Months Of Dual Antiplatelet Therapy Research Articles

Ticagrelor with or without aspirin following percutaneous coronary intervention in high-risk patients with concomitant peripheral artery disease: A subgroup analysis of the TWILIGHT randomized clinical trial

The optimal antiplatelet regimen after percutaneous coronary intervention (PCI) in patients with peripheral artery disease (PAD) is still debated. This analysis aimed to compare the effect of ticagrelor monotherapy versus ticagrelor plus aspirin in patients with PAD undergoing PCI. In the TWILIGHT trial, patients at high ischemic or bleeding risk that underwent PCI were randomized after 3 months of dual antiplatelet therapy (DAPT) to aspirin or matching placebo in addition to open-label ticagrelor for 12 additional months. In this post-hoc analysis, patient cohorts were examined according to the presence or absence of PAD. The primary endpoint was Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding. The key secondary endpoint was a composite of all-cause death, myocardial infarction (MI), or stroke. Endpoints were assessed at 12 months after randomization. Among 7,119 patients, 489 (7%) had PAD and were older, more likely to have comorbidities, and multivessel disease. PAD patients had more bleeding or ischemic complications than no-PAD patients. Ticagrelor monotherapy compared to ticagrelor plus aspirin was associated with less BARC 2, 3, or 5 bleeding in PAD (4.6% vs 8.7%; HR 0.52; 95%CI 0.25-1.07) and no-PAD patients (4.0% vs 7.0%; HR 0.56; 95%CI 0.45-0.69; interaction P-value .830) and a similar risk of death, MI, or stroke in these 2 groups (interaction P-value .446). Despite their higher ischemic and bleeding risk, patients with PAD undergoing PCI derived a consistent benefit from ticagrelor monotherapy after 3 months of DAPT in terms of bleeding reduction without any relevant increase in ischemic events. CLINICAL TRIAL REGISTRY INFORMATION:: https://www. gov/study/NCT02270242.

Prolonged Dual Antiplatelet Therapy in Acute Myocardial Infarction Patients Without Revascularization: China Acute Myocardial Infarction Registry Study

At least 12-month dual antiplatelet therapy (DAPT) is one of the standards of care following Percutaneous Coronary Intervention (PCI) in patients with acute coronary syndrome. However, study on prolonged DAPT for acute myocardial infarction (AMI) patients without revascularization is limited. We studied 1744 AMI patients without revascularization from the China Acute Myocardial Infarction registry between January 2013 and September 2014. These patients were on DAPT and did not experience AMI, stroke, or bleeding events at 12-month follow-up. We divided them into two groups: 12-month DAPT group (DAPT for at least 12 months but less than 18 months) and 18-month DAPT group (DAPT for at least 18 months). The primary outcome is 24-month all-cause death. Overall, 1221 (70.0%) patients took DAPT for ≥12 months but <18 months, while 523 (30.0%) patients took DAPT for ≥18 months. The two groups had comparable proportions with high ischemic risk (27.0% vs. 25.6%, P = 0.5418), as well as high bleeding risk (29.0% vs. 28.5%, P = 0.8316). At 24 months, the all-cause mortality rate of 18-month DAPT group was significantly lower than that for 12-month DAPT group (3.7% vs 5.9%, P = 0.0471). Adjusted hazard ratio for all-cause death also showed statistical significance (0.59, 95% CI: 0.35-0.99, P = 0.0444). In conclusion, DAPT for at least 18 months appears to be associated with lower 24-month mortality for non-revascularization AMI patients without events within 12 months after onset.

After placement of a newer-generation drug-eluting coronary artery stent in a patient with a high bleeding risk, does one month of dual antiplatelet therapy effectively reduce the incidence of major bleeding while also maintaining stent effectiveness?

After placement of a newer-generation drug-eluting coronary artery stent in a patient with a high bleeding risk, does one month of dual antiplatelet therapy effectively reduce the incidence of major bleeding while also maintaining stent effectiveness?

Randomized evaluation of 5-month Ticagrelor monotherapy after 1-month dual-antiplatelet therapy in patients with acute coronary syndrome treated with drug-coated balloons: REC-CAGEFREE II trial rationale and design

BackgroundPatients treated with drug-coated balloons (DCB) have the theoretical advantage of adopting a low-intensity antiplatelet regimen due to the absence of struts and polymers. Nevertheless, the optimal antiplatelet strategy for patients undergoing DCB-only treatment remains a topic of debate and has not been investigated in randomized trials.MethodsThe REC-CAGEFREE II is an investigator-initiated, prospective, open-label, multi-center, randomized, non-inferiority trial aimed to enroll 1908 patients from ≥ 40 interventional cardiology centers in China to evaluate the non-inferiority of an antiplatelet regimen consisting of Aspirin plus Ticagrelor for one month, followed by five months Ticagrelor monotherapy, and then Aspirin monotherapy for six months (Experimental group) compared to the conventional treatment of Aspirin plus Ticagrelor for 12 months (Reference group) in patients with acute coronary syndrome (ACS) who have undergone percutaneous coronary intervention (PCI) using paclitaxel-coated balloons (DCB) exclusively. Participants will be randomly assigned to the Experimental or Reference group in a 1:1 ratio. The randomization will be stratified based on the center and the type of lesion being treated (De novo or in-stent restenosis). The primary endpoint is net adverse clinical events (NACE) within 12 months of PCI, which includes the composite of all-cause death, any stroke, any myocardial infarction, any revascularization and Bleeding Academic Research Consortium (BARC) defined type 3 or 5 bleeding. The secondary endpoint, any ischemic and bleeding event, which includes all-cause death, any stroke, MI, BARC-defined type 3 bleeding, any revascularization, and BARC-defined type 2 bleeding events, will be treated as having hierarchical clinical importance in the above order and analyzed using the win ratio method.DiscussionThe ongoing REC-CAGEFREE II trial aims to assess the efficacy and safety of a low-intensity antiplatelet approach among ACS patients with DCB. If non-inferiority is shown, the novel antiplatelet approach could provide an alternative treatment for ACS patients with DCB.Trial registrationClinicalTrials.gov identifier: NCT04971356.

1- Versus 3-Month DAPT in Older Patients at a High Bleeding Risk Undergoing PCI: Insights from the XIENCE Short DAPT Global Program

This analysis aimed to evaluate the effect of 1- versus 3-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in older patients. Data from three prospective, single-arm studies (XIENCE Short DAPT Program), including high bleeding risk (HBR) patients successfully treated with an everolimus-eluting stent (XIENCE, Abbott) were analyzed. DAPT was discontinued at 1 or at 3 months in patients free from ischemic events and adherent to DAPT. Patients were stratified according to age (≥75 and <75 years). The primary endpoint was all-cause death or myocardial infarction (MI). The key secondary endpoint was Bleeding Academic Research Consortium (BARC) type 2-5 bleeding. Outcomes were assessed from 1 to 12 months after index PCI. Out of 3,364 patients, 2,241 (66.6%) were ≥75 years old. The risk of death or MI was similar with 1- vs 3-month DAPT in patients ≥75 (8.5% vs 8.0%, adjusted HR 0.95, 95% CI 0.69-1.30) and <75 years old (6.9% vs 7.8%, adjusted HR 0.97, 95% CI 0.60-1.57; interaction p-value 0.478). BARC type 2-5 bleeding was consistently lower with 1- than with 3-month DAPT in patients ≥75 years old (7.2% vs 9.4%, adjusted HR 0.66, 95% CI 0.48-0.91) and <75 years old (9.7% vs 11.9%, adjusted HR 0.86, 95% CI 0.57-1.29; interaction p-value 0.737). In conclusion, among HBR patients undergoing PCI, patients older and younger than 75 years of age derived a consistent benefit from 1- as compared with 3-month DAPT in terms of bleeding reduction with no increase in all-cause death or MI at 1 year.

Progression of Gastrointestinal Injury During Antiplatelet Therapy After Percutaneous Coronary Intervention

Gastrointestinal injury progression induced by antiplatelet therapy in patients after percutaneous coronary intervention (PCI) has not been well studied. To assess the association of aspirin, clopidogrel, and their combination with gastrointestinal injury progression among patients without high bleeding risk after PCI. This secondary analysis assessed data from the Optimal Antiplatelet Therapy for Prevention of Gastrointestinal Injury Evaluated by ANKON Magnetically Controlled Capsule Endoscopy (OPT-PEACE) double-masked, placebo-controlled, multicenter randomized clinical trial. The OPT-PEACE trial was conducted at 28 centers in China, and recruitment took place from July 13, 2017, to July 13, 2019. The trial included patients with stable coronary artery disease or acute coronary syndromes without ST-segment elevation after PCI. Statistical analysis was conducted from September 13, 2022, to January 23, 2023. Patients underwent magnetically controlled capsule endoscopy (MCE) at baseline and after 6 months of dual antiplatelet therapy (DAPT) with aspirin (100 mg/d) plus clopidogrel (75 mg/d). Those with no evidence of gastrointestinal ulcers or bleeding (ie, the intention-to-treat [ITT] cohort) were randomized (1:1:1) to aspirin (100 mg/d) plus matching placebo (aspirin alone), clopidogrel (75 mg/d) plus matching placebo (clopidogrel alone), or DAPT for an additional 6 months. A third MCE was performed 12 months after PCI. The primary outcome was the rate of gastric injury progression as assessed with the results of the 3 MCEs (at baseline, 6 months, and 12 months) in the modified intention-to-treat (mITT) population. The key secondary outcome was the rate of small-intestinal injury progression. Gastric or small-intestinal injury progression was defined as a quantitative increase in erosions or ulcers between the second and third MCEs (at 6 and 12 months, respectively). This study included the 394 patients in the mITT cohort. Their mean (SD) age was 56.9 (8.7) years, and most were men (296 [75.1%]). A total of 132 patients were randomized to aspirin alone, 132 to clopidogrel alone, and 130 to DAPT. Gastric injury progression occurred in 49 aspirin users (37.1%), 64 clopidogrel users (48.5%), and 69 DAPT users (53.1%) (P = .02), reflecting a lower rate of gastric injury progression among aspirin users vs DAPT users (risk ratio [RR], 0.70 [95% CI, 0.49-0.99]; P = .009). No significant difference was observed between clopidogrel alone and DAPT (48.5% vs 53.1%; P = .46) or between aspirin alone and clopidogrel alone (37.1% vs 48.5%; P = .06). A total of 51 aspirin users (38.6%), 65 clopidogrel users (49.2%), and 71 DAPT users (54.6%) (P = .03) developed progressive small-intestinal injury, reflecting a lower rate of small-intestinal injury among aspirin users vs DAPT users (RR, 0.71 [95% CI, 0.50-0.99]; P = .01). No difference was observed between patients treated with clopidogrel vs DAPT (49.2% vs 54.6%; P = .38) or with aspirin vs clopidogrel (38.6% vs 49.2%; P = .08). In this secondary analysis of a randomized clinical trial, ongoing use of aspirin, clopidogrel, or their combination between 6 and 12 months after PCI was associated with progressive gastric and small-intestinal injury in a substantial proportion of patients, more so with DAPT than with monotherapy. Clopidogrel was at least as likely as aspirin to induce gastrointestinal injury progression. Future research is warranted to determine what impact the findings from MCEs would have on decision-making of antiplatelet therapy. ClinicalTrials.gov Identifier: NCT03198741.

A meta-analysis on the efficacy of ticagrelor monotherapy after 3 months of dual antiplatelet therapy vs ticagrelor plus aspirin dual therapy on patients with ACS who underwent PCI

Abstract Background Major adverse cardiovascular events remain the major cause of mortality and morbidity after acute coronary syndrome, including patients who underwent percutaneous coronary intervention. Several studies have shown increased incidence of re-infarction, cardiac death, stroke, stent thrombosis, and all-cause mortality among these patients. The use of dual antiplatelet therapy has been recommended for post-procedural patients, according to guidelines. However, prolonged exposure to dual antiplatelets raised concerns on risk of bleeding. Our study aims to determine whether short term dual antiplatelet therapy followed with Ticagrelor monotherapy will benefit patients who are at higher risk of bleeding. Objective To determine the efficacy of Ticagrelor monotherapy after three months of Dual Antiplatelet Therapy versus 12 months of Ticagrelor plus Aspirin dual therapy in the prevention of MACE and bleeding among patients who had ACS and have undergone PCI. METHODOLOGY Randomized controlled trials on Ticagrelor monotherapy vs Ticagrelor + Aspirin Dual Therapy with outcomes on myocardial infarction, cardiac death, stroke, stent thrombosis, bleeding, all-cause mortality, were searched through PubMed. Results A total of 10,175 participants who had Acute Coronary Syndrome who have undergone Percutaneous Coronary Intervention were included in this analysis. Our results showed that discontinuing Aspirin after 3 months of Dual antiplatelet was not associated with significant increase in the risk of Major Adverse Cardiovascular Events: Myocardial Infarction (RR 0.96 95% CI 0.73-1.25), Cardiac Death (RR 0.92 95% CI 0.74-1.14), Stroke (RR 1.27 95% CI 0.69 -2.31), Stent Thrombosis (RR 0.87, 95% CI 0.48-1.59), Bleeding (RR 0.58 , 95% CI 0.49- 0.69) and All Cause Death (RR 0.77, 95% CI 0.52 – 1.14). Discontinuing Aspirin 3 months was associated with lower risk of bleeding (RR 0.58, 95% CI 0.49 - 0.69). Conclusion Minimizing the duration of exposure to antiplatelet agents with the use of Ticagrelor monotherapy after three months of DAPT among ACS patients who underwent PCI significantly reduced the incidence of bleeding, particularly among those who are at higher risk of bleeding. There is no significant difference in the risk for myocardial infarction, cardiac-related deaths, stroke, stent thrombosis, and all-cause mortality between the two groups.

Parsimonious versus extensive score: can we simplify bleeding risk stratification after percutaneous coronary intervention without losing specificity?

Abstract Background/Introduction Prediction of bleeding risk in patients receiving dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) has been repeatedly attempted and resulted in multiple risk models. To promote the adoption and use of risk stratification among clinicians, a consortium in the South East of the Netherlands, the "ZON-HR", has created a simple binary variant of the existing logistic models. This model includes commonly available factors which can be incorporated into the PCI report to generate stratification. In this "parsimonious" model, high bleeding risk (HBR) is stratified according to: history of intracranial haemorrhage, previous spontaneous bleeding, Hb &amp;lt; 11 g/dL, eGFR&amp;lt; 30. Purpose We aimed to perform an external validation of our model for bleeding risk and to demonstrate its discriminative value in comparison with the PRECISE DAPT score, an acknowledged risk score. Methods We performed a post hoc analysis of the GLOBAL LEADERS trial, a multicenter randomized trial, comparing ticagrelor monotherapy after one month of DAPT with standard DAPT after PCI. We stratified the patients for HBR according to the ZON-HR or a PRECISE-DAPT score ≥ 25. Bleeding events one year after PCI were compared in the entire population and in subgroups for chronic coronary syndrome (CCS), acute coronary syndrome (ACS), Ticagrelor monotherapy and DAPT. Results Of the 15968 patients included in GLOBAL LEADERS, 1059 patients were excluded due to missing variables required for either model. Among the 14909 patients, 17% had HBR according to the PRECISE DAPT score, 4% according to ZON-HR and 3% according to both. Bleeding events occurred in 8.5% and 13% of HBR defined by PRECISE DAPT or ZON-HR respectively. Patients with HBR according to both models showed 13% bleedings as opposed to 5% in non-HBR. Table 1 presents the sensitivity and specificity. Regression analysis (figure 1) demonstrated that patients with HBR according to either model have significantly more bleedings. This was also significant in all subgroups except for ACS patients receiving standard DAPT when the ZON-HR model was used. Conclusion The ZON-HR model is more conservative compared to the PRECISE DAPT score as depicted by the sensitivity and specificity. This can be explained by the larger number of risk factors used in the PRECISE DAPT score that cumulatively contributes to the sensitivity as opposed to the binary ZON-HR model which is more specific. However, the survival curves and hazard ratios showed good predictive value of both models for bleeding risk in the overall population.Table 1.Figure 1.

Meta-analysis of 3-month vs 12-month dual anti-platelet therapy after percutaneous coronary intervention

Abstract Background The optimal duration of dual antiplatelet therapy (DAPT) in the era of second generation drug-eluting stents is a matter of debate as increasing evidence suggests that shorter periods of DAPT are feasible and reduce bleeding events. However, the non-inferiority design of the published trials regarding ischemic events still raises doubt on its effectiveness. Methods We performed a meta-analysis to evaluate short-term (≤ 3 months) vs long-term (≥ 12 months) DAPT after percutaneous coronary intervention (PCI). PubMed, Embase and Cochrane Central were searched from inception to February 2023 to identify randomized controlled trials that compared outcomes of patients between these two regimens. Primary outcome of interest included a composite of ischemic events (cardiovascular death, myocardial infarction, re-revascularization and stroke) and secondary outcome was major bleeding as assessed by Bleeding Academic Research Consortium (BARC) classification ≥ 3 after 1 year of follow up. Event rates were extracted and Mantel-Haenszel fixed-effects model was used to perform the meta-analysis. Results We identified a total of 5 trials with 18.682 randomized patients. The use of short-term DAPT was not associated with increased risk of ischemic events (0.90 [0.75-1.08], p=0.250; Figure 1) and was associated with reduced risk of major bleeding (0.74 [0.65-0.84], p&amp;lt;0.001; Figure 2). Conclusion The present meta-analysis provides an updated data on the use of DAPT duration. Short-term DAPT appears to be equivalent to long-term DAPT regarding ischemic risk and a superior strategy in optimizing bleeding risk reduction.Forest plot of ischemic outcomesForest plot of bleeding outcomes

Abstract 14885: Updated Meta-Analysis of 1 Month versus Greater Than 1 Month of Dual Anti-Platelet Therapy (DAPT) After Percutaneous Coronary Intervention Supports Shorter DAPT Duration

Introduction: The ideal duration of dual anti-platelet therapy (DAPT) after percutaneous coronary intervention (PCI) remains elusive, a balancing act between bleeding and ischemic risks. Recent evidence suggests a shorter duration may be safe. This updated meta-analysis evaluates the safety and efficacy of 1 month of DAPT in patients after PCI with a drug eluting stent. Hypothesis: 1 month of DAPT will be more favorable than greater than 1 month of DAPT Methods: This meta-analysis reviewed literature obtained systematically. Inclusion criteria encompassed randomized study designs comparing the efficacy of 1-month DAPT versus greater than 1-month of DAPT treatment in patients with PCI for stable coronary artery disease (CAD) or acute coronary syndrome (ACS), minimum follow-up of 12 months, and full-text studies published in peer-reviewed journals. Exclusion criteria include studies that did not include DAPT longer than 1-month, non-randomized studies, unpublished studies, and ongoing trials. We reviewed 96 articles; 7 were included in our meta-analysis. We included 2 more studies compared to the most recent meta-analysis. Our statistical analysis calculated weighted pooled risk ratios, confidence intervals, and p-values using the Mantel-Haenszel method. Results: The sample size was 24,412. The primary outcome of overall mortality favored 1 month of DAPT compared to greater than one month DAPT [RR 0.57, (CI 0.48-0.66) P&lt;0.00001]. The secondary outcomes of cardiovascular death [RR 0.68, (CI 0.56-0.83) P=0.0001] and bleeding [RR 0.70, (CI 0.63-0.78) P&lt;0.00001) favored 1 month of DAPT compared to greater than 1 month of DAPT. The secondary outcome of myocardial infarction [RR 1.25, (CI 1.08-1.44) P=0.002] favored greater than 1 month of DAPT compared to 1 month of DAPT. Stent thrombosis [RR 1.21, (CI 0.84-1.74) P= 0.31] did not meet statistical significance. Conclusions: Our meta-analysis suggests that 1 month of DAPT was associated with improved overall mortality, cardiovascular death and bleeding, at the expense of increased myocardial infarction. One month of DAPT is a reasonable treatment option for high bleeding risk patients undergoing PCI.

Abstract 15324: Biodegradable Polymer Ultrathin Sirolimus-Eluting Stent is Associated With Better Outcomes Compared With Polymer-Free Ultrathin Sirulimus-Eluting Stent in Complex Percutaneous Coronary Intervention: A Post Hoc Analysis of the HOST-IDEA Randomized Clinical Trial

Introduction: Third generation drug-eluting stents with ultrathin struts and advanced polymer technology have been introduced. However, their safety and efficacy have not been fully elucidated, particularly in complex percutaneous intervention (PCI). Aim To investigate the clinical outcomes of complex PCI using the Coroflex ISAR polymer-free sirolimus-eluting stent (SES) or Orsiro biodegradable polymer SES. Methods: This study was a post-hoc analysis of the HOST-IDEA trial that randomly assigned 2,013 patients undergoing PCI with Orsiro or Coroflex ISAR into either 3-month dual antiplatelet therapy (DAPT) or 12-month DAPT arms from January 2016 to May 2021 at 37 centers in South Korea. We compared a 1:1 propensity score (PS)–matched cohort balanced by patient and procedural characteristics. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization at 1 year. Complex PCI was defined as any of the following features: ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI, total stent length ≥ 60 mm, left main PCI, or heavy calcification. Results: After PS matching, baseline patient and procedural characteristics were balanced between Coroflex ISAR and Orsiro groups (n=542 in each). Complex PCI was significantly associated with a higher rate of TLF compared with non-complex PCI (5.3% vs. 1.1%, hazard ratio (HR) 5.12 [95% confidence interval (CI) 2.21-11.86], P&lt;0.001). Compared with the Coroflex ISAR SES, the better outcomes of TLF associated with the Orsiro SES was more pronounced in the complex PCI group (HR 0.14 [95% CI 0.03-0.60], P =0.008 in complex PCI; HR 0.99 [95% CI 0.25-3.98], P =0.993 in non-complex PCI; P for interaction 0.054). Conclusion In patients undergoing complex PCI with third-generation DES, the Orsiro SES was associated with significantly better outcomes in terms of TLF than the Coroflex ISAR SES.

Duration of Dual Antiplatelet Treatment After Percutaneous Coronary Intervention in Patients With Diabetes: A Systematic Review and Meta-analysis.

Aim of our systematic review and meta-analysis is to compare shortened (≤3 months) dual antiplatelet therapy (DAPT) with longer DAPT in diabetic patients undergoing percutaneous coronary interventions.We systematically screened 3 major databases (MEDLINE, Cochrane Central Register of Controlled Trials, and Scopus) searching for randomized-controlled trials or subanalyses of them, which compared shortened DAPT (S-DAPT) with longer DAPT regimens of DAPT. Primary end point of systematic review and meta-analysis is the net adverse clinical events (NACE), and secondary are major adverse cardiac events (MACE), mortality, bleedings, myocardial infarction, and stent thrombosis. Subgroup analyses included studies using only ticagrelor-based regimens and 3-month duration of DAPT.A total of 8 studies and 12,665 patients were included in our analysis. Our meta-analysis met its primary end point because S-DAPT was associated significantly with a reduced risk ratio (RR) by 17% [RR: 0.83, 95% confidence intervals (CI), 0.72-0.96]. Nonsignificant difference among the rest end points was detected between the 2 groups. Subgroup analyses showed that ticagrelor-based regimens were associated with a significant reduction of mortality (RR: 0.67, 95% CI, 0.48-0.93) and 3-month DAPT reduced furtherly NACE by 27% (RR: 0.73, 95% CI, 0.60-0.89).In conclusion, our systematic review and meta-analysis showed that (i) S-DAPT was significantly associated with a lower incidence of NACE, (ii) ticagrelor-based S-DAPT was associated with decreased mortality rates, and (iii) the benefit of 3-month duration of DAPT achieved an even greater NACE reduction. Thus, S-DAPT could be considered as a safe and feasible option in diabetic patients.

Short duration of dual antiplatelet therapy following complex percutaneous coronary intervention: A systematic review and meta-analysis

Introduction and aimThe optimal composition and duration of antiplatelet therapy after complex percutaneous coronary intervention (PCI) remains unclear. We conducted a meta-analysis to compare 1–3 months of dual antiplatelet therapy (DAPT) followed by monotherapy vs. 12 months of DAPT. MethodMEDLINE/PubMed, EMBASE, and Cochrane Central Register of Controlled Trials were queried for studies comparing 1–3 months of DAPT followed by monotherapy vs. 12 months of DAPT in the outcomes of complex PCI from inception through January 2023. Outcomes of interest included major bleeding, all-cause mortality, cardiovascular mortality, myocardial infarction (MI), stent thrombosis, target vessel revascularization, and stroke. ResultsCompared to 12 months, 1–3 months of dual antiplatelet therapy had a weak association with less major bleeding (OR 0.67; 95 % CI, 0.44–1.00; p = 0.05; I2 = 28 %). There were no significant differences between the shorter and longer antiplatelet therapy in terms of all-cause mortality (OR 0.83; 95 % CI, 0.59–1.16; p = 0.21; I2 = 17 %), cardiovascular mortality (OR 0.87; 95 % CI, 0.53–0.42; p = 0.50; I2 = 0), MI (OR 0.97; 95 % CI, 0.69–1.35; p = 0.82; I2 = 32 %), stent thrombosis (OR 1.17, 95 % CI, 0.77–1.76; p = 0.38; I2 = 0 %), target vessel revascularization (OR 1.05, 95 % CI, 0.58–1.89; p = 0.82; I2 = 64 %), or stroke (OR 1.10, 95 % CI, 0.55–2.17; p = 0.37; I2 = 7 %);. ConclusionAmong patients undergoing complex PCI, DAPT for 1–3 months may be associated with less major bleeding but similar rates of cardiovascular events (death, MI, stroke, stent thrombosis, and revascularization) compared to DAPT for 12 months.

Clopidogrel vs Aspirin Monotherapy Beyond 1 Year After Percutaneous Coronary Intervention

BackgroundIt remains unclear whether clopidogrel is better suited than aspirin as the long-term antiplatelet monotherapy following dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). ObjectivesThis study compared clopidogrel monotherapy following 1 month of DAPT (clopidogrel group) with aspirin monotherapy following 12 months of DAPT (aspirin group) after PCI for 5 years. MethodsSTOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy 2) is a multicenter, open-label, adjudicator-blinded, randomized clinical trial conducted in Japan. Patients who underwent PCI with cobalt-chromium everolimus-eluting stents were randomized in a 1-to-1 fashion either to clopidogrel or aspirin groups. The primary endpoint was a composite of cardiovascular outcomes (cardiovascular death, myocardial infarction, stroke, or definite stent thrombosis) or major bleeding (TIMI major or minor bleeding). ResultsAmong 3,005 study patients (age: 68.6 ± 10.7 years; women: 22.3%; acute coronary syndrome: 38.3%), 2,934 patients (97.6%) completed the 5-year follow-up (adherence to the study drugs at 395 days: 84.7% and 75.9%). The clopidogrel group compared with the aspirin group was noninferior but not superior for the primary endpoint (11.75% and 13.57%, respectively; HR: 0.85; 95% CI: 0.70-1.05; Pnoninferiority < 0.001; Psuperiority = 0.13), whereas it was superior for the cardiovascular outcomes (8.61% and 11.05%, respectively; HR: 0.77; 95% CI: 0.61-0.97; P = 0.03) and not superior for major bleeding (4.44% and 4.92%, respectively; HR: 0.89; 95% CI: 0.64-1.25; P = 0.51). By the 1-year landmark analysis, clopidogrel was numerically, but not significantly, superior to aspirin for cardiovascular events (6.79% and 8.68%, respectively; HR: 0.77; 95% CI: 0.59-1.01; P = 0.06) without difference in major bleeding (3.99% and 3.32%, respectively; HR: 1.23; 95% CI: 0.84-1.81; P = 0.31). ConclusionsClopidogrel might be an attractive alternative to aspirin with a borderline ischemic benefit beyond 1 year after PCI.

Duration of dual-antiplatelet therapy after stent-assisted coil for unruptured intracranial aneurysm: A nationwide cohort study.

Stent-assisted coil (SAC) is increasingly used to treat unruptured intracranial aneurysm (UIA). However, the optimal duration of dual-antiplatelet therapy (DAPT) after SAC insertion remains unknown. To assess the time-dependent effect of DAPT on the risk of ischemic and hemorrhagic complications after SAC. This is a retrospective cohort study among patients with UIA treated with SAC using the nationwide health claims database in South Korea between 2009 and 2020. Multivariate Cox regression analysis was used, which included the use of DAPT as a time-dependent variable. The effect of DAPT was investigated for each period of "within 90 days," "91 to 180 days," "181 to 365 days," and "366 to 730 days" after SAC. The primary outcome was a composite of ischemic stroke and major bleeding in each period within two years after SAC. Of the 15,918 patients, mean age at SAC was 57.6 ± 10.8 years, and 3815 (24.0%) were men. The proportion of patients on DAPT was 79.4% at 90 days, 58.3% at 180 days, and 28.9% at 1 year after SAC. During the 2 years after SAC, the primary composite outcome occurred in 356 patients (2.2%). DAPT significantly reduced the primary composite outcome within 90 days after SAC (adjusted hazard ratio (aHR), 0.44; 95% confidence interval (CI), 0.28-0.69; p < 0.001); however, this was not the case after 90 days (all p > 0.05). DAPT reduced ischemic stroke risk within 90 days (aHR, 0.31; 95% CI 0.18-0.54; p < 0.001), and 91 to 180 days after SAC (aHR 0.40; 95% CI 0.18-0.88; p = 0.022); however, after 180 days, DAPT was no longer beneficial. In patients with UIA treated with SAC, 3 months of DAPT was associated with a decreased risk of the composite of ischemic and hemorrhagic complications.

A novel noble metal stent coating reduces in vitro platelet activation and acute in vivo thrombosis formation: a blinded study

Inherent to any stenting procedure is the prescription of dual antiplatelet therapy (DAPT) to reduce the platelet response. Clinical guidelines recommend 6–12 months of DAPT, depending on stent type, clinical picture and patient factors. Our hypothesis is that a nanostructured noble metal coating has the potential to reduce protein deposition and platelet activation. These effects would reduce subsequent thrombo-inflammatory reactions, potentially mitigating the need for an extensive DAPT in the acute phase. Here, a noble metal nanostructure coating on stents is investigated. Twelve pigs underwent endovascular implantation of coated and non-coated stents for paired comparisons in a blinded study design. The non-coated control stent was placed at the contralateral corresponding artery. Volumetric analysis of angiographic data, performed by a treatment blinded assessor, demonstrated a significant thrombus reduction for one of the coatings compared to control. This effect was already seen one hour after implantation. This finding was supported by in vitro data showing a significant reduction of coagulation activation in the coated group. This novel coating shows promise as an implant material addition and could potentially decrease the need for DAPT in the early phases of stent implementation.

1- or 3-Month DAPT in Patients With HBR With or Without Oral Anticoagulant Therapy After PCI

BackgroundThe optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in patients on long-term oral anticoagulation (OAC) therapy is still uncertain. ObjectivesThe aim of this analysis was to assess the effects of 1- vs 3-month DAPT in patients with and those without concomitant OAC included in the XIENCE Short DAPT program. MethodsThe XIENCE Short DAPT program enrolled patients with high bleeding risk who underwent successful PCI with a cobalt-chromium everolimus-eluting stent. DAPT was discontinued at 1 or 3 months in patients free from ischemic events and adherent to treatment. The effect of 1- vs 3-month DAPT was compared in patients with and those without OAC using propensity score stratification. The primary endpoint was all-cause death or any myocardial infarction (MI). The key secondary endpoint was Bleeding Academic Research Consortium (BARC) types 2 to 5 bleeding. Outcomes were assessed from 1 to 12 months after index PCI. ResultsAmong 3,364 event-free patients, 1,462 (43%) were on OAC. Among OAC patients, the risk for death or MI was similar between 1- and 3-month DAPT (7.4% vs 8.8%; adjusted HR: 0.74; 95% CI: 0.49-1.11; P = 0.139), whereas BARC types 2 to 5 bleeding was lower with 1-month DAPT (adjusted HR: 0.71; 95% CI: 0.51-0.99; P = 0.046). These effects were consistent in patients with and those without OAC (P for interaction = NS). ConclusionsBetween 1 and 12 months after PCI, 1-month compared with 3-month DAPT was associated with similar rates of all-cause death or MI and a reduced rate of BARC types 2 to 5 bleeding, irrespective of OAC treatment.

TCT-37 The Association of CHADS-P2A2RC Risk Score With Clinical Outcomes in Patients Taking P2Y12 Inhibitor Monotherapy After 3 Months of Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention

TCT-37 The Association of CHADS-P2A2RC Risk Score With Clinical Outcomes in Patients Taking P2Y12 Inhibitor Monotherapy After 3 Months of Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention

TCT-706 3- to 6-Month vs 12-Month Dual Antiplatelet Therapy After Drug-Eluting Stent Placement: An Updated Meta-Analysis

TCT-706 3- to 6-Month vs 12-Month Dual Antiplatelet Therapy After Drug-Eluting Stent Placement: An Updated Meta-Analysis

One-Month Dual Antiplatelet Therapy in Patients With Chronic and Acute Coronary Syndromes Treated With Bioresorbable Polymer Everolimus-Eluting Stents

There is a paucity of data regarding the safety of a 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in patients at high bleeding risk (HBR) presenting with acute coronary syndromes (ACS). We aimed to compare the clinical outcomes of patients at HBR with chronic coronary syndrome (CCS) or ACS treated with PCI using bioresorbable polymer everolimus-eluting stent (BP-EES) followed by 1-month DAPT. Patients at HBR who underwent PCI with BP-EES were prospectively enrolled in 10 Italian centers. All patients were treated with 1-month DAPT. In case of need for anticoagulation, patients received an oral anticoagulant in addition to a P2Y12 inhibitor for 1month, followed by oral anticoagulation only after that. The primary end point was a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis at 12months. Overall, 263 patients (59.4%) with CCS and 180 patients (40.6%) with ACS were enrolled. No significant difference was evident between patients with CCS and ACS for the primary end point (4.3% vs 5.6%, respectively, p=0.497) and for each isolated component. The risk for Bleeding Academic Research Consortium (BARC) type 1 to 5 or type 3 to 5 bleedings was also similar between patients with CCS and ACS (4.3% vs 5.2%, p=0.677, and 1.6% vs 2.9%, p=0.351, respectively). In conclusion, among HBR patients with ACS who underwent PCI with BP-EES, a 1-month DAPT strategy is associated with a similar risk of ischemic and bleeding events compared with those with CCS.