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 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.

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.

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.

Ventricular Septal Perforation after Biventricular Takotsubo Cardiomyopathy Successfully Repaired with an Amplatzer Device: First Report in the Literature.

A 79-year-old female was admitted with sudden onset dyspnea, mild oppressive chest pain, and severe anxiety disorder. Patient had history of hypertension, dyslipidemia, smoking, and chronic obstructive pulmonary disease. On admission blood pressure was 160/90 and heart rate was 130 bpm. Transthoracic echocardiography (TE) and contrast tomography showed a thin septum with an abnormal left and right ventricular contraction with an "apical ballooning" pattern and mild increase of cardiac enzymes. At the 4th day of admission, the patient presented symptoms and signs of congestive heart failure and developed cardiogenic shock. EKG showed an inversion of T waves in all precordial leads. In a new TE, a ventricular septal perforation (VSP) in the apical portion of the septum was seen. Coronary angiogram showed angiographically "normal" coronary arteries. With a diagnosis of VSP in takotsubo cardiomyopathy, a percutaneous procedure to repair the VSP was performed 11 days after admission. The VSP was closed with an Amplatzer device. TE performed 24 hours after showed significant improvement of ventricular function and good apposition of the Amplatzer device. Three days later she was discharged from the hospital. To our knowledge, this is the first reported case of a VSP in a TCM repaired percutaneously with an occluder device.

[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.

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 / Characterization of pesticide exposures reported between 2006 and 2013 to a poison information center in 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.

Transapical Implantation of a 2nd-Generation JenaValve Device in Patient with Extremely High Surgical Risk.

Transcatheter Aortic Valve Replacement (TAVR) is performed in patients who are poor surgical candidates. Many patients have inadequate femoral access, and alternative access sites have been used such as the transapical approach discussed in this paper. We present an elderly and fragile patient not suitable for surgery for unacceptable high risk, including poor ventricular function, previous myocardial infarction with percutaneous coronary intervention, pericardial effusion, and previous cardiac surgery with replacement of mechanical mitral valve. Transapical aortic valve replacement with a second-generation self-expanding JenaValve is performed. The JenaValve is a second-generation transapical TAVR valve consisting of a porcine root valve mounted on a low-profile nitinol stent. The valve is fully retrievable and repositionable. We discuss transapical access, implantation technique, and feasibility of valve implantation in this extremely high surgical risk patient.

Modifying angiographic syntax score according to PCI strategy: lessons learnt from ERACI IV Study.

In recent years an angiographic score was introduced in clinical practice to stratified different levels of risk after percutaneous coronary interventions (PCI) with drug eluting stents. The SYNTAX score (SS) classified patients in three different risk levels and was included in revascularization guidelines that patients allocated with low SS could be equally treated with either PCI or CABG, whereas those with intermediate or high SS were better off with CABG. However, using original SS each coronary lesion with a diameter stenosis ≥50% in vessels ≥1.5 mm was scored. In ERACI IV registry we used a revascularization strategy during PCI where operators were advised to only treat lesions≥than 70% in a≥2.0 mm reference vessel; therefore, no intermediate lesions should be treated, and severe stenosis in vessels<2.0 mm was discouraged as well. If we recalculated SS using the above-mentioned operators' advices all intermediate lesions were not scored, and severe stenosis in vessels<2.0 mm were excluded for the analysis, including bifurcations, trifurcations and chronic total occlusions; after this new scoring, the original SS dropped significantly which is in accordance with the goal of complete functional revascularization strategy of the ERACI IV study and the low one year adverse events of such study. In conclusion, if we performed an SS scoring, only severe stenosis in vessels with a reference diameter ≥2.0 mm would allow a more rational assessment of coronary anatomy, and the use of a more conservative PCI strategy.

[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.

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

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.