scholarly journals Implementing a pharmacogenetic-driven algorithm to guide dual antiplatelet therapy (DAPT) in Caribbean Hispanics: protocol for a non-randomised clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e038936
Author(s):  
Dagmar F Hernandez-Suarez ◽  
Kyle Melin ◽  
Frances Marin-Maldonado ◽  
Hector J Nunez ◽  
Ariel F Gonzalez ◽  
...  
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
Antiplatelet Therapy ◽  
Dual Antiplatelet Therapy ◽  
Standard Of Care ◽  
Randomised Clinical Trial ◽  
Low Risk ◽  
High Risk Patients ◽  
Coronary Syndrome ◽  
Risk Patients

IntroductionMinority populations in the USA are disproportionately affected by cardiovascular conditions. Reduced responsiveness to clopidogrel among carriers of CYP2C19 variants has been reported in patients with either coronary artery disease (CAD) or acute coronary syndrome (ACS) after the percutaneous coronary intervention (PCI). Previous studies have evaluated CYP2C19 genotyping-guided antiplatelet therapy in selected populations; however, this has yet to be tested among Hispanics. Given the paucity of clinical research on CYP2C19 and antiplatelet clinical outcomes in Hispanics, our study will test the safety and efficacy of a genetic-driven treatment algorithm to guide dual antiplatelet therapy (DAPT) in Caribbean Hispanics.Methods and analysisThis is a multicentre, prospective, non-randomised clinical trial that proposes an assessment of pharmacogenomic-guided DAPT in post-PCI Caribbean Hispanic patients with ACS or CAD. We will recruit 250 patients to be compared with a matched non-concurrent cohort of 250 clopidogrel-treated patients (standard-of-care). Major adverse cardiovascular events (MACEs) such as all-cause death, myocardial infarction (MI), stroke, coronary revascularisation, stent thrombosis and bleedings over 6 months will be the study endpoints. Among the recruited, high-risk patients will be escalated to ticagrelor and low-risk patients will remain on clopidogrel. The primary objective is to determine whether genetic-guided therapy is superior to standard of care. The secondary objective will determine if clopidogrel treatment in low-risk patients is not associated with a higher rate of MACEs compared with escalated antiplatelet therapy in high-risk patients. Patients will be enrolled up to the group’s completion.Ethics and disseminationApproval was obtained from the Institutional Review Board of the University of Puerto Rico Medical Sciences Campus (protocol # A4070417). The study will be carried out in compliance with the Declaration of Helsinki and International Conference on Harmonization Good Clinical Practice Guidelines. Findings will be published in a peer-reviewed journal and controlled access to experimental data will be available.Trial registration numberNCT03419325; Pre-results.

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.

T1963 High-Risk Patients for GI Bleeding On Dual Antiplatelet Therapy in Spain Are More Like to Receive PPI Therapy Than Their American Peers

2009 ◽  
Vol 136 (5) ◽  
pp. A-610
Author(s):  
Angel Lanas ◽  
Liz Guastello ◽  
Ruben Casado ◽  
Sameer D. Saini ◽  
Monica Polo-Tomas ◽  
...  
Keyword(s):  
High Risk ◽  
Antiplatelet Therapy ◽  
Dual Antiplatelet Therapy ◽  
Gi Bleeding ◽  
High Risk Patients ◽  
Risk Patients ◽  
To Receive

Dual antiplatelet therapy prolongation in high-risk patients with prior myocardial infarction: insights from the post-PCI registry

2020 ◽  
Vol 21 (8) ◽  
pp. 603-609 ◽  
Author(s):  
Marco Ferlini ◽  
Roberta Rossini ◽  
Giuseppe Musumeci ◽  
Stefano Cornara ◽  
Alberto Somaschini ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
High Risk ◽  
Antiplatelet Therapy ◽  
Dual Antiplatelet Therapy ◽  
High Risk Patients ◽  
Prior Myocardial Infarction ◽  
Risk Patients

scholarly journals The impact of discontinuation of aspirin within 24 months among the high risk patients who are receiving prolonged dual antiplatelet therapy after implantation of second-generation drug-eluting stents

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S.W Cho ◽  
D.Y Kim ◽  
T.K Park ◽  
J.M Lee ◽  
J.H Yang ◽  
...  
Keyword(s):  
High Risk ◽  
Antiplatelet Therapy ◽  
Second Generation ◽  
Dual Antiplatelet Therapy ◽  
High Risk Patients ◽  
Cerebrovascular Events ◽  
Risk Patients ◽  
Drug Eluting ◽  
The Impact

Abstract Background The clinical impact of discontinuation of aspirin within 24 months after PCI for high risk patients who are receiving prolonged dual antiplatelet therapy (DAPT) is not known. We investigated the long-term outcomes prolonged DAPT among high risk patients after second-generation drug-eluting stent (DES) implantation. Methods and results Of 2082 consecutive patients undergoing PCI using 2nd generation DES, we studied 637 patients at high risk either angiographically or clinically who received clopidogrel longer than 24 months and were event-free at 12 months after index PCI. Patients were divided into 2 groups: the clopidogrel monotherapy group (aspirin discontinued within 24 months) and the prolonged DAPT group. The primary outcome was major adverse cardiac and cerebrovascular events (a composite of all-cause death, non-fatal myocardial infarction, or stroke) between 12 and 36 months after the index procedure. In propensity score-matched population, the risk of major adverse cardiac and cerebrovascular events (4.7%, 12/256 versus 4.3%, 11/256, hazard ratio (HR) 0.95, 95% confidence interval (CI) 0.42–2.16, p=0.91), all-cause mortality (3.1%, 8/256 versus 2.0%, 5/256, HR 0.70, CI 0.23–2.14), cardiovascular death (0.4%, 1/256 versus 0.8%, 2/256, HR 2.34, CI 0.21–25.80, p=0.49), non-fatal myocardial infarct (0.8%, 2/256 versus 0.4%, 1/256, HR 0.57, CI 0.05–6,32, p=0.65), stroke (0.8%, 2/256 versus 0.8%, 2/256, HR 1.09, CI 0.15–7.76, p=0.93) were not significantly different between patients receiving clopidogrel monotherapy and prolonged DAPT. Conclusion Compared to prolonged DAPT, aspirin discontinuation 12–24 months after PCI for high risk patients who received DAPT has similar long-term risk of major adverse cardiac and cerebrovascular events in patients after second-generation DES implantation. Funding Acknowledgement Type of funding source: None

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