ST-elevation myocardial infarction (STEMI) complicated by cardiogenic shock (STEMI-CS) confers high mortality. Although temporary mechanical circulatory support (tMCS) may improve outcomes, previous studies evaluating intra-aortic balloon pump (IABP) and venoarterial extracorporeal oxygenation (VA-ECMO), including IABPII and extracorporeal life support shock (ECLS-Shock), did not reduce mortality.1 The recent Danish-German Cardiogenic Shock (DanGer) trial demonstrated a 12.7% absolute mortality reduction using a microaxial flow pump STEMI networks in Canada, STEMI-CS protocols are STEMI registry, this article aims to provide an estimate of volume and resource needs to enable a framework for integrating a DanGer-like strategy into Canadian centres.
BACKGROUND:Endovascular cooling catheters are used to induce and maintain therapeutic hypothermia. While generally considered safe, complications have been reported, notably catheter-related inferior vena cava (IVC) thrombosis. We sought to determine the frequency and clinical impact of this complication in patients managed with therapeutic hypothermia following out-of-hospital cardiac arrest (OHCA). METHODS:We performed a post hoc analysis of the Effect of Moderate vs Mild Therapeutic Hypothermia on Mortality and Neurologic Outcomes in Comatose Survivors of Out-of-Hospital Cardiac Arrest (CAPITAL-CHILL) trial, which randomized 367 comatose OHCA survivors to mild (34 °C) vs moderate (31 °C) hypothermia using endovascular cooling catheters. Patients were routinely screened for IVC thrombosis using abdominal ultrasonography. Patients with IVC thrombosis were compared with patients without. The primary outcome was death or poor neurological outcome at 180 days. RESULTS:We excluded 48 patients who died before ultrasonography. Amongst the remaining 319, 21 (6.6 %) developed IVC thrombosis. In patients who developed an IVC thrombosis versus those who did not, there was no difference in the primary outcome (47.6 % vs 38.3 %, P = 0.39). In-hospital bleeding was higher in the IVC thrombosis group, but not statistically significant (33.3 % vs 22.8 %, P = 0.24). Patients with IVC thrombosis were more likely to be discharged from hospital on an anticoagulant (76.9 % vs 22.5 %, P < 0.0001). CONCLUSION:Despite intravenous anticoagulation, IVC thrombosis remains a relevant complication of endovascular cooling. Though not associated with death or poor neurological outcomes, it was associated with high in-hospital bleeding rates and anticoagulant use at discharge.
ImportancePerioperative bleeding is a major concern in patients receiving ticagrelor for acute coronary syndromes (ACS) when coronary artery bypass graft (CABG) surgery is required.ObjectiveTo evaluate whether early CABG surgery at 2 to 3 days after ticagrelor cessation is noninferior to waiting 5 to 7 days.Design, Setting, and ParticipantsRAPID CABG was a noninferiority, open-label randomized trial with 6 months of follow-up. Participants were patients with ACS who had received ticagrelor and required CABG. Patients were enrolled in tertiary centers in Canada between January 2016 and March 2021. Data were analyzed from March 2021 to December 2023.InterventionEarly or delayed CABG.Main Outcomes and MeasuresThe primary outcome was based on noninferiority comparison of class 3 or 4 universal definition of perioperative bleeding (UDPB). Noninferiority was prespecified as 8% between groups. Twelve-hour chest tube drainage was reported as a noninferiority comparison. Other bleeding, ischemic, and length-of-stay outcomes were assessed for superiority.ResultsAmong 143 randomized patients, the median (IQR) age was 65 (58-72) years; there were 117 male patients (82%) and 26 female (18%). Of these, 123 patients (86.0%) underwent surgery in the allocated time frame (per protocol). The median (IQR) time to surgery was 3 (2-3) days in the early group and 6 (5-7) days in the delayed group (P < .001). In a per-protocol analysis, severe or massive UDPB occurred in 3 of 65 early-group patients (4.6%) and 3 of 58 patients (5.2%) in the delayed group (between-group difference, −0.6%; 95% CI, −8.3% to 7.1%; P = .03 for noninferiority). Median (IQR) chest tube drainage was 470 (330-650) mL vs 495 (380-610) mL (between-group difference −25 mL; 95% CI, −111.25 to 35; P = .01 for noninferiority). Median (IQR) hospital stay was 9 (7-13) days and 12 (10-15) days for the early and delayed groups (P < .001).Conclusion and RelevanceThis study found that an early surgical strategy, 2 to 3 days after ticagrelor cessation, was noninferior in incurring perioperative bleeding. The data support a reduction in the delay between ticagrelor cessation and CABG surgery and may decrease hospital length of stay.Trial RegistrationClinicalTrials.gov Identifier: NCT02668562
Importance:Perioperative bleeding is a major concern in patients receiving ticagrelor for acute coronary syndromes (ACS) when coronary artery bypass graft (CABG) surgery is required. Objective:To evaluate whether early CABG surgery at 2 to 3 days after ticagrelor cessation is noninferior to waiting 5 to 7 days. Design, Setting, and Participants:RAPID CABG was a noninferiority, open-label randomized trial with 6 months of follow-up. Participants were patients with ACS who had received ticagrelor and required CABG. Patients were enrolled in tertiary centers in Canada between January 2016 and March 2021. Data were analyzed from March 2021 to December 2023. Intervention:Early or delayed CABG. Main Outcomes and Measures:The primary outcome was based on noninferiority comparison of class 3 or 4 universal definition of perioperative bleeding (UDPB). Noninferiority was prespecified as 8% between groups. Twelve-hour chest tube drainage was reported as a noninferiority comparison. Other bleeding, ischemic, and length-of-stay outcomes were assessed for superiority. Results:Among 143 randomized patients, the median (IQR) age was 65 (58-72) years; there were 117 male patients (82%) and 26 female (18%). Of these, 123 patients (86.0%) underwent surgery in the allocated time frame (per protocol). The median (IQR) time to surgery was 3 (2-3) days in the early group and 6 (5-7) days in the delayed group (P < .001). In a per-protocol analysis, severe or massive UDPB occurred in 3 of 65 early-group patients (4.6%) and 3 of 58 patients (5.2%) in the delayed group (between-group difference, -0.6%; 95% CI, -8.3% to 7.1%; P = .03 for noninferiority). Median (IQR) chest tube drainage was 470 (330-650) mL vs 495 (380-610) mL (between-group difference -25 mL; 95% CI, -111.25 to 35; P = .01 for noninferiority). Median (IQR) hospital stay was 9 (7-13) days and 12 (10-15) days for the early and delayed groups (P < .001). Conclusion and Relevance:This study found that an early surgical strategy, 2 to 3 days after ticagrelor cessation, was noninferior in incurring perioperative bleeding. The data support a reduction in the delay between ticagrelor cessation and CABG surgery and may decrease hospital length of stay. Trial Registration:ClinicalTrials.gov Identifier: NCT02668562.
Objectives. Presentation with ST -segment -elevation myocardial infarction (STEMI) during off -hours may impact timely reperfusion and clinical outcomes. We investigated the association between off -hours presentation, door -to -balloon time, and in -hospital mortality in patients with STEMI referred for primary percutaneous coronary intervention (PCI). Methods.We included consecutive patients referred for primary PCI at the University of Ottawa Heart Institute between July 2004 and December 2017. The off -hours group included patients presenting on weekends, statutory holidays, or between 18:00 to 07:59 hours on weekdays. The on -hours group included patients presenting between 08:00 and 17:59 hours on weekdays. The primary clinical outcome was the adjusted inhospital mortality. The primary quality -of -care indicator was door -to -balloon time. Results. A total of 5132 patients were included, with 3152 (61.4%) in the off -hours group and 1980 (38.6%) in the on -hours group. The median door -to -balloon time was longer in the off -hours group compared with the on -hours group (102 minutes vs 77 minutes; P<.001), while the median onset -to -door time was similar (P=.40). There was no difference in the rates of in -hospital mortality (3.5% vs 3.0%; P=.32) or in the adjusted mortality (odds ratio, 1.2; 95% confidence interval, 0.8-1.8; P=.44) between off -hours and on -hours groups. However, door -to -balloon time was an independent predictor of in -hospital mortality (P<.01) and off -hours presentation was an independent predictor of longer door -to -balloon time (P<.001), with an excess of 22.1 minutes. Conclusion. Patients treated with primary PCI during off -hours had longer door -to -balloon times. Treatment during off -hours was an independent predictor of longer door -to -balloon time and longer door -to -balloon times were associated with higher mortality.
Aortic valve intervention can take several forms: surgical valve replacement with a stented or stentless bioprosthesis or with a mechanical prosthesis, transcatheter aortic valve implantation (TAVI), and the Ross procedure.1 Mazine A. El-Hamamsy I. Verma S. et al. Ross procedure in adults for cardiologists and cardiac surgeons: JACC State-of-the-Art Review. J Am Coll Cardiol. 2018; 72: 2761-2777 Crossref PubMed Scopus (76) Google Scholar Although the choice of strategy is often straightforward in the elderly and high-risk population, young and low-risk patients with aortic stenosis are challenging to the heart team, namely because of their longer life expectancy, and higher cumulative lifetime risk of valve-related complications.1 Mazine A. El-Hamamsy I. Verma S. et al. Ross procedure in adults for cardiologists and cardiac surgeons: JACC State-of-the-Art Review. J Am Coll Cardiol. 2018; 72: 2761-2777 Crossref PubMed Scopus (76) Google Scholar Herein, we review the currently available options for first and subsequent interventions for managing aortic stenosis in low-risk patients. The Tale of Two Valves: Role of the Ross Procedure for Aortic Stenosis in Young AdultsCanadian Journal of CardiologyVol. 38Issue 9PreviewIn the June 2022 issue of the Canadian Journal of Cardiology, Rahmouni and colleagues reviewed management strategies for aortic stenosis in the low-risk patient.1 We commend the authors for their well-written overview. Although the treatment for aortic valve pathologies in older patients is more straightforward, the ideal treatment in younger low-risk patients remains a subject of debate.2 This subset of patients constitutes a clinical challenge owing to longer life expectancy and higher cumulative lifetime risk of prosthesis-related complications. Full-Text PDF
Importance Comatose survivors of out-of-hospital cardiac arrest experience high rates of death and severe neurologic injury. Current guidelines recommend targeted temperature management at 32 °C to 36 °C for 24 hours. However, small studies suggest a potential benefit of targeting lower body temperatures. Objective To determine whether moderate hypothermia (31 °C), compared with mild hypothermia (34 °C), improves clinical outcomes in comatose survivors of out-of-hospital cardiac arrest. Design, Setting, and Participants Single-center, double-blind, randomized, clinical superiority trial carried out in a tertiary cardiac care center in eastern Ontario, Canada. A total of 389 patients with out-of-hospital cardiac arrest were enrolled between August 4, 2013, and March 20, 2020, with final follow-up on October 15, 2020. Interventions Patients were randomly assigned to temperature management with a target body temperature of 31 °C (n = 193) or 34 °C (n = 196) for a period of 24 hours. Main Outcomes and Measures The primary outcome was all-cause mortality or poor neurologic outcome at 180 days. Neurologic outcome was assessed using the Disability Rating Scale, with poor neurologic outcome defined as a score greater than 5 (range, 0-29, with 29 being the worst outcome [vegetative state]). There were 19 secondary outcomes, including mortality at 180 days and length of stay in the intensive care unit. Results Among 367 patients included in the primary analysis (mean age, 61 years; 69 women [19%]), 366 (99.7%) completed the trial. The primary outcome occurred in 89 of 184 patients (48.4%) in the 31 °C group and in 83 of 183 patients (45.4%) in the 34 °C group (risk difference, 3.0% [95% CI, 7.2%-13.2%]; relative risk, 1.07 [95% CI, 0.86-1.33]; P = .56). Of the 19 secondary outcomes, 18 were not statistically significant. Mortality at 180 days was 43.5% and 41.0% in patients treated with a target temperature of 31 °C and 34 °C, respectively (P = .63). The median length of stay in the intensive care unit was longer in the 31 °C group (10 vs 7 days; P = .004). Among adverse events in the 31 °C group vs the 34 °C group, deep vein thrombosis occurred in 11.4% vs 10.9% and thrombus in the inferior vena cava occurred in 3.8% and 7.7%, respectively. Conclusions and Relevance In comatose survivors of out-of-hospital cardiac arrest, a target temperature of 31 °C did not significantly reduce the rate of death or poor neurologic outcome at 180 days compared with a target temperature of 34 °C. However, the study may have been underpowered to detect a clinically important difference. Trial Registration ClinicalTrials.gov Identifier: NCT02011568.
BACKGROUND In patients with ST-segment elevation myocardial infarction (STEMI), presentation during off-hours may have an impact on clinical outcomes. Research in this area is not only scarce, but also conflicting. This study investigated the relationship between off-hours presentation and in-hospital clinical outcomes in patients presenting with STEMI. METHODS AND RESULTS We included all consecutive STEMI patients referred to the University of Ottawa Heart Institute as part of a primary percutaneous coronary intervention (PCI) strategy between July 2004 and December 2017 inclusive. Patients were included if they had < 24 hrs of ischemic symptoms and >=1mm ST-segment elevation in two contiguous leads on a 12-lead ECG. Patients who received fibrinolysis or required therapeutic hypothermia were excluded. Patients were stratified into two groups based on the time of presentation at the PCI center: Group 1 consisted of patients presenting during on-hours defined as between 08:00 and 17:59 hrs; Group 2 consisted of patients presenting during the off-hours defined as 18:00 and 07:59 hrs, on weekends, or statutory holidays. The primary outcome was defined as in-hospital mortality. We identified 5626 patients meeting the inclusion criteria: 2150 (38%) in the on-hours group, and 3476 (62%) in the off-hours group. At baseline, the two groups were similar except for lower rates of diabetes (17.6% vs. 20.4%, p=0.01) and smokers (38.2% vs. 41.5%, p=0.02) in the on-hours group. The median door-to-balloon time was 77 min (interquartile range [IQR]: 43-116) in the on-hours group and 102 min (IQR: 76-134) in the off-hours group (p < 0.001), while the median onset-to-door times were no different between the two groups; 95 min (IQR: 58-202) vs 99 min (IQR: 59-208; p=0.5). There were no differences in the rates of stent insertion (91% vs. 90%), balloon-alone PCI (2.9% vs. 2.7%), and coronary bypass surgery (2.9% vs. 2.9%). While the rate of initial TIMI-3 flow in the infarct-related artery was lower in the on-hours group (20% vs. 22.8%, p=0.001), there was no difference between groups in post-catheterization TIMI-3 flow rates (91.8% vs. 91%, p=0.1). In-hospital mortality was lower in the on-hours group (3.4% vs. 4.8%, p=0.03). Cardiogenic shock also occurred less often in the on-hours group (4.8% vs. 6.4%, p=0.02); whereas, there was no difference in stroke (1.1% vs 0.9%, p=0.4) or reinfarction (1.6% vs. 2.5%, p=0.7). CONCLUSION Patients who presented for primary PCI during regular hours had significantly lower in-hospital mortality as compared to patients presenting during off-hours. In patients with ST-segment elevation myocardial infarction (STEMI), presentation during off-hours may have an impact on clinical outcomes. Research in this area is not only scarce, but also conflicting. This study investigated the relationship between off-hours presentation and in-hospital clinical outcomes in patients presenting with STEMI. We included all consecutive STEMI patients referred to the University of Ottawa Heart Institute as part of a primary percutaneous coronary intervention (PCI) strategy between July 2004 and December 2017 inclusive. Patients were included if they had < 24 hrs of ischemic symptoms and >=1mm ST-segment elevation in two contiguous leads on a 12-lead ECG. Patients who received fibrinolysis or required therapeutic hypothermia were excluded. Patients were stratified into two groups based on the time of presentation at the PCI center: Group 1 consisted of patients presenting during on-hours defined as between 08:00 and 17:59 hrs; Group 2 consisted of patients presenting during the off-hours defined as 18:00 and 07:59 hrs, on weekends, or statutory holidays. The primary outcome was defined as in-hospital mortality. We identified 5626 patients meeting the inclusion criteria: 2150 (38%) in the on-hours group, and 3476 (62%) in the off-hours group. At baseline, the two groups were similar except for lower rates of diabetes (17.6% vs. 20.4%, p=0.01) and smokers (38.2% vs. 41.5%, p=0.02) in the on-hours group. The median door-to-balloon time was 77 min (interquartile range [IQR]: 43-116) in the on-hours group and 102 min (IQR: 76-134) in the off-hours group (p < 0.001), while the median onset-to-door times were no different between the two groups; 95 min (IQR: 58-202) vs 99 min (IQR: 59-208; p=0.5). There were no differences in the rates of stent insertion (91% vs. 90%), balloon-alone PCI (2.9% vs. 2.7%), and coronary bypass surgery (2.9% vs. 2.9%). While the rate of initial TIMI-3 flow in the infarct-related artery was lower in the on-hours group (20% vs. 22.8%, p=0.001), there was no difference between groups in post-catheterization TIMI-3 flow rates (91.8% vs. 91%, p=0.1). In-hospital mortality was lower in the on-hours group (3.4% vs. 4.8%, p=0.03). Cardiogenic shock also occurred less often in the on-hours group (4.8% vs. 6.4%, p=0.02); whereas, there was no difference in stroke (1.1% vs 0.9%, p=0.4) or reinfarction (1.6% vs. 2.5%, p=0.7). Patients who presented for primary PCI during regular hours had significantly lower in-hospital mortality as compared to patients presenting during off-hours.
The optimal length of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) remains debated. Current guidelines recommend individualized treatment with consideration of risk scores. We sought to evaluate the degree of agreement in treatment recommendations and the ability to predict ischemic and bleeding complications of the PRECISE-DAPT (predicting bleeding complications in patients undergoing stent implantation and subsequent dual antiplatelet therapy) and DAPT scores. Consecutive patients receiving 12 months of DAPT were grouped based on score treatment recommendation at the time of PCI: PRECISE-DAPT prolonged or shortened (PRECISE DAPT <25 vs >= 25) and DAPT prolonged or shortened (DAPT >= 2 vs <2). One-year ischemic and bleeding outcomes were compared for each group. In 451 patients, the PRECISE-DAPT and DAPT score recommendations were concordant in 56.7% of patients (Cohen's kappa for agreement of k = 0.139, 95% confidence interval 0.065 to 0.212). There was no difference in composite major adverse cardiovascular and cerebrovascular events between patients with high versus low PRECISE-DAPT or DAPT scores. In patients with a high PRECISE-DAPT score versus a low score, there was an increased incidence of 1-year all-cause mortality (2.13% vs 0%, p = 0.04) and an increase in bleeding (Bleeding Academic Research Consortium >= 3a: 17.0% vs 2.8%; p <0.001; Bleeding Academic Research Consortium 3b/c and 5: 8.5% vs 1.4%; p = 0.001). There were no differences in rates of mortality or bleeding for patients with high versus low DAPT scores. In conclusion, when applied at the baseline, the PRECISE-DAPT and DAPT scores frequently make discordant DAPT duration recommendations. The PRECISE-DAPT, but not the DAPT score, demonstrated associations with all-cause mortality and bleeding in patients prescribed 12 months of DAPT after PCI. (C) 2021 Elsevier Inc. All rights reserved.
Abstract Background Patients with high bleeding risk characteristics (HBR) presenting with acute coronary syndrome (ACS) pose a clinical challenge to balance risk for recurrent ischemic events versus incurring bleeding with dual antiplatelet therapy. Purpose We seek to determine the incidence and predictors of short and long term ischemic and bleeding outcomes in patients with HBR factors presenting with ACS after percutaneous coronary intervention (PCI). Method Consecutive patients over a 1-year period, who underwent PCI for ACS were categorized as having HBR based on: age ≥75, anemia (hemoglobin<110g/L), thrombocytopenia (platelet<100x109/L), renal failure (eGFR<30umol/L) or concurrent use of oral anticoagulation. Primary outcome was major adverse cardiovascular event (MACE) defined as composite of cardiovascular death, myocardial infarction, and stroke at 1 year. Key secondary outcomes include significant bleeding defined as Bleeding Academic Research Consortium (BARC) type 3 or 5, and net adverse cardiovascular event (NACE), as a composite of MACE and significant bleeding. Results Of 1351 patients presented with ACS, 389 (28.8%) had at least one HBR criteria. At 1 year, patients with HBR, compared to those without, had increased MACE (11.1% vs 4.2%, p<0.001) and cardiovascular death (5.7% vs 1.7%, p<0.001). Patients with HBR had increased significant bleeding (3.6% vs 2.3%, p=0.011) and NACE (14.4% vs 5.4%, p<0.001). Multivariate analysis showed the presence of HBR and prior history of myocardial infarction were predictors for 1-year MACE (OR 2.67, CI [1.62–4.42], p<0.001 and OR 2.18, CI [1.29–3.70], p=0.004, respectively), whereas the use of second-generation antiplatelet agent was not. Increased MACE and NACE were observed in HBR patients beyond 1 month of DAPT. Conclusion Among patients with ACS undergoing PCI, those with HBR had higher risk for both ischemic and bleeding complications. Novel strategies need to be considered for this high-risk group. Current guidelines, recommending 1 year of DAPT for patients with ACS, should be re-evaluated among patients with HBR. Funding Acknowledgement Type of funding sources: None. Kaplan-Meier curve for 1 year MACEKaplan-Meier curve for 1 year death
AIMS:Cardiogenic shock (CS) is a state of low cardiac output resulting in end-organ hypoperfusion. Despite high in-hospital mortality rates, little evidence exists regarding the optimal mean arterial pressure (MAP) target in CS. We therefore evaluated the relationship between achieved MAP and clinical outcomes in patients with CS.METHODS AND RESULTS:We performed a post hoc analysis of the CAPITAL DOREMI trial: a randomized, double-blind trial comparing dobutamine to milrinone in patients with CS. We divided patients into a high MAP group (average MAP ≥ 70 mmHg over the 36 h following randomization), and a low MAP group (average MAP < 70 mmHg). Our primary outcome included in-hospital all-cause mortality, resuscitated cardiac arrest, need for cardiac transplantation or mechanical circulatory support, non-fatal myocardial infarction, transient ischaemic attack or stroke, or initiation of renal replacement therapy. In total, 71 (37.0%) patients achieved an average MAP < 70 mmHg, and 121 (63.0%) achieved an average MAP ≥ 70 mmHg. The primary outcome occurred in 48 (67.6%) patients in the low MAP group and 51 (42.2%) patients in the high MAP group [adjusted relative risk (aRR) 0.70; 95% confidence interval (CI) 0.53-0.92; P = 0.01]. All-cause mortality occurred in 41 (57.8%) and 35 (28.9%) patients in the low and high MAP groups, respectively (aRR 0.56; 95% CI 0.40-0.79; P < 0.01). There were no significant differences in any secondary outcomes between each group.CONCLUSIONS:In patients with CS treated with inotrope therapy, low MAP is associated with worse clinical outcomes. Randomized data evaluating optimal MAP targets in CS is needed to guide medical therapy.
BACKGROUND:De-escalation from potent platelet P2Y12 inhibitors to clopidogrel is common. Despite having a clinical rationale, non-bleeding-related de-escalation when a lateral change between potent agents is an option may put patients at increased ischemic risk. We set out to define the scope of P2Y12 inhibitor de-escalation in a large clinical registry and evaluate the potential impact of non-bleeding-related de-escalation on clinical outcomes.METHODS:: A retrospective cohort study was performed on consecutive patients in the Cardiovascular Percutaneous Intervention Trial (CAPITAL) registry to identify those who underwent a switch in therapy within 1 year of percutaneous coronary intervention. The de-escalations were categorized as bleeding-related or non-bleeding-related. The primary outcome was major adverse cardiovascular events, a composite of death, myocardial infarction, and stroke. Secondary outcomes included individual components of major adverse cardiovascular events and a safety endpoint of thrombolysis in myocardial infarction bleeding.RESULTS:Of 1854 patients, 209 (11.3%) underwent de-escalation: 24.9% of cases were bleeding-related, 37.8% were non-bleeding-related, and 37.3% were for unknown reasons. All patients with non-bleeding-related de-escalation were switched from ticagrelor to clopidogrel. The primary outcome occurred in 14 (6.7%) patients, of which 50% underwent non-bleeding-related de-escalation (P = 0.430). Among those with non-bleeding-related de-escalation, 7.6% were hospitalized for myocardial infarction, compared to 1.9% and 3.8% among those with a bleeding-related and unknown rationale, respectively (P = 0.293).CONCLUSIONS:De-escalation, particularly non-bleeding-related de-escalation, of P2Y12 inhibitors is common. A substantial proportion of such de-escalation may be avoidable. Given the potential risk of ischemic complications, strategies should be considered to encourage both the upfront use of potent P2Y12 inhibitors and alternative strategies to de-escalation.
BACKGROUND:Physician perception of procedural risk and clinical outcome can affect revascularization decision making. Public reporting of percutaneous coronary intervention outcomes accentuates the need for accuracy in risk prediction in order to avoid a treatment paradox of undertreating the highest risk patients. Our study compares a validated risk score to physician prediction (PP) of 1-year mortality based on clinical impression at the time of invasive angiography.METHODS AND RESULTS:We performed a cohort study between August 2015 and May 2018 to determine the discriminative accuracy of interventional cardiologists on one-year mortality of the treated patient. PP of one-year mortality was compared to the New York State Percutaneous Coronary Intervention Reporting System (NYPCIRS) score in predicting mortality. Three thousand seven hundred ninety-two patients were followed with a median follow-up period of 14.4 months (interquartile range 12.4-18.1 months) and 165 patients (4.4%) died within one-year. PP of mortality was associated with one-year mortality with a hazard ratio of 8.78 (95% confidence interval 5.24-14.71, P < 0.0001). Clinical presentation in the form of cardiogenic shock, return of spontaneous circulation, and liver and renal dysfunction were associated with PP. Diagnostic accuracy and specificity were improved in PP compared to NYPCIRS. The combination of PP to NYPCIRS improved the overall c-statistic and diagnostic yield.CONCLUSION:PP appears to be especially specific and accurate for prediction of mortality compared to NYPCIRS though it lacks sensitivity. Furthermore, the combination of PP with NYPCIRS improved the c-statistic and diagnostic yield. Overall, the utility of PP with an objective risk score improves the diagnostic accuracy of mortality prediction.
Background: Transradial access (TRA) has emerged as the preferred vascular access site for coronary angiography and percutaneous coronary intervention. This systematic review and meta-analysis was performed to evaluate 30-day all-cause mortality comparing TRA with transfemoral access for percutaneous coronary intervention in patients with ST-segment–elevation myocardial infarction. Methods: We performed a systematic literature search and meta-analysis of randomized controlled studies published from inception until January 7, 2020, in MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and Web of Science Core Collection. Preferred Reported Items for Systematic Reviews and Meta-Analyses guidelines were used for abstracting data. The primary outcome was all-cause mortality at 30 days. Secondary outcomes included myocardial infarction, major bleeding, stroke, and access site complications. Results: A total of 14 studies representing 11 707 patients (5802 patients with TRA; 5905 patients with transfemoral access) were included in this systematic review. All-cause mortality (N=8 studies) was significantly reduced in the TRA group with an overall risk ratio (RR) of 0.72 (95% CI, 0.56–0.92) in the pooled analysis. Major bleeding (N=12 studies; RR, 0.60 [95% CI, 0.45–0.80]) and access site complications (N=9 studies; RR, 0.40 [95% CI, 0.30–0.53]) were significantly higher in the transfemoral access group. There was no statistical difference in reinfarction (N=10 studies; RR, 0.96 [95% CI, 0.75–1.25]) or stroke (N=8 studies; RR, 1.47 [95% CI, 0.87–2.50]). Conclusions: TRA is associated with lower 30-day mortality, major bleeding, and access site complications when compared with transfemoral access in ST-segment–elevation myocardial infarction patients who undergo percutaneous coronary intervention. Registration: URL: https://www.crd.york.ac.uk/PROSPERO/ ; Unique identifier: 127955.
Background Acute kidney injury (AKI) complicating primary percutaneous coronary intervention (PCI) is an independent predictor of short-and long-term outcomes in patients presenting with ST-elevation myocardial infarction (STEMI). Prior studies suggest a lower incidence of AKI in patients undergoing PCI through radial artery compared to femoral artery access; however, no randomized clinical trials have specifically investigated this question in patients presenting with STEMI. Methods To determine whether radial access (RA) is associated with a reduced frequency of AKI following primary PCI, we performed a substudy of the SAFARI-STEMI trial. The SAFARI-STEMI trial was an open-label, multicenter trial, which randomized patients presenting with STEMI to RA or femoral access (FA), between July 2011 and December 2018. The primary outcome of this post hoc analysis was the incidence of AKI, defined as an absolute ( > 0.5 mg/dL) or relative ( > 25%) increase in serum creatinine from baseline. Results In total 2,285 (99.3%) of the patients enrolled in SAFARI-STEMI were included in the analysis?1,132 RA and 1,153 FA. AKI occurred in 243 (21.5%) RA patients and 226 (19.6%) FA patients (RR: 0.91, 95% CI: 0.78-1.07, P = .27). An absolute increase in serum creatinine > 0.5 mg/dL was seen in 49 (4.3%) radial and 52 (4.5%) femoral patients (RR: 1.04, 95% CI: 0.71-1.53, P = .83). AKI was lower in both groups when the KDIGO definition was applied (RA 11.9% vs FA 10.8%; RR: 0.90, 95% CI: 0.72-1.13, P = .38). Conclusions Among STEMI patients enrolled in the SAFARI-STEMI trial, there was no association between catheterization access site and AKI, irrespective of the definition applied. These results challenge the independent association between catheterization access site and AKI noted in prior investigations. (Am Heart J 2021;234:12?22.)