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Background: Women have a worse prognosis after ST-segment elevation myocardial infarction (STEMI) than men. The prognostic role of thrombus burden (TB) in influencing the sex-related differences in clinical outcomes after STEMI has not been clearly investigated. Objectives: The aim of this study was to assess the sex-related differences in TB and its clinical implications in patients with STEMI. Methods: Individual patient data from the 3 major randomized clinical trials of manual thrombus aspiration were analyzed, encompassing a total of 19,047 patients with STEMI, of whom 13,885 (76.1%) were men and 4,371 (23.9%) were women. The primary outcome of interest was 1-year cardiovascular (CV) death. The secondary outcomes of interest were recurrent myocardial infarction, heart failure, all-cause mortality, stroke, stent thrombosis (ST), and target vessel revascularization at 1 year. Results: Patients with high TB (HTB) had worse 1-year outcomes compared with those presenting with low TB (adjusted HR for CV death: 1.52; 95% CI: 1.10-2.12; P = 0.01). In unadjusted analyses, female sex was associated with an increased risk for 1-year CV death regardless of TB. After adjustment, the risk for 1-year CV death was higher only in women with HTB (HR: 1.23; 95% CI: 1.18-1.28; P < 0.001), who also had an increased risk for all-cause death and ST than men. Conclusions: In patients with STEMI, angiographic evidence of HTB negatively affected prognosis. Among patients with HTB, women had an excess risk for ST, CV, and all-cause mortality than men. Further investigations are warranted to better understand the pathophysiological mechanisms leading to excess mortality in women with STEMI and HTB.

Diabetes mellitus (DM) is an important predictor of neointimal hyperplasia (NIH) and adverse clinical outcomes after percutaneous coronary intervention (PCI). LABR-312, a novel intravenous formulation of liposomal alendronate, has been shown in animal models to decrease NIH at vascular injury sites and around stent struts. The aim of the Biorest Liposomal Alendronate Administration for Diabetic Patients Undergoing Drug-Eluting Stent Percutaneous Coronary Intervention trial was to assess the safety, effectiveness, and dose response of LABR-312 administered intravenously at the time of PCI withDES in reducing NIH as measured by optical coherence tomography postprocedure in patients with DM.Patients with DM were randomized to a bolus infusion of LABR-312 vs placebo at the time of PCI. Dose escalation of LABR-312 in the study arm was given: 0.01 mg, 0.03 mg, and 0.08 mg. The primary endpoint was the in-stent %NIH volume at 9 months as measured by optical coherence tomography.From September 2016 to December 2017, 271 patients with DM undergoing PCI were enrolled; 136 patients were randomized to LABR-312 infusion and 135 patients were randomized to placebo. At 9-month follow-up, no difference was seen in the primary endpoint of %NIH between LABR-312 and placebo (13.3% ± 9.2 vs 14.6% ± 8.5, P = .35). No differences were present with the varying LABR-312 doses. Clinical outcomes at 9 months were similar between groups.Among patients with DM undergoing PCI with drug-eluting stents, a bolus of LABR-312 injected systematically at the time of intervention did not result in a lower rate in-stent %NIH volume at 9-month follow-up.

BACKGROUND: Early cardiac allograft vasculopathy (CAV) prognostication is needed to improve long-term outcomes after heart transplantation. We characterized first year posttransplant coronary anatomic-physiologic alterations to determine predictors of early CAV progression. METHODS: Heart transplant recipients at 2 institutions (enrolled January 2018 to March 2021) underwent prospective evaluation 3 and 12-month posttransplant with angiography and left anterior descending artery intravascular ultrasound, optical coherence tomography, fractional flow reserve, coronary flow reserve, and index of microcirculatory resistance measurements. CAV progression was assessed by intravascular ultrasound change in percentage intimal volume from baseline to 12-month follow-up. RESULTS: Eighty-two patients (mean age, 51 years; 60% men) completed evaluation at mean 13.8 and 56.3 weeks posttransplant. Donor atherosclerosis (baseline intravascular ultrasound maximal intimal thickness, ≥0.5 mm) was evident in 50%. De novo (follow-up maximal intimal thickness, ≥0.5 mm) and rapidly progressive CAV (maximal intimal thickness, ≥0.5-mm increase from baseline) developed in 24% and 13%, respectively. On optical coherence tomography, baseline to follow-up median intimal volume increased 42% (0.58 mm 3 /mm), percentage intimal volume increased 44% (4.6%), vessel volume decreased 4% (−0.50 mm 3 /mm) and lumen volume decreased 9% (−1.02 mm 3 /mm); P CONCLUSIONS: Fibrotic plaque on optical coherence tomography and index of microcirculatory resistance early posttransplant predict CAV progression in the first year of transplantation. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03217786.

The evidence for use of dual antiplatelet therapy (DAPT) for patients undergoing percutaneous coronary intervention (PCI) in the elective setting is relatively sparse and is based on data from more than two decades ago. We will review the evidence supporting the use of DAPT with focus on stable patients undergoing elective PCI, including the role of potent PClopidogrel is the recommended P

Accumulating evidence from clinical trials suggests that a lower (restrictive) hemoglobin threshold (8% g/dL) for red blood cell (RBC) transfusion, compared with a higher (liberal) threshold (≥10 g/dL) is safe. However, in anemic patients with acute myocardial infarction (MI), maintaining a higher hemoglobin level may increase oxygen delivery to vulnerable myocardium resulting in improved clinical outcomes. Conversely, RBC transfusion may result in increased blood viscosity, vascular inflammation, and reduction in available nitric oxide resulting in worse clinical outcomes. We hypothesize that a liberal transfusion strategy would improve clinical outcomes as compared to a more restrictive strategy.We will enroll 3500 patients with acute MI (type 1, 2, 4b or 4c) as defined by the Third Universal Definition of MI and a hemoglobin10 g/dL at 144 centers in the United States, Canada, France, Brazil, New Zealand, and Australia. We randomly assign trial participants to a liberal or restrictive transfusion strategy. Participants assigned to the liberal strategy receive transfusion of RBCs sufficient to raise their hemoglobin to at least 10 g/dL. Participants assigned to the restrictive strategy are permitted to receive transfusion of RBCs if the hemoglobin falls below 8 g/dL or for persistent angina despite medical therapy. We will contact each participant at 30 days to assess clinical outcomes and at 180 days to ascertain vital status. The primary endpoint is a composite of all-cause death or recurrent MI through 30 days following randomization. Secondary endpoints include all-cause mortality at 30 days, recurrent adjudicated MI, and the composite outcome of all-cause mortality, nonfatal recurrent MI, ischemia driven unscheduled coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting), or readmission to the hospital for ischemic cardiac diagnosis within 30 days. The trial will assess multiple tertiary endpoints.The MINT trial will inform RBC transfusion practice in patients with acute MI.

Background: It is unclear whether more effective forms of thrombus removal than current aspiration catheters would lead to improved outcomes. We sought to evaluate the prognostic role of residual thrombus burden (rTB), after manual thrombectomy, in patients undergoing primary percutaneous coronary intervention with routine manual thrombectomy in the TOTAL trial (Thrombectomy Versus PCI Alone). Methods: This is a single-arm analysis of patients from the TOTAL trial who underwent routine manual aspiration thrombectomy. The rTB was quantified by an angiographic core laboratory using the Thrombolysis in Myocardial Infarction criteria and validated using existing optical coherent tomography data. Large rTB was defined as grade ≥3. The primary outcome was death from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or new or worsening heart failure within 180 days. Results: Of 5033 patients randomized to routine thrombectomy, 2869 patients had quantifiable rTB (1014 [35%] had large rTB). Patients with large rTB were more likely to have hypertension, previous percutaneous coronary intervention, myocardial infarction, or Killip class III on presentation but less likely to have Killip class I. The primary outcome occurred more frequently in patients with large rTB, even after adjustment for known risk predictors (8.6% versus 4.6%; adjusted hazard ratio, 1.83 [95% CI, 1.34–2.48]). These patients also had a higher risk of cardiovascular death (adjusted hazard ratio, 1.83 [95% CI, 1.13–2.95]), cardiogenic shock (adjusted hazard ratio, 2.02 [95% CI, 1.08–3.76]), and heart failure (adjusted hazard ratio, 1.74 [95% CI, 1.02–2.96]) but not myocardial infarction or stroke. Conclusions: Large rTB is a common finding in primary percutaneous coronary intervention and is associated with increased risk of adverse cardiovascular outcomes, including cardiovascular death. Future technologies offering better thrombus removal than current devices may decrease or even eliminate the risk associated with rTB. This, potentially, can turn into a strategic option to be studied in clinical trials. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01149044.

Background: Defining the optimal conduction of percutaneous-coronary-intervention (PCI) to treat bifurcation lesions has been the subject of many clinical studies showing that the applied stenting technique may influence clinical outcome. Accordingly, bifurcation stenting classifications and technical sequences should be standardized to allow proper reporting and comparison. Methods: The European Bifurcation Club (EBC) is a multidisciplinary group dedicated to optimize the treatment of bifurcations and previously created a classification of bifurcation stenting techniques that is based on the first stent implantation site. Since some techniques have been abandoned, others have been refined and dedicated devices became available, EBC promoted an international task force aimed at updating the classification of bifurcation stenting techniques as well as at highlighting the best practices for most popular techniques. Original descriptive images obtained by drawings, bench tests and micro-computed-tomographic reconstructions have been created in order to serve as tutorials in both procedure reporting and clinical practice. Results: An updated Main-Across-Distal-Side (MADS)-2, classification of bifurcation stenting techniques has been realized and is reported in the present article allowing standardized procedure reporting in both clinical practice and scientific studies. The EBC-promoted task force deeply discussed, agreed on and described (using original drawings and bench tests) the optimal steps for the following major bifurcation stenting techniques: (a) 1-stent techniques (“provisional” and “inverted provisional”) and (b) 2-stent techniques (“T/TAP,” “culotte,” and “DK-crush”). Conclusions: The present EBC-promoted paper is intended to facilitate technique selection, reporting and performance for PCI on bifurcated lesions during daily clinical practice.

There is a paucity of data regarding the safety and efficacy of different antiplatelet regimens according to standardized body mass index (BMI) categories.The aim of this study was to investigate bleeding and ischemic outcomes according to BMI in the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) trial.The TWILIGHT trial randomized high-risk patients to ticagrelor plus aspirin or ticagrelor plus placebo at 3 months after percutaneous coronary intervention. In this secondary analysis, patients were stratified by standard BMI categories, as recommended by the European Society of Cardiology Working Group on Thrombosis (normal weight [BMI 18.5-24.99 kg/mAmong 7,038 patients randomized and with available BMI, 1,807 (25.7%) were normal weight, 2,927 (41.6%) were overweight, and 2,304 (32.7%) were obese. In normal-weight, overweight, and obese patients, ticagrelor monotherapy, compared with ticagrelor plus aspirin, reduced the primary endpoint of Bleeding Academic Research Consortium type 2, 3, or 5 bleeding (normal weight: HR: 0.48 [95% CI: 0.32-0.73]; overweight: HR: 0.57 [95% CI: 0.41-0.78]; obese: HR: 0.63 [95% CI: 0.44-0.91]; P for interaction = 0.627), without any increase in the composite ischemic endpoint of all-cause death, myocardial infarction, or stroke (normal weight: HR: 1.36 [95% CI: 0.84-2.19]; overweight: HR: 0.92 [95% CI: 0.63-1.35]; obese: HR: 0.84 [95% CI: 0.56-1.25]; P for interaction = 0.290). These findings were consistent with the prespecified analysis by median BMI.Among high-risk patients undergoing percutaneous coronary intervention, ticagrelor monotherapy, compared with ticagrelor plus aspirin, reduced bleeding events without any increase in ischemic risk across different BMI categories.

The aim of this study was to evaluate if patients with prior myocardial infarction (MI) could benefit from ticagrelor monotherapy in terms of bleeding reduction without any compromise in ischemic event prevention.Patients with history of MI who undergo percutaneous coronary intervention (PCI) remain at risk for recurrent ischemic events. The optimal antithrombotic strategy for this cohort remains debated.In this prespecified analysis of the randomized TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial, the authors evaluated the impact of history of MI on treatment effect of ticagrelor monotherapy versus ticagrelor plus aspirin in patients undergoing PCI with drug-eluting stent with at least 1 clinical and 1 angiographic high-risk feature and free from adverse events at 3 months after index PCI. The primary endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding, and the key secondary endpoint was the composite of all-cause death, MI, or stroke, both at 12 months after randomization.A total of 1,937 patients (29.7%) with and 4,595 patients (70.3%) without prior MI were randomized to ticagrelor and placebo or ticagrelor and aspirin. At 1 year after randomization, patients with prior MI experienced higher rates of death, MI, or stroke (5.7% vs 3.2%; P 0.001) but similar BARC types 2 to 5 bleeding (5.0% vs 5.5%; P = 0.677) compared with patients without prior MI. Ticagrelor monotherapy consistently reduced the risk for the primary bleeding outcome in patients with (3.4% vs 6.7%; HR: 0.50; 95% CI: 0.33-0.76) and without (4.2% vs 7.0%; HR: 0.58; 95% CI: 0.45-0.76; PTicagrelor monotherapy is associated with significantly lower risk for bleeding events compared with ticagrelor plus aspirin, without any compromise in ischemic prevention, among high-risk patients with history of MI undergoing PCI. (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention [TWILIGHT]; NCT02270242).

BACKGROUND: Prior studies on the use of multivessel percutaneous coronary intervention (MV PCI) for patients with STEMI and multivessel coronary artery disease have yielded heterogeneous results. The recent COMPLETE trial demonstrated that MV PCI was superior to culprit-only PCI among patients with STEMI. It is unclear how these trial results apply to clinical decisions encountered in routine practice. METHODS: We studied STEMI admissions among patients >65 years with multivessel disease and CMS-linked data in the NCDR CathPCI Registry® from 7/1/2009–12/31/2017. MV PCI was defined as PCI to a non-culprit lesion ≤45 days of the index procedure. The primary outcome was the composite of death, myocardial infarction, and revascularization from 45 days through 1 year. To account for unmeasured confounders, an instrumental variable analysis (IVA) was used to compare treatment strategies. The instrument was institutional rates of MV PCI. A falsification endpoint of post-discharge major bleeding was utilized to assess for residual confounding. RESULTS: Of 56,332 admissions from 1,102 institutions, 37.7% received MV PCI ≤45 days of index STEMI PCI. Of those undergoing MV PCI, 74.8% received complete revascularization. In unadjusted analysis, MV PCI was associated with a lower cumulative incidence of the composite outcome between 45 days and 1 year (13.9% vs 18.2% for non-MV PCI, p

Patients with chronic kidney disease (CKD) have an increased risk of obstructive coronary artery disease (CAD), whereas patients with end stage renal disease who are receiving hemodialysis represent a population at particularly high risk of developing cardiac ischemic events. Patients with CKD and acute coronary syndromes should be treated the same way as acute coronary syndromes patients without kidney dysfunction. The benefit of revascularization in patients with advanced kidney failure and CAD is unknown. Observational studies suggest that revascularization might confer a survival benefit compared with medical therapy alone. Little evidence from randomized trials exists regarding the effectiveness of revascularization of patients with CAD with either coronary artery bypass grafting or percutaneous coronary intervention vs medical therapy alone in patients with CKD. The risk of contrast-induced nephropathy is a major concern when percutaneous coronary intervention is performed in patients with CKD. Strict rehydration protocols and techniques to minimize contrast use are paramount to reduce this risk. Finally, in CKD patients who are awaiting kidney transplantation, a noninvasive or invasive CAD screening approach according to the cardiovascular risk profile should be used. Revascularization should be performed in candidates with critical lesions.

Background: The systemic inflammatory response syndrome (SIRS) frequently occurs in patients with cardiogenic shock and may aggravate shock severity and organ failure. We sought to determine the association of SIRS with illness severity and survival across the spectrum of shock severity in cardiac intensive care unit (CICU) patients. Methods: We retrospectively analyzed 8995 unique patients admitted to the Mayo Clinic CICU between 2007 and 2015. Patients with ≥2/4 SIRS criteria based on admission laboratory and vital sign data were considered to have SIRS. Patients were stratified by the 2019 Society for Cardiovascular Angiography and Interventions (SCAI) shock stages using admission data. The association between SIRS and mortality was evaluated across SCAI shock stage using logistic regression and Cox proportional-hazards models for hospital and 1-year mortality, respectively. Results: The study population had a mean age of 67.5±15.2 years, including 37.2% women. SIRS was present in 33.9% of patients upon CICU admission and was more prevalent in advanced SCAI shock stages. Patients with SIRS had higher illness severity, worse shock, and more organ failure, with an increased risk of mortality during hospitalization (16.8% versus 3.8%; adjusted odds ratio, 2.1 [95% CI, 1.7–2.5]; P P P Conclusions: One-third of CICU patients meet clinical criteria for SIRS at the time of admission, and these patients have higher illness severity and worse outcomes across the spectrum of SCAI shock stages. The presence of SIRS identified CICU patients at increased risk of short-term and long-term mortality. Further study is needed to determine whether systemic inflammation truly drives SIRS in this population and whether patients with SIRS respond differently to supportive therapies for shock.

Aims The aim of this study was to determine the effect of ticagrelor monotherapy on clinically relevant bleeding and major ischaemic events in relation to clinical presentation with and without non-ST elevation acute coronary syndromes (NSTE-ACS) among patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Methods and results We conducted a pre-specified subgroup analysis of The Ticagrelor With Aspirin or Alone in High Risk Patients After Coronary Intervention (TWILIGHT) trial, which enrolled 9006 patients with high-risk features undergoing PCI with DES. After 3 months of dual antiplatelet therapy (DAPT) with ticagrelor plus aspirin, 7119 adherent and event-free patients were randomized in a double-blind manner to ticagrelor plus placebo versus ticagrelor plus aspirin for 12 months. The primary outcome was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding while the composite of all-cause death, myocardial infarction (MI), or stroke was the key secondary outcome. Among patients with NSTE-ACS (n = 4614), ticagrelor monotherapy reduced BARC 2, 3, or 5 bleeding by 53% [3.6% vs. 7.6%; hazard ratio (HR) 0.47; 95% confidence interval (CI) 0.36–0.61; P < 0.001) and in stable patients (n = 2503) by 24% (4.8% vs. 6.2%; HR 0.76; 95% CI 0.54–1.06; P = 0.11; nominal P int = 0.03). Rates of all-cause death, MI, or stroke among those with (4.3% vs. 4.4%; HR 0.97; 95% CI 0.74–1.28; P = 0.84) and without (3.1% vs. 3.2%; HR 0.96; 95% CI 0.61–1.49; P = 0.85) NSTE-ACS were similar between treatment arms irrespective of clinical presentation (P int = 0.96). Conclusion Among patients with or without NSTE-ACS who have completed an initial 3-month course of DAPT following PCI with DES, ticagrelor monotherapy reduced clinically meaningful bleeding events without increasing ischaemic risk as compared with ticagrelor plus aspirin. The benefits of ticagrelor monotherapy with respect to bleeding events were more pronounced in patients with NSTE-ACS. Trial registration Clinicaltrials.gov identifier: NCT02270242.

Background Routine thrombus aspiration in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) does not improve clinical outcomes. However, there is remaining uncertainty about the potential benefit in those patients with high thrombus burden, where there is a biological rationale for greater benefit. Objectives The purpose of this study was to evaluate the benefit of thrombus aspiration among STEMI patients with high thrombus burden. Methods TOTAL (ThrOmbecTomy with PCI vs. PCI ALone in patients with STEMI) was a randomized trial of routine manual thrombectomy versus PCI alone in patients with STEMI (n = 10,732). High thrombus burden (Thrombolysis In Myocardial Infarction thrombus grade ≥3) was a pre-specified subgroup. Results The primary outcome of cardiovascular (CV) death, MI, cardiogenic shock, or heart failure was not different at 1 year with thrombus aspiration in patients with high thrombus burden (8.1% vs. 8.3% thrombus aspiration; hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.84 to 1.13) or low thrombus burden (6.0% vs. 5.0% thrombus aspiration; HR: 1.22; 95% CI: 0.73 to 2.05; interaction p = 0.41). However, among patients with high thrombus burden, stroke at 30 days was more frequent with thrombus aspiration (31 [0.7%] thrombus aspiration vs. 16 [0.4%] PCI alone, HR: 1.90; 95% CI: 1.04 to 3.48). In the high thrombus burden group, thrombus aspiration did not significantly improve CV mortality at 30 days (HR: 0.78; 95% CI: 0.61 to 1.01; p = 0.06) and at 1 year (HR: 0.88; 95% CI: 0.72 to 1.09; p = 0.25). Irrespective of treatment assignment, high thrombus burden was an independent predictor of death (HR: 1.78; 95% CI: 1.05 to 3.01). Conclusions In patients with high thrombus burden, routine thrombus aspiration did not improve outcomes at 1 year and was associated with an increased rate of stroke. High thrombus burden is still an important predictor of outcome in STEMI. (A Trial of routine aspiration ThrOmbecTomy with PCI vs. PCI ALone in patients with STEMI [TOTAL]; NCT01149044)

Thrombus aspiration in ST-segment–elevation myocardial infarction has been an area of intense debate among interventional cardiologists. A prior single-center trial (n=1071) observed an unexpected nearly 50% reduction in mortality with routine thrombus aspiration.1 These findings led to the development of the randomized trial of routine aspiration TOTAL (Thrombectomy With PCI Versus PCI Alone in Patients With STEMI; n=10 732).2 During the conduct of the TOTAL trial, thrombus aspiration was recommended by guidelines and was commonly used in clinical practice and believed to improve patient outcomes. In the TOTAL trial, thrombus aspiration did not reduce the primary outcome of cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure at 180 days but was associated with a significant increase in stroke at 30 days. The objective of this research letter is to show the importance of a data monitoring committee (DMC) continuing a trial despite emerging treatment findings. A Cox proportional hazards model was used to compare patients randomized to thrombus aspiration with percutaneous coronary intervention (PCI) and PCI alone. A modified intent-to-treat analysis was prespecified to include only patients who underwent PCI because patients were randomized before angiography. Outcomes presented are at 30 days given that during early analyses data at longer-term follow-up had few patients and were not reliable. The data were compiled from actual DMC reports. The outcomes analyzed for this article include the primary outcome (cardiovascular death, myocardial infarction, cardiogenic shock, or heart failure), death, and stroke. The stopping guidelines for efficacy were exceeding a difference of 4 …

Objectives The aim of this study was to examine the clinical and procedural outcomes of patients undergoing percutaneous coronary intervention (PCI) within 1 year of coronary artery bypass graft surgery (CABG). Background CABG is the preferred revascularization strategy for patients with complex coronary artery disease due to a lower rate of repeat revascularization. Despite advances in surgical technique and medical therapy, >5% of patients require repeat revascularization within 1 year of CABG. Methods and Results Patients who underwent PCI within 1 year of CABG were identified from a prospective registry with data on over 20,000 PCI procedures (April 2000–June 2011). 203 post-CABG patients underwent 228 PCI procedures on 390 lesions during this period. 45% of patients had elective PCI while 55% had PCI on an urgent basis. 81% of PCI was performed in native coronary arteries, usually following graft failure in a previously grafted vessel (60%) or in an ungrafted native vessel (21%). Conclusions Patients who required PCI within 1 year of CABG were more likely to present on an urgent basis and have PCI performed in grafted native coronary vessels. However, nearly third of the patients had PCI to an ungrafted native vessel or to a lesion in the native vessel where the graft was still patent. Further studies are needed to determine whether the use of hybrid revascularization strategies (combination CABG and planned PCI) in appropriate patients could reduce the need for urgent PCI within the first year after CABG. © 2016 Wiley Periodicals, Inc.

In patients with a ST-segment elevation myocardial infarction (STEMI), the prevalence of chronic total occlusion (CTO) in a non–infarct-related artery (non-IRA) is 8% to 15% [(1)][1] with 2-fold greater morbidity and mortality than in those with single-vessel disease (SVD) [(2)][2]. The TOTAL (

Objectives To assess the relationship between preprocedural anticoagulation use and clinical and angiographic outcomes. Background For patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), the optimal timing of anticoagulant administration remains uncertain. Methods Patients enrolled in the TOTAL trial were stratified based on whether or not they had received any parenteral anticoagulant prior to randomization and PCI. Baseline and procedural characteristics were compared. For one-year clinical outcomes, Cox proportional modeling adjusted on a propensity score was used to analyze differences between groups. Angiographic endpoints were analyzed by logistic regression models adjusted for propensity scores. Results In the trial, 10,064 patients were enrolled and underwent PCI. Preprocedural anticoagulation was used in 6,381 patients (63%).The most common anticoagulant was intravenous unfractionated heparin (5,188, 81%). Patients who received preprocedural anticoagulation had higher rates of TIMI-2-3 or TIMI-3 flow and lower grades of thrombus prior to PCI. Pretreatment with anticoagulation was associated with lower use of bailout thrombectomy, GP IIb/IIIa inhibitors, and intra-aortic balloon pump. After adjustment, preprocedural anticoagulation was associated with lower rates of CABG and minor bleeding at 1 year but there were no significant differences in death, stroke, recurrent MI, cardiogenic shock, or congestive heart failure. Conclusions Preprocedural anticoagulation is associated with improved flow and reduced thrombus in the IRA prior to PCI, less bailout thrombectomy during PCI but no difference in death, recurrent infarction, or heart failure at 1 year.

BACKGROUND: Monotherapy with a P2Y12 inhibitor after a minimum period of dual antiplatelet therapy is an emerging approach to reduce the risk of bleeding after percutaneous coronary intervention (PCI). METHODS: In a double-blind trial, we examined the effect of ticagrelor alone as compared with ticagrelor plus aspirin with regard to clinically relevant bleeding among patients who were at high risk for bleeding or an ischemic event and had undergone PCI. After 3 months of treatment with ticagrelor plus aspirin, patients who had not had a major bleeding event or ischemic event continued to take ticagrelor and were randomly assigned to receive aspirin or placebo for 1 year. The primary end point was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. We also evaluated the composite end point of death from any cause, nonfatal myocardial infarction, or nonfatal stroke, using a noninferiority hypothesis with an absolute margin of 1.6 percentage points. RESULTS: We enrolled 9006 patients, and 7119 underwent randomization after 3 months. Between randomization and 1 year, the incidence of the primary end point was 4.0% among patients randomly assigned to receive ticagrelor plus placebo and 7.1% among patients assigned to receive ticagrelor plus aspirin (hazard ratio, 0.56; 95% confidence interval [CI], 0.45 to 0.68; P

Robust comparisons between oral P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) in ST-elevation myocardial infarction (STEMI) patients who undergo primary percutaneous coronary intervention are lacking. We sought to evaluate outcomes on the basis of P2Y12 inhibitor therapy in patients from the Thrombectomy With PCI Versus PCI Alone in Patients With STEMI Undergoing Primary PCI (TOTAL) trial.We grouped 9932 patients according to P2Y12 inhibitor at hospital discharge: clopidogrel (n = 6500; 65.5%), prasugrel (n = 1244; 12.5%), or ticagrelor (n = 2188; 22.0%). The primary composite end point of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or New York Heart Association class IV heart failure was examined at 1 year. Secondary efficacy and safety end points were also assessed. Cox proportional hazard ratios were determined and adjusted for confounders via propensity scoring.Baseline characteristics differing between the 3 groups were mainly age 75 years or older, diabetes, and previous stroke. After adjustment, ticagrelor use was associated with a lower rate of the primary composite outcome compared with clopidogrel (adjusted hazard ratio [aHR], 0.72; 95% confidence interval [CI], 0.57-0.91; P0.02) and prasugrel (aHR, 0.65; 95% CI, 0.48-0.89; P = 0.02). Prasugrel use was not associated with a lower rate of the primary outcome compared with clopidogrel (aHR, 1.09; 95% CI, 0.86-1.39; P 0.99). Neither prasugrel nor ticagrelor were associated with increased risk of stroke compared with clopidogrel. Compared with clopidogrel, ticagrelor was associated with significantly lower rates of major bleeding.In this observational analysis of STEMI patients who underwent primary percutaneous coronary intervention, ticagrelor was associated with improved outcomes compared with clopidogrel and prasugrel. An appropriately powered randomized trial is needed to confirm these findings.

Key Points Question Is thrombus aspiration beneficial for patients who present early with ST-segment elevation myocardial infarction (STEMI)? Findings In this post hoc analysis of a randomized clinical trial, thrombus aspiration was associated with a greater reduction in distal embolization in patients who presented early with STEMI; however, it was not associated with improved clinical outcomes irrespective of time. Total ischemic time and door-to-device time were also important factors associated with mortality among patients with STEMI. Meaning This analysis suggests that thrombus aspiration does not appear to be associated with a benefit irrespective of ischemic time among patients with STEMI., Importance Patients with shorter ischemic times have a greater viable myocardium and may derive greater benefit from thrombus aspiration. Objective To study the association of thrombus aspiration with outcomes among patients presenting with ST-segment elevation myocardial infarction (STEMI) based on time. Design, Setting, and Participants The TOTAL (Thrombectomy With PCI vs PCI Alone in Patients with STEMI) trial was an international randomized clinical trial of 10 732 patients with STEMI undergoing primary percutaneous coronary intervention (PCI) within 12 hours of symptom onset. Patients were recruited between August 5, 2010, and July 25, 2014, and were followed up for 1 year. Data analysis was performed from February 22, 2019, to January 5, 2021. Interventions Thrombus aspiration vs PCI alone. Main Outcomes and Measures Post hoc subgroup analyses were performed for total ischemic time and first medical contact (FMC)–to–device time for the primary outcomes (cardiovascular [CV] mortality, myocardial Infarction [MI], cardiogenic shock, and New York Heart Association class IV heart failure) and angiographically determined distal embolization. In addition, a multivariable analysis was performed to assess the association of total ischemic time and FMC-to-device time with CV mortality at 1 year. Results The study randomized 10 732 patients, and 9986 underwent primary PCI and had time data available (7737 men [77.5%]; mean [SD] age, 61.0 [12.0] years). For the randomized comparison of thrombus aspiration, there was a reduction in angiographic distal embolization with thrombus aspiration that was more pronounced in patients with short ischemic times (6 hours: OR, 0.70 [95% CI, 0.33-1.50]; P = .12 for interaction). However, for the primary composite outcome, there was no benefit based on (1) total ischemic time (6 hours: HR, 0.87 [95% CI, 0.60-1.27]; P = .46 for interaction) or (2) FMC-to-device time (90-120 minutes: HR, 1.19 [95% CI, 0.85-1.67]; >120 minutes: HR, 0.89 [95% CI, 0.70-1.14]; P = .54 for interaction). In a multivariable analysis, both total ischemic time (>2 hours: HR, 1.26 [95% CI, 1.00-1.58) and FMC-to-device time (>120 minutes: HR, 1.45 [95% CI, 1.18-1.79]) were independently associated with CV mortality. Conclusions and Relevance This analysis suggests that thrombus aspiration does not appear to be associated with an improvement in clinical outcomes regardless of ischemic time. In the current STEMI era, both total ischemic time and FMC-to-device times continue to be important factors associated with mortality. Trial Registration ClinicalTrials.gov Identifier: NCT01149044, This post hoc analysis of a randomized clinical trial studies the association of thrombus aspiration with outcomes among patients presenting with ST-segment elevation myocardial infarction based on time.

Background Percutaneous coronary intervention (PCI) procedures are increasingly performed on complex tortuous and heavily calcified coronary lesions. The GuideLiner® catheter (Vascular Solutions, Inc. Minneapolis, MN) is a rapid exchange guide catheter extension system. There is paucity of data about the efficacy of this device in complex PCI. Therefore, we aim to report the indications, success, and efficacy of GuideLiner use in treating complex lesion subset in the present study. Methods We collected data from all patients in whom the GuideLiner was used to facilitate PCI between April 1, 2011 and December 31, 2014 at a tertiary referral center in Toronto, Canada. Demographic and procedural data were obtained from an institutional prospective data registry. Indications for use of the GuideLiner, and angiographic and procedural data specific to the device were also collected. Results The GuideLiner was utilized in 307 (317 lesions) of 6105 PCI procedures performed at our institution during the study period. The mean age was 68.4 ± 11.2 years and 82% were male. The majority of lesions were types B2 or C (98%), calcified (86.3%), with proximal tortuosity (88.6%). The overall technical success rate of the GuideLiner was 88%. The procedural success rate was 98.7%. The complication rate was low (1.6%). Conclusions Use of the GuideLiner catheter facilitated successful completion of PCI procedures in a majority of patients with complex lesions. Operators should be aware of the potential complications associated with GuideLiner use.

BackgroundThe Summary Hospital-level Mortality Indicator (SHMI) for Myocardial Infarction (MI) is the ratio of the observed to the expected number of deaths due to MI. We aimed to assess (1) the accuracy of MI as a diagnosis in the SHMI for MI and (2) the healthcare received by patients with type 1 MI included in the SHMI for MI.MethodsRetrospective review of patients included in SHMI for MI from April 2017 to March 2018. The diagnosis of MI was divided into type 1, type 2 and non-MI. For patients with type 1 MI who underwent intervention, we applied the prognostic Toronto Risk Score (TRS) and classified into group 0: score ResultsSHMI for MI was 96 (41/42.83) falling to 65.4 with the inclusion of only type 1 MI (28 patients, 28/42.83). About 41.5% (n=17) underwent intervention of whom three were in the lowest risk TRS (group 0) and all received appropriate healthcare. Conservative management was appropriate for the 26.8% (n=11) treated medically, the most common reason was severe cognitive dysfunction.ConclusionsWe have demonstrated that SHMI for MI can be inaccurate due to the inclusion of type 2 MI or non-MI. Grouping patients into intervention versus conservative management helps in assessment of healthcare.

Radial access for percutaneous coronary intervention is associated with lower rates of access site complications and bleeding. However, elderly patients have more complex vascular anatomy and radial access may be more challenging in this population. There remains uncertainty regarding the role of radial access in elderly patients undergoing cardiac catheterization.The RIVAL trial randomized patients with acute coronary syndromes undergoing cardiac catheterization to radial versus femoral access. In this analysis, the rates of access site complications and access site cross-over were compared across different age groups. Among the 7,021 patients, 1035 (15%) were ≥75 years of age. Across all age categories, radial access was consistently associated with higher rates of access site cross over and lower rates of major access site complications, with no significant interaction between age and access site. Radial access was associated with lower rates of major vascular access site complications in patients ≥75 years of age (3.6% vs 6.6%; P = .03) and in patients75 years of age (1.0% vs 3.2%; P.001; P value for interaction = .2). The rates of access site crossover were higher with radial access among patients ≥75 (12.5% vs 2.6%; P.001) and75 (6.7% vs 1.9%; P.001; P value for interaction = .9). There were no significant differences in the primary composite outcome (death, myocardial infarction, stroke or non coronary artery bypass graft major bleeding) or its individual components in either age group. In patients ≥75 years of age undergoing primary percutaneous coronary intervention, there was no significant difference in procedure time (120 vs 115 minutes; P = .3).Consistent with the overall RIVAL trial population, elderly patients undergoing cardiac catheterization have lower rates of major bleeding or access site complications and higher rates of access site crossover with radial access compared to femoral access.

Background Diabetes mellitus has worse outcome after percutaneous coronary intervention. Aim We assessed stent thrombosis (ST), major adverse cardiac events (MACE), and major bleeding rates at 1 year after implantation of sirolimus-eluting stents (SES) in patients with diabetes mellitus in a large multicenter registry. Methods From May 2006 to April 2008, 15,147 unselected consecutive patients were enrolled at 320 centers in 56 countries in a prospective, observational registry after implantation of ≥ 1 SES. Source data were verified in 20% randomly chosen patients at > 100 sites. Adverse events were adjudicated by an independent Clinical Event Committee. Results Complete follow-up at 1 year was obtained in 13,693 (92%) patients, 4,577 (30%) of whom were diabetics. Within diabetics, 1,238 (9%) were insulin-treated diabetics (ITD). Diabetics were older (64 vs. 62 years, P

The primary outcome occurred in 347 of 5033 patients (6.9%) in the thrombectomy group versus 351 of 5030 patients (7.0%) in the PCI-alone group (hazard ratio in the thrombectomy group, 0.99; 95% confidence interval [CI], 0.85 to 1.15; P = 0.86). The rates of cardiovascular death (3.1% with thrombectomy vs. 3.5% with PCI alone; hazard ratio, 0.90; 95% CI, 0.73 to 1.12; P = 0.34) and the primary outcome plus stent thrombosis or target-vessel revascularization (9.9% vs. 9.8%; hazard ratio, 1.00; 95% CI, 0.89 to 1.14; P = 0.95) were also similar. Stroke within 30 days occurred in 33 patients (0.7%) in the thrombectomy group versus 16 patients (0.3%) in the PCI-alone group (hazard ratio, 2.06; 95% CI, 1.13 to 3.75; P = 0.02). Conclusions In patients with STEMI who were undergoing primary PCI, routine manual thrombectomy, as compared with PCI alone, did not reduce the risk of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or NYHA class IV heart failure within 180 days but was associated with an increased rate of stroke within 30 days. (Funded by Medtronic and the Canadian Institutes of Health Research; TOTAL ClinicalTrials.gov number, NCT01149044.)

Aims Preliminary studies suggest that direct stenting (DS) during percutaneous coronary intervention (PCI) may reduce microvascular obstruction and improve clinical outcome. Thrombus aspiration may facilitate DS. We assessed the impact of DS on clinical outcome and myocardial reperfusion and its interaction with thrombus aspiration among ST-segment elevation myocardial infarction (STEMI) patients undergoing PCI. Methods and results Patient-level data from the three largest randomized trials on routine manual thrombus aspiration vs. PCI only were merged. A 1:1 propensity matched population was created to compare DS and conventional stenting. Synergy between DS and thrombus aspiration was assessed with interaction P-values in the final models. In the unmatched population (n= 17 329), 32% underwent DS and 68% underwent conventional stenting. Direct stenting rates were higher in patients randomized to thrombus aspiration as compared with PCI only (41% vs. 22%; P < 0.001). Patients undergoing DS required less contrast (162mL vs. 172mL; P< 0.001) and had shorter fluoroscopy time (11.1min vs. 13.3 min; P< 0.001). After propensity matching (n= 10 944), no significant differences were seen between DS and conventional stenting with respect to 30-day cardiovascular death [1.7% vs. 1.9%; hazard ratio 0.88, 95% confidence interval (CI) 0.55-1.41; P=0.60; Pinteraction = 0.96) and 30-day stroke or transient ischaemic attack (0.6% vs. 0.4%; odds ratio 1.02; 95% CI 0.14-7.54; P=0.99; Pinteraction = 0.81). One-year results were similar. No significant differences were seen in electrocardiographic and angiographic myocardial reperfusion measures. Conclusion Direct stenting rates were higher in patients randomized to thrombus aspiration. Clinical outcomes and myocardial reperfusion measures did not differ significantly between DS and conventional stenting and there was no interaction with thrombus aspiration.

Despite widespread use, evidence to support preemptive intraaortic balloon pump (IABP) insertion for patients undergoing high-risk coronary artery bypass graft (CABG) surgery remains sparse, and in need of a well-defined clinical trial. To inform the design of a prospective trial, we sought to review outcomes in randomized controlled trials (RCTs) of anticipatory IABP use vs control in patients undergoing high-risk CABG through meta-analysis. The primary endpoint was all-cause mortality within 30 days of surgery. The secondary endpoint was major adverse cardiac and cerebrovascular event (MACCE), a composite of death, myocardial infarction, stroke, or repeat revascularization.Using Ovid MEDLINE, we systematically reviewed all RCTs comparing preoperative IABP with control in patients undergoing high-risk CABG, defined as: left ventricular ejection fraction (LVEF) ≤40%, left main stenosis ≥70%, unstable angina, recent myocardial infarction, or prior myocardial revascularization undergoing elective or emergent CABG on or off pump.Of 950 articles assessed for eligibility, 10 RCTs of 1261 subjects (mean age, 65.0 years; 21.8% women; mean LVEF, 35%) were included. Mortality was significantly lower in patients receiving IABP compared with control (relative risk [RR], 0.48; 95% confidence interval [CI], 0.30-0.76; P.01). The risk of MACCE was also lower with IABP (RR, 0.67; 95% CI, 0.54-0.84; P.001). No significant differences in major bleeding events (RR, 1.27; 95% CI, 0.44-3.72) or vascular complications (RR, 1.13; 95% CI, 0.42-3.06) were detected.A strategy of routine prophylactic IABP use may reduce short-term mortality and MACCE in high-risk CABG patients. A definitive, adequately powered, prospective, randomized trial is warranted to confirm these results.

The safety and efficacy of drug eluting stents (DES) in the setting of ST elevation myocardial infarction (STEMI) is not well established.In the TOTAL trial, patients presenting with STEMI were randomized to routine thrombectomy versus PCI alone. In this post-hoc analysis, propensity matching was used to assess relative safety and efficacy according to type of stent used.Each propensity-matched cohort included 2313 patients. The composite primary outcome of cardiovascular death, recurrent MI, cardiogenic shock or class IV heart failure within one year was lower in the DES group (HR 0.67; 95% CI 0.54 to 0.84, p=0.0004). Cardiovascular death (HR 0.61; 95% CI 0.43 to 0.86, p=0.005), recurrent MI (HR 0.51; 95% CI 0.35 to 0.75, p=0.0005), target vessel revascularization (HR 0.47; 95% CI 0.36 to 0.62, p0.0001) and stent thrombosis (HR 0.60; 95% CI 0.40 to 0.89, p=0.01) were lower in the DES group. There was no difference in major bleeding between groups.In this observational analysis, the use of DES was associated with improvement in cardiovascular outcomes compared to the use of BMS. These results support the use of DES during primary PCI for STEMI.

Karamasis and colleagues describe their own registry of patients with ST-segment–elevation myocardial infarction undergoing thrombus aspiration in whom they performed serial ECGs and showed worsening in ST-segment elevation in 13.5% of cases after the first wire passage, in 19.7% of cases after thrombus aspiration, and in 12.5% of cases at the end of the procedure. Thus, >50% ST-segment resolution occurred in 15.2% after wire passage, in 21.8% after thrombus aspiration, and in 44.3% at the end of the procedure.1 However, without a control group for comparison, one should be cautious about the interpretation of these results. Thrombus aspiration devices may cause transient reductions in flow after thrombus aspiration, which may be related to disruption of culprit plaque or distal embolization. Although we agree that thrombus aspiration can in some cases “effectively remove thrombus and …

Percutaneous intervention of coronary bifurcation lesions continues to challenge interventional cardiologists. Nonetheless, the past decade has seen an explosion in the development of clinical novel techniques and well-conducted trials validating the relative efficacy and safety of these techniques. For the most part, consensus has emerged regarding the preferred technique, that being provisional stenting of the side-branch (SB), based on the results of several randomised trials that, with the exception of one, have shown no benefit of a two-stent approach, utilising any one of several techniques, including the crush, culotte, or other modifications. Only the double-kiss (DK) crush appears to confer better clinical outcomes, possibly because of the superiority of the technique in optimising access to the SB. Trial data are still pending regarding the efficacy of two-stent techniques in patients with complex SB lesions and with large-calibre SBs. The use of second-generation drug-eluting stents is associated with better results compared to historical data. Preliminary data from studies utilising dedicated bifurcation stents similarly shows favourable results. Bifurcation stenting using bioresorbable vascular scaffolds is at an early stage, with prospective trial data needed to validate this technology for the use in this subset of patients. Modern imaging tools such as intravascular ultrasound and optical coherence tomography, as well as physiological assessment of SB lesions, are now utilised in decision-making regarding stent strategy, though trial data showing better outcomes with routine use of these tools are lacking.

The Occluded Artery Trial (OAT) randomized stable patients (n=2201)24 h (calendar days 3-28) after myocardial infarction (MI) with totally occluded infarct-related arteries (IRA), to percutaneous coronary intervention (PCI) with optimal medical therapy, or optimal medical therapy alone (MED). PCI had no impact on the composite of death, reinfarction, or class IV heart failure over extended follow-up of up to 9 years. We evaluated the impact of early and late reinfarction and definition of MI on subsequent mortality.Reinfarction was adjudicated according to an adaptation of the 2007 universal definition of MI and the OAT definition (≥2 of the following--symptoms, EKG and biomarkers). Cox regression models were used to analyze the effect of post-randomization reinfarction and baseline variables on time to death. After adjustment for baseline characteristics the 169 (PCI: n=95; MED: n=74) patients who developed reinfarction by the universal definition had a 4.15-fold (95% CI 3.03-5.69, p0.001) increased risk of death compared to patients without reinfarction. This risk was similar for both treatment groups (interaction p=0.26) and when MI was defined by the stricter OAT criteria. Reinfarctions occurring within 6 months of randomization had similar impact on mortality as reinfarctions occurring later, and the impact of reinfarction due to the same IRA and a different epicardial vessel was similar.For stable post-MI patients with totally occluded infarct arteries, reinfarction significantly independently increased the risk of death regardless of the initial management strategy (PCI vs. MED), reinfarction definition, location and early or late occurrence.

Radial artery occlusion occurs after transradial cardiac catheterization or percutaneous coronary intervention. Although use of a sheath larger than the artery is a risk factor for radial artery occlusion, radial artery size is not routinely measured. We aimed to identify bedside predictors of radial artery diameter.Using ultrasound, we prospectively measured radial, ulnar, and brachial artery diameters of 130 patients who presented for elective percutaneous coronary intervention or diagnostic angiography. Using prespecified candidate variables we used multivariable linear regression to identify predictors of radial artery diameter.Mean internal diameters of the right radial, ulnar, and brachial arteries were 2.44 ± 0.60, 2.14 ± 0.53, and 4.50 ± 0.88 mm, respectively. Results for the left arm were similar. The right radial artery was larger in men than in women (2.59 vs 1.91 mm; P0.001) and smaller in patients of South Asian descent (2.00 vs 2.52 mm; P0.001). Radial artery diameter correlated with wrist circumference (r(2) = 0.26; P0.001) and shoe size (r(2) = 0.25; P0.001) and weakly correlated with height (r(2) = 0.14; P0.001), weight (r(2) = 0.18; P0.001), body mass index (r(2) = 0.07; P = 0.002), and body surface area (r(2) = 0.22; P0.001). The independent predictors of a larger radial artery were wrist circumference (r(2) = 0.26; P0.001), male sex (r(2) = 0.06; P0.001), and non-South Asian ancestry (r(2) = 0.05; P = 0.006; final model r(2) = 0.37; P0.001). A risk score using these variables predicted radial artery diameter (c-statistic, 0.71).Wrist circumference, male sex, and non-South Asian ancestry are independent predictors of increased radial artery diameter. A risk score using these variables can identify patients with small radial arteries.

Guidelines recommend β-blockers and renin-angiotensin-aldosterone system blockers to improve long-term survival in hemodynamically stable myocardial infarction patients with a reduced left ventricular ejection fraction. The prevalence and outcomes associated with β and renin-angiotensin-aldosterone system blocker therapy in patients with ongoing cardiogenic shock is unknown.Secondary analysis of a randomized controlled trial.In patients with cardiogenic shock lasting more than 24 hours enrolled in Tilarginine Acetate Injection in a Randomized International Study in Unstable Myocardial Infarction Patients With Cardiogenic Shock, we compared 30-day mortality in patients who received β or renin-angiotensin-aldosterone system blockers (angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or aldosterone antagonists) within 24 hours of randomization with those who did not.None.The final study population included 240 patients. A total of 66 patients (27.5%) had either β blocker or renin-angiotensin-aldosterone system blocker administered within the first 24 hours after the diagnosis of cardiogenic shock. β-blockers, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and aldosterone antagonists were prescribed in 18.8%, 10.6%, and 5.0% of patients, respectively.The observed 30-day mortality among patients was higher in patients who received β or renin-angiotensin-aldosterone system blockers prior to cardiogenic shock resolution (27.3% vs 16.9%; adjusted hazard ratio, 2.36; 95% CI, 1.06-5.23; p = 0.035). Compared with patients not given β or renin-angiotensin-aldosterone system blockers, the 30-day mortality was higher among patients treated only with β-blockers (33.3% vs 16.9%, p = 0.017) but not among those only treated with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (18.2% vs 16.9%, p = 1.000).The administration of β or renin-angiotensin-aldosterone system blockers is common in North America and Europe in patients with myocardial infarction and cardiogenic shock prior to cardiogenic shock resolution. This therapeutic practice was independently associated with higher 30-day mortality, although a statistically significant difference was only observed in the subgroup of patients administered β-blockers.

Objectives This study sought to evaluate the feasibility of performing contemporary bifurcation techniques with the Absorb everolimus-eluting bioresorbable vascular scaffold (Abbott Vascular, Santa Clara, California) (BVS). Background The feasibility of using the BVS in bifurcation lesions is unknown. Methods We performed bifurcation stenting procedures including main-vessel stenting with ballooning of the side branch through the BVS struts, T-stenting and crush and culotte procedures, in a synthetic arterial model. Low-pressure final kissing balloon (FKB) inflation was performed to complete the procedures. Results Single-stent procedures optimally opened the side-branch ostium without deforming the main vessel BVS. T-stenting completely covered the side-branch ostium. In crush cases, we could easily re-cross the crushed BVS with the wire and balloon and achieve good results after deployment of the main-vessel BVS and FKB inflation. A 2-BVS culotte resulted in good paving of the main vessel. Disruption of 1 BVS strut was observed after FKB inflation with the 2 balloons inflated beyond the recommended limit of the BVS, as calculated by Finet's law. Conclusions Intervention of bifurcation lesions using the Absorb BVS using modern bifurcation techniques appears feasible in a coronary bifurcation model. Provisional stenting is recommended in the majority, with sequential balloon inflations and FKB inflation only when necessary. T or T-stenting and small protrusion stenting with a metal drug-eluting stent is preferable in case of crossover. A 2-BVS, T-stent technique can be performed in a high-angle bifurcation; otherwise, crush or culotte should be considered, using metal DES in the side branch. Two-BVS crush and culotte require careful evaluation, and should only be considered in patients with large-caliber main vessels.

Objective To study rotational atherectomy (RA) outcomes in patients undergoing high-risk PCI randomized to receive hemodynamic support using either IABP or Impella 2.5 in the PROTECT II trial. Background RA of heavily calcified lesions is often necessary for complex PCI but can be associated with slow-flow, hypotension, and higher risk of periprocedural MI. Methods We compared baseline, angiographic, procedural characteristics, and outcomes of patients treated with and without RA. We examined also RA technique and outcomes. Results RA was used in 52 of 448 patients (32 with Impella vs 20 with IABP, P = 0.08). RA patients were older (72 vs. 67 yo, P = 0.0009), more likely to have prior CABG (48 vs. 32%, P = 0.017), higher STS (8.1 vs. 5.7, P = 0.012) and higher SYNTAX scores (37 vs. 29, P

The aim of this analysis was to analyze outcomes of patients undergoing Xience V EES treatment of bifurcation lesions, a subset in which treatment is particularly challenging. The SPIRIT V Study provided an evaluation of the Xience V everolimus eluting stent (EES) performance in complex patient and lesion population. The SPIRIT V Single Arm Study enrolled 2700 patients with de novo coronary artery lesions suitable to be optimally treated with a maximum of four planned Xience V EES. Lesion evaluation was by visual assessment. The outcomes of the 492 patients undergoing Xience V EES stenting of ≥1 bifurcation lesion were compared to those with no bifurcation lesion treated. Compared to those without bifurcation treatment, patients with bifurcation treatment were more likely to have multi-vessel disease (49% vs 40%), left main treatment (3.1% vs 0.9%), more lesions treated (1.5 vs 1.3), calcification (36.4% vs 27.5%), and ostial (17.1% vs 8.2%) and angulated lesions (29.3% vs 21.1%), all P