Clopidogrel Monotherapy After 1-Month Dual Antiplatelet Therapy in Patients With Diabetes Undergoing Percutaneous Coronary Intervention

BackgroundDiabetes was reported to be associated with an impaired response to clopidogrel.ObjectivesThe aim of this study was to evaluate the safety and efficacy of clopidogrel monotherapy after very short dual antiplatelet therapy (DAPT) in patients with diabetes undergoing percutaneous coronary intervention (PCI).MethodsA subgroup analysis was conducted on the basis of diabetes in the STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent–2) Total Cohort (N = 5,997) (STOPDAPT-2, n = 3,009; STOPDAPT-2 ACS [Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent–2 for the Patients With ACS], n = 2,988), which randomly compared 1-month DAPT followed by clopidogrel monotherapy with 12-month DAPT with aspirin and clopidogrel after cobalt-chromium everolimus-eluting stent implantation. The primary endpoint was a composite of cardiovascular (cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) or bleeding (TIMI [Thrombolysis In Myocardial Infarction] major or minor) endpoints at 1 year.ResultsThere were 2,030 patients with diabetes (33.8%) and 3967 patients without diabetes (66.2%). Regardless of diabetes, the risk of 1-month DAPT relative to 12-month DAPT was not significant for the primary endpoint (diabetes, 3.58% vs 4.12% [HR: 0.87; 95% CI: 0.56-1.37; P = 0.55]; nondiabetes, 2.46% vs 2.49% [HR: 0.99; 95% CI: 0.67-1.48; P = 0.97]; P_interaction = 0.67) and for the cardiovascular endpoint (diabetes, 3.28% vs 3.05% [HR: 1.10; 95% CI: 0.67-1.81; P = 0.70]; nondiabetes, 1.95% vs 1.43% [HR: 1.38; 95% CI: 0.85-2.25; P = 0.20]; P_interaction = 0.52), while it was lower for the bleeding endpoint (diabetes, 0.30% vs 1.50% [HR: 0.20; 95% CI: 0.06-0.68; P = 0.01]; nondiabetes, 0.61% vs 1.21% [HR: 0.51; 95% CI: 0.25-1.01; P = 0.054]; P_interaction = 0.19).ConclusionsClopidogrel monotherapy after 1-month DAPT compared with 12-month DAPT reduced major bleeding events without an increase in cardiovascular events regardless of diabetes, although the findings should be considered as hypothesis generating, especially in patients with acute coronary syndrome, because of the inconclusive result in the STOPDAPT-2 ACS trial. (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent–2 [STOPDAPT-2], NCT02619760; Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent–2 for the Patients With ACS [STOPDAPT-2 ACS], NCT03462498)     

Comparison of three-year clinical outcomes with nonextended versus extended dual antiplatelet therapy between first- and second-generation drug-eluting stent implantation in patients with acute myocardial infarction: data from the infarct prognosis study registry

Background: The difference of the clinical outcomes between nonextended (≤12 months) and extended (>12 months) dual antiplatelet therapy (DAPT) remains unclear in patients with acute myocardial infarction (AMI) implanted by different generations of drug‐eluting stent (DES). Methods: We identified 790 consecutive patients with AMI who were free from major adverse cardiac events for 12 months after first‐generation (n = 537) or second‐generation DES (n = 253) implantation; each DES generation group was further divided into nonextended and extended DAPT. Results: During follow‐up (median: 40 months), nonextended DAPT in the first‐generation DES group showed a higher rate of cardiac death or MI than was observed in the extended DAPT group (14% vs 2%, P < 0.001). However, in the second‐generation DES group, there was no difference in the occurrence of cardiac death and MI between the extended and nonextended groups (4% vs 3%, P = 0.809). Nonextended DAPT was the most significant predictor of cardiac death and MI for first‐generation DES implantation [hazard ratio (HR) = 5.47, 95% confidence interval (CI) = 1.53–19.59, P = 0.009] but not for second‐generation DES implantation [HR = 3.21, 95% CI = 0.21–50.65, P = 0.401]. Conclusion: This study suggested that the clinical outcomes between nonextended and extended DAPT might be different depending on the generation of implanted DESs in patients with AMI. (J Interven Cardiol 2012;25:245–252)     

Duration of dual antiplatelet therapy and outcomes after coronary stenting with the genous™ bio‐engineered R stent™ in patients from the e‐healing registry

Objective : We investigated the relation between duration of dual antiplatelet therapy (DAPT) and clinical outcomes up to 12 months after Genous? endothelial progenitor cell capturing R stent? placement in patients from the e‐HEALING registry. Background : Cessation of (DAPT) has been shown to be associated with the occurrence of stent thrombosis (ST). After Genous placement, 1 month of DAPT is recommended. Methods : Patients were analyzed according to continuation or discontinuation of DAPT at a 30‐day and 6‐month landmark, excluding patients with events before the landmark. Each landmark was a new baseline, and outcomes were followed up to 12 months after stenting. The main outcome for our current analysis was target vessel failure (TVF), defined as target vessel‐related cardiac death or myocardial infarction and target vessel revascularization. Secondary outcomes included ST. (Un)adjusted hazard ratios (HR) for TVF were calculated with Cox regression. Results : No difference was observed in the incidence of TVF [HR: 1.03; 95% confidence intervals (CI): 0.65–1.65, P = 0.89] in patients continuing DAPT (n = 4,249) at 30 days versus patients stopped (n = 309), and HR: 0.82 (95% CI: 0.55–1.23, P = 0.34) in patients continuing DAPT (n = 2,654) at 6 months versus patients stopped [n = 1,408] DAPT). Furthermore, no differences were observed in ST. Even after addition of identified independent predictors for TVF, adjusted TVF hazards were comparable. Conclusions : In a post‐hoc analysis of e‐HEALING, duration of DAPT was not associated with the occurrence of the outcomes TVF or ST. The Genous stent may be an attractive treatment especially in patients at increased risk for (temporary) cessation of DAPT or bleeding. © 2011 Wiley Periodicals, Inc.     

Elevated concentration of placental growth factor (PlGF) and long term risk in patients with acute coronary syndrome in the PROVE IT-TIMI 22 trial

Placental growth factor (PlGF), a member of the vascular endothelial growth factor (VEGF) family, acts via the flt-1 receptor and promotes endothelial activation and macrophage recruitment into atherosclerotic lesions. We investigated the relationship of PlGF with cardiovascular outcomes in a large cohort of patients presenting across the spectrum of ACS. PlGF was measured at baseline (n = 3,761) and at four-months (n = 3,369) in patients randomized to atorvastatin 80 mg or pravastatin 40 mg after ACS in the PROVE IT-TIMI 22 trial. The primary endpoint was death, myocardial infarction (MI), unstable angina, revascularization or stroke (mean follow-up 24 months). Elevated baseline PlGF was associated with a higher incidence of the primary endpoint through 2 years (Q1 vs. Q5: 18.7 vs. 29.3%, p < 0.0001). The risk of death or MI was also higher in patients with elevated baseline PlGF (Q1 vs. Q5: 7.0 vs. 11.6%, p = 0.029). Adjusting for baseline characteristics and risk factors, elevated baseline PlGF was independently associated with the risk of the primary endpoint (adjusted-HR for Q5 vs. Q1 1.45; 95% CI 1.16-1.83; p = 0.001). Elevated PlGF at four months was associated with higher risk of death or MI (Adjusted HR Q5 vs. Q1 2.79, 95% CI: 1.37-5.68; p = 0.005), and higher risk of the primary endpoint (Adjusted HR Q5 vs. Q1 1.78, 95% CI: 1.26-2.51; p = 0.001). Higher concentration of PlGF after ACS is associated with long-term risk of recurrent cardiovascular events independent of traditional risk factors. This association is present early after ACS and appears to be stronger at four months.     

Incidence of thromboembolic and bleeding events in patients with newly diagnosed nonvalvular atrial fibrillation: An Asian multicenter retrospective cohort study in Singapore

Background

Real‐world effectiveness and safety of antithrombotics in nonvalvular atrial fibrillation (NVAF) patients in Singapore has not been thoroughly studied.

Hypothesis.

Users of various antithrombotics experience a significantly different risk of stroke and major bleed compared with warfarin users.

Methods

This multicenter retrospective cohort study included patients age ≥ 21 years newly diagnosed with NVAF between July 2012 and September 2015. Using electronic medical records, data on patients' demographics, antithrombotics prescribed, and CHA₂DS₂‐VASc and HAS‐BLED risk factors were collected. Patients were followed for 1 year from diagnosis for the primary effectiveness and safety endpoints of incident stroke or systemic embolism and major bleed, respectively. The secondary safety endpoint was overall bleed. Hazard ratios (HR) were determined from Cox regression.

Results

Of 743 patients included, 224 were on warfarin, 156 on direct oral anticoagulants (DOACs), 277 on single antiplatelet therapy (SAPT), 28 on dual antiplatelet therapy (DAPT), and 58 on no therapy. Mean age (±SD) was 68.7 ± 13.0 years. Compared with warfarin users, SAPT (adjusted [adj.] HR: 3.70, 95% confidence interval [CI]: 1.21‐11.3) and DAPT users (adj. HR: 10.1, 95% CI: 1.51‐67.2) were more likely to develop thromboembolic outcomes. Also, DOAC users (adj. HR: 0.304, 95% CI: 0.158‐0.585), SAPT users (adj. HR: 0.142, 95% CI: 0.0680‐0.295), and DAPT users (adj. HR: 0.112, 95% CI: 0.0146‐0.857) were less likely to experience any bleed compared with warfarin users.

Conclusions

SAPT and DAPT are less effective than warfarin in NVAF patients. DOACs may be considered in view of lower risk of overall bleed.

     

P2Y12 Inhibitor Monotherapy or Dual Antiplatelet Therapy After Complex Percutaneous Coronary Interventions

BackgroundIt remains unclear whether P2Y₁₂ inhibitor monotherapy preserves ischemic protection while limiting bleeding risk compared with dual antiplatelet therapy (DAPT) after complex percutaneous coronary intervention (PCI).ObjectivesWe sought to assess the effects of P2Y₁₂ inhibitor monotherapy after 1-month to 3-month DAPT vs standard DAPT in relation to PCI complexity.MethodsWe pooled patient-level data from randomized controlled trials comparing P2Y₁₂ inhibitor monotherapy and standard DAPT on centrally adjudicated outcomes after coronary revascularization. Complex PCI was defined as any of 6 criteria: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary efficacy endpoint was all-cause mortality, myocardial infarction, and stroke. The key safety endpoint was Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding.ResultsOf 22,941 patients undergoing PCI from 5 trials, 4,685 (20.4%) with complex PCI had higher rates of ischemic events. The primary efficacy endpoint was similar between P2Y₁₂ inhibitor monotherapy and DAPT among patients with complex PCI (HR: 0.87; 95% CI: 0.64-1.19) and noncomplex PCI (HR: 0.91; 95% CI: 0.76-1.09; P_interaction = 0.770). The treatment effect was consistent across all the components of the complex PCI definition. Compared with DAPT, P2Y₁₂ inhibitor monotherapy consistently reduced BARC 3 or 5 bleeding in complex PCI (HR: 0.51; 95% CI: 0.31-0.84) and noncomplex PCI patients (HR: 0.49; 95% CI: 0.37-0.64; P_interaction = 0.920).ConclusionsP2Y₁₂ inhibitor monotherapy after 1-month to 3-month DAPT was associated with similar rates of fatal and ischemic events and lower risk of major bleeding compared with standard DAPT, irrespective of PCI complexity. (PROSPERO [P2Y12 Inhibitor Monotherapy Versus Standard Dual Antiplatelet Therapy After Coronary Revascularization: Individual Patient Data Meta-Analysis of Randomized Trials]; CRD42020176853)     

Optimal Duration of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome: Insights From a Network Meta-Analysis of Randomized Trials

BackgroundWith newer generation drug eluting stents (DES), the minimal duration of dual antiplatelet therapy (DAPT) recommended by guidelines has been reduced to 6 months in patients with stable coronary artery disease. Whether shorter duration of DAPT is safe in patients presenting with acute coronary syndrome (ACS) remains controversial. Our aim of this study was to investigate the optimal DAPT duration (≤3 months vs. 6 months vs. 12 months vs. >12 months) among patients with ACS undergoing percutaneous coronary intervention (PCI).MethodsPUBMED and EMBASE were searched through January 2020 for randomized controlled trials of DAPT duration in patients with ACS. The ischemic outcomes were all-cause death, myocardial infarction, and stent thrombosis. The safety outcome was major and/or clinically relevant bleeding.ResultsOur search identified 14 eligible trials enrolling a total of 31,837 patients comparing different DAPT duration in patients with ACS. Short-term DAPT (≤3 months or 6 months) did not increase ischemic outcomes compared to long-term DAPT (12 months and >12 months). For bleeding outcomes, ≤3 months DAPT was associated with significant reduction in bleeding compared to 6 months, 12 months or >12 months DAPT (OR [95% CI]: 0.60 [0.37–0.98]; 0.68 [0.54–0.85] and 0.43 [0.34–0.54], respectively). These findings were similar when limited to 2nd generation DES.ConclusionsData from this meta-analysis of randomized trials support short-term (≤3 months and 6 months) DAPT in patients with ACS undergoing PCI. Guidelines might need to consider short-term DAPT even in patients presenting with ACS, especially in this era of newer generation DES.     

Multivessel vs single-vessel revascularization in patients with non-ST-segment elevation acute coronary syndrome and multivessel disease in the drug-eluting stent era

Background:

We sought to compare long‐term outcomes for multivessel revascularization (MVR) vs single‐vessel revascularization (SVR) with drug‐eluting stents (DES) in patients with non–ST‐segment elevation acute coronary syndrome (NSTE‐ACS) and multivessel coronary artery disease (MVD).

Hypothesis:

In DES era, MVR would improve long‐term clinical outcomes in patients with NSTE‐ACS.

Methods:

We studied 179 patients undergoing MVR and 187 patients undergoing SVR for NSTE‐ACS and MVD. Major adverse cardiac events (MACE) were defined as death, myocardial infarction, or any revascularization.

Results:

During follow‐up (median 36 months), MACE occurred in 96 patients (26.2%); 35 (19.6%) in the MVR group and 61 (32.6%) in the SVR group (P = 0.003). In multivariate analysis, MVR was associated with a lower incidence of MACE (hazard ratio [HR]: 0.50, 95% confidence interval [CI]: 0.30–0.85) and revascularization (HR: 0.43, 95% CI: 0.24–0.78), but not of death (HR: 0.69, 95% CI: 0.25–1.93) and myocardial infarction (HR: 0.39, 95% CI: 0.11–1.47). The incidence of periprocedural renal dysfunction was not significantly different between patients undergoing MVR vs SVR (3.4% vs 1.6%, P = 0.33). Definite or probable stent thrombosis occurred at a similar rate (2.2% in the MVR group and 2.7% in the SVR group, P = 0.99).

Conclusions:

In patients with NSTE‐ACS and MVD, MVR using drug‐eluting stents may reduce MACE. Our findings should be confirmed by a prospective, randomized trial. © 2011 Wiley Periodicals, Inc. This work was supported by Sungkyunkwan University Foundation for Corporate Collaboration (2008‐1366‐000) and the IN‐SUNG Foundation for Medical Research, Republic of Korea (CA88161). The authors have no other funding, financial relationships, or conflicts of interest to disclose.     

A Short‐Term,Randomized, Double‐Blind,Parallel‐Group Study to Evaluate the Efficacy and Safety of Dronedarone versus Amiodarone in Patients with Persistent Atrial Fibrillation: The DIONYSOS Study

Dronedarone versus Amiodarone in Patients with AF. Introduction: We compared the efficacy and safety of amiodarone and dronedarone in patients with persistent atrial fibrillation (AF). Methods: Five hundred and four amiodarone‐naïve patients were randomized to receive dronedarone 400 mg bid (n = 249) or amiodarone 600 mg qd for 28 days then 200 mg qd (n = 255) for at least 6 months. Primary composite endpoint was recurrence of AF (including unsuccessful electrical cardioversion, no spontaneous conversion and no electrical cardioversion) or premature study discontinuation. Main safety endpoint (MSE) was occurrence of thyroid‐, hepatic‐, pulmonary‐, neurologic‐, skin‐, eye‐, or gastrointestinal‐specific events, or premature study drug discontinuation following an adverse event. Results: Median treatment duration was 7 months. The primary composite endpoint was 75.1 and 58.8% with dronedarone and amiodarone, respectively, at 12 months (hazard ratio [HR] 1.59; 95% confidence interval [CI] 1.28–1.98; P < 0.0001), mainly driven by AF recurrence with dronedarone compared with amiodarone (63.5 vs 42.0%). AF recurrence after successful cardioversion was 36.5 and 24.3% with dronedarone and amiodarone, respectively. Premature drug discontinuation tended to be less frequent with dronedarone (10.4 vs 13.3%). MSE was 39.3 and 44.5% with dronedarone and amiodarone, respectively, at 12 months (HR = 0.80; 95% CI 0.60–1.07; P = 0.129), and mainly driven by fewer thyroid, neurologic, skin, and ocular events in the dronedarone group. Conclusion: In this short‐term study, dronedarone was less effective than amiodarone in decreasing AF recurrence, but had a better safety profile, specifically with regard to thyroid and neurologic events and a lack of interaction with oral anticoagulants. (J Cardiovasc Electrophysiol, Vol. 21, pp. 597‐605, June 2010)     

Clinical Outcome of First‐ vs Second‐Generation DES According to DAPT Duration: Results of ARCTIC‐Generation

There is an apparent benefit with extension of dual antiplatelet therapy (DAPT) beyond 1 year after implantation of drug‐eluting stents (DES). Assessment by a Double Randomization of a Conventional Antiplatelet Strategy vs a Monitoring‐Guided Strategy for Drug‐Eluting Stent Implantation, and of Treatment Interruption vs Continuation One Year After Stenting (ARCTIC)‐Generation assessed whether there is a difference of outcome between first‐ vs second‐generation DES and if there is an interaction with DAPT duration in the ARCTIC‐Interruption study. ARCTIC‐Interruption randomly allocated 1259 patients 1 year after stent implantation to a strategy of interruption of DAPT (n = 624), in which aspirin antiplatelet treatment only was maintained, or DAPT continuation (n = 635) for 6 to 18 additional months. The primary endpoint was the composite of death, myocardial infarction, stent thrombosis, stroke, or urgent revascularization. A total of 520 and 722 patients received a first‐ and a second‐generation DES, respectively. After a median follow‐up of 17 months (interquartile range, 15–18 months) after randomization, the primary endpoint occurred in 32 (6.2%) and 19 (2.6%) patients with first‐ and second‐generation DES, respectively (hazard ratio: 2.31, 95% confidence interval: 1.31‐4.07, P = 0.004). This was observed irrespective of the strategy of interruption or continuation of DAPT and timing of study recruitment. Major bleeding events occurred in 4 (0.8%) and 3 patients (0.4%) with first‐ and second‐generation DES, respectively (hazard ratio: 1.79, 95% confidence interval: 0.40‐8.02, P = 0.44). Results did not change after multiple adjustments for potential confounding variables. ARCTIC‐Generation showed worse clinical outcome with first‐ vs second‐generation DES, a difference that appeared to persist even with prolonged DAPT.     

Non-vitamin K antagonist oral anticoagulation versus left atrial appendage occlusion for primary and secondary stroke prevention after cardioembolic stroke

IntroductionThis study aimed to evaluate the performance of non-vitamin K antagonist oral anticoagulation (NOAC) in patients with previous stroke and non-valvular atrial fibrillation (AF) compared with left atrial appendage occlusion (LAAO) in primary and secondary stroke prevention settings.MethodsThis was a prospective, single-center, non-randomized cohort study of 302 consecutive patients with non-valvular AF and at high risk for stroke. Two treatment strategies were compared: LAAO (n=91) and long-term treatment with NOAC (n=149). The primary outcome was the composite endpoint of death, stroke and major bleeding. Propensity score and cause-of-death analyses were performed to compare outcomes.ResultsIn a mean follow-up of 13 months, there were 30 deaths (LAAO 8.8% vs. NOAC 14.8%), five strokes (LAAO 1.1% vs. NOAC 2.7%) and six major bleeds (LAAO 1.1% vs. NOAC 3.4%). There was a non-significant trend for a lower incidence of the primary endpoint in the LAAO group (11.0% vs. 20.9%; HR 0.42, 95% CI 0.17-1.05, p=0.064). Considering only secondary prevention LAAO patients (34.1% of the LAAO group), there was also a non-significant lower incidence of the primary endpoint (LAAO 6.5% vs. 20.9%; HR 0.30, 95% CI 0.07-1.39, p=0.12). While about a fifth of LAAO patients stopped antiplatelet treatment six months after device implantation due to recurrent minor bleeding, no adverse cardiovascular event or major bleeding occurred in this subset of patients.ConclusionIn this registry-based study, LAAO was a reasonable alternative to NOAC for the prevention of a composite endpoint of all-cause mortality, stroke and major bleeding in patients at high risk for stroke.     

Short Duration of DAPT Versus De-Escalation After Percutaneous Coronary Intervention for Acute Coronary Syndromes

ObjectivesThe aim of this study was to compare short dual antiplatelet therapy (DAPT) and de-escalation in a network meta-analysis using standard DAPT as common comparator.BackgroundIn patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI), shortening DAPT and de-escalating to a lower potency regimen mitigate bleeding risk. These strategies have never been randomly compared.MethodsRandomized trials of DAPT modulation strategies in patients with ACS undergoing PCI were identified. All-cause death was the primary outcome. Secondary outcomes included net adverse cardiovascular events (NACE), major adverse cardiovascular events, and their components. Frequentist and Bayesian network meta-analyses were conducted. Treatments were ranked on the basis of posterior probability. Sensitivity analyses were performed to explore sources of heterogeneity.ResultsTwenty-nine studies encompassing 50,602 patients were included. The transitivity assumption was fulfilled. In the frequentist indirect comparison, the risk ratio (RR) for all-cause death was 0.98 (95% CI: 0.68-1.43). De-escalation reduced the risk for NACE (RR: 0.87; 95% CI: 0.70-0.94) and increased major bleeding (RR: 1.54; 95% CI: 1.07-2.21). These results were consistent in the Bayesian meta-analysis. De-escalation displayed a >95% probability to rank first for NACE, myocardial infarction, stroke, stent thrombosis, and minor bleeding, while short DAPT ranked first for major bleeding. These findings were consistent in node-split and multiple sensitivity analyses.ConclusionsIn patients with ACS undergoing PCI, there was no difference in all-cause death between short DAPT and de-escalation. De-escalation reduced the risk for NACE, while short DAPT decreased major bleeding. These data characterize 2 contemporary strategies to personalize DAPT on the basis of treatment objectives and risk profile.     

Association between hyper- and hypoglycaemia and 2 year all-cause mortality risk in diabetic patients with acute coronary events.

AIMS: The study evaluated the associations between glycometabolic parameters at admission and during hospitalization and 2 year all-cause mortality risk in an unselected cohort of consecutive patients with diabetes admitted for unstable angina or non-Q-wave myocardial infarction to a university hospital during 1988-98. METHODS AND RESULTS: A total of 713 consecutive patients with diabetes were included. During 2 years of follow-up, 242 (34%) patients died. All analyses were retrospective using prospectively collected clinical data. The primary study endpoint was 2 year all-cause mortality collected from the Swedish cause-specific mortality register. In unadjusted analyses, high admission blood glucose (highest vs. lowest quartile: hazard ratio (HR) 2.66; 95% confidence interval (CI) 1.83, 3.86) and hypoglycaemia recorded during hospitalization (hypoglycaemia vs. normal: HR 1.77; 95% CI 1.09, 2.86) were both significantly associated with increased 2 year all-cause mortality risk. These associations remained significant after multivariable adjustment. CONCLUSION: In the setting of acute coronary syndromes (ACS) among patients with diabetes, hyperglycaemia on arrival and hypoglycaemia during hospitalization are both independently associated with worse adjusted all-cause 2 year mortality risk. These observations suggest that the avoidance of both hyper- and hypoglycaemia during ACS events may be of similar importance, and glucose modulation remains an important objective to address in future randomized trials.     

Analysis of individualized antiplatelet therapy for patients of acute coronary syndrome after percutaneous coronary intervention under the guidance of platelet function: A one-center retrospective cohort study

There is controversy in clinical application of antiplatelet drugs by monitoring platelet function. Therefore, we explored whether early and dynamic medication could bring better clinical outcomes for patients under the guidance of platelet function tests (PFT).In this retrospective cohort study, we analyzed the prognostic events of 1550 patients with acute coronary syndrome (ACS) at Tianjin People''s Hospital in China. They received dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) from January 2017 to December 2018. The primary endpoint was based on the Bleeding Academic Research Consortium (BARC) 3 or 5 major bleeding. Secondary endpoints included MACCE (all-cause death, nonfatal myocardial infarction, stroke, stent thrombosis, and unplanned target vessel reconstruction) and BARC 1 to 2 minor bleeding. The endpoint events within 1 year after PCI were recorded. Patients were divided into a guided group and a control group according to the drug adjustment by PFT results. After the propensity scores matched, the end points of 2 groups were compared, and subgroup analysis was performed on major bleeding events.After propensity score matching, there were 511 cases in the guided group and the control group, respectively. The primary endpoint events occurred in 10 patients (1.96%) in the guided group and 23 patients (4.5%) in the control group (HR: 0.45; 95% CI, 0.21–0.95; P = .037). After the guided group adjusted drug doses, the risk of major bleeding was lower than standard DAPT of the control group. Although some patients in the guided group reduced doses earlier, the incidence of MACCE events did not increase in the guided group compared with the control group (4.89% vs 6.07%; P = .41). There was no statistical difference in BARC 1 to 2 minor bleeding (P = .22). Subgroup analysis showed that PFT was more effective in patients with diabetes and multivessel disease.Early observation of dynamic PFT in ACS patients after PCI can guide individualized antiplatelet therapy to reduce the risk of major bleeding without increasing the risk of ischemia.     

Ticagrelor Monotherapy Versus Dual-Antiplatelet Therapy After PCI: An Individual Patient-Level Meta-Analysis

ObjectivesThe aim of this study was to compare ticagrelor monotherapy with dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with drug-eluting stents.BackgroundThe role of abbreviated DAPT followed by an oral P2Y₁₂ inhibitor after PCI remains uncertain.MethodsTwo randomized trials, including 14,628 patients undergoing PCI, comparing ticagrelor monotherapy with standard DAPT on centrally adjudicated endpoints were identified, and individual patient data were analyzed using 1-step fixed-effect models. The protocol was registered in PROSPERO (CRD42019143120). The primary outcomes were the composite of Bleeding Academic Research Consortium type 3 or 5 bleeding tested for superiority and, if met, the composite of all-cause death, myocardial infarction, or stroke at 1 year, tested for noninferiority against a margin of 1.25 on a hazard ratio (HR) scale.ResultsBleeding Academic Research Consortium type 3 or 5 bleeding occurred in fewer patients with ticagrelor than DAPT (0.9% vs. 1.7%, respectively; HR: 0.56; 95% confidence interval [CI]: 0.41 to 0.75; p < 0.001). The composite of all-cause death, myocardial infarction, or stroke occurred in 231 patients (3.2%) with ticagrelor and in 254 patients (3.5%) with DAPT (HR: 0.92; 95% CI: 0.76 to 1.10; p < 0.001 for noninferiority). Ticagrelor was associated with lower risk for all-cause (HR: 0.71; 95% CI: 0.52 to 0.96; p = 0.027) and cardiovascular (HR: 0.68; 95% CI: 0.47 to 0.99; p = 0.044) mortality. Rates of myocardial infarction (2.01% vs. 2.05%; p = 0.88), stent thrombosis (0.29% vs. 0.38%; p = 0.32), and stroke (0.47% vs. 0.36%; p = 0.30) were similar.ConclusionsTicagrelor monotherapy was associated with a lower risk for major bleeding compared with standard DAPT, without a concomitant increase in ischemic events.     

Medium on-treatment platelet reactivity to ADP is favorable in patients with acute coronary syndromes undergoing coronary stenting

Bleeding in the setting of acute coronary syndromes (ACS) has negative prognostic implications. We sought to determine the impact of different levels of on-treatment platelet reactivity (PR) to ADP on both bleeding and ischemic events in ACS patients receiving coronary stenting. PR to ADP was measured with the VerifyNow P₂Y₁₂ assay (Accumetrics, San Diego, CA) in 374 patients with ACS receiving standard dual antiplatelet therapy. Patients were stratified into three tertiles according to the increasing values of P₂Y₁₂ reaction units with the first tertile defined as low, second as medium, and third as high PR. The end points were bleeding (TIMI major or minor), ischemic end point (cardiovascular death and non-fatal myocardial infarction), and combined end point (bleeding or ischemic end point). At 30 days: low PR was associated with increased risk of bleeding as compared to medium (adjusted hazard ratio [HR] 3.50, 95% confidence intervals (CI) 1.30–9.42, p?=?0.013) and high PR (HR 2.78, 95% CI 1.50–5.15, p?=?0.001); high PR posed increased risk of ischemic endpoint as compared with medium PR (HR 7.26, 95% CI 1.67–31.55, p?=?0.008) and a trend towards higher incidence of ischemic events was observed when compared with low PR (HR 1.51, 95% CI 0.96–2.36, p?=?0.074); patients with medium PR were at significantly lower risk of combined end point as compared to those with low (HR 0.30, 95% CI 0.12–0.75, p?=?0.01) and high PR (HR 0.31, 95% CI 0.12–0.77, p?=?0.012). In conclusion, low PR to ADP is associated with increased hazard of bleeding and poses similar combined risk of bleeding and ischemic events as high PR. Medium PR predicts favorable net outcome in ACS patients.     

Short-Term Versus Long-Term Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation in Elderly Patients: A Meta-Analysis of Individual Participant Data From 6 Randomized Trials

Objectives

This study sought to evaluate the optimal duration of dual antiplatelet therapy (DAPT) after the implantation of a drug-eluting stent (DES) in elderly patients.

Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE

BackgroundResolute Onyx polymer-based zotarolimus-eluting stents (ZES) were noninferior in safety and effectiveness to BioFreedom polymer-free biolimus A9-coated stents (DCS) in high-bleeding-risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) at 1 year.ObjectivesThis study reports the final 2-year results of the randomized Onyx ONE trial.MethodsThe Onyx ONE (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients) trial randomly assigned HBR patients to treatment with ZES or DCS. Following 1-month DAPT, event-free patients received SAPT (either aspirin or a P2Y₁₂ inhibitor at physician discretion). The primary safety endpoint, a composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year, was determined at 1 year. Rates of primary and secondary endpoints were calculated after final follow-up at 2 years.ResultsA total of 1,003 patients were randomly allocated to ZES and 993 patients to DCS. Follow-up was complete in 980 (97.7%) ZES patients and 962 (96.9%) DCS patients at 2 years. The primary safety endpoint occurred in 208 (21.2%) patients in the ZES group and 199 (20.7%) patients in the DCS group (risk difference: 0.5%; 95% CI: ?3.1% to 4.2%; P = 0.78) at 2 years without significant differences in individual components of the composite endpoint. The secondary effectiveness endpoint occurred in 217 (22.1%) patients in the ZES group and 202 (21.0%) patients in the DCS group (risk difference: 1.1%; 95% CI: ?2.5% to 4.8%; P = 0.54).ConclusionsAmong patients at HBR treated with 1-month DAPT followed by SAPT, the Resolute Onyx polymer-based ZES had similar 2-year outcomes for the primary safety and secondary effectiveness endpoint compared with the BioFreedom polymer-free DCS. (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy [DAPT] for High-Bleeding Risk Patients [Onyx ONE]; NCT03344653)     

One-year clinical outcomes after sirolimus-eluting coronary stent implantation for acute myocardial infarction in the worldwide e-SELECT registry

Background: The aim was to ascertain the 1‐year clinical outcomes of 1,234 patients who underwent implantations of sirolimus‐eluting stents (SES) for acute myocardial infarction (MI) in the multinational e‐SELECT registry. Methods: Fifteen thousand and one hundred and forty‐seven patients treated with SES were entered in the e‐SELECT registry, of whom 1,234 presented within <24 hours of onset of acute MI. Results: At 1 year, the rates of major adverse cardiac events (MACE) (5.5% vs. 4.8%; P = 0.28) were similarly low in the acute and no acute MI groups. The rates of definite/probable stent thrombosis (ST) were higher in the acute MI group (2.1%vs; 0.88%, P < 0.001). ST was a strong independent predictor of death at 1 year (HR 13.4; 95% CI 5.0, 36.0; P < 0.001) and MI (HR 58.9; 95% CI 26.9, 129.1; P < 0.001). Dual antiplatelet therapy (DAPT) compliance at 6 months was 96.0% in the acute MI versus 94.5% in the no acute MI group (P = 0.03). Conclusion: In selected patients presenting within <24 hours of acute MI onset and highly compliant with DAPT, SES implantation was associated with similar rates of MACE, though higher rates of ST, as compared to no acute MI patients. Condensed abstract In the e‐SELECT registry which included 15,147 patients treated with sirolimus‐eluting stent (SES), we ascertained the 1‐year clinical outcomes of 1,234 patients who presented within <24 hours of acute MI onset. In acute MI patients SES implantation was associated with similar rates of MACE, though higher rates of ST, as compared to no acute MI patients (MACE: 5.5% vs. 4.8%; P = 0.28; ST: 2.1 vs. 0.88%, P < 0.001). (J Interven Cardiol 2012;25:253–261)     

Impact of Acute Coronary Syndrome Classification and Procedural Technique on Clinical Outcomes in Patients With Coronary Bifurcation Lesions Treated With Drug‐Eluting Stents

Background:

We examined the impact of non–ST‐segment elevation acute coronary syndrome (NSTE‐ACS) on clinical outcomes in patients with bifurcation lesions treated with drug‐eluting stents.

Hypothesis:

We hypothesized that NSTE‐ACS would be attributable to the increased risk of major adverse cardiac events (MACE) in bifurcation percutaneous coronary intervention.

Methods:

We enrolled 1668 patients, using data from a multicenter real‐world bifurcation registry. The primary objective was to compare the 2‐year cumulative risk of MACE in patients with NSTE‐ACS to those with stable angina. Major adverse cardiac events were defined as the composite endpoint of cardiac death, myocardial infarction (MI), and target‐lesion revascularization.

Results:

Non–ST‐segment elevation acute coronary syndrome was seen in 969 (58.1%) patients and stable angina in 699. Major adverse cardiac events occurred in 7.3% of NSTE‐ACS patients and in 5.2% with stable angina (P = 0.042). However, cardiac death, MI, and target‐lesion revascularization were similar between the 2 groups. We stratified patients with NSTE‐ACS into those with non–ST‐segment elevation MI and those with unstable angina. Cumulative risks of 2‐year MACEs were 7.0% in non–ST‐segment elevation MI patients and 7.5% in unstable angina patients (P = 0.87). In the NSTE‐ACS cohort, the baseline lesion length in the side branch (adjusted hazard ratio [HR]: 1.04, 95% confidence interval [CI]: 1.01‐1.07, P = 0.022), paclitaxel‐eluting stents in the main vessel (adjusted HR: 2.02, 95% CI: 1.21‐3.40, P = 0.008), and final kissing ballooning (adjusted HR: 1.88, 95% CI: 1.10‐3.21, P = 0.021) were independent predictors of MACE.

Conclusions:

Compared with stable angina patients, the NSTE‐ACS patients who underwent bifurcation percutaneous coronary intervention had an increased risk of MACE during the 2‐year follow‐up. Clin. Cardiol. 2012 doi: 10.1002/clc.22020 Drs Pil Sang Song and Dong Ryeol Ryu contributed equally to this work. Coronary Bifurcation Stenting (COBIS) Registry in South Korea, US Department of Health and Human Services, US National Institutes of Health, ClinicalTrials.gov no. NCT00851526. This work was supported by the Korean Society of Interventional Cardiology, Seoul, South Korea. The authors have no other funding, financial relationships, or conflicts of interest to disclose.