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BACKGROUND: Optimal duration of Dual Antiplatelet Therapy (DAPT) following percutaneous coronary intervention (PCI) of a bifurcation stenosis is still debated. We evaluated the impact of DAPT duration on clinical outcomes in all-comers patients undergoing bifurcation PCI included in the European Bifurcation Club (EBC) registry. METHODS: We enrolled 2284 consecutive patients who completed at least 18 months follow-up. The cumulative occurrence of Major Adverse Cardiac and Cardiovascular Events (MACCE), defined as a composite of overall-death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR) and stroke were evaluated. Bleedings classified as BARC ≥ 3 were evaluated too. RESULTS: Patients were divided into 3 groups: Short DAPT (<6-months, n=375); Standard DAPT (≥6-months but ≤12-months, n=636); Prolonged DAPT (>12- months, n=1273). At 24 months follow-up MACCE-free survival was significantly lower in Short DAPT patients (Log-Rank: 45.23, p for trend <0.001). MACCE occurred less frequently in the Prolonged DAPT group (148 (11.6%)) as compared with both the Short (83 (22.1%) HR:0.48 (0.37-0.63), p<0.001) and Standard DAPT groups (137 (21.5%) HR:0.51 (0.41-0.65), p<0.001). These differences remain after propensity score adjustment (respectively, HR: 0.27 (0.20-0.36) and HR: 0.44 (0.34-0.57)). Such finding was consistent in patients presenting with both acute and chronic coronary syndromes. BARC ≥ 3 bleedings were 0.3% in the Standard DAPT, 1.6% in Short and 1.9% in Prolonged DAPT groups. CONCLUSIONS: In the "real-world" EBC registry of patients undergoing PCI of coronary artery bifurcation stenosis, a prolonged DAPT duration was associated with a significantly lower risk of MACCE and a potential increased risk of major bleedings.

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BACKGROUND: New-generation drug-eluting stents (DES) reduce target-vessel revascularization compared with bare-metal stents (BMS), and recent data suggest that DES have the potential to decrease the risk of myocardial infarction and cardiovascular mortality. We evaluated the treatment effect of DES versus BMS according to the target artery (left anterior descending [LAD] and/or left main [LM] versus other territories [no-LAD/LM]). METHODS AND RESULTS: The Coronary Stent Trialist (CST) Collaboration gathered individual patient data of randomized trials of DES versus BMS for the treatment of coronary artery disease. The primary outcome was the composite of cardiac death or myocardial infarction. Hazard ratios (HRs) with 95% CIs were derived from a 1-stage individual patient data meta-analysis. We included 26 024 patients across 19 trials: 13 650 (52.4%) in the LAD/LM and 12 373 (47.6%) in the no-LAD/LM group. At 6-year follow-up, there was strong evidence that the treatment effect of DES versus BMS depended on the target vessel (P interaction=0.024). Compared with BMS, DES reduced the risk of cardiac death or myocardial infarction to a greater extent in the LAD/LM (HR, 0.76; 95% CI, 0.68­0.85) than in the no-LAD/LM territories (HR, 0.93; 95% CI, 0.83­1.05). This benefit was driven by a lower risk of cardiac death (HR, 0.83; 95% CI, 0.70­0.98) and myocardial infarction (HR, 0.74; 95% CI, 0.65­0.85) in patients with LAD/LM disease randomized to DES. An interaction (P=0.004) was also found for all-cause mortality with patients with LAD/LM disease deriving benefit from DES (HR, 0.86; 95% CI, 0.76­0.97). CONCLUSIONS: As compared with BMS, new-generation DES were associated with sustained reduction in the composite of cardiac death or myocardial infarction if used for the treatment of LAD or left main coronary stenoses.

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BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) of the culprit lesion reduces the risk of cardiovascular death or myocardial infarction. Whether PCI of nonculprit lesions further reduces the risk of such events is unclear. METHODS: We randomly assigned patients with STEMI and multivessel coronary artery disease who had undergone successful culprit-lesion PCI to a strategy of either complete revascularization with PCI of angiographically significant nonculprit lesions or no further revascularization. Randomization was stratified according to the intended timing of nonculprit-lesion PCI (either during or after the index hospitalization). The first coprimary outcome was the composite of cardiovascular death or myocardial infarction; the second coprimary outcome was the composite of cardiovascular death, myocardial infarction, or ischemia-driven revascularization. RESULTS: At a median follow-up of 3 years, the first coprimary outcome had occurred in 158 of the 2016 patients (7.8%) in the complete-revascularization group as compared with 213 of the 2025 patients (10.5%) in the culprit-lesion-only PCI group (hazard ratio, 0.74; 95% confidence interval [CI], 0.60 to 0.91; P=0.004). The second coprimary outcome had occurred in 179 patients (8.9%) in the complete-revascularization group as compared with 339 patients (16.7%) in the culprit-lesion-only PCI group (hazard ratio, 0.51; 95% CI, 0.43 to 0.61; P=0.62 and P=0.27 for interaction for the first and second coprimary outcomes, respectively). CONCLUSIONS: Among patients with STEMI and multivessel coronary artery disease, complete revascularization was superior to culprit-lesion-only PCI in reducing the risk of cardiovascular death or myocardial infarction, as well as the risk of cardiovascular death, myocardial infarction, or ischemia-driven revascularization. (Funded by the Canadian Institutes of Health Research and others; COMPLETE ClinicalTrials.gov number, NCT01740479.). (AU)

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Background New-generation drug-eluting stents (DES) have mostly been investigated in head-to-head non-inferiority trials against early-generation DES and have typically shown similar efficacy and superior safety. How the safety profile of new-generation DES compares with that of bare-metal stents (BMS) is less clear.Methods We did an individual patient data meta-analysis of randomized clinical trials to compare outcomes after implantation of new-generation DES or BMS among patients undergoing percutaneous coronary intervention. The primary outcome was the composite of cardiac death or myocardial infarction. Data were pooled in a one-stage random-effects meta-analysis and examined at maximum follow-up and a 1-year landmark. Risk estimates are reported as hazard ratios (HRs) with 95% CIs. This study is registered in PROSPERO, number CRD42017060520.Findings We obtained individual data for 26 616 patients in 20 randomized trials. Mean follow-up was 3·2 (SD 1·8) years. The risk of the primary outcome was reduced in DES recipients compared with BMS recipients (HR 0·84, 95% CI 0·78­0·90, p<0·001) owing to a reduced risk of myocardial infarction (0·79, 0·71­0·88, p<0·001) and a possible slight but non-significant cardiac mortality benefit (0·89, 0·78­1·01, p=0·075). All-cause death was unaffected (HR with DES 0·96, 95% CI 0·88­1·05, p=0·358), but risk was lowered for definite stent thrombosis (0·63, 0·50­0·80, p<0·001) and target-vessel revascularization (0·55, 0·50­0·60, p<0·001). We saw a time-dependent treatment effect, with DES being associated with lower risk of the primary outcome than BMS up to 1 year after placement. While the effect was maintained in the longer term, there was no further divergence from BMS after 1 year. Interpretation The performance of new-generation DES in the first year after implantation means that BMS should no longer be considered the gold standard for safety. Further development of DES technology should target improvements in clinical outcomes beyond 1 year. (AU)

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BACKGROUND: The optimal treatment of patients undergoing percutaneous coronary interventions (PCI) for lesions located at coronary bifurcations is still debated. METHODS: Data on 5036 consecutive patients who underwent PCI on coronary bifurcation at 17 major coronary intervention centers between January 2012 and December 2014 were collected. RESULTS: Follow-up at a median 18 months (IQR 11-28) was available for 4506 patients (89%). Major Adverse Cardiac Events (MACE) occurred in 395 patients (8.8%): cardiac death in 152 (3.4%), myocardial infarction, excluding periprocedural, in 156 (3.5%) and stent thrombosis in 110 cases (2.4%). At multivariable Cox regression, left ventricular ejection fraction ≤30% (P < 0.001), bail-out stenting (beyond a planned strategy of either single or double stenting) (P < 0.001), admission for an acute coronary syndrome (P < 0.001), age >66 years (P < 0.001), multivessel disease (P < 0.001) and diabetes (P < 0.001) were independently associated with MACE. Sensitivity analysis identified premature discontinuation of dual antiplatelet therapy (DAPT) (P < 0.001) and side branch (SB) lesion length ≥9 mm (P < 0.05) as additional independent predictors of MACE. CONCLUSIONS: Beyond traditional risk factors, multivessel disease, the length of the SB lesion, "bail-out" stenting and premature DAPT discontinuation are independent predictors of mid-term MACE after PCI of coronary bifurcations. This highlights the importance of a carefully planned PCI strategy and adequate therapy adherence to improve the clinical outcomes in these patients. (AU)

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BackgroundTwo large trials have reported contradictory results at 1 year after thrombus aspiration in ST elevation myocardial infarction (STEMI). In a 1-year follow-up of the largest randomised trial of thrombus aspiration, we aimed to clarify the longer-term benefits, to help guide clinical practice.MethodsThe trial of routine aspiration ThrOmbecTomy with PCI versus PCI ALone in Patients with STEMI (TOTAL) was a prospective, randomised, investigator-initiated trial of routine manual thrombectomy versus percutaneous coronary intervention (PCI) alone in 10 732 patients with STEMI. Eligible adult patients (aged ≥18 years) from 87 hospitals in 20 countries were enrolled and randomly assigned (1:1) within 12 h of symptom onset to receive routine manual thrombectomy with PCI or PCI alone. Permuted block randomisation (with variable block size) was done by a 24 h computerised central system, and was stratified by centre. Participants and investigators were not masked to treatment assignment. The trial did not show a difference at 180 days in the primary outcome of cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure. However, the results showed improvements in the surrogate outcomes of ST segment resolution and distal embolisation, but whether or not this finding would translate into a longer term benefit remained unclear...

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The indications for percutaneous coronary intervention (PCI) continue to evolve because of the steady improvement in technology, broadened patient and lesion selection criteria, and new evidence from clinical trials. Considerable controversy was generated by the main results from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial, in which no difference in long-term outcome was reported for stable patients with coronary disease randomized to an initial strategy of PCI plus optimal medical therapy versus optimal medical therapy alone. In patients with chronic stable angina, medical therapy remains the cornerstone and should be optimized for all patients, while the major achievable goals of PCI are to affect symptoms, either by decreasing or preventing them, reducing the need for subsequent procedures and relieving ischemia. In patients with stable coronary artery disease, however, no reduction in death or myocardial infarction has been observed, and these limitations of PCI in this clinical setting need to be emphasized. The message from the COURAGE trial may be refined based on recently presented nuclear and angiographic sub-studies, such that patients with substantial residual ischemia on optimal medical therapy should be considered for crossover PCI, as it is associated with greater likelihood of death and myocardial infarction. However, those findings need to be confirmed by prospective evaluation before being widely accepted by the interventional community.

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As indicações para intervenção coronária percutânea (ICP) continuam a evoluir devido ao contínuo desenvolvimento da tecnologia, critérios de seleção mais amplos para pacientes e lesões e novas evidências advindas de testes clínicos. Uma controvérsia considerável foi gerada pelos resultados principais do estudo COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation), o qual não demonstrou diferenças no resultado em longo prazo para pacientes estáveis com doença coronariana, randomizados para uma estratégia inicial de ICP mais tratamento médico otimizado versus tratamento médico otimizado isolado. Em pacientes com angina estável crônica, o tratamento médico permanece sendo a pedra fundamental e deveria ser otimizado em todos os pacientes, enquanto os maiores objetivos alcançáveis da ICP são ter efeito sobre os sintomas, através de sua diminuição ou prevenção, reduzir a necessidade de procedimentos subsequentes e aliviar a isquemia. Em pacientes com doença arterial coronariana (DAC) estável, entretanto, nenhuma redução na incidência de morte ou infarto do miocárdio foi observada e essas limitações da ICP nesse cenário clínico precisam ser enfatizadas. A mensagem do estudo COURAGE pode ser refinada com base nos recentes sub-estudos nuclear e angiográfico, de forma que os pacientes com isquemia residual significante, submetidos a tratamento médico otimizado, deveriam ser considerados para tratamento com ICP, já que estão associados com maior probabilidade de morte e infarto do miocárdio. Entretanto, esses achados precisam ser confirmados por avaliação prospectiva antes de sua mais ampla aceitação pela comunidade intervencionista.

The indications for percutaneous coronary intervention (PCI) continue to evolve because of the steady improvement in technology, broadened patient and lesion selection criteria, and new evidence from clinical trials. Considerable controversy was generated by the main results from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial, in which no difference in long-term outcome was reported for stable patients with coronary disease randomized to an initial strategy of PCI plus optimal medical therapy versus optimal medical therapy alone. In patients with chronic stable angina, medical therapy remains the cornerstone and should be optimized for all patients, while the major achievable goals of PCI are to affect symptoms, either by decreasing or preventing them, reducing the need for subsequent procedures and relieving ischemia. In patients with stable coronary artery disease, however, no reduction in death or myocardial infarction has been observed, and these limitations of PCI in this clinical setting need to be emphasized. The message from the COURAGE trial may be refined based on recently presented nuclear and angiographic sub-studies, such that patients with substantial residual ischemia on optimal medical therapy should be considered for crossover PCI, as it is associated with greater likelihood of death and myocardial infarction. However, those findings need to be confirmed by prospective evaluation before being widely accepted by the interventional community.

Las indicaciones para intervención coronaria percutánea (ICP) siguen evolucionando debido al desarrollo continuo de la tecnología, a criterios de selección más amplios para pacientes y lesiones y a nuevas evidencias advenidas de ensayos clínicos. Los resultados principales del estudio COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) generaron una controversia considerable, la que no reveló diferencias en el resultado a largo plazo para pacientes estables con enfermedad coronaria, randomizados para una estrategia inicial de ICP más tratamiento médico optimizado versus tratamiento médico optimizado aislado. En pacientes con angina estable crónica, el tratamiento médico sigue siendo la piedra fundamental y se debería optimizarlo en todos los pacientes; mientras que los mayores objetivos alcanzables de la ICP son producir efecto sobre los síntomas, a través de su disminución o prevención, reducir la necesidad de procedimientos subsecuentes y aliviar la isquemia. En pacientes con enfermedad arterial coronaria (EAC) estable, sin embargo, ninguna reducción en la incidencia de muerte o infarto de miocardio se observó, y han de enfatizarse esas limitaciones de la ICP en ese escenario clínico. El mensaje del estudio COURAGE se puede refinar con base en los recientes subestudios nuclear y angiográfico, de forma que los pacientes con isquemia residual significante, sometidos a tratamiento médico optimizado, se deberían tener en cuenta para tratamiento con ICP, ya que están asociados a una mayor probabilidad de muerte e infarto de miocardio. Sin embargo, esos hallazgos necesitan ser confirmados por evaluación prospectiva antes de su más amplia aceptación por la comunidad intervencionista.

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