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REDUCE trial DAPT

Final results of the randomised evaluation of short-term

  1. Final results of the randomised evaluation of short-term dual antiplatelet therapy in patients with acute coronary syndrome treated with a new-generation stent (REDUCE trial) The results show that, among ACS patients treated with the COMBO stent, three months is non-inferior to 12 months of DAPT
  2. COBRA REDUCE is a global, randomized control trial evaluating ultra-short, 14-day dual antiplatelet therapy (DAPT) in percutaneous coronary intervention (PCI) patients at High Bleeding Risk (HBR).2*. The COBRA PzF NanoCoated Coronary Stent is not currently approved or indicated for high bleeding risk patients with 14-day DAPT
  3. Stenting with the COBRA PzF Stent with short-duration (14 days) dual antiplatelet therapy (DAPT) did not reduce bleeding compared with drug-eluting stents (DES) and standard DAPT (3-6 months) in patients undergoing PCI for acute or chronic coronary syndromes and receiving oral anticoagulation, said researchers presenting the COBRA-REDUCE trial Oct. 17 during TCT 2020

Introduction. Dual antiplatelet therapy (DAPT) of aspirin and P2Y 12 inhibitors has been shown to reduce stent thrombosis after drug-eluting stents (DES). Based on PCI-CURE clinical trial (), a standard DAPT regimen for 12 months was recommended by acute coronary syndrome guidelines (2, 3).With the modification of the antiproliferative drug, the stent polymer and the stent platform in new. The REDUCE trial randomized ACS patients treated with the COMBO Dual Stent Therapy to either 3 or 12 months of DAPT. We currently perform a gender sub-analysis of the REDUCE trial among 300 women and 1196 me

COBRA REDUCE 14-Day DAPT Randomized Control Tria

Further evidence for short-term DAPT in patients with atherosclerotic disease is supported by CLAIR trial (Clopidogrel Plus Aspirin Versus Aspirin Alone for Reducing Embolization in Patients With Acute Symptomatic Cerebral or Carotid Artery Stenosis) and CARESS trial (Clopidogrel and Aspirin for Reduction of Emboli in Symptomatic Carotid Stenosis), which show reduced microembolic signals with transcranial Doppler in the first week after ischemic stroke. 3,4 Ninety-three percent of. Randomized trials have established the superiority of drug-eluting stents over bare-metal stents in patients at high bleeding risk receiving 1 month of dual antiplatelet therapy after undergoing. Findings In this randomized clinical trial that included 3045 patients, the 1-year cumulative incidence of a composite end point consisting of cardiovascular death, myocardial infarction, ischemic or hemorrhagic stroke, definite stent thrombosis, and major bleeding was 2.4% in the 1-month DAPT group and 3.7% in the 12-month DAPT group, a difference that met the noninferiority margin of a hazard ratio of 0.5, as well as superiority In the TOPIC trial, which was a small randomised trial done in France, and which showed similar results to those of our study, unguided de-escalation to aspirin plus clopidogrel was associated with a reduction in bleeding complications without an increase in ischaemic events in patients who have been event-free for the first month after an acute coronary syndrome on a combination of aspirin. CURE trial showed the superiority of DAPT with aspirin plus clopidogrel versus aspirin alone (20% of ischemic risk reduction) , . The mean duration of DAPT in this study was 9 months (from 3 to 12). Following this trial, clopidogrel has been considered the gold standard therapy after an ACS with a 1 year duration [1] , [2]

Short term DAPT in patients with ACS: REDUCE trial. Objective. to investigate whether treatment with DAPT for 3 months is non-inferior to standard 12 month DAPT in patients with ACS. Study. prospective, open-label multicentre, non-inferiority randomised study (margin 5%) Population. patients with ACS treated with COMBO stent Background Dual antiplatelet therapy (DAPT) has important implications for clinical outcomes in coronary disease. However, the optimal DAPT duration remains uncertain. Methods and results We searched four major databases for randomised controlled trials comparing long-term (≥12 months) with short-term (≤6 months) or shorter (≤3 months) DAPT in patients with coronary syndromes randomized trial. The Dual Antiplatelet Therapy (DAPT) study was an international, multicenter, randomized, placebo-controlled trial that was designed to determine the benefits and risks of.. Methods and results: REDUCE was a prospective, open-label, multicentre, investigator-initiated study that randomised 1,496 ACS patients after treatment with the COMBO stent to either three (n=751) or 12 months (n=745) of DAPT as primary stroke prevention in atrial fibrillation, trials showing DAPT benefit used DAPT for a relatively short period of time. Benefit with long-term DAPT was offset by increased bleeding. The MATCH trial (Aspirin and Clopidogrel Compared With Clopidogrel Alone After Recent Ischaemic Stroke or Transien

Short DAPT has been shown to help patients at high bleeding risk undergoing stenting with various devices. The COBRA-REDUCE open-label trial was conducted at 59 sites in Europe and the U.S The COBRA-REDUCE trial failed to show that an experimental stent was superior to a standard stent at reducing bleeding events. Description: The goal of the trial was to evaluate an experimental stent compared with a standard drug-eluting stent among patients undergoing percutaneous coronary intervention (PCI)

COBRA-REDUCE: Stenting With the COBRA PzF Stent and Short

Results from the COBRA-REDUCE trial reported at TCT Connect Randomized trial comparing a nano-coated coronary stent and shorter DAPT did not meet non-inferiority criteria for thrombotic event The STOPDAPT-2 trial previously demonstrated that among patients undergoing percutaneous coronary intervention (PCI), one month of DAPT followed by clopidogrel monotherapy resulted in a significantly lower rate of a composite of cardiovascular and bleeding events, compared with 12 months of DAPT with aspirin and clopidogrel. 2 In that trial, 62% of patients had stable coronary artery disease. COBRA-REDUCE was a randomized, open-label, active-controlled, assessor-blinded, multi-center trial. A total of 996 patients were enrolled between February 2016 and May 2020 at 59 sites in Europe. The REDUCE trial shows that among ACS patients treated with a COMBO stent, three months of DAPT is non-inferior to 12 months of DAPT, and this is consistent for all pre-specified subgroups, said Harry Suryapranata, MD, PhD, Professor of Interventional Cardiology at Radboud University Medical Center in Nijmegen, The Netherlands, and one of the Principal Investigators who presented the data at TCT In the main MASTER DAPT trial, 4579 patients at high bleeding risk were randomly assigned after 1-month DAPT to abbreviated or nonabbreviated antiplatelet strategies

CeloNova BioSciences, Inc. (CeloNova), a global medical device company that offers a family of innovative products based upon its proprietary Polyzene™-F nanocoating technology has announced interim results from the Randomized Trial of COBRA PzF Stenting to REDUCE Duration of Triple Therapy (COBRA-REDUCE), the world's first and only randomized, global 14-day dual antiplatelet therapy (DAPT) study of high bleeding risk patients (HBR), during a late-breaking clinical science. Long-term ticagrelor monotherapy after PCI lowered risk for bleeding compared with 1-year dual antiplatelet therapy followed by 1-year aspirin monotherapy in patients with ACS, but not for those. DAPT had been shown early on as effective pharmacotherapy for rate reduction of stent thrombosis. Initially the use of aspirin and ticlopidine was shown to be superior to aspirin alone or aspirin and warfarin in the STARS trial [6] Initiation of DAPT after minor ischemic stroke or high-risk TIA was shown to reduce risk of stroke without increasing hemorrhage in Chinese patients in the CHANCE trial. Questions about the generalizability of these data lead investigators of the POINT trial to conduct a similar study in an international population This potential caveat was even more pronounced in the subsequently presented REDUCE trial, where the investigators compared 3-month DAPT versus 12-month DAPT in patients with acute coronary syndromes who received the so-called dual-therapy stent

Dapt after pci how long SEPT 2016

The MASTER DAPT trial was conducted in patients at high risk for bleeding who had undergone biodegradable polymer sirolimus-eluting stent implantation. The objective was to assess whether one month of DAPT preserved the benefit in relation to cardiovascular events, while mitigating bleeding outcomes, compared with longer treatment durations The REDUCE trial, will be the first trial to determine whether a reduction from 12 to 3 months in DAPT is non-inferior after COMBO stent implantation, in a population of ACS only, with high rates of the new potent antiplatelet agents

Randomized Trial of COBRA PzF Stenting to Reduce Duration of Triple Therapy (COBRA-REDUCE) (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic events than compared with standard FDA-approved drug eluting stent (DES) plus 3 or 6-month DAPT.. Studies Evaluating Prolonged Duration of Dual Antiplatelet Therapy. The DAPT trial explored the effect of prolonged (30 months) versus 12-month DAPT (clopidogrel or prasugrel) duration in patients with ACS or SCAD at low risk of ischaemic and bleeding events and undergoing stent implantation.[] After first-or second-generation DES implantation, prolonged DAPT significantly reduce the risk of. Findings In this randomized clinical trial that included 3045 patients, the 1-year cumulative incidence of a composite end point consisting of cardiovascular death, myocardial infarction, ischemic or hemorrhagic stroke, definite stent thrombosis, and major bleeding was 2.4% in the 1-month DAPT group and 3.7% in the 12-month DAPT group, a difference that met the noninferiority margin of a. The CHANCE and POINT trials showed similar efficacy of DAPT with up to ~30% reduction of recurrent stroke , but the POINT trial also showed a 2.3-fold increase in the risk of major haemorrhage in the DAPT group compared with aspirin alone (P=0.02), whereas the CHANCE trial did not (P=0.73).1 2 This discrepancy is not completely understood, but a longer duration of DAPT (90 days in the POINT.

Video: Duration of Dual Antiplatelet Therapy in Patients With

Gender differences with short-term vs 12 months dual

(UPDATED) A 1-month dual antiplatelet strategy tested in the STOPDAPT-2 ACS trial has failed to match the results for safety and efficacy seen in the original, all-comers STOPDAPT-2 study, researchers reported today. STOPDAPT-2 ACS was larger than its predecessor, which also compared 1 month of dual antiplatelet therapy (DAPT) followed by clopidogrel monotherapy through 1 year against 12. Davide Cao, MD, of the Icahn School Medicine at Mount Sinai, New York, presented results from the TWILIGHT-HBR trial Sunday at the virtual European Society of Cardiology Congress 2021. DAPT using aspirin and a P2Y 12 receptor inhibitor prevents ischemic events following PCI at the cost of an increased risk of bleeding

Source Reference: Suryapranata H, et al REDUCE: a randomized trial of 3-month vs 12-month DAPT after implantation of a bioabsorbable polymer-based metallic DES with a luminal CD34+ antibody. The REDUCE trial shows that among ACS patients treated with a COMBO stent, three months of DAPT is non-inferior to 12 months of DAPT, and this is consistent for all pre-specified subgroups, said Harry Suryapranata, MD, PhD, Professor of Interventional Cardiology at Radboud University Medical Center in Nijmegen, The Netherlands, and one of the Principal Investigators who presented the data at. Ticagrelor Monotherapy Reduces Bleeding Events vs DAPT with Aspirin in HBR Patients. August 30, 2021. Patrick Campbell. TWILIGHT-HBR suggests ticagrelor monotherapy could lower bleeding risk among patients meeting ARC-HBR criteria. Study presenter Davide Cao, MD, offers further perspective on results of the post hoc analysis. A post hoc. The REDUCE trial shows that among ACS patients treated with a COMBO stent, three months of DAPT is non-inferior to 12 months of DAPT, and this is consistent for all pre-specified subgroups, said.

This is a ground-breaking new information for clinicians who now know that reducing DAPT duration to 1 month is the new standard of care in this selected high bleeding risk population. These results carry high clinical relevance considering that patients with acute coronary syndrome or who underwent complex or multivessel PCI, including left main stenting were similarly included in our trial Seminal clinical trials conducted in the balloon angioplasty and bare metal stent era established the superiority of dual antiplatelet therapy (DAPT) as compared with aspirin monotherapy or anticoagulation with respect to the prevention of thrombotic events. 1,2 Other studies found that the benefits of DAPT are durable for at least 1 year and extend to patients with acute coronary syndromes. 3. Because the PROTECT trial enrolled a lower-risk population than the DAPT Study, both ischemic and bleeding event rates were overestimated. After recalibration to the baseline event rates observed in the PROTECT trial, the models were well fit (P = .81 for the ischemia model, P = .91 for the bleeding model) (eAppendix in the Supplement)

Use of Dual Antiplatelet Therapy Following Ischemic Stroke

Dual Antiplatelet Therapy after PCI in Patients at High

MASTER DAPT is a truly global effort with hundreds of dedicated stakeholders sharing a vision of advancing care for a large and vulnerable patient population that has been too frequently excluded from major trials. A shorter DAPT protocol will save substantial healthcare resources by reducing cost for DAPT, the number of hospitalizations. The trial is designed to assess superiority in terms of bleeding reduction (BARC ≥ 2) and non-inferiority in the composite of death, MI, stent thrombosis, and ischemic stroke in patients assigned to 14-days DAPT* after stenting with COBRA PzF NCS vs 3 or 6- months of DAPT after stenting with standard FDA-approved DES COBRA REDUCE is the world's first and only study to evaluate 14-day DAPT in HBR patients. All enrolled patients are on oral anticoagulation therapy (OAC), a major bleeding criteria, per the. The Dual Antiplatelet Trial (DAPT) is the largest study and was powered for superiority for the primary endpoints of definite or probable ST and a composite endpoint of death, MI and stroke. 41 For both ST (definite and probable) and the composite primary endpoint, a significant decrease was found when prolonging DAPT (ST: HR 0.29, 95 % CI [0.17-0.48], p<0.001, composite endpoint: HR 0.71.

Release Summary. First patient enrolled in CeloNova BioSciences' highly anticipated COBRA REDUCE trial which will study the COBRA PzFTM nanocoated coronary stent system in patients at high risk of. Stopping DAPT after one-month improved to be superior in terms of the trial's primary that reduce the body's ability to clot blood can reduce the chance of clot-related problems. The hazard ratio for MACE in TWILIGHT-ACS trial was 0.96 for placebo versus aspirin, with an upper confidence interval of 1.28, meaning that the level of risk reduction seen with clopidogrel-based DAPT in the DAPT trial (29% relative risk reduction) and ticagrelor-based DAPT in PEGASUS-TIMI 54 trial (15-16% relative risk reduction) could not be confidently excluded, particularly in those with. COBRA-REDUCE was a randomized, open-label, active-controlled, assessor-blinded, multi-center trial. A total of 996 patients were enrolled between February 2016 and May 2020 at 59 sites in Europe and the United States

The DAPT trial explored the effect of prolonged (30 months) versus 12-month DAPT (clopidogrel or prasugrel) duration in patients with ACS or SCAD at low risk of ischaemic and bleeding events and undergoing stent implantation. 4 After first- or second-generation DES implantation, prolonged DAPT significantly reduce the risk of ST, cerebrovascular events and major adverse cardiovascular events Background: Ticagrelor monotherapy after 3 months dual antiplatelet therapy (DAPT) with aspirin and ticagrelor can reduce bleeding without increasing ischemic events after percutaneous coronary intervention (PCI). However, the impact of this approach among the patient with diabetes remains unknown.Methods: This was a sub-analysis of the Ticagrelor Monotherapy after 3 months in the Patients. Although aspirin had a higher risk of GI bleeding, overall safety was comparable between groups. 17 The Clopidogrel in Unstable Angina to Prevent Recurrent Events (CURE) trial assessed the effectiveness of clopidogrel and aspirin versus aspirin alone following ACS (without ST elevation) in preventing death from cardiovascular causes, nonfatal MI, or stroke. 18 The trial determined that DAPT. DAPT (GSI-IX) is a γ-secretase inhibitor with IC50 of 0.12 and 0.2 μM for total Aβ and Aβ42 levels, respectively. Find all the information about DAPT (GSI-IX) for cell signaling research

FDA Approves COBRA REDUCE Trial Expansion | DAICTWILIGHT: Ticagrelor monotherapy 3 months post-PCI

Effect of 1-Month Dual Antiplatelet Therapy Followed by

XIENCE™ Stent with 1-month DAPT showed no increase in ischemic events versus 6-month DAPT — all death or MI.1. XIENCE 28 met its primary non-inferiority endpoint and included over 1600 high-bleeding risk patients. 1. XIENCE™ Stent with 1-month DAPT had a significantly lower rate of severe bleeding versus 6-month DAPT. (BARC 3-5).1 DENVER, CO — Dual-antiplatelet therapy (DAPT) after PCI in patients with acute coronary syndromes might sometimes be shortened to as little as 3 months using a polymer drug-eluting stent (DES) loaded with sirolimus and an endothelium-promoting antibody—that is, if a preliminary study's results are confirmed in large randomized trials [1].. DAPT reduction strategies are of critical importance to the medical community, explained Roxana Mehran, M.D., Professor of Medicine and Director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Weiner Cardiovascular Institute at Mount Sinai School of Medicine

RxFiles Trial Summaries. rxfiles.ca/trials Lower vs higher systolic blood pressure in recent stroke. PIONEER AF-PCI. Rivaroxaban + P2Y12 inhibitor vs rivaroxaban + DAPT vs warafrin + DAPT in a-fib & PCI. MATCH. Clopiodgrel + ASA vs clopidogrel alone in recent stroke or TIA. SPS3 antiplatelet Early small randomized clinical trials (RCTs) and their meta-analyses were intended to support the use of dual antiplatelet therapy (DAPT) but consistently displayed no difference between DAPT and single antiplatelet therapy (SAPT) with respect to thrombotic and ischemic outcomes, while SAPT was associated with a reduction in bleeding complications. 14-17 In 2017, joint guidelines on the. Conclusion • The REDUCE trial is the first study restricted to ACS patients, comparing a short 3-month vs a standard 12-month DAPT • The main finding of the present study: Among ACS patients treated with the COMBO stent, 3-month DAPT is not inferior to 12-month DAPT • This finding is consistent for all pre-specified subgroups • Therefore, a shorter DAPT strategy could be considered, if.

Unguided de-escalation from ticagrelor to clopidogrel in

In the DAPT study, prolonged-DAPT as compared with short-DAPT was associated with marked risk reduction for ST and MI, while in the other trials, there was a trend favoring prolonged-DAPT over short-DAPT in terms of ST and MI, but the extent of risk reduction was much smaller than that in the DAPT study (ST: OR 0.29 [95%CI 0.17-0.48] versus pooled OR 0.63 [95%CI 0.38-1.03]: P = 0.03 for. In the COMPASS trial, patients with stable coronary or peripheral artery disease and no indication for oral anticoagulation or dual antiplatelet therapy (DAPT) were randomized to rivaroxaban 2.5 mg bid in combination with aspirin, rivaroxaban 5 mg bid monotherapy or aspirin monotherapy 1. Patients status-post placement of drug-eluting stents (DES) for acute coronary syndrome received three months of Ticagrelor and Aspirin dual-antiplatelet therapy (DAPT), followed by nine months of DAPT or Ticagrelor monotherapy. 2. At one year, patients who received Ticagrelor alone experienced significantly fewer adverse major bleeding events. There was no reduction in adverse cardiac or [ Request PDF | Short-Term Versus Long-Term Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Elderly Patients | Objectives: This study sought to evaluate the optimal duration of.

Dr. Robert Byrne and Dr. C. Michael Gibson Discuss: COBRA-REDUCE: A Randomized Trial of a Thromboresistant Polyzene F-Coated Stent With 14 Days DAPT in High-Bleeding Risk Patients View Video | Download Slide The PRECISE-DAPT Risk Calculator was developed to predict the risk of bleeding in individual patients with coronary artery disease, treated with coronary stenting and subsequent dual antiplatelet therapy (i.e. aspirin plus a P2Y12 receptor inhibitor) White blood cells. unit. u/mcL. 109 /L. Creatinine Clearance (ml/min) Prior Bleeding. simpleplot.php (300×200) In patients with high PRECISE-DAPT score (Score>=25) a short DAPT (3-6 months) as compared with a long DAPT (12-24 months) was associated with lower TIMI major and minor bleeding and similar rate of the composite ischemic endpoint While dual antiplatelet therapy (DAPT) is the standard of care post-percutaneous coronary intervention (PCI) using drug-eluting stents (DES), the optimal duration of therapy remains controversial. American and European guidelines recommend DAPT for a minimum of 12 months for acute coronary syndrome (ACS), and at least 6 months in stable coronary artery disease (CAD) without high [

[11-06-2015] A U.S. Food and Drug Administration (FDA) review has determined that long-term use of the blood-thinning drug Plavix (clopidogrel) does not increase or decrease overall risk of death. Results In 17 trials that evaluated platelet reactivity outcomes, the mean PRU value was 47.73 units lower with TAPT versus DAPT (95% CI −61.41 to −34.04, p<0.0001; mean PRU 182.90 vs 232.65). TAPT also increased platelet inhibition by 12.71% (95% CI 10.76 to 14.67, p<0.0001), and led to a 60% reduction in the risk of HTPR (relative risk=0.40; 95% CI 0.30 to 0.53) compared with DAPT DAPT antithrombotic protection can be modulated, i.e. escalated or de-escalated using different drugs or doses of these drugs but also by extending or reducing the duration of DAPT. Aspirin has been perceived as the cornerstone antithrombotic therapy This suggests that limiting DAPT to 21 days could prevent many of the excess hemorrhages, maximize benefit, and reduce risk, said Dr. Elm. The findings of the Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events (CHANCE) trial confirmed the efficacy of 21 days of DAPT following a minor stroke or TIA These clear-cut findings indicate that one month DAPT is becoming the standard of care for patients undergoing PCR in and where a HBR feature is present. We have shown that there is no penalty to pay with respect to ischaemic events by reducing DAPT duration down to one month, concludes Valgimigli

Although trials used various dosing strategies, members of the BMJ and MAGIC panel recommend a loading dose of 300 mg of clopidogrel followed by 75 mg daily, and low-dose aspirin at 75 to 81 mg daily DAPT reduces the risk of thromboembolic events in general But is also associated with a higher risk of major bleeding that can sometimes be fatal. No trial has shown that extending DAPT from 6 to 12 months after primary PCI for STEMI is associated with a meaningful improvement of stent thrombosis and other safety outcomes such as MI, stroke, or death

#VisualAbstract: Drug-coated balloons are noninferior toFDA Clears Nano-coated Coronary Stent to Reduce DAPT | DAIC

with extended DAPT was not offset by the reduction in myocardial infarction and DAPT trial, 5 which out of all trials included, had the highest weight with regard to the mortality outcome Randomized trials evaluating duration of dual antiplatelet therapy after coronary stenting have revealed a trade-off between increase in bleeding events and reduction in ischemic events. The score was developed from the DAPT Study randomized trial data, in which patients were randomized to continued thienopyridine therapy (clopidogrel or prasugrel) vs. placebo However, (2.1%) compared with the DAPT arm (0.6%).29 The it is reassuring to note that all the point estimates suggest a COMPASS trial reported that ISTH-defined major bleeding likely better efficacy for a regimen with a NOAC. events occurred more frequently in patients in the rivaroxa- It should be noted that the average lesion length observed ban + aspirin group vs the aspirin group (3.1% vs.

Tailoring DAPT in the setting of ACS patients

The COBRA REDUCE study randomized 996 HBR patients across 59 enrolling global sites to receive either COBRA PzF NCS (n=495) with 14-day DAPT or an FDA-approved DES (n=501) with 3 or 6 months DAPT Elderly patients undergoing percutaneous coronary intervention (PCI) often receive bare-metal stents (BMS) instead of drug-eluting stents (DES) to shorten the duration of dual antiplatelet therapy (DAPT) and reduce bleeding risk. A new randomised trial An antiplatelet drug (antiaggregant), also known as a platelet agglutination inhibitor or platelet aggregation inhibitor, is a member of a class of pharmaceuticals that decrease platelet aggregation and inhibit thrombus formation. They are effective in the arterial circulation where anticoagulants have little effect. [citation needed]They are widely used in primary and secondary prevention of. August 11, 2015 -- Today Mount Sinai Medical Center in New York announced the launch of a new and very large randomized clinical trial to test the safety and efficacy of ticagrelor alone versus ticagrelor and aspirin together in high risk PCI patients. The international study, called TWILIGHT, aims to enroll 9,000 patients at 100 sites in the U.S., Canada, Europe, South America, and Asia Dr. Rahul Ganatra would like to acknowledge that he works with many of the authors on the statins paper. He, and the rest of The Curbsiders, report no relevant financial disclosures. Citation. Ganatra RB, Roberts SP, Williams PN, Watto MF. #229 Hotcakes: COVID on steroids, statins over 75, and shortened duration DAPT