Long-term outcomes of high bleeding risk patients undergoing percutaneous coronary intervention: a Korean nationwide registry.

BACKGROUND AND AIMS: Patients with high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI) are at increased risk of not only bleeding, but also ischaemic events. This study aimed to determine the long-term relative risk of ischaemic and bleeding events in HBR patients. METHODS: This study was a nationwide cohort study, based on the Korean National Health Insurance Review and Assessment Service database. Patients diagnosed with stable angina or acute coronary syndrome and those who underwent PCI in Korea between 2009 and 2018 were included in the analysis. According to the Academic Research Consortium HBR criteria, the total population was divided into HBR and non-HBR groups. The co-primary outcomes were major bleeding events and ischaemic (composite of cardiac death, myocardial infarction, and ischaemic stroke) events. RESULTS: Among a total of 325 417 patients who underwent PCI, 66 426 patients (20.4%) had HBR. During the follow-up period, HBR patients had a higher risk for major bleeding events (23.9% vs. 8.9%, P < .001) and ischaemic events (33.8% vs. 14.4%, P < .001). However, the impact of HBR was significant for major bleeding events [hazard ratio (HR) 3.12, 95% confidence interval (CI) 3.04-3.21, P < .001] and for ischaemic events (HR 2.50, 95% CI 2.45-2.56, P < .001). The HBR group was also associated with a greater risk of all-cause mortality (HR 3.73, 95% CI 3.66-3.79, P < .001). The average annual rate of major bleeding events within the first year after PCI was 5.5% for a single major criterion, and 2.9% for a single minor criterion. CONCLUSIONS: Among patients undergoing PCI, those with HBR were at increased long-term risk for both bleeding and ischaemic events, with a greater risk of mortality compared to non-HBR patients.

Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients with Dyslipidemia and Hypertension: A Multicenter Randomized Clinical Trial.

Background: Hypertension and dyslipidemia significantly contribute to cardiovascular disease development. Their coexistence poses challenges in managing multiple medications, influencing treatment adherence. Objective: This study aimed to assess the efficacy and safety of a combined treatment approach using a fixed-dose combination therapy. Methods: This multicenter, 8-week, randomized, double-blind, Phase IV trial was named Telmisartan/Amlodipine/Rosuvastatin from Samjin Pharmaceuticals and evaluated the efficacy and safety of fixed-dose combination treatment in patients with essential hypertension and dyslipidemia. They were randomly assigned to 2 fixed-dose combination therapy groups, telmisartan 40 mg/amlodipine 5 mg/rosuvastatin 10 mg (TEL/ALD/RSV) or amlodipine 5 mg/atorvastatin 10 mg (ALD/ATV) after washout/run-in period. The primary outcomes were the change in mean sitting systolic blood pressure and the percentage change of LDL-C after 8 weeks of medical treatment. Adverse drug reactions and events were assessed. Results: Of a total of 304 patients who underwent screening, 252 were randomized to the TEL/ALD/RSV group (125 patients) and the ALD/ATV group (127 patients). The mean (SD) ages of the TEL/ALD/RSV group and the ALD/ATV group were 67.4 (11.3) and 68.2 (10.6) years, respectively (P = 0.563). The least-squares mean (SE) in mean sitting systolic blood pressure changes between the 2 groups were -16.27 (0.93) mm Hg in the TEL/ALD/RSV group, -6.85 (0.92) mm Hg in the ALD/ATV group (LSM difference = -9.42 mm Hg; 95% CI, -11.99 to -6.84; P < .001). For LDL-C level changes, a significant difference was noted between the 2 groups: -50.03% (1.18%) in the TEL/ALD/RSV group, -39.60% (1.17%) in the ALD/ATV group (LSM difference = -10.43%; 95% CI, -13.70 to -7.16; P < .001). No severe adverse events were observed. Conclusions: TEL/ALD/RSV proved to be more efficient than ALD/ATV in lowering blood pressure and reducing LDL-C levels among patients with hypertension and dyslipidemia, with no notable safety concerns. (Curr Ther Res Clin Exp. 2024; XX:XXX-XXX). ClinicalTrials.gov identifier: NCT03860220.

Impact of Complete Revascularization for Acute Myocardial Infarction In Multivessel Coronary Artery Disease Patients With Diabetes Mellitus.

BACKGROUND AND OBJECTIVES: The clinical benefits of complete revascularization (CR) in acute myocardial infarction (AMI) patients are unclear. Moreover, the benefit of CR is unknown in AMI with diabetes mellitus (DM) patients. We sought to compare the prognosis of CR and incomplete revascularization (IR) in patients with AMI and multivessel disease, according to the presence of DM. METHODS: A total of 2,150 AMI patients with multivessel coronary artery disease were analyzed. CR was defined based on the angiographic image. The primary endpoint of this study was the patient-oriented composite outcome (POCO) defined as a composite of all-cause death, any myocardial infarction, and any revascularization within 3 years. RESULTS: Overall, 3-year POCO was significantly lower in patients receiving angiographic CR (985 patients, 45.8%) compared with IR (1,165 patients, 54.2%). When divided into subgroups according to the presence of DM, CR reduced 3-year clinical outcomes in the non-DM group but not in the DM group (POCO: 11.7% vs. 23.2%, p<0.001, any revascularization: 7.2% vs. 10.8%, p=0.024 in the non-DM group, POCO: 24.3% vs. 27.8%, p=0.295, any revascularization: 13.3% vs. 11.3%, p=0.448 in the DM group, for CR vs. IR). Multivariate analysis showed that CR significantly reduced 3-year POCO (hazard ratio, 0.52; 95% confidence interval, 0.36-0.75) only in the non-DM group. CONCLUSIONS: In AMI patients with multivessel disease, CR may have less clinical benefit in DM patients than in non-DM patients.

The Impact of Transcatheter Aortic Valve Implantation on Healthcare Costs and Clinical Outcomes Based on Frailty Risk: A Nationwide Cohort Analysis.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is preferred for treating severe aortic stenosis in older, frail populations, yet the impact of frailty on TAVI's economic and clinical outcomes is not well-studied. METHODS: This retrospective cohort study included 2,175 TAVI patients from 2015 to 2019 using Korea's National Health Insurance Service database, stratifying patients into low, intermediate, and high-frailty groups using the Hospital Frailty Risk Score (HFRS). Healthcare costs, admissions, and total length of hospitalization were analyzed using Wilcoxon-rank test 12 months pre- and post-TAVI. Composite endpoint of death, stroke, and major bleeding, with individual outcomes, were compared using Chi-squared tests and Kaplan-Meier analysis. RESULTS: Mean age was 80.2 years, and 47.3% were male. 747 (34.3%) were low-frailty, 1,159 (53.3%) were moderate-frailty, and 269 (12.4%) were high-frailty. After TAVI, medical costs decreased in the intermediate (pre-TAVI: 2,269,000 KRW [1,668 USD], post-TAVI: 1,607,000 KRW [1,181 USD], p<0.001) and high frailty groups (pre-TAVI: 3,949,000 KRW [2,904 USD], post-TAVI: 2,188,000 KRW [1,609 USD], p<0.001). All frailty groups had shorter length of hospital stay post-TAVI (26 to 21 days in the low, 44 to 31 days in the intermediate, and 65 to 41 days in the high frailty group; all p<0.001). The composite outcome was higher in the frailer groups (27.8% in the low vs. 31.5% in the intermediate vs. and 37.9% in the high frailty group; p=0.008). All groups showed comparable rates of cardiovascular death, stroke or bleeding. CONCLUSION: TAVI is clinically viable and cost-saving treatment option for frail patients with severe aortic stenosis.

Durable-polymer versus biodegradable-polymer drug-eluting stents in acute coronary syndromes: three-year outcomes of the HOST REDUCE POLYTECH RCT Trial.

BACKGROUND: Long-term follow-up is essential to evaluate the impact of polymer degradation in drug-eluting stents (DES). AIMS: We aimed to compare durable-polymer DES (DP-DES) and biodegradable-polymer DES (BP-DES) during a 3-year follow-up to evaluate the entire period of polymer resolution (before, during, and after degradation). METHODS: The HOST REDUCE POLYTECH RCT Trial was a randomised clinical trial enrolling patients with acute coronary syndrome (ACS) and comparing the efficacy and safety of DP-DES and BP-DES. The primary outcome was a patient-oriented composite outcome (POCO), and the key secondary outcome was a device-oriented composite outcome (DOCO). RESULTS: A total of 3,413 ACS patients were randomised to either the DP-DES (1,713 patients) or BP-DES (1,700 patients) group. During the 3-year follow-up, the risk of the POCO was similar between the DP-DES and BP-DES groups (14.8% vs 15.4%, hazard ratio [HR] 0.96, 95% confidence interval [CI]: 0.80-1.14; p=0.613). However, the risk of the DOCO was lower in the DP-DES group (6.0% vs 8.0%, HR 0.73, 95% CI: 0.57-0.95; p=0.020). In a landmark analysis, the lower risk of the DOCO for the DP-DES group was evident during the transition from the early to the late period after percutaneous coronary intervention (PCI) (from 8 to 16 months post-PCI; 1.8% vs 3.3%, HR 0.54, 95% CI: 0.34-0.84; p=0.007), which was mainly driven by a risk reduction of target lesion revascularisation. CONCLUSIONS: In ACS patients, DP-DES showed similar results to BP-DES regarding the POCO up to 3 years. For the DOCO, DP-DES were superior to BP-DES; this was due to the higher event rate during the period of polymer degradation.

Biodegradable Polymer Versus Polymer-Free Ultrathin Sirolimus-Eluting Stents: Analysis of the Stent Arm Registry From the HOST-IDEA Randomized Trial.

BACKGROUND: The efficacy and safety of each third-generation drug-eluting stent with ultrathin struts and advanced polymer technology remain unclear. We investigated the clinical outcomes of percutaneous coronary intervention using the Coroflex ISAR polymer-free sirolimus-eluting stent (SES) or Orsiro biodegradable polymer SES. METHODS: The HOST-IDEA trial (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-Coronary Intervention With Next-Generation Drug-Eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy), initially designed with a 2×2 factorial approach, sought to randomize patients undergoing percutaneous coronary intervention based on dual antiplatelet therapy duration (3 versus 12 months) and stent type (Coroflex ISAR versus Orsiro). Despite randomizing 2013 patients for dual antiplatelet therapy duration, the stent arm transitioned to a registry format during the trial. Among these, 328 individuals (16.3%) were randomized for Coroflex ISAR or Orsiro SES, while 1685 (83.7%) underwent percutaneous coronary intervention without stent-type randomization. In this study, the Coroflex ISAR (n=559) and Orsiro groups (n=1449) were matched using a propensity score. The prespecified primary end point was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization at 12 months. RESULTS: The baseline patient and procedural characteristics were well balanced between the Coroflex ISAR and Orsiro groups after propensity score matching (n=559, each group). The Coroflex ISAR group was significantly associated with a higher rate of target lesion failure, mainly driven by clinically driven target lesion revascularization, compared with the Orsiro group (3.4% versus 1.1%; hazard ratio, 3.21 [95% CI, 1.28-8.05]; P=0.01). A higher risk of target lesion failure in the Coroflex ISAR group was consistently observed across various subgroups. The rates of any bleeding (hazard ratio, 0.85 [95% CI, 0.51-1.40]; P=0.52) and major bleeding (hazard ratio, 1.58 [95% CI, 0.61-4.08]; P=0.34) were comparable between the 2 groups. CONCLUSIONS: In this propensity score-matched analysis of the stent arm registry from the HOST-IDEA trial, the Orsiro SES was associated with significantly better outcomes in terms of 1-year target lesion failure, mainly driven by clinically driven target lesion revascularization, than the Coroflex ISAR SES. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02601157.

Bleeding-Related Deaths in Relation to the Duration of Dual-Antiplatelet Therapy After Coronary Stenting

BACKGROUND:Although some randomized controlled trials (RCTs) and meta-analyses have suggested that prolonged dual-antiplatelet therapy (DAPT) may be associated with increased mortality, the mechanistic underpinnings of this association remain unclear.OBJECTIVES:The aim of this study was to analyze the associations among bleeding, mortality, and DAPT duration after drug-eluting stent implantation in a meta-analysis of RCTs.METHODS:RCTs comparing different DAPT durations after drug-eluting stent placement were sought through the MEDLINE, Embase, and Cochrane databases and the proceedings of international meetings. Deaths were considered possibly bleeding related if occurring within 1 year of the episodes of bleeding. Primary analysis was by intention-to-treat. Secondary analysis was performed in a modified intention-to-treat population in which events occurring when all patients were on DAPT were excluded.

Short-versus long-term Dual Antiplatelet therapy after drug-eluting stent implantation in women versus men: A sex-specific patient-level pooled-analysis of six randomized trials

Background: Whether the efficacy and safety of dual antiplatelet therapy (DAPT) are uniform between sexes is unclear. We sought to compare clinical outcomes between short-(6 months) versus long-term (1 year) DAPT after drug-eluting stent (DES) placement inwomen and men. Methods and Results: We pooled individual patient data from 6 randomizedtrials of DAPT (EXCELLENT, OPTIMIZE, PRODIGY, RESET, SECURITY, ITALIC PLUS).The primary outcome was 1-year risk of major adverse cardiac events (MACE). The mainsecondary outcome was 1-year risk of any bleeding. Out of the 11,473 randomized patients included in the pooled dataset, 3,454 (30%) were females. At 1-year follow-up, women hadhigher risk of MACE (3.6% vs. 2.8%; P 5 0.01) but similar risk of bleeding (1.9% vs. 1.6%;P 5 0.16) as compared with men. Compared with long-term DAPT, short-term DAPT wasassociated with similar rates of MACE in both women (HR 0.88; 95% CI 0.62–1.25) and men(HR 1.25; 95% CI 0.95–1.6; P interaction 5 0.08)]. At 1-year follow-up, short-term DAPT wasassociated with lower rates of bleeding as compared with long-term DAPT in both women(HR 0.84; 95% CI 0.51–1.37) and men (HR 0.58; 95% CI 0.40–0.84; P–interaction 5 0.25). The presence of MVD was associated with higher MACE rates in the short-term DAPT group inwomen (HR: 1.16; CI 0.60–2.23) and men (HR: 2.29; CI 1.22–4.29; P interaction 5 0.25). Conclusions: Short-term DAPT is associated with similar rates of MACE but lower risk ofbleeding when as compared with prolonged DAPT. There was no significant difference between sexes in the population studied...

Risk-Benefit of 1-Year DAPT After DES Implantation in Patients Stratified by Bleeding and Ischemic Risk

BACKGROUND: Although a 1-year duration of dual antiplatelet therapy (DAPT) is used in many patients after drug-eluting stent (DES) implantation, the evidence supporting this duration is uncertain. OBJECTIVES: The authors investigated the risk-benefit profile of 1-year vs ≤6-month DAPT after DES using 2 novel scores to risk stratify bleeding and ischemic events. METHODS: Ischemic and bleeding risk scores were generated from ADAPT-DES (Assessment of Dual Antiplatelet Therapy with Drug-Eluting Stents), a multicenter, international, "all-comers" registry that enrolled 8,665 patients treated with DES. The risk-benefit profile of 1-year vs ≤6-month DAPT was then investigated across risk strata from an individual patient data pooled dataset of 7 randomized trials that enrolled 15,083 patients treated with DES. RESULTS: In the derivation cohort, the ischemic score and the bleeding score had c-indexes of 0.76 and 0.66, respectively, and both were well calibrated. In the pooled dataset, no significant difference was apparent in any ischemic endpoint between 1-year and ≤6-month DAPT, regardless of the risk strata. In the overall dataset, there was no significant difference in the risk of clinically relevant bleeding between 1-year and ≤6-month DAPT; however, among 2,508 patients at increased risk of bleeding, 1-year compared with ≤6-month DAPT was associated with greater bleeding (HR: 2.80; 95% CI: 1.12-7.13) without a reduced risk of ischemic events in any risk strata, including those with acute coronary syndromes. These results were consistent in a network meta-analysis. CONCLUSIONS: In the present large-scale study, compared with ≤6-month DAPT, a 1-year duration of DAPT was not associated with reduced adverse ischemic events in any risk strata (including acute coronary syndromes) but was associated with greater bleeding in patients at increased risk of bleeding.

Gravedad de la enfermedad coronaria definida por ultrasonido intravascular o tomografía de coherencia óptica y su relación con los índices fisiológicos / Intravascular ultrasound or optical coherence tomography-defined anatomic severity and hemodynamic severity assessed by coronary physiologic indices

INTRODUCCIÓN Y OBJETIVOS: La reserva fraccional de flujo o el índice instantáneo en el periodo libre de ondas se han convertido en criterios estándar para la revascularización. Se buscó evaluar la asociación entre las características cuantitativas de placa valoradas por ecocardiografía intravascular (IVUS) o tomografía de coherencia óptima (OCT) y la gravedad de la estenosis fisiológica. MÉTODOS: Se evaluaron un total de 365 estenosis en 330 pacientes. Se exploró la asociación entre los parámetros derivados de la IVUS o la OCT y los índices fisiológicos en reposo (índice instantáneo en el periodo libre de ondas, reposo de ciclo cardiaco completo y relación de presión diastólica) y la reserva fraccional de flujo. RESULTADOS: Entre el total de lesiones, 50,7% y 58,1% mostraron índice instantáneo en el periodo libre de ondas ≤ 0,89 y reserva fraccional de flujo ≤ 080, respectivamente. Los parámetros derivados de la IVUS o de la OCT mostraron correlaciones significativas con los índices fisiológicos en reposo (p <0,005). Los mejores valores de corte del área luminal mínima (ALM) del IVUS, la carga de placa, el OCT-ALM y el porcentaje de área de la estenosis por OCT para predecir la significación funcional fueron los mismos (IVUS-ALM: 3,4 mm2, carga de placa 72,0%, OCT-ALM: 2,0 mm2, OCT-área de la estenosis: 68,0%) para todos los índices fisiológicos en reposo (índice instantáneo en el periodo libre de ondas, reposo de ciclo cardiaco completo y relación de presión diastólica). Los mejores valores de corte para la reserva fraccional de flujo fueron IVUS-ALM de 3,8 mm2, carga de placa del 70,0%, OCT-ALM de 2,3 mm2, OCT-área de la estenosis de 65,0%. Independientemente de los parámetros derivados del IVUS y OCT, las predicciones generales de diagnóstico de los parámetros fueron inferiores al 70% y los índices de discriminación fueron inferiores a 0,75 para los índices fisiológicos en reposo o reserva fraccional de flujo. CONCLUSIONES: Los índices fisiológicos en reposo mostraron una correlación idéntica con las características cuantitativas de la placa definidas por IVUS u OCT. La reserva fraccional de flujo mostró una correlación más fuerte con los parámetros IVUS u OCT que los índices fisiológicos en reposo. La precisión diagnóstica y la capacidad de discriminación de los parámetros anatómicos fueron modestas para predecir la significación funcional definida por los índices fisiológicos invasivos hiperémicos y de reposo

INTRODUCTION AND OBJECTIVES: Fractional flow reserve or instantaneous wave-free ratio has become a standard criterion for revascularization. We sought to evaluate the association between intravascular ultrasound (IVUS) or optical coherence tomography (OCT)-derived quantitative plaque characteristics and the severity of physiologic stenosis. METHODS: A total of 365 stenoses from 330 patients were evaluated. The association between IVUS or OCT-derived parameters and resting physiologic indices (instantaneous wave-free ratio, resting full-cycle ratio, and diastolic pressure ratio) and fractional flow reserve were explored. RESULTS: Among the total number of lesions, 50.7% and 58.1% showed an instantaneous wave-free ratio ≤ 0.89 and fractional flow reserve ≤ 0.80, respectively. IVUS or OCT-derived parameters showed significant correlations with resting physiologic indices (P values <.005). The best cutoff values of IVUS minimum lumen area (MLA), plaque burden, OCT-MLA, and OCT-area stenosis to predict functional significance were the same (IVUS-MLA: 3.4 mm2, plaque burden: 72.0%, OCT-MLA: 2.0 mm2, OCT-area stenosis: 68.0%) for all resting physiologic indices (instantaneous wave-free ratio, resting full-cycle ratio, and diastolic pressure ratio). The best cutoff values for fractional flow reserve were an IVUS-MLA of 3.8 mm2, plaque burden of 70.0%, OCT-MLA of 2.3 mm2, and OCT-area stenosis of 65.0%. Regardless of IVUS or OCT-derived parameters, the overall diagnostic accuracies of the parameters were lower than 70% and discrimination indices were less than 0.75 for resting physiologic indices or fractional flow reserve. CONCLUSIONS: The resting physiologic indices showed an identical relationship with IVUS or OCT-defined quantitative plaque characteristics. The diagnostic accuracy and discrimination ability of anatomical parameters were modest in predicting functional significance defined by resting and hyperemic invasive physiologic indices

Racial Differences in Ischaemia/Bleeding Risk Trade-Off during Anti-Platelet Therapy: Individual Patient Level Landmark Meta-Analysis from Seven RCTs

BACKGROUND: Prolonged dual anti-platelet therapy (DAPT) is intended to reduce ischemic events, at the cost of an increased bleeding risk in patients undergoing percutaneous coronary intervention (PCI). In this study, we evaluated whether race influences the ischemia/bleeding risk trade-off. METHODS: We searched for randomized clinical trials (RCTs) comparing DAPT duration after PCI. To compare the benefit or harm between DAPT duration by race, individual patient-level landmark meta-analysis was performed after discontinuation of the shorter duration DAPT group in each RCT. The primary ischemic endpoint was major adverse cardiac events (MACEs), and the primary bleeding endpoint was major bleeding events (clinicaltrials.gov NCT03338335). RESULTS: Seven RCTs including 16,518 patients (8,605 East Asians, 7,913 non-East Asians) were pooled. MACE occurred more frequently in non-East Asians (0.8% vs. 1.8%, p < 0.001), while major bleeding events occurred more frequently in East Asians (0.6% vs. 0.3%, p = 0.001). In Cox proportional hazards model, prolonged DAPT significantly increased the risk of major bleeding in East Asians (hazard ratio [HR], 2.843, 95% confidence interval [CI], 1.474-5.152, p = 0.002), but not in non-East Asians (HR, 1.375, 95% CI, 0.523-3.616, p = 0.523). East Asians had a higher median probability risk ratio of bleeding to ischemia (0.66 vs. 0.15), and the proportion of patients with higher probability of bleeding than ischemia was significantly higher in East Asians (32.3% vs. 0.4%, p < 0.001). CONCLUSION: We suggest that the ischemia/bleeding trade-off may be different between East Asians and non-East Asians. In East Asians, prolonged DAPT may have no effect in reducing the ischemic risk, while significantly increases the bleeding risk. (AU)

Three, six, or twelve months of dual antiplatelet therapy after DES Implantation in patients with or without acute coronary syndromes: anindividual patient data pairwise and network meta-analysis of six randomized trials and 11 473 patients

AIM: We sought to determine whether the optimal dual antiplatelet therapy (DAPT) duration after drug-eluting stent (DES) placement varies according to clinical presentation.METHODS AND RESULTS:We performed an individual patient data pairwise and network meta-analysis comparing short-term (≤6-months) versus long-term (1-year) DAPT as well as 3-month vs. 6-month vs 1-year DAPT. The primary study outcome was the 1-year composite risk of myocardial infarction (MI) or definite/probable stent thrombosis (ST). Six trials were included in which DAPT after DES consisted of aspirin and clopidogrel. Among 11 473 randomized patients 6714 (58.5%) had stable CAD and 4758 (41.5%) presented with acute coronary syndrome (ACS), the majority of whom (67.0%) had unstable angina. In ACS patients, ≤6-month DAPT was associated with non-significantly higher 1-year rates of MI or ST compared with 1-year DAPT (Hazard Ratio (HR) 1.48, 95% Confidence interval (CI) 0.98-2.22; P = 0.059), whereas in stable patients rates of MI and ST were similar between the two DAPT strategies (HR 0.93, 95%CI 0.65-1.35; P = 0.71; Pinteraction = 0.09). By network meta-analysis, 3-month DAPT, but not 6-month DAPT, was associated with higher rates of MI or ST in ACS, whereas no significant differences were apparent in stable patients. Short DAPT was associated with lower rates of major bleeding compared with 1-year DAPT, irrespective of clinical presentation. All-cause mortality was not significantly different with short vs. long DAPT in both patients with stable CAD and ACS.

Short term versus long term dual antiplatelet therapy after implantation of drug eluting stent in patients with or without diabetes: systematic review and meta-analysis of individual participant data from randomised trials

OBJECTIVE: To compare clinical outcomes between short term (up to 6 months) and long term (12 months) dual antiplatelet therapy (DAPT) after placement of a drug eluting stent in patients with and without diabetes.DESIGN: Individual participant data meta-analysis. Cox proportional regression models stratified by trial were used to assess the impact of diabetes on outcomes.DATA SOURCE: Medline, Embase, and Cochrane databases and proceedings of international meetings searched for randomised controlled trials comparing durations of DAPT after placement of a drug eluting stent. Individual patient data pooled from six DAPT trials.PRIMARY OUTCOME: Primary study outcome was one year risk of major adverse cardiac events (MACE), defined as cardiac death, myocardial infarction, or definite/probable stent thrombosis. All analyses were conducted by intention to treat...

Efficacy and safety of dual antiplatelet therapy after complex PCI

BACKGROUND: Optimal upfront dual antiplatelet therapy (DAPT) duration after complex percutaneous coronary intervention (PCI) with drug-eluting stents (DES) remains unclear. OBJECTIVES: This study investigated the efficacy and safety of long-term (≥12 months) versus short-term (3 or 6 months) DAPT with aspirin and clopidogrel according to PCI complexity. METHODS: The authors pooled patient-level data from 6 randomized controlled trials investigating DAPT durations after PCI. Complex PCI was defined as having at least 1 of the following features: 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 major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, or stent thrombosis. The primary safety endpoint was major bleeding. Intention-to-treat was the primary analytic approach. RESULTS: Of 9,577 patients included in the pooled dataset for whom procedural variables were available, 1,680 (17.5%) underwent complex PCI. Overall, 85% of patients received new-generation DES. At a median follow-up time of 392 days (interquartile range: 366 to 710 days), patients who underwent complex PCI had a higher risk of MACE (adjusted hazard ratio [HR]: 1.98; 95% confidence interval [CI]: 1.50 to 2.60; p < 0.0001)...

Short- Versus Long-TermDual Antiplatelet Therapy AfterDrug-Eluting Stent Implantation

Randomized controlled trials comparing short- (#6 months) with long-term ($1 year) dual antiplatelettherapy (DAPT) after drug-eluting stent(s) (DES) placement have been insufficiently powered to detect significantdifferences in the risk of major adverse cardiac events (MACE).OBJECTIVES This study sought to compare clinical outcomes between short- (#6 months) and long-term (1 year)DAPT and among 3 months, 6 months, and 1 year of DAPT post-DES placement by performing an individual patient datapairwise and network meta-analysis.METHODS Randomized controlled trials comparing DAPT durations after DES placement were searched through theMEDLINE, EMBASE, and Cochrane databases and in international meeting proceedings. The primary study outcomewas 1-year risk of MACE (cardiac death, myocardial infarction, or definite/probable stent thrombosis).RESULTS Four trials including 8,180 randomized patients were identified. At 1-year follow-up, short-term DAPT wasassociated with similar rates of MACE (hazard ratio [HR]: 1.11; 95% confidence interval [CI]: 0.86 to 1.43; p » 0.44), butsignificantly lower rates of bleeding (HR: 0.66; 95% CI: 0.46 to 0.94; p » 0.03) versus prolonged DAPT. Comparableresults were apparent in the landmark period between DAPT discontinuation and 1-year follow-up (for MACE: HR: 1.20;95% CI: 0.77 to 1.89; p » 0.42) (for bleeding: HR: 0.44; 95% CI: 0.21 to 0.91; p » 0.03). There were no significantdifferences in 1-year rates of MACE among 3-month versus 1-year DAPT, 6-month versus 1-year DAPT, or 3-month versus6-month DAPT.CONCLUSIONS Compared with prolonged DAPT, short-term DAPT is associated with similar rates of MACE but lowerrates of bleeding after DES placement.

Mortality in patients treated with extended duration dual antiplatelet therapy after drug-eluting stent implantation: a pairwise and Bayesian network meta-analysis of randomised trials

BACKGROUND:Despite recent studies, the optimum duration of dual antiplatelet therapy (DAPT) after coronary drug-eluting stent placement remains uncertain. We performed a meta-analysis with several analytical approaches to investigate mortality and other clinical outcomes with different DAPT strategies.METHODS:We searched Medline, Embase, Cochrane databases, and proceedings of international meetings on Nov 20, 2014, for randomised controlled trials comparing different DAPT durations after drug-eluting stent implantation. We extracted study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes. DAPT duration was categorised in each study as shorter versus longer, and as 6 months or shorter versus 1 year versus longer than 1 year. Analyses were done by both frequentist and Bayesian approaches.FINDINGS:We identified ten trials published between Dec 16, 2011, and Nov 16, 2014, including 31,666 randomly assigned patients. By frequentist pairwise meta-analysis, shorter DAPT was associated with significantly lower all-cause mortality compared with longer DAPT (HR 0·82, 95% CI 0·69-0·98; p=0·02; number needed to treat [NNT]=325), with no significant heterogeneity apparent across trials. The reduced mortality with shorter compared with longer DAPT was attributable to lower non-cardiac mortality (0·67, 0·51-0·89; p=0·006; NNT=347), with similar cardiac mortality (0·93, 0·73-1·17; p=0.52). Shorter DAPT was also associated with a lower risk of major bleeding, but a higher risk of myocardial infarction and stent thrombosis. We noted similar results in a Bayesian framework with non-informative priors. By network meta-analysis, patients treated with 6-month or shorter DAPT and 1-year DAPT had higher risk of myocardial infarction and stent thrombosis but lower risk of mortality compared with patients treated with DAPT for longer than 1 year...