Thrombus aspiration in patients with ST-elevation myocardial infarction: results of a national registry of interventional cardiology.

BACKGROUND: We aimed to evaluate the impact of thrombus aspiration (TA) during primary percutaneous coronary intervention (P-PCI) in 'real-world' settings. METHODS: We performed a retrospective study, using data from the National Registry of Interventional Cardiology (RNCI 2006-2012, Portugal) with ST-elevation myocardial infarction (STEMI) patients treated with P-PCI. The primary outcome, in-hospital mortality, was analysed through adjusted odds ratio (aOR) and 95% confidence intervals (95%CI). RESULTS: We assessed data for 9458 STEMI patients that undergone P-PCI (35% treated with TA). The risk of in-hospital mortality with TA (aOR 0.93, 95%CI:0.54-1.60) was not significantly decreased. After matching patients through the propensity score, TA reduced significantly the risk of in-hospital mortality (OR 0.58, 95%CI:0.35-0.98; 3500 patients). CONCLUSIONS: The whole cohort data does not support the routine use of TA in P-PCI, but the results of the propensity-score matched cohort suggests that the use of selective TA may improve the short-term risks of STEMI.

Circulating miR-122-5p/miR-133b Ratio Is a Specific Early Prognostic Biomarker in Acute Myocardial Infarction.

BACKGROUND: MicroRNAs (miRNAs) are key players in cardiovascular development and disease. However, not only miRNAs of a cardiac origin have a critical role in heart function. Recent studies have demonstrated that miR-122-5p, a hepatic miRNA, increases in the bloodstream during ischemic cardiogenic shock and it is upregulated in the infarcted myocardium. The aim of the present study was to determine the potential of circulating miR-122-5p as a biomarker for early prognostic stratification of ST-segment elevation acute myocardial infarction (STEMI) patients. METHODS AND RESULTS: One hundred and forty-two consecutive STEMI patients treated with primary angioplasty were included in the study. Serum levels of miR-1-3p, -122-5p, -133a-3p, -133b, -208b-3p and -499a-5p were measured at the time of cardiac catheterization by quantitative polymerase chain reaction and related to in-hospital and long-term outcome. During a follow up of 20.8 months, 9 patients died, 6 had recurrence of myocardial infarction, and 26 patients suffered an adverse cardiovascular event. Event-free survival was significantly worse in patients with a higher miR-122-5p/133b ratio (3rd tertile distribution, above 1.42 Log(10)), having almost a 9-fold higher risk of death or myocardial infarction and a 4-fold higher risk of adverse cardiovascular events. CONCLUSIONS: This study showed that the miR-122-5p/133b ratio is a new prognostic biomarker for the early identification of STEMI patients at a higher risk of developing major adverse events after undergoing primary percutaneous coronary intervention. (Circ J 2016; 80: 2183-2191).

Chest pain in a patient with pulmonary arterial hypertension.

Chest pain is a frequent symptom in patients with pulmonary arterial hypertension (PAH). Left main coronary artery (LMCA) extrinsic compression from a pulmonary artery (PA) is an increasingly recognized cause of angina or complications, such as acute myocardial infarction, left ventricular dysfunction, arrythmia, and sudden death. We report the case of a 45-year-old patient with pre-capillary pulmonary hypertension (PH), a patent ductus arteriosus corrected surgically during adolescence, and chronic constrictive bronchiolitis. In 2016, the patient began to report oppressive chest pain and worsening fatigue. Computed tomography coronary angiography (CTCA) showed extrinsic LMCA compression by a dilated PA, which was confirmed by invasive coronary angiography and intravascular ultrasound. After stent implantation, the patient reported symptom resolution, and has been asymptomatic ever since. Imaging studies, in particular CTCA, play an important role in the diagnosis of LMCA compression in patients with PAH. The reported case supports the efficacy and safety of stent implantation as a therapeutic option, as already demonstrated in the literature. It shows the complexity of decision making on the operability of systemic-to-pulmonary shunts and reinforces the importance of continuous diagnostic testing.

Five-year clinical results of coronary angioplasty with drug-eluting stents. National initiative in strategic innovation, iNOS.

INTRODUCTION: The use of drug-eluting stents (DES) is beneficial in patients undergoing percutaneous coronary intervention (PCI) and there is particular interest in long-term follow-up. OBJECTIVE: We aimed to assess and characterize early DES use in Portugal during 2003 and patient follow-up over a 5-year period. We developed a web-based database to collect and organize patient and procedural data from PCI performed in ten cardiovascular interventional centers sharing the same database. METHODS: This was a multicenter retrospective study that included 1833 consecutive angiographically successful coronary angioplasties in which a DES was implanted in 2003. A subgroup of patients with 5-year clinical follow-up after the initial procedure was selected for which there was at least a 90% follow-up rate during one quarter of 2003. Demographic, clinical and angiographic characteristics of the entire population were assessed. In the clinical follow-up cohort, the incidence of major adverse cardiac events (MACE)--death, myocardial infarction and surgical or percutaneous target lesion revascularization--was analyzed by survival curves and logistic regression analysis. RESULTS: Of the total population, 23% were female, and mean age was 62 +/- 11 years (25-92). The main risk factors were hypertension (60.5%), dyslipidemia (42.9%), smoking (45.1%) and diabetes (23.9%, of whom 13.2% were on insulin therapy). There was a history of myocardial infarction, PCI or bypass surgery respectively in 23.1%, 25.1%, and 9.7% of the patients. Multivessel disease was present in 59.9% of patients (mean of 1.86 +/- 0.81 vessels). PCI was performed on average in 1.24 +/- 0.48 lesions, and complete revascularization in 58.8%. A total of 2058 stents were used (mean of 1.62 +/- 0.84) in 1271 patients. The longitudinal substudy included only 320 PCIs, for which follow-up was achieved in 319 (99%; median: 1875 days, P25: 1457 days, P75: 2045 days). Thirty-seven deaths (11.6%) and 61 MACE (19.1%) occurred in this group, with no differences between insulin-treated and other diabetic patients. CONCLUSION: This is the first study to analyze the early Portuguese experience with drug-eluting stents. The clinical results compare favorably with the first published international registries. The on-line platform used was successful in collecting data in a standardized format on the clinical experience of multiple centers.

The association of body mass index with long-term clinical outcomes after ticagrelor monotherapy following abbreviated dual antiplatelet therapy in patients undergoing percutaneous coronary intervention: a prespecified sub-analysis of the GLOBAL LEADERS Trial.

BACKGROUND: The efficacy of antiplatelet therapies following percutaneous coronary intervention (PCI) may be affected by body mass index (BMI). METHODS AND RESULTS: This is a prespecified subgroup analysis of the GLOBAL LEADERS trial, a prospective, multicenter, open-label, randomized controlled trial in an all-comer population undergoing PCI, comparing the experimental strategy (23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy [DAPT]) with a reference regimen (12-month aspirin monotherapy following 12-month DAPT). A total of 15,968 patients were stratified by baseline BMI with prespecified threshold of 27 kg/m2. Of those, 6973 (43.7%) patients with a BMI < 27 kg/m2 had a higher risk of all-cause mortality at 2 years than those with BMI ≥ 27 kg/m2 (adjusted HR 1.24, 95% CI 1.02-1.49). At 2 years, the rates of the primary endpoint (all-cause mortality or new Q-wave myocardial infarction) were similar between treatment strategies in either BMI group (pinteraction = 0.51). In acute coronary syndrome, however, the experimental strategy was associated with significant reduction of the primary endpoint compared to the reference strategy in patients with BMI < 27 kg/m2 (HR 0.69, 95% CI 0.51-0.94), but not in the ones with BMI ≥ 27 kg/m2 (pinteraction = 0.047). In chronic coronary syndrome, there was no between-group difference in the efficacy and safety of the two antiplatelet strategies. CONCLUSIONS: Overall, BMI did not influence the treatment effect seen with ticagrelor monotherapy; however, a beneficial effect of ticagrelor monotherapy was seen in ACS patients with BMI < 27 kg/m2. TRIAL REGISTRATION: The trial has been registered with ClinicalTrials.gov, Number NCT01813435.

Elective and primary angioplasty at hospitals without on-site surgery versus with on-site surgery: results from a national registry.

INTRODUCTION: Current European clinical guidelines do not restrict interventional cardiology at centers without on-site surgical backup, but disagreement still exists whether hospitals with cardiac catheterization laboratories, but without on-site cardiac surgery, should develop percutaneous coronary intervention (PCI) programs. Technical improvements in equipment and pharmacologic adjunctive therapy have increased the safety margins of diagnostic and therapeutic cardiac catheterization and more than half of the patients treated by PCI in Portugal are treated at hospitals without on-site cardiac surgery. OBJECTIVES: We set out to compare clinical outcomes of elective and primary PCI for ST-segment elevation myocardial infarction at centers without on-site cardiac surgery with those at centers with on-site cardiac surgery. METHODS: Based on the Portuguese Registry of Interventional Cardiology, we retrospectively reviewed a total of 13,235 PCI procedures performed from January 2002 to June 2006 and compared the results for 7,112 patients treated at hospitals without on-site cardiac surgery with 6,123 patients treated at hospitals with on-site cardiac surgery. RESULTS: Demographic data were similar, with a mean age of 64 (55-72) vs. 63 (54-71) years, 75% vs. 76% male and 25.0% vs. 24.2% with diabetes respectively at centers without and with on-site surgical backup. Hospital mortality at centers without and with on-site surgical backup respectively was: chronic angina: 0.3% vs. 0.3% (NS); acute coronary syndromes: 1.5% vs. 1.0% (NS); acute myocardial infarction with ST elevation and without cardiogenic shock: 4.0% vs. 5.0% (NS); cardiogenic shock: 50.9% vs. 53.4% (NS). CONCLUSIONS: Similar clinical outcomes for interventional cardiology were achieved at hospitals without on-site cardiac surgery and those with on-site cardiac surgery. In the era of coronary stents, adjunctive therapy and experienced operators, elective and primary PCI can safely be performed without on-site surgical backup.

First-in-man randomised comparison of the BuMA Supreme biodegradable polymer sirolimus-eluting stent versus a durable polymer zotarolimus-eluting coronary stent: the PIONEER trial.

AIMS: A second iteration of a sirolimus-eluting stent (SES) that has a biodegradable PLGA polymer coating with an electrografting base layer on a thin-strut (80 µm) cobalt-chromium platform (BuMA Supreme; SINOMED, Tianjin, China) has been developed. This first-in-man trial aimed to assess the efficacy and safety of the novel device. METHODS AND RESULTS: This randomised, multicentre, single-blinded, non-inferiority trial compared the BuMA Supreme SES versus a contemporary durable polymer zotarolimus-eluting stent (ZES) in terms of angiographic in-stent late lumen loss (LLL) at nine-month follow-up as the primary endpoint. A total of 170 patients were randomly allocated to treatment with either SES (n=83) or ZES (n=87). At nine-month angiographic follow-up, in-stent LLL was 0.29±0.33 mm in the SES group and 0.14±0.37 mm in the ZES group (pnon-inferiority=0.45). The in-stent percent diameter stenosis and the binary restenosis rate of the two treatment arms were similar (19.2±12.0% vs. 16.1±12.6%, p=0.09, and 3.3% vs. 4.4%, p=1.00, respectively). At 12-month clinical follow-up, there was no difference between treatment arms with regard to the device-oriented composite clinical endpoint (4.9% vs. 5.7%; p=0.72). CONCLUSIONS: The PIONEER trial did not meet its primary endpoint in terms of in-stent LLL at nine-month follow-up. However, this result did not translate into any increase in restenosis rate or impairment in 12-month clinical outcomes.

Functional comparison between the BuMA Supreme biodegradable polymer sirolimus-eluting stent and a durable polymer zotarolimus-eluting coronary stent using quantitative flow ratio: PIONEER QFR substudy.

AIMS: Quantitative flow ratio (QFR) based on three-dimensional quantitative coronary angiography (3D-QCA) is a novel method to assess physiological functionality after treatment with stents. The current study aimed to evaluate the difference in physiological functionality nine months after implantation of a bioresorbable polymer-based sirolimus-eluting stent with an electrografting base layer (BuMA Supreme: B-SES) versus a durable polymer-based zotarolimus-eluting stent (Resolute: R-ZES). METHODS AND RESULTS: The current post hoc analysis was performed in the PIONEER randomised trial (1:1 randomisation to B-SES [83 patients/95 lesions] and R-ZES [87 patients/101 lesions]). QFR was measured in stented vessels in both arms at preprocedural, post-procedural and nine-month angiography without pharmacologically induced hyperaemia (contrast QFR). At nine months, both the values of QFR distal to the stent (B-SES: 0.89±0.10 vs. R-ZES: 0.89±0.11, p=0.97) and the number of vessels with QFR ≤0.8 were not significantly different between the two groups (11.0% vs. 12.8%, p=0.72), while the in-stent binary restenosis rate was also comparable (3.7% vs. 3.5%, p=1.00). QFR gradient across the device (∆QFR) at nine months was also similar between the groups (B-SES: 0.03±0.04 vs. R-ZES: 0.03±0.07, p=0.95). CONCLUSIONS: Quantitative flow assessment nine months after stenting did not differ between B-SES and R-ZES, despite a significant difference in in-stent late lumen loss.

Portugal: coronary and structural heart interventions from 2010 to 2015.

The aim of the present paper is to report trends in Portuguese interventional cardiology from 2010 to 2015. We studied data from the prospective multicentre Portuguese National Registry of Interventional Cardiology (RNCI) to analyse percutaneous coronary intervention (PCI) procedures and structural heart interventions from 2010 to 2015. A total of 73,977 PCIs and 780 transcatheter aortic valve implants were performed during the study period. Since 2010 there has been a 60% increase in PCI procedures and a twofold increase in primary angioplasty rates reaching 316 per million population. Significant PCI trends were observed, notably the increase of radial access, a reduction in restenosis indications, as well as an increase in stent use, including DES, in imaging and in functional techniques. Importantly, there was a fourfold increase in the TAVI rates reaching 29 per million population.

Trends in percutaneous coronary intervention from 2004 to 2013 according to the Portuguese National Registry of Interventional Cardiology.

INTRODUCTION AND OBJECTIVES: The aim of the present paper is to report trends in Portuguese interventional cardiology from 2004 to 2013 and to compare them with other European countries. METHODS: Based on the Portuguese National Registry of Interventional Cardiology and on official data from the Directorate-General of Health, we give an overview of developments in coronary interventions from 2004 to 2013. RESULTS: In 2013, 36 810 diagnostic catheterization procedures were performed, representing an increase of 34% compared to 2007 and a rate of 3529 coronary angiograms per million population. Coronary interventions increased by 65% in the decade from 2004 to 2013, with a total of 13 897 procedures and a rate of 1333 coronary interventions per million population in 2013. Primary percutaneous coronary intervention (PCI) increased by 265% from 2004 to 2013 (1328 vs. 3524), an adjusted rate of 338 primary PCIs per million, representing 25% of total angioplasties. Stents were the most frequently used devices, drug-eluting stents being used in 73% in 2013. Radial access increased from 4.1% in 2004 to 57.9% in 2013. CONCLUSION: Interventional cardiology in Portugal has been expanding since 2004. We would emphasize the fact that in 2013 all Portuguese interventional cardiology centers were participating in the National Registry of Interventional Cardiology, as well as the growth in primary PCI and increased use of radial access.

Hybrid closure of postinfarction ventricular septal rupture enlargement after transcathether closure with Amplatzer occluder.

Ventricular septal rupture (VSR) is nowadays a rare complication of myocardial infarction (MI), but with a mortality rate still very high. Urgent surgical correction is recommended, although in specific cases percutaneous closure of a post-infarct VSR is a therapeutic option or a bridge to surgical correction. We report a case of an 80-year-old woman, with a subacute anterior MI with an antero-septal VSR. Rapid clinical deterioration in a high-surgical-risk patient led us to attempt percutaneous VSR closure at day 8 post MI. A 16-mm Amplatzer post-infarction (PI) muscular VSD closed the defect with intra-cardiac echocardiography guidance, that allowed conscious sedation. Clinical and haemodynamic improvement was immediate. Unfortunately, a small orifice distal to the device persisted, which enlarged to 8 mm over the following days, with a Qp/Qs shunt of 1.9. At day 17 post MI, the VSR was surgically closed by suturing the Amplatzer device to the septum. A residual shunt was evident, but with no progression, being the patient discharged in NYHA class I. Percutaneous closure of a post-MI VSR as a bridge to surgery is a therapeutic option in patients with high surgical risk, allowing haemodynamic stabilization and thus gaining time for a further surgical intervention if needed, improving these patients grim prognosis. Intra-cardiac echocardiography for monitoring the percutaneous procedure instead of a transoesophageal approach, as well as the surgical technique, make this case unique.

Cystatin C as prognostic biomarker in ST-segment elevation acute myocardial infarction.

Cystatin C is a marker of renal dysfunction, and preliminary studies have suggested it might have a role as a prognostic marker in patients with coronary artery disease. The aim of the present study was to evaluate the usefulness of cystatin C for risk stratification of patients with ST-segment elevation myocardial infarction, regarding in-hospital and long-term outcomes. We included 153 consecutive patients with ST-segment elevation myocardial infarction treated by primary angioplasty. The baseline cystatin C level was measured at coronary angiography. The in-hospital outcome was determined as progression to cardiogenic shock or in-hospital death, and the long-term outcome was assessed, considering the following end points: (1) death and (2) death or reinfarction. Of the 153 patients evaluated (age 61 ± 12 years; 75.6% men), 15 (14.4%) progressed to cardiogenic shock and 4 (2.7%) died during hospitalization. The patients who progressed to cardiogenic shock or died during hospitalization had significantly greater cystatin C levels (1.02 ± 0.44 vs 0.69 ± 0.24 mg/L; p = 0.001). Long-term follow-up was available for 130 patients (583 ± 163 days). Among them, 11 patients died and 7 had reinfarction. A high baseline cystatin C level was associated with an increased risk of death (hazard ratio 8.5; p = 0.009) and death or reinfarction (hazard ratio 3.89; p = 0.021). Furthermore, only high baseline cystatin C levels and left ventricular ejection fraction ≤40% were independent predictors of the long-term risk of death, with synergistic interaction between the 2. In conclusion, cystatin C is a new biomarker with significant added prognostic value for patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention, predicting both short- and long-term outcomes.

Early administration of abciximab bolus in the emergency department improves angiographic outcome after primary PCI as assessed by TIMI frame count: results of the early ReoPro administration in myocardial infarction (ERAMI) trial.

OBJECTIVES: We assessed the safety and efficacy of early administration of abciximab prior to percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI) patients. BACKGROUND: Research suggests that platelet glycoprotein IIb/IIIa receptor inhibitors, e.g. abciximab, may improve myocardial perfusion. In particular, early administration in the emergency department, prior to PCI, may result in more effective reperfusion. METHODS: Eighty AMI patients with planned PCI were randomized in a double-blind fashion to receive a 0.25 mg/kg abciximab bolus either "early" in the emergency department or "late" in the catheterization laboratory after angiographic assessment. In total, 74 patients underwent PCI after diagnostic angiography, all of which then received an abciximab infusion of 0.125 microg/kg/min for 12 hr. RESULTS: Prior to PCI, no significant differences were observed between the two groups regarding the angiographic endpoints or ST-segment resolution. After PCI, thrombolysis in MI (TIMI) frame count (TFC) was significantly improved in patients treated early rather than in those treated late (23 +/- 10 vs. 41 +/- 35; P = 0.02). Consistent trends, also favoring early treatment, were observed for TIMI flow grade 3 (TFG 3), corrected TFC (CTFC), and TIMI myocardial perfusion grade 3 (TMPG 3). Nine deaths (4 early, 5 late) and six significant bleeds (4 early, 2 late) were observed at 30 days after randomization. CONCLUSIONS: Early administration of abciximab is both feasible and safe in patients planned for primary PCI, increasing coronary flow and myocardial reperfusion after PCI, as demonstrated by significantly decreased TFC scores and trends toward improvements in TFG, CTFC, and TMPG.