Drug-Eluting Versus Bare-Metal Stents in Older Patients: A Meta-Analysis of Randomized Controlled Trials

BackgroundDespite the high prevalence of ischemic heart disease in older patients, there is a substantial lack of evidence to guide clinical decision-making in this population. Hence, we performed a meta-analysis to determine the safety and efficacy of percutaneous coronary intervention (PCI) with drug-eluting stents (DES) versus bare-metal stents (BMS).MethodsElectronic databases were searched for randomized trials comparing DES with BMS in patients ≥70 years-old. The primary outcome was major adverse cardiovascular events (MACE). Secondary outcomes included different ischemic and bleeding events. Subgroup analyses for dual-antiplatelet therapy (DAPT) duration were conducted.ResultsWe included 7 trials with a total of 5449 patients. The use of DES compared with BMS was associated with a significant reduction in MACE (odds ratio [OR]:0.76; 95% confidence interval [CI]:0.62–0.93; P = 0.007) with no increased risk of bleeding events (OR: 1.07; 95% CI: 0.89–1.27; P = 0.48). However, longer duration of DAPT (>6 months) for the DES group increased bleeding events (OR: 1.52; 95% CI: 1.05–2.20; P = 0.03). In contrast, shorter DAPT showed persistent efficacy in reducing MACE in DES-treated patients with no increased bleeding events (OR: 0.72; 95% CI: 0.60–0.87; P < 0.01 and OR: 1.01; 95% CI: 0.84–1.22; P = 0.89, respectively).ConclusionsIn older patients who had undergone PCI, DES showed superior efficacy in reducing MACE with no increased risk of bleeding compared with BMS. Persistent MACE reduction was evident with shorter DAPT durations in DES-treated patients.SummaryThis meta-analysis of randomized clinical trials demonstrated that drug-eluting stents were associated with a significant reduction in major adverse cardiovascular events with no increased risk of bleeding compared with bare-metal stents. The risk of bleeding was high with longer dual antiplatelet therapy duration for patients who underwent DES placement. However, short duration of dual antiplatelet therapy substantially reduced major adverse cardiovascular events with no increased bleeding risk.     

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.     

Outcomes with Drug-Coated Balloons in Percutaneous Coronary Intervention in Diabetic Patients

BackgroundPercutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) remains associated with inferior clinical outcomes and an increased risk of restenosis compared with non-diabetics even in the era of drug-eluting stents (DES). The outcomes with drug-coated balloons (DCBs) in diabetic patients have received limited study.MethodsWe performed a meta-analysis of all studies published between January 2000 and January 2019 reporting the outcomes with DCB vs. DES after PCI of de-novo coronary lesions in diabetic patients. Outcomes included major adverse cardiovascular events (MACE), target lesion revascularization (TLR), binary restenosis by quantitative coronary angiography (QCA), and late lumen loss (LLL).ResultsThree studies with 378 patients (440 lesions) were included in the meta-analysis. During 17.3 ± 11.3 months follow-up, DCB were associated with a similar risk of MACE (OR: 0.63, 95% CI [0.36, 1.12], p = 0.11), TLR (OR: 0.51, 95% CI [0.25, 1.06] p = 0.07), binary restenosis (OR: 0.42, 95% CI [0.09, 1.92], p = 0.26), and LLL (mean difference: −0.13 mm, 95% CI [−0.41, 0.14], p = 0.34) compared with DES.ConclusionIn diabetic patients with de-novo coronary lesions undergoing PCI, DCBs are associated with similar outcomes compared with first-generation DES, with a signal toward potential benefit in lowering target lesion revascularization. Further randomized studies are needed to compare the newer-generation DCBs and DES in this setting.     

Tratamiento antiagregante plaquetario doble tras la intervención coronaria percutánea del tronco coronario izquierdo

Introduction and objectivesThere are scarce data on the optimal duration and prognostic impact of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) with second-generation drug-eluting stents for left main coronary artery (LMCA) disease. The aim of this study was to investigate the practice pattern and long-term prognostic effect of DAPT duration in patients undergoing PCI with second-generation drug-eluting stents for LMCA disease.MethodsUsing individual patient-level data from the IRIS-MAIN and KOMATE registries, 1827 patients undergoing PCI with second-generation drug-eluting stents for LMCA disease with valid information on DAPT duration were included. The efficacy outcome was major adverse cardiovascular events (MACE, a composite of cardiac death, myocardial infarction, and stent thrombosis) and the safety outcome was TIMI major bleeding.ResultsDAPT duration was < 6 months (n = 273), 6 to 12 months (n = 477), 12 to 24 months (n = 637), and ≥ 24 months (n = 440). The median follow-up duration was 3.9 [interquartile range, 3.01-5.00] years. Prolonged DAPT duration was associated with lower incidences of MACE. In multigroup propensity score analysis, adjusted HR for MACE were significantly higher for DAPT < 6 months and DAPT 6 to 12 months than for DAPT 12 to 24 months (HR, 4.51; 95%CI, 2.96-6.88 and HR 1.92; 95%CI, 1.23-3.00). There was no difference in HR for major bleeding among the assessed groups.ConclusionsDAPT duration following PCI for LMCA disease is highly variable. Although the duration of DAPT should be considered in the context of the clinical situation of each patient, < 12 months of DAPT was associated with higher incidence of MACE. Registration identifiers: NCT01341327; NCT03908463.     

Prognostic implications of early and long-term bleeding events in patients on one-year dual antiplatelet therapy following drug-eluting stent implantation

Background : Bleeding has emerged as a predictor of early and late mortality after percutaneous coronary interventions. However, the prevalence and predictors of long‐term bleeding events in patients on prolonged dual antiplatelet therapy (DAPT) after drug‐eluting stent (DES) implantation has been poorly explored. Methods : A total of 1,437 patients undergoing DES implantation discharged on DAPT with aspirin and clopidogrel for 1 year were studied. Patients were followed for up to 4 years (34.3 ± 14.4 months) and the prevalence and predictors of in‐hospital and long‐term thrombolysis in myocardial infarction (TIMI) major and minor bleeding events evaluated. The impact of bleeding events on major adverse cardiac events (MACE), overall death, and stent thrombosis (ST) was also assessed. Results : The incidences of 30 days major and minor bleeding were 1.3 and 3.3%, respectively. The incidences of 1‐year major and minor bleeding were 3.0 and 5.6%, respectively. The incidences of major and minor bleeding up to 4‐year follow‐up were 3.6 and 6.9%, respectively. At multivariable analysis, 1‐year major bleeding was positively predicted by use of oral anticoagulants at hospital discharge [odds ratio (OR) = 13.4, 95% confidence interval (CI) 3.0–59.2, P = 0.001], anemia at admission (OR = 6.7, 95% CI = 2.7–16.5, P < 0.001) and use of glycoprotein IIb/IIIa inhibitors (OR = 2.7, 95% CI = 1.1–6.5, P = 0.03) and negatively predicted by male gender (OR = 0.39, 95% CI = 0.16–0.97, P = 0.042). Overall, major bleeding at 1 year and at long‐term follow‐up was associated with an increased risk of MACE, cardiac death and ST. Patients who had any bleeding event were more likely to prematurely discontinue antiplatelet therapy (50% vs. 9.6%, P < 0.001). Conclusions : In DES‐treated patients on prolonged DAPT, major bleeding occurring at 1 year and up to 4 years following DES implantation in patients on prolonged DAPT is associated with poor long‐term prognosis. © 2012 Wiley Periodicals, Inc.     

Transradial Versus Transfemoral Access for Percutaneous Coronary Intervention of Unprotected Left Main Coronary Artery Stenosis: A Systematic Review and Meta-Analysis

IntroductionPCI of ULMS is frequently performed through TFA because of technical complexity and safety concern. Studies have shown comparable efficacy and safety of TRA versus TFA, however, these studies are few in number. We intended to compare the clinical outcomes between transradial access (TRA) and transfemoral access (TFA) in patients undergoing percutaneous coronary intervention (PCI) for unprotected left main coronary artery stenosis (ULMS) by performing a meta-analysis.MethodA systematic search of database, including, PubMed, Web of Science, Google scholar and Cochrane Database were performed by two independent reviewers. Studies were included comparing “TRA” versus “TFA” in patients undergoing PCI in ULMS. The primary outcome was a procedural success rate. Secondary outcomes were major bleeding, access site complications, in-hospital and long term: major adverse cardiac events (MACE), myocardial infarction (MI) and cardiovascular mortality.ResultsEight studies were included in the analysis. The procedural success rate was 97.3% and there was no statistically significant difference between TRA and TFA groups (OR, 1.41 [CI 0.64, 3.12], I² = 26%). The rates of access site complications (OR, 0.17 [CI 0.07, 0.41], I² = 16%), major bleeding (OR, 0.39 [CI 0.17, 0.86], I² = 0%) and all-cause mortality (OR, 0.28 [CI 0.12, 0.64], I² = 0%) were lower in the TRA group. There were no significant differences in in-hospital and long term cardiovascular mortality, MI and MACE between the two groups.ConclusionIn contrast to TFA, TRA is associated with reduced bleeding and access site complications, with similar procedural success rate in patients undergoing PCI of ULMS.     

Bioactive or Drug-Eluting Stents in 75 Years or Older Patients: The BIODES-75 Registry

BackgroundTiNO-coated BAS have demonstrated competitive outcomes compared to drug-eluting stents (DES). These devices allow short antiplatelet regimens and may be a good option for the growing elderly population undergoing percutaneous coronary intervention (PCI).MethodsMulticenter observational trial in routine clinical practice. A propensity-score matched analysis compared a prospective cohort of patients ≥ 75 years undergoing PCI with BAS, with a contemporary and retrospective cohort treated with last-generation DES. The co-primary endpoints of the study were the Target-Lesion-Failure (Cardiac death, non-fatal myocardial infarction, or target lesion revascularization) and Major Adverse Cardiovascular Events (total death, non-fatal myocardial infarction, stroke, or new revascularization) at 1 year.ResultsWhole population included 1000 patients, and 326 patients in each group were matched for analysis. No differences in primary endpoints were found: TLF 10.4% vs. 11% (HR 0.96 (Confidence Interval 95%, 0.36–1.7; p = 0.87)) and MACE 16.3% vs. 17.2% (HR 0.98 (Confidence Interval 95%; 0.3–1.5, p = 0.93)). Patients treated with BAS received shorter antiplatelets regimens (dual antiplatelet therapy at 1 year, 25.7% vs. 70.6%, p = 0.0001), and they presented lower incidence of bleeding (3.7% vs. 11.7%, HR 0.3 (IC 95% 0.16–0.6, p = 0.001)).ConclusionIn this real-life registry of patients ≥ 75 years, BAS were similar to the latest-generation DES in terms of efficacy and reduced the duration of the antithrombotic therapy, lowering bleeding events.     

Dual Antiplatelet Therapy Discontinuation,Platelet Reactivity,and Adverse Outcomes After Successful Percutaneous Coronary Intervention

ObjectivesThe purpose of this study was to assess the extent to which the association between premature dual antiplatelet therapy (DAPT) discontinuation and excess risk of thrombotic events varies according to the reason and timing of DAPT discontinuation and whether high on-treatment platelet reactivity (HPR) influences the risk of thrombotic events after premature DAPT discontinuation.BackgroundDAPT after percutaneous coronary intervention (PCI) suppresses platelet reactivity, and HPR on clopidogrel after PCI is associated with an increased risk of thrombotic events.MethodsADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) was a prospective, multicenter registry of 8,582 patients successfully treated with coronary drug-eluting stents that assessed HPR on clopidogrel. For patients who discontinued aspirin or clopidogrel at any time during the study, the reasons for discontinuation were systematically categorized.ResultsPlanned DAPT discontinuation occurred within 2 years in 3,203 (37.3%) patients. One thousand four hundred eighteen (16.5%) patients discontinued DAPT for unplanned reasons, including surgery or trauma (n = 768 [8.9%]), patient nonadherence (n = 321 [3.7%]), bleeding complications (n = 264 [3.1%]), and drug allergy or hypersensitivity (n = 113 [1.3%]). Unplanned but not planned DAPT discontinuation was associated with an increased risk of a major adverse cardiac event (MACE, defined as the composite of cardiac death, myocardial infarction, or stent thrombosis); with highest risk within 3 months after PCI (adjusted HR: 7.65, 95% CI: 2.77-21.10 vs adjusted HR: 2.47, 95% CI: 1.70-3.58 for unplanned DAPT discontinuation ≥3 months after PCI). MACE risk after DAPT discontinuation was not moderated by HPR (P_interaction = 0.91).ConclusionsIn this large-scale all-comers registry, premature DAPT discontinuation for unplanned reasons occurred in approximately 1 of 6 patients after DES implantation and was associated with a markedly increased risk of MACEs. (Assessment of Dual AntiPlatelet Therapy With Drug Eluting Stents [ADAPT-DES]; NCT00638794)     

3- or 1-Month DAPT in Patients at High Bleeding Risk Undergoing Everolimus-Eluting Stent Implantation

ObjectivesThe aim of this study was to evaluate 2 abbreviated dual-antiplatelet therapy (DAPT) regimens in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI).BackgroundCurrent-generation drug-eluting stents are preferred over bare-metal stents for HBR patients, but their optimal DAPT management remains unknown.MethodsThe XIENCE Short DAPT program included 3 prospective, multicenter, single-arm studies enrolling HBR patients who underwent successful PCI with a cobalt-chromium everolimus-eluting stent. After 1 month (XIENCE 28 USA and XIENCE 28 Global) or 3 months (XIENCE 90) of DAPT, event-free patients discontinued the P2Y₁₂ inhibitor. The postmarketing approval XIENCE V USA study was used as historical control in a propensity score–stratified analysis.ResultsA total of 3,652 patients were enrolled. The propensity-adjusted rate of the primary endpoint of all-cause mortality or myocardial infarction was 5.4% among 1,693 patients on 3-month DAPT versus 5.4% in the 12-month DAPT historical control (P_{noninferiority} = 0.0063) and 3.5% among 1,392 patients on 1-month DAPT versus 4.3% in the 6-month DAPT historical control (P_{noninferiority} = 0.0005). Bleeding Academic Research Consortium (BARC) types 2 to 5 bleeding was not significantly lower with 3- or 1-month DAPT, while BARC types 3 to 5 bleeding was reduced in both experimental groups. The rate of definite or probable stent thrombosis was 0.2% in XIENCE 90 (P < 0.0001 for the performance goal of 1.2%) and 0.3% in XIENCE 28.ConclusionsAmong HBR patients undergoing PCI with cobalt-chromium everolimus-eluting stents, DAPT for 1 or 3 months was noninferior to 6 or 12 months of DAPT for ischemic outcomes and may be associated with less major bleeding and a low incidence of stent thrombosis.     

Tratamiento antiagregante de muy corta duración tras la ICP y nuevos SLF: metanálisis de 5 estudios aleatorizados

Introduction and objectivesVery early (1-3 months) discontinuation of dual antiplatelet therapy (DAPT) has been recently proposed in percutaneous coronary interventions with modern drug-eluting stents (DES), with contrasting results. The aim of the present meta-analysis was to evaluate the prognostic impact of very short DAPT regimens vs the standard 12-month regimen in patients undergoing percutaneous coronary intervention with new DES.MethodsLiterature and main scientific session abstracts were searched for randomized clinical trials (RCT). The primary efficacy endpoint was mortality, and the primary safety endpoint was major bleeding events. A prespecified analysis was conducted according to the long-term antiplatelet agent.ResultsWe included 5 RCTs, with a total of 30 621 patients; 49.97% were randomized to very short (1-3 months) DAPT, followed by aspirin or P2Y₁₂I monotherapy. Shorter DAPT duration significantly reduced the rate of major bleeding (2% vs 3.1%, OR, 0.62; 95%CI, 0.46-0.84; P = .002; Phet = .02), but did not significantly condition overall mortality (1.3% vs 2%, OR, 0.97; 95%CI, 0.73-1.29; P = .84; Phet = .18). The reduction in bleeding events was even more significant in trials randomizing event-free patients at the time of DAPT discontinuation. The occurrence of myocardial infarction and stent thrombosis was similar between shorter vs standard 12-month DAPT.ConclusionsBased on the current meta-analysis, a very short (1-3 months) period is associated with a significant reduction in major bleeding compared with the standard 12-month therapy, with no increase in major ischemic events and comparable survival.Full English text available from:www.revespcardiol.org/en     

Duration of dual anti‐platelet therapy following drug eluting stents

• This meta‐analysis suggests that abbreviated DAPT (<6 months) could be considered in patients undergoing PCI with current generation drug eluting stents (DES).
• Extended DAPT strategy (>1 year) may be appropriate in those patients in whom prevention of stent and non‐stent‐related coronary events are likely to offset the bleeding complications.
• Additional randomized trials are needed to evaluate the optimum duration of DAPT in patients with the latest generation DES and current antiplatelet drugs.

     

A comparison of drug-eluting stents versus bare metal stents in saphenous vein graft PCI outcomes: a meta-analysis

Aims: Studies demonstrate that percutaneous coronary intervention (PCI) with drug‐eluting stents (DES) is associated with reduced revascularization and major adverse cardiac events (MACE) rates compared to bare metal stents (BMS) in native coronary vessels. Optimal PCI treatment of saphenous vein graft (SVG) lesions remains unclear despite SVG procedures representing up to 10% of PCI cases. We therefore performed a meta‐analysis to compare outcomes between BMS and DES in SVG PCI. Methods and Results: A search (2004–2009) of MEDLINE and conference proceedings for all relevant studies comparing mortality and MACE outcomes in DES versus BMS in SVG PCI and meta‐analysis of the data was performed. Twenty studies were identified from 2005 to 2009 enrolling a total of 5,296 patients. Meta‐analysis revealed a decrease in mortality associated with DES use, odds ratio (OR) 0.68; 95% confidence interval (CI) 0.53–0.88; P = 0.004. Similarly, MACE (OR 0.64; 95% CI 0.51–0.82; P < 0.001), total lesion revascularization (OR 0.60; 95% CI 0.43–0.83; P = 0.002), and total vessel revascularization (OR 0.57; 95% CI 0.41–0.80; P = 0.001) were significantly decreased in the patients in which DES were used compared to BMS. This reduction in mortality and MACE events associated with DES use appears to be limited to registry studies and not randomized controlled studies. Conclusions: Our meta‐analysis suggests DES use to be safe in SVG PCI and associated with reduced mortality and MACE rates with reductions in revascularization also observed. (J Interven Cardiol 2011;24:172–180)     

Renal impairment is an independent predictor of adverse events post coronary intervention in patients with and without drug-eluting stents

Renal impairment (RI) is known to be an independent risk factor for the progression of cardiovascular disease. Its impact, however, on the outcomes in patients undergoing percutaneous coronary intervention (PCI) especially in the era of drug-eluting stents (DES) is not well known.We analysed data from patients undergoing PCI from April 1, 2004, to September 30, 2006, who were part of the Melbourne Interventional Group registry. RI was defined as an estimated glomerular filtration rate (eGFR), calculated using Cockcroft–Gault formula, of <60 ml/min. We compared outcomes at 30 days and 12 months in patients with and without RI.Four thousand one hundred ninety-five patients (3043 male) with an average age 65±12 years (mean±S.D.) underwent PCI. Twelve-month follow-up was available in 3963 (95%) patients, and these were included in the analysis. One thousand twelve patients (26%) had RI; of these, 608 (60%) presented with an acute coronary syndrome. Both 30-day major adverse cardiac events (MACE), 9.1% vs. 4.6% (P<.01), and all-cause mortality, 4.5% vs. 0.7% (P<.01), were significantly higher in those with RI compared to those without RI. Twelve-month mortality (8.8% vs. 1.7%, P<.01) and MACE (19.7% vs. 10.3%, P<.01) were also significantly higher in those with RI. In multiple regression analysis, RI was an independent predictor of 12-month MACE [OR 2.0 (CI 1.6–2.6), P<.01].RI is an independent predictor of 30-day and 12-month MACE and death after PCI in patients with stable and unstable coronary syndromes, even with widespread use of DES. eGFR should be used to help risk-stratify patients undergoing PCI.     

85岁及以上老年冠心病患者经皮冠状动脉支架治疗的临床观察

目的 探讨85～94岁冠心病患者经皮冠状动脉支架治疗的疗效和预后.方法 回顾性分析90例85岁以上冠心病患者经皮冠状动脉支架治疗的临床和造影特点、住院期间和长期疗效.结果 90例中,21例应用金属裸支架(BMS),69例应用药物洗脱支架(DES).三支病变41例,2支病变21例,单支病变28例.手术成功率为94.4%,术前与术后TIMI-3级血流比例分别为72.2%和94.4%.手术相关并发症为15.6%,主要为冠脉夹层(11.1%).住院期间主要心血管不良事件(MACE)为7.8%,其中DES组住院期间MACE为5.8%,BMS组为14.3%.DES组出现2例严重出血.86例患者随访1年时,总的MACE为4.6%,其中DES组为6.0%,BMS组没有任何MACE.DES组出现]例脑卒中和1例严重出血.47例患者随访2年时,总的MACE为14.9%,其中DES组MACE为19.4%,BMS组无任何MACE.DES组1例发生严重出血,BMS组1例发生脑卒中.多因素COX回归分析表明,肌酐水平和高血压是影响长期预后的重要因素.结论 85岁以上冠心病患者经皮冠状动脉支架治疗手术成功牢较高,住院期间和长期的MACE事件发生率较低,并存高血压和严重.肾功能不全的患者MACE的发生率相对较高.     

Clinical outcomes with 6 months dual antiplatelet therapy after implantation of Biolimus-A9 drug eluting coronary stents

Introduction

Duration of dual antiplatelet therapy (DAPT) following drug eluting stent (DES) implantation remains poorly defined. Endothelialisation of biodegradable polymer biolimus-eluting stents occurs early, and 6 months DAPT may be adequate.

Aims

We evaluated long term outcome in patients treated with biolimus-eluting stents who were treated with 6 months DAPT. Endpoints included cardiac death and non-fatal stent thrombosis occurring 6 to 12 months after stent implantation.

Methods

692 patients (77.2% male), aged 65.6 ± 12.5 years received biolimus-eluting DES (March 2008 –November 2011). Vital status was tracked through the Medical Research Information Service. Episodes of non-fatal stent thrombosis, (Academic Research Consortium definition) between months 6 and 12 were tracked via systematic database searches (5 PCI centres).

Results

Presentations included acute coronary syndrome (47.2%) and stable coronary disease (52.8%). Vessels treated included left main stem (6.8%), left anterior descending (37.4%), circumflex (19.1%), right coronary artery (34.5%) and saphenous vein graft (2.1%) respectively. High-risk subsets included diabetes (15.6%); AHA type C lesions (35.1%) and chronic total occlusions (12.8%). During median follow-up of 700 days (0 to 1392) there were 42 deaths (6.1%); 4.2% at 0–6 months, 1.0% at 6–12 months and 0.9% at > 12 months. Of the 7 deaths between 6 and 12 months, one death was adjudicated as possible stent thrombosis. There were no cases of non-fatal known stent thrombosis. All cause mortality accrued with smooth decremental incidence. Statistical examination showed no evidence of event clustering between 6 and 12 months.

Conclusions

After implantation of biodegradable polymer biolimus-eluting coronary stents, 6 months DAPT appears to be adequate, safe and effective.     

Prasugrel vs Ticagrelor for DAPT in Patients with ACS Undergoing PCI: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

IntroductionDual antiplatelet therapy (DAPT) with a P2Y12 inhibitor added to aspirin is considered the standard of care for patients with acute coronary syndrome (ACS) undergoing percutaneous intervention (PCI). Prasugrel and ticagrelor are commonly used P2Y12 inhibitors, and a few head-to-head randomized control trials (RCTs) have been performed. We performed a systematic review and meta-analysis of these RCTs to compare the efficacy and adverse effects between these two agents when used in patients with ACS undergoing PCI.MethodsWe searched PubMed/MEDLINE and Cochrane library for RCTs comparing prasugrel to ticagrelor in ACS. The primary endpoint was major adverse cardiovascular events (MACE). Secondary outcomes were all-cause mortality, cardiovascular mortality, myocardial infarction (MI), stent thrombosis, major bleeding, and all bleeding event. Estimates were calculated as random effects risk ratios (RRs) with 95% confidence intervals (CI).ResultsSix trials with 6807 patients were included. There were no significant difference of MACE (RR 0.93; 95% CI [0.72–1.20]; p = 0.59; I² = 26%), all-cause mortality (RR 0.92; 95% CI [0.73–1.17]; p = 0.51; I² = 0%), cardiovascular mortality (RR 0.99; 95% CI [0.75–1.31]; p = 0.96; I² = 0%), MI (RR 0.87; 95% CI [0.60–1.27]; p = 0.48; I² = 27%), stent thrombosis (RR 0.64; 95% CI [0.39–1.04]; p = 0.07; I² = 0%), major bleeding (RR 0.94; 95% CI [0.70–1.26]; p = 0.68; I² = 6%), and all bleeding event (RR 0.92; 95% CI [0.77–1.09]; p = 0.32; I² = 0%) for prasugrel compared with ticagrelor.ConclusionThere are no significant difference of MACE, all-cause mortality, cardiovascular mortality, MI, stent thrombosis, and bleeding between prasugrel and ticagrelor when added to aspirin among patients with ACS undergoing PCI.     

Outcomes With Drug-Coated Balloons vs. Drug-Eluting Stents in Small-Vessel Coronary Artery Disease

BackgroundThe use of drug-coated balloons (DCBs) in small-vessel coronary artery disease (SVD) remains controversial.MethodsWe performed a meta-analysis of all randomized controlled trials (RCTs) reporting the outcomes of DCB vs. DES in de-novo SVD. We included a total of 5 RCTs (1459 patients), with (DCB n = 734 and DES n = 725).ResultsOver a median follow-up duration of 6 months, DCB was associated with smaller late lumen loss (LLL) compared with DES (mean difference −0.12 mm) (95% confidence intervals (CI) [−0.21, −0.03 mm], p = 0.01). Over a median follow-up of 12 months, both modalities had similar risk of major adverse cardiovascular events (MACE) (8.7% vs. 10.2%; odds ratio (OR): 0.94, 95% CI [0.49–1.79], p = 084), all-cause mortality (1.17% vs. 2.38%; OR: 0.53, 95% CI [0.16–1.75], p = 0.30), target lesion revascularization (TLR) (7.9% vs. 3.9%; OR: 1.26, 95% CI [0.51–3.14], p = 0.62), and target vessel revascularization (TVR) (8.2% vs. 7.8%; OR: 1.06, 95% CI [0.40–2.82], p = 0.91). DCBs were associated with lower risk of myocardial infarction (MI) compared with DES (1.55% vs. 3.31%; OR: 0.48, 95% CI [0.23–1.00], p = 0.05, I2 = 0%).ConclusionPCI of SVD with DCBs is associated with smaller LLL, lower risk of MI, and similar risk of MACE, death, TLR, and TVR compared with DES over one year. DCB appears as an attractive alternative to DES in patients with de-novo SVD, but long-term clinical data are still needed.     

DAPT Score and the Impact of Ticagrelor Monotherapy During the Second Year After PCI

ObjectivesThis study assessed the ability of the dual-antiplatelet therapy (DAPT) score in stratifying ischemic and bleeding risk in a contemporary percutaneous coronary intervention (PCI) population.BackgroundThe DAPT score is recommended by guidelines as a tool to stratify ischemic and bleeding risk. Its utility in contemporary PCI is unknown.MethodsThe study studied patients in GLOBAL LEADERS (A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation) who were free of major ischemic and bleeding events and adhered to antiplatelet strategy during the first year after PCI. The primary ischemic endpoint was the composite of myocardial infarction or stent thrombosis. The primary bleeding endpoint was Bleeding Academic Research Consortium type 3 or 5. Outcomes from 12 to 24 months after PCI were compared according to the DAPT score.ResultsOf 11,289 patients that were event-free after the first year, 6,882 and 4,407 patients had low (<2) and high (≥2) DAPT scores, respectively. Compared with a low DAPT score, patients with a high DAPT score had a higher rate of the composites of myocardial infarction or stent thrombosis (0.70% vs. 1.55%; p < 0.0001). The rate of Bleeding Academic Research Consortium type 3 or 5 bleeding was 0.54% and 0.30% in the low and high DAPT score groups, respectively (p = 0.058). The effect of ticagrelor versus aspirin monotherapy on primary ischemic and bleeding endpoints during the second year were no different among the 2 groups.ConclusionsThe DAPT score can stratify ischemic but not bleeding risk in a contemporary PCI population during the second year. The score did not provide additional value for selection of antiplatelet strategy beyond the first year.     

Intravenous Antiplatelet Therapy Bridging in Patients Undergoing Cardiac or Non-Cardiac Surgery Following Percutaneous Coronary Intervention

BackgroundThe effect of perioperative bridging therapy on risks of ischemic cardiac events and major bleeding complications in patients on dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) remains undefined.MethodsWe report on 60 consecutive patients between 2010 and 2017 who required cardiac (CS; n = 15) or non-cardiac (NCS; n = 45) surgeries following PCI at our institution. Short-acting intravenous (IV) antiplatelet (APT) bridging with eptifibatide, tirofiban and cangrelor were instituted after DAPT interruption.ResultsAll patients were men with multiple atherosclerosis risk factors. An acute coronary syndrome indication (56.7%) was the most common PCI indication in the CS and NCS groups. Drug-eluting stents were used in 93.33% and 95.56% of the above groups, respectively. The median duration from PCI to CS and NCS were 11.17 and 18.25 months, respectively and 38.33% of all surgeries were performed within 6 months of the index PCI. Most patients were on background aspirin (83.33%) and clopidogrel (81.67%) and median duration of DAPT interruption was 7 days. Median duration of perioperative IV APT bridging was 3 days for CS and 5 days for NCS groups. In the CS group, two patients (13.33%) had non-fata myocardial infarction (MI), and four (26.67%) had clinically significant bleeding. No patients had perioperative stent thrombosis. In the NCS group, one patient (2.22%) had stent thrombosis; four (6.67%) had myocardial infarction, and five (11.11%) clinically significant bleeding.ConclusionsDespite using IV APT as bridging therapy during perioperative DAPT interruption in post-PCI patients, postoperative cardiac events and bleeding complications can still occur.     

Comparison of coronary DES and BMS in octogenarians: A systematic review and meta-analysis

Objective Uncertainty exists regarding the relative performance of drug-eluting stents (DES) versus bare-metal stents (BMS) in octogenarians undergoing percutaneous coronary intervention (PCI). We undertook a meta-analysis to assess outcomes for DES and BMS in octogenarians undergoing PCI. Methods Electronic data bases of PubMed, Cochrane, and EMBASE were searched. We included randomized, controlled clinical trials (RCT) and observational studies comparing DES and BMS in octogenarians receiving PCI. The methodological qualities of eligible trials were assessed using a “risk of bias” tool. The endpoints included all-cause death, major adverse cardiac events (MACE), myocardial infarction (MI), target vessel revascularization (TVR), major bleeding, and stent thrombosis (ST). Odds ratios (OR) and 95% confidence intervals (95% CI) were calculated for each endpoint. Results A total of one RCT and six observational studies were included and analyzed in this meta-analysis. All trials were of acceptable quality. At 30 days, compared with DES-treated patients, BMS-treated patients had a higher incidence of mortality (OR: 3.91, 95% CI: 1.10–13.91; P = 0.03). The OR for MACE (1.52, 95% CI: 0.56–4.17; P = 0.13), MI (0.81, 95% CI: 0.37–2.17; P = 0.23), TVR (0.75, 95% CI: 0.17–3.41; P = 0.41), major bleeding (0.77, 95% CI: 0.35–1.68; P = 0.43), and ST (1.44, 95% CI: 0.32–6.45; P = 0.33) did not reach statistical significance. At one year follow-up, the OR did not favor BMS over MACE (MACE, defined as the composite of death, myocardial infarction, and TVR) (1.87; 95% CI: 1.22–2.87; P < 0.01), MI (1.91, 95% CI: 1.22–2.99; P < 0.01), TVR (3.08, 95% CI: 1.80–5.26; P < 0.01) and ST (3.37, 95% CI: 1.12–10.13; P < 0.01). The OR for mortality (1.51; 95% CI: 0.92–2.47; P = 0.10) and major bleeding (0.85, 95% CI: 0.47–1.55; P = 0.60) did not reach statistical significance. At > 1 year follow-up, the OR for all endpoints, including mortality, MACE, MI, TVR, major bleeding, and ST, did not reach statistical significance. Conclusions Our meta-analysis suggests that DES is associated with favorable outcomes as compared with BMS in octogenarians receiving PCI.