Effect of direct intramyocardial autologous stem cell grafting in the sub-acute phase after myocardial infarction.

BACKGROUND: To assess the efficacy and safety of intramyocardial autologous bone marrow mononuclear stem cells (BMMNC) grafting combined with coronary artery bypass grafting (CABG) on ventricular remodeling and global and regional wall motion after acute transmural myocardial infarction (AMI). METHODS: Randomized controlled trial including 20 patients with non-revascularized transmural AMI, left ventricular ejection fraction (LVEF) lower than 50% and surgical indication for CABG. The stem cell group was treated with BMMNC grafting by direct intramyocardial injection between the 10th and 15th days after AMI (subacute phase) combined with CABG under cardiopulmonary bypass; the control group was only treated with CABG. Magnetic resonance imaging with gadolinium and stress echocardiography were performed presurgery and 9 months postsurgery. RESULTS: Seventeen patients completed the follow-up. The baseline characteristics of both groups were homogeneous. No significant differences were found in the increase in LVEF (control: 6.99±4.60, cells: 7.47±6.61, P=0.876) or in the decrease in global (control: 0.28±0.39, cells: 0.22±0.28, P=0.759) or regional (control: 0.52±0.38, cells: 0.74±0.60, P=0.415) wall motion indices between the control and stem cell groups of AMI patients. No differences were found in the recovered non-viable segments (control: 1.29±1.11, cells: 2.50±1.41, P=0.091) or in the decrease in end-diastolic (control: 14.05±19.72, cells: 18.40±29.89, P=0.725) or end-systolic (control: 15.42±13.93, cells: 23.06±25.03, P=0.442) volumes. No complications from stem cell grafting were observed. CONCLUSIONS: The results from our study reported herein suggest that intramyocardial BMMNC administration during CABG in patients with AMI causes no medium- to long-term improvement in ventricular remodeling.

Acquired Aseptic Intracardiac Shunts Following Transcatheter Aortic Valve Replacement: A Systematic Review.

OBJECTIVES: The aim of this study was to describe the incidence, mechanisms, features, and management of aseptic intracardiac shunts (AICS). BACKGROUND: AICS following transcatheter aortic valve replacement (TAVR) are an uncommon and barely described complication. METHODS: A systematic review was performed of all published cases of AICS following TAVR, and the incidence, predictors, main features, management, and related outcomes were analyzed. RESULTS: A total of 31 post-TAVR AICS were gathered. After excluding transapical fistulas, the 28 remaining cases corresponded with an incidence of about 0.5%. Mean age and mean logistic European System for Cardiac Operative Risk Evaluation score were 80 ± 11 years and 19.2 ± 8.3%, respectively. Prior radiation therapy for cancer was present in 14.3%, and 42.8% had severe calcification of the aortic valve. TAVR was undertaken using balloon-expandable prostheses in the majority of cases (85.7%), via the transapical approach in one-third. Median time from TAVR to diagnosis was 21 days (interquartile range: 7 to 30 days), with intraprocedural suspicion in 12 cases (42.9%) and a mean Qp/Qs ratio of 1.8 ± 0.6. The most common location for AICS was the interventricular septum (60.7%). Heart failure was frequent (46.4%), but 14 patients (50%) remained asymptomatic. Medical treatment (71.4%) was associated with poor outcomes (30-day mortality rate 25%), especially in symptomatic patients (35% vs. 0%; p = 0.020) and in those with higher Qp/Qs ratios (1.9 ± 0.6 vs. 1.4 ± 0.1), while cardiac surgery (3.6%), and percutaneous closure (25%) led to good outcomes after a median follow-up period of 3 months (interquartile range: 1 to 9 months). CONCLUSIONS: Post-TAVR AICS are uncommon but have high 30-day mortality if left untreated, especially in symptomatic patients. Percutaneous closure was feasible and safe in symptomatic patients but remains controversial in asymptomatic subjects.

Therapeutic alternatives after aborted sternotomy at the time of surgical aortic valve replacement in the TAVI Era-Five centre experience and systematic review.

BACKGROUND: We aimed to analyze causes, management, and outcomes of the unexpected need to abort sternotomy in aortic stenosis (AS) patients accepted for surgical aortic valve replacement (SAVR) in the transcatheter aortic valve implantation (TAVI) era. METHODS: Cases of aborted sternotomy (AbS) were gathered from 5 centers between 2009 and 2014. A systematic review of all published cases in the same period was performed. RESULTS: A total of 31 patients (71% males, 74±8years, LogEuroSCORE 11.9±7.4%) suffered an AbS (0.19% of all sternotomies). Main reasons for Abs included previously unknown porcelain aorta (PAo) in 83.9%, mediastinal fibrosis due to radiotherapy in 12.9%, and chronic mediastinitis in 3.2%. Median time between AbS and next intervention was 2.3months (IQR: 0.7-5.8) with no mortality within this period. Only a case was managed with open surgery. In 30 patients (96.8%) TAVI was performed with a rate of success of 86.7%. Three patients (9.7%) presented in-hospital death and 17 (54.8%) had in-hospital complications including heart failure (9.6%), major bleeding (6.9%), and acute kidney injury (9.6%). Older patients (76±8 vs. 70±8years, p=0.045), previous cardiac surgery (60% vs. 15.4%, p=0.029), and shorter time from AbS to next intervention (5.1±5 vs. 1±0.7months, p=0.001) were related to higher six-month mortality (22.6%). CONCLUSIONS: The main reason for AbS was PAo. This entity was associated to a higher rate of complications and mortality, especially in older patients and with prior cardiac surgery. A preventive strategy in these subgroups might be based on imaging evaluation. TAVI was the most extended therapy.

Propensity score matched comparison of transcatheter aortic valve implantation versus conventional surgery in intermediate and low risk aortic stenosis patients: A hint of real-world.

BACKGROUND: Recently, the use of transcatheter aortic valve implantation (TAVI) in inter-mediate-low risk patients has been evaluated in the PARTNER II randomized trial. However, in the last years, this therapy has been employed in this scenario with underreported results, as compared to surgical aortic valve replacement (SAVR). METHODS: We enrolled 362 consecutive patients with severe symptomatic aortic stenosis and intermediate-low surgical risk (logEuroSCORE < 20%), treated in our center with TAVI (103 patients) or single SAVR (259 patients) between 2009 and 2014. Patients were matched according to age, gender, logEuroSCORE, and use of bioprosthesis. RESULTS: Mean age of the patients was 73 ± 10.4 years, and 40.3% were women. LogEuroSCORE and Society Thoracic Surgeons score were 7.0 ± 4.4% and 4.2 ± 2.5%, respectively, with mean left ventricular ejection fraction of 52 ± 9%. There were no differences regarding other comorbidities. The length-of-hospitalization was 11 ± 5 days after TAVI vs. 17 ± 9 days after SAVR (p = 0.003). After matched comparison, no differences in terms of in-hospital mortality (5.7% after TAVI vs. 2.9% after SAVR, p = 0.687) and 1-year mortality (11.4% vs. 7.1%, p = 0.381) were found. The combined endpoint of stroke and mortality at 1-year was also similar between both groups (15.7% in TAVI patients vs. 14.4% after SAVR, p = 0.136). Multivariate analysis determined that aortic regurgitation (AR) was an independent predictor of mortality (OR = 3.623, 95% CI: 1.267-10.358, p = 0.016). Although the rate of AR was higher after TAVI, none of the patients treated with the newest generation devices (10.7%) presented more than a mild degree of AR. CONCLUSIONS: TAVI is feasible and shows comparable results to surgery in terms of early, 1-year mortality, as well as cerebrovascular events in patients with severe aortic stenosis and intermediate-low operative risk. Better transvalvular gradients, yet higher rates of AR were found, however, newer devices presented comparable rate of AR.

[Infective endocarditis in octogenarian patients]. / Endocarditis infecciosa en pacientes octogenarios.

Our aims were to investigate the clinical features and prognosis of endocarditis in octogenarian patients (aged > 79 years) and in comparison with those in younger elderly patients (aged 65-79 years) and young patients (aged < 65 years). Octogenarian subjects more frequently were male and had a community-acquired infection, mitral valve disease, and chronic anemia. Their clinical course was more insidious and benign: they presented less often with fever or new heart murmurs. When heart failure was present, it tended to be less severe. The most frequently isolated microorganisms were streptococci. The detection rate for vegetation on transesophageal echocardiography was lower in octogenarians. Octogenarians had shorter periods of hospitalization, needed surgery less frequently, and had lower mortality. Mortality in those undergoing surgery was not higher in elderly patients. Age was not an independent predictor of in-hospital mortality.

Inter- and intra-observer variability in the echocardiographic evaluation of right ventricular function.

INTRODUCTION AND OBJECTIVES: Echocardiographic evaluation of right ventricular systolic function remains subject to debate because of the anatomic peculiarities of the right ventricle. Several methods have been developed for quantifying right ventricular systolic function. The aim of this study was to determine the reliability and reproducibility of a number of echocardiographic parameters by evaluating their inter-observer and intra-observer variability. METHODS: The study included 30 patients with isolated mitral valvulopathy scheduled for heart surgery. All underwent echocardiography, which was performed independently by two echocardiographers within 24 hours. The intra-observer analysis was carried out using the recorded images at least 1 month after they had been obtained. The parameters studied were the tricuspid annular plane systolic excursion (TAPSE), the tricuspid annular peak systolic velocity on tissue Doppler imaging, right ventricular outflow tract fractional shortening, fractional shortening of right ventricular diameters, and fractional shortening of right ventricular areas. Variability was analyzed using the intraclass correlation coefficient. RESULTS: The degree of concordance on TAPSE and tricuspid annular peak systolic velocity measurement was good in the inter-observer analysis and excellent in the intra-observer analysis. However, concordance was poor on measurements of the fractional shortening of the right ventricular outflow tract, areas and diameters on both inter-observer and intra-observer analyses. CONCLUSIONS: The most reliable and reproducible echocardiographic parameters for evaluating right ventricular systolic function in patients with isolated mitral valvulopathy were the TAPSE and the tricuspid annular peak systolic velocity.

Absence of accelerated atherosclerotic disease progression after intracoronary infusion of bone marrow derived mononuclear cells in patients with acute myocardial infarction--angiographic and intravascular ultrasound--results from the TErapia Celular Aplicada al Miocardio Pilot study.

BACKGROUND: We tried to evaluate a putative negative effect on coronary atherosclerosis in patients receiving intracoronary infusion of unfractionated bone marrow mononuclear cells (BMMC) following an acute ST-elevation myocardial infarction. Peripheral blood mononuclear cells or enriched CD133(+) BMMC have been associated with accelerated atherosclerosis of the distal segment of the infarct related artery (IRA). METHODS: Thirty-seven patients with ST-elevation myocardial infarction from the TECAM pilot study underwent intracoronary infusion of autologous BMMC 9 +/- 3.1 days after onset of symptoms. We compared angiographic changes from baseline to 9 months of follow-up in the distal non-stented segment of the IRA, as well as in the contralateral coronary artery, with a matched control group. A subgroup of 15 treated patients underwent additional IVUS within the distal segment of the IRA. RESULTS: No difference between stem cell and control group were found regarding changes in minimum lumen diameter (0.006 +/- 0.42 vs 0.06 +/- 0.41 mm, P = ns) and the percentage of stenosis (-2.68 +/- 12.33% vs -1.78 +/- 8.75%, P = ns) at follow-up. Likewise, no differences were seen regarding changes in the contralateral artery (minimum lumen diameter -0.004 +/- 0.54 mm vs -0.06 +/- 0.35 mm, P = ns). In the intravascular ultrasound substudy, no changes were demonstrated comparing baseline versus follow-up in maximum area stenosis and plaque volume. CONCLUSIONS: In this pilot study, analysis of a subgroup of patients found that intracoronary injection of unfractionated BMMC in patients with acute ST-elevation myocardial infarction was not associated with accelerated atherosclerosis progression at mid term. Prospective, randomised studies in large cohorts with long-term angiographic and intravascular ultrasound follow-up are necessary to determine the safety of this therapy.

In-hospital prognosis of prosthetic valve endocarditis after urgent surgery.

INTRODUCTION AND OBJECTIVES: Prosthetic valve endocarditis is associated with high morbidity and mortality, particularly when urgent surgery is needed. The identification of factors that predict a poor prognosis is the first step in improving outcomes. The study objectives were to characterize patients with prosthetic valve endocarditis who need urgent surgery and to identify factors that predict in-hospital mortality in this high-risk group. METHODS: From a database of 648 consecutive patients with infective endocarditis diagnosed between 1996 and 2006 at four tertiary-care centers with cardiac surgery facilities, 46 patients with left-sided prosthetic valve endocarditis who needed urgent surgery were identified. A retrospective study was carried out to determine these patients' main characteristics and to identify predictors of in-hospital mortality. RESULTS: The main indications for urgent surgery were heart failure (57%) and persistent infection (33%). In-hospital mortality was 41%. Factors significantly associated with a poor prognosis were fever at admission, persistent infection, positive blood cultures, persistently positive cultures, and echocardiographic evidence of vegetations (P< .05). No specific microorganism was associated with a poor prognosis. CONCLUSIONS: Prosthetic valve endocarditis was associated with high mortality when urgent surgery was needed. Although heart failure was the principle reason for urgent surgery, it did not lead to a worse in-hospital prognosis. The presence of vegetations and uncontrolled infection were the main factors associated with higher in-hospital mortality in patients with left-sided infective endocarditis who needed urgent surgery.

Spanish Acute Aortic Syndrome Study (RESA). Better diagnosis is not reflected in reduced mortality.

INTRODUCTION AND OBJECTIVES: Because acute aortic syndrome (AAS) is associated with high mortality, early diagnosis and treatment are vital. The aim of the Spanish Acute Aortic Syndrome Study (RESA) was to investigate the effectiveness of current treatment of AAS in a broad range of tertiary care hospitals in Spain. METHODS: Between January 2005 and December 2007, 24 tertiary care hospitals reported data on 519 patients with AAS (78% male, mean age 61 +/- 13 years, range 20-92 years): 357 had type-A AAS and 162 had type B. RESULTS: The time delay between symptom onset and diagnosis was <24 hours in 67% of cases and >72 hours in 11%. Some 80% of patients with type-A AAS were treated surgically. The interval between diagnosis and surgery was <24 hours in 90% of cases. In patients with type-B AAS, 34% received invasive treatment: 11% had surgery and 23% underwent endovascular procedures. Mortality during hospitalization in patients with type-A disease was 33% in those treated surgically and 71% in those treated medically. Mortality in patients with type-B disease was 17% with medical treatment, 27% with endovascular treatment and 50% with surgical treatment. CONCLUSIONS: Despite significant advances in the diagnosis of AAS, in-hospital mortality remains high. The findings of this study are representative of a broad range of unselected patients undergoing treatment for the disease and support the need for continuing improvements in therapeutic approaches to AAS.

[Effect of persistent microvascular obstruction on post-infarction ventricular remodeling following intracoronary bone-marrow cell transplantation: a contrast-enhanced cardiac magnetic resonance study]. / Impacto de la obstrucción microvascular persistente en el remodelado ventricular postinfarto tras el implante intracoronario de células mononucleadas de médula ósea: un estudio de cardiorresonancia con contraste.

INTRODUCTION AND OBJECTIVES: Late contrast-enhanced cardiac magnetic resonance (CMR) enables areas of persistent microvascular obstruction (PMO) to be detected early after acute myocardial infarction. Our aim was to evaluate the impact of PMO on subsequent ventricular remodeling in a cohort of patients with acute ST-elevation myocardial infarction (STEMI) who underwent intracoronary autologous bone-marrow mononuclear cell (ABMMC) transplantation. METHODS: In total, 14 patients underwent intracoronary transplantation of 66+/-39 x 10(6) ABMMCs 8+/-2 days following successful revascularization of a STEMI (i.e., TIMI flow grade 3 in the affected artery). Serial CMR studies with gadolinium-DTPA enhancement were performed at baseline and 10 months after infarction. Left ventricular volume and ejection fraction, regional contractility and the infarct size were measured and the presence of PMO (defined as hypoenhanced areas within the infarcted zone) was investigated. RESULTS: Overall, PMO was detected in five of the 14 patients (36%). Those with PMO tended to have a larger infarct size, larger ventricular volumes, and poorer regional and global left ventricular systolic function in baseline studies than those without PMO. At follow-up, there were significant associations between PMO and an increase in end-diastolic volume (25+/-24 mL vs. -2+/-19 mL; P=.037), the absence of an increase in end-diastolic parietal thickness (P=.027), and a smaller reduction in the number of akinetic or dyskinetic segments. CONCLUSIONS: The detection of PMO by CMR early after successful revascularization of a STEMI in patients who underwent intracoronary ABMMC transplantation was associated with adverse left ventricular remodeling.

Association between self-replicating calcifying nanoparticles and aortic stenosis: a possible link to valve calcification.

AIMS: Among various hypotheses proposed for pathological tissue calcification, recent evidence supports the possibility that self-replicating calcifying nanoparticles (CNPs) can contribute to such calcification. These CNPs have been detected and isolated from calcified human tissues, including blood vessels and kidney stones, and are referred to as nanobacteria. We evaluated calcific aortic valves for the presence of CNP. METHODS AND RESULTS: Calcific aortic valves were obtained from 75 patients undergoing surgical valve replacement. The control group was formed by eight aortic valves corresponding to patients with heart transplants. In the microbiology laboratory, valves were screened for CNP using a 4-6 weeks specific culture method. The culture for CNP was positive in 48 of the 75 valves with aortic stenosis (64.0%) in comparison with zero of eight (0%) for the control group (P = 0.0005). The observation of cultures by way of scanning electron microscopy highlighted the resemblance in size and morphology of CNP. CONCLUSION: Self-replicating calcific nanometer-scale particles, similar to those described as CNP from other calcific human tissues, can be cultured and visualized from calcific human aortic valves. This finding raises the question as to whether CNP contribute to the pathogenesis of the disease or whether they are only innocent bystanders.

Bone-marrow-derived cells for cardiac stem cell therapy: safe or still under scrutiny?

Cardiac stem cell therapy with bone-marrow-derived stem cells is a promising approach to facilitate myocardial regeneration after acute myocardial infarction or in congestive heart failure. The clinical data currently available seem to indicate that this approach is safe and is not associated with an increase in the number of adverse clinical events; nevertheless, the level of safety confidence is limited because of the small number of patients who have been treated and the absence of long-term clinical follow-up data. In order to establish the clinical safety of cardiac stem cell therapy, it will be necessary to collect additional data from both previous and ongoing clinical trials in subsets of patients relative to their background risk. Several conceptual safety concerns should also be addressed. These concerns relate to a number of operational mechanisms and include biological effects on differentiation, remote homing of transplanted stem cells, progression of atherosclerosis, and arrhythmias. The proactive scrutiny of these phenomena could eventually facilitate the translation of the promise of cardiac regeneration into a safe and effective therapy.

Clinical and prognostic profile of patients with infective endocarditis who need urgent surgery.

AIMS: Surgery in patients with infective endocarditis (IE) can be elective (upon completion of antibiotic treatment) or urgent (before antibiotic treatment has ended) when the clinical course is unfavourable. However, urgent surgery for left-sided endocarditis is associated with high mortality. The aims of this study were to describe the profile of patients with left-sided endocarditis who underwent urgent surgery and to analyse the factors that predicted mortality. METHODS AND RESULTS: Among 508 consecutive episodes of IE, 391 were left-sided and 89 required urgent surgery. The main reasons for urgent surgery were heart failure that did not respond to medication (72%) and persistent infection despite appropriate antibiotic treatment (31%). Thirty-two patients (36%) died during their hospital stay. Univariate analysis identified renal failure, septic shock, Gram-negative bacteria, persistent infection, and surgery for persistent infection as factors associated with mortality. Multivariate analysis confirmed only persistent infection and renal insufficiency as factors independently associated with a poor prognosis. CONCLUSION: Patients with IE who need urgent surgery have a poor clinical course. Heart failure, the main cause of urgent surgery, was not associated with higher mortality. However, persistent infection and renal failure were factors associated with higher post-surgical mortality.

[Current profile of left-sided native valve endocarditis caused by coagulase-negative Staphylococcus]. / Perfil actual de la endocarditis por estafilococo coagulasa negativo en válvulas nativas izquierdas.

Coagulase-negative staphylococci are the most frequently isolated microorganisms in early prosthetic valve endocarditis. However, they rarely cause endocarditis in native valves. The profile of patients with left-sided native valve endocarditis by coagulase-negative staphylococci is unknown, because available data are scarce and outdated. We analyzed the epidemiological, clinical, radiographic, microbiological, and echocardiographic features and clinical course in 17 patients with this entity out of a total of 441 consecutive patients diagnosed as having endocarditis. The results show that left-sided native valve endocarditis caused by coagulase-negative staphylococci is more common than previously reported, can cause heart failure due to valvular involvement, often needs surgery, and is associated with high mortality.

[Clinical, echocardiographic and prognostic profile of Streptococcus viridans left-sided endocarditis]. / Perfil clínico, ecocardiográfico y pronóstico de las endocarditis izquierdas por Streptococcus viridans.

INTRODUCTION AND OBJECTIVES: Published case series on Streptococcus viridans endocarditis are scarce and outdated. The aims of our study were multiple: to analyze the profile of the Streptococcus viridans endocarditis, to compare it with other types of left-sided endocarditis and with cases caused by Staphylococcus aureus, and to determine predictors of poor outcome in Streptococcus viridans endocarditis. PATIENTS AND METHOD: We analyzed 441 episodes of endocarditis: 330 left-sided and 54 caused by Streptococcus viridans (16%). We compared the 54 cases due to Streptococcus viridans with the remaining cases of left-sided endocarditis in our series, and also with cases caused by Staphylococcus aureus. We also analyzed the predictors of death and urgent surgery in Streptococcus viridans endocarditis. RESULTS: Left-sided endocarditis due to Streptococcus viridans led to a similar degree of valvular destruction, showed acute onset less frequently, and led to less renal failure, septic shock and mortality than the remaining cases of left-sided endocarditis in our series. The same differences were found in comparison to Streptococcus viridans endocarditis. Prognostic factors for Streptococcus viridans left-sided endocarditis were heart failure and periannular complications. CONCLUSIONS: Although Streptococcus viridans is a nonaggressive microorganism, valvular destruction is similar to that caused by other pathogens when it causes left-sided endocarditis. Nonetheless its prognosis is better, a feature which may be related to the fact that the systemic infectious syndrome can be treated more effectively. Prognostic factors in left-sided endocarditis due to Streptococcus viridans are heart failure and periannular complications.

[Hepatosplenic and renal embolisms in infective endocarditis]. / Endocarditis infecciosa y embolias del eje hepatoesplenorrenal.

INTRODUCTION AND OBJECTIVES: Among the complications of infective endocarditis, systemic embolisms are an ominous prognostic sign. The aim of the present study was to compare the demographic, clinical, microbiologic and echocardiographic features of episodes of endocarditis accompanied and unaccompanied by embolisms in the spleen, kidney or liver. We also assessed the prognostic impact of these embolisms. MATERIAL AND METHOD: Prospective, multicenter clinical cohort study. We analyzed 338 consecutive episodes of left-sided infective endocarditis in 308 patients. Episodes were classified in two groups: group I, episodes with hepatosplenic or renal embolisms (n=34); group II, episodes without embolisms (n=304). RESULTS: There were 41 embolisms in 34 episodes (10%). Of these, 34 were located in the spleen, 5 in the kidney and 2 in the liver. Some forms of clinical presentation predominated in group I, e.g., abdominal pain, splenomegaly, cutaneous stigmata, hematuria, embolisms in other locations, and septic shock. Staphylococcus aureus and enterococci were more commonly isolated in group I. Detection of vegetations (by transesophageal echocardiography) was more frequent in group I, and they were larger than vegetations in group II. Hepatosplenic and renal embolisms were not independently associated with the need for cardiac surgery or death. CONCLUSIONS: Hepatosplenic and renal embolisms occur in 10% of left-sided episodes of infective endocarditis. The clinical presentation of these episodes has characteristic features. Vegetations are larger than in episodes without these embolism. Hepatosplenic and renal embolisms do not increase neither the need of cardiac surgery nor the risk of death.

Routine invasive strategy within 24 hours of thrombolysis versus ischaemia-guided conservative approach for acute myocardial infarction with ST-segment elevation (GRACIA-1): a randomised controlled trial.

BACKGROUND: In patients with ST-segment elevated myocardial infarction (STEMI), early post-thrombolysis routine angioplasty has been discouraged because of its association with high incidence of events. The GRACIA-1 trial was designed to reassess the benefits of an early post-thrombolysis interventional approach in the era of stents and new antiplatelet agents. METHODS: 500 patients with thrombolysed STEMI (with recombinant tissue plasminogen activator) were randomly assigned to angiography and intervention if indicated within 24 h of thrombolysis, or to an ischaemia-guided conservative approach. The primary endpoint was the combined rate of death, reinfarction, or revascularisation at 12 months. Analysis was by intention to treat. FINDINGS: Invasive treatment included stenting of the culprit artery in 80% (199 of 248) patients, bypass surgery in six (2%), non-culprit artery stenting in three, and no intervention in 40 (16%). Predischarge revascularisation was needed in 51 of 252 patients in the conservative group. By comparison with patients receiving conservative treatment, by 1 year, patients in the invasive group had lower frequency of primary endpoint (23 [9%] vs 51 [21%], risk ratio 0.44 [95% CI 0.28-0.70], p=0.0008), and they tended to have reduced rate of death or reinfarction (7% vs 12%, 0.59 [0.33-1.05], p=0.07). Index time in hospital was shorter in the invasive group, with no differences in major bleeding or vascular complications. At 30 days both groups had a similar incidence of cardiac events. In-hospital incidence of revascularisation induced by spontaneous recurrence of ischaemia was higher in patients in the conservative group than in those in the invasive group. INTERPRETATION: In patients with STEMI, early post-thrombolysis catheterisation and appropriate intervention is safe and might be preferable to a conservative strategy since it reduces the need for unplanned in-hospital revascularisation, and improves 1-year clinical outcome.