Individual Patient Data Meta-analysis of Drug-eluting Versus Bare-metal Stents for Percutaneous Coronary Intervention in Chronic Versus Acute Coronary Syndromes.

New-generation drug-eluting stents (DES) strongly reduce restenosis and repeat revascularization compared with bare-metal stents (BMS) for percutaneous coronary intervention. There is residual uncertainty as to whether other prognostically relevant outcomes are affected by DES versus BMS concerning initial presentation (chronic coronary syndrome [CCS] vs acute coronary syndrome [ACS]). We performed an individual patient data meta-analysis of randomized trials comparing new-generation DES versus BMS (CRD42017060520). The primary outcome was the composite of cardiac death or myocardial infarction (MI). Outcomes were examined at maximum follow-up and with a 1-year landmark. Risk estimates are expressed as hazard ratio (HR) with 95% confidence interval (CI). A total of 22,319 patients were included across 14 trials; 7,691 patients (34.5%) with CCS and 14,628 patients (65.5%) with ACS. We found evidence that new-generation DES versus BMS consistently reduced the risk of cardiac death or MI in both patients with CCS (HR 0.83, 95% CI 0.70 to 0.98, p <0.001) and ACS (HR 0.83, 95% CI 0.75 to 0.92, p <0.001) (p-interaction = 0.931). This benefit was mainly driven by a similar reduction in the risk of MI (p-interaction = 0.898) for both subsets (HRCCS 0.80, 95% CI 0.65 to 0.97; HRACS 0.79, 95% CI 0.70 to 0.89). In CCS and ACS, we found a time-dependent treatment effect, with the benefit from DES accumulating during 1-year follow-up, without offsetting effects after that. In conclusion, patients with CCS were slightly underrepresented in comparative clinical trials. Still, they benefited similarly to patients with ACS from new-generation DES instead of BMS with a sustained reduction of cardiac death or MI because of lower event rates within 1 year.

Drug-Eluting or Bare-Metal Stents for Left Anterior Descending or Left Main Coronary Artery Revascularization.

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, 0.68-0.85) than in the no-LAD/LM territories (HR, 0.93; 95% CI, 0.83-1.05). This benefit was driven by a lower risk of cardiac death (HR, 0.83; 95% CI, 0.70-0.98) and myocardial infarction (HR, 0.74; 95% CI, 0.65-0.85) 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, 0.76-0.97). 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. Registration URL: https://www.crd.york.ac.uk/PROSPERO; Unique identifier: CRD42017060520.

Drug-Eluting or Bare-Metal Stents for Left Anterior Descending or Left Main Coronary Artery Revascularization

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.

High risk coronavirus disease 2019: The primary results of the CoronaHeart multi-center cohort study

BACKGROUND: Patients with Coronavirus Disease 2019 (COVID-19) may present high risk features during hospitalization, including cardiovascular manifestations. However, less is known about the factors that may further increase the risk of death in these patients. METHODS: We included patients with COVID-19 and high risk features according to clinical and/or laboratory criteria at 21 sites in Brazil from June 10th to October 23rd of 2020. All variables were collected until hospital discharge or in-hospital death. RESULTS: A total of 2546 participants were included (mean age 65 years; 60.3% male). Overall, 70.8% were admitted to intensive care units and 54.2% had elevated troponin levels. In-hospital mortality was 41.7%. An interaction among sex, age and mortality was found (p = 0.007). Younger women presented higher rates of death than men (30.0% vs 22.9%), while older men presented higher rates of death than women (57.6% vs 49.2%). The strongest factors associated with in-hospital mortality were need for mechanical ventilation (odds ratio [OR] 8.2, 95% confidence interval [CI] 5.4­12.7), elevated C-reactive protein (OR 2.3, 95% CI 1.7­2.9), cancer (OR 1.8, 95 %CI 1.2­2.9), and elevated troponin levels (OR 1.8, 95% CI 1.4­2.3). A risk score was developed for risk assessment of in-hospital mortality. CONCLUSIONS: This cohort showed that patients with COVID-19 and high risk features have an elevated rate of in-hospital mortality with differences according to age and sex. These results highlight unique aspects of this population and might help identifying patients who may benefit from more careful initial surveillance and potential subsequent interventional therapies

A Coronary Artery Anomaly Presenting as Acute Coronary Syndrome: A Case Report.

BACKGROUND Coronary artery anomalies (CAAs) are rare congenital malformations with different clinical presentations and pathophysiological mechanisms. These anomalies are frequently the cause of sudden death in young patients. Most CAAs are incidental findings owing to the lack of symptoms; however, they may be associated with acute coronary syndrome in rare cases. CASE REPORT We describe the case of a 47-year-old man who presented with a 1-day history of progressive typical chest pain and elevated troponin levels. The patient underwent a coronary angiography, which unveiled the anomalous origin of the left main coronary artery arising from the right coronary artery, with an interarterial course between the ascending aorta and the pulmonary artery, without coronary artery disease. Coronary computed tomography angiography confirmed the CAA and its relationship with the symptoms. An uneventful coronary artery bypass graft was undertaken, and at the 1-year follow-up, the patient was asymptomatic, with a normal stress test. CONCLUSIONS This case depicts the presentation of atypical acute coronary syndrome in a young patient with a rare CAA. In such patients, coronary angiography and coronary computed tomography angiography are essential tools to confirm the diagnosis and to determine treatment. Although controversial, in young individuals presenting CAA with an interarterial course, such as the left main coronary artery arising from the right coronary artery, coronary artery bypass graft may be an important treatment option to avoid sudden death in the future.

High risk coronavirus disease 2019: The primary results of the CoronaHeart multi-center cohort study.

BACKGROUND: Patients with Coronavirus Disease 2019 (COVID-19) may present high risk features during hospitalization, including cardiovascular manifestations. However, less is known about the factors that may further increase the risk of death in these patients. METHODS: We included patients with COVID-19 and high risk features according to clinical and/or laboratory criteria at 21 sites in Brazil from June 10th to October 23rd of 2020. All variables were collected until hospital discharge or in-hospital death. RESULTS: A total of 2546 participants were included (mean age 65 years; 60.3% male). Overall, 70.8% were admitted to intensive care units and 54.2% had elevated troponin levels. In-hospital mortality was 41.7%. An interaction among sex, age and mortality was found (p = 0.007). Younger women presented higher rates of death than men (30.0% vs 22.9%), while older men presented higher rates of death than women (57.6% vs 49.2%). The strongest factors associated with in-hospital mortality were need for mechanical ventilation (odds ratio [OR] 8.2, 95% confidence interval [CI] 5.4-12.7), elevated C-reactive protein (OR 2.3, 95% CI 1.7-2.9), cancer (OR 1.8, 95 %CI 1.2-2.9), and elevated troponin levels (OR 1.8, 95% CI 1.4-2.3). A risk score was developed for risk assessment of in-hospital mortality. CONCLUSIONS: This cohort showed that patients with COVID-19 and high risk features have an elevated rate of in-hospital mortality with differences according to age and sex. These results highlight unique aspects of this population and might help identifying patients who may benefit from more careful initial surveillance and potential subsequent interventional therapies.

Seattle Angina Pectoris Questionnaire and Canadian Cardiovascular Society Angina Categories in the Assessment of Total Coronary Atherosclerotic Burden.

The patient reported angina measurement with the Seattle Angina Questionnaire (SAQ) has shown to have prognostic implications and became an endpoint in clinical trials. Our objective was to study physician-reported and SAQ severity with the total coronary atherosclerotic burden as assessed by 4 angiographic scores. We prospectively analyzed data of consecutive patients scheduled for coronary angiography or percutaneous coronary intervention. The Canadian Cardiovascular Society (CCS) angina categories was used as physician-reported angina. SAQ domains were categorized as severe (0 to 24), moderate 25 to 75 and mild angina (>75). All angina assessments were done before coronary angiography. Gensini, Syntax, Friesinger, and Sullivan angiographic scores were used for total atherosclerotic burden quantification: 261 patients were included in the present analysis. The median age was 66.0 (59.0 to 71.8) years, 53.6% were male and 43.7% had diabetes. The median SYNTAX score was 6.0 (0 to 18.0). The worse the symptoms of CCS categories, the more severe was the atherosclerotic burden in all angiographic scores: SYNTAX (p = 0.01); Gensini (p <0.01); Friesinger (p = 0.02) and Sullivan (p = 0.03). Conversely, SAQ domains were not able to discriminate the severity of CAD in any of the scores. The only exception was the severe SAQ quality of life that had worse Gensini score than the mild SAQ quality of life (p = 0.04). In conclusion, CCS angina categories are related to the total atherosclerotic burden in coronary angiography, by all angiographic scores. SAQ domains should be used as a measure of patient functionality and quality of life but not as a measure of CAD severity.

Comparative clinical performance of two types of drug-eluting stents with abluminal biodegradable polymer coating: Five-year results of the DESTINY randomized trial

Resumo Introdução e objetivos: Stents Coated with the Biodegradable Polymer on their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions (Destiny Trial) é um estudo randomizado de não inferioridade que comparou o stent farmacológico eluído com Sirolimus Inspiron® (SES) ao controle o stent Biomatrix® Flex eluído com biolimus (BES). Relatórios dentro do primeiro ano mostraram resultados semelhantes para ambos os stents, em seguimento clínico, angiográfico e também em análise de tomografia de coerência ótica e ultrassom intracoronário. A presente análise tem como objetivo comparar o desempenho clínico desses dois stents farmacológicos com polímeros biodegradáveis após cinco anos do procedimento índice. Métodos: Foram randomizados 170 pacientes (194 lesões) em uma proporção de 2:1 para trata mento com SES ou BES, respetivamente. O desfecho primário para o presente estudo foi a taxa em cinco anos de eventos cardíacos adversos maiores combinados, definida como morte cardíaca, infarto do miocárdio ou revascularização da lesão-alvo. Resultados: Em cinco anos, o desfecho primário ocorreu em 12,5% e 17,9% para o grupo SES e BES, respectivamente (p=0,4). Não houve trombose de stent definitiva ou provável entre os pacientes tratados com o novo SES durante os cinco anos de seguimento e ausência de trombose de stent após o primeiro ano no grupo BES. Conclusões: O novo stent Inspiron® apresentou uma boa e semelhante performance clínica no seguimento em longo prazo, quando comparado com o controle o stent de última geração Biomatrix® Flex.

Atypical chest pain due to multiple coronary arteries fistulas occluded with percutaneous interlock coils: A case report.

Coronary artery fistulas, although rare, should be included in the differential diagnosis of atypical chest pain, generally unveiled by cardiac catheterization or multidetector computed tomography. Such anatomical findings in conjunction with detectable ischemia and severe symptoms should prompt their closure. Transcatheter closure of fistulas is an attractive alternative to surgery, especially with the novel devices such as the interlock fibered detachable coils, which can be safely and effectively performed in a variety of circumstances, including the coronary arteries with tortuous anatomies. We present a case of atypical chest pain and large burden of ischemia in the stress scintigraphy, due to multiple coronary fistulas to the bronchial arteries successfully occluded with percutaneous interlock coils. .

Comparative clinical performance of two types of drug-eluting stents with abluminal biodegradable polymer coating: Five-year results of the DESTINY randomized trial.

INTRODUCTION AND OBJECTIVES: The Stents Coated With the Biodegradable Polymer on Their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions - DESTINY Trial is a non-inferiority randomized study that compared the Inspiron™ sirolimus-eluting stent (SES) with the control Biomatrix™ Flex biolimus-eluting stent (BES). Previous reports in the first year showed similar outcomes for both stents, in clinical, angiographic, optical coherence tomography, and intravascular ultrasound assessments. The present analysis aims to compare the clinical performance of these two biodegradable polymer drug-eluting stents five years after the index procedure. METHODS: A total of 170 patients (194 lesions) were randomized in a 2:1 ratio for treatment with SES or BES, respectively. The primary endpoint for the present study was the five-year rate of combined major adverse cardiac events, defined as cardiac death, myocardial infarction, or target lesion revascularization. RESULTS: At five years, the primary endpoint occurred in 12.5% and 17.9% of the SES and BES groups, respectively (p=0.4). There was no definite or probable stent thrombosis among patients treated with the novel SES stent during the five years of follow-up, and no stent thrombosis after the first year in the BES group. CONCLUSIONS: The novel Inspiron™ stent had similar good clinical performance in long-term follow-up when compared head-to-head with the control latest-generation Biomatrix™ Flex biolimus-eluting stent.

Natural History of Adapted Leaman Score Assessing Coronary Artery Disease Progression by Computed Tomography Angiography: A 7-Year Follow-Up Report.

BACKGROUND: Coronary computed tomographic angiography (CCTA) provides a non-invasive assessment of the coronary artery tree. Computed Tomography - adapted Leaman Score (CT-LeSc) has been shown to be an independent predictor of cardiac events in coronary artery disease (CAD) patients with a score greater than 5 (high). PURPOSE: To investigate the relationship between CT-LeSc and the progression of CAD and to provide vessel- and segment-level CAD qualification and quantification at baseline and 7-year follow-up. METHODS: Patients with multivessel CAD and CCTA assessments at baseline and follow-up were included. The CT-LeSc analysis was performed in a paired fashion. The patient-level scores and the differences between each phase were assessed by 2 analysts in an independent core laboratory. RESULTS: This study analyzed 248 coronary segments from 17 patients with a mean follow-up interval of 7.5 ± 0.6 years. The mean CT-LeSc at baseline and follow-up were 14.6 ± 4.2 and 16.9 ± 1.5, respectively, with an absolute increase of 2.3 ± 1.8. The mean cumulative increase of new lesions was 0.2 ± 0.2 per year. Over time, 14.6% of the non-obstructive lesions became obstructive, and 15.0% of the non-calcified plaques became calcified. There were 29 new lesions found at follow-up, and out of these, 16 were obstructive and 19 were non-calcified. CONCLUSION: In patients at high risk for cardiac events, as determined by CT-LeSc, there was an increase in CT-LeSc, obstructive lesions, and calcified plaques over the 7-year follow-up period. Most of the new lesions were obstructive and non-calcified. This is the first report showing long-term serial imaging CCTA changes in a high-risk population.

Cluster of climatic and pollutant characteristics increases admissions for acute myocardial infarction: Analysis of 30,423 patients in the metropolitan area of Sao Paulo.

BACKGROUND: The impact of simultaneous adverse climate conditions in the risk of myocardial infarction (MI) was not tested before. The aim of the present study was to investigate the impact of the combination of climate and air pollution features in the number of admissions and mortality due to acute myocardial infarction in 39 municipalities of São Paulo from 2012 to 2015. METHODS: Data about MI admissions were obtained from the Brazilian public health system (DataSUS). Daily information on weather were accessed from the Meteorological Database for Teaching and Research. Additionally, daily information on air pollution were obtained from the Environmental Company of the State of São Paulo. A hierarchical cluster analysis was applied for temperature, rainfall patterns, relative air humidity, nitrogen dioxide, particulate matter 2.5 and particulate matter 10. MI admissions and in-hospital mortality were compared among the clusters. RESULTS: Data analysis produced 3 clusters: High temperature variation-Low humidity-high pollution (n=218 days); Intermediate temperature variation/high humidity/intermediate pollution (n=751 days) and low temperature variation/intermediate humidity-low pollution (n=123 days). All environmental variables were significantly different among clusters. The combination of high temperature variation, dry weather and high pollution resulted in a significant 9% increase in hospital admissions for MI [30.5 (IQR 25.0-36.0)]; patients/day; P<0.01). The differences in weather and pollution did not have impact on in-hospital mortality (P=0.88). CONCLUSION: The combination of atmospheric conditions with high temperature variation, lower temperature, dryer weather and increased inhalable particles was associated with a marked increase of hospital admissions due to MI.

The Clinical Course of Takotsubo Syndrome Diagnosed According to the InterTAK Criteria

Abstract Background There has been an increase in the number of cases of Takotsubo syndrome (TTS) and of scientific publications on the theme over the last years. However, little is known about the status of this disease in Brazilian hospitals. Objective To assess mortality and major adverse cardiovascular events (MACE) during hospitalization and follow-up of TTS patients seen in a tertiary hospital in Brazil. Methods This was a retrospective, observational study on 48 patients. Clinical data, signs and symptoms, complementary tests, MACE and all-cause mortality were assessed on admission and during follow-up. Kaplan-Meier curves were used for analysis of all-cause mortality and risk for MACE at median follow-up. The 95% confidence interval was also calculated for a significance level of 5%. Results Mean age of patients was 71 years (SD±13 years), and most patients were women (n=41; 85.4%). During hospitalization, four patients (8.3%) died and five (10.4%) developed MACE. At median follow-up of 354.5 days (IQR of 81.5-896.5 days), the risk of all-cause mortality and MACE was 11.1% (95% CI= 1.8-20.3%) and 12.7% (95% CI= 3.3-22.3%), respectively. Conclusion TTS was associated with high morbidity and mortality rates in a tertiary hospital in Brazil, which were comparable to those observed in acute coronary syndrome. Therefore, the severity of TTS should not be underestimated, and new therapeutic strategies are required. Int J Cardiovasc Sci. 2020; [online].ahead print, PP.0-0

Correlation between computed tomography adapted leaman score and computed tomography liver and spleen attenuation parameters for non-alcoholic fatty liver disease as well as respective inflammatory mediators.

Metabolic syndrome is a primary driver of vascular inflammation, plaque development, and atherosclerotic disease. The Computed Tomography-adapted Leaman Score (CT-LeSc) has been shown to be an independent predictor of cardiac events in coronary artery disease (CAD) patients but has never been studied for broader applicability. Non-alcoholic fatty liver disease (NAFLD) is associated with similar systemic inflammatory processes as CAD, and its presence as assessed by Computed Tomography Liver and Spleen Attenuation (CT-LSA) may impact on the extension of the CT-LeSc. The purpose of this study was to investigate the association between the CT-LeSc and NAFLD and to characterize and compare the inflammatory processes of each disease state. This was an exploratory study in which patients with known multivessel CAD who were scheduled to undergo percutaneous coronary intervention were included. CT-LeSc were graded on pre-existing criteria by two independent CoreLab analysts. CT-LSA parameters analyzed included the liver absolute attenuation value, liver and spleen attenuation difference and liver-to-spleen attenuation ratio and were scored by two independent CoreLab analysts as well. Inflammatory mediator analysis included routine laboratory draws for a variety of known signal molecules. The overall liver absolute attenuation value did not correlate significantly with the CT-LeSc, but the subgroup 50 to 65 HU showed moderately negative correlation (R = - 0.629; p = 0.008). The overall liver and spleen attenuation difference did not correlate significantly with the CT-LeSc, but the subgroup 1 to 18 HU showed moderately positive correlation (R = 0.513; p = 0.017). The overall and subgroup liver-to-spleen attenuation ratio did not correlate with the CT-LeSc. The eosinophil and leukocyte ratio showed weakly negative correlation with the overall CT-LeSc (R = - 0.4602; p = 0.008), and VCAM-1 showed moderately negative correlation with CT-LeSc < 16.0 (R = - 0.5678; p = 0.022). Some CT-LSA parameters correlate with high risk CT-LeSc and may both provide complementary information for cardiovascular risk stratification. The significant metrics of liver absolute attenuation value and liver and spleen attenuation difference can be quickly completed in the clinical setting and may support a suspicion of CAD.

Aspirin-Free Prasugrel Monotherapy Following Coronary Artery Stenting in Patients With Stable CAD: The ASET Pilot Study.

OBJECTIVES: The aim of this study was to evaluate the hypothesis that prasugrel monotherapy following successful everolimus-eluting stent implantation is feasible and safe in patients with stable coronary artery disease (CAD). BACKGROUND: Recent studies have suggested that short dual-antiplatelet therapy strategies may provide an adequate balance between ischemic and bleeding risks. However, the complete omission of aspirin immediately after percutaneous coronary intervention (PCI) has not been tested so far. METHODS: The study was a multicenter, single-arm, open-label trial with a stopping rule based on the occurrence of definite stent thrombosis (if >3, trial enrollment would be terminated). Patients undergoing successful everolimus-eluting stent implantation for stable CAD with SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) scores <23 were included. All participants were on standard dual-antiplatelet therapy at the time of index PCI. Aspirin was discontinued on the day of the index procedure but given prior to the procedure; prasugrel was administered in the catheterization laboratory immediately after the successful procedure, and aspirin-free prasugrel became the therapy regimen from that moment. Patients were treated solely with prasugrel for 3 months. The primary ischemic endpoint was the composite of cardiac death, spontaneous target vessel myocardial infarction, or definite stent thrombosis, and the primary bleeding endpoint was Bleeding Academic Research Consortium types 3 and 5 bleeding up to 3 months. RESULTS: From February 22, 2018, to May 7, 2019, 201 patients were enrolled. All patients underwent PCI for stable CAD. Overall, 98.5% of patients were adherent to prasugrel at 3-month follow-up. The primary ischemic and bleeding endpoints occurred in 1 patient (0.5%). No stent thrombosis events occurred. CONCLUSIONS: Aspirin-free prasugrel monotherapy following successful everolimus-eluting stent implantation demonstrated feasibility and safety without any stent thrombosis in selected low-risk patients with stable CAD. These findings may help underpin larger randomized controlled studies to evaluate the aspirin-free strategy compared with traditional dual-antiplatelet therapy following PCI. (Acetyl Salicylic Elimination Trial: The ASET Pilot Study [ASET]; NCT03469856).

Drug-eluting or bare-metal stents for percutaneous coronary intervention: a systematic review and individual patient data meta-analysis of randomised clinical trials

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)

Drug-eluting or bare-metal stents for percutaneous coronary intervention: a systematic review and individual patient data meta-analysis of randomised clinical trials.

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 randomised 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 randomised 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 0·78-0·90, p<0·001) owing to a reduced risk of myocardial infarction (0·79, 0·71-0·88, p<0·001) and a possible slight but non-significant cardiac mortality benefit (0·89, 0·78-1·01, p=0·075). All-cause death was unaffected (HR with DES 0·96, 95% CI 0·88-1·05, p=0·358), but risk was lowered for definite stent thrombosis (0·63, 0·50-0·80, p<0·001) and target-vessel revascularisation (0·55, 0·50-0·60, 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. FUNDING: Bern University Hospital.

SYNTAX Score in Patients With Diabetes Undergoing Coronary Revascularization in the FREEDOM Trial.

BACKGROUND: Diabetes mellitus (DM) is associated with complex coronary artery disease (CAD), which in turn results in increased morbidity and mortality from cardiovascular disease. OBJECTIVES: This study sought to evaluate the utility of SYNTAX score (SS) for predicting future cardiovascular events in patients with DM and complex CAD undergoing either coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). METHODS: The FREEDOM (Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease) trial randomized patients with DM and multivessel CAD to undergo either PCI with drug-eluting stents or CABG. The SS was calculated retrospectively by a core laboratory. The endpoint of hard cardiovascular events (HCE) was a composite of death from any cause, nonfatal myocardial infarction, and nonfatal stroke, while the endpoint of major adverse cardiac and cerebrovascular events (MACCE) was a composite of HCE and repeat revascularization. RESULTS: A total of 1,900 patients were randomized to PCI (n = 953) or CABG (n = 947). The SS was considered an independent predictor of 5-year MACCE (hazard ratio per unit of SS: 1.02; 95% confidence interval: 1.00 to 1.03; p = 0.014) and HCE (hazard ratio per unit of SS: 1.03; 95% confidence interval: 1.01 to 1.04; p = 0.002) in the PCI cohort, but not in the CABG group. There was a higher incidence of MACCE in PCI patients with low, intermediate, and high SS compared with those who underwent CABG (36.6% vs. 25.9%, p = 0.02; 43.9% vs. 26.8%, p < 0.001; 48.7% vs. 29.7%, p = 0.003, respectively). CONCLUSIONS: In DM patients with multivessel CAD, the complexity of CAD evaluated by the SS is an independent risk factor for MACCE and HCE only in patients undergoing PCI. The SS should not be utilized to guide the choice of coronary revascularization in patients with DM and multivessel CAD. (Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes [FREEDOM]; NCT00086450).