Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits ...trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention-related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.
Summary Background Elderly patients are at high risk of ischaemic and bleeding events. Platelet function monitoring offers the possibility to individualise antiplatelet therapy to improve the ...therapeutic risk–benefit ratio. We aimed to assess the effect of platelet function monitoring with treatment adjustment in elderly patients stented for an acute coronary syndrome. Methods We did this multicentre, open-label, blinded-endpoint, randomised controlled superiority study at 35 centres in France. Patients aged 75 years or older who had undergone coronary stenting for acute coronary syndrome were randomly assigned (1:1), via a central interactive voice-response system based on a computer-generated permuted-block randomisation schedule with randomly selected block sizes, to receive oral prasugrel 5 mg daily with dose or drug adjustment in case of inadequate response (monitoring group) or oral prasugrel 5 mg daily with no monitoring or treatment adjustment (conventional group). Randomisation was stratified by centre. Platelet function testing was done 14 days after randomisation and repeated 14 days after treatment adjustment in patients in the monitoring group. Study investigators and patients were not masked to treatment allocation, but allocation was concealed from an independent clinical events committee responsible for endpoint adjudication. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, stent thrombosis, urgent revascularisation, and Bleeding Academic Research Consortium-defined bleeding complications (types 2, 3, or 5) at 12 months' follow-up. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT01538446. Findings Between March 27, 2012, and May 19, 2015, we randomly assigned 877 patients to the monitoring group (n=442) or the conventional group (n=435). The primary endpoint occurred in 120 (28%) patients in the monitoring group compared with 123 (28%) patients in the conventional group (hazard ratio HR, 1·003, 95% CI 0·78–1·29; p=0·98). Rates of bleeding events did not differ significantly between groups. Interpretation Platelet function monitoring with treatment adjustment did not improve the clinical outcome of elderly patients treated with coronary stenting for an acute coronary syndrome. Platelet function testing is still being used in many centres and international guidelines still recommend platelet function testing in high-risk situations. Our study does not support this practice or these recommendations. Funding Eli Lilly and Company, Daiichi Sankyo, Stentys, Accriva Diagnostics, Medtronic, and Fondation Coeur et Recherche.
The aim of this study was to evaluate 2 abbreviated dual-antiplatelet therapy (DAPT) regimens in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI).
...Current-generation drug-eluting stents are preferred over bare-metal stents for HBR patients, but their optimal DAPT management remains unknown.
The XIENCE Short DAPT program included 3 prospective, multicenter, single-arm studies enrolling HBR patients who underwent successful PCI with a cobalt-chromium everolimus-eluting stent. After 1 month (XIENCE 28 USA and XIENCE 28 Global) or 3 months (XIENCE 90) of DAPT, event-free patients discontinued the P2Y12 inhibitor. The postmarketing approval XIENCE V USA study was used as historical control in a propensity score–stratified analysis.
A total of 3,652 patients were enrolled. The propensity-adjusted rate of the primary endpoint of all-cause mortality or myocardial infarction was 5.4% among 1,693 patients on 3-month DAPT versus 5.4% in the 12-month DAPT historical control (Pnoninferiority = 0.0063) and 3.5% among 1,392 patients on 1-month DAPT versus 4.3% in the 6-month DAPT historical control (Pnoninferiority = 0.0005). Bleeding Academic Research Consortium (BARC) types 2 to 5 bleeding was not significantly lower with 3- or 1-month DAPT, while BARC types 3 to 5 bleeding was reduced in both experimental groups. The rate of definite or probable stent thrombosis was 0.2% in XIENCE 90 (P < 0.0001 for the performance goal of 1.2%) and 0.3% in XIENCE 28.
Among HBR patients undergoing PCI with cobalt-chromium everolimus-eluting stents, DAPT for 1 or 3 months was noninferior to 6 or 12 months of DAPT for ischemic outcomes and may be associated with less major bleeding and a low incidence of stent thrombosis.
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The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) among patients at high bleeding risk (HBR) is unknown.
The purpose of this analysis was to ...compare 1 vs 3 months of DAPT in HBR patients undergoing drug-eluting stent implantation.
The XIENCE Short DAPT program comprised 3 prospective, multicenter, single-arm studies of HBR patients treated with a short DAPT course followed by aspirin monotherapy after PCI with a cobalt-chromium everolimus-eluting stent. In this exploratory analysis, patients who received 1-month DAPT (XIENCE 28 USA and 28 Global) were compared with those on 3-month DAPT (XIENCE 90) using propensity score stratification. Ischemic and bleeding outcomes were assessed between 1 and 12 months after index PCI.
A total of 3,652 patients were enrolled and 1,392 patients after 1-month DAPT and 1,972 patients after 3-month DAPT were eligible for the analyses. The primary endpoint of all-cause mortality or myocardial infarction was similar between the 2 groups (7.3% vs 7.5%; difference −0.2%; 95% CI: −2.2% to 1.7%; P = 0.41). The key secondary endpoint of BARC (Bleeding Academic Research Consortium) type 2-5 bleeding was lower with 1-month DAPT compared with 3-month DAPT (7.6% vs 10.0%; difference −2.5%; 95% CI: −4.6% to −0.3%; P = 0.012). Major BARC type 3-5 bleeding did not differ at 12 months (3.6% vs 4.7%; difference −1.1%; 95% CI: −2.6% to 0.4%; P = 0.082), but was lower with 1-month DAPT at 90 days (1.0% vs 2.1%; P = 0.015).
Among HBR patients undergoing PCI, 1 month of DAPT, compared with 3 months of DAPT, was associated with similar ischemic outcomes and lower bleeding risk. (XIENCE 90 Study; NCT03218787; XIENCE 28 USA Study; NCT03815175; XIENCE 28 Global Study; NCT03355742)
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Aims
Several invasive techniques are available in clinical practice to assess coronary flow. Nevertheless, the test–retest repeatability of these techniques in a controlled setting has not been ...reported. Therefore, we sought to evaluate fractional flow reserve (FFR), coronary flow reserve (CFR), index of microvascular resistance (IMR), and absolute coronary blood flow (ABF) with absolute microvascular resistance (AMR) test–retest repeatability using a coronary flow simulator.
Methods and Results
Using a coronary flow simulator (FFR WetLab version 2.0; Abbott Vascular, Santa Clara, CA), we created stenoses ranging from 0% to 70%, with 10% increments. Three different flows were established with their hyperemic phases, and two consecutive measurements were obtained, evaluating the following indices: FFR, CFR, IMR, ABF, and AMR, using a pressure/temperature wire and an infusion catheter. One hundred and thirty‐eight pairs of measurements were performed. Test–retest reliability was compared in 48 FFR, 18 CFR, 24 IMR, 24 ABF, and 24 AMR. Test–retest repeatability showed excellent reproducibility for FFR, ABF, and AMR; respectively 0.98 (0.97–0.99), 0.92 (0.81–0.97) and 0.91 (0.79–0.96) (P < 0.0001 for all). However, test–retest repeatability was weaker for IMR and poor for CFR; respectively 0.53 (0.16–0.77) (P = 0.006) and 0.27 (−0.26–0.67) (P = 0.30).
Conclusions
Using a coronary flow simulator, FFR and ABF with AMR had excellent test–retest reliability. IMR and CFR demonstrated weaker test–retest reliability.
Patent foramen ovale (PFO) is causally associated with stroke in some patients younger than 60 years, especially when it is large or associated with an atrial septal aneurysm (ASA). After 60 years of ...age, this association is less well understood. We assessed the relationships between detailed atrial septal anatomy and the cryptogenic nature of stroke in this population.
We reviewed all patients aged 60 to 80 years admitted to our stroke center for ischemic stroke who underwent contrast echocardiography between 2016 and 2021. The atherosclerosis, small-vessel disease, cardiac pathology, other causes, and dissection (ASCOD) classification was used to reevaluate the etiological workup. Associations between cryptogenic stroke and (1) PFO presence or (2) categories of PFO anatomy (nonlarge PFO without ASA, nonlarge PFO with ASA, large PFO without ASA, and large PFO with ASA) were assessed using logistic regression. Among 533 patients (median National Institutes of Health Stroke Scale score=1), PFO was present in 152 (prevalence, 28.5% 95% CI, 24.9-32.5). Compared with noncryptogenic stroke, cryptogenic stroke (n=218) was associated with PFO presence (44.5% versus 17.5%;
<0.0001). Among patients with a PFO, septal anatomy categories were associated with cryptogenic stroke (
=0.02), with a strong association for patients with both large PFO and ASA (38.1% versus 14.5%,
=0.002).
PFO presence remains strongly associated with cryptogenic stroke between 60 and 80 years of age. Large PFO, ASA, and their association were strongly associated with cryptogenic stroke in this age group. Our results support performing contrast echocardiography even after 60 years of age, although the optimal secondary prevention therapy in this population remains to be determined in randomized trials.
Abstract Aim To compare the feasibility, safety and outcome of IMPELLA Recover LP2.5 cardiac assistance and intra aortic balloon pump (IABP) in patients with post-cardiac arrest shock. Background The ...high early mortality rate of post-cardiac arrest patients is attributed to a “post cardiac arrest syndrome” characterized by an acute and transient left ventricular (LV) systolic dysfunction. LV assistance with IMPELLA Recover LP2.5 is proposed in most severe patients. Methods Retrospective single center registry from January 2007 to October 2010. All survivors of out-of-hospital cardiac arrest with patent or predictive factors for the occurrence of post-resuscitation shock assisted by either IMPELLA or intra aortic balloon pump (IABP) device immediately after the coronary angiogram were included. Results 78 post-cardiac arrest patients were assisted by one of the devices (35 by IMPELLA and 43 by IABP). Median “no flow” and median “low flow” were similar at admission as were hemodynamic parameters. The feasibility of IMPELLA implantation was good (97%). At 28 days, the survival rate without sequellae was 23.0% in the IMPELLA and 29.5% in the IABP group ( p = 0.61). Vascular complications were observed equally in both groups (3 vs 2, p = 0.9). Serious bleeding complications occurred in 26% of IMPELLA patients vs 9% of IABP patients ( p = 0.06). Conclusion Early LV assistance by the IMPELLA LP2.5 is feasible in patients with post-resuscitation shock. The rate of complications did not differ substantially in the two groups, except for a trend toward a higher rate of bleeding events with IMPELLA. These encouraging findings must be confirmed in a larger clinical study.
Out-of-hospital cardiac arrest (OHCA) continues to be a major global cause of death, affecting approximately 67 to 170 per 100,000 inhabitants annually in Europe, with a persisting high rate of ...mortality of up to 90% in most countries. Acute coronary syndrome (ACS) represents one of the most significant cause of cardiac arrest, and therefore invasive coronary angiography (CAG) with subsequent percutaneous coronary intervention (PCI) has emerged as a fundamental component in the management of OHCA patients. Recent evidence from large randomized controlled trials (RCTs) challenges the routine use of early CAG in the larger subgroup of patients with non-ST segment elevation myocardial infarction (NSTEMI). Additionally, emerging data suggest that individuals resuscitated from OHCA related to ACS face an elevated risk of thrombotic and bleeding events. Thus, specific invasive coronary strategies and anti-thrombotic therapies tailored to this unique setting of OHCA need to be considered for optimal in-hospital management. We sought to provide an overview of the prevalence and complexity of coronary artery disease observed in this specific population, discuss the rationale and timing for CAG after return of spontaneous circulation (ROSC), summarize invasive coronary strategies, and examine recent findings on antithrombotic therapies in the setting of ACS complicated by OHCA. By synthesizing the existing knowledge, this review aims to contribute to the understanding and optimization of care for OHCA patients to improve outcomes in this challenging clinical scenario.
Objectives The aim of this study was to assess the long-term safety and efficacy of the CYPHER (Cordis, Johnson and Johnson, Bridgewater, New Jersey) sirolimus-eluting coronary stent (SES) in ...percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). Background Concern over the safety of drug-eluting stents implanted during PCI for STEMI remains, and long-term follow-up from randomized trials are necessary. TYPHOON (Trial to assess the use of the cYPHer sirolimus-eluting stent in acute myocardial infarction treated with ballOON angioplasty) randomized 712 patients with STEMI treated by primary PCI to receive either SES (n = 355) or bare-metal stents (BMS) (n = 357). The primary end point, target vessel failure at 1 year, was significantly lower in the SES group than in the BMS group (7.3% vs. 14.3%, p = 0.004) with no increase in adverse events. Methods A 4-year follow-up was performed. Complete data were available in 501 patients (70%), and the survival status is known in 580 patients (81%). Results Freedom from target lesion revascularization (TLR) at 4 years was significantly better in the SES group (92.4% vs. 85.1%; p = 0.002); there were no significant differences in freedom from cardiac death (97.6% and 95.9%; p = 0.37) or freedom from repeat myocardial infarction (94.8% and 95.6%; p = 0.85) between the SES and BMS groups. No difference in definite/probable stent thrombosis was noted at 4 years (SES: 4.4%, BMS: 4.8%, p = 0.83). In the 580 patients with known survival status at 4 years, the all-cause death rate was 5.8% in the SES and 7.0% in the BMS group (p = 0.61). Conclusions In the 70% of patients with complete follow-up at 4 years, SES demonstrated sustained efficacy to reduce TLR with no difference in death, repeat myocardial infarction or stent thrombosis. (The Study to Assess AMI Treated With Balloon Angioplasty TYPHOON; NCT00232830 )
Cardiovascular disease, including ischemic heart disease, is the leading cause of death worldwide, and percutaneous coronary interventions (PCIs) have been demonstrated to improve the prognosis of ...these patients on top of optimal medical therapy. PCIs have evolved from plain old balloon angioplasty to coronary stent implantation at the end of the last century. There has been a constant technical and scientific improvement in stent technology from bare metal stents to the era of drug-eluting stents (DESs) to overcome clinical challenges such as target lesion failure related to in-stent restenosis or stent thrombosis. A better understanding of the underlying mechanisms of these adverse events has led DESs to evolve from first-generation DESs to thinner and ultrathin third-generation DESs with improved polymer biocompatibility that seems to have reached a peak in efficiency. This review aims to provide a brief historical overview of the evolution of coronary DES platforms and an update on clinical studies and major characteristics of the most currently used DESs.
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