpoint was major adverse cardiac events (MACE, defined as the composite of death, myocardial infarction, stroke, heart failure, ventricular arrhythmia needing defibrillation). Results Mean patient age (standard deviation) was 70.7 (±12.5) years, 76% were male, and average time from prasugrel intake to PRU calculation was 101 (±48.8) min. During a mean hospital stay of 15.4 (±8.0) days, there were 22 (16%) MACE events and 6 (4%) deaths. The post-procedure PRU value was 241±66. HPR was significantly higher in MACE group than non-MACE group [287 (±55) vs 232 (±64), p&lt;0.001]. The ROC curve analysis of PRU for discriminating significant in-hospital MACE showed a cut off value of 293 (sensitivity: 64%, specificity: 84% [AUC=0.764, p&lt;0.0001]). Thus, 33 patients (25%) were found to have HPR (PRU&gt;293) immediately after emergent PCI. Kaplan-Meier curve analysis showed MACE events occurred more frequently in the HPR group than in the non-HPR group (42% vs 8%, log rank p&lt;0.001). Multiple Cox regression analysis showed that peak creatine phosphokinase &gt;3,000 U/L and HPR were independent predictors of MACE in patients with ACS who underwent PCI (OR 4.96, 95% CI 1.86–13.26, p=0.001, and OR 7.52, 95% CI 2.73–20.7, p&lt;0.0001, respectively). HPR was significantly correlated with age, female sex, and reference lumen short diameter (pre-dilation) used in PCI. Conclusion HPR was significantly associated with adverse event during hospitalization in ACS patients. Female patients with large culprit lesion diameter were more likely to have HPR. Appropriate cut-off value of HPR in this study was 293. HPR in early-phase of ACS with prasugrel loading is a useful predictor of adverse events during hospitalization.

P3590Impact of right ventricular branch slow flow phenomenon post percutaneous coronary intervention for acute coronary syndrome to predict sustained right ventricular dysfunction

Abstract Background Although Right Ventricular dysfunction (RVD) is one of the predictor of poor prognosis, it is believed that ischemic RVD after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) restores quickly. Because right ventricular perfusion has more ischemic preconditioning compared with left ventricle, due to their complex perfusion system. However, little is known about the time courses of RVD after ACS-PCI andtheir prognosis. We evaluated the relationship between right ventricular branch slow flow phenomenon (RVB-SF) post ACS-PCI in right coronary artery (RCA) and RVD at 6–8 months follow-up. Method We retrospectively analyzed consecutive 82 patients who underwent PCI for ACS in proximal or mid portion of RCA from August 2011 to March 2018 in our institution. Finally, both baseline and follow-up data were obtained from 70 patients. We analyzed TIMI frame count (TFC) to confirm the presence of RVB-SF (TFC ≥40 frame) after PCI. We also analyzed right ventricular fractional area change (RVFAC) at baseline and follow-up using echocardiography to detect sustained RVD (RVFAC ≤35%). Result We divided the patients into two groups (RVB-SF: 36 patients, RVB non-SF: 34 patients). Patient clinical characteristics were similar in both groups (sex, age, risk factors, medication, onset to balloon time, left ventricular stroke volume, max creatine kinase). Baseline RVFAC and follow-up RVFAC was significantly smaller in RVB-SF than in RVB non-SF, respectively. (27.1±1.7% vs. 38.3±1.8%, 31.4±1.0% vs. 48.7±1.1%, P&lt;0.0001). However, ΔRVFAC (follow-up RVFAC – baseline RVFAC) was similar between groups. The size of inferior vena cava and systolic pulmonary artery pressure at follow-up were similar in both groups (12.1±0.6 mm vs. 11.7±0.7 mm, P=0.67, 25.7±1.5 mmHg vs. 25.2±1.5 mmHg, P=0.82). In RVB non-SF, 10 patients (29.4%) were diagnosed clinical RVAMI. However, follow-up RVFAC were similar and preserved in both groups (RVAMI: 48.1±1.3%, non-RVAMI: 49.9±1.9%, P=0.85). In RVB-SF, 19 patients (52.7%) were diagnosed clinical RVAMI. Follow-up RVFAC did not improved significantly in both groups (RVAMI: 30.4±1.4% vs. non-RVAMI: 32.6±1.5%, P=0.70). Multivariate analysis showed RVB-SF was the only independent predictor of sustained RVD at 6–8 months follow-up after ACS-PCI. Conclusion RVB-SF findings after ACS-PCI for RCA could predict sustained RVD at mid-term follow-up, which may indicate future prolonged RVD.

Benefit and Risks of Aspirin in Addition to Ticagrelor in Acute Coronary Syndromes

The role of aspirin as part of antiplatelet regimens in acute coronary syndromes (ACS) needs to be clarified in the context of newer potent P2Y12 antagonists. To evaluate the benefit and risks of aspirin in addition to ticagrelor among patients with ACS beyond 1 month after percutaneous coronary intervention (PCI). This is a nonprespecified, post hoc analysis of GLOBAL LEADERS, a randomized, open-label superiority trial comparing 2 antiplatelet treatment strategies after PCI. The trial included 130 secondary/tertiary care hospitals in different countries, with 15 991 unselected patients with stable coronary artery disease or ACS undergoing PCI. Patients had outpatient visits at 1, 3, 6, 12, 18, and 24 months after index procedure. The experimental group received aspirin plus ticagrelor for 1 month followed by 23-month ticagrelor monotherapy; the reference group received aspirin plus either clopidogrel (stable coronary artery disease) or ticagrelor (ACS) for 12 months, followed by 12-month aspirin monotherapy. In this analysis, we examined the clinical outcomes occurring between 31 days and 365 days after randomization, specifically in patients with ACS who, within this time frame, were assigned to receive either ticagrelor alone or ticagrelor and aspirin. The primary outcome was the composite of all-cause death or new Q-wave myocardial infarction. Of 15 968 participants, there were 7487 patients with ACS enrolled; 3750 patients were assigned to the experimental group and 3737 patients to the reference group. Between 31 and 365 days after randomization, the primary outcome occurred in 55 patients (1.5%) in the experimental group and in 75 patients (2.0%) in the reference group (hazard ratio [HR], 0.73; 95% CI, 0.51-1.03; P = .07); investigator-reported Bleeding Academic Research Consortium-defined bleeding type 3 or 5 occurred in 28 patients (0.8%) in the experimental group and in 54 patients (1.5%) in the reference arm (HR, 0.52; 95% CI, 0.33-0.81; P = .004). Between 1 month and 12 months after PCI in ACS, aspirin was associated with increased bleeding risk and appeared not to add to the benefit of ticagrelor on ischemic events. These findings should be interpreted as exploratory and hypothesis generating; however, they pave the way for further trials evaluating aspirin-free antiplatelet strategies after PCI. ClinicalTrials.gov identifier: NCT01813435.

Safety and cost analysis of early discharge following percutaneous coronary intervention for acute coronary syndrome in patients with diabetes mellitus.

ObjectiveTo evaluate the safety and cost of early discharge compared with ordinary discharge in patients with diabetes mellitus (DM) following percutaneous coronary intervention (PCI) for acute coronary syndrome.MethodsWe performed a retrospective analysis of prospectively collected data from 474 patients with DM who were discharged from hospital following PCI at a regional center between 2012 and 2015.ResultsA total of 192 patients (40.5%) were included in the early discharge group and 282 patients (59.5%) were included in the ordinary group. Mortality and morbidity after PCI were recorded. Kaplan–Meier analysis showed similar prognosis between the two groups at 30 days and at 1 year after discharge. However, hospitalization expenses for the regular discharge group were significantly higher than those of the early discharge group (RMB65,750 vs. RMB50,983).ConclusionOur findings demonstrate that early discharge of patients with DM following PCI for acute coronary syndrome is safe compared with ordinary discharge, and may reduce hospitalization costs.

Application of virtual histological intravascular ultrasound in plaque composition assessment of saphenous vein graft diseases.

Objective:Saphenous vein grafts disease (SVGD) is a common complication after coronary artery bypass graft (CABG) and normally treated by percutaneous coronary intervention (PCI). The most common complication after SVG-PCI is slow or no-reflow. It is known that the no-reflow phenomenon occurs in up to 15% of the SVG-PCI and is associated with high risk of major adverse cardiac events (MACEs) and mortality, therefore, it is important to investigate the factors that could predict the clinical outcome of PCI for risk stratification and guiding interventions. In recent years, the spectral analysis of intravascular ultrasound (IVUS) radiofrequency data (virtual histology-IVUS [VH-IVUS]) has been used to provide quantitative assessment on both plaque compositions and morphologic characteristics.Data sources:The PubMed, Embase, and Central databases were searched for possible relevant studies published from 1997 to 2018 using the following index keywords: “Coronary artery bypass grafting,” “Saphenous venous graft disease,” “Virtual histology-intravascular ultrasound,” “Virtual histology-intravascular ultrasound,” and “Percutaneous coronary intervention.”Study selection:The primary references were Chinese and English articles including original studies and literature reviews, were identified and reviewed to summarize the advances in the application of VH-IVUS techniques in situ vascular and venous graft vascular lesions.Results:With different plaque components exhibiting a defined spectrum, VH-IVUS can classify atherosclerotic plaque into four types: fibrous tissue (FT), fibro fatty (FF), necrotic core (NC), and dense calcium (DC). The radiofrequency signal is mathematically transformed into a color-coded representation, including lipid, fibrous tissue, calcification, and necrotic core. Several studies have demonstrated the independent relationship between VH-IVUS–defined plaque classification or plaque composition and MACEs, but a significant association between plaque components and no-reflow after PCI in acute coronary syndrome. In recent years, VH-IVUS are applied to assess the plaque composition of SVGD, based on the similarity of pathophysiological mechanisms between coronary artery disease (CAD) and SVGD, further studies with the larger sample size, the long-term follow-up, multicenter clinical trials may be warranted to investigate the relationship between plaque composition of saphenous vein graft (SVG) by VH-IVUS and clinical outcomes in patients with SVGD undergoing PCI.Conclusions:In degenerative SVG lesions, VH-IVUS found that plaque composition was associated with clinical features, future studies need to explore the relationship between VH-IVUS defined atherosclerotic plaque components and clinical outcomes in SVGD patients undergoing PCI, an innovative prediction tool of clinical outcomes can be created.

Safety and efficacy of the COMBO bio-engineered stent in an all-comer PCI cohort: 1-Year final clinical outcomes from the MASCOT post-marketing registry

BackgroundThe COMBO stent (OrbusNeich Medical, Ft. Lauderdale, Florida) is a new-generation bio-engineered drug eluting stent, combining an abluminal coating of a bioabsorbable polymer matrix for sustained release of sirolimus and luminal anti-CD34 coating for endothelial progenitor cell capture and rapid endothelialization. MethodsThe Multinational Abluminal Sirolimus Coated BiO-Engineered StenT (MASCOT) registry was a prospective post-marketing study conducted from June 2014–May 2017 across 60 centers globally. Patients were eligible if COMBO stent implantation was attempted, and they received dual antiplatelet therapy (DAPT) per local guidelines. Follow-up was conducted by trained research staff at 1, 6 and 12 months by phone or clinic visit to capture clinical events and DAPT cessation events. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, non-fatal myocardial infarction not clearly attributable to a non-target vessel, or ischemia-driven target lesion revascularization. ResultsA total of 2614 patients were enrolled over the study period with 96.7% completion of 1-year follow-up. The mean age of enrolled patients was 62.9 ± 11.2 years and 23.0% were female. Diabetes mellitus was present at baseline in 33.5%. A total of 56.1% patients underwent PCI for acute coronary syndrome (ACS). The 1-year primary endpoint of TLF occurred in 3.4% patients (n = 88). Definite stent thrombosis occurred in 0.5% patients (n = 12). ConclusionThe MASCOT post marketing registry provides comprehensive safety and efficacy outcomes following contemporary PCI using the novel COMBO stent in an all-comer population. This platform is associated with low rates of 1-year TLF and ST. Clinicaltrials.gov identifierNCT02183454.

Gender Disparity in Secondary Prevention Medication and Outcomes Following Percutaneous Coronary Intervention for Acute Coronary Syndrome

Background: Women continue to receive suboptimal secondary prevention medications following acute coronary syndrome (ACS), however, impact on long-term outcomes are not well documented. Methods: We analysed data on medical management 30-days post percutaneous coronary intervention for ACS in 20,976 consecutive patients in the Melbourne Interventional Group registry (2005-2018). Optimal medical therapy (OMT) was defined as 5 guideline-recommended medications, near-optimal (NMT) as 4 medications, and sub-optimal (SMT) as ≤3 medications. Long-term mortality was determined by National-Death Index linkage. Results: 65% of patients were prescribed OMT, 27% NMT and 8% SMT. Mean age 64 ± 12 years; 24% (4,931) female. Women were older (68 ± 12 vs. 62 ± 12 years) and had more comorbidities (higher BMI, hypertension, dyslipidaemia, diabetes and renal failure) than males, all p ≤ 0.001. Women were less likely to receive OMT (61% vs. 66%) and more likely to receive SMT (10% vs. 8%) compared to men, p < 0.001. At 12-months (n = 17,224) women were more likely to have recurrent MI (6% vs. 5%, p = 0.001), major bleeding (2.3% vs. 0.9%, p = 0.001), stroke (1.5% vs. 0.8%, p < 0.001) and MACE (13% vs. 11%, p = 0.026). At mean 5.3 year follow up, women had higher mortality (20% vs. 13%, p < 0.001). Conclusion: Women are less likely to be prescribed optimal secondary prevention medications following ACS and have poorer 12-month outcomes and long-term survival.

Efficacy and safety of short-term dual antiplatelet therapy (≤6 months) after percutaneous coronary intervention for acute coronary syndrome: A systematic review and meta-analysis of randomized controlled trials.

Patients who undergo percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) are at increased risk for subsequent ischemic events. Short-term dual antiplatelet therapy (DAPT) (≤6 months) is inferior to standard or long-term DAPT in patients who undergo PCI for ACS events. We conducted a systematic review and meta-analysis of randomized controlled trials that compared short-term (≤6 months) to long-term (≥12 months) DAPT after PCI for ACS. We searched MEDLINE, EMBASE, SCOPUS, and the Cochrane Central Register of Controlled Trials database. Ten randomized controlled trials, including a total of 12 696 patients, met our inclusion criteria. For short-term DAPT, duration of therapy ranged from 3 to 6 months, while long-term DAPT ranged from 12 to 24 months. The majority of studies used clopidogrel and second-generation drug-eluting stents. No statistically significant difference was found between short-term and long-term DAPT with regard to myocardial infarction (odds ratio 1.21; 95% confidence interval 0.94-1.57; P = 0.14), stent thrombosis (odds ratio 1.54; 95% confidence interval 1.00-2.38; P = 0.052), or major bleeding events (odds ratio 0.74; 95% confidence interval 0.49-1.11; P = 0.14). There was no significant difference in all-cause mortality, cardiac death, or net adverse cardiac and cerebrovascular events. Our meta-analysis demonstrated that short-term DAPT (<6 months) after PCI for ACS was not associated with increased risk of myocardial infarction or stent thrombosis when compared to long-term DAPT.

Rationale and design of PREvalence of DyspneA in patients treated with TicagrelOR (PREDATOR) program

Background: Ticagrelor, a reversible P2Y12 inhibitor, is a mainstay of antiplatelet strategy in patients with acute coronary syndrome (ACS). However, a large number of ticagrelor-induced dyspnea decrease patients’ adherence and reduce an overall efficacy of the therapy. Design: The PREDATOR program consists of phase III and IV, multicenter, randomized, double-blind, placebo-controlled clinical trials and preceding pilot studies that assesses the prevalence and treatment of ticagrelor-induced dyspnea in coronary artery disease (CAD) and ACS patients. The PREDATOR LD is designed to evaluate the occurrence of dyspnea after 180 mg ticagrelor loading dose, and relief of dyspnea by theophylline administration in low-to-high risk acute coronary syndromes without ST-segment elevation (NSTE-ACS) and stable CAD designated to undergo invasive treatment. The PREDATOR MD is a cross-over trial in stable CAD patients 1 year after percutaneous coronary intervention for ACS. Enrolled patients will be randomized to one of four antiplatelet treatment regimens (ticagrelor 2x90 mg, ticagrelor 2x60 mg, ticagrelor 2x45 mg or clopidogrel 75 mg [morning]+placebo [evening]) or placebo and will be assessed for dyspnea at the day 7, then undergo a switch of treatment and reassessment at day 14. The sample size will be estimated based on preceding pilot studies. Discussion: The PREDATOR LD is expected to prospectively assess dyspnea rate with a loading dose of ticagrelor, and analyze a potential of theophylline to elevate symptoms of ticagrelor-induced dyspnea, while the PREDATOR MD will prospectively assess dyspnea and adverse events rate with a maintenance dose of P2Y12 inhibitors prospectively assess. All evaluations will be conducted using standardized metrics for dyspnea quantification.

Coronary perfusion pressure and left ventricular hemodynamics as predictors of cardiovascular collapse following percutaneous coronary intervention.

Appropriate patient selection for mechanical circulatory support following percutaneous coronary intervention (PCI) remains a challenge. This study aims to evaluate the role of coronary perfusion pressure and other left ventricular hemodynamics to predict cardiovascular collapse following PCI. We retrospectively analyzed all patients who underwent PCI for acute coronary syndrome (ACS) from 2003 to 2016. Coronary perfusion pressure was calculated for each patient and defined as the difference in mean arterial pressure and left ventricular end diastolic pressure (LVEDP). Logistic regression analysis was performed to determine predictor of composite outcome of in-hospital mortality, myocardial infarction (MI), congestive heart failure (CHF), and cardiogenic shock. Nine hundred twenty-two patients were analyzed. Two-hundred twenty-eight (25%) presented with ST-elevation MI (STEMI) while 694 (75%) underwent PCI for unstable angina or non-Q-wave MI. The mean LVEDP was significantly higher in the STEMI patients (24 ± 9 vs. 19 ± 8 mm Hg, p < 0.05) and perfusion pressure significantly lower (68 ± 24 vs. 74 ± 18 mm Hg, p < 0.05). Eighty-seven (9.4%) reached the composite endpoint, and there was no difference between the STEMI and Not-STEMI groups. Neither LVEDP nor coronary perfusion pressure was a predictor of the composite outcome following multivariable logistic regression analysis for either STEMI or Not-STEMI patients. Increasing age, chronic renal insufficiency (CRI), CHF, and low left ventricular ejection fraction were predictors of the composite outcome for Not-STEMI patients, whereas only history of cerebrovascular accident and CRI were predictors for STEMI patients. In hemodynamically stable patients presenting with ACS, LVEDP and coronary perfusion pressure are not predictive of in-hospital cardiovascular collapse. The authors retrospectively analyzed 922 patients from a single center who underwent percutaneous coronary intervention (PCI) for acute coronary syndromes to evaluate the role of coronary perfusion pressure and other left ventricular hemodynamics to predict cardiovascular collapse following PCI. They found that neither coronary perfusion pressure nor left ventricular end diastolic pressure was predictive of in-hospital cardiovascular collapse.

Short-term effect of percutaneous coronary intervention on ischemic mitral regurgitation

BackgroundThe effect of revascularization by PCI for acute coronary syndrome (ACS) on the severity of ischemic mitral regurge (IMR) is still unclear. ObjectiveTo evaluate the effect of successful total revascularization by PCI for ACS on the degree of IMR. MethodsA total of 240 patients presenting with ACS for the first time were studied by this an open-label, multicenter, prospective clinical trial between July 2015 to February 2017. All patients were subjected for clinical assessment, transthoracic echocardiographic assessment and coronary angiography. The patients divided into two groups: group A; those who had undergone successful total revascularization of a significant coronary artery disease using PCI, and group B; those who had optimal medical treatment with no total revascularization, failed PCI or for CABG. Group A patients subdivided into subgroup I, patients with improvement of the IMR; and subgroup II, patients with no improvement of IMR. ResultsOnly 65% of the patients showed IMR and 149 of them underwent successful complete revascularization by PCI; 68% of them showed IMR improvement and 32% showed no improvement. There was a significant improvement of the IMR degree after total revascularization by PCI. Moreover, this improvement was significant in subgroup I (p < 0.001). Percutaneous coronary intervention, EF and SWMI were significant predictors of IMR improvement following successful complete revascularization. ConclusionSuccessful total revascularization by early PCI improve IMR degree.

Thrombomodulin can predict the incidence of second events in patients with acute coronary syndrome: Single-center, retrospective cohort study

BackgroundPlasma levels of atherothrombosis-related markers such as endothelial biomarkers have been reported to predict the risk of first acute coronary syndrome (ACS) events. Percutaneous coronary intervention (PCI) by balloon angioplasty and stenting established as a treatment for ACS enabled early discharge and early clinic care. The procedure of PCI, however, may itself be associated with arterial injury with endothelial dysfunction. The clinical significance of those biomarkers for second events in patients after PCI has not yet been completely understood to identify patients who need strict follow-up. MethodsAfter the exclusion of 100 patients (60 deaths during hospitalization, 40 severe renal failure), 400 ACS patients (291 males, 71.1±13.0 years) who had undergone successful PCI followed by biomarker assessment within the first postoperative hour were enrolled. We evaluated atherothrombosis-related biomarkers: thrombomodulin (TM), C-reactive protein (CRP), and D-dimer, prothrombin fragment F1+2, and plasminogen activator inhibitor-1, other than those assessed by routine biochemical tests. The outcome after PCI in ACS patients was assessed by the incidence of major adverse cardiovascular events (MACEs). ResultsMACEs occurred in 112 patients during the follow-up period (813.9±474.8 days). As in previous reports, patients with MACEs showed decreased left ventricular ejection fraction (LVEF) by echocardiography, elevated brain natriuretic peptide and HbA1c than patients without MACEs. Not only these markers but also TM were significantly associated with MACEs in multivariate analysis. There were no significant correlations between MACEs and CRP. The association between TM and MACEs was especially high (odds ratio 2.73) and unaffected by the stage of cardiac (≤40, 40<LVEF≤55, 55<%) or renal function (≤40, 40<creatinine clearance≤75, 75<ml/min). ConclusionsTM is independently associated with MACEs and may be predictive of second events in patients after PCI for ACS. ACS patients with high TM value need strict follow up.

Association of Beta-Blockers with Survival on Patients Presenting with ACS Treated with PCI: A Propensity Score Analysis from the BleeMACS Registry

The aim was to evaluate prognostic value of beta-blocker (BB) administration in acute coronary syndromes (ACS) patients in the percutaneous coronary intervention (PCI) era. The BleeMACS project is a multicenter, observational, retrospective registry enrolling patients with ACS worldwide in 15 hospitals. Patients discharged with BB therapy were compared to those discharged without a BB before and after propensity score with matching. The primary endpoint was all-cause mortality at 1year. Secondary endpoints included in-hospital reinfarction, in-hospital heart failure, 1-year myocardial infarction, 1-year bleeding and 1-year composite of death and recurrent myocardial infarction. After matching, 2935 patients for each group were enrolled. The primary endpoint of 1-year death was significantly lower in the group on BB therapy (4.5 vs 7%, p < 0.05), while only a trend was noted for recurrent acute myocardial infarction (4.5 vs 4.9%, p = 0.54). These results were consistent for patients older than 80years of age, for ST-elevation myocardial infarction (STEMI) patients, and for those discharged with complete versus incomplete revascularization, but not for non-STEMI/unstable angina patients. BB therapy was related to 1-year lower risk of all-cause mortality, independently from completeness of revascularization, admission diagnosis, age and ejection fraction. Randomized controlled trials for patients treated with PCI for ACS should be performed.

The relationship between timing of prasugrel pretreatment and in-stent thrombus immediately after percutaneous coronary intervention for acute coronary syndrome: an optical coherence tomography study.

The optimal timing of pretreatment with prasugrel in percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) is unclear. We used optical coherence tomography (OCT) to compare in-stent thrombus volume immediately after PCI between the administration of low-dose prasugrel (20mg loading dose) at the time of diagnosis of ACS (early prasugrel: n = 34) and the administration of low-dose prasugrel immediately after diagnostic angiography prior to PCI for ACS (late prasugrel: n = 56). The durations between the administration of prasugrel and OCT in the early prasugrel group and late prasugrel group were 5.1 ± 6.5 and 0.9 ± 0.7h, respectively (p < 0.001). OCT detected thrombus/plaque protrusion in all stented segments. In-stent thrombus/plaque protrusion volume (2.92 ± 1.96 vs. 6.48 ± 4.97mm3, p < 0.001), mean in-stent thrombus/plaque protrusion area (0.13 ± 0.07 vs. 0.29 ± 0.23mm2, p < 0.001) and maximum in-stent thrombus/plaque protrusion area (0.70 ± 0.36 vs. 1.06 ± 0.56mm2, p < 0.001) were significantly smaller in the early prasugrel group as compared with the late prasugrel group. The administration of prasugrel at the time of diagnosis of ACS was associated with significantly reduced in-stent thrombus/plaque protrusion immediately after PCI as compared with the administration of prasugrel after the coronary angiography prior to PCI.