Reduction In Target Vessel Revascularization Research Articles

Long-term impact of intravascular ultrasound-guidance for percutaneous coronary intervention on unprotected left main. The IMPACTUS-LM, an observational, multicentric study

IntroductionThe potential benefit on long term outcomes of Percutaneous Coronary Intervention (PCI) on Unprotected Left Main (ULM) driven by IntraVascular UltraSound (IVUS) remains to be defined. MethodsIMPACTUS LM-PCI is an observational, multicenter study that enrolled consecutive patients with ULM disease undergoing coronary angioplasty in 13 European high-volume centers from January 2002 to December 2015. Major Adverse Cardiovascular Events (MACEs) a composite of cardiovascular (CV) death, target vessel revascularization (TVR) and myocardial infarction (MI) were the primary endpoints, while its single components along with all cause death the secondary ones. Results627 patients with ULM disease were enrolled, 213 patients (34%) underwent IVUS-guided PCI while 414 (66%) angioguided PCI. Patients in the two cohorts had similar prevalence of risk factors except for active smoking and clinical presentation. During a median follow-up of 7.5 years, 47 (22%) patients in the IVUS group and 211 (51%) in the angio-guided group underwent the primary endpoint (HR 0.42; 95% CI [0.31–0.58] p < 0.001). After multivariate adjustment, IVUS was significantly associated with a reduced incidence of the primary endpoint (adj HR 0.39; 95% CI [0.23–0.64], p < 0.001), mainly driven by a reduction of TVR (ad HR 0.30, 95% CI [0.15–0.62], p = 0.001) and of all-cause death (adj HR 0.47, 95% CI [0.28–0.82], p = 0.008). IVUS use, age, diabetes, side branch stenosis, DES and creatinine at admission were independent predictors of MACE. ConclusionsIn patients undergoing ULM PCI, the use of IVUS was associated with a reduced risk at long-term follow-up of MACE, all-cause death and subsequent revascularization.

Long term clinical outcome after success re-attempt percutaneous coronary intervention of chronic total occlusion

BackgroundTo evaluate the long-term outcome after re-attempt CTO-PCI.MethodsThis is a retrospective cohort study that included 113 re-attempt CTO-PCI patients who were consecutively registered from January 2019 to December 2020 at Beijing Anzhen Hospital's Center of Coronary Artery Disease. All patients were divided into two groups based on procedural success or failure. The primary endpoint was major adverse cardiac events (MACE), a composite of all-cause mortality, myocardial infarction and target vessel revascularization (TVR). The secondary endpoint was angina after PCI.ResultsOverall, the successful re-attempt CTO-PCI was archived in 77 patients, the failed CTO-PCI was performed in 36 patients. After a median follow-up of 21.7 months (interquartile range: 10.9–26.0), the incidence of the primary outcome was significantly lower in the success group [14.2% vs. 38.9%, adjusted hazard ratio (HR) 0.351, 95% CI 0.134–0.917, P = 0.033], mainly driven by the reduction of TVR (9.1% vs. 30.6%, adjusted HR 0.238, 95% CI: 0.078–0.72, P = 0.011). Furthermore, patients who had successful re-attempt CTO-PCI had a lower risk of angina after PCI (27.3% vs.61.1%, adjusted HR 0.357, 95% CI 0.167–0.76, P = 0.008). The risk factors of TVR in the patients with successful re-attempt CTO-PCI were stent length > 100 mm (adjusted HR 21.805, 95% CI 1.765–269.368, P = 0.016) and J-CTO score > 3(adjusted HR: 9.733, 95% CI:1.533–61.797, P = 0.016).ConclusionsFor the patients with previous CTO-PCI failure, a successful re-attempt CTO-PCI was associated with significantly lower MACE, which was primarily driven by a lower TVR rate. More complex CTO lesions and longer stents were the independent predictors of TVR after successful CTO-PCI.

Invasive versus conservative management in spontaneous coronary artery dissection: a meta-analysis and meta-regression study

Abstract Background There is a paucity of data regarding the best treatment for spontaneous coronary artery dissection (SCAD). Purpose To compare the prognostic impact of conservative versus invasive treatment in patients with SCAD. Methods We systematically searched the literature for studies evaluating the comparative efficacy and safety of invasive revascularization versus medical therapy for the treatment of SCAD from 1990 to 2019. Random-effect meta-analysis was performed comparing clinical outcomes between the two groups. Results 24 observational studies with 1720 patients were included. After 28±14 months, a conservative approach reduced target vessel revascularization rate compared with invasive treatment (OR=0.50; 95% CI 0.28–0.90; P=0.02). No difference was found regarding all-cause mortality (OR=0.81; 95% CI 0.31–2.08; P=0.66), cardiovascular mortality (OR=0.89; 95% CI 0.15–5.40; P=0.89), myocardial infarction (OR=0.95; 95% CI 0.50–1.81; P=0.87), heart failure (OR 0.96; 95% CI 0.41–2.22; P=0.92) and SCAD recurrence (OR=0.94; 95% CI 0.52–1.72; P=0.85). The meta-regression analysis suggested that male gender, diabetes mellitus, smoking habit, prior coronary artery disease, left main coronary artery involvement and lower ejection fraction at admission are related with higher overall mortality, whereas SCAD recurrence was higher among patients with fibromuscular dysplasia. Conclusion A conservative approach provides similar clinical outcomes and lower target vessel revascularization rates compared to an invasive strategy in the setting of SCAD; therefore, when feasible, it should be preferred in this scenario. Forest plots on the study outcomes Funding Acknowledgement Type of funding source: None

Drug-coated balloon versus plain old balloon angioplasty in femoropopliteal disease: An updated meta-analysis of randomized controlled trials.

Drug-coated balloon (DCB) angioplasty has emerged as a mainstay of therapy for the treatment of peripheral arterial disease (PAD) involving the superficial femoral and popliteal arteries. We performed a meta-analysis including all available randomized controlled trials (RCTs) to date which compare DCB to plain balloon angioplasty (POBA) in femoropopliteal disease (FPD). Five databases were analyzed including EMBASE, PubMed, Cochrane, Scopus, and Web-of-Science from January 2000 to September 2018 for RCTs comparing DCB to POBA in patients with FPD. Heterogeneity was determined using Cochrane's Q-statistics. Random effects model was used. Twenty-two RCTs, including five trials of in-stent restenosis (ISR) intervention, with 3,217 patients were included in the analysis. Mean follow-up was approximately 21.6 ± 14.4 months. Overall, DCB use was associated with a 51% reduction in target vessel revascularization (TLR) when compared to POBA at follow-up (relative risk [RR]: 0.49, 95% confidence interval [CI]: 0.40-0.61, P < 0.0001). Rates of TLR were 45% lower in the DCB group when compared to POBA in patients with ISR (RR: 0.55, 95% CI: 0.37-0.81, P = 0.002). DCB was associated with lower rates of binary stenosis, late lumen loss and higher primary safety endpoints. Major amputation and mortality were not different between DCB and POBA. Use of DCBs is associated with improved vessel patency and a lower risk of TLR when compared to POBA in patients with FPD, especially in the setting of ISR. There was no difference in mortality between DCB and POBA in our meta-analysis. Extended follow-up of the available RCT data will be essential to analyze long-term device-related mortality.

Five-year outcomes after first- and second-generation drug-eluting stent implantation in all patients undergoing percutaneous coronary intervention

BackgroundUse of the everolimus-eluting stent (EES) instead of the sirolimus-eluting stent (SES) has been shown to improve clinical outcomes in patients undergoing percutaneous coronary intervention (PCI) out to 3 years. However, it is not known whether the differences in efficacy and safety outcomes remain constant throughout 5 years. MethodsThis was a retrospective, non-randomized, observational study. We followed 1460 consecutive patients undergoing PCI in our institutions from April 2005 to March 2012. There were 718 cases in patients with SES (SES group) and 742 with EES (EES group). Ten-month angiographic follow-up results and 5-year clinical follow-up outcomes were compared between the EES and SES groups. The primary outcome of this study was major adverse cardiac events (MACE), defined as the composite of cardiac death, recurrent myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis (ST). ResultsAt 5 years, the rates of target lesion revascularization (TLR), TVR, recurrent MI and ST were significantly lower in the EES group compared to the SES group (TLR: 4.6% vs. 8.2%, p<0.05; TVR: 5.0% vs. 9.0%, p<0.05; recurrent MI: 1.5% vs. 4.4%, p<0.05; ST: 1.2% vs. 3.9%, p<0.05). Thus, MACE were significantly lesser in the EES group compared to the SES group (8.8% vs. 12.8%, p=0.006). ConclusionsEES improved clinical outcomes compared to SES, and specifically, was associated with reductions in TVR, ST, and recurrent MI out to 5 years.

Drug-Eluting Stents Versus Bare-Metal Stents for Saphenous Vein Grafts Lesions

A best-evidence topic was written according to a structured protocol addressing the question “For patients with saphenous vein graft (SVG) lesions requiring percutaneous coronary intervention, do long-term clinical outcomes differ between drug-eluting stents (DES) or bare-metal stents (BMS)?” Altogether, 1,466 papers were found using the reported search, of which eight represented the best evidence to answer the clinical question. Randomised data are conflicting. “DIVA,” a major recent neutral randomised trial, has superior methodology in terms of sample size, blinding, allocation concealment, angiographic follow-up, and use of embolic protection devices. Four earlier randomised trials showed significant benefit with DES, driven by a reduction in target vessel revascularisation (TVR); however, reductions in myocardial infarction (MI) and stent thrombosis rates were also demonstrated in DES groups. The validity of these earlier trials is hampered by small sample size, lack of blinding, and inconsistent use of embolic protection devices. Both observational trials included favoured DES. Outcome measures at follow-up for DES and BMS groups were 2%–55% versus 5.6%–77% for major adverse cardiac events, 4.9%–37% versus 11%–49% for TVR, 2%–17% versus 6%–46% for MI. Mortality did not differ between groups. We conclude that in the management of SVG lesions, DES should continue to be standard of care as the weight of evidence points toward benefit, in particular rates of target lesion or target-vessel revascularisation. In light of the recent neutral trial, we postulate that with modern techniques and improved patient selection, BMS may be non-inferior to DES; however, further research is needed before changing routine practice.

The EluNIRTM Ridaforolimus Eluting Coronary Stent System

ABSTRACTIntroduction: First-generation drug-eluting stents (DES) were developed and indeed proved their superiority compared to bare-metal stent in minimizing neo-intimal hyperplasia and in-stent restenosis (ISR), overall, reducing target vessel revascularization (TVR). Newer-generation DES are characterized by thinner struts, more biocompatible and either durable, biodegradable or polymer-free surfaces, better device profile and refined drug elution.Area covered: The EluNIRTM (Medinol, Tel Aviv, Israel) Ridaforolimus Eluting Coronary Stent System is a new DES with unique properties. In this review, we highlight the special characteristics of the stent and summarize relevant clinical data. The EluNIRTM was studied in two clinical trials, the NIREUS trial and the larger, pivotal, BIONICS trial. These trials collectively provide data on the safety, performance, and efficacy of the device.Expert commentary: The newly FDA-approved EluNIRTM stent features an elastomeric durable polymer which elutes a novel drug, Ridaforolimus. The stent has thin struts with variable widths and a delivery catheter with a spring tip. These characteristics may explain the good angiographic and clinical results of this stent, which were noninferior to the FDA-approved Medtronic ResoluteTM stent DES.

Intravascular ultrasound-guided drug-eluting stent implantation for patients with unprotected left main coronary artery lesions: A single-center randomized trial.

Objective:Intravascular ultrasound (IVUS) has developed as a preferable choice for optimizing the stenting procedures mainly because it will have good access to vessel size, lesion length, or severity accurately. However, it still remains unclear about the benefits of IVUS guidance in drug-eluting stent (DES) implantation for patients with unprotected left main coronary artery (ULMCA) stenosis. The aim of the present study was to evaluate the clinical outcomes with respect to IVUS-guided DES implantation for these patients.Methods:A total of 336 consecutive patients from December 2010 to December 2015 were enrolled in the study. The patients were then randomly assigned into two groups: IVUS-guided group (n=167) and control group (n=169). The primary endpoint was the incidence of composite major adverse cardiac events (MACEs), including cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR). The risk of stent thrombosis (ST) was chosen as the safety endpoint.Results:After a 1-year follow-up, the occurrence of composite MACE in the IVUS-guided group was significantly lower than that in the control group (13.2% vs. 21.9%, p=0.031), which might mainly result from the significant reduction in the risk of cardiac death (1.8% vs. 5.9%, p=0.048). Dramatically, the risk of MI did not differ significantly between the two groups (11.4% vs. 13.6%, p=0.478), though a tended reduction in TVR was observed under IVUS guidance (4.2% vs. 8.9%, p=0.068). There was no statistical significance between the two groups with respect to the risk of target lesion revascularization (IVUS-guided vs. control: 1.2% vs. 3.0%, p=0.239) and ST (IVUS-guided vs. control: 1.2% vs. 3.0%, p=0.246).Conclusion:The possible feasibility of IVUS-guided DES implantation for patients with ULMCA stenosis was supported by the present study. Larger and more powerful randomized trials were still warranted to research the whole benefits of IVUS guidance for these patients.

Contemporary Context of Drug-Eluting Stents in Brazil: A Cost Utility Study.

Although drug-eluting stents (DES) have been widely incorporated into clinical practice in developed countries, several countries restrict their use mainly because of their high cost and unfavorable incremental cost-effectiveness ratios (ICER). To evaluate the cost-effectiveness of DES in comparison with bare-metal stents (BMS) for treatment of coronary artery disease (CAD). Markov model. Published literature, government database, and CAD patient cohort. Single-vessel CAD patients. One year and lifetime. Brazilian Public Health System (SUS). Six strategies composed of percutaneous intervention with a BMS or 1 of 5 DES (paclitaxel, sirolimus, everolimus, zotarolimus, and zotarolimus resolute). Cost for target vessel revascularization avoided and cost for quality-adjusted life year gained. In the short-term analysis, sirolimus was the most effective and least costly among DES (ICER of I$20,642 per target vessel revascularization avoided), with all others DES dominated by sirolimus. Lifetime cumulative costs ranged from I$18,765 to I$21,400. In the base case analysis, zotarolimus resolute had the most favorable ICER among the DES (ICER I$62,761), with sirolimus, paclitaxel, and zotarolimus being absolute dominated and everolimus extended dominated by zotarolimus resolute, although all the results were above the willingness-to-pay threshold of 3 times the gross domestic product per capita (I$35,307). In deterministic sensitivity analysis, results were sensitive to cost of DES, number of stents used per patient, baseline probability, and duration of stent thrombosis risk. The probabilistic sensitivity analysis demonstrated a probability of 81% for BMS being the strategy of choice, with 9% for everolimus and 9% zotarolimus resolute, at the willingness-to-pay threshold. DES is not a good value for money in SUS perspective, despite its benefit in reducing target vessel revascularization. Since the cost-effectiveness of DES is mainly driven by the stents' cost difference, they should cost less than twice the BMS price to become a cost-effective alternative.

Drug-eluting stents appear superior to bare metal stents for vein-graft PCI in vessels up to a stent diameter of 4 mm.

Research trials have shown improved short-term outcome with drug-eluting stents (DES) over bare metal stents (BMS) in saphenous vein graft (SVG) percutaneous coronary intervention (PCI), primarily by reducing target vessel revascularization (TVR) for in-stent restenosis. We compared the outcomes in patients undergoing SVG stent implantation treated with DES or BMS. In exploratory analyses we investigated the influence of stent generation and diameter. Data were obtained from a prospective database of 657 patients who underwent PCI for SVG lesions between 2003 and 2011. A total of 344 patients had PCI with BMS and 313 with DES. Propensity scores were developed based on 15 observed baseline covariates in a logistic regression model with stent type as the dependent variable. The nearest-neighbour-matching algorithm with Greedy 5-1 Digit Matching was used to produce two patient cohorts of 313 patients each. We assessed major adverse cardiac events (MACE) out to a median of 3.3 years (interquartile range: 2.1-4.1). MACE was defined as all-cause mortality, myocardial infarction (MI), TVR and stroke. There was a significant difference in MACE between the two groups in favour of DES (17.9% DES vs. 31.2% BMS group; p = 0.0017) over the 5-year follow-up period. MACE was driven by increased TVR in the BMS group. There was no difference in death, MI or stroke. Adjusted Cox analysis confirmed a decreased risk of MACE for DES compared with BMS 0.75 (95% confidence interval (CI) 0.52-0.94), with no difference in the hazard of all-cause mortality (hazard ratio: 1.08; 95% CI: 0.77-1.68). However, when looking at stent diameters greater than 4 mm, no difference was seen in MACE rates between BMS and DES. Overall in our cohort of patients who had PCI for SVG disease, DES use resulted in lower MACE rates compared with BMS over a 5-year follow-up period; however, for stent diameters over 4 mm no difference in MACE rates was seen.

The efficacy of everolimus-eluting stent implantation in patients with ST-segment elevation myocardial infarction: outcomes of 2-year clinical follow-up.

First-generation drug-eluting stents (DES) demonstrated delay in vascular healing and increase in incidence of late and very late stent thrombosis compared with bare-metal stents (BMS). Second-generation DES, however, have shown a reduction of late and very late stent thrombosis compared with first-generation DES. Thus, we decided to evaluate whether the second-generation everolimus-eluting stent (EES) has an advantage over BMS in Japanese patients with ST-segment elevation myocardial infarction (STEMI). This study was conducted in two centers, retrospective, non-randomized and observational design in patients with STEMI. Three-hundred eighty patients were randomly selected to receive EES (198 patients) or cobalt-chromium BMS (182 patients). The primary endpoints were cardiac death, recurrent myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis (ST). At 2years, the rates of TLR, TVR, and recurrent MI were significantly lower in the EES group than in the BMS group (TLR 1.5 vs. 8.3%, p<0.05; TVR 2.5 vs. 9.4%, p<0.05; recurrent MI 1.0 vs. 4.1%, p<0.05), and the rate of ST was also significantly lower in the EES group than in the BMS group (0.5 vs. 4.3%, p<0.05). Thus, major adverse cardiac events defined at the composite cardiac death, MI, TLR, TVR, or ST were significantly lower in EES group than in BMS group (3.0 vs. 9.9%, p=0.008). The rate of cardiac death, however, did not differ between both groups. In STEMI patients, EES may be associated with improved outcomes-specifically, a significant reduction in TVR, ST, and recurrent MI compared to BMS throughout 2years.

Abstract 15829: Hybrid Coronary Revascularization versus Multivessel Pci-Stenting: A Propensity Match Analysis

Introduction: Despite current guidelines and the proven LIMA-LAD superiority, PCI-stenting is still largely performed in patients with multi-vessel coronary disease (MVD). Hypothesis: We investigated the role of hybrid revascularization (HCR) meaning MIDCAB combined with PCI as a planned strategy and compared it with PCI alone in patients with multi-vessel coronary disease involving proximal LAD. Methods: We retrospectively analyzed 605 patients with MVD: 179 hybrid and 426 multi-vessel PCI revascularizations. All patients have been discussed within the heart team, based on pre-operative risk (Logistic EuroSCORE II) and on coronary lesions complexity (SYNTAX score). A propensity score matching has been performed and 127 patients from each series selected. Early results were evaluated, and survival analysis for all-causes mortality, cardiac death and MACCE were performed. Results: One-hundred forty-two patients (142/254) had two-vessel disease and 78/254 (41 HCR and 37 PCI patients) had left main involvement. 28 LAD total occlusion in HCR and 18 in PCI groups. 20 PCI patients had recent STEMI and 25 HCR patients. Mean SYNTAX score was 27.5±3.5 and 27±4.0 in HCR and PCI (p=0.8) respectively. No hospital mortality was reported. Overall survival rate at 60 months was (HCR 95% CI: 84.8%, 80.6-91% vs PCI 78.7%, 72.1-85.3%, p=0.23). Freedom from cardiac death survival rate at 60 months was (HCR 95% CI: 91.4%, 85.8-97% vs PCI 84.5%, 78.1-90.9%, p=0.33). Freedom from MACCE survival rate at 60 months was better in HCR group than PCI (95% CI: 74.5%, 66.8-82.4% vs 54.4%, 46.6-62.2%, p=0.015). The reduced target vessel revascularization rate in HCR group was due to LAD repeated revascularization in PCI group. Conclusions: Hybrid Coronary revascularization is a safe and effective strategy to achieve a complete revascularization in patients with multi-vessel disease. HCR, reducing SYNTAX score when due to LAD lesions and the number of stents used to complete revascularization, improved results of PCI-stenting in patients with MVD providing a significantly better freedom from MACCE at mid-term.

Safety and clinical effectiveness of drug-eluting stents for saphenous vein graft intervention in older individuals: Results from the medicare-linked National Cardiovascular Data Registry(®) CathPCI Registry(®) (2005-2009).

To evaluate the safety of drug-eluting stents (DES) when treating patients with failing saphenous vein grafts (SVG). DES reduce target vessel revascularization in patients with failing SVGs; however, compared with bare metal stents (BMS), DES have been variably associated with increased mortality. Clinical records from National Cardiovascular Data Registry(®) CathPCI Registry(®) (49,325 older individuals [≥65 years] who underwent SVG stenting 2005-2009) were linked to Medicare claims to create a longitudinal record. Death, myocardial infarction (MI), and urgent revascularization with DES versus BMS were evaluated to 3 years using propensity matching (PM). Results were stratified by clinical presentation (acute coronary syndrome [ACS], non-ACS), previous lesion treatment (in-stent, de novo), and graft segment (aortic, body, distal anastomosis). In this older cohort (median age, 75 years), acute presentations were prevalent (ACS, 69%; TIMI flow <3, 45%), and adverse clinical outcomes were common by 3 years (death, 24.5%; MI, 14.6%; urgent revascularization, 29.5%). Among DES patients (n = 31,403), 3-year mortality was lower (vs. BMS) (22.7% vs. 28.0%, P < 0.001; PM hazard ratio [HR] 0.87, 95% confidence interval 0.83-0.91), and no difference was observed in the adjusted risk for MI (PM HR 0.97, 0.91 to 1.03) or urgent revascularization (PM HR 1.04, 0.99-1.08). These findings were independent of clinical presentation, previous lesion treatment, and graft segment (P interaction, ns). In this large SVG PCI cohort, all-cause mortality was lower among those receiving DES, and no difference in MI or urgent revascularization was observed to 3 years. © 2015 Wiley Periodicals, Inc.

Optimal- vs. standard-antiplatelet therapy on platelet function and long-term clinical outcomes in patients with high on-treatment platelet reactivity: 2-year outcomes of the multicentre, randomized Optimal-antiPlatelet Therapy (OPT) trial

Optimal strategy for the management of high on-treatment platelet reactivity (HPR), an independent predictor of ischaemic events, is not yet clear. The aim of this study was to explore the safety and efficacy of personalized antiplatelet therapy based on platelet function testing in patients with HPR. A total of 840 patients with HPR who underwent coronary stenting for acute coronary syndrome (ACS) were randomly assigned in a 1:2 ratio to receive standard dual-antiplatelet therapy ( n = 280) or platelet function-guided optimal-antiplatelet therapy ( n = 560). In the optimal group, patients initially received clopidogrel 150 mg/day on top of aspirin and switched to triple antiplatelet therapy with additional cilostazol if repeat platelet function assay after 3 days indicated a sustained HPR. The primary endpoint was the composite of all-cause death, myocardial infarction, clinically driven target vessel revascularization (TVR), or stroke. Optimal therapy resulted in significantly lower 30-day HPR rate (30.1 vs. 44.3%, P < 0.001). At 1-year follow up, optimal therapy was associated with significantly lower incidence of primary endpoint events (2.7 vs. 6.8%, P = 0.006) compared with standard therapy, mainly due to the reduction of TVR. These beneficial effects were sustained at 2 years (4.5 vs. 9.2%, P = 0.006), with similar bleeding event rates between groups (7.3 vs. 6.5%, P = 0.565). Optimal-antiplatelet therapy based on platelet function testing is effective in attenuating HPR and improving long-term outcomes for ACS patients with no increase in bleeding events.

Resultados Angiográficos e do Seguimento Clínico de 5 Anos Após Implante de Stents Farmacológicos com Revestimento Biodegradável em Pacientes com Alto Risco de Reestenose. Análise de Subgrupo do Estudo Randomizado PAINT

Introdução: Polímeros biodegradáveis foram desenvolvidos para reduzir a reação de hipersensibilidade associada aos polímeros duráveis dos stents farmacológicos de primeira geração, mantendo sua eficácia antiproliferativa e aumentado sua segurança. Avaliamos os resultados angiográficos de 9 meses e os resultados clínicos de longo prazo dos stents farmacológicos com polímeros biodegradáveis em pacientes com alto risco de reestenose. Métodos: Pacientes com diâmetro de referência ≤ 2,5 mm, extensão da lesão ≥ 15 mm, diabetes, ou uma combinação dessas características foram selecionados da população do estudo PAINT. Esses pacientes foram previamente randomizados e alocados para intervenção coronária percutânea recebendo os stents farmacológicos com polímeros biodegradáveis com sirolimus ou com paclitaxel ou stents metálicos, na razão 2:2:1. Resultados: Cento e setenta e oito pacientes foram tratados com stents farmacológicos com polímeros biodegradáveis (n = 142) ou stents metálicos (n = 36). No acompanhamento angiográfico de 9 meses, os primeiros mostraram menor perda tardia (0,40 ± 0,42 mm vs. 0,90 ± 0,47 mm; p < 0,01) e reestenose binária (7,4% vs. 25%; p < 0,01). No acompanhamento clínico de 5 anos, o grupo com stents farmacológicos com polímeros biodegradáveis mostrou menores taxas do desfecho combinado de morte cardíaca, infarto do miocárdio e revascularização do vaso-alvo (16,2% vs. 38,0%; p = 0,03), principalmente devido à redução da revascularização do vaso-alvo (9,9% vs. 36,1%; p < 0,01). Morte total, morte cardíaca e infarto do miocárdio não foram diferentes entre os grupos. A trombose do stent, provável ou definitiva, ocorreu em 2,8% vs. 0% (p = 0,30). Conclusões: Os stents farmacológicos com polímeros biodegradáveis eluidores de paclitaxel ou sirolimus foram eficazes na redução de reestenose angiográfica aos 9 meses e na necessidade de reintervenção por reestenose clínica em 5 anos, sem aumentar o risco de trombose do stent.

New generation drug‐eluting stents for ST‐elevation myocardial infarction: A new paradigm for safety

The objective of this study is to compare the long-term safety of new generation drug-eluting stents (DES) with early generation DES and bare metal stents (BMS) for ST-segment elevation myocardial infarction (STEMI). Early generation DES for STEMI have reduced target vessel revascularization, but have more very late ST compared with BMS raising concerns about their safety. New compared with early generation DES have lower rates of ST, but there are limited data in STEMI patients. From 2003 to 2011, 3,464 STEMI patients were treated with BMS (n = 1,187), early generation DES (n = 1,525), or new generation DES (n = 752) and were followed for 1-9 years. Patients with new generation DES were younger, had less cardiogenic shock, and less prior infarction versus BMS, and more hypertension versus early generation DES. At 2 years, new generation DES had lower mortality (4.0% vs. 12.4%, P < 0.001), similar reinfarction (4.4% vs. 5.1%, P = 0.35), and less ST (1.4% vs. 3.8%, P = 0.031) versus BMS; and similar mortality (4.0% vs. 5.8%, P = 0.23), similar reinfarction (4.4% vs. 5.2%, P = 0.64), and trends for less ST (1.4% vs. 3.3%, P = 0.17) versus early generation DES. By Cox multivariable analyses, BMS had more ST than new generation DES (HR [95% CI] = 1.93 [1.01-3.66], P = 0.045). New generation DES in STEMI patients have less ST compared to BMS and trends for less ST compared to early generation DES. These data suggest a new safety paradigm and should encourage the use of new generation DES in most STEMI patients treated with primary percutaneous coronary intervention (PCI).

Drug-eluting stents in patients with anterior STEMI undergoing primary angioplasty: a substudy of the DESERT cooperation

Several concerns have emerged on the higher risk of in-stent thrombosis after drug-eluting stent (DES) implantation, especially in the setting of STEMI patients. Few data have even been reported in high-risk patients, such as those with anterior MI. Therefore this represents the aim of the current study. The literature was scanned by formal searches of electronic databases (MEDLINE and CENTRAL). We examined all completed randomized trials of DES for STEMI. The following key words were used for study selection: randomized trial, myocardial infarction, reperfusion, primary angioplasty, stenting, DES, sirolimus-eluting stent (SES), Cypher, paclitaxel-eluting stent (PES), Taxus. No language restrictions were enforced. Individual patient's data were obtained from 11 out of 13 trials, including a total of 2,782 patients with anterior MI [1,739 or 62.5% randomized to DES and 1,043 or 37.5% randomized to bare-metal stent (BMS)]. At long-term follow-up, no significant benefit was observed with DES as compared to BMS in terms of mortality [9.8 vs 10.9%, HR (95% CI) = 0.81 (0.61, 1.07), p = 0.13, p heterogeneity = 0.18], reinfarction [8.8 vs 6.4%, respectively; HR (95% CI) = 1.14 (0.80, 1.61), p = 0.47, p heterogeneity = 0.82], and stent thrombosis [5.6 vs 5%, OR (95% CI) = 0.88 (0.59, 1.30), p = 0.51, p heterogeneity = 0.65], whereas DES was associated with a significant reduction in terms of target-vessel revascularization (TVR) [13.7 vs 23.4%; OR (95% CI) = 0.56 (0.46, 0.69), p < 0.0001, p het = 0.81] that was observed at both early (within 1 year) [7 vs 14.7%, HR (95% CI) = 0.56 (0.46, 0.69), p < 0.0001, p het = 0.81] and late (>1 year) follow-up [7.2 vs 9%, HR (95% CI) = 0.67 (0.47, 0.96), p = 0.03, p het = 0.96]. This study showed that among patients with anterior STEMI undergoing primary angioplasty, SES and PES, as compared to BMS, are associated with a significant reduction in TVR at long-term follow-up. No concerns were found with the use of first-generation DES in terms of mortality.

Drug-eluting versus bare-metal stents in large coronary arteries of patients with ST-segment elevation myocardial infarction: Findings from the ICAS registry

Background and purposeThere are a few retrospective subgroup analyses or registries of large-vessel (≥3.5mm) stenting. We investigated clinical outcomes of patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and bare-metal stents (BMS) in large coronary vessels. Methods and subjectsOf 1100 STEMI patients registered in the Ibaraki Cardiovascular Assessment Study (ICAS) multicenter registry from April 2007 to June 2012 who underwent PCI, we enrolled 454 patients (65.8±12.7 years old, 81% male) with ≥3.5-mm stents. We excluded 53 patients with cardiogenic shock or left main trunk lesions. The remaining 401 patients were divided into Group-D, PCI with DES (n=184), and Group-B, PCI with BMS (n=217). Propensity score analysis matched 1:1 according to treatment with DES (n=101) or with BMS (n=101). We evaluated major adverse cardiac and cerebrovascular events (MACCE) and incidence of stent thrombosis (ST). MACCE was defined as all-cause death, myocardial infarction (MI), target-vessel revascularization (TVR), or cerebrovascular accident (CVA). Essential resultsDuring a mean follow-up period of 526 days, all-cause death, MI, CVA, MACCE, and ST were not significantly different in Group-D versus Group-B (all-cause death: 4.35% vs. 4.61%, p=0.90; MI: 0% vs. 0%; CVA: 2.72% vs. 3.23%, p=0.76; MACCE: 15.2% vs. 20.3%, p=0.19; and ST: 0.0% vs. 1.38%, p=0.11). After adjusting for age, insulin use, multivessel disease, intra-aortic balloon pump use, culprit lesions, and estimated glomerular filtration rate <60ml/min/1.73m2, MACCE was not significantly different between the groups (odds ratio: 0.69; 95% CI: 0.40–1.23; p=0.21). However, TVR was significantly lower in Group-D than Group-B in Kaplan–Meier analysis (p=0.048) after propensity score matching. Principal conclusionThere was no advantage to using a DES in large vessels for preventing a hard endpoint, whereas DES use resulted in a significant reduction in TVR in the patients with STEMI in this registry.

Risk factors for clinical events at 1-year follow-up after drug-eluting stent implantation: results from the prospective multicenter German DES.DE registry

Drug-eluting stents (DES) have substantially reduced target vessel revascularization (TVR) after percutaneous coronary interventions. Risk factors for clinical events need to be redefined with this treatment option. In the prospective DES.DE registry, baseline clinical and angiographic characteristics as well as in-hospital and follow-up events were recorded for all enrolled patients. Between October 2005 and May 2009, 21,774 patients receiving DES were enrolled at 98 DES.DE sites. The composite of death, myocardial infarction (MI) and stroke defined as major adverse cardiac and cerebrovascular events (MACCE) and TVR were predefined as primary endpoints. At 1-year follow-up rates for overall death, MI, stroke, MACCE, TVR and definite stent thrombosis were 2.7, 3.1, 1.4, 7.1, 11.5 and 0.6 %, respectively. Aside from well-known risk factors like age, diabetes mellitus and triple-vessel disease, stratification in patients with or without MACCE revealed atrial fibrillation, non-ST-segment elevation myocardial infarction, renal failure, impaired ejection fraction and peripheral vascular disease as strong predictors of MACCE at 1 year. Data collected in the DES.DE registry, reflecting the clinical practice in Germany, revealed favorable clinical outcomes after DES implantation in a real world setting but also identifying several high-risk populations.

Five-year Outcomes for First Generation Drug-eluting Stents versus Bare-metal Stents in Patients with ST-segment Elevation Myocardial Infarction: A Meta-analysis of Randomised Controlled Trials

Drug-eluting stent (DES) implantation has been proved more effective compared with bare-metal stent (BMS) implantation for ST-segment elevation myocardial infarction (STEMI) within medium follow up. However, limited information is available on the long-term safety and efficacy of DES. We performed a meta-analysis of randomised controlled trials (RCT) comparing DES with BMS in patients with STEMI at long-term follow up, defined as five years or more. The clinical end points were target vessel revascularisation (TVR), death, recurrent myocardial infarction (MI), stent thrombosis and very late stent thrombosis. We calculated the pooled estimate based on a fixed-effects model using odds ratio (OR) for rare events. Four RCT were included, with a total of 1414 patients enrolled. Up to five years, DES showed a significant reduction in TVR (OR, 0.55; 95% confidence interval [CI], 0.55-0.77; P = 0.0005), but an increase in very late stent thrombosis (OR, 3.03; 95% CI, 1.28-7.18; P = 0.01), without increasing mortality (OR, 0.85; 95% CI, 0.59-1.20; P = 0.35), recurrent MI (OR, 1.05; 95% CI, 0.69-1.60; P = 0.80), and overall stent thrombosis (OR, 1.10; 95% CI, 0.66-1.82; P = 0.72). At long-term follow-up, primary percutaneous coronary intervention with DES improved efficacy, without reducing overall safety. However, a trade-off must be made between the reduction of reintervention with DES and an increase in very late stent thrombosis.