RESUMO
BACKGROUND: The impact of intracoronary imaging on outcomes, after provisional versus dual-stenting for bifurcation left main (LM) lesions, is unknown. OBJECTIVES: We investigated the effect of intracoronary imaging in the EBC MAIN trial (European Bifurcation Club LM Coronary Stent study). METHODS: Four hundred and sixty-seven patients were randomized to dual-stenting or a stepwise provisional strategy. Four hundred and fifty-five patients were included. Intravascular ultrasound (IVUS) or optical coherence tomography (OCT) was undertaken at the operator's discretion. The primary endpoint was death, myocardial infarction or target vessel revascularization at 1-year. RESULTS: Intracoronary imaging was undertaken in 179 patients (39%; IVUS = 151, OCT = 28). As a result of IVUS findings, operators reintervened in 42 procedures. The primary outcome did not differ with intracoronary imaging versus angiographic-guidance (17% vs. 16%; odds ratio [OR]: 0.92 (95% confidence interval [CI]: 0.51-1.63) p = 0.767), nor for reintervention based on IVUS versus none (14% vs. 16%; OR: 0.88 [95% CI: 0.32-2.43] p = 0.803), adjusted for syntax score, lesion calcification and ischemic symptoms. With angiographic-guidance, primary outcome events were more frequent with dual versus provisional stenting (21% vs. 10%; adjusted OR: 2.11 [95% CI: 1.04-4.30] p = 0.039). With intracoronary imaging, there were numerically fewer primary outcome events with dual versus provisional stenting (13% vs. 21%; adjusted OR: 0.56 [95% CI: 0.22-1.46] p = 0.220). CONCLUSIONS: In EBC MAIN, the primary outcome did not differ with intracoronary imaging versus none. However, in patients with angiographic-guidance, outcomes were worse with a dual-stent than provisional strategy When intracoronary imaging was used, there was a trend toward better outcomes with the dual-stent than provisional strategy.
Assuntos
Doença da Artéria Coronariana , Infarto do Miocárdio , Intervenção Coronária Percutânea , Humanos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Doença da Artéria Coronariana/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Resultado do Tratamento , Infarto do Miocárdio/etiologia , Stents , Angiografia Coronária/métodosRESUMO
BACKGROUND: Techniques for provisional and dual-stent left main bifurcation stenting require optimization. AIM: To identify technical variables influencing procedural outcomes and periprocedural myocardial infarction following left main bifurcation intervention. METHODS: Procedural and outcome data were analyzed in 438 patients from the per-protocol cohort of the European Bifurcation Club Left Main Trial (EBC MAIN). These patients were randomized to the provisional strategy or a compatible dual-stent extension (T, T-and-protrude, or culotte). RESULTS: Mean age was 71 years and 37.4% presented with an acute coronary syndrome. Transient reduction of side vessel thrombolysis in myocardial infarction flow occurred after initial stent placement in 5% of procedures but was not associated with periprocedural myocardial infarction. Failure to rewire a jailed vessel during any strategy was more common when jailed wires were not used (9.5% vs. 2.5%, odds ratio [OR]: 6.4, p = 0.002). In the provisional cohort, the use of the proximal optimization technique was associated with less subsequent side vessel intervention (23.3% vs. 41.9%, OR: 0.4, p = 0.048). Side vessel stenting was predominantly required for dissection, which occurred more often following side vessel preparation (15.3% vs. 4.4%, OR: 3.1, p = 0.040). Exclusive use of noncompliant balloons for kissing balloon inflation was associated with reduced need for side vessel intervention in provisional cases (20.5% vs. 38.5%, OR: 0.4, p = 0.013), and a reduced risk of periprocedural myocardial infarction across all strategies (2.9% vs. 7.7%, OR: 0.2, p = 0.020). CONCLUSION: When performing provisional or compatible dual-stent left main bifurcation intervention, jailed wire use is associated with successful jailed vessel rewiring. Side vessel preparation in provisional patients is linked to increased side vessel dissection requiring stenting. Use of the proximal optimization technique may reduce the need for additional side vessel intervention, and noncompliant balloon use for kissing balloon inflation is associated with a reduction in both side vessel stenting and periprocedural myocardial infarction. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02497014.
Assuntos
Angioplastia Coronária com Balão , Doença da Artéria Coronariana , Stents Farmacológicos , Infarto do Miocárdio , Humanos , Idoso , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/métodos , Resultado do Tratamento , Stents , Infarto do Miocárdio/etiologia , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Doença da Artéria Coronariana/etiologia , Angiografia CoronáriaRESUMO
BACKGROUND: Improvements in drug-eluting stent design have led to a reduced frequency of repeat revascularisation and new biodegradable polymer coatings may allow a shorter duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). AIMS: The Improved Drug-Eluting stent for All-comers Left Main (IDEAL-LM) study aims to investigate long-term clinical outcomes after implantation of a biodegradable polymer platinum-chromium everolimus-eluting stent (BP-PtCr-EES) followed by 4 months DAPT compared to a durable polymer cobalt-chromium everolimus-eluting stent (DP-CoCr-EES) followed by 12 months DAPT in patients undergoing PCI of unprotected left main coronary artery (LMCA) disease. METHODS: This is a multicentre randomised clinical trial study in patients with an indication for coronary artery revascularisation who have been accepted for PCI for LMCA disease after Heart Team consultation. Patients were randomly assigned in a 1:1 ratio to receive either the BP-PtCr-EES or the DP-CoCr-EES. The primary endpoint was a non-inferiority comparison of the rate of major adverse cardiovascular events (MACE), defined as all-cause death, myocardial infarction, or ischaemia-driven target vessel revascularisation at 2 years. RESULTS: Between December 2014 and October 2016, 818 patients (410 BP-PtCr-EES and 408 DP-CoCr-EES) were enrolled at 29 centres in Europe. At 2 years, the primary endpoint of MACE occurred in 59 patients (14.6%) in the BP-PtCr-EES group and 45 patients (11.4%) in the DP-CoCr-EES group; 1-sided upper 95% confidence interval (CI) 7.18%; p=0.04 for non-inferiority; p=0.17 for superiority. The secondary endpoint event of BARC 3 or 5 bleeding occurred in 11 patients (2.7%) in the BP-PtCr-EES group and 2 patients (0.5%) in the DP-CoCr-EES group (p=0.02). CONCLUSIONS: In patients undergoing PCI of LMCA disease, after two years of follow-up, the use of a BP-PtCr-EES with 4 months of DAPT was non-inferior to a DP-CoCr-EES with 12 months of DAPT with respect to the composite endpoint of all-cause death, myocardial infarction or ischaemia-driven target vessel revascularisation.
Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Infarto do Miocárdio , Intervenção Coronária Percutânea , Implantes Absorvíveis , Cromo , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos/efeitos adversos , Everolimo/uso terapêutico , Humanos , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea/métodos , Inibidores da Agregação Plaquetária/uso terapêutico , Platina , Polímeros , Resultado do TratamentoRESUMO
Background: Personalized prognosis plays a vital role in deciding between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in patients with three-vessel disease (3VD). The aim of this study is to compare the modality of revascularization chosen by the local heart team to that recommended by using individualized predictions of medium, and long-term all-cause mortality amongst patients with 3VD screened in the Multivessel TALENT trial. Methods: The SYNTAX score II (SS-II) and SS-2020 were evaluated in 200 consecutive patients by a core laboratory and compared to the decision of the "on site" heart team. Results: According to the SS-II, CABG was the recommended treatment in 51 patients (25.5%) however 34 (66.6%) of them received PCI. According to SS-2020 the predicted absolute risk differences (ARD) between PCI and CABG were significantly higher in patients receiving CABG compared to those treated by PCI for major adverse cardiovascular and cerebrovascular events, a composite of all-cause mortality, stroke or myocardial infarction at 5-years (8.8 ± 4.6% vs 6.0 ± 4.0%, p < 0.001) and all-cause mortality at 5- (5.2 ± 3.5% vs 3.7 ± 3.0%, p = 0.008) and 10-years (9.3 ± 4.8% vs 6.2 ± 4.2%, p < 0.001). Based on the novel threshold of equipoise (individual absolute risk differences [ARD] < 4.5%), 133 patients were eligible for PCI however 23 of them underwent CABG; conversely, amongst the 67 patients where CABG was recommendation (individual ARD > 4.5%), only 19 received it. Conclusions: Despite the robustness of the risk models proposed for screening, several deviations from the recommended mode of revascularization were observed by the core laboratory among the first 200 patients with 3VD screened in the Multivessel TALENT trial. Clinical Trial Registration: ClinicalTrials.gov reference: NCT04390672.
RESUMO
BACKGROUND: Patients with non-left-main coronary bifurcation lesions are usually best treated with a stepwise provisional approach. However, patients with true left main stem bifurcation lesions have been shown in one dedicated randomized study to benefit from systematic dual stent implantation. METHODS AND RESULTS: Four hundred and sixty-seven patients with true left main stem bifurcation lesions requiring intervention were recruited to the EBC MAIN study in 11 European countries. Patients were aged 71 ± 10 years; 77% were male. Patients were randomly allocated to a stepwise layered provisional strategy (n = 230) or a systematic dual stent approach (n = 237). The primary endpoint (a composite of death, myocardial infarction, and target lesion revascularization at 12 months) occurred in 14.7% of the stepwise provisional group vs. 17.7% of the systematic dual stent group (hazard ratio 0.8, 95% confidence interval 0.5-1.3; P = 0.34). Secondary endpoints were death (3.0% vs. 4.2%, P = 0.48), myocardial infarction (10.0% vs. 10.1%, P = 0.91), target lesion revascularization (6.1% vs. 9.3%, P = 0.16), and stent thrombosis (1.7% vs. 1.3%, P = 0.90), respectively. Procedure time, X-ray dose and consumables favoured the stepwise provisional approach. Symptomatic improvement was excellent and equal in each group. CONCLUSIONS: Among patients with true bifurcation left main stem stenosis requiring intervention, fewer major adverse cardiac events occurred with a stepwise layered provisional approach than with planned dual stenting, although the difference was not statistically significant. The stepwise provisional strategy should remain the default for distal left main stem bifurcation intervention. STUDY REGISTRATION: http://clinicaltrials.gov NCT02497014.
Assuntos
Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Angiografia Coronária , Humanos , Masculino , Stents , Fatores de Tempo , Resultado do TratamentoRESUMO
AIMS: To report procedural and 1-year outcomes following COBRA PzF NCS implantation in a routine daily setting with high bleeding risk (HBR) patients treated with clopidogrel as mono antiplatelet therapy (MAPT). METHODS: This is a prospective, consecutive, observational study in HBR patients who underwent PCI with COBRA PzF NCS and treated with clopidogrel alone at discharge. The primary endpoint was definite stent thrombosis at one month. The secondary endpoint was MACE (Cardiac Death, myocardial infarction (MI), target lesion revascularization (TLR)) at 12â¯months. RESULTS: From October 2015 to December 2018, 77 patients with 120 lesions were enrolled and treated. Mean age was 78.7⯱â¯8.89â¯years, 58.5% men and 18.2% had ACS. Patients included had a minimum of 2.0 inclusion LEADERS FREE criteria. Angiographic success was achieved in all cases. The primary endpoint occurred in 0%, no stent thrombosis was occurred. MACE at 12-months (available for 52 patients) was 3.8% including cardiac death 0%, MI 0% and TLR 3.8%. No severe bleeding events (BARC3-5) or stroke or late stent thrombosis were noted. CONCLUSION: Clopidogrel as MAPT after COBRA PzF NCS implantation in HBR patients is feasible and an attractive option. One-year follow-up was associated with excellent clinical outcomes and should be confirmed with large randomised study. CONDENSED ABSTRACT: This is prospective registry of high bleeding risk patients treated with the COBRA PzF NCS and MAPT at discharge. The primary end point demonstrated no stent thrombosis. The rate of major cardiac adverse events (a composite of cardiovascular death, myocardial infarction and target lesion revascularisation) at 1â¯year was 3.8%. No severe bleeding events, stroke or late stent thrombosis were noted. One-year follow-up was associated with good clinical outcomes and compared favorably with current devices.
Assuntos
Angioplastia Coronária com Balão/instrumentação , Clopidogrel/administração & dosagem , Materiais Revestidos Biocompatíveis , Doença da Artéria Coronariana/terapia , Trombose Coronária/prevenção & controle , Inibidores da Agregação Plaquetária/administração & dosagem , Stents , Idoso , Idoso de 80 Anos ou mais , Angioplastia Coronária com Balão/efeitos adversos , Ligas de Cromo , Clopidogrel/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Trombose Coronária/etiologia , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Compostos Organofosforados , Inibidores da Agregação Plaquetária/efeitos adversos , Polímeros , Estudos Prospectivos , Desenho de Prótese , Sistema de Registros , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: The COBRA PzF coronary stent, which has a unique nano-coating of Polyzene-F, was developed to reduce the risk of stent thrombosis. AIMS: To report procedural and 1-year clinical outcomes following COBRA PzF coronary stent implantation in a real-world percutaneous coronary intervention (PCI) registry. METHODS: All patients assigned to treatment with the COBRA PzF in the GCS Axium Rambot Center, Aix-en-Provence, France between February 2013 to June 2014 were prospectively enrolled. RESULTS: Among 100 patients (71% men, mean±standard error age 71.4±11.0 years), 38% had acute coronary syndromes. The population was consistent with real-world experience and included patients with multiple co-morbidities and 26% with diffuse multivessel disease. A total of 151 lesions were treated with 166 stents, including 26% of lesions with a type B2 or C classification. Pre- and post-procedural quantitative coronary angiography analyses showed a mean acute gain of 2.2±0.2mm. Angiographic success was achieved in all cases. One-year follow-up was available for all patients and the target vessel failure (composite of all-cause mortality, myocardial infarction or target vessel revascularization) rate was 12%, including 2% mortality (end-stage cardiomyopathy), 5% myocardial infarction (five periprocedural myocardial infarctions with isolated troponin elevation without chest pain or Q waves) and 5% target lesion revascularization. There were no cases of definite stent thrombosis. CONCLUSION: The COBRA PzF stent was safe and effective in routine practice. One-year follow-up was associated with excellent clinical outcomes and compared favourably with current devices. These results are very promising in a real-world population of complex patients, and further study is warranted.
Assuntos
Angina Estável/terapia , Materiais Revestidos Biocompatíveis , Estenose Coronária/terapia , Nanoestruturas , Infarto do Miocárdio sem Supradesnível do Segmento ST/terapia , Intervenção Coronária Percutânea/instrumentação , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Stents , Idoso , Idoso de 80 Anos ou mais , Angina Estável/diagnóstico por imagem , Angina Estável/mortalidade , Angiografia Coronária , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/mortalidade , Trombose Coronária/etiologia , Feminino , França , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Nanomedicina , Infarto do Miocárdio sem Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio sem Supradesnível do Segmento ST/mortalidade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Estudos Prospectivos , Desenho de Prótese , Recidiva , Sistema de Registros , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Propriedades de Superfície , Fatores de Tempo , Resultado do TratamentoRESUMO
AIMS: Limited long-term data are available to support drug-eluting stent (DES) unprotected left main (LM) intervention. We sought to evaluate long-term outcomes of LM intervention with paclitaxel-eluting stents. METHODS AND RESULTS: In this prospective multicentre registry, 291 patients with unprotected LM stenosis underwent percutaneous revascularisation with the TAXUS® Express® stent, using a consistent technical approach for both ostial/shaft and bifurcation lesions (provisional side branch stenting). At five years (n=263), the cumulative incidence of major adverse cardiac events (MACE) and cardiac death were 23.6% and 12.5%, respectively. Myocardial infarction (MI) occurred in 16 patients (6.1%), definite stent thrombosis in 0.4%, and target lesion revascularisation (TLR) was required in 10.3%. Patients with distal LM lesions requiring two-stent procedures had increased MACE compared with those with single-stent interventions (34.1% vs. 17.8%, p=0.009). This was primarily driven by an increased incidence of cardiac death (18.2% vs. 8.5%, p=0.05). Diabetes was associated with increased TLR and was an independent predictor of MACE at five years (odds ratio [OR] 2.10, 95% confidence interval [CI] 1.10-3.99, p=0.02). CONCLUSIONS: This study confirms the long-term safety and efficacy of the TAXUS® DES in unprotected LM stenting. Diabetes and the need for a second stent in distal LM interventions were associated with an increased risk of adverse outcomes.
Assuntos
Estenose Coronária/terapia , Stents Farmacológicos/estatística & dados numéricos , Revascularização Miocárdica/estatística & dados numéricos , Paclitaxel/uso terapêutico , Intervenção Coronária Percutânea/estatística & dados numéricos , Sistema de Registros , Idoso , Idoso de 80 Anos ou mais , Reestenose Coronária/epidemiologia , Trombose Coronária/epidemiologia , Trombose Coronária/prevenção & controle , Falha de Equipamento/estatística & dados numéricos , Feminino , Seguimentos , França/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/prevenção & controle , Intervenção Coronária Percutânea/instrumentação , Estudos Prospectivos , Fatores de Risco , Resultado do TratamentoRESUMO
BACKGROUND: Coronary stents have evolved over time, from bare-metal stents to drug-eluting stents, and now to bioactive stents. AIMS: We sought to explore the immediate outcome of the titanium-nitride-oxide-coated bioactive stent, Titan2(®), in real-world practice, and the incidence of major cardiac events at follow-up. METHODS: Consecutive patients admitted for percutaneous intervention for at least one significant (≥50%) lesion in a native coronary artery were treated with Titan2(®) stent implantation. The primary endpoint was total major adverse cardiac events at 12-month follow-up. Secondary endpoints included target lesion revascularization at 12-month follow-up and the duration of dual antiplatelet therapy. RESULTS: Among 356 patients (mean age 67.4 ± 12.1 years), 77.2% were male and 39.3% were treated for myocardial infarction (MI). A total of 546 Titan2(®) stents were implanted in 420 lesions. Angiographic and clinical procedural success was achieved in all cases. No cases of in-hospital major adverse cardiac events or acute stent thrombosis were reported. Of 335 patients (94.1%) with 12-month clinical follow-up, four (1.2%) died, MI occurred in five (1.5%), target lesion revascularization was performed in 17 (5.1%) and major adverse cardiac events occurred in 24 (7.2%). One patient (0.3%) suffered late stent thrombosis during follow-up, but no cases of acute or subacute stent thrombosis occurred. Dual antiplatelet therapy continued beyond 6 months in 64.5% of patients. CONCLUSIONS: In real-world practice, Titan2(®) stent implantation achieves an excellent immediate outcome, with a low incidence of major adverse cardiac events at 12-month follow-up.
Assuntos
Angioplastia Coronária com Balão/instrumentação , Materiais Revestidos Biocompatíveis , Estenose Coronária/terapia , Infarto do Miocárdio/terapia , Stents , Titânio , Idoso , Idoso de 80 Anos ou mais , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/mortalidade , Angiografia Coronária , Estenose Coronária/complicações , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/mortalidade , Quimioterapia Combinada , Feminino , França , Órgãos Governamentais , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico por imagem , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/mortalidade , Inibidores da Agregação Plaquetária/uso terapêutico , Estudos Prospectivos , Desenho de Prótese , Sistema de Registros , Índice de Gravidade de Doença , Trombose/etiologia , Fatores de Tempo , Resultado do TratamentoRESUMO
AIMS: To evaluate the angiographic and clinical outcome of patients undergoing paclitaxel-eluting stent (PES) implantation for unprotected left main coronary artery (ULMCA) stenosis in a "real-world" multicentre, prospective registry. Percutaneous coronary intervention (PCI) is an increasingly utilised method of revascularisation in patients with ULMCA. METHODS AND RESULTS: A prospective registry including all patients with a significant (>50%) ULMCA stenosis. Of 151 such patients, the target lesion involved the distal bifurcation in 100 patients (66%), which was treated predominantly by a "provisional T-stenting" strategy. In the distal ULMCA disease group, 72% had only one stent implantation while 28% had multiple (either two or three) stents implanted. At a median follow-up of 1,123±80 days, cardiac death occurred in five patients (3.3%) and major adverse cardiac and cerebrovascular events (MACCE) in 32 patients (21.2%). The three-year survival rate was 93.3%. CONCLUSIONS: In the drug-eluting stent era, paclitaxel-eluting stent implantation of ULMCA stenosis provided excellent immediate and long-term results in this selected population, suggesting that this approach may be considered as a safe and effective alternative to CABG for selected patients with ULMCA who are treated in experienced institutions performing large numbers of PCI procedures.
Assuntos
Angioplastia Coronária com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Estenose Coronária/terapia , Stents Farmacológicos , Paclitaxel/administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/mortalidade , Transtornos Cerebrovasculares/etiologia , Distribuição de Qui-Quadrado , Angiografia Coronária , Reestenose Coronária/etiologia , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/mortalidade , Intervalo Livre de Doença , Feminino , França , Mortalidade Hospitalar , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Estudos Prospectivos , Desenho de Prótese , Sistema de Registros , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Análise de Sobrevida , Taxa de Sobrevida , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Cardiac surgery is the reference treatment for patients with left main (LM) disease, although percutaneous coronary intervention with drug-eluting stents is emerging as a possible alternative. The objective of this registry was to evaluate the 2-year outcome of elective percutaneous coronary intervention for unprotected LM disease with paclitaxel-eluting stents. METHODS AND RESULTS: A total of 291 patients were prospectively included from 4 centers. Acute myocardial infarction and cardiogenic shock were the only exclusion criteria. Patients were 69+/-11 years old, 29% were diabetic, and 25% had 3-vessel disease. For distal LM lesions (78%), the provisional side-branch T-stenting approach was used in 92% of cases and final kissing balloon inflation in 97%. Angiographic success was obtained in 99.7% of cases. At 2-year follow-up, the total cardiac death rate was 5.4% (1 EuroSCORE point was associated with a 15% [95% confidence interval 2.9% to 28.2%, P=0.013] higher risk of cardiac death), target-lesion revascularization was 8.7%, and incidence of Q-wave or non-Q-wave myocardial infarction was 0.9% and 3.1%, respectively. The combined end point occurred in 15.8% of cases and stroke in 0.7%. The incidence of definite and probable LM stent thrombosis was 0.7%, whereas the incidence of any stent thrombosis was 3.8%, with a higher risk in patients with side-branch stenting in the presence of LM bifurcation lesions (hazard ratio 9.6, 95% confidence interval 1.2 to 77.7, P=0.035). CONCLUSIONS: Unprotected LM stenting with paclitaxel-eluting stents, with a strategy of provisional side-branch T-stenting for distal lesions, provides excellent acute angiographic results and good mid-term clinical outcomes, with a 15.8% rate of major adverse cardiac events at 2-year follow-up.
Assuntos
Estenose Coronária/cirurgia , Stents Farmacológicos , Paclitaxel/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Doenças Cardiovasculares/etiologia , Angiografia Coronária , Estenose Coronária/complicações , Estenose Coronária/mortalidade , Stents Farmacológicos/efeitos adversos , Feminino , Seguimentos , França , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sistema de Registros , Análise de Sobrevida , Trombose/etiologia , Resultado do TratamentoRESUMO
AIMS: To evaluate the angiographic and clinical outcome of patients undergoing paclitaxel-eluting stent (PES) implantation for unprotected left main coronary artery (ULMCA) stenosis in a multicentre, prospective registry. The overall event rate for PCI of ULMCA disease remains higher than in on-label use making additional outcome data and risk-stratification tools for the ULMCA population desirable. METHODS AND RESULTS: A prospective registry included all patients with a significant (> 50%) stenosis in ULMCA disease. In 151 of these patients the target lesion involved the distal bifurcation in 100 patients (66%), which was treated by predominantly using a "provisional T stenting" strategy. In distal ULMCA disease group, 72% had only one stent implantation while 28% had multiple (either 2 or 3) stents implanted. At a median follow-up of 472 +/- 75 days, cardiac death occurred in 3 patients (2%) and major adverse cardiac and cerebrovascular events (MACCE) in 16 patients (10.6%). CONCLUSIONS: In the drug-eluting stent era, paclitaxel eluting stent implantation of ULMCA stenosis provided excellent immediate and mid-term results in this selected population, suggesting that it may be considered as a safe and effective alternative to CABG for selected patients with ULMCA who are treated in institutions performing large numbers of PCI procedures.