Real-World Safety and Effectiveness Outcomes of a Zotarolimus-Eluting Stent: Final 3-Year Report of the RESOLUTE International Study

Objectives: We evaluated the safety and effectiveness of the Resolute™ zotarolimus-eluting stent (R-ZES) in real-world clinical practice through 3 years. Background: A randomized comparison of the R-ZES and the XIENCE V™ everolimus-eluting stent showed no difference in any outcomes through 3-year follow-up in high-volume academic centers. RESOLUTE International is a confirmatory trial designed to evaluate the R-ZES in real-world clinical practice. Methods: RESOLUTE International is a single arm, observational trial that enrolled 2,349 patients from 88 centers with only a few inclusion and exclusion criteria. The primary end-point was the composite of cardiac death and target vessel myocardial infarction (TV-MI) at 1 year. Secondary end-points include target lesion failure (TLF), target vessel revascularization (TVR), and their components, and stent thrombosis (ST). Results: At 3 years 97.2% of patients completed clinical follow-up. The mean age was 63.4 ± 11.2 years, 77.8% were male, and 30.4% had diabetes. The average number of stents per patient was 1.6 ± 1.0; and mean stent length was 30.9 ± 20.5 mm. Dual antiplatelet therapy was used in 91.1% of patients at 1 year, 43.0% at 2 years, and 34.6% at 3 years. Cardiac death and TV-MI occurred in 161 patients (7.0%). There were 6 (0.3%) very late ST events for a total ST rate of 1.1% through 3 years. The rates of clinically driven target lesion revascularization (TLR), TVR, and TLF were 5.7%, 7.4%, and 11.4%, respectively. Conclusions: The safety and effectiveness of the R-ZES through 3 years in this real-world all-comer study was consistent with previously reported all-comer trials. (J Interven Cardiol 2013;26:515-523

Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation

Aim The optimal duration of dual antiplatelet therapy (DAPT) following the use of new generation drug-eluting stents is unknown. Methods and results The association between DAPT interruption and the rates of stent thrombosis (ST) and cardiac death/target-vessel myocardial infarction (CD/TVMI) in patients receiving a Resolute zotarolimus-eluting stent (R-ZES) was analysed in 4896 patients from the pooled RESOLUTE clinical programme. Daily acetylsalicylate (ASA) and a thienopyridine for 6-12 months were prescribed. A DAPT interruption was defined as any interruption of ASA and/or a thienopyridine of >1 day; long interruptions were >14 days. Three groups were analysed: no interruption, interruption during the first month, and >1-12 months. There were 1069 (21.83%) patients with a DAPT interruption and 3827 patients with no interruption. Among the 166 patients in the 1-month interruption group, 6 definite/probable ST events occurred (3.61%; all long DAPT interruptions), and among the 903 patients in the >1-12 months (60% occurred between 6 and 12 months) interruption group, 1 ST event occurred (0.11%; 2-day DAPT interruption). Among patients with no DAPT interruption, 32 ST events occurred (0.84%). Rates of CD/TVMI were 6.84% in the 1-month long interruption group, 1.41% in the >1-12 months long interruption group, and 4.08% in patients on continuous DAPT. Conclusion In a pooled population of patients receiving an R-ZES, DAPT interruptions within 1 month are associated with a high risk of adverse outcomes. Dual antiplatelet therapy interruptions between 1 and 12 months were associated with low rates of ST and adverse cardiac outcomes. Randomized clinical trials are needed to determine whether early temporary or permanent interruption of DAPT is truly safe. Clinical Trials.gov identifiers NCT00617084; NCT00726453; NCT00752128; NCT0092794

Telehealth in Heart Failure Care during COVID-19 Pandemic Lockdown in Argentina

Background and Objectives: During the coronavirus disease 2019 (COVID-19) pandemic, virtual visits (VVs) were recommended as an innovative and necessary alternative for patients with heart failure (HF). To assess the feasibility and acceptability of VVs in patients with HF, pulmonary hypertension (PH), and heart transplant (HT). Methods: We designed a single-centre cohort study. Consecutive VVs performed in our HF unit were analysed. The period comprehended between January 1st and March 19th (before COVID-19) and March 20th and June 30th (during COVID-19) was compared. We assessed acceptability, feasibility and the need for diagnostic studies, in-person medical evaluation, and hospitalization at 30 days. Results: HF unit medical doctors conducted 22 VVs in the pre-COVID period and 416 VVs during the COVID period. The VV was able to be performed in all patients scheduled for it and 44% answered the survey. Ninety percent of the patients who answered the survey strongly agreed that VVs were easy to be carried out. All the patients “strongly agreed” or “agreed” that their health problem could be resolved. Most patients (95%) rated the global experience as very good or excellent, with an overall average rate of 9.76±0.5 out of 10. We found no differences regarding the requirement of diagnostic studies, in-person medical evaluation and hospitalization during the first month after VVs between the 2 periods. Conclusions: VVs were feasible, presented high acceptability, and the overall experience was positive in patients with HF, PH, and HT, being this modality a valuable tool that complements in-person care.Fil: Burgos, Lucrecia María. Instituto Cardiovascular de Buenos Aires; ArgentinaFil: Benzadón, Mariano. Instituto Cardiovascular de Buenos Aires; ArgentinaFil: Candiello, Alfonsina. Instituto Cardiovascular de Buenos Aires; ArgentinaFil: Cabral, Miguel Héctor. Instituto Cardiovascular de Buenos Aires; ArgentinaFil: Conde, Diego. Instituto Cardiovascular de Buenos Aires; ArgentinaFil: Alves de Lima, Alberto Enrique. Instituto Cardiovascular de Buenos Aires; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Belardi, Jorge. Instituto Cardiovascular de Buenos Aires; ArgentinaFil: Diez, Mirta. Instituto Cardiovascular de Buenos Aires; Argentin

Cardiovascular disease in times of COVID-19

Existen crecientes informes sobre una drástica caída en consultas y realización de procedimientoscardiovasculares (incluyendo urgencias y emergencias) en regiones afectadas por la pandemia deCOVID-19, con el consecuente incremento marcado de la mortalidad total que no se explica totalmente por las defunciones atribuidas a COVID-19. En Argentina, la enfermedad cardiovascular lidera el ranking de muertes en adultos con 280 muertes por día, y en las últimas décadas hemos reducido su mortalidad entre 20 y 30% mediante diversas intervenciones basadas en la evidencia. En el presente trabajo realizamos análisis predictivos para entender cuáles podrían ser las consecuencias de una peor implementación de dichas intervenciones. Estimamos que un menor control de los factores de riesgo cardiovascular de abril a octubre de 2020 podría causar hasta 10 500 nuevos casos prevenibles de enfermedad cardiovascular. En términos de infarto de miocardio, una caída del 40% al 60% del tratamiento de reperfusión podría incrementar la mortalidad del 3% al 5%. Un incremento marginal de riesgo relativo de 10% a 15% de muerte cardiovascular equivaldría a un exceso de 6000 a 9000 muertes evitables. En conclusión, dada la alta prevalencia y fatalidad de la enfermedad cardiovascular, incluso un pequeño impacto negativo en la eficacia de su cuidado se traducirá en grandes cantidades de afectados en Argentina. Es necesario informar a las autoridades y educar al público para que sigan controlando enfermedades cardiovasculares y sus factores de riesgo, siempre que existan recursos y minimizando el riesgo de contagio y propagación del virus.There are increasing reports of a drastic drop in consultations and cardiovascular procedures (including urgencies and emergencies) in regions affected by the COVID-19 pandemic, with a consequent marked increase in total mortality that is not fully explained by COVID-19. Cardiovascular disease leads the ranking in deaths in adults in Argentina with 280 deaths per day, and in recent decades we have reduced its mortality by 20-30% through various evidence-based interventions. Herein we conducted predictive analyses to understand what could be the consequences of a worse implementation of those interventions. We estimate that less control of cardiovascular risk factors from April to October 2020 could cause up to 10 500 new preventable cases of cardiovascular disease. In terms of myocardial infarction, a drop from 40% to 60% of the reperfusion treatment could increase mortality by 3% to 5%. A marginal 10% to 15% increase in relative risk of cardiovascular death would be equivalent to an excess of 6000 to 9000 preventable deaths. In conclusion, given the high prevalence and fatality of cardiovascular disease, even a small negative impact on the efficacy of its care will translate into large numbers of people affected in Argentina. It is necessary to inform the authorities and educate the public so cardiovascular diseases and their risk factors remain a health priority, as long as resources exist and minimizing the risk of contagion and spread of the virus.Fil: Lamelas, Pablo. Instituto Cardiovascular de Buenos Aires; Argentina. McMaster University. Department of Health Research Methods, Evidence, and Impact; Estados UnidosFil: Botto, Fernando. Instituto Cardiovascular de Buenos Aires; ArgentinaFil: Pedernera, Gustavo. Instituto Cardiovascular de Buenos Aires; ArgentinaFil: Alves de Lima, Alberto Enrique. Instituto Cardiovascular de Buenos Aires; ArgentinaFil: Costabel, Juan Pablo. Instituto Cardiovascular de Buenos Aires; ArgentinaFil: Belardi, Jorge. Instituto Cardiovascular de Buenos Aires; Argentin

Coronary flow velocity reserve after percutaneous interventions is predictive of periprocedural outcome

BACKGROUND: Because heterogeneous results have been reported, we assessed coronary flow velocity changes in individuals who underwent percutaneous transluminal coronary angioplasty (PTCA) and examined their impact on clinical outcome. METHODS AND RESULTS: As part of the Doppler Endpoints Balloon Angioplasty Trial Europe (DEBATE) II study, 379 patients underwent Doppler flow-guided angioplasty. All patients were evaluated according to their coronary flow velocity reserve (CFVR) results (> or =2.5 or < 2.5) at the end of the procedure. A CFVR < 2.5 after angioplasty was associated with an elevated baseline blood flow velocity in both the target artery and reference artery. CFVR before PTCA and CFVR in the reference artery were independent predictors of an optimal CFVR after balloon angioplasty (CFVR before PTCA: odds ratio [OR], 2.26; 95% confidence interval [CI], 1.57 to 3.24; CFVR in reference artery: OR, 1.90; 95% CI, 1.21 to 2.98; both P<0.001) and stent implantation (before PTCA: OR, 2.54; 95% CI, 1.47 to 4.36; reference artery: OR, 1.97; 95% CI, 1.07 to 3.87; both P<0.05). A low CFVR at the end of the procedure was an independent p

Uncomplicated moderate coronary artery dissections after balloon angioplasty: good outcome without stenting

OBJECTIVE: To study the relation between moderate coronary dissections, coronary flow velocity reserve (CFVR), and long term outcome. METHODS: 523 patients undergoing balloon angioplasty and sequential intracoronary Doppler measurements were examined as part of the DEBATE II trial (Doppler endpoints balloon angioplasty trial Europe). After successful balloon angioplasty, patients were randomised to stenting or no further treatment. Dissections were graded at the core laboratory by two observers and divided into four categories: none, mild (type A-B), moderate (type C), severe (types D to F). Patients with severe dissections (n = 128) or without available reference vessel CFVR (n = 139) were excluded. The remaining 256 patients were divided into two groups according to the presence (group A, n = 45) or absence (group B, n = 211) of moderate dissection. RESULTS: Following balloon angioplasty, there was no difference in CFVR between the two groups. At 12 months follow up, a higher rate of major adverse cardiac events was observed overall in group A than in group B (10 (22%) v 23 (11%), p = 0.041). However, the risk of major adverse events was similar in the subgroups receiving balloon angioplasty (group A, 6 (19%) v group B, 16 (16%), NS). Among group A patients, the adverse events risk was greater in those randomised to stenting (odds ratios 6.603 v 1.197, p = 0.046), whereas there was no difference in risk if the group was analysed according to whether the CFVR was /= 2.5 after balloon angioplasty. CONCLUSIONS: Moderate dissections left untreated result in no increased risk of major adverse cardiac events. Additional stenting does not improve the long term outcome

Evaluation of the XIENCE TM V everolimus-eluting coronary stent system in the female latin american population of the SPIRIT Women single-arm study: one-year clinical follow-up data

INTRODUÇÃO: Os estudos com stents farmacológicos têm avaliado predominantemente populações masculinas de descendência europeia. O estudo de braço único SPIRIT Women avalia o stent eluidor de everolimus XIENCE TM V em lesões de novo complexas em uma população feminina do mundo real, incluindo pacientes latino-americanas. Esta análise permite compreender como essa população responde ao implante de stent, comparativamente a pacientes não-latino-americanas. MÉTODOS: Das 1.572 pacientes matriculadas em 73 locais fora dos Estados Unidos, 138 (9%) foram recrutadas na Argentina, no Brasil e na Venezuela. RESULTADOS: As lesões-alvo tinham diâmetro de referência do vaso entre 2,25 mm e 4 mm e extensão da lesão &#8804; 28 mm. As características basais foram semelhantes entre os grupos, com exceção de maior prevalência de hipertensão arterial, infarto do miocárdio (IM) de parede anterior e história familiar de doença arterial coronária na coorte latino-americana. As lesões tendiam a ser mais complexas em mulheres latino-americanas, com menor diâmetro de referência do vaso-alvo, maior extensão da lesão, maior excentricidade e angulação e mais lesões tipo B2/C. Os eventos foram adjudicados de acordo com as definições do Academic Research Consortium. Em um ano, o desfecho combinado de morte por todas as causas, IM e revascularização do vaso-alvo (RVA) foi de 12,1% na população não-latino-americana e de 10,1% na população latino-americana (P = 0,58). CONCLUSÕES: Em um ano, os baixos índices de eventos cardíacos adversos, incluindo trombose do stent, falha da lesão-alvo, morte cardíaca, IM e RVA nas mulheres latino-americanas foram comparáveis aos das mulheres não-latino-americanas, apesar da maior complexidade das lesões. Esses resultados demonstram a segurança e a eficácia do stent XIENCE TM V nessa pequena coorte de pacientes latino-americanas, à semelhança do que é observado com populações maiores e mais variadas

Randomized comparison of primary stenting and provisional balloon angioplasty guided by flow velocity measurement.

BACKGROUND: Coronary stenting improves outcomes compared with balloon angioplasty, but it is costly and may have other disadvantages. Limiting stent use to patients with a suboptimal result after angioplasty (provisional angioplasty) may be as effective and less expensive. METHODS AND RESULTS: To analyze the cost-effectiveness of provisional angioplasty, patients scheduled for single-vessel angioplasty were first randomized to receive primary stenting (97 patients) or balloon angioplasty guided by Doppler flow velocity and angiography (523 patients). Patients in the latter group were further randomized after optimization to either additional stenting or termination of the procedure to further investigate what is "optimal." An optimal result was defined as a flow reserve >2.5 and a diameter stenosis <36%. Bailout stenting was needed in 129 patients (25%) who were randomized to balloon angioplasty, and an optimal result was obtained in 184 of the 523 patients (35%). There was no significant difference in event-free survival at 1 year between primary stenting (86.6%) and provisional angioplasty (85.6%). Costs after 1 year were significantly higher for provisional angioplasty (EUR 6573 versus EUR 5885; P:=0.014). Results after the second randomization showed that stenting was also more effective after optimal balloon angioplasty (1-year event free survival, 93.5% versus 84.1%; P:=0. 066). CONCLUSIONS: After 1 year of follow-up, provisional angioplasty was more expensive and without clinical benefit. The beneficial value of stenting is not limited to patients with a suboptimal result after balloon angioplasty