Impact of smoking on outcomes in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention.

INTRODUCTION: Smoking is a well­established risk factor for cardiovascular diseases. However, in patients with ST­segment elevation myocardial infarction (STEMI), smoking has been associated with better clinical outcomes; this phenomenon became known as the "smoker's paradox." OBJECTIVES: The aim of this study was to evaluate the association between smoking and clinical outcomes in STEMI patients treated with primary percutaneous coronary intervention (PCI), using 3 large national registries. PATIENTS AND METHODS: We retrospectively analyzed the data of 82 235 hospitalized STEMI patients treated with primary PCI. Among the analyzed population, 30 966 patients (37.96%) were smokers, and 51 269 (62.36%) were nonsmokers. We evaluated the baseline characteristics, pharmacotherapy, clinical outcomes, and readmission causes in a 36­month follow­up. RESULTS: The smokers were significantly younger (median [interquartile range] age, 58 [52-64] vs 68 [59-77] years; P <0.001) than the nonsmokers, and there were more men in this group. The patients who smoked were less likely to have traditional risk factors, as compared with the nonsmokers. In the unadjusted analysis, in­hospital and 36­month mortality and rehospitalization rates were lower in the smokers group. However, after adjustment for baseline characteristics that differed between the 2 groups, the multivariable analysis showed that tobacco use was one of the independent risk factors for 36­month mortality (hazard ratio, 1.11; 95% CI, 1.06-1.18; P <0.001). CONCLUSIONS: In the present large­scale, registry­based analysis, the observed lower 36­month crude rates of adverse events among the smokers, as compared with the nonsmokers, might be partially explained by a significantly lower burden of traditional risk factors and younger age of the smokers. After accounting for age and other baseline differences, smoking was found to be one of the independent risk factors for 36­month mortality.

Safety and feasibility of minimally invasive coronary artery bypass surgery early after drug-eluting stent implantation due to acute coronary syndrome.

BACKGROUND: The evidence on performing minimally invasive coronary artery surgery early after drug-eluting stent (DES) implantation due to acute coronary syndrome (ACS) is limited. AIM: The study aimed to determine the safety and feasibility of this approach. METHODS: This registry included 115 (78% male) patients treated from 2013 to 2018, who underwent non-left anterior descending (LAD) percutaneous coronary intervention (PCI) due to ACS with contemporary DES implantation (39% diagnosed with myocardial infarction at baseline), followed by endoscopic atraumatic coronary artery bypass (EACAB) surgery within 180 days, after temporary P2Y12 inhibitor discontinuation. Primary composite endpoint of MACCE (major adverse cardiac and cerebrovascular events), defined as death, myocardial infarction (MI), cerebrovascular incident, and repeat revascularization was evaluated in long-term follow-up. The follow-up was collected via a telephone survey and in line with National Registry for Cardiac Surgery Procedures. RESULTS: The median (interquartile range [IQR]) time interval separating both procedures was 100.0 (62.0-136.0) days. Median (IQR) follow-up duration was 1338.5 (753.0-2093.0) days and was completed for all patients with regard to mortality. Eight patients (7%) died; 2 (1.7%) had a stroke; 6 (5.2%) suffered from MI, and 12 (10.4%) required repeat revascularization. Overall, the incidence of MACCE was 20 (17.4%). CONCLUSIONS: EACAB is a safe and feasible method of LAD revascularization in patients who received DES for ACS within 180 days before surgery despite early dual antiplatelet therapy discontinuation. The adverse event rate is low and acceptable.

Controlled Release of Encapsuled Stromal-Derived Factor 1α Improves Bone Marrow Mesenchymal Stromal Cells Migration.

Stem cell treatment is a promising method of therapy for the group of patients whose conventional options for treatment have been limited or rejected. Stem cells have the potential to repair, replace, restore and regenerate cells. Moreover, their proliferation level is high. Owing to these features, they can be used in the treatment of numerous diseases, such as cancer, lung diseases or ischemic heart diseases. In recent years, stem cell therapy has greatly developed, shedding light on stromal-derived factor 1α (SDF-1α). SDF-1α is a mobilizing chemokine for application of endogenous stem cells to injury sites. Unfortunately, SDF-1α presented short-term results in stem cell treatment trials. Considering the tremendous benefits of this therapy, we developed biodegradable polymeric microspheres for the release of SDF-1α in a controlled and long-lasting manner. The microspheres were designed from poly(L-lactide/glycolide/trimethylene carbonate) (PLA/GA/TMC). The effect of controlled release of SDF-1α from microspheres was investigated on the migration level of bone marrow Mesenchymal Stromal Cells (bmMSCs) derived from a pig. The study showed that SDF-1α, released from the microspheres, is more efficient at attracting bmMSCs than SDF-1α alone. This may enable the controlled delivery of selected and labeled MSCs to the destination in the future.

Five-year outcomes after state-of-the-art percutaneous coronary revascularization in patients with de novo three-vessel disease: final results of the SYNTAX II study.

AIMS: The SYNTAX II study evaluated the impact of advances in percutaneous coronary intervention (PCI), integrated into a single revascularization strategy, on outcomes of patients with de novo three-vessel disease. The study employed decision-making utilizing the SYNTAX score II, use of coronary physiology, thin-strut biodegradable polymer drug-eluting stents, intravascular ultrasound, enhanced treatments of chronic total occlusions, and optimized medical therapy. Patients treated with this approach were compared with predefined patients from the SYNTAX I trial. METHODS AND RESULTS: SYNTAX II was a multicentre, single-arm, open-label study of patients requiring revascularization who demonstrated clinical equipoise for treatment with either coronary artery bypass grafting (CABG) or PCI, predicted by the SYNTAX score II. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), which included any revascularization. The comparators were a matched PCI cohort trial and a matched CABG cohort, both from the SYNTAX I trial. At 5 years, MACCE rate in SYNTAX II was significantly lower than in the SYNTAX I PCI cohort (21.5% vs. 36.4%, P < 0.001). This reflected lower rates of revascularization (13.8% vs. 23.8%, P < 0.001), and myocardial infarction (MI) (2.7% vs. 10.4%, P < 0.001), consisting of both procedural MI (0.2% vs. 3.8%, P < 0.001) and spontaneous MI (2.3% vs. 6.9%, P = 0.004). All-cause mortality was lower in SYNTAX II (8.1% vs. 13.8%, P = 0.013) reflecting a lower rate of cardiac death (2.8% vs. 8.4%, P < 0.001). Major adverse cardiac and cerebrovascular events' outcomes at 5 years among patients in SYNTAX II and predefined patients in the SYNTAX I CABG cohort were similar (21.5% vs. 24.6%, P = 0.35). CONCLUSIONS: Use of the SYNTAX II PCI strategy in patients with de novo three-vessel disease led to improved and durable clinical results when compared to predefined patients treated with PCI in the original SYNTAX I trial. A predefined exploratory analysis found no significant difference in MACCE between SYNTAX II PCI and matched SYNTAX I CABG patients at 5-year follow-up.

Short and long-term results of endoscopic atraumatic coronary artery off-pump bypass grafting in patients with left anterior descending artery stenosis.

BACKGROUND: To perform a retrospective analysis of patients who underwent endoscopic atraumatic coronary artery off-pump bypass grafting (EACAB) in a single center over a period of 11 years. METHODS: Data was acquired from the hospital registry and patient medical records. In order to determine changes in clinical profile, patients were subdivided into three groups regarding year of surgery: 1998-2002 (group 1), 2003-2005 (group 2), 2006-2009 (group 3). In-hospital analysis up to 30 days and long-term observation were conducted. RESULTS: The study cohort consisted of 714 patients (581 male). Procedural success accounted for 99% of all patients. No mortality was observed up to 30 days. Complications in the early period included pleural effusion (7.6%), cardiac arrhythmias (3.6%), bleeding related revision (2.7%) and wound infection (1.6%). Mean follow-up was 6 years (2132 ± 1313 days; median: 1918.5). Nineteen (2.7%) patients died, of which 52.6% (10 patients) were due to heart related conditions. Overall frequency of major adverse cerebral and cardiovascular events (MACCE) was 10.8% (77 patients). The Kaplan-Meyer analysis defined survival rate and event-free survival in long-term observation of 96.1% and 85.3%, respectively. Ejection fraction (EF) < 50% was the only independent factor of mortality (OR: 3.35). Regarding cumulative MACCE, older age (OR: 1.72), lower EF (OR: 3.03), the history of percutaneous coronary intervention (OR: 2.13) and higher New York Heart Association class (OR: 2.63) influenced the incidence rate. CONCLUSIONS: The presented short and very long-term results confirm that EACAB is an efficient alternative for patients requiring revascularization of the left anterior descending artery. The elimination of cardiopulmonary bypass significantly reduces the number of complications.

Aborted myocardial infarction in patients with ST-segment elevation myocardial infarction treated with mechanical reperfusion.

BACKGROUND: Aborted myocardial infarction (abMI) is a type of acute coronary syndrome in which patients treated with reperfusion avoid the great burden of necrosis. Yet, no definition of abMI in patients undergoing primary percutaneous coronary intervention (pPCI) has been proposed so far. AIMS: This study aimed to identify patients with abMI and compare them with the remaining patients with ST­segment elevation myocardial infarction (STEMI). METHODS: It was a retrospective study of 1693 consecutive patients with STEMI treated with pPCI. The median (IQR) follow­up was 3.45 (1.45-5.09) years. Aborted MI was diagnosed if ST­segment elevation was reduced by more than 50%, no new abnormal Q waves were observed, the maximal level of creatine kinase MB did not reach a value 5­fold higher than the upper limit of normal (below 125 U/l), and there was successful reperfusion defined as the Thrombolysis in Myocardial Infarction score of 3 after PCI. RESULTS: Using our definition, abMI was diagnosed in 176 cases (10.4%). Compared with the remaining patients with STEMI, those with abMI were younger (mean [SD] age, 61.8 [11.5] vs 64.4 [11.6] years; P = 0.005) and were more frequent smokers (48.9% vs 36.7%; P = 0.002). They had greater left ventricular ejection fraction (median [interquartile range (IQR)], 49% [40%-55%] vs 55% [51%-60.5%]; P <0.001), were discharged earlier from the hospital (hospitalization time, median [IQR], 73 [60-90.5] hours vs 87 [69-98] hours; P <0.001), and had a lower mortality rate at 1 month and long­term follow­up (2.27% vs 8%; P = 0.006 and 10.8% vs 23.9%; P <0.001, respectively). CONCLUSION: Patients with abMI had better short­ and long­term outcomes than other patients with STEMI. Some negative cardiovascular factors such as smoking were more often observed in the abMI group.

Iatrogenic occlusion of bilateral jugular veins, subclavian vein, and superior vena cava after repeated jugular cannulation associated with Arnold-Chiari malformation: Successful endovascular treatment.

An Arnold-Chiari malformation is a congenital central nervous system defect. Raised intracranial pressure is commonly observed, and posterior decompression neurosurgery is the treatment of choice. We describe a patient with iatrogenic occlusion of bilateral jugular veins, subclavian vein, and superior vena cava resulting from repeated central venous cannulations. Because of venous hypertension, the patient suffered from neurologic symptoms: headaches, vision disturbances, and marked head edema. Two stents were used to recanalize the right internal jugular vein and superior vena cava. Symptoms subsided, and the patient returned to work. During 24-month follow-up, stents were patent. The patient remains symptom free and continues working.

Ticagrelor monotherapy beyond one month after PCI in ACS or stable CAD in elderly patients: a pre-specified analysis of the GLOBAL LEADERS trial.

AIMS: Antiplatelet treatment in the elderly post percutaneous coronary interventions (PCI) remains a complex issue. Here we report the results of the pre-specified subgroup analysis of the GLOBAL LEADERS trial evaluating the long-term safety and cardiovascular efficacy of ticagrelor monotherapy among patients categorised according to the pre-specified cut-off value of 75 years of age. METHODS AND RESULTS: This was a pre-specified analysis of the randomised GLOBAL LEADERS trial (n=15,991), comparing 23-month ticagrelor monotherapy (after one month of DAPT) with the reference treatment (12-month DAPT followed by 12 months of aspirin). Among elderly patients (>75 years; n=2,565), the primary endpoint (two-year all-cause mortality or new Q-wave core lab-adjudicated myocardial infarction [MI]) occurred in 7.2% and 9.4% of patients in the ticagrelor monotherapy and the reference group, respectively (hazard ratio [HR] 0.75, 95% confidence interval [CI]: 0.58-0.99, p=0.041; pint=0.23); BARC-defined bleeding type 3/5 occurred in 5.2% and 4.1%, respectively (HR 1.29, 95% CI: 0.89-1.86; p=0.180; pint=0.06). The elderly with stable CAD had a higher rate of BARC 3/5 type bleeding (HR 2.05, 95% CI: 1.18-3.55) with ticagrelor monotherapy versus the reference treatment (pint=0.02). Elderly patients had a lower rate of definite or probable stent thrombosis (ST) with ticagrelor monotherapy (0.4% vs 1.4%, p=0.015, pint=0.01), compared with the reference group. CONCLUSIONS: In this pre-specified, exploratory analysis of the overall neutral trial, there was no differential treatment effect of ticagrelor monotherapy (after one-month dual therapy with aspirin) found in elderly patients undergoing PCI with respect to the rate of the primary endpoint of all-cause death or new Q-wave MI. The lower rate of ST in the elderly with ticagrelor monotherapy is hypothesis-generating. ClinicalTrials.gov identifier: NCT01813435.

Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease.

BACKGROUND: Long-term outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents, as compared with coronary-artery bypass grafting (CABG), in patients with left main coronary artery disease are not clearly established. METHODS: We randomly assigned 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity (according to assessment at the participating centers) to undergo either PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). The primary outcome was a composite of death, stroke, or myocardial infarction. RESULTS: At 5 years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (difference, 2.8 percentage points; 95% confidence interval [CI], -0.9 to 6.5; P = 0.13). Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1). In the PCI and CABG groups, the incidences of definite cardiovascular death (5.0% and 4.5%, respectively; difference, 0.5 percentage points; 95% CI, -1.4 to 2.5) and myocardial infarction (10.6% and 9.1%; difference, 1.4 percentage points; 95% CI, -1.3 to 4.2) were not significantly different. All cerebrovascular events were less frequent after PCI than after CABG (3.3% vs. 5.2%; difference, -1.9 percentage points; 95% CI, -3.8 to 0), although the incidence of stroke was not significantly different between the two groups (2.9% and 3.7%; difference, -0.8 percentage points; 95% CI, -2.4 to 0.9). Ischemia-driven revascularization was more frequent after PCI than after CABG (16.9% vs. 10.0%; difference, 6.9 percentage points; 95% CI, 3.7 to 10.0). CONCLUSIONS: In patients with left main coronary artery disease of low or intermediate anatomical complexity, there was no significant difference between PCI and CABG with respect to the rate of the composite outcome of death, stroke, or myocardial infarction at 5 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776.).

Impact of long-term ticagrelor monotherapy following 1-month dual antiplatelet therapy in patients who underwent complex percutaneous coronary intervention: insights from the Global Leaders trial.

AIMS: To evaluate the impact of an experimental strategy [23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT)] vs. a reference regimen (12-month aspirin monotherapy following 12-month DAPT) after complex percutaneous coronary intervention (PCI). METHODS AND RESULTS: In the present post hoc analysis of the Global Leaders trial, the primary endpoint [composite of all-cause death or new Q-wave myocardial infarction (MI)] at 2 years was assessed in patients with complex PCI, which includes at least one of the following characteristics: multivessel PCI, ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI with ≥2 stents, or total stent length >60 mm. In addition, patient-oriented composite endpoint (POCE) (composite of all-cause death, any stroke, any MI, or any revascularization) and net adverse clinical events (NACE) [composite of POCE or Bleeding Academic Research Consortium (BARC) Type 3 or 5 bleeding] were explored. Among 15 450 patients included in this analysis, 4570 who underwent complex PCI had a higher risk of ischaemic and bleeding events. In patients with complex PCI, the experimental strategy significantly reduced risks of the primary endpoint [hazard ratio (HR): 0.64, 95% confidence interval (CI): 0.48-0.85] and POCE (HR: 0.80, 95% CI: 0.69-0.93), but not in those with non-complex PCI (Pinteraction = 0.015 and 0.017, respectively). The risk of BARC Type 3 or 5 bleeding was comparable (HR: 0.97, 95% CI: 0.67-1.40), resulting in a significant risk reduction in NACE (HR: 0.80, 95% CI: 0.69-0.92; Pinteraction = 0.011). CONCLUSION: Ticagrelor monotherapy following 1-month DAPT could provide a net clinical benefit for patients with complex PCI. However, in view of the overall neutral results of the trial, these findings of a post hoc analysis should be considered as hypothesis generating.

Predictive ability of ACEF and ACEF II score in patients undergoing percutaneous coronary intervention in the GLOBAL LEADERS study.

BACKGROUND: ACEF score has been shown to have predictive ability in the patients undergoing percutaneous coronary intervention (PCI). The ACEF II score has recently been developed to predict short-term mortality after cardiac surgery. We compared the predictive ability of the ACEF and ACEF II scores to predict mortality after PCI in the all-comers population. METHODS: The ACEF and ACEF II scores were calculated in 15,968 patients enrolled in the GLOBAL LEADERS study. Discrimination and calibration were assessed for outcomes after PCI. Recalibration of the regression model by updating the intercept and slope were performed to adjust the original ACEF model to the PCI setting. In a stratified approach, patients were divided into quintiles according to the score. Outcomes were compared between quintiles. RESULTS: The ACEF and ACEF II score were available in 14,941 and 14,355 patients respectively. Discrimination for 30-day all-cause mortality was acceptable for both scores (C-statistic ACEF 0.75 and ACEF II 0.77). For 2-year all-cause mortality, the discrimination of ACEF score was acceptable (C-statistic 0.72) while the discrimination of ACEF II score was moderate (C-statistic 0.69). Both scores identified patients at high risk of mortality but overestimated all-cause mortality at 30 days in all quintiles. After recalibration, agreement between predicted and observed 30-day all-cause mortality in both scores are close to the identity line. CONCLUSIONS: The ACEF II model did not improve the predictive ability of the ACEF score. Recalibrated ACEF model can be used to estimated all-cause mortality rate at 30 days after PCI.

Clinical outcomes of state-of-the-art percutaneous coronary revascularisation in patients with three-vessel disease: two-year follow-up of the SYNTAX II study.

AIMS: The purpose of the study was to investigate whether the favourable outcomes of state-of-the-art PCI in the SYNTAX II trial, demonstrated at one year, were maintained at two-year follow-up. METHODS AND RESULTS: The SYNTAX II study was a multicentre, single-arm study that investigated the impact of a contemporary PCI strategy on clinical outcomes in 454 patients with de novo three-vessel coronary artery disease, without left main disease. Clinical outcomes in SYNTAX II were compared to the predefined PCI (SYNTAX-I PCI) and coronary artery bypass graft (SYNTAX-I CABG) cohorts from the landmark SYNTAX trial (SYNTAX-I), selected on the basis of equipoise for long-term (four-year) mortality utilising the SYNTAX score II. At two years, major adverse cardiac and cerebrovascular events (MACCE: a composite of all-cause death, any stroke, myocardial infarction, or revascularisation) in SYNTAX II were significantly lower compared to SYNTAX-I PCI (13.2% vs. 21.9%, p=0.001). Furthermore, similar two-year outcomes for MACCE were evident between SYNTAX II PCI and SYNTAX-I CABG (13.2% vs. 15.1%, p=0.42). CONCLUSIONS: At two years, clinical outcomes with the SYNTAX II strategy remained superior to the predefined SYNTAX-I PCI cohort, and similar to the predefined SYNTAX-I CABG cohort.

Five-year outcomes after revascularization of superficial femoral artery occlusion using Ocelot catheter.

INTRODUCTION: The population of patients with lower limb atherosclerosis includes a considerable proportion of individuals with long superficial femoral artery (SFA) lesions. Chronic total occlusions (CTOs) represent the "last frontier" of percutaneous interventions. While open strategies are considered earlier as standard management for these lesions, the results of a number of trials indicate that endovascular management might become an effective alternative to surgery. MATERIAL AND METHODS: This paper presents 5-year outcomes of a first-in-man (FIM) study (before CE mark) and the registry of OCT Guided Ocelot Catheter (Avinger) for chronic total occlusions of the superficial femoral artery. The study group comprised 10 patients with Rutherford 3 lower limb ischemia including nine men and one woman. RESULTS: The efficacy of the primary intervention was 90%. Angiography performed at 6 months of the procedure, according to the study protocol, revealed 3 and 1 cases of restenosis and reocclusion, respectively, repaired using PTA and open common and deep femoral artery patch plasty. Doppler ultrasound performed at 1, 2 and 5 years after the primary intervention did not reveal significant target vessel restenosis. The primary and primary-assisted patency was 89%. During a 5-year follow-up, four peripheral percutaneous interventions and one femoropopliteal bypass surgery were performed in non-target limbs. There were no cardiovascular deaths, myocardial infarction or stroke and no amputation was required. CONCLUSIONS: This is a first-in-man study reporting long-term follow-up after SFA CTO revascularization using the Ocelot catheter. The catheter proved to have a satisfactory safety profile and a high proportion of CTO crossings. A 5-year follow-up revealed high primary and primary-assisted patency rates.

New-Onset Atrial Fibrillation After PCI or CABG for Left Main Disease: The EXCEL Trial.

BACKGROUND: There is limited information on the incidence and prognostic impact of new-onset atrial fibrillation (NOAF) following percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD). OBJECTIVES: This study sought to determine the incidence of NOAF following PCI and CABG for LMCAD and its effect on 3-year cardiovascular outcomes. METHODS: In the EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, 1,905 patients with LMCAD and low or intermediate SYNTAX scores were randomized to PCI with everolimus-eluting stents versus CABG. Outcomes were analyzed according to the development of NOAF during the initial hospitalization following revascularization. RESULTS: Among 1,812 patients without atrial fibrillation on presentation, NOAF developed at a mean of 2.7 ± 2.5 days after revascularization in 162 patients (8.9%), including 161 of 893 (18.0%) CABG-treated patients and 1 of 919 (0.1%) PCI-treated patients (p < 0.0001). Older age, greater body mass index, and reduced left ventricular ejection fraction were independent predictors of NOAF in patients undergoing CABG. Patients with versus without NOAF had a significantly longer duration of hospitalization, were more likely to be discharged on anticoagulant therapy, and had an increased 30-day rate of Thrombolysis In Myocardial Infarction major or minor bleeding (14.2% vs. 5.5%; p < 0.0001). By multivariable analysis, NOAF after CABG was an independent predictor of 3-year stroke (6.6% vs. 2.4%; adjusted hazard ratio [HR]: 4.19; 95% confidence interval [CI]: 1.74 to 10.11; p = 0.001), death (11.4% vs. 4.3%; adjusted HR: 3.02; 95% CI: 1.60 to 5.70; p = 0.0006), and the primary composite endpoint of death, MI, or stroke (22.6% vs. 12.8%; adjusted HR: 2.13; 95% CI: 1.39 to 3.25; p = 0.0004). CONCLUSIONS: In patients with LMCAD undergoing revascularization in the EXCEL trial, NOAF was common after CABG but extremely rare after PCI. The development of NOAF was strongly associated with subsequent death and stroke in CABG-treated patients. Further studies are warranted to determine whether prophylactic strategies to prevent or treat atrial fibrillation may improve prognosis in patients with LMCAD who are undergoing CABG. (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776).

Clinical outcomes of state-of-the-art percutaneous coronary revascularization in patients with de novo three vessel disease: 1-year results of the SYNTAX II study.

Aims: To investigate if recent technical and procedural developments in percutaneous coronary intervention (PCI) significantly influence outcomes in appropriately selected patients with three-vessel (3VD) coronary artery disease. Methods and results: The SYNTAX II study is a multicenter, all-comers, open-label, single arm study that investigated the impact of a contemporary PCI strategy on clinical outcomes in patients with 3VD in 22 centres from four European countries. The SYNTAX-II strategy includes: heart team decision-making utilizing the SYNTAX Score II (a clinical tool combining anatomical and clinical factors), coronary physiology guided revascularisation, implantation of thin strut bioresorbable-polymer drug-eluting stents, intravascular ultrasound (IVUS) guided stent implantation, contemporary chronic total occlusion revascularisation techniques and guideline-directed medical therapy. The rate of major adverse cardiac and cerebrovascular events (MACCE [composite of all-cause death, cerebrovascular event, any myocardial infarction and any revascularisation]) at one year was compared to a predefined PCI cohort from the original SYNTAX-I trial selected on the basis of equipoise 4-year mortality between CABG and PCI. As an exploratory endpoint, comparisons were made with the historical CABG cohort of the original SYNTAX-I trial. Overall 708 patients were screened and discussed within the heart team; 454 patients were deemed appropriate to undergo PCI. At one year, the SYNTAX-II strategy was superior to the equipoise-derived SYNTAX-I PCI cohort (MACCE SYNTAX-II 10.6% vs. SYNTAX-I 17.4%; HR 0.58, 95% CI 0.39-0.85, P = 0.006). This difference was driven by a significant reduction in the incidence of MI (HR 0.27, 95% CI 0.11-0.70, P = 0.007) and revascularisation (HR 0.57, 95% CI 0.37-0.9, P = 0.015). Rates of all-cause death (HR 0.69, 95% CI 0.27-1.73, P = 0.43) and stroke (HR 0.69, 95% CI 0.10-4.89, P = 0.71) were similar. The rate of definite stent thrombosis was significantly lower in SYNTAX-II (HR 0.26, 95% CI 0.07-0.97, P = 0.045). Conclusion: At one year, clinical outcomes with the SYNTAX-II strategy were associated with improved clinical results compared to the PCI performed in comparable patients from the original SYNTAX-I trial. Longer term follow-up is awaited and a randomized clinical trial with contemporary CABG is warranted. ClinicalTrials.gov Identifier: NCT02015832.

A prospective, randomized, open-label trial of 6-month versus 12-month dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction: Rationale and design of the "DAPT-STEMI trial".

BACKGROUND: The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention with second-generation drug eluting stents (DESs) is unclear. Because prolonged DAPT is associated with higher bleeding risk and health care costs, establishing optimal DAPT duration is of paramount importance. No other randomized controlled trials have evaluated the safety of shorter DAPT duration in ST-elevation myocardial infarction (STEMI) patients treated with second-generation DESs and latest P2Y12 platelet receptor inhibitors. HYPOTHESIS: Six months of DAPT after Resolute Integrity stent implantation in STEMI patients is not inferior to 12 months of DAPT in clinical outcomes. STUDY DESIGN: The Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation In ST-elevation Myocardial Infarction (DAPT-STEMI) trial is a randomized, multicenter, international, open-label trial designed to examine the safety (noninferiority) of 6-month DAPT after Resolute Integrity stent implantation in STEMI patients compared with 12-month DAPT. Event-free patients on DAPT at 6month will be randomized (1:1 fashion) between single (aspirin only) versus DAPT for an additional 6 months and followed until 2 years after primary percutaneous coronary intervention. The primary end point is a patient-oriented composite endpoint of all-cause mortality, any myocardial infarction, any revascularization, stroke, and major bleeding (net adverse clinical events [NACE]) at 18 months after randomization. To achieve a power of 85% for a noninferiority limit of 1.66, a total of 1100 enrolled patients are required. SUMMARY: The DAPT-STEMI trial aims to assess in STEMI patients treated with second-generation DESs whether discontinuation of DAPT after 6 months of event-free survival is noninferior to routine 12-month DAPT.

Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease.

BACKGROUND: Patients with obstructive left main coronary artery disease are usually treated with coronary-artery bypass grafting (CABG). Randomized trials have suggested that drug-eluting stents may be an acceptable alternative to CABG in selected patients with left main coronary disease. METHODS: We randomly assigned 1905 eligible patients with left main coronary artery disease of low or intermediate anatomical complexity to undergo either percutaneous coronary intervention (PCI) with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). Anatomic complexity was assessed at the sites and defined by a Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score of 32 or lower (the SYNTAX score reflects a comprehensive angiographic assessment of the coronary vasculature, with 0 as the lowest score and higher scores [no upper limit] indicating more complex coronary anatomy). The primary end point was the rate of a composite of death from any cause, stroke, or myocardial infarction at 3 years, and the trial was powered for noninferiority testing of the primary end point (noninferiority margin, 4.2 percentage points). Major secondary end points included the rate of a composite of death from any cause, stroke, or myocardial infarction at 30 days and the rate of a composite of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses. RESULTS: At 3 years, a primary end-point event had occurred in 15.4% of the patients in the PCI group and in 14.7% of the patients in the CABG group (difference, 0.7 percentage points; upper 97.5% confidence limit, 4.0 percentage points; P=0.02 for noninferiority; hazard ratio, 1.00; 95% confidence interval, 0.79 to 1.26; P=0.98 for superiority). The secondary end-point event of death, stroke, or myocardial infarction at 30 days occurred in 4.9% of the patients in the PCI group and in 7.9% in the CABG group (P<0.001 for noninferiority, P=0.008 for superiority). The secondary end-point event of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years occurred in 23.1% of the patients in the PCI group and in 19.1% in the CABG group (P=0.01 for noninferiority, P=0.10 for superiority). CONCLUSIONS: In patients with left main coronary artery disease and low or intermediate SYNTAX scores by site assessment, PCI with everolimus-eluting stents was noninferior to CABG with respect to the rate of the composite end point of death, stroke, or myocardial infarction at 3 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776 .).

Computing Methods for Composite Clinical Endpoints in Unprotected Left Main Coronary Artery Revascularization: A Post Hoc Analysis of the DELTA Registry.

OBJECTIVES: The study sought to investigate the impact of different computing methods for composite endpoints other than time-to-event (TTE) statistics in a large, multicenter registry of unprotected left main coronary artery (ULMCA) disease. BACKGROUND: TTE statistics for composite outcome measures used in ULMCA studies consider only the first event, and all the contributory outcomes are handled as if of equal importance. METHODS: The TTE, Andersen-Gill, win ratio (WR), competing risk, and weighted composite endpoint (WCE) computing methods were applied to ULMCA patients revascularized by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at 14 international centers. RESULTS: At a median follow-up of 1,295 days (interquartile range: 928 to 1,713 days), all analyses showed no difference in combinations of death, myocardial infarction, and cerebrovascular accident between PCI and CABG. When target vessel revascularization was incorporated in the composite endpoint, the TTE (p = 0.03), Andersen-Gill (p = 0.04), WR (p = 0.025), and competing risk (p < 0.001) computing methods showed CABG to be significantly superior to PCI in the analysis of 1,204 propensity-matched patients, whereas incorporating the clinical relevance of the component endpoints using WCE resulted in marked attenuation of the treatment effect of CABG, with loss of significance for the difference between revascularization strategies (p = 0.10). CONCLUSIONS: In a large study of ULMCA revascularization, incorporating the clinical relevance of the individual outcomes resulted in sensibly different findings as compared with the conventional TTE approach. In particular, using the WCE computing method, PCI and CABG were no longer significantly different with respect to the composite of death, myocardial infarction, cerebrovascular accident, or target vessel revascularization at a median of 3 years.

Causes of hospitalization and prognosis in patients with cardiovascular diseases. Secular trends in the years 2006-2014 according to the SILesian CARDiovascular (SILCARD) database.

INTRODUCTION Despite the progress in cardiology in recent years, cardiovascular (CV) diseases remain the main cause of death in European countries. The knowledge concerning the structure of hospital admissions for CV diseases and clinical outcomes is fragmentary. OBJECTIVES The aim of the study was to analyze the characteristics and outcome of patients with CV disease, hospitalized between 2006 and 2014 and included in the Silesian Cardiovascular Database (SILCARD) covering a population of 4.6 million patients. PATIENTS AND METHODS SILCARD is based on the data from the Regional Department of the National Health Fund in Poland. The enrollment criteria were any hospitalization at a department of cardiology, cardiac surgery, diabetology or vascular surgery and hospitalization with a cardiovascular diagnosis at a department of internal medicine or intensive care. The data come from 310 hospital departments and 1863 outpatient clinics, and contain information on 487 518 patients and 956 634 hospitalizations. RESULTS Heart failure (20%) and stable coronary artery disease (18.5%) were the most frequent primary causes of hospitalization. The number of hospitalizations due to heart failure, aortic stenosis, and pulmonary embolism significantly increased. The highest 12­month mortality was reported in patients with heart failure and pulmonary embolism (>30%). A decrease in 12­month mortality in patients with heart failure, stable coronary artery disease, myocardial infarction, and atrial fibrillation was noted, although for some disease entities, it remained relatively high. CONCLUSIONS Between the years 2006 and 2014, in­hospital and 12­month mortality showed a trend for decline in many disease entities, with considerable space for prognostic improvement.