One month after the implantation of biodegradable-polymer sirolimus-eluting coronary stents, patients at high bleeding risk were randomly assigned to stop dual antiplatelet therapy or to continue it ...for at least 2 additional months. At 1 year, 1 month of DAPT was noninferior to the longer treatment for ischemic cardiovascular events and was superior for bleeding.
The optimal duration of antiplatelet therapy in high–bleeding risk (HBR) patients with coronary artery disease treated with newer-generation drug-eluting bioresorbable polymer-coated stents remains ...unclear.
MASTER DAPT (clinicaltrial.govNCT03023020) is an investigator-initiated, open-label, multicenter, randomized controlled trial comparing an abbreviated versus a standard duration of antiplatelet therapy after bioresorbable polymer-coated Ultimaster (TANSEI) sirolimus-eluting stent implantation in approximately 4,300 HBR patients recruited from ≥100 interventional cardiology centers globally. After a mandatory 30-day dual-antiplatelet therapy (DAPT) run-in phase, patients are randomized to (a) a single antiplatelet regimen until study completion or up to 5 months in patients with clinically indicated oral anticoagulation (experimental 1-month DAPT group) or (b) continue DAPT for at least 5 months in patients without or 2 in patients with concomitant indication to oral anticoagulation, followed by a single antiplatelet regimen (standard antiplatelet regimen). With a final sample size of 4,300 patients, this study is powered to assess the noninferiority of the abbreviated antiplatelet regimen with respect to the net adverse clinical and major adverse cardiac and cerebral events composite end points and if satisfied for the superiority of abbreviated as compared to standard antiplatelet therapy duration in terms of major or clinically relevant nonmajor bleeding. Study end points will be adjudicated by a blinded Clinical Events Committee.
The MASTER DAPT study is the first randomized controlled trial aiming at ascertaining the optimal duration of antiplatelet therapy in HBR patients treated with sirolimus-eluting bioresorbable polymer-coated stent implantation.
In patients with multivessel disease and STEMI undergoing primary PCI, fractional flow reserve–guided complete revascularization of non–infarct-related arteries resulted in a lower risk of a ...composite cardiovascular outcome than treatment of the infarct-related artery only.
Patients presenting with acute ST-segment elevation myocardial infarction (STEMI) are best treated with percutaneous coronary intervention (PCI) of the infarct-related coronary artery and the implantation of stents.
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Approximately 50% of these patients have additional, severe stenotic lesions in non–infarct-related coronary arteries.
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The need for a high-quality, evidence-directed treatment strategy for non–infarct-related coronary artery lesions remains.
On the basis of nonrandomized clinical trials, a conservative approach to non–infarct-related coronary artery lesions has been advocated previously.
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Two randomized clinical trials challenged this concept by showing that the preventive use of stents for non–infarct-related coronary artery lesions in the . . .
Although drug-eluting stents are still the default interventional treatment of coronary artery disease, drug-coated balloons (DCBs) represent a novel alternative therapeutic strategy in certain ...anatomic conditions. The effect of DCBs is based on the fast and homogenous transfer of antiproliferative drugs into the vessel wall during single balloon inflation by means of a lipophilic matrix without the use of permanent implants. Although their use is established for in-stent restenosis of both bare-metal and drug-eluting stents, recent randomized clinical data demonstrate a good efficacy and safety profile in de novo small-vessel disease and high bleeding risk. In addition, there are other emerging indications (e.g., bifurcation lesions, large-vessel disease, diabetes mellitus, acute coronary syndromes). Because the interaction among the different delivery balloon designs, doses, formulations, and release kinetics of the drugs used is important, there seems to be no "class effect" of DCBs. On the basis of the amount of recently published data, the International DCB Consensus Group provides this update of previous recommendations summarizing the historical background, technical considerations such as choice of device and implantation technique, possible indications, and future perspectives.
The optimal duration of antiplatelet therapy (APT) in patients at high bleeding risk with or without oral anticoagulation (OAC) after coronary stenting remains unclear.
In the investigator-initiated, ...randomize, open-label MASTER DAPT trial (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen), 4579 patients at high bleeding risk were randomized after 1-month dual APT to abbreviated or nonabbreviated APT strategies. Randomization was stratified by concomitant OAC indication. In this subgroup analysis, we report outcomes of populations with or without an OAC indication. In the population with an OAC indication, patients changed immediately to single APT for 5 months (abbreviated regimen) or continued ≥2 months of dual APT and single APT thereafter (nonabbreviated regimen). Patients without an OAC indication changed to single APT for 11 months (abbreviated regimen) or continued ≥5 months of dual APT and single APT thereafter (nonabbreviated regimen). Coprimary outcomes at 335 days after randomization were net adverse clinical outcomes (composite of all-cause death, myocardial infarction, stroke, and Bleeding Academic Research Consortium 3 or 5 bleeding events); major adverse cardiac and cerebral events (all-cause death, myocardial infarction, and stroke); and type 2, 3, or 5 Bleeding Academic Research Consortium bleeding.
Net adverse clinical outcomes or major adverse cardiac and cerebral events did not differ with abbreviated versus nonabbreviated APT regimens in patients with OAC indication (n=1666; hazard ratio HR, 0.83 95% CI, 0.60-1.15; and HR, 0.88 95% CI, 0.60-1.30, respectively) or without OAC indication (n=2913; HR, 1.01 95% CI, 0.77-1.33; or HR, 1.06 95% CI, 0.79-1.44;
=0.35 and 0.45, respectively). Bleeding Academic Research Consortium 2, 3, or 5 bleeding did not significantly differ in patients with OAC indication (HR, 0.83 95% CI, 0.62-1.12) but was lower with abbreviated APT in patients without OAC indication (HR, 0.55 95% CI, 0.41-0.74;
=0.057). The difference in bleeding in patients without OAC indication was driven mainly by a reduction in Bleeding Academic Research Consortium 2 bleedings (HR, 0.48 95% CI, 0.33-0.69;
=0.021).
Rates of net adverse clinical outcomes and major adverse cardiac and cerebral events did not differ with abbreviated APT in patients with high bleeding risk with or without an OAC indication and resulted in lower bleeding rates in patients without an OAC indication. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03023020.
In line, inflation pressures were significantly lower in the DCB group. ...some of the patients may have almost fulfilled the criteria for a restenosis just at baseline. Plain Angioplasty for ...Drug-eluting Stent Restenosis), hazard ratio for overall mortality was 0.38 (6.0% vs. 15.3%, respectively; p = 0.02) and 0.27 for cardiac mortality (p = 0.03) in favor of DCB versus DES.
BACKGROUNDThe optimal duration of antiplatelet therapy (APT) after coronary stenting in patients at high bleeding risk (HBR) presenting with an acute coronary syndrome remains unclear. OBJECTIVESThe ...objective of this study was to investigate the safety and efficacy of an abbreviated APT regimen after coronary stenting in an HBR population presenting with acute or recent myocardial infarction. METHODSIn the MASTER DAPT trial, 4,579 patients at HBR were randomized after 1 month of dual APT (DAPT) to abbreviated (DAPT stopped and 11 months single APT or 5 months in patients with oral anticoagulants) or nonabbreviated APT (DAPT for minimum 3 months) strategies. Randomization was stratified by acute or recent myocardial infarction at index procedure. Coprimary outcomes at 335 days after randomization were net adverse clinical outcomes events (NACE); major adverse cardiac and cerebral events (MACCE); and type 2, 3, or 5 Bleeding Academic Research Consortium bleeding. RESULTSNACE and MACCE did not differ with abbreviated vs nonabbreviated APT regimens in patients with an acute or recent myocardial infarction (n = 1,780; HR: 0.83; 95% CI: 0.61-1.12 and HR: 0.86; 95% CI: 0.62-1.19, respectively) or without an acute or recent myocardial infarction (n = 2,799; HR: 1.03; 95% CI: 0.77-1.38 and HR: 1.13; 95% CI: 0.80-1.59; Pinteraction = 0.31 and 0.25, respectively). Bleeding Academic Research Consortium 2, 3, or 5 bleeding was significantly reduced in patients with or without an acute or recent myocardial infarction (HR: 0.65; 95% CI: 0.46-0.91 and HR: 0.71; 95% CI: 0.54-0.92; Pinteraction = 0.72) with abbreviated APT. CONCLUSIONSA 1-month DAPT strategy in patients with HBR presenting with an acute or recent myocardial infarction results in similar NACE and MACCE rates and reduces bleedings compared with a nonabbreviated DAPT strategy. (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen MASTER DAPT; NCT03023020).
Objective
To estimate the net effect of living in a gentrified neighborhood on probability of having serious psychological distress.
Data Sources
We pooled 5 years of secondary data from the ...California Health Interview Survey (2011‐2015) and focused on southern California residents.
Study Design
We compared adults (n = 43 815) living in low‐income and gentrified, low‐income and not gentrified, middle‐ to high‐income and upscaled, and middle‐ to high‐income and not upscaled neighborhoods. We performed a probit regression to test whether living in a gentrified neighborhood increased residents' probabilities of having serious psychological distress in the past year and stratified analyses by neighborhood tenure, homeownership status, and low‐income status. Instrumental variables estimation and propensity scores were applied to reduce bias arising from residential selection and simultaneity. An endogenous treatment effects model was also applied in sensitivity analyses.
Data Collection/Extraction Methods
Adults who completed the survey on their own and lived in urban neighborhoods with 500 or more residents were selected for analyses. Survey respondents who scored 13 and above on the Kessler 6 were categorized as having serious psychological distress in the past year. We used eight neighborhood change measures to classify respondents' neighborhoods.
Principal Findings
Living in a gentrified and upscaled neighborhood was associated with increased likelihood of serious psychological distress relative to living in a low‐income and not gentrified neighborhood. The average treatment effect was 0.0141 (standard error = 0.007), which indicates that the prevalence of serious psychological distress would have been 1.4 percentage points less if none of the respondents lived in gentrified neighborhoods. Gentrification appears to have a negative impact on the mental health of renters, low‐income residents, and long‐term residents. This effect was not observed among homeowners, higher‐income residents, and recent residents.
Conclusions
Gentrification levies mental health costs on financially vulnerable community members and can worsen mental health inequities.
Coronary artery perforation during percutaneous coronary intervention (PCI) is a rare but severe complication which has been associated with a high rate of major adverse outcomes and is potentially ...fatal. We report a case of a 70‐year‐old male who presented with an anterior ST‐elevation myocardial infarction. Coronary angiogram revealed a proximal left anterior descending (LAD) artery occlusion. Successful PCI was performed with stenting of the LAD. However, subsequent attempts to retrieve a jailed diagonal branch inadvertently led to distal coronary perforation of the LAD. After failed attempts to tamponade the perforation with prolonged balloon inflation, this was successfully sealed with the MicroVascular Plug (Medtronic) system. To our knowledge, this is the first reported case of such an application in the coronary system. This may prove to be a viable alternative in closure of distal coronary perforations.
This article reports the outcome of a project to develop and assess a predictive model of vulnerability indicators for COVID-19 infection in Los Angeles County. Multiple data sources were used to ...construct four indicators for zip code tabulation areas: (1) pre-existing health condition, (2) barriers to accessing health care, (3) built environment risk, and (4) the CDC's social vulnerability. The assessment of the indicators finds that the most vulnerable neighborhoods are characterized by significant clustering of racial minorities. An overwhelming 73% of Blacks reside in the neighborhoods with the two highest levels of pre-existing health conditions. For the barriers to accessing health care indicator, 40% of Latinx reside in the highest vulnerability places. The built environment indicator finds that selected Asian ethnic groups (63%), Latinx (55%), and Blacks (53%) reside in the neighborhoods designated as high or the highest vulnerability. The social vulnerability indicator finds 42% of Blacks and Latinx and 38% of selected Asian ethnic group residing in neighborhoods of high vulnerability. The vulnerability indicators can be adopted nationally to respond to COVID-19. The metrics can be utilized in data-driven decision making of re-openings or resource distribution such as testing, vaccine distribution and other pandemic-related resources to ensure equity for the most vulnerable.
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