Period Of Dual Antiplatelet Therapy Research Articles

One-month DAPT after biodegradable-polymer everolimus-eluting stent implantation in women at high-bleeding risk: Insights from the POEM trial.

We conducted a prespecified subanalysis of the POEM trial to assess the association between sex and clinical outcomes following a short 1-month dual-antiplatelet-therapy (DAPT) period after percutaneous coronary intervention (PCI) with bioresorbable polymer everolimus-eluting stent (BP-EES) among patients at high bleeding risk (HBR). Shortening the DAPT period after PCI is an effective bleeding avoidance strategy with contemporary drug-eluting stents. Whether sex affects the risk of adverse events following PCI is still debated. Patients at HBR undergoing PCI with BP-EES were enrolled and treated with 1-month DAPT. If anticoagulation was needed, study participants received an oral anticoagulant (OAC) in addition to a P2Y12 inhibitor for 1 month, followed by OAC only thereafter. The primary endpoint was a composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis at 12 months. We report sex-based outcomes of patients included in the POEM study. We enrolled 129 (29.1%) women and 314 (70.9%) men. Women were older, with lower hemoglobin levels, and worse renal function. Accordingly, they had a trend for a greater number of HBR criteria fulfilled and a higher PARIS bleeding score. However, they were not at a significantly higher risk for the primary endpoint (men vs. women: 5.17% vs. 3.94%; HR 1.30; 95% CI: 0.48-3.54, p = 0.61), or any of the hemorrhagic and ischemic secondary endpoints. This prespecified subanalysis of the POEM trial suggests that 1-month DAPT following PCI with BP-EES may be a safe and effective therapeutic strategy for women at HBR.

Neoadjuvant therapy bridging percutaneous coronary intervention (PCI) and video-assisted thoracoscopic (VATS) lobectomy: a retrospective study.

Currently, there is no unified standard for the treatment of coronary artery disease (CAD) in non-small cell lung cancer (NSCLC), and the treatments have their own advantages and disadvantages. Thus, this study aimed to analyze the safety and feasibility of neoadjuvant therapy during the dual antiplatelet therapy (DAPT) period before surgery in patients with NSCLC coexisting with CAD after percutaneous coronary intervention (PCI) treatment. We retrospectively included 13 patients with T2aN0M0 (stage IB) NSCLC who also had concomitant CAD. After PCI treatment, neoadjuvant targeted or immunotherapy was administered based on the type of lung cancer, and the effects on treatment and impact on surgery were observed. The objective response rate (ORR) after neoadjuvant treatment in 13 patients was 53.8% [95% confidence interval (CI): 25.1-80.8%], and the disease control rate (DCR) reached 100%. Ten patients (76.9%) experienced adverse events (AEs) ≤ grade 2. All patients underwent standard VATS lobectomy with lymph node dissection. One case (7.7%) required conversion to open thoracotomy, and all cases achieved R0 resection. The median operative time was 150 [interquartile range (IQR) 125-250] minutes, median intraoperative blood loss was 180 (IQR 150-235) mL, median postoperative drainage tube placement time was 4 (IQR 3-5) days, median total drainage volume was 1,310 (IQR 780-1,705) mL, and the median postoperative hospitalization was 7 (IQR 7-8) days. One patient (7.7%) experienced rapid atrial fibrillation. No deaths occurred. Postoperative pathological evaluation in three cases achieved major pathological response (MPR) (23.1%, 95% CI: 5-53.8%), with two cases achieving pathological complete response (pCR) (15.4%, 95% CI: 1.9-45.4%). The study presents initial evidence suggesting for the safety and feasibility of performing PCI treatment followed by neoadjuvant therapy during the DAPT period for patients with T2aN0M0 (IB) stage NSCLC coexisting with CAD. This approach presents a potential treatment option to control the disease while eliminating concerns about tumor progression and metastasis.

Relation between duration of dual antiplatelet therapy and risk of ischemic stroke after stent-assisted treatment of cerebral aneurysm (DAPTS ACE-registry)

BackgroundThe optimal duration of dual antiplatelet therapy (DAPT) in patients with cerebral aneurysm who undergo stent-assisted coil embolization (SACE) has not been established. We aimed to clarify the association between...

Extended Clopidogrel Monotherapy vs DAPT in Patients With Acute Coronary Syndromes at High Ischemic and Bleeding Risk

Purinergic receptor P2Y12 (P2Y12) inhibitor monotherapy after a certain period of dual antiplatelet therapy (DAPT) may be an attractive option of maintenance antiplatelet treatment for patients undergoing percutaneous coronary intervention (PCI) who are at both high bleeding and ischemic risk (birisk). To determine if extended P2Y12 inhibitor monotherapy with clopidogrel is superior to ongoing DAPT with aspirin and clopidogrel after 9 to 12 months of DAPT after PCI in birisk patients with acute coronary syndromes (ACS). This was a multicenter, double-blind, placebo-controlled, randomized clinical trial including birisk patients with ACS who had completed 9 to 12 months of DAPT after drug-eluting stent implantation and were free from adverse events for at least 6 months at 101 China centers between February 2018 and December 2020. Study data were analyzed from April 2023 to May 2023. Patients were randomized either to clopidogrel plus placebo or clopidogrel plus aspirin for an additional 9 months. The primary end point was Bleeding Academic Research Consortium (BARC) types 2, 3, or 5 bleeding 9 months after randomization. The key secondary end point was major adverse cardiac and cerebral events (MACCE; the composite of all-cause death, myocardial infarction, stroke or clinically driven revascularization). The primary end point was tested for superiority, and the MACCE end point was tested for sequential noninferiority and superiority. A total of 7758 patients (mean [SD] age, 64.8 [9.0] years; 4575 male [59.0%]) were included in this study. The primary end point of BARC types 2, 3, or 5 bleeding occurred in 95 of 3873 patients (2.5%) assigned to clopidogrel plus placebo and 127 of 3885 patients (3.3%) assigned to clopidogrel plus aspirin (hazard ratio [HR], 0.75; 95% CI, 0.57-0.97; difference, -0.8%; 95% CI, -1.6% to -0.1%; P = .03). The incidence of MACCE was 2.6% (101 of 3873 patients) in the clopidogrel plus placebo group and 3.5% (136 of 3885 patients) in the clopidogrel plus aspirin group (HR, 0.74; 95% CI, 0.57-0.96; difference, -0.9%; 95% CI, -1.7% to -0.1%; P < .001 for noninferiority; P = .02 for superiority). Among birisk patients with ACS who completed 9 to 12 months of DAPT after drug-eluting stent implantation and were free from adverse events for at least 6 months before randomization, an extended 9-month clopidogrel monotherapy regimen was superior to continuing DAPT with clopidogrel in reducing clinically relevant bleeding without increasing ischemic events. ClinicalTrials.gov Identifier: NCT03431142.

Efficacy and safety of 3-month dual antiplatelet therapy in patients after mechanical thrombectomy for acute ischemic stroke: a retrospective study.

Mechanical thrombectomy (MT) is one of the effective treatment methods for acute ischemic stroke (AIS), which requires a period of dual antiplatelet therapy (DAPT) after endovascular treatment. This study aimed to compare the efficacy and safety of 3-month DAPT and 1-month DAPT in AIS patients receiving MT through a retrospective study. AIS patients who received MT from May 2018 to March 2023 were grouped into a 1-month group (1-M group) and a 3-month group (3-M group) according to the duration of DAPT after MT. The primary outcome was the mRS score at 90 days. Secondary outcomes included a good prognosis (mRS score of 0-2) at 90 days post-surgery, 6-month mortality, recurrence of cerebral infarction, Barthel's index, Montreal Cognitive Assessment (MoCA) score, and incidence of symptomatic intracranial hemorrhage (sICH) during hospitalization. A total of 147 patients with AIS were included in the final analysis, with 78 patients in the 1-M group and 69 patients in the 3-M group. The baseline and neurological characteristics were comparable between both groups. At 3-month follow-up, a total of 61 patients had an mRS of 0-2 at 90 days, with an average mRS of 3.3 ± 0.9 for all patients. There was no statistically significant difference in the mRS between the two groups of patients at 90 days (P > 0.05). There was no statistically significant difference in the mortality rate and incidence of sICH between the two groups of patients during the 6-month follow-up period (P > 0.05), but the recurrence rate of AIS in the 3-M group was lower than that in the 1-M group (P < 0.05). The improvement of Barthel index and MoCA in patients in the 3-M group was higher than those in the 1-M group at 6 months but not statistically different (P > 0.05). For AIS patients undergoing mechanical thrombectomy, compared to 1-month DAPT, 3-month DAPT can reduce the recurrence rate of IS during a 6-month follow-up period, without increasing the mortality and risk of cerebral hemorrhage.

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

Safety and Efficacy of Ticagrelor Monotherapy in Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention: An Individual Patient Data Meta-Analysis of TWILIGHT and TICO Randomized Trials.

Dual antiplatelet therapy with a potent P2Y12 inhibitor coupled with aspirin for 1 year is the recommended treatment for patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). As an alternative, monotherapy with a P2Y12 inhibitor after a short period of dual antiplatelet therapy has emerged as a bleeding reduction strategy. We pooled individual patient data from randomized trials that included patients with ACS undergoing PCI treated with an initial 3-month course of dual antiplatelet therapy followed by ticagrelor monotherapy versus continued ticagrelor plus aspirin. Patients sustaining a major ischemic or bleeding event in the first 3 months after PCI were excluded from analysis. The primary outcome was Bleeding Academic Research Consortium type 3 or 5 bleeding occurring between 3 and 12 months after index PCI. The key secondary end point was the composite of death, myocardial infarction, or stroke. Hazard ratios and 95% CIs were generated using Cox regression with a one-stage approach in the intention-to-treat population. The pooled cohort (n=7529) had a mean age of 62.8 years, 23.2% were female, and 55% presented with biomarker-positive ACS. Between 3 and 12 months, ticagrelor monotherapy significantly reduced Bleeding Academic Research Consortium 3 or 5 bleeding compared with ticagrelor plus aspirin (0.8% versus 2.1%; hazard ratio, 0.37 [95% CI, 0.24-0.56]; P<0.001). Rates of all-cause death, myocardial infarction, or stroke were not significantly different between groups (2.4% versus 2.7%; hazard ratio, 0.91 [95% CI, 0.68-1.21]; P=0.515). Findings were unchanged among patients presenting with biomarker-positive ACS. Among patients with ACS undergoing PCI who have completed a 3-month course of dual antiplatelet therapy, discontinuation of aspirin followed by ticagrelor monotherapy significantly reduced major bleeding without incremental ischemic risk compared with ticagrelor plus aspirin. URL: https://www.crd.york.ac.uk/prospero; Unique identifier: CRD42023449646.

P2Y12 Inhibitor vs Aspirin Monotherapy Following Dual Antiplatelet Therapy after Percutaneous Coronary Intervention: An Updated Meta-Analysis.

With the publication of a large number of clinical studies on antiplatelet therapy in recent years, it is still controversial which antiplatelet monotherapy should be continued after a period of dual antiplatelet therapy (DAPT) in the post percutaneous coronary intervention (post-PCI) population. We conducted a meta-analysis to investigate the efficacy and safety of inhibitors versus aspirin in the post-PCI population after completing DAPT. We searched studies in electronic databases from January 1, 2015 to November 20, 2022. We conducted a meta-analysis to estimate the effect of inhibitor monotherapy on clinical end-points in post-PCI patients after a period of DAPT, using trial-level data with consistent end-point definitions. The primary outcome was major adverse cardiovascular events (MACE). Odd ratio (OR) was pooled with 95% confidence interval (CI) for dichotomous data. This study is registered with INPLASY 2022120011. We included five studies that included 24,460 patients. The patients who received a inhibitor showed a lower risk of MACE than patients who received aspirin (OR 0.70 [95% CI 0.60-0.80], = 0%, p 0.00001) monotherapy. Subgroup analysis of MACE based on patient characteristics showed consistent results with the main analysis. The risk of major bleeding was similar in patients who received a inhibitor and those who received aspirin (OR 0.86 [95% CI 0.53-1.39], = 57%, p = 0.54). The risk of major bleeding was borderline increased in patients who received ticagrelor versus aspirin (OR 1.81 [95% CI 0.99-3.31], p = 0.05). In the post-PCI population, inhibitor monotherapy may be superior to aspirin for MACE, repeat revascularization, and stroke without increasing the risk of major bleeding.

P2Y12 Inhibitor Monotherapy Combined With Colchicine Following PCI in ACS Patients: The MACT Pilot Study

BackgroundAfter a brief period of dual antiplatelet therapy, P2Y12 inhibitor monotherapy in the absence of aspirin effectively reduces bleeding without increasing recurrent ischemia in patients undergoing percutaneous coronary intervention (PCI). In addition, early anti-inflammatory therapies may have clinical benefits in acute coronary syndrome (ACS) patients. ObjectivesThe aim of this study was to investigate the feasibility of ticagrelor or prasugrel P2Y12 inhibitor monotherapy combined with colchicine immediately after PCI in patients with ACS. MethodsThis was a proof-of-concept pilot trial. ACS patients treated with drug-eluting stents were included. On the day after PCI, low-dose colchicine (0.6 mg daily) was administered in addition to ticagrelor or prasugrel maintenance therapy, whereas aspirin therapy was discontinued. The primary outcome was any stent thrombosis at 3 months. The key secondary outcomes were platelet reactivity measured by the VerifyNow assay (Accriva) before discharge and a reduction in high-sensitivity C-reactive protein (hs-CRP) over 1 month. ResultsWe enrolled 200 patients, 190 (95.0%) of whom completed the 3-month follow-up. The primary outcome occurred in 2 patients (1.0%): 1 definite and 1 probable stent thrombosis. The level of platelet reactivity overall was 27 ± 42 P2Y12 reaction units, and only 1 patient had high platelet reactivity (>208 P2Y12 reaction units). The hs-CRP levels decreased from 6.1 mg/L (IQR: 2.6-15.9 mg/L) at 24 hours after PCI to 0.6 mg/L (IQR: 0.4-1.2 mg/L) at 1 month (P < 0.001), and the prevalence of high-inflammation criteria (hs-CRP ≥2 mg/L) decreased from 81.8% to 11.8% (P < 0.001). ConclusionsIn ACS patients undergoing PCI, it is feasible to discontinue aspirin therapy and administer low-dose colchicine on the day after PCI in addition to ticagrelor or prasugrel P2Y12 inhibitors. This approach is associated with favorable platelet function and inflammatory profiles. (Mono Antiplatelet and Colchicine Therapy [MACT]; NCT04949516)

P2Y12 INHIBITOR MONOTHERAPY OR DUAL ANTIPLATELET THERAPY AFTER PERCUTANEOUS CORONARY INTERVENTION IN PATIENTS WITH HYPERTENSION

Objective: P2Y12 inhibitor monotherapy after a brief period of dual antiplatelet therapy (DAPT, a combination of aspirin and a P2Y12 inhibitor) can reduce bleeding without increasing ischemic harm after percutaneous coronary intervention (PCI). The impact of this approach among patients with hypertension remains unknown. We sought to examine the effect of P2Y12 inhibitor monotherapy versus DAPT among patients with hypertension undergoing PCI. Design and method: This is a post-hock analysis of the hypertension cohort in the SMART-CHOICE trial. The SMART-CHOICE trial was a randomized trial that compared P2Y12 inhibitor monotherapy after 3 months of DAPT with prolonged DAPT (12 months or longer) in patients who underwent PCI. The primary endpoint was Bleeding Academic Research Consortium (BARC) 2 to 5 bleeding. The composite ischemic endpoint was all-cause death, myocardial infarction, or stroke. Treatment effects were estimated according to presence of hypertension with formal interaction testing to assess for effect modification. Results: Patients with hypertension comprised 61.5% (n = 1,840) of the randomized cohort and were characterized by more frequent comorbidities. At 3 years after randomization, patients with hypertension experienced higher rates of all-cause death (3.9% vs 2.5%; p = 0.039), stroke (1.6% vs 0.6%; p = 0.014), or MACCE (6.8% vs 3.8%; p&lt;0.001) but similar BARC types 2 to 5 bleeding (5.4% vs 4.9%; p = 0.601) compared with patients without hypertension. The incidence of BARC 2 to 5 bleeding was 2.9% and 7.8% among patients with hypertension randomized to P2Y12 inhibitor monotherapy versus DAPT [hazard ratio (HR): 0.382; 95% confidence interval (CI): 0.243 to 0.600; p&lt;0.001]. However, P2Y12 inhibitor monotherapy was not associated with an increase in ischemic events compared with DAPT (7.2% vs. 6.5%; HR: 1.135; 95% CI: 0.767 to 1.679; p = 0.527) in patients with hypertension. In the overall trial population, there was no significant interaction between hypertension status and treatment group for the primary bleeding (adjusted p for interaction 0.835) or ischemic endpoints (adjusted p for interaction 0.707). Conclusions: P2Y12 inhibitor monotherapy is associated with significantly lower risk for bleeding events compared with DAPT, without any compromise in ischemic prevention, among patients with history of hypertension undergoing PCI.

Thirty-Days versus Longer Duration of Dual Antiplatelet Treatment after Percutaneous Coronary Interventions with Newer Drug-Eluting Stents: A Systematic Review and Meta-Analysis.

Abbreviation of the duration of dual antiplatelet therapy (DAPT) (one or three months) has been recently proposed, especially for high bleeding risk patients, after percutaneous coronary intervention (PCI) with drug-eluting stent (DES). Three databases were screened for eligible randomized control trials. The primary endpoint was the incidence of net adverse clinical events (NACE). Secondary endpoints consisted of major adverse cardiovascular events (MACE), all-cause and cardiovascular mortality, myocardial infarction, stroke, stent-thrombosis, repeat revascularization and major bleeding. We included four RCTs with a total of 26,576 patients; 13,282 patients were grouped in 30-days DAPT, while the remaining 13,294 were allocated in a longer period of DAPT. One month of DAPT did not significantly reduce NACE (odds ratio [OR]: 0.87, 95% confidence intervals [Cl]: 0.74-1.03); however, major bleedings were significantly reduced by 22% (OR: 0.78, 95% Cl: 0.65-0.94). Mortality or ischemic events (stroke, myocardial infarction, revascularization and stent thrombosis) were not affected. Thus, 30-days DAPT could be considered as safe and feasible after PCI with DES in selected patients, especially those with high bleeding risk. Forthcoming RCTs could shed light on the optimal duration of DAPT.

Tailoring oral antiplatelet therapy in acute coronary syndromes: from guidelines to clinical practice.

The assessment of bleeding and ischemic risk is a crucial step in establishing appropriate composition and duration of dual antiplatelet therapy (DAPT) in patients with acute coronary syndrome (ACS) treated with percutaneous coronary angioplasty. Evidence from recent randomized clinical trials led to some paradigm shifts in current guidelines recommendations. Options alternative to the standard 12-month DAPT duration include shorter periods of DAPT followed by single antiplatelet treatment with either aspirin or P2Y12 monotherapy, guided or unguided de-escalation DAPT, prolonged DAPT beyond the 12-month treatment period. Although DAPT composition and duration should be selected for each ACS patient on an individual basis weighing clinical and procedural variables, data from latest trials and meta-analyses may permit suggesting the most appropriate DAPT strategy according to the ischemic and bleeding risk assessed using validated tools and scores.

P2Y12 Inhibitor or Aspirin Following Dual Antiplatelet Therapy After Percutaneous Coronary Intervention: A Network Meta-Analysis

BackgroundIt is still unknown which antiplatelet monotherapy should be continued after a period of dual antiplatelet therapy (DAPT) in patients undergoing percutaneous coronary intervention (PCI). ObjectivesThe aim of this study was to compare aspirin vs P2Y12 inhibitor (P2Y12-I) monotherapy after dual antiplatelet therapy (DAPT) discontinuation in patients undergoing percutaneous coronary intervention (PCI). MethodsRandomized studies enrolling patients undergoing PCI with second-generation drug-eluting stents and comparing aspirin or P2Y12-I monotherapy after DAPT discontinuation vs prolonged DAPT or aspirin vs P2Y12-I monotherapy after DAPT were included. Primary efficacy and safety endpoints were myocardial infarction (MI) and major bleeding (MB), respectively. Point estimates for dichotomous outcomes were pooled using frequentist and Bayesian frameworks. Sensitivity analyses and treatment hierarchy were performed. ResultsNineteen studies encompassing 73,126 patients were included. The transitivity assumption was met. Under the frequentist framework, patients receiving aspirin had a significantly higher risk for MI compared with P2Y12-I monotherapy (risk ratio: 1.32; 95% CI: 1.08-1.62). Compared with DAPT, both monotherapies reduced MB, but only P2Y12-I showed equivalent efficacy in preventing MI. No significant differences in MB, death, and other thrombotic outcomes were observed. However, point estimates for the risk for stent thrombosis and stroke favored P2Y12-I monotherapy. Consistent results were found in a fixed-effects model and the Bayesian framework, with all models having adequate convergence. P2Y12-I vs aspirin monotherapy had the highest probability of being ranked first for reduction of all assessed outcomes. ConclusionsP2Y12-I monotherapy following DAPT discontinuation after PCI is associated with a significantly lower risk for MI and similar risk for MB, suggesting a potentially relevant net clinical benefit vs aspirin monotherapy. These findings strengthen the rationale for further studies directly comparing the 2 monotherapies after DAPT in PCI patients.

P2Y12 Inhibitor Monotherapy: Considerations for Acute and Long-Term Secondary Prevention Post-PCI.

Following percutaneous coronary intervention (PCI), an initial course of dual antiplatelet therapy (DAPT) with aspirin and a inhibitor ( -i) is recommended to minimize the risk of thrombotic complications. After the initial period of DAPT, antiplatelet monotherapy, usually consisting of aspirin, is administered for long-term secondary prevention. However, over the last few years there has been accruing evidence on -i monotherapy, both in the acute (i.e., post-PCI; after a brief period of DAPT, transitioning to monotherapy before six or 12 months in patients with chronic or acute coronary syndrome, respectively) and chronic (i.e., long-term secondary prevention; after completion of six or 12 months of DAPT, in patients with chronic or acute coronary syndrome, respectively) settings. In aggregate, most studies of short DAPT with transition to -i monotherapy showed a reduced risk of bleeding complications, without any significant increase in ischemic events as compared to standard DAPT. On the other hand, the evidence on long-term -i monotherapy is scarce, but results from a randomized trial showed that clopidogrel monotherapy outperformed aspirin monotherapy in terms of net benefit, ischemic events and bleeding. Antiplatelet therapy is also recommended for patients undergoing PCI and with an established indication for long-term oral anticoagulation (OAC). In this scenario, a brief period of triple therapy (i.e., aspirin, -i and OAC) is followed by a course of dual antithrombotic therapy (usually with -i and OAC) and ultimately by lifelong OAC alone. European and American guidelines have been recently updated to provide new recommendations on antithrombotic therapy, including the endorsement of -i monotherapy in different settings. However, some areas of uncertainty still remain and further randomized investigations are ongoing to fulfil current gaps in knowledge. In this review, we assess the current knowledge and evidence on -i monotherapy for the early and long-term secondary prevention in patients undergoing PCI, and explore upcoming research and future directions in the field.

P2Y12 Inhibitor Monotherapy after Percutaneous Coronary Intervention.

In patients with acute and chronic coronary artery disease undergoing percutaneous coronary intervention (PCI), dual antiplatelet therapy (DAPT) has been the cornerstone of pharmacotherapy for the past two decades. Although its antithrombotic benefit is well established, DAPT is associated with an increased risk of bleeding, which is independently associated with poor prognosis. The improvement of the safety profiles of drug-eluting stents has been critical in investigating and implementing shorter DAPT regimens. The introduction into clinical practice of newer generation oral P2Y12 inhibitors such as prasugrel and ticagrelor, which provide more potent and predictable platelet inhibition, has questioned the paradigm of standard DAPT durations after coronary stenting. Over the last five years, several trials have assessed the safety and efficacy of P2Y12 inhibitor monotherapy after a short course of DAPT in patients treated with PCI. Moreover, ongoing studies are testing the role of P2Y12 inhibitor monotherapy immediately after PCI in selected patients. In this review, we provide up-to-date evidence on the efficacy and safety of P2Y12 inhibitor monotherapy after a short period of DAPT compared to DAPT in patients undergoing PCI as well as outcomes associated with P2Y12 inhibitor monotherapy compared to aspirin for long-term prevention.

Thirty-days versus standard duration of dual antiplatelet treatment after percutaneous coronary interventions: a systematic review and meta-analysis

Abstract Background/Introduction Abbreviation of duration of dual antiplatelet therapy (DAPT) (one or three months) has been recently proposed, especially for high-bleeding risk patients, after percutaneous coronary intervention (PCI) with drug-eluting stent (DES). Purpose The purpose of the specific systematic review and meta-analysis was to compare 30-days versus longer duration (≥3 months) of DAPT in patients undergoing PCI with DES, focusing on ischemic and bleeding events. Methods Three databases were screened for eligible randomized-control trials. The primary endpoint was the incidence of net adverse clinical events (NACE), as they were defined in each trial. Secondary endpoints consisted of major adverse cardiovascular events (MACE), all-cause and cardiovascular mortality, myocardial infraction, stroke, stent-thrombosis, repeat revascularization and major bleeding. Results We included 4 RCTs with a total of 26,576 patients; 13,282 patients were grouped in 30-days DAPT, while the remaining 13,294 were allocated in longer period of DAPT. One-month of DAPT did not significantly reduce NACE (odds ratio [OR]: 0.87, 95% confidence intervals [Cl]: 0.74–1.03); however major bleedings were significantly reduced by 22% (OR: 0.78, 95% Cl: 0.65–0.94). Mortality or ischemic events (stroke, myocardial infraction, revascularization and stent thrombosis) were not affected. Conclusions Thirty-days DAPT did not significantly affect NACEs. However, odds of major bleedings were reduced significantly by 22%. Mortality and ischemic events did not differ between the two arms. Thus, 30-days DAPT could be considered as a safe and feasible after PCI with DES in selected patients, especially those in high-bleeding risk. Forthcoming RCTs could shed light on the optimal duration of DAPT. Funding Acknowledgement Type of funding sources: None.

Abstract 119: P2Y12 Inhibitor With Or Without Aspirin In Patients With Hypertension Undergoing Percutaneous Coronary Intervention

Background: P2Y12 inhibitor monotherapy after a brief period of dual antiplatelet therapy (DAPT) can reduce bleeding without increasing ischemic harm after percutaneous coronary intervention (PCI). We sought to examine the effect of P2Y12 inhibitor monotherapy vs. prolonged DAPT among patients with hypertension undergoing PCI. Methods: This is a post-hoc analysis of the SMART-CHOICE trial, in which patients undergoing PCI were randomly assigned to either P2Y12 inhibitor monotherapy after 3-month DAPT (n=1495) or DAPT for 12 months or longer (n=1498). The primary endpoint was Bleeding Academic Research Consortium (BARC) 2~5 bleeding. The composite ischemic endpoint was all-cause death, myocardial infarction, or stroke. Treatment effects were estimated according to the presence of hypertension with formal interaction testing. Results: Patients with hypertension comprised 61.5% of the randomized cohort, and were characterized by more frequent comorbidities, a higher PRECISE-DAPT score, and a higher prevalence of the multivessel disease. At 3 years, patients with hypertension experienced higher rates of all-cause death (3.9% vs 2.5%; p=0.039), stroke (1.6% vs 0.6%; p=0.014), or a composite ischemic endpoint (6.8% vs 3.8%; p&lt;0.001), but similar BARC 2~5 bleeding (5.4% vs 4.9%; p=0.601) compared with patients without hypertension. The incidence of BARC 2~5 bleeding was 2.9% and 7.8% among patients with hypertension randomized to P2Y12 inhibitor monotherapy versus DAPT [hazard ratio (HR), 0.382; 95% confidence interval (CI), 0.243 to 0.600; p&lt;0.001]. However, P2Y12 inhibitor monotherapy was not associated with an increase in ischemic events compared with DAPT (7.2% vs. 6.5%; HR: 1.135; 95% CI: 0.767 to 1.679; p=0.527) in patients with hypertension. In the overall population, there was no significant interaction between hypertension and treatment for the primary bleeding (adjusted p for interaction 0.835) or ischemic endpoints (adjusted p for interaction 0.707). Conclusions: P2Y12 inhibitor monotherapy is associated with a significantly lower risk for bleeding events compared with DAPT, without any compromise in ischemic prevention, among patients with hypertension undergoing PCI.

May Literature Synopsis

May Literature Synopsis

Appraising the contemporary role of aspirin for primary and secondary prevention of atherosclerotic cardiovascular events

ABSTRACT Introduction Although the role of aspirin for primary prevention of atherosclerotic cardiovascular disease (ASCVD) has been disputed, its use in secondary ASCVD prevention is well established. Recent trials of primary prevention do not suggest a significant net benefit with aspirin, whereas accruing evidence supports adopting aspirin-free strategies in the context of potent P2Y12 inhibition for the secondary prevention of selected patients undergoing percutaneous coronary intervention. Areas covered This updated review aims at summarizing and appraising the pharmacological characteristics and the contemporary role of aspirin for the primary and secondary prevention of ASCVD. Expert opinion Recent trials and metanalyses in the context of primary prevention highlighted a modest reduction in ischemic events with aspirin use, counterbalanced by a significant increase in bleeding events. However, ongoing studies on cancer prevention could modify the current paradigm of the unfavorable benefit-risk ratio of aspirin in patients with no overt ASCVD. Conversely, aspirin use is crucial for secondary ASCVD prevention, both in chronic and acute coronary syndromes. Nevertheless, after a brief period of dual antiplatelet therapy, patients at high bleeding risk may benefit from discontinuation of aspirin if a P2Y12 inhibitor is used, hence reducing the bleeding risk with no rebound in thrombotic events.

Impact of DAPT duration on clinical outcome after stent implantation for coronary bifurcation lesions: multicentre experience

Abstract Background The period of dual antiplatelet therapy (DAPT) following acute coronary syndrome (ACS) or stable coronary artery disease (SCAD) that is managed with coronary stenting is still under consideration. In real-world registries, the association between length of DAPT, bifurcation intervention and its effect on clinical outcome has been poorly studied. In sequential all-comer patients treated with stenting of coronary artery bifurcation lesions we examined the effect of DAPT length on clinical results including our single centre registry. Methods Responses were extracted from January 2017 to December 2018 on 536 consecutive patients who had PCI on coronary bifurcation at three centres in India. The primary endpoint of the analysis was the cumulative incidence of major adverse cardiac cerebrovascular events (MACCE), identified as a composite of cardiac death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR) and stroke during follow-up; the secondary objectives were the single occurrence of any of the aforementioned incidents. 496 patients (92.5 percent) had data on the length of DAPT. Group 1) DAPT&amp;lt;6-months (n=174); group 2) DAPT&amp;gt;6-months but &amp;lt;12-months (n=162); group 3) DAPT &amp;gt;12-months (n=160). Results In 490 (98.8 percent) patients with an 18-month median (CI: 12–28) follow-up was concluded. MACCE developed more often in the 18 Group 1 patients (10.3%) than in Group 2 and 3 versus 14 [8.6%] and 8 [5%], HR: 0.76, 95% CI: 0.67- 0.92, p&amp;lt;0.001), respectively. After correction for clinical and angiographic features this disparity persisted (HR: 0.68, 95% CI: 0.68–0.79, p&amp;lt;0.001). At Kaplan-Meier analysis, in patients who received DAPT with less than 6 months (p&amp;lt;0.001) the freedom from MACCE survival was substantially lower. Conclusions In a real-world registry of hospitalized patients with DES-PCI for coronary artery bifurcation stenosis, short DAPT length (&amp;lt;6 months) is correlated with a considerably higher risk of MACCE relative to longer DAPT. Funding Acknowledgement Type of funding sources: None.