Months Of Dual Antiplatelet Therapy Research Articles

Impact of proton pump inhibitors on efficacy of antiplatelet strategies with ticagrelor or aspirin after percutaneous coronary intervention: Insights from the GLOBAL LEADERS trial.

BackgroundSeveral studies have suggested that proton pump inhibitors (PPIs) may reduce the antiplatelet effects of clopidogrel and/or aspirin, possibly leading to cardiovascular events.AimsWe aimed to investigate the association between PPI and clinical outcomes in patients treated with ticagrelor monotherapy or conventional antiplatelet therapy after percutaneous coronary intervention (PCI).MethodsThis is a subanalysis of the randomized GLOBAL LEADERS trial, comparing the experimental antiplatelet arm (23‐month ticagrelor monotherapy following 1‐month dual antiplatelet therapy [DAPT]) with the reference arm (12‐month aspirin monotherapy following 12‐month DAPT) after PCI. Patient‐oriented composite endpoints (POCEs: all‐cause mortality, myocardial infarction, stroke, or repeat revascularization) and its components were assessed stratified by PPI use as a time‐dependent covariate in patients with the experiment or reference antiplatelet arm.ResultsAmong 15,839 patients, 2115 patients (13.5%) experienced POCE at 2 years. In the reference arm, the use of PPIs was independently associated with POCE (hazard ratio [HR]: 1.27; 95% confidence interval [CI]: 1.12–1.44) and its individual components, whereas it was not in the experimental arm (HR: 1.04; 95% CI: 0.92–1.19; p interaction = 0.035). During the second‐year follow‐up, patients taking aspirin with PPIs had a significantly higher risk of POCE compared to those on aspirin without PPIs (HR: 1.57; 95% CI: 1.27–1.94), whereas the risk did not differ significantly irrespective of PPI in ticagrelor monotherapy group (HR: 1.03; 95% CI: 0.83–1.28; p interaction = 0.008).ConclusionsIn contrast to conventional antiplatelet strategy, there were no evidence suggesting the interaction between ticagrelor monotherapy and PPIs on increased cardiovascular events, which should be confirmed in further studies.Clinical Trial RegistrationURL: https://clinicaltrials.gov

Prognosis impact of ticagrelor vs clopidogrel based DAPT discontinuation after acute coronary syndrome. Insights from the multicenter CREA ARIAM Andalucia registry

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): The study project was financially supported by a non-conditional grant by Astrazeneca. Background/Introduction Premature cessation of dual antiplatelet therapy (DAPT) after acute coronary syndrome (ACS) has been associated with increased risk of major adverse cardiovascular events (MACE) Purpose To assess the relationship between premature DAPT discontinuation versus therapy continuation and outcomes in ACS patients discharged on ticagrelor or clopidogrel. Methods Prospective, observational, multicentre all-comers registry of ACS patients who were intended to receive 12-month DAPT with ticagrelor or clopidogrel. Adherence was defined by the medication possession ratio metric (MPA, proportion of days of medication supply within a time interval). Categories for DAPT cessation included: physician-recommended discontinuation, brief interruption (invasive procedures), or disruption due to non-compliance or because of bleeding. Fully-adjusted Cox models with time-varying covariates to account for informative censoring, were used to examine the effect of DAPT cessation on MACE (a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, definite stent thrombosis, or target-lesion revascularization). Moderation analysis was also performed to assess for potential exposure-adherence interaction. Results Among 2070 patients included (mean age 63 years, 73% men), 150 (7.3%) prematurely discontinued DAPT, median (IQR) 214 (101-236) days. Significantly more clopidogrel than ticagrelor users discontinued medication (9.5% vs 5%, respectively; P = .001), though timing of cessation was similar in both groups. At 1 year, MPR was slightly higher, but not significantly different, in the clopidogrel group than in the ticagrelor group (70±30 vs 64±29; P = .06). Overall, physician-guided discontinuation and bleeding were the main reasons for DAPT cessation. These were observed with a similar rate in both groups, while non-compliant disruption was more common among ticagrelor- than clopidogrel-treated patients (8% vs 2%, respectively; P for trend .04). After adjustments, DAPT cessation was associated with significantly increased risk of MACE (adjusted HR 2.94; 95% CI 1.82 – 4.74; P < .0001), regardless of the P2Y12 inhibitor (P interaction = 0.665). Non-compliance related cessation resulted in higher risk of MACE (HR 6.04, 95%CI 2.15 – 16.95; P = .001). Conclusion(s) Overall, approximately 7% of patients discontinued DAPT. Early cessation of either ticagrelor- or clopidogrel-based DAPT portended to a near 3-fold increased risk of MACE. Disruption due to non-compliance resulted in higher risk for ischemic events. These data warrant efforts to focus on patient education in subgroups at high risk of non-compliance.

D-48 | Optimal Duration of Dual Anti-Platelet Therapy after Percutaneous Patent Foramen Ovale and Atrial Septal Defect Closure

The AHA/ASA recommend PFO closure in patients with cryptogenic stroke (CS) and ASD closure for patients with a shunt resulting in RA/RV enlargement. Clinical efficacy and safety for closure has been well documented. Current guidelines suggest 6 months of dual anti-platelet therapy (DAPT) to prevent device thrombosis. However, data on the optimal duration of DAPT post device placement remains sparse.

A-13 | One Month DAPT in High Bleeding Risk ACS Patients: 2-year Subgroup Analysis from Onyx ONE Clear

The safety and efficacy of Resolute Onyx zotarolimus-eluting stents in high bleeding risk (HBR) patients with 1-month dual antiplatelet therapy (DAPT) was previously demonstrated. This subgroup analysis examines 2-year outcomes in ACS and non-ACS patients in the Onyx ONE Clear study.

Short-term dual antiplatelet therapy in diabetic patients admitted for acute coronary syndrome treated with a new-generation drug-eluting stent.

BackgroundThe optimal duration of dual antiplatelet therapy (DAPT) in patients with diabetes mellitus (DM) admitted with acute coronary syndrome (ACS) and treated with a drug‐eluting stent (DES) remains unclear. This is a prespecified sub‐study from the Randomised Evaluation of short‐term DUal antiplatelet therapy in patients with acute Coronary syndromE treated with a new generation DES (REDUCE) trial that was designed to determine the efficacy and safety of short‐term versus standard 12 months DAPT in diabetic patients with ACS undergoing percutaneous coronary intervention (PCI) using the COMBO stent.MethodsIn this study we included ACS diabetic patients enroled in the REDUCE trial treated with the COMBO stent and randomly assigned to either 3 or 12 months of DAPT. The primary study endpoint was the composite of all‐cause mortality, myocardial infarction (MI), stent thrombosis (ST), stroke, target vessel revascularisation (TVR), and bleeding complications at 12 and 24 months follow‐up.ResultsA total of 307 diabetic patients were included, of which 162 (52.8%) in the 3 months DAPT group and 145 (47.2%) in the 12 months DAPT group. Patient characteristics, PCI success, and number of stents used were similar in the 3 and 12 months DAPT groups. Occurrence of the primary study endpoint at 12 and 24 months follow‐up was comparable between the two groups (3.1 vs. 3.5%, p = 0.865, and 15.8 vs. 14.9%, p = 0.824, respectively). Moreover, the prevalence of the specific clinical outcome parameters (all‐cause mortality), MI, ST, stroke, TVR, and bleeding was similar in both study groups.ConclusionsThis sub‐analysis shows similar clinical outcomes following 3 months DAPT as compared to 12 months DAPT in diabetic patients undergoing PCI for ACS using the COMBO stent. These results suggest that, even in this particular subset of patients, short duration of DAPT might be considered safe. Future larger studies are warranted to provide more precise estimations in terms of safety and efficacy of short term DAPT in these high‐risk patients.

Clinical Outcomes in Patients Treated With Biodegradable-Polymer Biolimus-Eluting Stents and 6 Months of Dual-Antiplatelet Therapy: The French eBiomatrix 6-Month DAPT Registry.

Dual-antiplatelet treatment (DAPT) has conventionally been prescribed for 1 year after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation. Recent evidence suggests that a duration of only 6 months may be equally safe and effective when using contemporary DES options. The aim of this study was to assess clinical outcomes in patients treated with the BioMatrix biodegradable-polymer coated biolimus-eluting stent (BP-BES; Biosensors International) who received only 6 months of DAPT. This prospective "all-comers" registry enrolled 2038 patients in France. Following PCI, DAPT was started for a recommended period of 6 months. Patients were followed up at 6 and 24 months. The primary endpoint of major adverse cardiac and cerebrovascular event (MACCE) was a composite of all-cause death, cerebrovascular accidents, non-fatal myocardial infarction, or clinically driven target-vessel revascularization. Secondary endpoints included stent thrombosis (ST) and major bleeding (MB). The mean age of the study population was 67 ± 10.5 years and 77% of patients were male. Follow-up data were available in 96.9% and 95.3% of patients at 6 and 24 months, respectively. At 6 months, the incidences of MACCE, ST, and MB were 3.1%, 0.3%, and 0.4%, respectively. At 24 months, 21.2% of patients were still on DAPT and the cumulative incidences of MACCE, ST, and MB were 9.7%, 0.54%, and 0.79%, respectively. In this unselected population of patients undergoing PCI with a BP-BES, a 6-month duration of DAPT after implantation is safe and effective.

Comparative Efficacy and Safety of P2Y12 Inhibitor Monotherapy and Dual Antiplatelet Therapy in Patients with and without Diabetes Mellitus Undergoing Percutaneous Coronary Intervention.

Increasing evidence has shown P2Y12 inhibitor monotherapy is a feasible alternative treatment for patients after percutaneous coronary intervention (PCI) with stent implantation in the modern era. However, patients with diabetes mellitus (DM) have a higher risk of ischemic events and more complex coronary artery disease. The purpose of this study is to evaluate the efficacy and safety of this novel approach among patients with DM and those without DM. We conducted a systematic review and meta-analysis of randomized controlled trials that compared P2Y12 inhibitor monotherapy with 12 months of dual antiplatelet therapy (DAPT) in patients who underwent PCI with stent implantation. PubMed, Embase, Cochrane library database, ClinicalTrials.gov, and three other websites were searched for our data from the earliest report to January 2022. The primary efficacy outcome was major adverse cardiovascular and cerebrovascular events (MACCE): a composite of all-cause mortality, myocardial infarction, stent thrombosis, and stroke. The primary safety outcome was major or minor bleeding events. The secondary endpoint was net adverse clinical events (NACE) which are defined as a composite of major bleeding and adverse cardiac and cerebrovascular events. A total of four randomized controlled trials with 29,136 patients were included in our meta-analysis. The quantitative analysis showed a significant reduction in major or minor bleeding events in patients treated with P2Y12 inhibitor monotherapy compared to standard DAPT (OR: 0.68, 95% CI: 0.46–0.99, p = 0.04) without increasing the risk of MACCE (OR: 0.96, 95% CI: 0.85–1.09, p = 0.50). The number of NACE was significantly lower in the patients treated with P2Y12 inhibitor monotherapy (OR: 0.84, 95% CI: 0.72–0.97, p = 0.019). In DM patients, P2Y12 inhibitor monotherapy was associated with a lower risk of MACCE compared to standard DAPT (OR: 0.85, 95% CI: 0.74–0.98, p = 0.02). Furthermore, P2Y12 inhibitor monotherapy was accompanied by a favorable reduction in major or minor bleeding events (OR: 0.80, 95% CI: 0.64–1.05, p = 0.107). In non-DM patients, P2Y12 inhibitor monotherapy showed a significant reduction in major or minor bleeding events (OR: 0.58, 95% CI: 0.38–0.88, p = 0.01), but without increasing the risk of MACCE (OR: 0.99, 95% CI: 0.82–1.19, p = 0.89). Based on these findings, P2Y12 inhibitor monotherapy could significantly decrease bleeding events without increasing the risk of stent thrombosis or myocardial infarction in the general population. The benefit of reducing bleeding events was much more significant in non-DM patients than in DM patients. Surprisingly, P2Y12 inhibitor monotherapy could lower the risk of MACCE in DM patients. Our study supports that P2Y12 inhibitor monotherapy is a promising alternative choice of medical treatment for patients with DM undergoing PCI with stent implantation in the modern era.

Bioabsorbable polymer drug-eluting stents with 4-month dual antiplatelet therapy versus durable polymer drug-eluting stents with 12-month dual antiplatelet therapy in patients with left main coronary artery disease: the IDEAL-LM randomised trial.

Improvements in drug-eluting stent design have led to a reduced frequency of repeat revascularisation and new biodegradable polymer coatings may allow a shorter duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). The Improved Drug-Eluting stent for All-comers Left Main (IDEAL-LM) study aims to investigate long-term clinical outcomes after implantation of a biodegradable polymer platinum-chromium everolimus-eluting stent (BP-PtCr-EES) followed by 4 months DAPT compared to a durable polymer cobalt-chromium everolimus-eluting stent (DP-CoCr-EES) followed by 12 months DAPT in patients undergoing PCI of unprotected left main coronary artery (LMCA) disease. This is a multicentre randomised clinical trial study in patients with an indication for coronary artery revascularisation who have been accepted for PCI for LMCA disease after Heart Team consultation. Patients were randomly assigned in a 1:1 ratio to receive either the BP-PtCr-EES or the DP-CoCr-EES. The primary endpoint was a non-inferiority comparison of the rate of major adverse cardiovascular events (MACE), defined as all-cause death, myocardial infarction, or ischaemia-driven target vessel revascularisation at 2 years. Between December 2014 and October 2016, 818 patients (410 BP-PtCr-EES and 408 DP-CoCr-EES) were enrolled at 29 centres in Europe. At 2 years, the primary endpoint of MACE occurred in 59 patients (14.6%) in the BP-PtCr-EES group and 45 patients (11.4%) in the DP-CoCr-EES group; 1-sided upper 95% confidence interval (CI) 7.18%; p=0.04 for non-inferiority; p=0.17 for superiority. The secondary endpoint event of BARC 3 or 5 bleeding occurred in 11 patients (2.7%) in the BP-PtCr-EES group and 2 patients (0.5%) in the DP-CoCr-EES group (p=0.02). In patients undergoing PCI of LMCA disease, after two years of follow-up, the use of a BP-PtCr-EES with 4 months of DAPT was non-inferior to a DP-CoCr-EES with 12 months of DAPT with respect to the composite endpoint of all-cause death, myocardial infarction or ischaemia-driven target vessel revascularisation.

Ticagrelor monotherapy after PCI in patients with concomitant diabetes mellitus and chronic kidney disease: TWILIGHT DM-CKD.

We aimed to evaluate the treatment effects of ticagrelor monotherapy in the very high risk cohort of patients with concomitant diabetes mellitus (DM) and chronic kidney disease (CKD) undergoing percutaneous coronary intervention (PCI). In the TWILIGHT (Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention) trial, after 3-month dual antiplatelet therapy with ticagrelor and aspirin post-PCI, event-free patients were randomized to either aspirin or placebo in addition to ticagrelor for 12 months. Those with available information on DM and CKD status were included in this subanalysis and were stratified by the presence or absence of either condition: 3391 (54.1%) had neither DM nor CKD (DM-/CKD-), 1822 (29.0%) had DM only (DM+/CKD-), 561 (8.9%) had CKD only (DM-/CKD+), and 8.0% had both DM and CKD (DM+/CKD+). The incidence of the primary endpoint of Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding did not differ according to DM/CKD status (P-trend = 0.13), but there was a significant increase in BARC 3 or 5 bleeding (P-trend < 0.001) as well as the key secondary endpoint of death, myocardial infarction, or stroke (P-trend < 0.001). Ticagrelor plus placebo reduced bleeding events compared with ticagrelor plus aspirin across all four groups, including DM+/CKD+ patients with respect to BARC 2-5 [4.5% vs. 8.7%; hazard ratio (HR) 0.49, 95% confidence interval (CI) 0.24-1.01] as well as BARC 3-5 (0.8% vs. 5.3%; HR 0.15, 95% CI 0.03-0.53) bleeding, with no evidence of heterogeneity. The risk of death, myocardial infarction, or stroke was similar between treatment arms across all groups. Irrespective of the presence of DM, CKD, and their combination, ticagrelor monotherapy reduced the risk of bleeding without a significant increase in ischaemic events compared with ticagrelor plus aspirin.

A primary lung cancer patient who underwent lobectomy after one month of dual antiplatelet therapy following coronary stent deployment

A primary lung cancer patient who underwent lobectomy after one month of dual antiplatelet therapy following coronary stent deployment

Comparison of Clopidogrel Monotherapy After 1 to 2 Months of Dual Antiplatelet Therapy With 12 Months of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome

Clopidogrel monotherapy after short dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) has not yet been fully investigated in patients with acute coronary syndrome (ACS). To test the hypothesis of noninferiority of 1 to 2 months of DAPT compared with 12 months of DAPT for a composite end point of cardiovascular and bleeding events in patients with ACS. This multicenter, open-label, randomized clinical trial enrolled 4169 patients with ACS who underwent successful PCI using cobalt-chromium everolimus-eluting stents at 96 centers in Japan from December 2015 through June 2020. These data were analyzed from June to July 2021. Patients were randomized either to 1 to 2 months of DAPT followed by clopidogrel monotherapy (n = 2078) or to 12 months of DAPT with aspirin and clopidogrel (n = 2091). The primary end point was a composite of cardiovascular (cardiovascular death, myocardial infarction [MI], any stroke, or definite stent thrombosis) or bleeding (Thrombolysis in MI major or minor bleeding) events at 12 months, with a noninferiority margin of 50% on the hazard ratio (HR) scale. The major secondary end points were cardiovascular and bleeding components of the primary end point. Among 4169 randomized patients, 33 withdrew consent. Of the 4136 included patients, the mean (SD) age was 66.8 (11.9) years, and 856 (21%) were women, 2324 (56%) had ST-segment elevation MI, and 826 (20%) had non-ST-segment elevation MI. A total of 4107 patients (99.3%) completed the 1-year follow-up in June 2021. One to 2 months of DAPT was not noninferior to 12 months of DAPT for the primary end point, which occurred in 65 of 2058 patients (3.2%) in the 1- to 2-month DAPT group and in 58 of 2057 patients (2.8%) in the 12-month DAPT group (absolute difference, 0.37% [95% CI, -0.68% to 1.42%]; HR, 1.14 [95% CI, 0.80-1.62]; P for noninferiority = .06). The major secondary cardiovascular end point occurred in 56 patients (2.8%) in the 1- to 2-month DAPT group and in 38 patients (1.9%) in the 12-month DAPT group (absolute difference, 0.90% [95% CI, -0.02% to 1.82%]; HR, 1.50 [95% CI, 0.99-2.26]). The major secondary bleeding end point occurred in 11 patients (0.5%) in the 1- to 2-month DAPT group and 24 patients (1.2%) in the 12-month DAPT group (absolute difference, -0.63% [95% CI, -1.20% to -0.06%]; HR, 0.46 [95% CI, 0.23-0.94]). In patients with ACS with successful PCI, clopidogrel monotherapy after 1 to 2 months of DAPT failed to attest noninferiority to standard 12 months of DAPT for the net clinical benefit with a numerical increase in cardiovascular events despite reduction in bleeding events. The directionally different efficacy and safety outcomes indicate the need for further clinical trials. ClinicalTrials.gov Identifiers: NCT02619760 and NCT03462498.

Individualizing Dual Antiplatelet Therapy (DAPT) Duration Based on Bleeding Risk, Ischemic Risk, or Both: An Analysis From the DAPT Study

BackgroundGuidelines recommend individualization of dual antiplatelet therapy (DAPT) duration. Whether to guide decisions based on bleeding risk, ischemic risk or a combination is not known. AimsTo compare a bleeding prediction model, an ischemic prediction model, and the DAPT score in guiding DAPT duration. Methods11,648 patients in the DAPT Study were categorized into higher and lower risk using a bleeding model, an ischemic model, and the DAPT score. Effect of 30 vs. 12 months of DAPT on bleeding events, ischemic events, and the combination (net-adverse clinical events [NACE]) was assessed. ResultsAmong patients stratified with the bleeding model, 30 vs. 12 months of DAPT resulted in similar ischemic and bleeding event rates. With the ischemic model, however, higher risk patients had a greater reduction in ischemic events with extended duration of DAPT (difference in risk differences [DRD]: −2.6%, 95% CI: −3.9 to −1.3%; p < 0.01), and a smaller increase in bleeding (DRD: −1.0%, 95% CI: −2.1–0.0%; p = 0.04). Similarly, high DAPT score patients had a greater reduction in ischemic events with extended DAPT duration (DRD: −2.4%, 95%: CI: −3.6 to −1.1%; p < 0.01) and a smaller increase in bleeding (DRD: −1.2%, 95%: CI: −2.2–0.0%; p = 0.02). Although NACE was similar for bleeding risk groups, NACE was significantly reduced with extended DAPT in the higher ischemic risk and high DAPT score groups. ConclusionsIn this low-bleeding risk population, stratifying patients based on predicted ischemic risk and the DAPT score best discerned benefit versus harm of extended DAPT duration on ischemic events, bleeding events, and NACE. Condensed abstractDuration of dual antiplatelet therapy (DAPT) should be guided by an individualized risk assessment. Bleeding risk tools have emerged to identify patients at high bleeding risk for whom truncated DAPT therapy may be safest. In a lower bleeding risk population, however, whether DAPT duration should be guided by bleeding risk, ischemic risk, or a combination is unknown.In this analysis, implementation of a score based on ischemic risk prediction and the DAPT score (a combination of ischemic and bleeding risk) best predicted ischemic events, bleeding events, and net-adverse clinical events (NACE).

Angiography-derived physiology guidance vs usual care in an All-comers PCI population treated with the healing-targeted supreme stent and Ticagrelor monotherapy: PIONEER IV trial design

Current ESC guidelines recommend the use of intra-coronary pressure guidewires for functional assessment of intermediate-grade coronary stenoses. Angiography-derived quantitative flow ratio (QFR) is a novel method of assessing these stenoses, and guiding percutaneous coronary intervention (PCI). The PIONEER IV trial is a prospective, all-comers, multi-center trial, which will randomize 2,540 patients in a 1:1 ratio to PCI guided by angiography-derived physiology or usual care, with unrestricted use in both arms of the Healing-Targeted Supreme sirolimus-eluting stent (HT Supreme). The stent's fast, biologically healthy, and robust endothelial coverage allows for short dual-antiplatelet therapy (DAPT); hence the antiplatelet regimen of choice is 1-month DAPT, followed by ticagrelor monotherapy. In the angiography-derived physiology guided arm, lesions will be functionally assessed using on-line QFR, with stenting indicated in lesions with a QFR ≤0.80. Post-stenting, QFR will be repeated in the stented vessel(s), with post-dilatation or additional stenting recommended if the QFR<0.91 distal to the stent, or if the delta QFR (across the stent) is >0.05. Usual care PCI is performed according to standard clinical practice. The primary endpoint is a non-inferiority comparison of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, any myocardial infarction, or any clinically, and physiologically driven revascularization with a non-inferiority risk-difference margin of 3.2%, at 1-year post-procedure. Clinical follow-up will be up to 3 years. The PIONEER IV trial aims to demonstrate non-inferiority of QFR-guided PCI to usual care PCI with respect to POCE at 1-year in patients treated with HT Supreme stents and ticagrelor monotherapy. ClinicalTrials.gov UNIQUE IDENTIFIER: NCT04923191 CLASSIFICATIONS: Interventional Cardiology.

Non-inferiority of 1 month versus longer dual antiplatelet therapy in patients undergoing PCI with drug-eluting stents: a systematic review and meta-analysis of randomized clinical trials.

Aim:The aim of this meta-analysis was to evaluate the safety of 1-month dual antiplatelet therapy (DAPT) followed by aspirin or a P2Y12 receptor inhibitor, after percutaneous coronary intervention (PCI) with drug-eluting stents (DES), based on the available evidence.Methods:PubMed, MEDLINE, Embase, Scopus, Google Scholar, CENTRAL, and ClinicalTrials.gov database search identified four RCTs of 26,431 patients who underwent PCI with DES and compared 1-month versus >1-month DAPT. The primary endpoint was major bleeding and co-primary endpoint stent thrombosis, and secondary endpoints included all-cause mortality, cardiovascular death, myocardial infarction (MI), stroke, and major adverse clinical events (MACE).Results:Compared with >1-month DAPT, the 1-month DAPT was associated with a similar rate of major bleeding (OR = 0.74, 95%CI: 0.51–1.07, p = 0.11, I2 = 67%), stent thrombosis (OR = 1.10, 95%CI: 0.82–1.47, p = 0.53, I2 = 0.0%), similar risk for all-cause mortality (OR = 0.89, 95%CI: 0.77–1.04, p = 0.14, I2 = 0%), CV death (OR = 0.80, 95% CI: 0.55–1.60, p = 0.24, I2 = 0.0%), MI (OR = 1.02, 95% CI: 0.88–1.19, p = 0.78, I2 = 0.0%), and stroke (OR = 0.76, 95% CI: 0.54–1.08, p = 0.13, I2 = 29%). The risk of MACE was lower (OR = 0.84, 95% CI: 0.73–0.98, p = 0.02, I2 = 39%) in the 1-month DAPT compared with the >1-month DAPT. Only patients with stable CAD had lower risk of MACE with 1-month DAPT (OR = 0.81, 95% CI: 0.67–0.98, p = 0.03, I2 = 21%) compared with >1-month DAPT.Conclusion:This meta-analysis proved the non-inferiority of 1-month DAPT followed by aspirin or a P2Y12 receptor inhibitor compared with long-term DAPT in patients undergoing PCI with DES.

Ticagrelor Monotherapy After 3-Month Dual Antiplatelet Therapy in Acute Coronary Syndrome by High Bleeding Risk: The Subanalysis From the TICO Trial.

Identifying patients with high bleeding risk (HBR) is important when making decisions for antiplatelet therapy strategy. This study evaluated the impact of ticagrelor monotherapy after 3-month dual antiplatelet therapy (DAPT) according to HBR in acute coronary syndrome (ACS) patients treated with drug eluting stents (DESs). In this post-hoc analysis of the TICO trial, HBR was defined by 2 approaches: meeting Academic Research Consortium for HBR (ARC-HBR) criteria or Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent DAPT (PRECISE-DAPT) score ≥25. The primary outcome was a 3-12 months net adverse clinical event (composite of major bleeding and adverse cardiac and cerebrovascular events). Of the 2,980 patients without adverse events during the first 3 months after DES implantation, 453 (15.2%) were HBR by ARC-HBR criteria and 504 (16.9%) were HBR by PRECISE-DAPT score. The primary outcome rate was higher in HBR versus non-HBR patients (by ARC-HBR criteria: hazard ratio [HR], 2.87; 95% confidence interval [CI], 1.76-4.69; p<0.001; by PRECISE-DAPT score: HR, 3.09; 95% CI, 1.92-4.98; p<0.001). Ticagrelor monotherapy after 3-month DAPT was associated with lower primary outcome rate than ticagrelor-based 12-month DAPT regardless of HBR by ARC-HBR criteria, with similar magnitudes of therapy effect for HBR and non-HBR patients (p-interaction=0.400). Results were consistent by PRECISE-DAPT score (p-interaction=0.178). In ACS patients treated with DESs, ticagrelor monotherapy after 3-month DAPT was associated with lower rate of adverse clinical outcomes regardless of HBR, with similar magnitudes of therapy effect between HBR and non-HBR. ClinicalTrials.gov Identifier: NCT02494895.

P2Y12 inhibitor monotherapy in complex percutaneous coronary intervention: A post-hoc analysis of SMART-CHOICE randomized clinical trial

BackgroundIt remains unclear whether P2Y12 monotherapy, especially clopidogrel, following short-duration dual antiplatelet therapy (DAPT) is associated with favorable outcomes in patients undergoing complex percutaneous coronary intervention (PCI). Therefore, this study analyzed the efficacy and safety of P2Y12 inhibitor monotherapy, mostly clopidogrel (78%), in complex PCI following short-term DAPT.MethodsThe post-hoc analysis of the SMART-CHOICE trial involving 2,993 patients included 498 cases of complex PCIs, defined by at least one of the following features: 3 vessels treated, ≥ 3 stents implanted, ≥ 3 lesions treated, bifurcation with ≥ 2 stents implanted, and a total stent length of ≥ 60 mm. The primary endpoint was major adverse cardiac and cerebrovascular event (MACCE), defined as the composite of all-cause death, myocardial infarction, and stroke. The primary safety endpoint included bleeding, defined as Bleeding Academic Research Consortium (BARC) types 2 to 5.ResultsComplex PCI group had a higher risk of MACCE (4.0% vs. 2.3%, hazard ratio [HR] = 1.74, 95% confidence interval [CI]: 1.05–2.89, p = 0.033) and a similar risk of BARC types 2–5 bleeding (2.6% vs. 2.6%, HR = 1.02, 95% CI: 0.56–1.86, p = 0.939) compared with those without complex PCIs. Patients undergoing complex PCIs, followed by P2Y12 inhibitor monotherapy and 12 months of DAPT exhibited similar rates of MACCE (3.8% vs. 4.2%, HR = 0.92, 95% CI: 0.38–2.21, p = 0.853).ConclusionsP2Y12 inhibitor monotherapy, mostly clopidogrel, following 3 months of DAPT did not increase ischemic events in patients with complex PCIs.

Outcomes of prolonged dual anti-platelet therapy in patients with acute coronary syndrome undergoing percutaneous coronary intervention: A nationwide registry-based study

Randomized controlled trials have shown a reduced risk of ischemic events and an increased risk of bleeding in patients treated with prolonged dual anti-platelet therapy (DAPT) beyond 12 months following acute coronary syndrome (ACS). We aimed to investigate outcomes of prolonged DAPT vs aspirin monotherapy (ASA) in a real-world population. Using nationwide registries, we identified all patients with ACS who underwent percutaneous coronary intervention and received 12-month DAPT between January 2013 and October 2016. Patients still on DAPT were compared to patients on ASA at index date (15 months after ACS-date) and followed for up to 2 years. Cox regression models were employed to calculate standardized risks of all-cause mortality, major adverse cardiovascular event (MACE), and major bleeding. The study included 7,449 patients, 1,901 on DAPT (median age 66, 72.1% male) and 5,548 on ASA (median age 65, 75.1% male). Standardized absolute 2-year risk of all-cause mortality, MACE, and major bleeding was 2.7%, 3.7%, and 5.4% for DAPT vs 2.2%, 3.8%, and 1.3% for ASA. DAPT was not associated with a significant standardized 2-year risk difference (SRD) of all-cause mortality (SRD: 0.5%, 95% confidence interval [CI]: -0.9 to 1.7) or MACE (SRD: -0.1%, 95% CI -1.8 to 1.6), but a significantly higher risk of major bleeding (SRD: 4.1%, 95% CI 1.8-6.6). In a nationwide cohort of ACS patients undergoing percutaneous coronary intervention, prolonged DAPT was not significantly associated with a reduced risk of all-cause mortality or MACE, but an increased risk of major bleeding. Future randomized controlled trials should investigate the optimal anti-platelet regimen in this patient group.

Abstract 11865: New Insights Into Optimal Duration of Dual Antiplatelet Therapy After Left Main Coronary Stenting: Findings From the Largest LM PCI Cohort

Background: The optimal duration of dual antiplatelet therapy (DAPT) and the risk-benefit ratio for long-term DAPT in patients with left main coronary artery disease (LMCAD) undergoing PCI remains uncertain. Objectives: The aim of this study was to assess the efficacy and safety of extended duration DAPT (&gt;12-month) versus ≤12-month DAPT in patients who received PCI for LMCAD. Methods: A total of 4,561 consecutive patients undergoing PCI and stenting of LMCAD at a single center from January 2004 to December 2016 were enrolled. The primary outcome was 3-year MACCE (death, myocardial infarction, stent thrombosis, or stroke). The key safety outcome was BARC 2, 3, or 5 bleeding at 3 years. Results: 3,865 patients free of major ischemic or bleeding events in the first 12 months were included in the primary analysis. The distal LM bifurcation disease was involved in 80.5% of cases, in whom 27.0% were treated with a 2-stent strategy. DAPT&gt;12-month (n=1,727) versus ≤12-month DAPT (n=2,138) was associated with a reduced risk of 3-year primary outcome (2.5% vs. 4.5%; adjusted HR [aHR]: 0.592, 95% CI: 0.414-0.948). Similar results were found for the other ischemic end points: all-cause mortality (0.9% vs. 3.0%; aHR: 0.315 [0.179-0.554]), cardiovascular mortality (0.5% vs. 1.6%; aHR: 0.354 [0.169-0.739]), myocardial infarction (0.8% vs. 1.9%; aHR: 0.451 [0.245-0.831]), and stent thrombosis (0.4% vs. 1.1%; aHR: 0.400 [0.171-0.936]). Long-term DAPT showed similar risks of BARC 2, 3, or 5 bleeding compared to short-term DAPT (1.8% vs. 1.6%; aHR: 1.109; 95% CI: 0.681-1.806). The lower risk of a net adverse clinical event (a composite of BARC 2, 3, or 5 bleeding and MACCE) was identified in patients in patients treated with extended-term DAPT (4.1% vs. 5.7%; aHR: 0.729; 95% CI: 0.543-0.980). The effect of DAPT&gt;12-month on the reduction of primary outcome was consistent across clinical presentations (stable CAD vs. ACS), P2Y 12 inhibitor (clopidogrel vs. ticagrelor), and LM bifurcation PCI (1- vs. 2-stent strategy). Conclusions: In a large cohort of consecutive patients undergoing LM PCI, longer DAPT duration (&gt;12 months) could achieve more favorable outcomes by reducing ischemic risk, not significantly offsetting the increases in clinically relevant bleeding events.

Abstract 9972: Estimation of DAPT Study Treatment Effects in Contemporary Clinical Practice: Findings from the EXTEND-DAPT Study

Introduction: Differences in patient characteristics, changes in treatment algorithms, and advances in medical technology could each influence the applicability of older randomized trial results to contemporary clinical practice. Objectives: To evaluate whether the Dual Antiplatelet Therapy (DAPT) Study population is different from a contemporary population of US patients receiving percutaneous coronary intervention (PCI), and to estimate the treatment effect of extended duration antiplatelet therapy after PCI in this more contemporary cohort. Methods: We compared characteristics of drug-eluting stent (DES)-treated patients randomized in the DAPT Study to a sample of more contemporary DES-treated patients in the NCDR CathPCI Registry from July 2016-June 2017. After linking trial and registry data, we employed inverse-odds of trial participation weighting to account for patient and procedural characteristics and estimated a contemporary “real-world” treatment effect of 30 vs. 12 months of DAPT after coronary stent procedures. Results: The US DES-treated trial cohort included 8864 DAPT Study patients and the registry cohort included 568,540 patients. Compared to the trial population, registry patients had more comorbidities and were more likely to present with myocardial infarction and receive 2nd generation DES. After reweighting trial results to represent the registry population, there was no longer a significant effect of prolonged DAPT on reducing stent thrombosis (reweighted treatment effect: -0.40, 95% CI: -0.99%, 0.15%), MACCE ( reweighted treatment effect: -0.52, 95% CI: -2.62%, 1.03%), or MI (reweighted treatment effect: -0.97%, 95% CI: -2.75%, 0.18%), but the increase in bleeding with prolonged DAPT persisted (reweighted treatment effect: 2.42%, 95% CI: 0.79%, 3.91%). Conclusions: Differences between patients and devices used in contemporary clinical practice compared with the DAPT Study may be associated with attenuation of benefits and relatively greater harms attributable to prolonged DAPT duration. These findings may limit applicability of average treatment effects from the DAPT Study in modern clinical practice.

Abstract 9914: Three Months vs 12-Months Dual Antiplatelet Therapy Duration in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

Introduction: Recent American Heart Association/American College of Cardiology guidelines on duration of dual antiplatelet therapy (DAPT) recommend DAPT for 12 months in patients presenting with an acute coronary syndrome (ACS) who underwent percutaneous intervention (PCI) (grade IIb recommendation). With the advent of newer generation stents, multiple randomized controlled trials (RCTs) have studied the role of short term -3 months DAPT compared to the guideline-indicated12 months DAPT. We aim to assess the evidence using a meta-analytic approach. Methods: PubMed, Embase and Cochrane Central databases were searched from inception until May 31, 2021. RCTs comparing short term (3 months) vs extended (12 months) DAPT in patients with ACS undergoing PCI were included. Outcomes assessed were MACE, cardiovascular mortality, all-cause mortality, myocardial infarction, stent thrombosis and bleeding events. A random-effects model was used to calculate pooled relative risk (RR) and 95% confidence intervals (CI). Results: We included 5 trials comprising 16,781 patients with an acute coronary syndrome that underwent percutaneous intervention. There was no significant difference in MACE (RR 0.92; 95% CI, 0.76-1.11), cardiovascular mortality (RR 1.26; 95% CI, 0.38-4.17), or all-cause mortality (RR 0.92; 95% CI, 0.48-1.77) between the 2 groups. In addition, there was no difference in rates of myocardial infarction (RR 0.98; 95% CI, 0.74-1.30), or stent thrombosis (RR 1.30; 95% CI, 0.55-3.05) between short-term and extended DAPT. However, compared with extended DAPT, 3-month DAPT showed significantly reduced risk of major bleeding (RR 0.53; 95% CI, 0.43-0.64). Conclusions: In patients with acute coronary syndrome undergoing PCI, short term DAPT may be reasonable for some patients, while extended DAPT may be appropriate for select others. An individualized approach on optimal DAPT duration should be used considering the risks of ischemic events and bleeding.