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Angioplastia Coronaria con Balón , Enfermedad de la Arteria Coronaria , Sistema de Registros , Sirolimus , Humanos , Enfermedad de la Arteria Coronaria/terapia , Sirolimus/uso terapéutico , Sirolimus/administración & dosificación , Resultado del Tratamiento , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/métodos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Stents Liberadores de FármacosRESUMEN
BACKGROUND: In the elderly people with unprotected left main distal bifurcation lesions (ULMD), percutaneous coronary intervention (PCI) is often selected as first choice treatment strategy because of perioperative high risk of coronary artery bypass graft surgery due to their large number of comorbidities. Also, some recent papers reported that geriatric nutritional risk index (GNRI) is also strongly associated with clinical outcomes after interventional procedures in elderly patients. OBJECTIVES: We assessed clinical outcomes after PCI for ULMD and the impact of GNRI in elderly patients. METHODS: We identified 669 non dialysis patients treated with current generation drug-eluting stent for ULMD from MITO registry. We divided the patients to the following 2 groups; elderly group (n = 240, age ≥75) and young group (n = 429, age <75). Additionally, we could calculate GNRI and divided elderly group into 2 group based on the median value of the GNRI. The primary endpoint was all-cause mortality. RESULTS: All-cause mortality was significantly higher in elderly group [adjusted hazard ratio (HR) 2.37; 95% confidence interval (CI), 1.40-4.02; p = 0.001]. All-cause mortality was significantly higher in low GNRI elderly group compared to other 2 groups (Adjusted HR of elderly with low GNRI: 3.56, 95%CI (1.77-7.14), p < 0.001). Cardiovascular mortality was comparable between two groups. TLR rate was significantly lower in elderly group (adjusted HR 0.57; 95% CI, 0.34-0.97; p = 0.035). CONCLUSIONS: The elderly had higher all-cause mortality after PCI for ULMD compared to young people. Especially, the elderly with low GNRI were extremely associated with poorer outcomes.
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Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Evaluación Geriátrica , Intervención Coronaria Percutánea , Sistema de Registros , Humanos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Intervención Coronaria Percutánea/instrumentación , Anciano , Masculino , Femenino , Enfermedad de la Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Factores de Riesgo , Resultado del Tratamiento , Medición de Riesgo , Factores de Edad , Factores de Tiempo , Anciano de 80 o más Años , Persona de Mediana Edad , Estado Nutricional , Estudios Retrospectivos , JapónRESUMEN
BACKGROUND: Mitral regurgitation (MR) is frequent in patients with aortic stenosis (AS). Although primary MR is an established negative prognostic factor, whether different mechanisms of MR have different effects on outcome is currently unknown. The aim of this study was to evaluate the impact of the MR mechanism in patients undergoing transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: This is a retrospective observational study of patients who underwent TAVR for severe aortic stenosis in a high-volume tertiary care center. Echocardiographic comprehensive MR assessment was performed at baseline and within 3 months post TAVR. The study population was divided into 4 groups according to MR mechanism: Group I: fibro-calcific leaflet degeneration; Group II: prolapse/flail; Group III: ventricular secondary MR (functional MR); and Group IV: atrial functional MR. The study end point was a combination of death from cardiovascular cause and heart failure-related hospitalization. The study population included 427 patients (mean age 81.7±6.5 years; 71% primary MR; 62% ≥moderate MR). At 3-year follow-up, survival free from the composite end point significantly differs according to MR mechanism: it was higher in group IV (atrial functional MR, 96.6%) compared with group I (80.4%, P=0.002) and group II patients (60.7%, P=0.001), and group III (84.8%, P=0.037); patients with MR due to leaflet prolapse showed poorer prognosis compared with patients with functional MR (group III, P=0.023 and group IV, P=0.001) and with group I (P=0.040). Overall, severe MR after TAVR identified patients with poorer prognosis and was significantly more frequent in group II (46.4%, P=0.001). CONCLUSIONS: In patients undergoing TAVR, preprocedural identification of MR mechanism and mechanism provides prognostic insights.
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Estenosis de la Válvula Aórtica , Insuficiencia de la Válvula Mitral , Índice de Severidad de la Enfermedad , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Masculino , Femenino , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/mortalidad , Insuficiencia de la Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/complicaciones , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Estudios Retrospectivos , Anciano de 80 o más Años , Anciano , Resultado del Tratamiento , Ecocardiografía , Factores de Riesgo , Factores de Tiempo , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatologíaRESUMEN
Tricuspid regurgitation (TR) is common both in patients with left side valvular heart disease and in patients with permanent atrial fibrillation and is associated with increased mortality, morbidity, and an increased risk of hospitalization. Surgery for isolated tricuspid repair is a viable option but burdened by a high-operative risk and a post-operative course characterized by high morbidity. Recently, percutaneous interventional techniques have emerged as a viable option in selected high-risk patients who may clinically benefit from tricuspid valve repair. The purpose of this article is to provide an overview of the current state of transcatheter restorative treatment of TR by providing an overview of new devices in clinical development.
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Balloon angioplasty achieves luminal enlargement by fracturing the atherosclerotic intima at its point of least resistance, thereby creating a dissection plane and space with dehiscence of the intima from the media. This barotraumatic dissection triggers an inflammatory and proliferative reaction, resulting in a restenosis process at medium-term. In the era of plain old balloon angioplasty, quantitative angiographic studies at follow-up demonstrated that - the greater the acute luminal gain was after balloon angioplasty, the greater the late luminal loss was at follow-up. The interventional cardiologists coined the following motto "the more you gain, the more you lose". However, in the current era of drug coated balloon (DCB), it appears that this vexing conundrum could have been abrogated. A recently published DCB study in small de novo vessel has demonstrated that there was a slightly negative correlation between the volume of dissection assessed by optical coherence tomography and the angiographic late luminal loss (now gain) after Paclitaxel coated balloon treatment. In other words, the barotraumatic dissection does not necessarily herald a restenosis process in the era of DCB. This article revisits the mechanism of balloon angioplasty and explores how DCB with Paclitaxel may change the paradigm of balloon angioplasty as default treatment in CAD percutaneous treatment.
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Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Diseño de Prótesis , Válvula Tricúspide , Humanos , Resultado del Tratamiento , Válvula Tricúspide/cirugía , Válvula Tricúspide/fisiopatología , Válvula Tricúspide/diagnóstico por imagen , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Factores de Tiempo , Cateterismo Cardíaco/instrumentación , Masculino , Insuficiencia de la Válvula Tricúspide/cirugía , Insuficiencia de la Válvula Tricúspide/fisiopatología , Insuficiencia de la Válvula Tricúspide/diagnóstico por imagen , Hemodinámica , AncianoRESUMEN
BACKGROUND: Coronary obstruction (CO) is a potentially life-threatening complication of transcatheter aortic valve replacement (TAVR). Chimney stenting or leaflet laceration with transcatheter electrosurgery (Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction [BASILICA]) are 2 techniques developed to prevent CO. OBJECTIVES: The aim of the present study was to compare periprocedural and 1-year outcomes of chimney and BASILICA in TAVR patients at high risk of CO. METHODS: This multicenter observational registry enrolled consecutive TAVR patients at high risk of CO, undergoing either preventive chimney stenting or BASILICA. Clinical success was defined as successful performance of the chimney or BASILICA technique without clinically relevant ostial CO. The primary endpoint was major adverse cardiovascular events, a composite of death, myocardial infarction, stroke, or unplanned target lesion coronary revascularization at 1 year. RESULTS: A total of 168 patients were included: 71 (42.3%) received chimney stenting, and 97 (57.7%) underwent BASILICA. Patients undergoing BASILICA had higher preprocedural risk of CO, as indicated by lower sinotubular junction height (18.2 ± 4.8 mm vs 14.8 ± 3.4 mm; P < 0.001) and diameter (28.2 ± 4.5 vs 26.8 ± 3.4; P = 0.029). Rates of periprocedural complications were similar between the 2 groups. Clinical success was 97.2% and 96.9% in chimney and BASILICA, respectively (P = 0.92). At 1-year follow-up, the cumulative incidence of major adverse cardiovascular events was 18.7% (95% CI: 11%-30.6%) in the chimney group and 19.9% (95% CI: 12.1%-31.5%) in the BASILICA group (log-rank P = 0.848), whereas chimney was associated with a numerically higher cardiovascular mortality than BASILICA (6.7% vs 1.3%; log-rank P = 0.168). CONCLUSIONS: Chimney stenting and BASILICA effectively prevent TAVR-induced acute CO. Both techniques seem to have comparable acceptable periprocedural and 1-year outcomes.
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Estenosis de la Válvula Aórtica , Oclusión Coronaria , Prótesis Valvulares Cardíacas , Laceraciones , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Laceraciones/complicaciones , Laceraciones/cirugía , Prótesis Valvulares Cardíacas/efectos adversos , Resultado del Tratamiento , Oclusión Coronaria/etiología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/complicaciones , Diseño de PrótesisRESUMEN
BACKGROUND: Acute ischemic stroke remains a serious complication of transcatheter aortic valve replacement (TAVR). Cerebral embolic protection devices (CEPD) were developed to mitigate the risk of acute ischemic stroke complicating TAVR (AISCT). However, the existing body of evidence does not clearly support CEPD efficacy in AISCT prevention. OBJECTIVES: In a cohort of patients with AISCT, we aimed to compare the characteristics and outcomes of patients who have had unprotected TAVR (CEPD-) vs CEPD-protected TAVR (CEPD+). METHODS: Data were derived from an international multicenter registry focusing on AISCT. We included all patients who experienced ischemic stroke within 72 hours of TAVR. Stroke severity was assessed using the National Institutes of Health Stroke Scale (NIHSS). Primary outcomes were neurologic disability status according to the modified Rankin Score at 30 days, and 6-month all-cause death. Propensity score matched analysis was used to control for differences between groups. RESULTS: In 18,725 TAVR procedures, 416 AISCT (2.2%) within 72 hours were documented, of which 376 were in the CEPD- TAVR group and 40 in the CEPD+ TAVR group. Although the middle cerebral artery stroke rate was similar in both groups (29.7% CEPD- vs 33.3% CEPD+; P = 0.71), AISCT in the CEPD+ group was characterized by a lower rate of internal carotid artery occlusion (0% vs 4.7%) and higher rate of vertebrobasilar system strokes (15.4% vs 5.7%; P = 0.04). AISCT was severe (NIHSS ≥15) in 21.6% CEPD- and 23.3% CEPD+ AISCT (P = 0.20). Disabling stroke rates (modified Rankin Score >1 at 30 days) were 47.3% vs 42.5% (P = 0.62), and 6-month mortality was 31.3% vs 23.3% (P = 0.61), in the CEPD- and CEPD+ groups, respectively. In the propensity score matched cohort, disabling stroke rates were 56.5% vs 41.6% (P = 0.16), and 6-month mortality was 33% vs 19.5% (P = 0.35), in the CEPD- and CEPD+ groups, respectively. CONCLUSIONS: In a large cohort of patients with AISCT, the use of CEPD had little effect on stroke distribution, severity, and outcomes.
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Estenosis de la Válvula Aórtica , Dispositivos de Protección Embólica , Accidente Cerebrovascular Isquémico , Accidente Cerebrovascular , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Accidente Cerebrovascular Isquémico/etiología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/complicaciones , Resultado del Tratamiento , Accidente Cerebrovascular/diagnóstico por imagen , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Factores de Riesgo , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugíaRESUMEN
BACKGROUND: The outcomes of percutaneous coronary intervention (PCI) in diabetic patients are still suboptimal, and it is unclear if diabetic patients might derive a benefit from the use of drug-coated balloons. AIMS: To evaluate the impact of diabetes mellitus on the outcomes of patients undergoing PCI with sirolimus-coated balloon (SCB) MagicTouch (Concept Medical, India). METHODS: We conducted a subgroup analysis of the prospective, multicenter, investigator-initiated EASTBOURNE registry, evaluating the performance of MagicTouch SCB in patients with and without diabetes. The study primary endpoint was target lesion revascularization (TLR) at 12-month follow-up. Secondary clinical endpoints were major adverse clinical events (MACE), death, myocardial infarction (MI), and BARC 2-5 bleedings. RESULTS: Among 2,083 enrolled patients, a total of 864 suffered from diabetes (41.5%). Patients with diabetes had a numerically higher occurrence of TLR (6.5% vs. 4.7% HR 1.38, 95%CI 0.91-2.08), all-cause death (3.8% vs. 2.6%, HR 1.81, 95%CI 0.95-3.46), and MACE (12.2% vs. 8.9%; HR 1.26 95%CI 0.92-1.74). The incidence of spontaneous MI was significantly higher among diabetic patients (3.4% vs. 1.5%, HR 2.15 95%CI 1.09-4.25); bleeding events did not significantly differ. The overall incidence of TLR was higher among in-stent restenosis (ISR) as compared to de-novo coronary lesions, irrespectively from diabetes status. CONCLUSIONS: In the EASTBOURNE DIABETES registry, diabetic patients treated with the MagicTouch SCB did not have a significant increase in TLR when compared to non-diabetic patients; moreover, diabetic status did not affect the study device performance in terms of TLR, in both de-novo lesions and ISR.
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Enfermedad de la Arteria Coronaria , Reestenosis Coronaria , Diabetes Mellitus , Infarto del Miocardio , Intervención Coronaria Percutánea , Humanos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/complicaciones , Sirolimus/efectos adversos , Intervención Coronaria Percutánea/efectos adversos , Resultado del Tratamiento , Infarto del Miocardio/epidemiología , Infarto del Miocardio/etiología , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/epidemiología , Diabetes Mellitus/inducido químicamente , Sistema de Registros , Reestenosis Coronaria/epidemiología , Reestenosis Coronaria/etiologíaRESUMEN
BACKGROUND: Double kissing (DK)-crush and T-stenting and small protrusion (TAP) techniques are gaining popularity, but the comparison for both techniques is still lacking. This study sought to retrospectively evaluate the long-term outcomes of DK-crush and TAP techniques in patients with complex bifurcation lesions. METHODS: A total of 255 (male: 205 [80.3%], mean age: 59.56 ± 10.13 years) patients who underwent coronary bifurcation intervention at a single-center between January 2014 and May 2021 were included. Angiographic features, procedure details, and in-hospital or long-term outcomes were assessed. The primary endpoint was target lesion failure (TLF), defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven-target lesion revascularization (TLR). The regression models were adjusted applying by the inverse probability weighted (IPW) approach to reduce treatment selection bias. RESULTS: The initial management strategy was DK-crush in 152 (59.6%) patients and TAP in 103 (40.4%) cases. The SYNTAX scores (24.58 ± 7.4 vs. 24.26 ± 6.39, p = 0.846) were similar in both groups. The number of balloon (6.32 ± 1.82 vs. 3.92 ± 1.19, p < 0.001) usage was significantly higher in the DK-crush group than in the TAP group. The rates of TLF (11.8 vs. 22.3%, p = 0.025) and clinically driven TLR (6.6 vs. 15.5%, p = 0.020) were significantly lower in the DK-crush group compared to the TAP group. The long-term TLF was significantly higher in the TAP group compared to the DK-crush group (unadjusted HR: 1.974, [95% CI: 1.044-3.732], p = 0.035 and adjusted HR [IPW]: 2.498 [95% CI: 1.232-5.061], p = 0.011). CONCLUSION: The present study showed that the DK-crush technique of bifurcation treatment was associated with lower long-term TLF and TLR rates compared to the TAP technique.
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Angioplastia Coronaria con Balón , Stents Liberadores de Fármacos , Humanos , Masculino , Persona de Mediana Edad , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Estudios Retrospectivos , Resultado del Tratamiento , Sistema de RegistrosRESUMEN
BACKGROUND: Despite the initial evidence supporting the utility of intravascular imaging to guide percutaneous coronary intervention (PCI), adoption remains low. Recent new trial data have become available. An updated study-level meta-analysis comparing intravascular imaging to angiography to guide PCI was performed. This study aimed to evaluate the clinical outcomes of intravascular imaging-guided PCI compared with angiography-guided PCI. METHODS AND RESULTS: A random-effects meta-analysis was performed on the basis of the intention-to-treat principle. The primary outcomes were major adverse cardiac events, cardiac death, and all-cause death. Mixed-effects meta-regression was performed to investigate the impact of complex PCI on the primary outcomes. A total of 16 trials with 7814 patients were included. The weighted mean follow-up duration was 28.8 months. Intravascular imaging led to a lower risk of major adverse cardiac events (relative risk [RR], 0.67 [95% CI, 0.55-0.82]; P<0.001), cardiac death (RR, 0.49 [95% CI, 0.34-0.71]; P<0.001), stent thrombosis (RR, 0.63 [95% CI, 0.40-0.99]; P=0.046), target-lesion revascularization (RR, 0.67 [95% CI, 0.49-0.91]; P=0.01), and target-vessel revascularization (RR, 0.60 [95% CI, 0.45-0.80]; P<0.001). In complex lesion subsets, the point estimate for imaging-guided PCI compared with angiography-guided PCI for all-cause death was a RR of 0.75 (95% CI, 0.55-1.02; P=0.07). CONCLUSIONS: In patients undergoing PCI, intravascular imaging is associated with reductions in major adverse cardiac events, cardiac death, stent thrombosis, target-lesion revascularization, and target-vessel revascularization. The magnitude of benefit is large and consistent across all included studies. There may also be benefits in all-cause death, particularly in complex lesion subsets. These results support the use of intravascular imaging as standard of care and updates of clinical guidelines.
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Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Trombosis , Humanos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Angiografía Coronaria/métodos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Ultrasonografía Intervencional/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , Trombosis/etiología , Resultado del Tratamiento , MuerteRESUMEN
BACKGROUND: Current European guidelines support transcatheter aortic valve implantation (TAVI) in intermediate-to-low-risk patients ≥75 years-old, but its prognostic relevance is unknown. METHODS: Intermediate-to-low-risk (The Society of Thoracic Surgeons score <8%) patients enrolled in the HORSE registry were included. We compared the populations aged under 75 with those over 75. The primary endpoint was all-cause mortality. RESULTS: A total of 2685 patients were included: 280 (8.6%) < 75 and 2405 ≥ 75 years. Through a mean follow-up of 437 ± 381 days, 198 (8.2%) and 23 (8.2%) patients died in the two arms without statistically significant differences (log-rank p = 0.925). At Cox regression analysis, age did not predict the occurrence of all-cause death, neither as a continuous variable (HR 1.01, 95% CI 0.99-1.04, p = 0.294) nor dichotomizing according to the prespecified cutoff of 75 years (HR 0.97, 95% CI 0.63-1.51, p = 0.924). Time-to-event ROC curves showed low accuracy of age to predict all-cause mortality (area under the curve of 0.54 for both 1-year and 2-year outcomes). CONCLUSIONS: TAVI has comparable benefits across age strata for intermediate-to-low-risk patients. The age cutoff suggested by the current guidelines is not predictive of the risk of adverse events during hospital stays or of all-cause mortality through a mid-term follow-up.
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Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Insuficiencia de la Válvula Mitral , Obstrucción del Flujo Ventricular Externo , Humanos , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Resultado del Tratamiento , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Obstrucción del Flujo Ventricular Externo/cirugía , Cateterismo CardíacoAsunto(s)
Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento , Enfermedad de la Arteria Coronaria/cirugía , Puente de Arteria CoronariaAsunto(s)
Aterectomía Coronaria , Enfermedad de la Arteria Coronaria , Calcificación Vascular , Humanos , Aterectomía Coronaria/efectos adversos , Resultado del Tratamiento , Aterectomía , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Angiografía Coronaria , Calcificación Vascular/diagnóstico por imagen , Calcificación Vascular/terapiaRESUMEN
BACKGROUND: Stent implantation represents the standard of care in coronary intervention. While a short stent implanted on a focal lesion located on the left anterior descending artery (LAD) seems a reasonable alternative to an internal mammary implant, the same for long stents is still debated. METHODS: We reported the long-term data of 531 consecutive patients who underwent Percutaneous Coronary Intervention (PCI) with long stents in two highly specialized centres. The main inclusion criteria were the implantation of stents longer than 30 mm on the LAD and a minimum follow-up (FU) of five years. The primary endpoint was mortality, and the secondary endpoints were any myocardial infarction (MI), target vessel and lesion revascularization (TVR and TLR, respectively), and stent thrombosis (ST) observed as definite, probable, or possible. RESULTS: In this selected population with characteristics of complex PCI (99.1%), the long-term follow-up (mean 92.18 ± 35.5 months) estimates of all-cause death, cardiovascular death, and any myocardial infarction were 18.3%, 10.5%, and 9.3%, respectively. Both all-cause and cardiovascular deaths are significantly associated with three-vessel disease (HR 6.8; confidence of interval (CI) 95% 3.844-11.934; p < 0.001, and HR 4.7; CI 95% 2.265-9.835; p < 0.001, respectively). Target lesion (TLR) and target vessel revascularization (TVR) are associated with the presence of three-lesion disease on the LAD (HR 3.4; CI 95% 1.984-5.781; p < 0.001; HR 3.9 CI 95% 2.323-6.442; p < 0.001, respectively). Re-PCI for any cause occurred in 31.5% of patients and shows an increased risk for three-lesion stenting (HR 4.3; CI 95% 2.873-6.376; p < 0.001) and the treatment of bifurcation with two stents (HR 1.6; 95% CI 1.051-2.414; p = 0.028). Stent thrombosis rate at the 5-year FU was 4.4% (1.3% definite; 0.9% probable; 2.1% possible), including a 1.7% rate of very-late thrombosis. The stent length superior to 40 mm was not associated with poor outcomes (all-cause death p = 0.349; cardiovascular death p = 0.855; MI p = 0.691; re-PCI p = 0.234; TLR p = 0.805; TVR p = 0.087; ST p = 0.189). CONCLUSION: At an FU of longer than five years, patients treated with stents longer than 30 mm in their LAD showed acceptable procedural results but poor outcomes.
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Background: The DynamX Novolimus-Eluting Coronary Bioadaptor System ( DynamX ® Bioadaptor) has uncaging elements that disengage after the resorption of the polymer coating, aiming to restore vessel function in the treated segment and to avoid long-term adverse outcomes associated with the permanent caging of the coronary artery seen with conventional stenting. Methods: This prospective, multicenter, single-arm first-in-human study enrolled 50 patients in Belgium and Italy who were treated with the DynamX Bioadaptor. Eligible patients had de novo lesions in coronary arteries measuring between 2.5 and 3.5 mm in diameter and ≤ 24 mm in length. Clinical follow-up was performed up to 36 months. This analysis includes the intention-to-treat population and is based on data available. The preclinical studies include optical coherence tomography (OCT) analyses of 5 DynamX Bioadaptors implanted in 3 mini Yucatan pigs (at 3, 12 and 24 months), and assessment of smooth muscle cell gene expression profile in 8 pigs of which each was implanted with the DynamX Bioadaptor and the Xience drug-eluting stent. To assess the gene expression profile by quantitative real-time polymerase chain reaction, animals were sacrificed at 3, 6, 9 and 12 months. Results: Target lesion failure at 36 months was 8.7% (4/46), consisting of one clinically-driven target lesion revascularization and 3 cardiac deaths (all site-reported to be unrelated to the device or procedure). There were no additional target vessel revascularization and no definite or probable scaffold thrombosis. Preclinical data confirmed late lumen enlargement (from 7.02 ± 1.31 mm 2 at baseline to 8.46 ± 1.31 mm 2 at 24 months) and identified an increased expression of contractile genes around 9 months compared to a conventional drug-eluting stent. Conclusions: The DynamX Bioadaptor demonstrated very good 36-month clinical outcomes, highlighted by the absence of target-vessel myocardial infarction and definite or probable device thrombosis, and only one target lesion revascularization up to 36 months. These data are supported by preclinical studies that showed late lumen enlargement by OCT and an increased expression of contractile genes around 9 months compared to conventional drug-eluting stents, indicating faster vessel healing. Larger clinical studies are necessary to compare outcomes against contemporary drug-eluting stents. Clinical Trial Registration: https://clinicaltrials.gov/: NCT03429894.