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

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

Can We Improve the Outcomes of Multivessel Disease Using Modified SYNTAX and Residual SYNTAX Scores?

PURPOSE OF REVIEW: In spite of the benefits of drug eluting (DES), these advantages were not translated to better outcome when percutaneous coronary interventions (PCI) were compared with coronary artery bypass surgery. PCI strategy allowing stent deployment in all intermediate lesions including small vessels together with DES design may be the reasons of these findings. RECENT FINDINGS: Recently randomized and observational studies demonstrated using functional flow reserve analysis, residual Syntax score risk, or residual ERACI score after PCI that a reasonably incomplete revascularization was associated with good long-term outcome and low events rate at follow-up. In the ERACI IV study, which included patients with multiple vessel disease and left main, all intermediate lesions and severe lesions in small vessels were excluded from the revascularization strategy, and the 3-year follow-up results showed a remarkable low incidence of death/MI and stroke. Intermediate stenosis or severe lesions in small vessels should not be incorporated in the PCI strategy in order to define patient clinical cardiac prognosis or completeness of revascularization.

[Characterization of pesticide exposures reported between 2006 and 2013 to a poison information center in Chile]. / Caracterización de las exposiciones a plaguicidas entre los años 2006 y 2013 reportadas al Centro de Información Toxicológica de la Pontificia Universidad Católica de Chile.

BACKGROUND: Pesticides are widely used to increase crop yields and vector control. However, both acute and chronic exposure have health consequences. There is paucity of information about the global occurrence of pesticide poisonings. AIM: To characterize the reports of pesticide exposures received by a University Poison Information Center. MATERIAL AND METHODS: All pesticide exposures reported in Chile between 2006 and 2013 were analyzed. A data-collection sheet provided by the International Programme on Chemical Safety of the World Health Organization, was used to collect information. RESULTS: In the study period, 13,181 reports were analyzed. The main age groups exposed were preschoolers and adults. Sixty one percent of exposures occurred accidentally and 24.8% were suicide attempts. Exposures to acetylcholinesterase inhibitors was reported in 29.3% of cases, to superwarfarin rodenticides in 28.5% and to pyrethroids in 24.0%. An increased risk of suicide attempts with pesticides was observed among women, when compared with men (odds ratio: 1.5; 95% confidence intervals: 1.4-1.6; p < 0.001). The risk was higher among teenage girls. CONCLUSIONS: The amount of cases under acetyl cholinesterase inhibitor exposure, the most toxic pesticides currently in use should be highlighted. Workers should be educated and all cases should be reported to take actions aiming at reducing these events.

[Exposure to occupational biological risks: experience of a toxicology information center]. / Exposición a agentes de riesgo biológico en trabajadores chilenos: Reporte del Centro de Información Toxicológica de la Pontificia Universidad Católica de Chile (CITUC).

BACKGROUND: Exposure to Biological Agents during work is an emergent type of occupational risk. AIM: To characterize occupational biological risk exposure among Chilean workers which have been registered by the Toxicology Information Center, between January 2006 and December 2009. MATERIAL AND METHODS: All incoming calls reporting exposure to biological agents during the studied period were analyzed. The information obtained from the caller was registered using the Communication Record Instrument of the WHO International Programme on Chemical Safety (IPCS INTOX). RESULTS: In the studied period, 77 calls were received. The mean age of exposed patients was 35 ± 15 years and 57% of them were females. The most common involved agents were vaccines for veterinary use (42%) followed by Loxosceles laeta bites in 16%. The main routes of exposure were injections, cuts and needle stick injuries in 39% and stings and bites in 38%. The highest exposure rates were observed in Southern Chile due to self-inoculation of veterinary vaccines used in the salmon industry (22.7/100.000 actual workers). Fifty-eight percent of calls were from health care workers, and 51% of them were from health care facilities. Sixty percent of exposures occurred during summer and spring. There was a fourfold higher risk of calls involving women exposed to bites or stings (odds ratio (OR) 4.5 (CI95 1.5-13.9, p < 0.01). Men had a fourfold higher risk of being exposed to vaccines or medications for veterinary use (OR 4.2, CI95 1.4-12.6 p < 0.01). CONCLUSIONS: Most calls involving an exposure to a biological agent were caused by self-inoculation of veterinary medications.

Trends in primary percutaneous coronary intervention for the treatment of acute coronary ST-elevation myocardial infarction in Latin American countries: insights from the CECI consortium.

Background: ST-elevation myocardial infarction (STEMI) requires revascularization treatment, preferably via primary percutaneous coronary interventions (pPCI). There is a lack of data about contemporary management of STEMI in Latin America. Methods: This was a multicenter, multinational, prospective, and dynamic registry of patients undergoing pPCI in Latin America for STEMI (STEMI/LATAMI Registry) that was carried out in nine centers from five countries (Argentina, Ecuador, Venezuela, Bolivia, and the Dominican Republic) between June 2021 and June 2023. All interventionalists involved in the study were originally trained at the same institution (Centro de Estudios en Cardiología Intervencionista, Buenos Aires, Argentina). The primary objective was to evaluate procedural and in-hospital outcomes of pPCI in STEMI and in-hospital outcome in the Latin America (LATAM) region; as secondary endpoints, we analyzed the following subgroups: differences between pPCI vs. pharmaco-invasive or late presenters, gender, elderly and very elderly patients, cardiogenic shock outcomes, and causes of STEMI. Results: In total, 744 STEMI patients who underwent PCI between June 2021 and June 2023 in five countries (nine centers) in our continent were included; 76.3% had a pPCI, 8.1% pharmaco-invasive PCI, and 15.6% had late STEMI PCI. There were no differences in region or center when we evaluated in-hospital and 30 days of death. The rate of procedural success was 96.2%, and the overall in-hospital mortality rate was 2.2%. In the subgroup of pPCI, mean symptom onset-to-balloon time was 295.3 ± 246 min, and mean door-to-balloon time was 55.8 ± 49.9 min. The femoral approach was chosen in 60.5%. In 3.0% of patients, the left main disease was the culprit artery, with 1.63 ± 1.00 stents per patient (564 drug-eluting stents and 652 bare metal stents), with 34 patients receiving only plain optimal balloon angioplasty. Definitive stent thrombosis was related to the infarct artery as the primary cause of STEMI in 7.5% of patients. The use of assistant mechanical devices was low, at 2.1% in the pPCI group. Women were older, with large numbers in very elderly age (≥90 years), greater mortality, and incidence of spontaneous coronary dissection as a cause of STEMI (p < 0.001, p < 0.001, p < 0.001, and p < 0.003, respectively). Conclusion: In suitable LATAM Centers from low/medium-income countries, this prospective registry in patients with STEMI, PCI performed by well-trained operators has comparable results to those reported in well-developed countries.

Abbreviated or Standard Dual Antiplatelet Therapy by Sex in Patients at High Bleeding Risk: A Prespecified Secondary Analysis of a Randomized Clinical Trial.

Importance: Abbreviated dual antiplatelet therapy (DAPT) reduces bleeding with no increase in ischemic events in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI). Objectives: To evaluate the association of sex with the comparative effectiveness of abbreviated vs standard DAPT in patients with HBR. Design, Setting, and Patients: This prespecified subgroup comparative effectiveness analysis followed the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated vs Standard DAPT Regimen (MASTER DAPT) trial, a multicenter, randomized, open-label clinical trial conducted at 140 sites in 30 countries and performed from February 28, 2017, to December 5, 2019. A total of 4579 patients with HBR were randomized at 1 month after PCI to abbreviated or standard DAPT. Data were analyzed from July 1 to October 31, 2022. Interventions: Abbreviated (immediate DAPT discontinuation, followed by single APT for ≥6 months) or standard (DAPT for ≥2 additional months, followed by single APT for 11 months) treatment groups. Main Outcomes and Measures: One-year net adverse clinical events (NACEs) (a composite of death due to any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (MACCEs) (a composite of death due to any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding (MCB). Results: Of the 4579 patients included in the analysis, 1408 (30.7%) were women and 3171 (69.3%) were men (mean [SD] age, 76.0 [8.7] years). Ischemic and bleeding events were similar between sexes. Abbreviated DAPT was associated with comparable NACE rates in men (hazard ratio [HR], 0.97 [95% CI, 0.75-1.24]) and women (HR, 0.87 [95% CI, 0.60-1.26]; P = .65 for interaction). There was evidence of heterogeneity of treatment effect by sex for MACCEs, with a trend toward benefit in women (HR, 0.68 [95% CI, 0.44-1.05]) but not in men (HR, 1.17 [95% CI, 0.88-1.55]; P = .04 for interaction). There was no significant interaction for MCB across sex, although the benefit with abbreviated DAPT was relatively greater in men (HR, 0.65 [95% CI, 0.50-0.84]) than in women (HR, 0.77 [95% CI, 0.53-1.12]; P = .46 for interaction). Results remained consistent in patients with acute coronary syndrome and/or complex PCI. Conclusions and Relevance: These findings suggest that women with HBR did not experience higher rates of ischemic or bleeding events compared with men and may derive particular benefit from abbreviated compared with standard DAPT owing to these numerically lower rates of events. Trial Registration: ClinicalTrials.gov Identifier: NCT03023020.

High Non-Cardiac Death Incidence Should Be a Limitation of Drug-Eluting Stents Implantation? Insights from Recent Randomized Data.

Despite the introduction of drug-eluting stents (DES) significantly improved the efficacy and safety of percutaneous coronary interventions (PCI), particularly in a high-risk group of patients, the gap between PCI with his competitor's coronary artery bypass surgery (CABG) and/or optimal medical treatment alone was not reduced. In this revision, we highlighted the fact that in recent years landmark randomized studies reported at mid and long-term follow-ups a high incidence of non-cardiac death, cancer incidence, or both in the DES group of patients. The overall incidence of non-cardiac death was significantly higher in the DES vs. the comparator arm: 5.5% and 3.8%, respectively, p = 0.000018, and non-cardiac death appears to be more divergent between DES vs. the comparator at the extended follow-up to expenses of the last one. One of these trials reported five times greater cancer incidence in the DES arm at late follow-up, 5% vs. 0.7% p < 0.0018. We review the potential reason for these unexpected findings, although we can discard that DES biology could be involved in it. Until all these issues are resolved, we propose that DES implantation should be tailored accorded patient age, life expectancy, and lesion complexity.

Randomized comparison of cost-saving and effectiveness of oral rapamycin plus bare-metal stents with drug-eluting stents: three-year outcome from the randomized oral rapamycin in Argentina (ORAR) III trial.

OBJECTIVES: The Oral Rapamycin in ARgentina (ORAR) III trial is a randomized study comparing a strategy of oral rapamycin (OR) plus bare-metal stent (BMS) versus a strategy of drug-eluting stents (DES) in patients with de novo coronary lesions. The purpose of this study was to assess the 3 years cost-effectiveness outcome of each strategy. BACKGROUND: OR after BMS has been associated with reduction of target vessel revascularization (TVR) although its value in long-term efficacy in comparison with DES is unknown. METHODS: In three hospitals in Buenos Aires, Argentina, 200 patients were randomized to OR plus BMS (n = 100) or DES (n = 100). Primary objectives were costs and effectiveness. Cost analysis included in-hospital and follow-up costs. Safety was defined as the composite of death, myocardial infarction (MI), and stroke. Efficacy was defined as TVR. RESULTS: Baseline characteristics between groups were similar. The 3-year follow-up rate was 99%. Cardiac mortality was 2% and 5% in OR group and DES group, respectively (P = 0.44). The composite of death, MI and stroke rate was 11% in OR group and 20% in DES group (P = 0.078). TVR rate was 14.5% in OR group and 17.6% in DES group (P = 0.50), respectively. Three year cumulative costs were significantly lower in the OR arm as compared to the DES arm (P = 0.0001) and DES strategy did not result cost-effective according to the non-inferiority test. CONCLUSIONS: At 3 years follow-up, there were no differences in effectiveness between the two strategies, and DES strategy was not more cost-effective as compared to OR plus BMS.

[Characterization of paracetamol overdose: report of a poison information center in Chile]. / Caracterización de la ingestión por sobredosis de paracetamol: reporte de un centro de información toxicológica Chileno.

BACKGROUND: Paracetamol (acetaminophen) is an analgesic and antipyretic drug widely used across the world. Its ingestion is one of the most common causes of drug overdose. In the United States is the first cause of acute hepatitis in adults. AIM: To describe the epidemiological profile of paracetamol overdose in Chile. MATERIAL AND METHODS: Cross sectional retrospective study that included all the phone call inquiries received at the Poison Control Center of the Pontificia Universidad Catolica de Chile (CITUC) during 2009. RESULTS: Nine hundred fifty nine inquiries involving acute paracetamol exposures were received. Women represented a 63.1% of the cases. Half of the cases were suicide attempts, of which 74.8% were women. Accidental exposures occurred mainly in children. In 29.3% of the patients, the exposure was considered to involve a hepatotoxic dose. Women had 2.7 times the risk of men to ingest a toxic dose of paracetamol with suicidal purpose (Odds ratio (OR) = 2.7; 95% confidence interval (Cl): 2.1-3.6; p < 0.001). Adolescents had 3.4 times the risk of the general consultants (OR: 3.4; 95% Cl: 2.4-4.7; p < 0.001). CONCLUSIONS: Paracetamol overdose is common in Chile. Authorities should carry out preventive measures. Antidotes and the capacity to measure plasma levels of paracetamol should be available in healthcare centers.

Efficacy and safety of a double-coated paclitaxel-eluting coronary stent: the EUCATAX trial.

OBJECTIVES: The aim of this study was the comparison of a new double-coated paclitaxel-eluting coronary stent with bare-metal stent (BMS) in patients undergoing percutaneous coronary intervention. BACKGROUND: Stent coating with biodegradable polymers as a platform for elution of drugs has the potential for complete elution of drugs and for decreasing the risk of late complications. METHODS: Multicenter randomized trial comparing a paclitaxel-eluting stent (PES) coated with a biodegradable polymer and glycocalyx with the equivalent BMS. We randomly assigned 422 patients with de novo coronary lesions to PES (211 patients) or to BMS (211 patients). Primary end point was target vessel failure (TVF) defined as cardiac death, myocardial infarction, and target vessel revascularization. Clinical secondary end points were target vessel revascularization, target lesion revascularization, stent thrombosis (ST), and major adverse cardiovascular events (MACE). Angiographic secondary end points were late loss and binary restenosis. RESULTS: At 1 year of follow-up, TVF rate was 9.5% in the PES group and 17.1% in the BMS group (P=0.02), and MACE rate was 10% in PES and 19% in BMS arm (P=0.009). All other secondary end points were reached but ST. ST rate was low and similar in both study arms. CONCLUSIONS: The study shows that patients treated with PES with dual coating technology had significantly lower incidence of TVF and MACE than those treated with BMS design; however, longer follow-up should be necessary to assess true advantages of this technology compared with the previous one.

Randomized comparison between bare-metal stent plus colchicine versus drug-eluting stent alone in prevention of clinical adverse events after percutaneous coronary intervention.

The use of colchicine is associated with a significant reduction of cardiac adverse events in patients with coronary artery disease. Past small randomized trials with oral immunosuppressive or anti-inflammatory therapies have demonstrated a reduction of adverse clinical events after bare metal stent implantation. The potential role of adjunctive colchicine after bare-metal stent implantation, compared with drug-eluting stent alone, is unknown. The primary end point of the study will be to compare cost-effectiveness at 1 year of follow-up of coronary intervention with bare-metal stent implantation plus 1 mg of colchicine during 3 months versus percutaneous coronary intervention with drug-eluting stent implantation alone. ClinicalTrials.gov identifier: NCT04382443.

Increased incidence of serious late adverse events with drug-eluting stents when compared with coronary artery bypass surgery: a cause of concern.

Percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) in pre-drug-eluting stents (DESs) era, randomized trials and meta-analysis showed that the extension of coronary artery disease was not associated with a better survival with CABG, and only diabetic patients had an inferior survival with PCI. After the introduction of DES, we would expect a substantial improvement in PCI results compared with CABG, narrowing the gap between both revascularization strategies, However, on the contrary, most randomized studies between DES and CABG showed that rate of recurrences remained and there is an unexpected increased of late serious adverse events including spontaneous myocardial infarction and death. In this review, we try to described each of these problems and find out explanations for these new findings searching for potential solutions.

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

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

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

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

Acute respiratory distress syndrome resulting from inhalation of powdered copper.

BACKGROUND: Copper is an essential element. Poisoning with elemental copper is infrequent and manifestations rarely include the ones that our case presented. CASE REPORT: A previously healthy 2-year-old female patient unintentionally inhaled copper dust, developed respiratory failure a few hours later, and required mechanical ventilation. On hospital day three, the patient developed acute respiratory distress syndrome and was treated with high-frequency oscillatory ventilation for six days. She also developed hemolytic anemia, liver failure, oliguric renal failure, and evidence of acute tubular injury. During her stay in the intensive care unit she received inotropic support, packed red cells transfusion, and diuretics. A sample of bronchoalveolar lavage showed macrophages that stained positive for copper. Serum and urine copper concentrations were within the normal range after several days. Extubation was successfully achieved after two weeks and the patient was discharged on day 30 without sequelae. This is the first report of acute respiratory distress syndrome secondary to copper aspiration in a pediatric patient. CONCLUSION: To our knowledge, this is the first case reported of acute respiratory distress syndrome secondary to elemental copper aspiration. It is important to the clinician to be aware of acute respiratory distress syndrome as a differential diagnosis to copper aspiration by treating the patient aggressively in an adequate clinical setting.