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Background--The clinical impact of prior percutaneous coronary intervention (PCI) in patients requiring coronary artery bypass grafting (CABG) remains unsettled. We sought to determine whether prior PCI is associated with adverse outcome after CABG. Methods and Results--Data from the prospective E-CABG (European Multicenter Study on Coronary Artery Bypass Grafting) conducted between January 2015 and March 2016 at 16 European centres were analyzed using propensity weighted methodology to adjust for confounding. A parallel systematic review/meta-analysis (MEDLINE, Embase, SCOPUS, and Cochrane Library) through September 2017 was accomplished. Of a total of 3641 adult patients included in the E-CABG study, 685 (19%) patients had a history of PCI. At multivariable level, prior PCI was not associated with an increased hospital mortality in both unweighted and weighted patient groups (odds ratio, 0.73; 95% confidence interval, 0.29-1.38; P=0.33 and odds ratio, 0.90; 95% confidence interval, 0.39-2.08; P=0.81, respectively). Subgroup analyses confirmed that prior PCI had no impact on hospital mortality and morbidity, including reexploration for bleeding, blood transfusion, hospital resource use, and neurological, renal, and cardiac complications. The systematic review provided a total of 71 366 individuals and showed a trend toward higher in-hospital/30-day mortality (adjusted odds ratio, 1.30; 95% confidence interval, 0.99-1.70; I2=43.1%) in patients with prior PCI. Conclusions--Our prospective multicenter study showed that prior PCI was not associated with an increased risk of mortality or other adverse outcomes in patients undergoing CABG. In light of a trend toward increased mortality observed in the meta-analysis, further studies are needed to ascertain the prognostic impact of prior PCI in the outcome after CABG. [ABSTRACT FROM AUTHOR]

The Comparison of Bioactive-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome (BASE-ACS) trial demonstrated an outcome of titanium-nitride-oxide-coated bioactive stents (BAS) non-inferior to everolimus-eluting stents (EES) in patients presenting with acute coronary syndrome (ACS). We performed a post hoc analysis of the BASE-ACS trial in patients with, versus those without, preexisting vascular disease. We randomized 827 patients (1:1) presenting with ACS to receive either BAS or EES. The primary end point was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR). A total of 169 (20.4%) patients had preexisting vascular disease. Median follow-up was 5.0 years. The incidence of MACE was higher in patients with, versus those without, preexisting vascular disease (22.5% vs 13.5%, respectively, P = .004). This was driven by more frequent cardiac death and non-fatal MI (5.9% vs 2.4% and 11.8% vs 5.5%, P = .02 and P = .003, respectively). The rates of ischemia-driven TLR were comparable (P > .05). All events were comparable between the 2 matched-pair subgroups (P > .05 for all). In patients treated with early percutaneous coronary intervention for ACS, the long-term outcome was worse in patients with, versus those without, preexisting vascular disease. [ABSTRACT FROM AUTHOR]

Objectives: We performed a post hoc analysis of outcome in patients with, versus those without, calcified target lesions from the BASE ACS trial.Background: The outcome of contemporary stent implantation in patients with calcified lesions presenting with acute coronary syndrome is unknown.Methods: The BASE ACS trial randomized 827 patients (1:1) presenting with acute coronary syndrome to receive either titanium-nitride-oxide-coated stents or everolimus-eluting stents. Calcified lesions were defined as moderate or severe calcification in the vessel wall by coronary angiography. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction or ischemia-driven target lesion revascularization. Follow-up was planned at 12 months, and yearly thereafter for up to 7 years.Results: Of 827 patients enrolled in the trial, 352 (42.6%) had calcified target lesions. Median follow-up was 5.0 years. The incidence of MACE was higher in patients with, versus those without, calcified target lesions (19.6% vs. 12.2%, respectively, P = 0.004). This was driven by more frequent cardiac death and non-fatal myocardial infarction events (P < 0.05, both). The rates of ischemia-driven target lesion revascularization were comparable (P > 0.05). MACE and the other endpoints were comparable between the 2 propensity-score matched subgroups (P > 0.05 for all). Hypertension and smaller vessel size independently predicted MACE in patients treated for calcified lesions.Conclusions: Patients presenting with acute coronary syndrome who were treated for calcified lesions had worse long-term clinical outcome, compared with those treated for non-calcified lesions, mainly due to more frequent safety events. In the propensity score-matched analysis, the outcome was comparable. [ABSTRACT FROM AUTHOR]

Background. The Swedish-speaking minority of Finland is unique, because it has a higher socioeconomic status (SES) and longer life expectancy than the Finnish-speaking majority. We hypothesized that this minority may have a lower attack rate of coronary events and analysed whether this could be explained by their higher SES. Methods. The population-based myocardial infarction (MI) registers recorded 4,845 MI events in Turku during 1988-1998. Individual-level indicators of SES were obtained from Statistics Finland. The population-based FINRISK surveys recorded cardiovascular risk factors and native languages of 10,432 people in 1987, 1997, and 2002. Results. The age-standardized attack rate of MI was lower among the 35-64-year-old Swedish-speaking men than among Finnish-speaking men (rate ratio 0.66; 95% confidence interval 0.47-0.85) and the difference remained significant after adjustment for SES. The Swedish-speaking inhabitants had higher age-, sex-, and SES-adjusted high-density lipoprotein cholesterol, and lower triglycerides, body mass index, and diastolic blood pressure. Conclusion. The Swedish-speaking inhabitants of Turku had lower MI morbidity and coronary mortality than the Finnish-speaking inhabitants. After controlling for SES, these differences remained significant among men, suggesting that other factors, such as differences in the risk factor profiles may also play a role. [ABSTRACT FROM AUTHOR]

The introduction of drug-eluting stents has revolutionized the field of interventional cardiology, since it has reduced the incidence of restenosis by 50-70%. However, recent worrisome data from registries and meta-analyses emphasized higher rates of late and very late stent thrombosis associated with drug-eluting stents. The recently introduced titanium-nitride-oxide-coated stent (Titan-2) has demonstrated an excellent biocompatibility, as reflected by lower rates of platelet aggregation and fibrin deposition, and better endothelialization. Preclinical and clinical trials and registries involving both real-life unselected populations and populations with the most challenging patient and lesion characteristics have shown a low rate of major adverse cardiac events in the long-term, with a restenosis rate comparable with that of drug-eluting stents, with the virtual absence of stent thrombosis. INSET: Key issues. [ABSTRACT FROM AUTHOR]

Objectives: Atrial fibrillation (AF) is associated with increased mortality. Previous studies have reported conflicting results in temporal trends of mortality after AF diagnosis. We aim to address this disparity by investigating the 1-year mortality and causes of death in Finnish patients diagnosed with AF between 2010 and 2017., Design: The Finnish AntiCoagulation in Atrial Fibrillation (FinACAF) study is a nationwide retrospective register-based cohort study., Setting: The FinACAF study has gathered information on all Finnish AF patients between 2004 and 2018, with information from all national healthcare registers and data from all levels of care (primary, secondary and tertiary care)., Participants: We included patients with an incident AF diagnosis (International Classification of Diseases, 10th Revision code I48) between 2010 and 2017. To ensure a cohort of only incident AF, we excluded patients who used any oral anticoagulant during the year before cohort entry as well as patients with a recorded use of warfarin between 2004 and 2006. Patients under 20 years of age were excluded, and patients with permanent migration abroad before 1 January 2019 were excluded, N=157 658., Primary Outcome Measures: 1-year all-cause, cardiovascular (CV) and cause-specific mortality following AF diagnosis., Results: The study cohort consisted of 157 658 incident AF cases (50.1% male, mean age 72.9 years). Both all-cause and CV mortality declined from cohort entry years 2010-2017 (from 12.9% to 10.6%, mortality rate ratio (MRR) 0.77; 95% CI 0.73 to 0.82 in cohort entry year 2017 with 2010 as reference; and from 7.4% to 5.2%, MRR 0.68; 95% CI 0.63 to 0.74, respectively). Overall mortality and CV mortality were lower in women than in men throughout the study period (MRR 0.66; 95% CI 0.63 to 0.69 and MRR 0.53; 95% CI 0.50 to 0.56, respectively). Deaths attributable to ischaemic heart disease decreased during the study period (from 30.7% to 21.6%, MRR 0.51; 95% CI 0.49 to 0.62 in 2017 vs 2010), whereas dementia and Alzheimer's disease increased as a cause of death over time (6.2% to 9.9%, MRR 1.19; 95% CI 0.96 to 1.48 in 2017 vs 2010). The CHA 2 DS 2 -VASc score associated strongly with 1-year survival (p<0.0001)., Conclusions: Our study reiterates that mortality after diagnosis of AF has decreased. The CHA 2 DS 2 -VASc score highlights the need to treat comorbidities as it strongly associates with patient 1-year survival after initial AF diagnosis., Competing Interests: Competing interests: EK: none. BS: Speaker: BMS, Boehringer Ingelheim, Pfizer; Advisory board: Pfizer. AA: Research grants: Finnish Foundation for Cardiovascular Research; Speaker: Abbott, Johnson & Johnson, Sanofi, Bayer, Boehringer-Ingelheim. OH: none. KT: The Finnish Foundation for Cardiovascular Research. JHaukka: Consultant: Research Janssen R&D; Speaker: Bayer Finland. JP: Consultant: Boehringer-Ingelheim, Bayer, BMS-Pfizer, Abbott/St. Jude Medical, Vital Signum, Nokia Technologies, Bittium, BcB Medical, Herantis Pharma, Medixine and Portola. Speaker: Boehringer-Ingelheim, Bayer, BMS-Pfizer and Terve Media; Research grants: BMS-Pfizer, Abbott/St. Jude Medical, Business Finland, and Amgen. MLinna: Speaker: BMS-Pfizer-alliance, Bayer, Boehringer-Ingelheim. PM: Consultant: Roche, BMS-Pfizer-alliance, Novartis Finland, Boehringer Ingelheim, MSD Finland. JHartikainen: Research grants: The Finnish Foundation for Cardiovascular Research, Advisory Board Member: BMS-Pfizeralliance, Novo Nordisk, Amgen. Speaker: Cardiome, Bayer. JKEA Research grants: The Finnish Foundation for Cardiovascular Research; Speaker: Bayer, Pfizer and Boehringer-Ingelheim. Member in the advisory boards: Bayer, Pfizer and AstraZeneca. MLehto: Consultant: BMS-Pfizer-alliance, Bayer, Boehringer-Ingelheim and MSD; Speaker: BMS-Pfizer-alliance, Bayer, Boehringer-Ingelheim, MSD, Terve Media and Orion Pharma. Research grants: Aarne Koskelo Foundation, The Finnish Foundation for Cardiovascular Research, and Helsinki and Uusimaa Hospital District research fund., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: This study sought to compare next-generation cobalt-chromium-based titanium-nitride-oxide (TiNO)-coated stents with a platinum-chromium-based biodegradable polymer everolimus-eluting stent (EES) in patients with acute coronary syndrome (ACS)., Background: Previous generation TiNO-coated stents showed acceptable performance in patients with ACS., Methods: In a multicenter, randomized trial, we randomly assigned 1,491 ACS patients (2:1) to receive either a TiNO-coated stent (n = 989) or EES (n = 502). The primary endpoint was the rate of a composite of cardiac death, myocardial infarction (MI), or ischemia-driven target lesion revascularization at 12-month follow-up. The co-primary endpoint was a composite of cardiac death, MI, or major bleeding at 18 months., Results: A primary endpoint event occurred in 6.3% of patients in the TiNO-coated stent group versus in 7.0% in the EES group (hazard ratio: 0.93; 95% confidence interval: 0.71 to 1.22; p = 0.66 for superiority; p < 0.001 for noninferiority). A co-primary endpoint event occurred in 3.7% of the patients in the TiNO group and in 7.8% in the EES group (hazard ratio: 0.64; 95% confidence interval: 0.51 to 0.80; p = 0.001). TiNO-coated stents were associated with lower rates of cardiac death (0.6% vs. 2.6%; p = 0.002) and MI (2.2% vs. 5.0%; p = 0.007) at 18 months of follow-up. Rates of target lesion revascularization were not significantly different at 18 months (5.8% vs. 4.4%; p = 0.27)., Conclusions: In patients with ACS, cobalt-chromium-based TiNO-coated stents were noninferior to platinum-chromium-based biodegradable polymer EES for major cardiac events at 12 months, and were superior for the co-primary endpoint of cardiac death, MI, and bleeding at 18 months. (Comparison of Titanium-Nitride-Oxide-Coated Bio-Active-Stent (Optimax™) to the Drug (Everolimus) -Eluting Stent (Synergy™) in Acute Coronary Syndrome [TIDES-ACS]; NCT02049229)., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: The prognostic impact of cross-clamp time (XCT) in patients undergoing isolated coronary artery bypass grafting (CABG) has not been thoroughly investigated., Material and Methods: 2957 patients who underwent on-pump isolated CABG from the prospective multicentre E-CABG study were the subjects of this analysis., Results: The mean XCT in this series was 58±25minutes Cross-clamp time was >60 minutes in 1134 patients (38.3%), >75minutes in 619 patients (20.9%) and >90minutes in 296 patients (10.0%). Multivariate analysis showed that XCT was an independent predictor of 30-day mortality (p<0.0001, OR 1.027, 95%CI 1.015-1.039) along with age (p<0.0001), female gender (p=0.001), pulmonary disease (p=0.001), poor mobility (p=0.002), urgency status (p=0.007), critical preoperative status (p=0.002) and participating centres (p=0.015). Adjusted risk of 30-day mortality was highest for XCT >75minutes (2.9% vs. 1.7%, p=0.002, OR 3.479, 95%CI 1.609-7.520). Analysis of 428 propensity score matched pairs showed that XCT >75minutes was associated with significantly increased risk of early mortality, prolonged use of inotropes, postoperative use of intra-aortic balloon pump, use of extracorporeal membrane oxygenation, atrial fibrillation, prolonged stay in the intensive care unit and of composite major adverse events., Conclusions: Isolated CABG is currently performed with prolonged XCT in a significant number of patients and this seems to be a determinant of poor early outcome., (Copyright © 2017 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.)

Objective: The aim of this study was to pool data on the proportion and prognostic impact of sources of bleeding in patients requiring re-exploration after adult cardiac surgery., Design: Systematic review of the literature and meta-analysis., Setting: Multistitutional study., Measurements and Main Results: A literature review was performed to identify studies published since 1990 evaluating the outcome after reoperation for bleeding or tamponade after adult cardiac surgery. Eighteen studies including 5,1497 patients fulfilled the selection criteria. Reoperation for bleeding/tamponade was performed in 2,455 patients (4.6%; 95% confidence interval [CI] 3.9%-5.2%, I 2 92%). These had a significantly higher risk of in-hospital/30-day mortality compared with patients not reoperated for bleeding (pooled rates: 9.3% v 2.3%; risk ratio 3.30; 95% CI 2.52-4.32; I 2 47%; 8 studies; 25,463 patients). Surgical sites of bleeding were identified in 65.7% of cases (95% CI 58.3%-73.2%; I 2 94%), cardiac site bleeding in 40.9% of cases (95% CI 29.7%-52.0%; I 2 94%), and mediastinal/sternum site bleeding in 27.0% of cases (95% CI 16.8%-37.3%; I 2 94%). The main sites of bleeding were the body of the graft (20.2%), the sternum (17.0%), vascular sutures (12.5%), the internal mammary artery harvest site (13.0%), and anastomoses (9.9%). In metaregression, surgical site bleeding was associated with a lower risk of in-hospital/30-day mortality compared with diffuse bleeding (p = 0.003)., Conclusions: Surgical site bleeding is identified in two-thirds of patients undergoing re-exploration after adult cardiac surgery. Meticulous surgical technique and systematic intraoperative checking of potential surgical sites of bleeding at the time of the original cardiac surgery may reduce the risk of such a severe complication., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: The MANTA system is a novel vascular closure device (VCD) and its safety and efficacy were compared to the ProGlide VCD in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI)., Methods: This is a retrospective study including 222 patients who underwent transfemoral TAVI at three Finnish University Hospitals. The MANTA VCD was used in 107 patients and their outcome was compared with that of 115 patients in whom the arterial access was closed with the ProGlide VCD., Results: VARC-2 VCD failure occurred less frequently in the MANTA cohort (3.7% vs. 7.8%, p = 0.378), but the difference did not reach statistical significance. When adjusted for the introducer outer diameter, the MANTA cohort had similar rates of VARC-2 major vascular complications (9.3% vs. 12.2%, adjusted: p = 0.456), VARC-2 life-threatening/disabling bleeding (9.3% vs. 6.1%, adjusted: p = 0.296) and need of invasive treatment of bleeding (4.7% vs. 7.0%, adjusted: p = 0.416) compared to the ProGlide cohort. Additional VCDs were more frequently needed in the ProGlide cohort (58.3% vs. 1.9%, p < 0.0001)., Conclusions: In patients undergoing transfemoral TAVI, the MANTA VCD showed a similar risk of VARC-2 vascular and bleeding complications compared to the ProGlide VCD, but it reduced significantly the need of additional VCDs for completion of hemostasis., (Copyright © 2018. Published by Elsevier B.V.)

Objective: This study was planned to pool existing data on outcome and to evaluate the efficacy of postcardiotomy venoarterial extracorporeal membrane oxygenation (VA-ECMO) in adult patients., Design: Systematic review of the literature and meta-analysis., Setting: Multi-institutional study., Participants: Adult patients with acute heart failure immediately after cardiac surgery., Interventions: VA-ECMO after cardiac surgery. Studies evaluating only heart transplant patients were excluded from this analysis., Measurements and Main Results: A literature search was performed to identify studies published since 2000. Thirty-one studies reported on 2,986 patients (mean age, 58.1 years) who required postcardiotomy VA-ECMO. The weaning rate from VA-ECMO was 59.5% and hospital survival was 36.1% (95% CI 31.5-40.8). The pooled rate of reoperation for bleeding was 42.9%, major neurological event 11.3%, lower limb ischemia 10.8%, deep sternal wound infection/mediastinitis 14.7%, and renal replacement therapy 47.1%. The pooled mean number of transfused red blood cell units was 17.7 (95% CI 13.3-22.1). The mean stay in the intensive care unit was 13.3 days (95% CI 10.2-16.4). Survivors were significantly younger (mean, 55.7 v 63.6 years, p = 0.015) and their blood lactate level before starting VA-ECMO was lower (mean, 7.7 v 10.7 mmol/L, p = 0.028) than patients who died. One-year survival rate was 30.9% (95% CI 24.3-37.5)., Conclusions: Pooled data showed that VA-ECMO may salvage one-third of patients unresponsive to any other resuscitative treatment after adult cardiac surgery., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Aims: Non-vitamin K antagonist oral anticoagulants (NOAC) have been shown to be safe and effective alternatives to warfarin for the prevention of thromboembolic complications in patients with non-valvular atrial fibrillation (AF). The aim of this study was to investigate the complications and the use of NOACs in AF patients undergoing elective cardioversion., Methods and Results: This nationwide multicentre study included consecutive elective cardioversions in AF patients treated with NOACs between October 2011 and May 2016. Data on patient characteristics, antithrombotic treatment and acute (<30 days) complications were collected. One thousand twenty-one patients (mean age 64 years, 70% men) underwent 1291 elective cardioversions, of which 680 (52.7%) cardioversions were performed in patients using dabigatran, 431 (33.4%) rivaroxaban, and 159 (12.3%) apixaban. Mean CHA2DS2-VASc score was 1.8 (±1.5). A total of 3 thromboembolic events occurred after the cardioversion (0.2%): 1 patient receiving dabigatran experienced an ischaemic stroke on Day 2 and 1 rivaroxaban treated patient on Day 4. One patient receiving dabigatran experienced a transient ischaemic attack on Day 11. All 3 patients had used recommended doses of the NOAC. A total of 6 (0.5%) clinically relevant, but not serious bleeding events occurred. Only short duration of AF was associated with lower rate of AF recurrence., Conclusion: Thrombotic and bleeding complications related to NOACs were uncommon (<0.5%) in real life AF patients undergoing elective cardioversion.

Stent underexpansion is associated with worse outcome after stent implantation. Whether post-dilation (PD) improves outcome in patients with acute coronary syndrome (ACS) remains unclear. We performed post hoc analysis of outcome in patients from the BASE ACS (A prospective randomized comparison of titanium-nitride-oxide-coated bioactive stents with everolimus-eluting stents in acute coronary syndrome) trial who underwent PD versus those who did not. The BASE ACS trial randomized 827 patients (1:1) with ACS to receive either titanium-nitride-oxide-coated bioactive stents or everolimus-eluting stents. The primary end point was major adverse cardiac events (MACE): a composite of cardiac death, nonfatal myocardial infarction (MI), or ischemia-driven target lesion revascularization. Follow-up was planned at 12 months and yearly thereafter for up to 7 years. Of 827 patients enrolled in the BASE ACS trial, 357 (43.2%) underwent PD. Median follow-up duration was 5 years. Patients who underwent PD had less frequent nonfatal MI events at long-term follow-up, compared with those who did not (4.5% vs 8.5%, respectively, p = 0.02). The rates of MACE (15.7% vs 15.1%, respectively, p = 0.81), and the other endpoints, were not significantly different (p >0.5 for all). The results were consistent in propensity score-matched analysis (270 pairs). In patients treated with bioactive stents, those who underwent PD had a trend for a fewer nonfatal MI events (p = 0.076). Comparably, in patients treated with everolimus-eluting stents, MACE and all the individual end points were comparable (p >0.5 for all). In conclusion, patients treated with early percutaneous coronary intervention for ACS who underwent PD had less frequent nonfatal MI events at long-term follow-up, compared with those who did not; MACE rates were not significantly different., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: The purpose of this retrospective study was to present our assessment of modifiable perioperative factors for major cardiac and cerebrovascular events (MACCE)., Methods: This study included an unselected cohort of patients with head and neck cancer (n = 456) treated in Turku University Hospital between 1999 and 2008., Results: Perioperative and postoperative univariate predictors of MACCE at 30-day follow-up were: total amount of fluids (during 24 hours) over 4000 mL, any red blood cell (RBC) infusion, treatment in the intensive care unit (ICU), tracheostomy, and microvascular reconstruction surgery. Median time from operation to MACCE was 3 days. Patients receiving >4000 mL of fluids had MACCE more often compared with those receiving <4000 mL (10.8% vs 2.4%; p < .001, respectively). Moreover, every RBC unit transfused or every liter of fluid administered over 4000 mL/24h increased the risk of MACCE 18% per unit/liter, respectively., Conclusion: Patients with head and neck cancer receiving excessive intravenous fluid administration perioperatively and postoperatively are at high risk for cardiac complications, especially heart failure. © 2016 Wiley Periodicals, Inc. Head Neck 39: 37-41, 2017., (© 2016 Wiley Periodicals, Inc.)

Afferent renal sympathetic nerve signaling regulates central sympathetic outflow. In this regard, renal sympathetic denervation has emerged as a novel interventional strategy for treatment of patients with resistant hypertension. Despite the disappointing results of the Simplicity HTN-3 randomized controlled trial, promoters of renal denervation argue that the negative results were due to ineffective denervation technique and poor patient selection. Yet, long-term "pathologic" increase of efferent sympathetic nerve activity is observed in many chronic disease states characterized by sympathetic overactivity, such as arrhythmia, heart failure, insulin resistance, and chronic kidney disease. In this review, we highlight the contemporary evidence on the safety/efficacy of renal denervation in the treatment of patients with atrial fibrillation., (Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: The BASE ACS randomized trial demonstrated non-inferiority of titanium-nitride-oxide-coated bioactive stents (BAS), compared with everolimus-eluting stents (EES), for the primary endpoint of major adverse cardiac events (MACE) in patients presenting with acute coronary syndrome (ACS) at 12-month follow-up. We report the final long-term clinical outcome of the trial., Methods: We randomly assigned 827 patients with ACS to receive either BAS (417) or EES (410). The primary endpoint was MACE: a composite of cardiac death, non-fatal myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR) at 12-month follow-up. Analysis was performed by intention to treat. Follow-up was planned at 12months, and yearly thereafter through 7years., Results: Mean follow-up duration was 4.2±1.9years (median 5.0years). At 5-year follow-up, BAS was non-inferior to EES for the primary endpoint of MACE (14.4% versus 17.8%, respectively; hazard ratio for BAS versus EES, 0.82; 95% confidence interval, 0.58-1.16; p=0.26 for superiority; p<0.001 for non-inferiority). The rate of non-fatal MI was lower in the BAS group (5.9% versus 9.7%, respectively, p=0.028). The rates of cardiac death and ischemia-driven TLR were comparable (2.8% versus 3.8%, and 8.3% versus 9.9%; p=0.76 and p=0.58, respectively)., Conclusions: In the current final report of the randomized BASE ACS trial in patients with ACS, BAS implantation was associated with a rate of cumulative MACE at long-term follow-up that was statistically non-inferior to EES., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: The BASE ACS trial demonstrated an outcome of titanium-nitride-oxide-coated bioactive stents (BAS) that was non-inferior to everolimus-eluting stents (EES) in patients with acute coronary syndrome (ACS). We performed a post-hoc analysis of diabetic versus non-diabetic patients from the trial., Methods: We randomised 827 patients (1:1) with ACS to receive either BAS or EES. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction (MI) or ischaemia-driven target lesion revascularisation (TLR). Follow-up was planned yearly through 7 years., Results: Of 827 patients, 140 (16.9%) were diabetic; of these, 36 (25.7%) were insulin-treated. Mean follow-up duration was 4.2 ± 1.9 years. MACE was more frequent in diabetics versus non-diabetics (23.6% versus 13.7%, respectively, p = 0.003), mainly driven by more frequent cardiac death (7.9% versus 2.2%, respectively, p = 0.002). The rates of non-fatal MI, ischaemia-driven TLR were comparable (p > 0.05 for all). In diabetic patients, MACE was comparable between the two stent arms (18.5% versus 28.0%, for BAS versus EES, respectively, p = 0.18)., Conclusions: Diabetic patients treated with early percutaneous coronary intervention for ACS had worse long-term outcome, compared with non-diabetics, mainly driven by more frequent cardiac death. The long-term outcome of BAS was comparable to EES in diabetics. Key Messages Diabetic patients presenting with acute coronary syndrome who were treated with early percutaneous coronary intervention had worse long-term clinical outcome, compared with non-diabetics, mainly driven by a high incidence of cardiac death. Age independently predicted both major adverse cardiac events and cardiac death in diabetic patients. The long-term clinical outcome of titanium-nitride-oxide-coated bioactive stents was comparable to that of everolimus-eluting stents in the diabetic, as well as in the non-diabetic subgroup.