The dawn of aspirin free strategy after short term dual antiplatelet for percutaneous coronary intervention: meta-analysis of randomized controlled trials.

There is still a debate about the safety and efficacy of an aspirin free strategy after percutaneous coronary intervention (PCI). Hence, we performed a meta-analysis comparing aspirin free strategy to dual antiplatlets therapy (DAPT). Randomized trials (RCTs) comparing aspirin free strategy to DAPT in patients who received PCI were included. The primary outcome of interest was bleeding, defined per the Bleeding Academic Research Consortium (BARC). Secondary outcomes included major adverse cardiovascular and cerebrovascular events (MACE); defined as all-cause mortality, myocardial infarction or stroke, the individual component of MACE and stent thrombosis. A total of 4 RCTs with 29,089 patients were included. There was significant reduction in BARC 2,3 or 5 bleeding events in patients who were treated with aspirin free strategy versus DAPT (HR 0.61, 95% CI 0.39-, p = 0.03, I2 = 89%). Moreover, although there was a trend of reduced major bleeding (BARC 3 or 5) outcomes in the aspirin free strategy group compared to the DAPT group, this did not achieve statistical significance (HR 0.63, 95% CI 0.37-1.06, p = 0.08, I2 = 795). Additionally, there was no difference between the aspirin free strategy and DAPT in term of MACE (HR 0.92, 95% CI 0.82-1.03, p = 0.13, I2 = 0%), all-cause mortality (HR 0.89, 95% CI 0.77-1.04, p = 0.15, I2 = 0%), MI (HR 0.89, 95% CI 0.74-1.08, p = 0.24, I2 = 0%), stroke (HR 1.13, 95% CI 0.65-1.99, p = 0.66, I2 = 60%) or stent thrombosis (HR 0.1.01, 95% CI 0.83-1.22, p = 0.93, I2 = 0%). Aspirin free strategy is as effective as DAPT in reducing MACE with better safety profile in term of bleeding.

10-Year Follow-Up of Patients With Everolimus-Eluting Versus Bare-Metal Stents After ST-Segment Elevation Myocardial Infarction.

BACKGROUND: Outcomes data for a durable-polymer everolimus-eluting stent (EES) at extended long-term follow-up in patients with ST-segment elevation myocardial infarction (STEMI) are unknown. OBJECTIVES: The aim of this study was to assess the 10-year outcomes of patients enrolled in the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) trial. METHODS: The EXAMINATION-EXTEND (10-Years Follow-Up of the EXAMINATION Trial) study is an investigator-driven 10-year follow-up of the EXAMINATION trial, which randomly assigned 1,498 patients with STEMI in a 1:1 ratio to receive either EES (n = 751) or bare-metal stents (n = 747). The primary endpoint was a patient-oriented composite endpoint of all-cause death, any myocardial infarction, or any revascularization. Secondary endpoints included a device-oriented composite endpoint of cardiac death, target vessel myocardial infarction, or target lesion revascularization; the individual components of the combined endpoints; and stent thrombosis. RESULTS: Complete 10-year clinical follow-up was obtained in 94.5% of the EES group and 95.9% of the bare-metal stent group. Rates of the patient-oriented composite endpoint and device-oriented composite endpoint were significantly reduced in the EES group (32.4% vs. 38.0% [hazard ratio: 0.81; 95% confidence interval: 0.68 to 0.96; p = 0.013] and 13.6% vs. 18.4% [hazard ratio: 0.72; 95% confidence interval: 0.55 to 0.93; p = 0.012], respectively), driven mainly by target lesion revascularization (5.7% vs. 8.8%; p = 0.018). The rate of definite stent thrombosis was similar in both groups (2.2% vs. 2.5%; p = 0.590). No differences were found between the groups in terms of target lesion revascularization (1.4% vs. 1.3%; p = 0.963) and definite or probable stent thrombosis (0.6% vs. 0.4%; p = 0.703) between 5 and 10 years. CONCLUSIONS: At 10-year follow-up, EES demonstrated confirmed superiority in combined patient- and device-oriented composite endpoints compared with bare-metal stents in patients with STEMI requiring primary percutaneous coronary intervention. Between 5- and 10-year follow-up, a low incidence of adverse cardiovascular events related to device failure was found in both groups. (10-Years Follow-Up of the EXAMINATION Trial; NCT04462315).

Dual antiplatelet therapy after carotid artery stenting: trends and outcomes in a large national database.

BACKGROUND: While dual antiplatelet therapy (dAPT) is standard of care following carotid artery stenting (CAS), the optimal dAPT regimen and duration has not been established. METHODS: We canvassed a large national database (IBM MarketScan) to identify patients receiving carotid endarterectomy (CEA) or CAS for treatment of ischemic stroke or carotid artery stenosis from 2007 to 2016. We performed univariable and multivariable regression methods to evaluate the impact of covariates on post-CAS stroke-free survival, including post-discharge antiplatelet therapy. RESULTS: A total of 79 084 patients diagnosed with ischemic stroke or carotid stenosis received CEA (71 178; 90.0%) or CAS (7906; 10.0%). After adjusting for covariates, <180 days prescribed post-CAS P2Y12-inhibition was associated with increased risk for stroke (<90 prescribed days HR=1.421, 95% CI 1.038 to 1.946; 90-179 prescribed days HR=1.484, 95% CI 1.045 to 2.106). The incidence of hemorrhagic complications was higher during the period of prescribed P2Y12-inhibition (1.16% per person-month vs 0.49% per person-month after discontinuation, P<0.001). The rate of extracranial hemorrhage was nearly six-fold higher while on dAPT (6.50% per patient-month vs 1.16% per patient-month, P<0.001), and there was a trend towards higher rate of intracranial hemorrhage that did not reach statistical significance (5.09% per patient-month vs 3.69% per patient-month, P=0.0556). Later hemorrhagic events beyond 30 days post-CAS were significantly more likely to be extracranial (P=0.028). CONCLUSIONS: Increased duration of post-CAS dAPT is associated with lower rates of readmissions for stroke, and with increased risk of hemorrhagic complications, particularly extracranial hemorrhage. The potential benefit of prolonging dAPT with regard to ischemic complications must be balanced with the corresponding increased risk of predominantly extracranial hemorrhagic complications.

Nuisance bleeding complications in patients with cerebral aneurysm treated with Pipeline embolization device.

BACKGROUND: Patients with cerebral aneurysms treated with the Pipeline embolization device (PED) are maintained on dual antiplatelet therapy (DAPT) to prevent thromboembolic complications. Rates of minor, "nuisance" bleeding in these patients remain unknown. We sought to evaluate the frequency and factors associated with this bleeding and its effect on DAPT compliance. METHODS: We performed a multicenter retrospective cohort study on consecutive cases of intracranial aneurysms treated with PED. Patient characteristics, aneurysm characteristics, and bleeding complications were analyzed. Severity of bleeding was defined according to a previously published classification defining nuisance bleeding as easy bruising, bleeding from small cuts, petechia, and ecchymosis. RESULTS: 245 PED aneurysm procedures on 243 patients were retrospectively collected from three academic centers over a 4.25-year period. Sixty-seven patients (27%) had nuisance bleeds. Patients with a higher risk of nuisance bleeding were older (59.1±3.4 vs . 54.7±2.2, P=0.032). Patients with nuisance bleeds were more likely to have their DAPT regimen changed or dose lowered (29% vs 8.3%, P<0.001), were on DAPT for less time (10.0 months±2.60 vs. 14.6 months±1.95, P=0.005) and were more likely to have aneurysm occlusion at 6 months (P<0.001). Stepwise logistic regression found age predictive of a nuisance bleed (OR=1.033) CONCLUSIONS: Nuisance bleeding was a common complaint of PED-treated aneurysm patients maintained on DAPT. Increasing age and aneurysmal occlusion at 6 months were the only factors predictive of nuisance bleeds. Clinicians were more likely to adjust antiplatelet regimens or stop DAPT early given a nuisance bleed.

Pipeline Embolization Device for Intracranial Aneurysms in a Large Chinese Cohort: Complication Risk Factor Analysis.

During intracranial aneurysm embolization with the Pipeline embolization device (PED), ischemic and hemorrhagic complications have been observed in cases among Western populations. The postmarket multicenter registry study on the embolization of intracranial aneurysms with the PED in China, i.e., the PLUS study, was performed to assess real-world predictors of complications and functional outcomes in patients treated with the PED in a Chinese population. All patients with intracranial aneurysms who underwent embolization using the PED between November 2014 and October 2019 across 14 centers in China were included. The study endpoints included preoperative and early postoperative (< 30 days) functional outcomes (modified Rankin scale [mRS] scores) and complications related to PED treatment at early postoperative and follow-up time points (3-36 months). Multivariate analysis was performed to identify risk factors for complications. A total of 1171 consecutive patients (mean age, 53.9 ± 11.4; female, 69.6% [813/1171]) with 1322 aneurysms were included in the study. Hypertension, basilar artery aneurysms, and successful deployment after adjustment or unsuccessful device deployment were found to be independent predictors of ischemic stroke, while the use of the Flex PED and incomplete occlusion immediately after treatment were protective factors. An aneurysm size > 10 mm, distal anterior circulation aneurysms, and adjunctive coiling were found to be independent predictors of delayed aneurysm rupture, distal intraparenchymal hemorrhage, and neurological compression symptoms, respectively. The rate of PED-related complications in the PLUS study was similar to that in Western populations. The PLUS study identified successful deployment after adjustment or unsuccessful device deployment and the degree of immediate postoperative occlusion as novel independent predictors of PED-related ischemic stroke in a Chinese population. ClinicalTrial.gov Identifier: NCT03831672.

Coronary Revascularization in the Past Two Decades in Japan (From the CREDO-Kyoto PCI/CABG Registries Cohort-1, -2, and -3).

The treatment of coronary artery disease has substantially changed over the past two decades. However, it is unknown whether and how much these changes have contributed to the improvement of long-term outcomes after coronary revascularization. We assessed trends in the demographics, practice patterns and long-term outcomes in 24,951 patients who underwent their first percutaneous coronary intervention (PCI) (n = 20,106), or isolated coronary artery bypass grafting (CABG) (n = 4,845) using the data in a series of the CREDO-Kyoto PCI/CABG Registries (Cohort-1 [2000 to 2002]: n = 7,435, Cohort-2 [2005 to 2007]: n = 8,435, and Cohort-3 [2011 to 2013]: n = 9,081). From Cohort-1 to Cohort-3, the patients got progressively older across subsequent cohorts (67.0 ± 10.0, 68.4 ± 9.9, and 69.8 ± 10.2 years, ptrend < 0.001). There was increased use of PCI over CABG (73.5%, 81.9%, and 85.2%, ptrend < 0.001) and increased prevalence of evidence-based medications use over time. The cumulative 3-year incidence of all-cause death was similar across the 3 cohorts (9.0%, 9.0%, and 9.3%, p = 0.74), while cardiovascular death decreased over time (5.7%, 5.1%, and 4.8%, p = 0.03). The adjusted risk for all-cause death and for cardiovascular death progressively decreased from Cohort-1 to Cohort-2 (HR:0.89, 95%CI:0.80 to 0.99, p = 0.03, and HR:0.80, 95%CI:0.70 to 0.92, p = 0.002, respectively), and from Cohort-2 to Cohort-3 (HR:0.86, 95%CI:0.78 to 0.95, p = 0.004, and HR:0.77, 95%CI:0.67-0.89, p < 0.001, respectively). The risks for stroke and repeated coronary revascularization also improved over time. In conclusions, we found a progressive and substantial reduction of adjusted risk for all-cause death, cardiovascular death, stroke, and repeated coronary revascularization over the past two decades in Japan.

Discharge Prescription Patterns for Antiplatelet Therapy Following Lower Extremity Peripheral Vascular Intervention.

BACKGROUND: Despite current guidelines suggesting a benefit for dual antiplatelet therapy (DAPT) following peripheral vascular intervention (PVI), there are limited data on antiplatelet prescribing patterns post-procedure. We attempted to determine variables associated with DAPT prescription following lower extremity PVI. METHODS: Retrospective analysis of patients undergoing lower extremity PVI in the Vascular Quality Initiative (2017-2018) was performed. Participants not on anticoagulation or DAPT before the procedure were considered for the final analysis. Postdischarge antiplatelet therapy regimen rates were determined (none, aspirin only, P2Y12 inhibitor only, and DAPT). Multivariate logistic regression was performed to determine variables associated with DAPT initiation compared with those discharged on single-agent or no antiplatelet therapy. RESULTS: A total of 16 597 procedures were included for analysis, with 49% initiated on DAPT post-PVI. Male sex (odds ratio [OR], 1.12 [95% CI, 1.05-1.20]), smoking (OR, 1.20 [95% CI, 1.09-1.32]), and coronary artery disease (OR, 1.19 [95% CI, 1.11-1.27]) were associated with an increased likelihood of post-PVI DAPT prescription. Procedures requiring multiple types of interventions (OR, 1.28 [95% CI, 1.15-1.42]), stent placement (OR, 1.16 [95% CI, 1.06-1.27]), and with complications (OR, 1.31 [95% CI, 1.14-1.52]) were also positively associated with DAPT prescription. CONCLUSIONS: In patients not already receiving anticoagulation or on DAPT at the time of lower extremity PVI, prescription of DAPT following intervention is ≈50%. Multiple factors were associated with the decision for DAPT versus single antiplatelet therapy, and further study is required to understand how this affects postintervention adverse limb and cardiovascular events.

Are We Optimizing the Use of Dual Antiplatelet Therapy in Patients Hospitalized with Acute Myocardial Infarction?

BACKGROUND: Dual antiplatelet therapy (DAPT) is a mainstay treatment for hospital survivors of an acute myocardial infarction (AMI). However, there are limited data on the prescribing patterns of DAPT among patients hospitalized with AMI during recent years. OBJECTIVE: To examine decade-long trends (2001-2011) in the use of DAPT versus antiplatelet monotherapy and patient characteristics associated with DAPT use. METHODS: The study population consisted of 2389 adults hospitalized with an initial AMI at all 11 central Massachusetts medical centers on a biennial basis between 2001 and 2011. DAPT was defined as the discharge use of aspirin plus either clopidogrel or prasugrel. Logistic regression analysis was used to identify patient characteristics associated with DAPT use. RESULTS: The average age of the study population was 65 years, and 69% of patients were discharged on DAPT. The use of DAPT at the time of hospital discharge increased from 49% in 2001 to 74% in 2011; this increasing trend was seen across all age groups, both sexes, types of AMI, and in those who underwent a PCI. After multivariable adjustment, patients 65-74 years old (adjusted odds ratio (aOR) = 0.53, 95% CI: 0.36-0.80) and those who underwent coronary artery bypass surgery (aOR = 0.11, 95% CI: 0.07-0.18) were less likely to have received DAPT, while men (aOR = 14.60, 95% CI: 10.66-19.98) and those who underwent cardiac catheterization and stenting (aOR = 14.60, 95% CI: 10.66-19.98) were significantly more likely to have received DAPT at discharge than respective comparison groups. CONCLUSIONS: Between 2001 and 2011, the use of DAPT increased markedly among patients hospitalized with AMI. However, a significant proportion of patients were not discharged on this therapy. Greater awareness is needed to incorporate DAPT into the management of patients hospitalized with AMI.

Epidemiological trends of acute coronary syndrome in Shimla district of the hilly state of Northern India: Six-year data from the prospective Himachal Pradesh acute coronary syndrome registry.

OBJECTIVES: The epidemiological trends of incidence, treatment practices, and outcomes are reported from Shimla district of the northern state of India. METHODS: The data of clinical characteristics, treatment practices, and outcomes of patients with acute coronary syndrome (ACS) diagnosed using standard criteria were collected systematically from the defined hilly geographical region of the northern state of India from January 2013 to December 2018 as the part of Himachal Pradesh acute coronary syndrome (HP ACS) registry. The year-wise trends of incidence, demographic, clinical characteristics, treatment practices, and in-hospital mortality are reported. RESULTS: The incidence of ACS shows declining trends. The mean age at incident ACS is increasing without change in gender predilection. The prevalence of overweight/obesity and diabetes has increased significantly since 2013 but tobacco consumption has not changed. The reperfusion therapy has increased significantly (20.9% in 2013 to 42.1% in 2018, p < 0.01) primarily because of an increased use of percutaneous coronary angioplasty. There is a trend of increasing use of beta blockers. The use of other oral secondary preventive drugs remained more than 90% since 2013. The in-hospital mortality rate is declining (9.0% in 2013 to 6.0% in 2018, p < 0.01). CONCLUSIONS: Epidemiological characteristics of the ACS population in Shimla district are changing. The trends of use of reperfusion therapy in ST segment elevated myocardial infarction population has although increased but is still suboptimal, and there is a need for taking initiatives both at the system and population level to improve the reperfusion therapy.

Patterns of treatment with antiplatelet therapy after an acute coronary syndrome: Data from a large database in a community setting.

AIMS: Current guidelines strongly recommend antiplatelet therapy with aspirin plus a P2Y12 receptor inhibitor (dual therapy) for patients with acute coronary syndrome (ACS). To better understand how antiplatelet treatment is prescribed in clinical practice, the aim of this study was to provide a more detailed description of real-world patients with and without antiplatelet treatment after an ACS, their outcomes at one-year follow-up and the related integrated cost. METHODS: The ReS database, including more than 12 million inhabitants, was evaluated. During the accrual period ACS patients discharged alive were identified on the basis of ICD-IX-CM code. Antiplatelet drug prescriptions and healthcare costs were analysed over one-year follow-up. RESULTS: In 2014, of the 25,129 patients discharged alive after an ACS, 5796 (23%) did not receive any antiplatelet therapy during the first month after hospital discharge. Among them, 3846 (66%) subjects were prescribed an antiplatelet drug subsequently, while 7.7% did not receive any antiplatelet treatment during the whole following year. Dual therapy in the subgroup of patients undergoing a revascularization procedure ( n = 8436) was prescribed to 79.2% of cases and to 46.1% ( n = 4009) of medically managed patients. The patients not treated with an antiplatelet treatment in the first month showed the highest one-year healthcare costs, mostly due to hospital re-admissions. CONCLUSIONS: This analysis of a large patient community shows that a considerable proportion of patients remained untreated with antiplatelet treatment after an ACS event. A clearer characterization of these subjects can help to improve the adherence to the current guidelines and recommendations.