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Background: There are limited clinical data on drug-coated balloon (DCB)-based percutaneous coronary intervention (PCI) compared with drug-eluting stent (DES)-only PCI in patients with complex coronary artery lesions. Objectives: The goal of the current study was to investigate the efficacy of DCB in patients undergoing PCI for complex coronary artery lesions. Methods: From an institutional registry of patients with de novo complex coronary artery lesions, 126 patients treated with DCB-based PCI were compared with 234 propensity score-matched patients treated with DES-only PCI. Complex coronary artery lesions were defined as the presence of at least 1 of the following: bifurcation, chronic total occlusion, unprotected left main disease, long lesion ≥38 mm, multivessel disease, lesion requiring ≥3 devices, or severe calcification. The primary endpoint was target vessel failure (TVF) at 2 years, a composite of cardiac death, target vessel-related myocardial infarction, and target vessel revascularization. Results: Baseline characteristics were comparable between the 2 groups. DCB-based PCI showed a comparable risk of TVF vs DES-based PCI (7.6% vs 8.1%; HR: 0.81; 95% CI: 0.33-1.99; P = 0.638). The risks of cardiac death (5.0% vs 5.7%; HR: 0.78; 95% CI: 0.24-2.49), target vessel-related myocardial infarction (0.9% vs 1.3%; HR: 2.65; 95% CI: 0.26-27.06), and target vessel revascularization (3.5% vs 2.0%; HR: 1.30; 95% CI: 0.30-5.67) were also comparable between the 2 groups. Conclusions: DCB-based PCI showed comparable risks of TVF vs those of DES-only PCI in patients with complex coronary artery lesions. DCB might be considered as a suitable alternative device to DES in patients undergoing complex PCI. (Long-term Outcomes and Prognostic Factors in Patient Undergoing CABG or PCI; NCT03870815).
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BACKGROUND: Artificial intelligence-based quantitative coronary angiography (AI-QCA) has been developed to provide a more objective and reproducible data about the severity of coronary artery stenosis and the dimensions of the vessel for intervention in real-time, overcoming the limitations of significant inter- and intraobserver variability, and time-consuming nature of on-site QCA, without requiring extra time and effort. Compared with the subjective nature of visually estimated conventional CAG guidance, AI-QCA guidance provides a more practical and standardized angiography-based approach. Although the advantage of intravascular imaging-guided PCI is increasingly recognized, their broader adoption is limited by clinical and economic barriers in many catheterization laboratories. METHODS: The FLASH (fully automated quantitative coronary angiography versus optical coherence tomography guidance for coronary stent implantation) trial is a randomized, investigator-initiated, multicenter, open-label, noninferiority trial comparing the AI-QCA-assisted PCI strategy with optical coherence tomography-guided PCI strategy in patients with significant coronary artery disease. All operators will utilize a novel, standardized AI-QCA software and PCI protocol in the AI-QCA-assisted group. A total of 400 patients will be randomized to either group at a 1:1 ratio. The primary endpoint is the minimal stent area (mm2), determined by the final OCT run after completion of PCI. Clinical follow-up and cost-effectiveness evaluations are planned at 1 month and 6 months for all patients enrolled in the study. RESULTS: Enrollment of a total of 400 patients from the 13 participating centers in South Korea will be completed in February 2024. Follow-up of the last enrolled patients will be completed in August 2024, and primary results will be available by late 2024. CONCLUSION: The FLASH is the first clinical trial to evaluate the feasibility of AI-QCA-assisted PCI, and will provide the clinical evidence on AI-QCA assistance in the field of coronary intervention. CLINICAL TRIAL REGISTRATION: URL: https://www. CLINICALTRIALS: gov. Unique identifier: NCT05388357.
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AIMS: Few studies have reported data on the optimal timing of left ventricular (LV) unloading during venoarterial extracorporeal membrane oxygenation (VA-ECMO) for cardiac arrest or shock. This study evaluated the feasibility of an early LV unloading strategy compared with a conventional strategy in VA-ECMO. METHODS AND RESULTS: Between December 2018 and August 2022, 60 patients at two institutions were randomized in a 1:1 ratio to receive early (n = 30) or conventional (n = 30) LV unloading strategies. The early LV unloading strategy was defined as LV unloading performed at the time of VA-ECMO insertion. LV unloading was performed using a percutaneous transseptal left atrial cannulation via the femoral vein incorporated into the ECMO venous circuit. The early and conventional LV unloading groups included 29 (96.7%) and 23 (76.7%) patients, respectively (median time from VA-ECMO insertion to LV unloading: 48.4 h, interquartile range 47.8-96.5 h). The groups showed no significant differences in the rate of VA-ECMO weaning as the primary endpoint (70.0% vs. 76.7%; relative risk 0.91; 95% confidence interval 0.67-1.24; p = 0.386) and survival to discharge (53.3% vs. 50.0%, p = 0.796). However, the pulmonary congestion score index at 48 h after LV unloading was significantly improved only in the early LV unloading group (2.0 ± 0.7 vs. 1.7 ± 0.6 at baseline vs. at 48 h; p = 0.008). CONCLUSIONS: Compared with the conventional approach, early LV unloading did not improve the VA-ECMO weaning rate, despite the rapid improvement in pulmonary congestion. Therefore, the results of this study do not support the application of this strategy after VA-ECMO insertion.
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Oxigenación por Membrana Extracorpórea , Insuficiencia Cardíaca , Edema Pulmonar , Humanos , Insuficiencia Cardíaca/terapia , Choque Cardiogénico/etiología , Choque Cardiogénico/terapia , Oxigenación por Membrana Extracorpórea/métodos , Atrios Cardíacos , DescompresiónRESUMEN
It is unknown whether edoxaban versus dual antiplatelet therapy (DAPT) has differential treatment effects on leaflet thrombosis, cerebral thromboembolism, and neurologic or neurocognitive dysfunction according to clinical and anatomic factors after transcatheter aortic valve implantation. To investigate the relative effects of edoxaban and DAPT on leaflet and cerebral thromboembolism in patients with major risk factors. The primary end point of this study was the incidence of leaflet thrombosis on computed tomography at 6 months. The secondary end points were new cerebral lesions on brain magnetic resonance imaging and neurologic and neurocognitive dysfunction between baseline and 6-month follow-up. Cox regression models assessed the consistency of the treatment effects in the prespecified subgroups. The favorable effect of edoxaban versus DAPT on the leaflet thrombosis was consistent across multiple clinical or anatomic subgroups, without significant interaction between the drug effect and each subgroup (p for interaction for age = 0.597, gender = 0.557, body mass index = 0.866, Society of Thoracic Surgeons score = 0.307, valve type = 0.702, edoxaban reduction criteria = 0.604, and valve morphology = 0.688). However, the incidence of new cerebral lesions on brain magnetic resonance imaging and worsening of neurologic and neurocognitive function were not significantly different between the groups among the various key subgroups. The relative effects of edoxaban and DAPT on the risk of leaflet thrombosis, cerebral thromboembolism, and neurologic dysfunction were consistent across a diverse spectrum of clinical or anatomical factors. Further studies are required to define tailored antithrombotic therapy for high-risk groups with specific clinical or anatomic characteristics.
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Estenosis de la Válvula Aórtica , Trombosis Intracraneal , Tromboembolia , Trombosis , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Lactante , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/complicaciones , Inhibidores de Agregación Plaquetaria , Tromboembolia/epidemiología , Tromboembolia/etiología , Tromboembolia/prevención & control , Trombosis/epidemiología , Trombosis/etiología , Trombosis/prevención & control , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Resultado del Tratamiento , Masculino , FemeninoRESUMEN
Myocardial viability test to guide revascularization remains uncertain in patients with ischemic cardiomyopathy. We evaluated the different impacts of revascularization on cardiac mortality according to the extent of myocardial scar assessed by cardiac magnetic resonance (CMR) with late gadolinium enhancement (LGE) in patients with ischemic cardiomyopathy. A total of 404 consecutive patients with significant coronary artery disease and an ejection fraction ≤35% were assessed by LGE-CMR before revascularization. Of them, 306 patients underwent revascularization and 98 patients received medical treatment alone. The primary outcome was cardiac death. During a median follow-up of 6.3 years, cardiac death occurred in 158 patients (39.1%). Revascularization was associated with a significantly lower risk of cardiac death than medical treatment alone in the overall population (adjusted hazard ratio [aHR] 0.29, 95% confidence interval (CI) 0.19 to 0.45, p <0.001). There was a significant interaction between the number of segments with >75% transmural LGE and revascularization on the risk of cardiac death (p = 0.037 for interaction). In patients with limited myocardial scar (<6 segments with >75% transmural LGE, n = 354), revascularization had a significantly lower risk of cardiac death than medical treatment alone (aHR 0.24, 95% CI 0.15 to 0.37, p <0.001); in patients with extensive myocardial scar (≥6 segments with >75% transmural LGE, n = 50), there was no significant difference between revascularization and medical treatment alone regarding the risk of cardiac death (aHR 1.33, 95% CI 0.46 to 3.80, p = 0.60). In conclusion, the assessment of myocardial scar by LGE-CMR may be helpful in the decision-making process for revascularization in patients with ischemic cardiomyopathy.
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Cardiomiopatías , Isquemia Miocárdica , Humanos , Medios de Contraste , Gadolinio , Cicatriz/complicaciones , Imagen por Resonancia Cinemagnética , Pronóstico , Isquemia Miocárdica/complicaciones , Espectroscopía de Resonancia Magnética , Muerte , Cardiomiopatías/complicaciones , Valor Predictivo de las PruebasRESUMEN
Background: Limited data are available on the relative performances of diverse contemporary drug-eluting stents (DES) in patients undergoing complex high-risk indicated procedures (CHIP). Objectives: The purpose of this study was to evaluate the comparative effectiveness of contemporary second-generation DES for CHIP patients in "real-world" settings. Methods: Of 28,843 patients enrolled in the IRIS-DES registry, a total of 6,645 patients with CHIP characteristics who received 5 different types of contemporary DES were finally included: 3,752 with cobalt-chromium everolimus-eluting stents (CoCr-EES), 1,258 with Resolute zotarolimus-eluting stents (Re-ZES), 864 with platinum-chromium EES (PtCr-EES), 437 with ultrathin strut biodegradable-polymer sirolimus-eluting stents (UT-SES), and 334 with bioresorbable polymer SES (BP-SES). The primary outcome was target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, and target-vessel revascularization) at 12 months. Results: At 12 months, the rate of target-vessel failure was highest in the CoCr-EES (7.1%) group; intermediate in the Re-ZES (5.0%), PtCr-EES (4.6%), and BP-SES (4.2%) groups; and lowest in the UT-SES (3.8%) group (overall long-rank P = 0.001). In multiple-treatment propensity-score analysis, the adjusted hazard ratios (HRs) for target-vessel failure were significantly lower in the Re-ZES (HR: 0.71; 95% confidence interval [CI]: 0.52-0.97), the UT-SES (HR: 0.52; 95% CI: 0.29-0.95), and BP-SES (HR: 0.33; 95% CI: 0.16-0.70) groups than in the CoCr-EES group (referent). Conclusions: In this contemporary PCI registry, we observed the differential risks of target-vessel failure according to various types of contemporary DES in patients with CHIP characteristics. However, owing to inherent selection bias, the results should be considered hypothesis-generating, highlighting the need for further randomized trials. (Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice [IRIS-DES]; NCT01186133).
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BACKGROUND: It is unknown whether the direct oral anticoagulant edoxaban can reduce leaflet thrombosis and the accompanying cerebral thromboembolic risk after transcatheter aortic valve replacement. In addition, the causal relationship of subclinical leaflet thrombosis with cerebral thromboembolism and neurological or neurocognitive dysfunction remains unclear. METHODS: We conducted a multicenter, open-label randomized trial comparing edoxaban with dual antiplatelet therapy (aspirin plus clopidogrel) in patients who had undergone successful transcatheter aortic valve replacement and did not have an indication for anticoagulation. The primary end point was an incidence of leaflet thrombosis on 4-dimensional computed tomography at 6 months. Key secondary end points were the number and volume of new cerebral lesions on brain magnetic resonance imaging and the serial changes of neurological and neurocognitive function between 6 months and immediately after transcatheter aortic valve replacement. RESULTS: A total of 229 patients were included in the final intention-to-treat population. There was a trend toward a lower incidence of leaflet thrombosis in the edoxaban group compared with the dual antiplatelet therapy group (9.8% versus 18.4%; absolute difference, -8.5% [95% CI, -17.8% to 0.8%]; P=0.076). The percentage of patients with new cerebral lesions on brain magnetic resonance imaging (edoxaban versus dual antiplatelet therapy, 25.0% versus 20.2%; difference, 4.8%; 95% CI, -6.4% to 16.0%) and median total new lesion number and volume were not different between the 2 groups. In addition, the percentages of patients with worsening of neurological and neurocognitive function were not different between the groups. The incidence of any or major bleeding events was not different between the 2 groups. We found no significant association between the presence or extent of leaflet thrombosis with new cerebral lesions and a change of neurological or neurocognitive function. CONCLUSIONS: In patients without an indication for long-term anticoagulation after successful transcatheter aortic valve replacement, the incidence of leaflet thrombosis was numerically lower with edoxaban than with dual antiplatelet therapy, but this was not statistically significant. The effects on new cerebral thromboembolism and neurological or neurocognitive function were also not different between the 2 groups. Because the study was underpowered, the results should be considered hypothesis generating, highlighting the need for further research. REGISTRATION: URL: https://www. CLINICALTRIALS: gov. Unique identifier: NCT03284827.
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Estenosis de la Válvula Aórtica , Tromboembolia , Trombosis , Reemplazo de la Válvula Aórtica Transcatéter , Anticoagulantes/uso terapéutico , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Humanos , Inhibidores de Agregación Plaquetaria/efectos adversos , Piridinas , Factores de Riesgo , Tiazoles , Tromboembolia/diagnóstico por imagen , Tromboembolia/epidemiología , Tromboembolia/etiología , Trombosis/diagnóstico por imagen , Trombosis/tratamiento farmacológico , Trombosis/epidemiología , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Resultado del TratamientoAsunto(s)
Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Humanos , Factores Raciales , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
Background There are still limited data about the differential effect of sex on long-term outcomes after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for left main coronary artery disease. This extended follow-up study of the MAIN-COMPARE (Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease) registry evaluated clinical outcomes beyond 10 years. Methods and Results Of 2240 patients with unprotected left main coronary artery disease (PCI=1102 and CABG=1138), all-cause mortality, the composite of death, Q-wave myocardial infarction, or stroke, and target vessel revascularization were separately evaluated in both sexes. Of 2240 patients, 631 (28.2%) were women and 1609 (71.8%) were men. Women had lower 10-year incidences of death and serious composite outcomes than men. The adjusted 10-year risks of adverse outcomes were similar in men. However, the adjusted 10-year risks were different according to a prespecified period in women. In the short-term (0-1 year) period, PCI had a significantly lower risk for serious composite outcomes (adjusted hazard ratio [HR], 0.41; 95% CI, 0.19-0.91; P=0.03) compared with CABG. The adjusted risks for death and serious composite outcomes were significantly higher after PCI than after CABG, during the midterm (1-5 years) period (death; adjusted HR, 3.99; 95% CI, 2.01-7.92; P<0.001 and composite outcome; adjusted HR, 2.93; 95% CI, 1.59-5.39; P=0.001). Beyond 5 years, adjusted risks were similar after PCI and CABG in women. Conclusions In this 10-year extended follow-up study of patients undergoing left main coronary artery revascularization, we observed a time-dependent impact of sex on the long-term outcomes after PCI and CABG, especially in women, with significant interactions. However, these results warrant confirmation on larger series of studies. Registration URl: https://www.clinicaltrials.gov; Unique identifier: NCT02791412.
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Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Enfermedad de la Arteria Coronaria/etiología , Enfermedad de la Arteria Coronaria/cirugía , Femenino , Estudios de Seguimiento , Humanos , Masculino , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE: Little information exists about inter-racial differences in patients with aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). We investigated whether differences in baseline characteristics between Asian and non-Asian population may contribute to disparities in clinical outcomes after TAVI. METHODS: We performed a registry-based, multinational cohort study of patients with severe AS who underwent TAVI at two centres in the USA and one centre in South Korea. The primary outcome was a composite of death, stroke or rehospitalisation at 1 year. RESULTS: Of 1412 patients, 581 patients were Asian and 831 were non-Asian (87.5% white, 1.7% black, 6.1% Hispanic or 4.7% others). There were substantial differences in baseline characteristics between two racial groups. The primary composite outcome was significantly lower in the Asian group than in the non-Asian group (26.0% vs 35.0%; HR 0.73; 95% CI 0.59 to 0.89; p=0.003). However, after adjustment of baseline covariates, the risk of primary composite outcome was not significantly different (HR 0.79; 95% CI 0.60 to 1.03; p=0.08). The all-cause mortality at 1 year was significantly lower in the Asian group than the non-Asian group (7.4% vs 12.5%; HR 0.60; 95% CI 0.41 to 0.88; p=0.009). After multivariable adjustment, the risk of all-cause mortality was also similar (HR 1.17; 95% CI 0.73 to 1.88; p=0.52). CONCLUSIONS: There were significant differences in baseline and procedural factors among Asian and non-Asian patients who underwent TAVI. Observed inter-racial differences in clinical outcomes were largely explained by baseline differences in clinical, anatomical and procedural factors. TRIAL REGISTRATION NUMBER: NCT03826264 (https://wwwclinicaltrialsgov).
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Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Estudios de Cohortes , Humanos , Factores Raciales , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
Percutaneous coronary intervention (PCI) is used to treat obstructive coronary artery disease (CAD). The role of PCI is well defined in acute coronary syndrome, but that for stable CAD remains debatable. Although PCI generally relieves angina in patients with stable CAD, it may not change its prognosis. The extent and severity of CAD are major determinants of prognosis, and complete revascularization (CR) of all ischemia-causing lesions might improve outcomes. Several studies have shown better outcomes with CR than with incomplete revascularization, emphasizing the importance of functional angioplasty. However, different definitions of inducible myocardial ischemia have been used across studies, making their comparison difficult. Various diagnostic tools have been used to estimate the presence, extent, and severity of inducible myocardial ischemia. However, to date, there are no agreed reference standards of inducible myocardial ischemia. The hallmarks of inducible myocardial ischemia such as electrocardiographic changes and regional wall motion abnormalities may be more clinically relevant as the reference standard to define ischemia-causing lesions. In this review, we summarize studies regarding myocardial ischemia, PCI guidance, and possible explanations for similar findings across studies. Also, we provide some insights into the ideal definition of inducible myocardial ischemia and highlight the appropriate PCI strategy.
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BACKGROUND: Limited data are available on the long-term outcomes of drug-eluting stents (DES) vs bare-metal stents (BMS) in patients with left main coronary artery (LMCA) disease. METHODS: In this observational cohort of the Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty vs Surgical Revascularization (MAIN-COMPARE) registry, we evaluated patients with unprotected LMCA stenosis who received DES or BMS between January 2000 and June 2006. The primary outcome was a composite of all-cause death or myocardial infarction (MI) at 10 years. Adjusted outcomes were compared using propensity scores and inverse probability of treatment weighting. RESULTS: A total of 1102 patients underwent DES (n = 784) or BMS (n = 318) during the study period. At 10 years, the adjusted rate of the primary outcome was significantly lower in DES group than in the BMS group (27.9% vs 37.0%; hazard ratio [HR], 0.71; 95% confidence interval [CI], 0.53-0.94; P = 0.02). The adjusted 10-year mortality rate was significantly lower in DES group than in the BMS group (20.6% vs 29.6%; HR, 0.65; 95% CI, 0.46-0.91; P = 0.01), whereas the 10-year rate of MI was similar between the 2 groups (9.9% vs 11.0%; HR, 0.93; 95% CI, 0.54-1.59; P = 0.78). DES use was associated with a significant reduction in the rate of target-lesion revascularization (10.2% vs 21.8%; HR, 0.41; 95% CI, 0.27-0.61; P < 0.001). CONCLUSIONS: In this 10-year follow-up study in patients with LMCA disease, DES use was associated with a significant reduction in the rate of the composite of death or MI, mortality, and target-lesion revascularization, when compared with BMS.
CONTEXTE: On dispose de peu de données sur les résultats à long terme de la mise en place d'endoprothèses médicamentées par rapport aux endoprothèses non médicamentées chez les patients atteints d'une maladie de l'artère coronaire principale gauche. MÉTHODOLOGIE: Dans cette cohorte d'observation du registre MAIN-COMPARE (Revascularization for Unprotected Left Main Coronary Artery Stenosis: Comparison of Percutaneous Coronary Angioplasty vs Surgical Revascularization), nous avons évalué les patients présentant une sténose de l'artère coronaire principale gauche non protégée et ayant reçu une endoprothèse médicamentée ou une endoprothèse non médicamentée entre janvier 2000 et juin 2006. Le paramètre d'évaluation principal était composé de la mortalité toutes causes confondues et de l'infarctus du myocarde (IM) à 10 ans. Les résultats ajustés ont été comparés en utilisant des scores de propension et la pondération inverse sur la probabilité d'être traité. RÉSULTATS: Au total, 1 102 patients ont reçu des endoprothèses médicamentées (n = 784) ou des endoprothèses non médicamentées (n = 318) pendant la période d'étude. À 10 ans, le taux ajusté de survenue du paramètre d'évaluation principal était nettement plus faible dans le groupe endoprothèses médicamentées que dans le groupe endoprothèses non médicamentées (27,9 % vs 37,0 %; rapport des risques instantanés [RRI] : 0,71; intervalle de confiance [IC] à 95 % : 0,53-0,94; p = 0,02). Le taux de mortalité ajusté à 10 ans était considérablement plus faible dans le groupe endoprothèses médicamentées que dans le groupe endoprothèses non médicamentées (20,6 % vs 29,6 %; RRI : 0,65; IC à 95 % : 0,46-0,91; p = 0,01), tandis que le taux d'IM à 10 ans était similaire dans les deux groupes (9,9 % vs 11,0 %; RRI : 0,93; IC à 95 % : 0,54-1,59; p = 0,78). L'utilisation d'endoprothèses médicamentées était associée à une diminution importante du taux de revascularisation de la lésion cible (10,2 % vs 21,8 %; RRI : 0,41; IC à 95 % : 0,27-0,61; p < 0,001). CONCLUSIONS: Dans cette étude de suivi de 10 ans menée auprès de patients atteints d'une maladie de l'artère coronaire principale gauche, l'utilisation d'endoprothèses médicamentées a été associée à une diminution importante du taux des décès ou des IM regroupés, de la mortalité et du taux de revascularisation de la lésion cible, par rapport à l'utilisation d'endoprothèses non médicamentées.
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OBJECTIVES: The aim of this study was to compare the incidence and prognostic significance of prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) according to racial groups. BACKGROUND: PPM after TAVR may be of more concern in Asian populations considering their relatively small annular and valve sizes compared with Western populations. METHODS: TP-TAVR (Transpacific TAVR Registry) was an international multicenter cohort study of patients with severe aortic stenosis who underwent TAVR in the United States and South Korea from January 2015 to November 2019. PPM was defined as moderate (0.65-0.85 cm2/m2) or severe (<0.65 cm2/m2) at the indexed effective orifice area. The primary outcome was a composite of death, stroke, or rehospitalization at 1 year. RESULTS: Among 1,101 eligible patients (533 Asian and 569 non-Asian), the incidence of PPM was significantly lower in the Asian population (33.6%; moderate, 26.5%; severe, 7.1%) than in the non-Asian population (54.5%; moderate, 29.8%; severe, 24.7%). The 1-year rate of the primary outcome was similar between the PPM and non-PPM groups (27.5% vs 28.1%; P = 0.69); this pattern was consistent between Asian (25.4% vs 25.2%; P = 0.31) and non-Asian (28.7% vs 32.1%; P = 0.97) patients. After multivariable adjustment, the risk for the primary outcome did not significantly differ between the PPM and non-PPM groups in the overall population (HR: 0.95; 95% CI: 0.74-1.21), in Asian patients (HR: 1.07; 95% CI: 0.74-1.55), and in non-Asian patients (HR: 0.86; 95% CI: 0.63-1.19). CONCLUSIONS: In this study of patients with severe aortic stenosis who underwent TAVR, the incidence of PPM was significantly lower in Asian patients than in non-Asian patients. The 1-year risk for the primary composite outcome was similar between the PPM and non-PPM groups regardless of racial group. (Transpacific TAVR Registry [TP-TAVR]; NCT03826264).
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Estenosis de la Válvula Aórtica , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/etiología , Estenosis de la Válvula Aórtica/cirugía , Estudios de Cohortes , Prótesis Valvulares Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Incidencia , Diseño de Prótesis , Factores Raciales , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento , Estados Unidos/epidemiologíaRESUMEN
[Figure: see text].
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Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Humanos , Intervención Coronaria Percutánea/efectos adversos , Stents , Resultado del Tratamiento , Ultrasonografía IntervencionalRESUMEN
More evidence is required with respect to the comparative effectiveness of percutaneous coronary intervention (PCI) with second-generation drug-eluting stents (DESs) versus coronary artery bypass grafting (CABG) in contemporary clinical practice. This prospective observational registry-based study compared the outcomes of 6,647 patients with multivessel disease who underwent PCI with second-generation DES (n = 3,858) or CABG (n = 2,789) between January 2006 and June 2018 and for whom follow-up data were available for at least 2 to 13 years (median 4.8). The primary outcome was a composite of death, spontaneous myocardial infarction, or stroke. Baseline differences were adjusted using propensity scores and inverse probability weighting. In the overall cohort, there were no significant between-group differences in the adjusted risks for the primary composite outcome (hazard ratio [HR] for PCI vs CABG 1.03, 95% confidence interval [CI] 0.86 to 1.25, p = 0.73) and all-cause mortality (HR 0.95, 95% CI 0.76 to 1.20, p = 0.68). This relative treatment effect on the primary outcome was similar in patients with diabetes (HR 1.15, 95% CI 0.91 to 1.46, p = 0.25) and without diabetes (HR 0.95, 95% CI 0.73 to 1.22, p = 0.67) (p for interaction = 0.24). The adjusted risk of the primary outcome was significantly greater after PCI than after CABG in patients with left main involvement (HR 1.39, 95% CI 1.01 to 1.90, p = 0.044), but not in those without left main involvement (HR 0.94, 95% CI 0.76 to 1.16, p = 0.56) (p = 0.03 for interaction). In this prospective real-world long-term registry, we observed that the risk for the primary composite of death, spontaneous myocardial infarction, or stroke was similar between PCI with contemporary DES and CABG.
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Puente de Arteria Coronaria , Enfermedad de la Arteria Coronaria/cirugía , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Anciano , Enfermedad de la Arteria Coronaria/complicaciones , Complicaciones de la Diabetes/complicaciones , Diabetes Mellitus , Femenino , Humanos , Masculino , Persona de Mediana Edad , Mortalidad , Infarto del Miocardio/epidemiología , Puntaje de Propensión , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Sistema de Registros , Accidente Cerebrovascular/epidemiología , Resultado del TratamientoRESUMEN
Background The long-term impact of newly discovered, asymptomatic abnormal ankle-brachial index (ABI) in patients with significant coronary artery disease is limited. Methods and Results Between January 2006 and December 2009, ABI was evaluated in 2424 consecutive patients with no history of claudication or peripheral artery disease who had significant coronary artery disease. We previously reported a 3-year result; therefore, the follow-up period was extended. The primary end point was a composite of all-cause death, myocardial infarction (MI), and stroke over 7 years. Of the 2424 patients with significant coronary artery disease, 385 had an abnormal ABI (ABI ≤0.9 or ≥1.4). During the follow-up period, the rate of the primary outcome was significantly higher in the abnormal ABI group than in the normal ABI group (P<0.001). The abnormal ABI group had a significantly higher risk of composite of all-cause death/MI/stroke than the normal ABI group, after adjustment with multivariable Cox proportional hazards regression analysis (hazard ratio [HR], 2.07; 95% CI, 1.67-2.57; P<0.001) and propensity score-matched analysis (HR, 1.97; 95% CI, 1.49-2.60; P<0.001). In addition, an abnormal ABI was associated with a higher risk of all-cause death, MI, and stroke, but not repeat revascularization. Conclusions Among patients with significant coronary artery disease, asymptomatic abnormal ABI was associated with sustained and increased incidence of composite of all-cause death/MI/stroke, all-cause death, MI, and stroke during extended follow-up over 7 years.
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Índice Tobillo Braquial , Enfermedad de la Arteria Coronaria , Causas de Muerte , Enfermedad de la Arteria Coronaria/epidemiología , Enfermedad de la Arteria Coronaria/fisiopatología , Estudios de Seguimiento , Humanos , Infarto del Miocardio/epidemiología , Valor Predictivo de las Pruebas , Factores de Riesgo , Accidente Cerebrovascular/epidemiologíaRESUMEN
To compare 10-year outcomes after implantation of sirolimus-eluting stents (SES) versus paclitaxel-eluting stents (PES) for left main coronary artery (LMCA) stenosis. Very long-term outcome data of patients with LMCA disease treated with drug-eluting stents (DES) have not been well described. In 10-year extended follow-up of the MAINCOMPARE registry, we evaluated 778 patients with unprotected LMCA stenosis who were treated with SES (n = 607) or PES (n = 171) between January 2000 and June 2006. The primary composite outcome (a composite of death, myocardial infarction [MI] or target-vessel revascularization [TVR]) was compared with an inverse-probability-of-treatment-weighting (IPTW) adjustment. Clinical events have linearly accumulated over 10 years. At 10 years, there were no significant differences between SES and PES in the observed rates of the primary composite outcome (42.0% vs. 47.4%; hazard ratio [HR] 0.85; 95% confidence interval [CI] 0.66-1.10), and definite stent thrombosis (ST) (1.9% vs. 1.8%; HR 1.02, 95% CI 0.28-3.64). In the IPTW-adjusted analyses, there were no significant differences between SES and PES in the risks for the primary composite outcome (HR 0.89, 95% CI 0.65-1.14) or definite ST (adjusted HR 1.05, 95% CI 0.29-3.90). In patients who underwent DES implantation, high overall adverse clinical event rates (with a linearly increasing event rate over time) were observed during extended follow-up. At 10 years, there were no measurable differences in outcomes between patients treated with SES vs. PES for LMCA disease. The incidence of stent thrombosis was quite low and comparable between the groups.
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Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Humanos , Paclitaxel/efectos adversos , Sirolimus/efectos adversos , Stents , Resultado del TratamientoRESUMEN
Background The long-term prognostic effect of the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS) after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for left main coronary artery disease is controversial. Methods and Results In the PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease) trial, 600 patients with left main coronary artery disease were randomized to undergo PCI with drug-eluting stents (n=300) or CABG (n=300). We compared 10-year outcomes after PCI and CABG according to SS categories and evaluated the predictive value of SS in each revascularization arm. The primary outcome was a major adverse cardiac or cerebrovascular event (composite of death, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization) at 10 years. Among 566 patients with valid SS measurement at baseline, 240 (42.4%) had low SS, 200 (35.3%) had intermediate SS, and 126 (22.3%) had high SS. The 10-year rates of major adverse cardiac or cerebrovascular events were not significantly different between PCI and CABG in low (21.6% versus 22.2%, P=0.97), intermediate (31.8% versus 22.2%; P=0.13), and high SS (46.2% versus 35.7%; P=0.31) (P-for-interaction=0.46). There were no significant interactions between SS categories and revascularization modalities for death (P=0.92); composite of death, myocardial infarction, or stroke (P=0.87); and target-vessel revascularization (P=0.06). Higher SS categories were associated with higher risks for major adverse cardiac or cerebrovascular events in the PCI arm but not in the CABG arm. Conclusions Ten-year clinical outcomes between PCI and CABG were not significantly different according to the SS. The SS was predictive of major adverse cardiac or cerebrovascular events after PCI but not after CABG. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03871127.
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Enfermedad de la Arteria Coronaria/cirugía , Vasos Coronarios/cirugía , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea/métodos , Medición de Riesgo/métodos , Sirolimus/farmacología , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/mortalidad , Vasos Coronarios/diagnóstico por imagen , Femenino , Estudios de Seguimiento , Humanos , Inmunosupresores/farmacología , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Prospectivos , República de Corea/epidemiología , Factores de Riesgo , Tasa de Supervivencia/tendencias , Factores de Tiempo , Resultado del TratamientoRESUMEN
Background Several trials reported differential outcomes after percutaneous coronary intervention with drug-eluting stents (DES) and coronary-artery bypass grafting (CABG) for multivessel coronary disease according to the presence of diabetes mellitus (DM). However, it is not well recognized how DM status affects very-long-term (10-year) outcomes after DES and CABG for left main coronary artery disease. Methods and Results In the PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) trial, patients with LMCA were randomly assigned to undergo PCI with sirolimus-eluting stents (n=300) or CABG (n=300). The primary outcome was the incidence of major adverse cardiac or cerebrovascular events (MACCE; a composite of death from any cause, myocardial infarction, stroke, or ischemia-driven target-vessel revascularization). Outcomes were examined in patients with (n=192) and without (n=408) medically treated diabetes. The follow-up was extended to at least 10 years for all patients (median, 11.3 years). The 10-year rates of MACCE were not significantly different between DES and CABG in patients with DM (36.3% versus 26.7%, respectively; hazard ratio [HR], 1.35; 95% CI, 0.83-2.19; P=0.23) and without DM (25.3% versus 22.9%, respectively; HR, 1.15; 95% CI, 0.79-1.67; P=0.48) (P-for-interaction=0.48). There were no significant between-group differences in composite of death, MI, or stroke, and all-cause mortality, regardless of DM status. TVR rates were consistently higher after DES than CABG. Conclusions In this 10-year extended follow-up of PRECOMBAT, we found no significant difference between DES and CABG with respect to the incidences of MACCE, serious composite outcome, and all-cause mortality in patients with and without DM with LMCA disease. However, owing to the limited number of patients and no adjustment for multiple testing, overall findings should be considered hypothesis-generating, highlighting the need for further research. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03871127 and NCT00422968.