P2Y12 Inhibitor Monotherapy Research Articles

Clopidogrel Monotherapy vs. Aspirin Monotherapy Following Short-Term Dual Antiplatelet Therapy in Patients Receiving Everolimus-Eluting Coronary Stent Implantation.

There is a scarcity of data on short-duration dual antiplatelet therapy (DAPT) followed by P2Y12 inhibitor monotherapy as compared with aspirin monotherapy after percutaneous coronary intervention (PCI). STOPDAPT-1 is a prospective trial enrolling patients who agreed to 3-month DAPT followed by aspirin monotherapy after everolimus-eluting stent (EES) implantation. STOPDAPT-2 is a randomized trial comparing 1-month DAPT followed by clopidogrel monotherapy with 12-month DAPT after EES implantation. We compared the clinical outcomes of patients assigned to the 1-month DAPT group in STOPDAPT-2 and the 3-month DAPT group enrolled in STOPDAPT-1. The current study population consisted of 1,480 patients in STOPDAPT-2 and 1,339 patients in STOPDAPT-1. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, definite stent thrombosis and TIMI major/minor bleeding. Cumulative 1-year incidence of the primary endpoint was not significantly different between STOPDAPT-2 and STOPDAPT-1 (2.3% vs. 2.3%, P=0.98). After adjusting for confounders, there was no excess risk of STOPDAPT-2 relative to STOPDAPT-1 for the primary endpoint. Between 3 and 12 months, the cumulative incidence of primary endpoint was not significantly different between STOPDAPT-2 and STOPDAPT-1 (1.7% vs. 1.6%, P=0.77). The effect of 1-month DAPT followed by clopidogrel monotherapy on clinical outcomes was similar to that of 3-month DAPT followed by aspirin monotherapy in patients receiving PCI.

Pooled Analysis of Bleeding, Major Adverse Cardiovascular Events, and All-Cause Mortality in Clinical Trials of Time-Constrained Dual-Antiplatelet Therapy After Percutaneous Coronary Intervention.

BackgroundThe net clinical benefit of dual antiplatelet therapy (DAPT) reflects the paradoxical effects of an increased risk of bleeding and a reduced risk of major adverse cardiovascular events. A time‐constrained approach to DAPT has been recently investigated in 5 multicenter trials including GLOBAL LEADERS, STOPDAPT2 (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus‐Eluting Cobalt‐Chromium Stent‐2), SMART‐CHOICE, TWILIGHT (Ticagrelor With Aspirin or Alone in High‐Risk Patients After Coronary Intervention), and TICO (Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus Stent for Acute Coronary Syndrome).Methods and ResultsWe undertook a pooled analysis of these trials to assess the overall associations between time‐constrained P2Y12 inhibitor monotherapy (aspirin‐free regimen) for bleeding events, major adverse cardiovascular events, and all‐cause mortality as compared to standard care with DAPT for at least 12 months post‐percutaneous coronary intervention. We implemented a DerSimonian and Laird random effects meta‐analysis using the metafor package in R. 32 361 randomized trial participants, including 16 898 (52.2%) who had a history of acute coronary syndrome, underwent percutaneous coronary intervention, and had outcome data available. P2Y12 inhibitor monotherapy from 1 to 3 months was associated with a reduced risk for bleeding (hazard ratio [HR] 0.60; 95% CI, 0.45‐0.81), including in the acute coronary syndrome group in which the magnitude of risk reduction was greatest (HR 0.50; 95% CI, 0.41‐0.61). The estimates of the effect of P2Y12 inhibitor monotherapy on the HR were also favorable for major adverse cardiovascular events (0.88; 95% CI, 0.77‐1.02) and all‐cause mortality (0.85; 95% CI, 0.71‐1.03).ConclusionsCompared with DAPT for 12 months post‐percutaneous coronary intervention, P2Y12 inhibitor monotherapy from 1 to 3 months substantially reduces the risk of major and fatal bleeding and, in addition, confers potentially protective effects, for major adverse cardiovascular events and all‐cause mortality. Considering patient safety, the results support a strategy of DAPT for 1 to 3 months followed by aspirin‐free P2Y12 inhibitor monotherapy.

Clinical outcomes of patients treated using very short duration dual antiplatelet therapy after implantation of biodegradable-polymer drug-eluting stents: rationale and design of a prospective multicenter REIWA registry.

Several studies have demonstrated the safety and feasibility of short (3-6months) and very short duration (< 2months) dual antiplatelet therapy (DAPT) in patients with a durable-polymer drug-eluting stent (DP-DES). However, the clinical importance of using very short duration DAPT has yet to be established in patients with a biodegradable polymer drug-eluting stent (BP-DES). The aim of this REIWA registry (multicenter and prospective registry; investigation of clinical outcomes of patients treated with short duration dual antiplatelet therapy after implantation of biodresorbable-polymer drug-eluting stent: a multicenter, prospective registry from Iwate medical university affiliated hospitals) is to determine the safety and feasibility of using 1-month DAPT followed by P2Y12 inhibitor monotherapy in patients after BP-DES implantation. This study is an observational, prospective, multicenter registry encompassing the entire local medical region of Iwate Prefecture (northern area of mainland Japan). A total of 1200 patients who underwent successful PCI with a novel thin strut BP-DES (Synergy, Ultimaster or Orsiro) and are considered to be appropriate patients for very short DAPT, are registered and subsequently administered 1-month DAPT followed by P2Y12 inhibitor monotherapy (clopidogrel 75mg/day or prasugrel 3.75mg/day). The primary endpoint was a composite of cardiovascular and bleeding events, which included cardiovascular death, spontaneous myocardial infarction, definite stent thrombosis, ischemic or hemorrhagic stroke, or TIMI major or minor bleeding at 12months. The REIWA registry (UMIN000037321) will demonstrate both the safety and feasibility of using 1-month DAPT in patients with BP-DES. Furthermore, results of this study will also be able to provide supportive evidence for P2Y12 inhibitor monotherapy after 1-month DAPT following BP-DES implantation.

Dual Antiplatelet Therapy After Percutaneous Coronary Intervention and Drug-Eluting Stents: A Systematic Review and Network Meta-Analysis.

The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention with drug-eluting stents remains uncertain. We compared short-term (<6-month) DAPT followed by aspirin or P2Y12 inhibitor monotherapy; midterm (6-month) DAPT; 12-month DAPT; and extended-term (>12-month) DAPT after percutaneous coronary intervention with drug-eluting stents. Twenty-four randomized, controlled trials were selected using Medline, Embase, Cochrane library, and online databases through September 2019. The coprimary end points were myocardial infarction and major bleeding, which constituted the net clinical benefit. A frequentist network meta-analysis was conducted with a random-effects model. In 79 073 patients, at a median follow-up of 18 months, extended-term DAPT was associated with a reduced risk of myocardial infarction in comparison with 12-month DAPT (absolute risk difference, -3.8 incident cases per 1000 person-years; relative risk, 0.68 [95% CI, 0.54-0.87]), midterm DAPT (absolute risk difference, -4.6 incident cases per 1000 person-years; relative risk, 0.61 [0.45-0.83]), and short-term DAPT followed by aspirin monotherapy (absolute risk difference, -6.1 incident cases per 1000 person-years; relative risk, 0.55 [0.37-0.83]), or P2Y12 inhibitor monotherapy (absolute risk difference, -3.7 incident cases per 1000 person-years; relative risk, 0.69 [0.51-0.95]). Conversely, extended-term DAPT was associated with a higher risk of major bleeding than all other DAPT groups. In comparison with 12-month DAPT, no significant differences in the risks of ischemic end points or major bleeding were observed with midterm or short-term DAPT followed by aspirin monotherapy, with the exception that short-term DAPT followed by P2Y12 inhibitor monotherapy was associated with a reduced risk of major bleeding. There were no significant differences with respect to mortality between the different DAPT strategies. In acute coronary syndrome, extended-term in comparison with 12-month DAPT was associated with a reduced risk of myocardial infarction without a significant increase in the risk of major bleeding. The present network meta-analysis suggests that, in comparison with 12-month DAPT, short-term DAPT followed by P2Y12 inhibitor monotherapy reduces major bleeding after percutaneous coronary intervention with drug-eluting stents, whereas extended-term DAPT reduces myocardial infarction at the expense of more bleeding events.

P2Y12 Inhibitor Monotherapy After a Short Dual Antiplatelet Therapy Versus Standard-Term Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention: A Contemporary Meta-Analysis.

Dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) reduces the incidence of thrombotic events but increases the risk of bleeding, which is associated with a substantial and durable risk of death and could offset the benefits of a reduction in thrombotic events. P2Y12 inhibitor monotherapy after short-term DAPT could be an option to reduce the risk of bleeding. We carried out a meta-analysis comparing P2Y12 inhibitor monotherapy after short-term DAPT with standard-term DAPT in patients undergoing PCI. We searched the PubMed and EMBASE databases through 11 April 2020. Two authors independently reviewed and selected eligible trials. The DerSimonian-Laird method with the binary random-effects model was used to calculate the relativerisk (RR) with 95% confidence interval (CI). Five trials involving 23,762 patients were included in the final analyses; four were open-label trials, while the TWILIGHT trial was double-blinded. Ticagrelor was used in three trials, and the other two trials included several P2Y12 inhibitors. P2Y12 inhibitor monotherapy after short-term DAPT significantly reduced the bleeding events, defined as Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding and Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding, by 39% (RR 0.61, 95% CI 0.38-0.99; p = 0.045) and 46% (RR 0.56, 95% CI 0.42-0.73; p < 0.001), respectively. A significant reduction in cardiovascular death was associated with P2Y12 inhibitor monotherapy after short-term DAPT (RR 0.75, 95% CI 0.58-0.98; p = 0.037; I2 = 0). No significant difference in all-cause mortality, myocardial infarction, stroke, or definite or probable stent thrombosis was observed. This meta-analysis showed a significantly lowered risk of major bleeding and similar benefits of P2Y12 inhibitor monotherapy after short-term DAPT compared with standard-term DAPT in patients undergoing PCI.

Comparative Efficacy and Safety of Duration of Dual Antiplatelet Therapy in Patients with CAD Undergoing Drug-eluting Stent Implantation: A Systematic Review and Network Meta-analysis.

The aim was to evaluate the efficacy and safety of duration of dual antiplatelet therapy (DAPT) for patients who received percutaneous coronary intervention (PCI) with a drug-eluting stent. The optimal duration of DAPT to balance the risk of ischemia and bleeding in CAD patients undergoing drug-eluting stent (DES) implantation remains controversial. PubMed, Cochrane Library, Web of Science, Clinicaltrials.gov, CNKI and Wanfang Databases were searched for randomized controlled trials of comparing different durations of DAPT after DES implantation. Primary outcomes were major adverse cardiac and cerebrovascular events (MACCE), and major bleeding, and were pooled by Bayes network meta-analysis. Net adverse clinical and cerebral events were used to estimate the surface under the cumulative ranking (SUCRA) curves. The subgroup analysis based on clinical status, follow-up and area was conducted using traditional pairwise meta-analysis. A total of nineteen trials (n=51,035) were included, involving six duration strategies. The network metaanalysis showed that T2 (<6-month DAPT followed by aspirin, HR:1.51, 95%CI:1.02-2.22), T3 (standard 6-month DAPT, HR:1.47, 95%CI:1.14-1.91), T4 (standard 12-month DAPT, HR:1.41, 95%CI:1.15-1.75) and T5 (18-24 months DAPT, HR:1.47, 95%CI:1.09-1.97) was associated with significantly increased risk of MACCE compared to T6 (>24-month DAPT). However, no significant difference was found in MACCE risk between T1 (<6-month DAPT followed by P2Y12 monotherapy) and T6. Moreover, T5 was associated with significantly increased risk of bleeding compared to T1(RR:3.94, 95%CI:1.66-10.60), T2(RR:3.65, 95%CI:1.32-9.97), T3(RR:1.93, 95%CI:1.21-3.50) and T4(RR:1.89, 95%CI:1.15-3.30). The cumulative probabilities showed that T6(85.0%), T1(78.3%) and T4(44.5%) were the most efficacious treatment compared to the other durations. In the ACS (<50%) subgroup, T1 was observed to significantly reduce the risk of major bleeding compared to T4, but not in the ACS (≥50%) subgroup. Compared with other durations, short DAPT followed by P2Y12 inhibitor monotherapy showed non-inferiority, with a lower risk of bleeding and not associated with an increased MACCE. In addition, the risk of major bleeding increased significantly, starting with DAPT for 18-month. Compared with the short-term treatment, patients with ACS with the standard 12-month treatment have a better prognosis, including lower bleeding rate and the decreased risk of MACCE. Due to study's limitations, the results should be verified in different risk populations.

The Safety and Efficacy of Aspirin Discontinuation on a Background of a P2Y12 Inhibitor in Patients After Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis.

Dual antiplatelet therapy with aspirin and a P2Y12 inhibitor has been shown to reduce the risk of major adverse cardiovascular events (MACE) compared with aspirin alone after percutaneous coronary intervention (PCI) or acute coronary syndrome but with increased risk of bleeding. The safety of discontinuing aspirin in favor of P2Y12 inhibitor monotherapy remains disputed. A meta-analysis was conducted from randomized trials (2001-2020) that studied discontinuation of aspirin 1 to 3 months after PCI with continued P2Y12 inhibitor monotherapy compared with traditional dual antiplatelet therapy. Five trials were included; follow-up duration ranged from 12 to 15 months after PCI. Primary bleeding and MACE outcomes were the prespecified definitions in each trial. The study population included 32 145 patients: 14 095 (43.8%) with stable coronary artery disease and 18 046 (56.1%) with acute coronary syndrome. In the experimental arm, background use of a P2Y12 inhibitor included clopidogrel in 2649 (16.5%) and prasugrel or ticagrelor in 13 408 (83.5%) patients. In total, 820 patients experienced a primary bleeding outcome and 937 experienced MACE. Discontinuation of aspirin therapy 1 to 3 months after PCI significantly reduced the risk of major bleeding by 40% compared with dual antiplatelet therapy (1.97% versus 3.13%; hazard ratio [HR], 0.60 [95% CI, 0.45-0.79]), with no increase observed in the risk of MACE (2.73% versus 3.11%; HR, 0.88 [95% CI, 0.77-1.02]), myocardial infarction (1.08% versus 1.27%; HR, 0.85 [95% CI, 0.69-1.06]), or death (1.25% versus 1.47%; HR, 0.85 [95% CI, 0.70-1.03]). Findings were consistent among patients who underwent PCI for an acute coronary syndrome, in whom discontinuation of aspirin after 1 to 3 months reduced bleeding by 50% (1.78% versus 3.58%; HR, 0.50 [95% CI, 0.41-0.61]) and did not appear to increase the risk of MACE (2.51% versus 2.98%; HR, 0.85 [95% CI, 0.70-1.03]). Discontinuation of aspirin with continued P2Y12 inhibitor monotherapy reduces risk of bleeding when stopped 1 to 3 months after PCI. An increased risk of MACE was not observed after discontinuation of aspirin, including in patients with acute coronary syndrome.

P2Y12 inhibitor monotherapy versus aspirin monotherapy after short-term dual antiplatelet therapy for percutaneous coronary intervention: Insights from a network meta-analysis of randomized trials

A number of trials have assessed the efficacy and safety of short-term dual antiplatelet therapy (DAPT) in patients who undergo percutaneous coronary intervention (PCI). However, whether to continue aspirin or a P2Y12 inhibitor after a short course of DAPT is actively debated. PUBMED and EMBASE were searched through March 2020 for randomized controlled trials evaluating short-term DAPT (≤6 months) when compared with longer-term (≥12 months) DAPT among patients undergoing PCI. The ischemic outcomes were all-cause death, myocardial infarction, stent thrombosis, and stroke. The safety outcome was major and/or clinically relevant bleeding. The primary objective was to investigate the outcomes with aspirin monotherapy (Aspirin group) versus P2Y12 inhibitor monotherapy (P2Y12i group) after short-term DAPT. Our search identified 17 eligible trials enrolling a total of 54,625 patients comparing different DAPT duration. Either of the 2 monotherapy groups did not increase the risk of ischemic outcomes when compared with the long-term DAPT group, without difference between the Aspirin versus the P2Y12i groups. However, both monotherapy groups significantly reduced bleeding when compared with long-term DAPT (Aspirin group: hazard ratio [95% CI]: 0.62 [0.45-0.86], P=.004 and P2Y12i group: 0.68 [0.50-0.93], P=.015). There was no difference in bleeding between the Aspirin versus P2Y12i groups (hazard ratio=0.91 [0.58-1.43], P=.70). Among patients undergoing PCI, short-term DAPT with continuation of either aspirin or P2Y12i reduced bleeding without increasing ischemic outcomes when compared with long-term DAPT. The choice of antiplatelet therapy after short-term DAPT should be evaluated in well-powered trials.

P2Y12 Inhibitor Monotherapy with Clopidogrel Versus Ticagrelor in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention.

Background: P2Y12 inhibitor monotherapy is an alternative antiplatelet strategy in patients undergoing percutaneous coronary intervention (PCI). However, the ideal P2Y12 inhibitor for monotherapy is unclear. Methods and Results: We performed a multicenter, retrospective, observational study to compare the efficacy and safety of monotherapy with clopidogrel versus ticagrelor in patients with acute coronary syndrome (ACS) undergoing PCI. From 1 January 2014 to 31 December 2018, 610 patients with ACS who received P2Y12 monotherapy with either clopidogrel (n = 369) or ticagrelor (n = 241) after aspirin was discontinued prematurely were included. Inverse probability of treatment weighting was used to balance covariates between the groups. The primary endpoint was the composite of all-cause mortality, recurrent ACS or unplanned revascularization, and stroke within 12 months after discharge. Overall, 84 patients reached the primary endpoint, with 57 (15.5%) in the clopidogrel group and 27 (11.2%) in the ticagrelor group. Multivariate adjustment in Cox proportional-hazards models revealed a lower risk of the primary endpoint with ticagrelor than with clopidogrel (adjusted hazard ratio (aHR): 0.67, 95% confidence interval (CI): 0.49–0.93). Ticagrelor significantly reduced the risk of recurrent ACS or unplanned revascularization (aHR: 0.46, 95% CI: 0.28–0.75). No significant difference in all-cause mortality and major bleeding events was observed between the 2 groups. Conclusions: Among patients with ACS undergoing PCI who cannot complete course of dual antiplatelet therapy, a significantly lower risk of cardiovascular events was associated with ticagrelor monotherapy than with clopidogrel monotherapy. The major bleeding risk was similar in both the groups.

Meta-Analysis of the Efficacy and Safety of P2Y12 Inhibitor Monotherapy After Short Course of Dual-Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention

BackgroundGuidelines recommend dual antiplatelet therapy (DAPT) following drug-eluting stent (DES) placement for ≥12 months in acute coronary syndrome or 6 months in stable coronary artery disease. However, with the advent of newer-generation stents, the optimal duration of DAPT to balance bleeding and thrombotic risks has been debated. ObjectivesWe aimed to perform a meta-analysis of randomized controlled trials (RCT) comparing P2Y12 monotherapy in short-duration group (SDG) vs. standard treatment group (STG) course of DAPT in patients undergoing PCI. MethodsElectronic databases were searched for RCTs of patients undergoing percutaneous coronary intervention (PCI) with DES placement who received short (≤ 3 months) vs. standard DAPT course (≥12 months) and were followed for ≥12-months. Rates of major adverse cardiovascular events (a composite of cardiovascular mortality, non-fatal myocardial infarction, and non-fatal stroke) were the primary outcome. Study-specific odds ratios (OR) and corresponding 95% confidence intervals were calculated using random-effects model. ResultsA total of 20,706 patients (10,344 in the SDG and 10,362 in the STG) were analysed from four studies. There was no significant difference observed for MACE (OR = 0.95, 95% CI: 0.81–1.08, P = .92, I2 = 0%) myocardial infarction or stent thrombosis. However, lower rates of major bleeding were noted in the SDG (1.20 vs. 1.80%; OR: 0.61; 95% CI: 0.37–0.99; P = .04; I2 = 71%) albeit with increased heterogeneity. ConclusionA short duration of DAPT followed by P2Y12 inhibitor monotherapy was comparable to 12 months of DAPT with respect to MACE and thrombotic events, with lower rates of major bleeding events in select group of patients undergoing PCI. More data is needed to assess efficacy in patients with complex lesions and high risk ACS population including those with STEMI presentation.

The year in review: advances in interventional cardiology in 2019.

Major studies in interventional cardiology in 2019 have added substantial new evidence for pharmaco-invasive management of coronary artery disease. The review highlights the main findings of a selection of these trials and summarizes their impact on clinical practice. Recent randomized studies examining the efficacy of revascularization or medical treatment in stable ischemic heart disease (SIHD), treatment of acute coronary syndromes, emerging interventional devices, adjunctive pharmacotherapy, and intravascular imaging and physiology guidance have substantially advanced the evidenced-based knowledge in interventional cardiology. Patients with SIHD and at least moderate myocardial ischemia have similar event-free survival after an initial conservative strategy of optimal medical therapy versus an upfront invasive strategy. Quality of life and angina-free status are significantly improved with revascularization. Percutaneous coronary intervention (PCI) and coronary artery bypass grafting provide similar 5-year outcomes in patients with left main coronary artery disease and low or intermediate disease complexity. An initially conservative management is equally effective as an early invasive approach in patients with out-of-hospital cardiac arrest without ongoing ischemia. Patients with ST-segment elevation myocardial infarction and multivessel disease benefit from staged complete revascularization after primary PCI. Post-PCI, patients with atrial fibrillation requiring anticoagulation can safely and effectively be treated with P2Y12 inhibitor monotherapy without aspirin. Lastly, intravascular imaging guidance improves post-PCI outcomes, warranting increased use in clinical practice.

Monotherapy with a P2Y12 inhibitor or aspirin for secondary prevention in patients with established atherosclerosis: a systematic review and meta-analysis

Antiplatelet therapy is recommended among patients with established atherosclerosis. We compared monotherapy with a P2Y12 inhibitor versus aspirin for secondary prevention. In this systematic review and meta-analysis, all randomised trials comparing P2Y12 inhibitor with aspirin monotherapy for secondary prevention in patients with cerebrovascular, coronary, or peripheral artery disease were evaluated for inclusion. On Dec 18, 2019, we searched PubMed, Embase, BioMedCentral, Google Scholar, and the Cochrane Central Register of Controlled Trials. Additionally, we reviewed references from identified articles and searched abstracts from 2017 to 2019 presented at relevant scientific meetings. Data about year of publication, inclusion and exclusion criteria, sample size, baseline patients' features including the baseline condition determining study inclusion (ie, cerebrovascular, coronary, or peripheral artery disease), P2Y12 inhibitor type and dosage, aspirin dosage, endpoint definitions, effect estimates, follow-up duration, and percentage of patients lost to follow-up were collected. Odds ratios (ORs) and 95% CIs were used as metric of choice for treatment effects with random-effects models. Co-primary endpoints were myocardial infarction and stroke. Key secondary endpoints were all-cause death and vascular death. Heterogeneity was assessed with the I2 index. This study is registered with PROSPERO (CRD42018115037). A total of nine randomised trials were identified and included in this study, and 42 108 patients randomly allocated to a P2Y12 inhibitor (n=21 043) or aspirin (n=21 065) were included in our analyses. Patients who received a P2Y12 inhibitor had a borderline reduction for the risk of myocardial infarction compared with those who received aspirin (OR 0·81 [95% CI 0·66-0·99]; I2=10·9%). Risks of stroke (OR 0·93 [0·82-1·06]; I2=34·5%), all-cause death (OR 0·98 [0·89-1·08]; I2=0%), and vascular death (OR 0·97 [0·86-1·09]; I2=0%) did not differ between patients who received a P2Y12 inhibitor and those who received aspirin. Similarly, the risk of major bleeding (OR 0·90 [0·74-1·10]; I2=3·9%) did not differ between patients who received a P2Y12 inhibitor and those who received aspirin. The number needed to treat to prevent one myocardial infarction with P2Y12 inhibitor monotherapy was 244 patients. Findings were consistent regardless of the type of P2Y12 inhibitor used. Compared with aspirin monotherapy, P2Y12 inhibitor monotherapy is associated with a risk reduction for myocardial infarction and a comparable risk of stroke in the setting of secondary prevention. The benefit of P2Y12 inhibitor monotherapy is of debatable clinical relevance, in view of the high number needed to treat to prevent a myocardial infarction and the absence of any effect on all-cause and vascular mortality. Italian Ministry of Education.

De-escalation of antiplatelets after percutaneous coronary intervention: a Bayesian network meta-analysis of various de-escalation strategies.

To compare early de-escalation of dual antiplatelet therapy (DAPT) (1-3 months) to monotherapy with either P2Y12 inhibitor or aspirin vs. 12 months DAPT after percutaneous coronary intervention (PCI) with drug-eluting stent (DES). Electronic databases of Medline, Embase, and Cochrane library were searched through February 2020 to identify randomized controlled trials. A Bayesian network meta-analysis was conducted with random effects model. The main endpoints of interest were cardiovascular mortality and total bleeding events. Among seven trials (35821 patients), 52.6% patients were presented with acute coronary syndrome. A total of 3359 patients and 14530 patients were de-escalated to aspirin and P2Y12 inhibitor monotherapy, respectively. At a median follow-up of 12 months, compared with 12 months of DAPT, there was no significant difference in cardiovascular mortality between 1-month DAPT followed by P2Y12 inhibitor monotherapy [hazard ratio (HR) 0.84 (95% credible interval 0.29-2.43)], 3 months of DAPT followed by P2Y12 inhibitor monotherapy [HR 0.74 (0.39-1.46)], or 3 months of DAPT [HR 1.00 (0.54-1.86)] followed by aspirin monotherapy. Except for de-escalation of DAPT to aspirin monotherapy after 3 months [HR 0.75 (0.43-1.20)], de-escalation to P2Y12 inhibitor monotherapy after 1 month [HR 0.28 (0.10-0.83)], or 3 months [HR 0.57 (0.33-0.98)] were associated with significant decrease in total bleeding events. There were no significant differences in terms of ischaemic endpoints among different DAPT strategies. Early de-escalation of DAPT (1-3 months) to monotherapy with a P2Y12 inhibitor instead of aspirin might be a safer and equally effective approach compared with 12 months of DAPT in patients with PCI and DES.

Duration of dual antiplatelet therapy after percutaneous coronary intervention with implantation of second-generation drug-eluting stent: A meta-analysis of randomized controlled trials.

Objective: The optimal duration of dual antiplatelet therapy (DAPT) in patients after PCI with implantation of a drugeluting stent is still controversial. We conducted a meta-analysis to compare the efficacy and safety of short term DAPT (≤ 3 months) followed by P2Y12 inhibitor monotherapy and standard DAPT (12 months) after PCI. Method: Relevant studies published in Medline, Embase, CoChrane Library were searched for randomized controlled trials (RCTs) until November 2019. Studies were screened by selection criteria then quality assessed through the Cochrane Collaboration's tool. Data were extracted from the included studies and statistically analyzed by RevMan 5.3 software. Results: Five RCTs (n=18,357) were included. Compared with standard DAPT, the short term DAPT was associated with a significant decrease in the major bleeding [odds ratio (OR)=0.43, 95% Confidence Interval (CI):0.32-0.58, P <0.00001] and any bleeding [OR=0.56, 95%CI:0.47-0.66, P<0.00001]. There were no significant differences in all-cause death [OR=0.91, 95%CI:0.71-1.16, P =0.45], major adverse cardiac and cerebrovascular event [OR=1.01, 95%CI:0.87-1.17, P =0.91] and stent thrombosis [OR=0.97, 95%CI:0.61-1.54, P =0.91] between with the short term DAPT group and the standard DAPT group. Conclusions: Short term DAPT followed by P2Y12 monotherapy could reduce the risk of bleeding without increasing the incidence of ischemic events after PCI with implantation of second-generation DES compared with standard DAPT. Therefore, short term DAPT may be a promising strategy to balance ischemic events and bleeding complications in patients after PCI.

Effect of P2Y12 inhibitor monotherapy versus dual antiplatelet therapy on cardiovascular events in patients undergoing percutaneous coronary intervention: systematic review and meta-analysis.

Clinical data on short mandatory dual antiplatelet therapy (DAPT) followed by P2Y12 inhibitor monotherapy, compared with prolonged DAPT in patients undergoing percutaneous coronary intervention (PCI) are insufficient. We aim to evaluate the effectiveness and safety of P2Y12 inhibitor monotherapy and prolonged DAPT after short mandatory DAPT on cardiovascular events in patients undergoing PCI. A systematic literature search was performed in seven medical databases from building the database until July 2019. Three studies with randomized controlled trial (RCTs), totaling 21,970 patients, were included in this meta-analysis. The included studies were assessed by the Cochrane risk of bias and analyzed by Review Manager v. 5.3 software. Our result of pooled analysis showed that there was noninferior rates of in major adverse cardiac and cerebrovascular events (MACCE), stroke, myocardial infarction and cardiac death between short mandatory DAPT followed by P2Y12 inhibitor monotherapy and prolonged DAPT in patients undergoing PCI. Pooled analysis showed that short mandatory DAPT followed by P2Y12 inhibitor monotherapy could significantly reduce the risk of bleeding BARC type 2-5 (OR=0.47, 95% CI: 0.31-0.70, P=0.002), compared with prolonged DAPT in patients undergoing PCI. However, Pooled analysis showed that short mandatory DAPT followed by P2Y12 inhibitor monotherapy was not associated with BARC type 3-5, compared with prolonged DAPT. This meta-analysis demonstrated that short mandatory DAPT followed by P2Y12 inhibitor monotherapy compared with prolonged DAPT resulted in noninferior rates of MACCE, all-cause mortality, cardiac death, stroke, myocardial infarction and stent thrombosis. Furthermore, short mandatory DAPT followed by P2Y12 inhibitor monotherapy could significantly reduce the risk of bleeding BARC type 2-5.

P2Y12 INHIBITOR MONOTHERAPY AFTER A SHORT DUAL ANTIPLATELET THERAPY VS. 12-MONTH DUAL ANTIPLATELET THERAPY IN PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION: A META-ANALYSIS

Dual Antiplatelet Therapy (DAPT) after PCI reduces the incidence of thrombotic events but increases the risk of bleeding, which is associated with a substantial and durable risk of death and could offset the benefits of a reduction in thrombotic events. P2Y12 inhibitor monotherapy after a short DAPT

After PCI and 3 mo of DAPT, ticagrelor for 12 mo reduced bleeding vs continued DAPT and did not increase ischemic events.

ACP Journal Club18 February 2020After PCI and 3 mo of DAPT, ticagrelor for 12 mo reduced bleeding vs continued DAPT and did not increase ischemic eventsKoKo Aung, MD, MPH, Thwe Htay, MDKoKo Aung, MD, MPHPaul L. Foster School of Medicine, El Paso, Texas, USA (K.A., T.H.)Search for more papers by this author, Thwe Htay, MDPaul L. Foster School of Medicine, El Paso, Texas, USA (K.A., T.H.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/ACPJ202002180-019 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Source CitationMehran R, Baber U, Sharma SK, et al. Ticagrelor with or without aspirin in high-risk patients after PCI. N Engl J Med. 2019;381:2032-42. https://pubmed.ncbi.nlm.nih.gov/31556978Clinical Impact RatingsGIM/FP/GP: Hospitalists: Cardiology: References1 Watanabe H, Domei T, Morimoto T, et al. Effect of 1-month dual antiplatelet therapy followed by clopidogrel vs 12-month dual antiplatelet therapy on cardiovascular and bleeding events in patients receiving PCI: the STOPDAPT-2 randomized clinical trial. JAMA. 2019;321:2414-27. [PMID: 31237644] Google Scholar2 Hahn JY, Song YB, Oh JH, et al. Effect of P2Y12 inhibitor monotherapy vs dual antiplatelet therapy on cardiovascular events in patients undergoing percutaneous coronary intervention: the SMART-CHOICE randomized clinical trial. JAMA. 2019;321:2428-37. [PMID: 31237645] Google Scholar Author, Article, and Disclosure InformationAffiliations: Paul L. Foster School of Medicine, El Paso, Texas, USA (K.A., T.H.)Disclosures: The commentators have disclosed no conflicts of interest. The form can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M19-3039.This article was published at Annals.org on 4 February 2020. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics 18 February 2020Volume 172, Issue 4Page: JC19KeywordsAspirinHemorrhageHospitalistsHospitalizationsIschemiaMyocardial infarctionPercutaneous coronary interventionShockSt segment elevation myocardial infarctionStent implantation ePublished: 18 February 2020 Issue Published: 18 February 2020 Copyright & PermissionsCopyright © 2020 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...

Very short vs. long dual antiplatelet therapy after second generation drug-eluting stents in 35 785 patients undergoing percutaneous coronary interventions: a meta-analysis of randomized controlled trials.

To provide an updated assessment of the efficacy-safety profile of very short (1 or 3 months) dual antiplatelet therapy (DAPT) compared with long (12 months) DAPT in patients undergoing percutaneous coronary interventions (PCIs). Seven randomized controlled trials (RCTs) comparing very short vs. long DAPT in 35785 patients undergoing PCI were selected. The primary efficacy endpoint was major adverse cardiovascular events (MACE) and the primary safety endpoint trial-defined major bleeding through at least 1 year. Compared with longer duration, very short DAPT yielded comparable rates of MACE [odds ratio (OR) 0.93, 95% confidence interval (CI) 0.84-1.03, P = 0.19], all-cause mortality (OR 0.92, 95% CI 0.80-1.06, P = 0.25), myocardial infarction (OR 1.01, 95% CI 0.88-1.15, P = 0.91), stroke (OR 1.04, 95% CI 0.72-1.50, P = 0.83), stent thrombosis (OR 1.05, 95% CI 0.80-1.37, P = 0.73), target vessel revascularization (OR 0.99, 95% CI 0.82-1.18, P = 0.89), and comparable net clinical benefit (OR 0.92, 95% CI 0.84-1.01, P = 0.08). Very short DAPT was associated with reduced rates of major bleeding (OR 0.61, 95% CI 0.40-0.94, P = 0.03) or any bleeding (OR 0.65, 95% CI 0.47-0.90, P = 0.009). Subgroup analyses showed consistent results for 1 vs. 3 month DAPT and for aspirin vs. P2Y12 inhibitor monotherapy following very short DAPT. Compared with long DAPT, very short DAPT did not increase the odds of ischaemic complications, while reducing the odds of major or any bleeding by over 30%.

Abbreviated Dual Antiplatelet Therapy Followed by P2Y12 Inhibitor Monotherapy versus 12 Months’ Dual Antiplatelet Therapy Post Percutaneous Coronary Intervention: A Systematic Review and Meta-analysis of Randomized Controlled Trials

An increased incidence of stent thrombosis after implantation of first-generation drug-eluting stents led to a recommendation of dual antiplatelet therapy (DAPT) for 12months after the procedure. However, given the use of second-generation and newer drug-eluting stents, this recommendation needs to be revisited. Several randomized controlled trials (RCTs) have studied an abbreviated DAPT regimen of ≤ 3months followed by P2Y12 inhibitor monotherapy, and results have been conflicting. We performed a systematic review with meta-analysis of RCTs of abbreviated DAPT for ≤ 3months followed by P2Y12 monotherapy compared with 12months of DAPT. We performed a systematic search of the MEDLINE/PubMed, Cochrane, and DARE (Database of Abstracts of Reviews of Effects) databases for eligible RCTs. Quantitative analysis was performed based on the intention-to-treat principle. We used the Mantel-Haenszel method with a random-effects model to calculate relative risks (RRs) with 95% confidence intervals (CIs). The final analysis included four RCTs. We found no difference in the risk of all-cause mortality (RR 0.90; 95% CI 0.77-1.05; p = 0.18; I2 = 0%; χ2p = 0.58), myocardial infarction (RR 0.99; 95% CI 0.86-1.15; p = 0.85; I2 = 0%; χ2p = 0.70), stroke (RR 1.14; 95% CI 0.65-1.98; p = 0.65; I2 = 59%; χ2p = 0.06), or stent thrombosis (RR 0.98; 95% CI 0.73-1.33; p = 0.90; I2 = 0%; χ2p = 0.48). Additionally, there was no difference in the risk for major bleeding, defined as BARC (Bleeding Academic Research Consortium) type 3 or 5, between the two groups (RR 0.62; 95% CI 0.37-1.05; p = 0.07; I2 = 79%; χ2p < 0.05). Abbreviated DAPT followed by P2Y12 monotherapy resulted in a similar risk of re-ischemic clinical outcomes post percutaneous coronary intervention as compared with the standard 12-month DAPT regimen. The risk of major bleeding (BARC type 3 or 5) also remained similar between the two groups. However, as trials have reported benefits with abbreviated DAPT followed by P2Y12 monotherapy in terms of combined endpoints and all bleeding (BARC type 2-5), additional research is needed.

The efficacy and safety of P2Y12 inhibitor monotherapy in patients after percutaneous coronary intervention.

The optimal antiplatelet therapy after percutaneous coronary intervention (PCI) remains to be elucidated. Monotherapy with a P2Y12 inhibitor may be inferior to dual antiplatelet therapy in patients after PCI. PubMed, EMBASE (by Ovidsp), Web of Science, and The Cochrane Library were searched from database inception to 2 October 2019. The composite of cardiovascular outcomes, all‐cause mortality, myocardial infarction (MI), stroke, stent thrombosis, and major bleeding were evaluated. Pooled outcomes were presented as relative risk (RR) and 95% confidence intervals (CIs). A total of four trials randomizing 29 089 participants were included. Compared with the dual antiplatelet therapy group (n = 14 559), the P2Y12 inhibitor monotherapy group (n = 14 530) significantly decreased the incidence of bleeding events (2.0% vs 3.1%; RR: 0.60; 95% CI: 0.43‐0.84; P = .005). There were no significant differences in all‐cause mortality (1.3% vs 1.5%; RR: 0.87; 95% CI, 0.71‐1.06; P = .16), myocardial infarction (2.1% vs 1.9%; RR, 1.06; 95% CI, 0.90‐1.25; P = .46), stroke (0.6% vs 0.5%; RR, 1.18; 95% CI, 0.67‐2.07; P = .57), or stent thrombosis (0.5% vs 0.4%; RR, 1.14; 95% CI, 0.81‐1.61; P = .44) between the two groups. P2Y12 inhibitor monotherapy did not show any significant difference in the adverse cardiac and cerebrovascular events, but markedly decreased the risk of bleeding among patients after PCI vs dual antiplatelet therapy. However, it still needs to be further confirmed due to limited data.