scholarly journals Sex-based outcomes in contemporary antiplatelet therapy trials

Open Heart ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. e001761
Author(s):  
Mirvat Alasnag ◽  
Tara L Jones ◽  
Yasmin Hanfi ◽  
Nicola Ryan
Keyword(s):  
High Risk ◽  
Antiplatelet Therapy ◽  
Bleeding Risk ◽  
Coronary Intervention ◽  
Representation Of Women ◽  
Percutaneous Coronary ◽  
Risk Patients ◽  
High Risk Populations ◽  
High Bleeding Risk ◽  
Randomised Controlled

Balancing ischaemic and bleeding risks in high-risk populations undergoing percutaneous coronary interventions has become an everyday dilemma for clinicians. It is particularly difficult to make decisions concerning combinations and duration of antiplatelet regimens in women given the poor representation of women in trials that have shaped current practice. Several contemporary landmark trials have recently been presented at the American College of Cardiology. The trials included the Harmonising Optimal Strategy for Treatment of coronary artery diseases-EXtended Antiplatelet Monotherapy, Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention and the TicAgrelor versus CLOpidogrel in Stabilised Patients With Acute Myocardial Infarction. In this article, we summarise the main findings of these trials and include the The Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk (LEADERS FREE) in search for evidence based best practices for women patients. Although some of these trials had prespecified a subanalysis of sex differences, women constituted only 17%–30% of participants making sex-specific analyses challenging. Data suggest that women benefit from de-escalation to both ticagrelor and clopidogrel monotherapy. However, given the increased bleeding risks observed in women further randomised controlled trials are necessary to determine the most appropriate combination and duration of dual antiplatelet therapy as well as maintenance single antiplatelet therapy.

TWILIGHT: A Randomized Trial of Ticagrelor Monotherapy Versus Ticagrelor Plus Aspirin Beginning at 3 Months in High-risk Patients Undergoing Percutaneous Coronary Intervention

2020 ◽  
Vol 14 ◽  
Author(s):  
Johny Nicolas ◽  
Usman Baber ◽  
Roxana Mehran
Keyword(s):  
Percutaneous Coronary Intervention ◽  
High Risk ◽  
Antiplatelet Therapy ◽  
Dual Antiplatelet Therapy ◽  
Coronary Intervention ◽  
Bleeding Events ◽  
High Risk Patients ◽  
Risk Of Death ◽  
Percutaneous Coronary ◽  
Risk Patients

A P2Y12 inhibitor-based monotherapy after a short period of dual antiplatelet therapy is emerging as a plausible strategy to decrease bleeding events in high-risk patients receiving dual antiplatelet therapy after percutaneous coronary intervention. Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention (TWILIGHT), a randomized double-blind trial, tested this approach by dropping aspirin at 3 months and continuing with ticagrelor monotherapy for an additional 12 months. The study enrolled 9,006 patients, of whom 7,119 who tolerated 3 months of dual antiplatelet therapy were randomized after 3 months into two arms: ticagrelor plus placebo and ticagrelor plus aspirin. The primary endpoint of interest, Bleeding Academic Research Consortium type 2, 3, or 5 bleeding, occurred less frequently in the experimental arm (HR 0.56; 95% CI [0.45–0.68]; p<0.001), whereas the secondary endpoint of ischemic events was similar between the two arms (HR 0.99; 95% CI [0.78–1.25]). Transition from dual antiplatelet therapy consisting of ticagrelor plus aspirin to ticagrelor-based monotherapy in high-risk patients at 3 months after percutaneous coronary intervention resulted in a lower risk of bleeding events without an increase in risk of death, MI, or stroke.

scholarly journals Primary Results of the EVOLVE Short DAPT Study

2021 ◽  
Vol 14 (3) ◽  
Author(s):  
Ajay J. Kirtane ◽  
Robert Stoler ◽  
Robert Feldman ◽  
Franz-Josef Neumann ◽  
Loukas Boutis ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Percutaneous Coronary Intervention ◽  
Stent Thrombosis ◽  
Upper Bound ◽  
Bleeding Risk ◽  
Coronary Intervention ◽  
Performance Goal ◽  
Percutaneous Coronary ◽  
Risk Patients ◽  
High Bleeding Risk

Background: Prolonged dual antiplatelet therapy (DAPT) after percutaneous coronary intervention is associated with increased bleeding, despite a reduced incidence of ischemic events. The SYNERGY everolimus-eluting stent is a thin-strut platinum-chromium stent that elutes everolimus from a thin abluminal layer of bioabsorbable polymer. These design elements may facilitate rapid endothelialization and enable shorter-duration DAPT. Methods: EVOLVE Short DAPT prospectively evaluated the safety of 3-month DAPT in high bleeding risk patients treated with the SYNERGY everolimus-eluting stent, enrolling 2009 patients at 110 global sites. Patients with acute myocardial infarction or complex lesions were excluded. After percutaneous coronary intervention, patients were required to take DAPT (aspirin+P2Y 12 inhibitor) for 3 months, except those on chronic anticoagulation in whom aspirin was optional. Patients free of events (stroke, myocardial infarction, revascularization, and stent thrombosis) who discontinued P2Y 12 inhibitor at 3 months, but continued aspirin, and had at least 1 year of follow-up or an end point event were included in the primary analysis. Two powered coprimary end points were (1) death/myocardial infarction compared with a historical control and (2) study stent-related definite/probable stent thrombosis compared to a performance goal. Results: The analysis population consisted of 1487 patients. The adjusted rate of death/myocardial infarction between 3 and 15 months was 5.6% among patients receiving 3-month DAPT versus 5.7% patients in the 12-month DAPT control (propensity adjusted difference=−0.12%; 97.5% upper bound=1.63% which was less than the prespecified margin of 2.52; P non-inferiority =0.0016). The rate of study stent-related stent thrombosis between 3-15 months was 0.2% in the 3-month DAPT group (97.5% upper bound=0.63%; P =0.0005 for comparison to 1% performance goal). Conclusions: Favorable rates of ischemic outcomes were observed among selected high bleeding risk patients undergoing percutaneous coronary intervention with the SYNERGY everolimus-eluting stent who tolerated 3 months of P2Y 12 inhibitor and then discontinued it, supporting the safety of abbreviated DAPT with this stent platform. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02605447.

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