The authors sought to evaluate the influence of coronary microcirculatory dysfunction (CMD) on the diagnostic performance of the quantitative flow ratio (QFR).
Functional angiographic assessment of ...coronary stenoses based on fluid dynamics, such as QFR, constitutes an attractive alternative to fractional flow reserve (FFR). However, it is unknown whether CMD affects the reliability of angiography-based functional indices.
FFR and the index of microcirculatory resistance (IMR) were measured in 300 vessels (248 patients) as part of a multicenter international registry. QFR was calculated at a blinded core laboratory. Vessels were classified into 2 groups according to microcirculatory status: low IMR (<23 U), and high IMR (≥23 U, CMD). The impact of CMD on the diagnostic performance of QFR, as well as on incremental value of QFR over quantitative angiography, was assessed using FFR as reference.
Percent diameter stenosis (%DS) and FFR were similar in low- and high-IMR groups (%DS 51 ± 12% vs. 53 ± 11%; p = 0.16; FFR 0.80 ± 0.11 vs. 0.81 ± 0.11; p = 0.23, respectively). In the overall cohort, classification agreement (CA) between QFR and FFR and diagnostic efficiency of QFR (area under the receiver-operating characteristics curve AUC) were high (CA: 88%; AUC: 0.93 95% confidence interval (CI): 0.90 to 0.96). However, when assessed according to microcirculatory status, a significantly lower CA and AUC of QFR were found in the high-IMR group as compared with the low-IMR group (CA: 76% vs. 92%; p < 0.001; AUC: 0.88 95% CI: 0.79 to 0.94 vs. 0.96 95% CI: 0.92 to 0.98; p < 0.05). Compared with angiographic assessment, QFR increased by 0.20 (p < 0.001) and by 0.16 (p < 0.001) the AUC of %DS in low- and high-IMR groups, respectively. Independent predictors of misclassification between QFR and FFR were high IMR and acute coronary syndrome.
CMD decreases the diagnostic performance of QFR. However, even in the presence of CMD, QFR remains superior to angiography alone in ascertaining functional stenosis severity.
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Aortic dissection type A is a disease with high mortality. Iatrogenic aortic dissection after interventional procedures is infrequent, and prognostic data are scarce. Our objective was to analyze its ...incidence, patient profile, and long-term prognosis.
Between 2000 and 2014, we retrospectively analyzed 74 patients with dissection of the ascending aorta. Clinical and procedural data were reviewed, and later, we performed a prospective clinical follow-up by telephone or in the office. The incidence of aortic dissection was 0.06%. Our patients, predominantly male (67.6%), had a mean age of 66.9±10.8 years. With multiple cardiovascular risk factors, the main reason for cardiac catheterization was an acute coronary syndrome (n=54). The complication was detected acutely in all, trying to engage the right coronary artery in 47 and the left main artery in 30 and after other maneuvers in 2, mostly complex therapeutic procedures (78.4%). A coronary artery was involved in 45 patients (60.8%). Thirty-five patients underwent an angioplasty and stent implantation; 3 had cardiac surgery; and 36 were managed conservatively. Two patients died of cardiogenic shock after the dissection. After a median follow-up of 51.2 months (range, 16.4-104.8 months), none of the remaining patients developed complications as a result of the dissection, progression, ischemia, pain, or dissection recurrence.
Iatrogenic catheter dissection of the aorta is a rare complication that carries an excellent short- and long-term prognosis with the adoption of a conservative approach. When a coronary artery is involved as an entry point, it usually can be safely sealed with a stent with good long-term outcomes.
This study sought to assess clinical, angiographic, and intravascular ultrasound (IVUS) findings in patients developing coronary aneurysms (CANs) after drug-eluting stent (DES) implantation.
The ...long-term safety of DES remains unsettled.
This study analyzed 1,197 consecutive patients with late angiographic evaluation after DES implantation. In 15 patients (1.25%, 95% confidence interval: 0.58 to 1.93), CANs developed at follow-up. Analyses included quantitative angiography and volumetric IVUS.
DES developing CANs were more frequently implanted during acute myocardial infarction and were longer than those without this outcome. The elapsed time from DES implantation to CAN diagnosis was 313 +/- 194 days. Angiographically, maximal CAN diameter measured 5.1 +/- 1.2 mm. On IVUS, CAN external elastic lamina area was 32 +/- 13.1 mm(2) and incomplete apposition area was 12.1 +/- 8.6 mm(2). Two patients presented with acute myocardial infarction secondary to DES thrombosis. Four additional patients presented with unstable angina and underwent CAN aggressive dilation (3 were also treated for concomitant in-stent restenosis). Dual antiplatelet therapy was recommended in the remaining 9 patients who were asymptomatic at CAN diagnosis, but 1 of them eventually died of cardiogenic shock after a CAN-related myocardial infarction. After a mean follow-up of 399 +/- 347 days, the 1-year event-free survival was 49 +/- 14% and was related to CAN size on IVUS. In 2 patients, CANs disappeared at repeated late angiography and IVUS showed abluminal CAN thrombosis.
After DES implantation, CANs are rare and may be detected in asymptomatic patients. However, CANs are frequently associated with adverse clinical events as a result of DES restenosis and DES thrombosis. Further studies are required to determine the implications of this distinct new entity.
Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study sought to compare the efficacy of everolimus-eluting stents (EESs) and drug-eluting balloons (DEBs) with ...paclitaxel in patients with ISR. A pooled analysis of the Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS IV) and Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS V) randomized trials was performed using patient-level data. In both trials, EESs were compared with DEBs in patients with ISR (RIBS V included 189 patients with bare-metal ISR; RIBS IV included 309 patients with drug-eluting ISR). Inclusion and exclusion criteria were identical in both trials. A total of 249 patients were allocated to EES and 249 to DEB. Clinical follow-up at 1 year was obtained in all (100%) patients and late angiography (median 249 days) in 91% of eligible patients. Compared with patients treated with DEBs, patients treated with EESs obtained better short-term results (postprocedural minimal lumen diameter 2.28 ± 0.5 vs 2.12 ± 0.4 mm, p <0.0001). At follow-up, patients treated with EESs had larger in-segment minimal lumen diameter (primary end point 2.16 ± 0.7 vs 1.88 ± 0.6 mm, p <0.0001; absolute mean difference 0.28 mm; 95% confidence interval CI 0.16 to 0.40) and net lumen gain (1.33 ± 0.6 vs 1.00 ± 0.7 mm, p <0.0001) and had lower %diameter stenosis (19 ± 21% vs 28 ± 22%, p <0.0001) and binary restenosis rate (8.7% vs 15.7%, p = 0.02). Consistent results were observed in the in-lesion analysis. No interactions were found between the underlying stent type and treatment effects. At 1-year clinical follow-up, the composite of cardiac death, myocardial infarction, and target vessel revascularization was significantly reduced in the EES arm (8.8% vs 14.5%, p = 0.03; hazard ratio 0.59, 95% CI 0.31 to 0.94) mainly driven by a lower need for target vessel revascularization (6% vs 12.4%, p = 0.01, hazard ratio 0.46, 95% CI 0.25 to 0.86). This pooled analysis of the RIBS IV and RIBS V randomized trials demonstrates the superiority of EES over DEB in the treatment of patients with ISR.
The COVID-19 pandemic severely disrupted cardiovascular care during the spring of 2020 in Europe. Our study analyzed the clinical profile, COVID-19 impact, and 30-day prognosis of invasively managed ...patients with acute coronary syndrome (ACS) compared to a historical cohort.All invasively managed ACS patients from March 1st to April 30th, 2020 were compared to a cohort from the same timeframe of 2019 (n = 316). COVID-19 confirmed cases were defined by a positive SARS-CoV-2 polymerase chain reaction (PCR) test (CoV+). The primary outcome was all-cause 30-day mortality and multivariable predictors of this outcome.A 40.4% reduction in ACS patients was noted (198 cases in 2019 to 118 in 2020), and 11% of 2020 ACS patients were CoV+. Baseline characteristics were similar between groups. There were significantly more in-hospital patients with ACS (15.3% versus 6.1%, P = 0.007), and fewer patients were found to have a culprit lesion (58.5% versus 74.2%, P = 0.004) in 2020 compared to 2019. Thirty-day mortality in 2020 (7%) was not different from that in 2019 (4.2%), P = 0.294, but it was significantly higher in CoV+ patients (23.1%) compared to that in negative SARS-CoV-2 PCR test (CoV−) patients (5%), P = 0.047, in the 2020 group. In the multivariate analysis, CoV+ was an independent mortality predictor (OR = 9.8, 95% CI = 1.48-64.78), along with the left ventricular ejection fraction (LVEF) (OR = 0.91, 95% CI = 0.86-0.97), P = 0.0006.This study found increased 30-day mortality of invasively managed CoV+ ACS patients compared to that of CoV− patients during the 2020 COVID-19 spring outbreak. In the multivariable analysis, a SARS-CoV-2 positive test was independently associated with 30-day mortality. Further investigations of the underlying physiopathological relations between COVID-19 and ACS are warranted.
We sought to synthesize the available evidence on the effectiveness of drug-eluting stents for bare-metal in-stent restenosis.
Although there is clinical evidence that drug-eluting stents are ...associated with better results than other treatments for in-stent restenosis, they are not yet approved for this indication. Meta-analysis of randomized trials may yield more precise estimates of treatment effects and enable a rapid adoption of effective treatments in clinical practice.
Data sources included PubMed and conference proceedings. Prespecified criteria were met by 4 randomized studies comparing sirolimus- or paclitaxel-eluting stents versus balloon angioplasty or vascular brachytherapy in 1,230 patients with bare-metal in-stent restenosis. Studies reported the clinical outcomes of efficacy and safety during a minimum of 9 months. The primary outcome was target lesion revascularization.
No significant heterogeneity was found across trials, thus showing a similar effect size regardless of the use of balloon angioplasty or vascular brachytherapy as comparators. The risk of target lesion revascularization (odds ratio 0.35, 95% confidence interval CI 0.25 to 0.49; p < 0.001) and that of angiographic restenosis (odds ratio 0.36, 95% CI 0.27 to 0.49; p = 0.001) were markedly lower in patients treated with drug-eluting stents. There were no differences between patients treated with drug-eluting stents and those treated with other techniques with respect to the composite of death or myocardial infarction (odds ratio 1.04, 95% CI 0.54 to 2.03; p = 0.55).
Drug-eluting stents are markedly superior to conventional techniques (balloon angioplasty and vascular brachytherapy) and should be considered as first-line treatment for patients with bare-metal in-stent restenosis.
ABSTRACT Introduction and objectives: The safety of physiology-based revascularization in patients with diabetes mellitus has been scarcely investigated. Our objective was to determine the safety of ...deferring revascularization based on the fractional flow reserve (FFR) or the instantaneous wave-free ratio (iFR) in diabetic patients. Methods: Single-center, retrospective analysis of patients with intermediate coronary stenoses in whom revascularization was deferred based on FFR > 0.80 or iFR > 0.89 values. The long-term rate of major adverse cardiovascular events, a composite of all-cause mortality, myocardial infarction, and target vessel revascularization (TVR), was assessed in diabetic and non-diabetic patients at the follow-up. The rate of TVR based on the type of physiological index used to defer the lesion was also evaluated. Results: We evaluated 164 diabetic (214 vessels) and 280 non-diabetic patients (379 vessels). No significant differences in the rate of major adverse cardiovascular events was seen between diabetic and non-diabetic patients (20.1% vs 13.2%; P = .245) at a median follow-up of 43 months. All-cause mortality and cardiac death were not statistically different between both groups in the adjusted analysis (P > .05). A trend towards a higher rate of myocardial infarction was seen in diabetic patients (6.7% vs 2.9%; P = .063). However, the rate of target vessel myocardial infarction was similar in both groups (P = .874). Overall, TVR was similar in diabetics and non-diabetics (4.7% vs 4.2%; P = .814); however, when analyzed based on the physiological index, numerically, diabetics had a higher rate of TVR when the FFR was used in the decision-making process compared to when the iFR was used (6.4% vs 0.0%; P = .064). Conclusions: Deferring the revascularization of intermediate stenoses in patients with DM based on the FFR or the iFR is safe regarding the risk of TVR or target vessel myocardial infarction, with a rate of events at the long-term follow-up similar to that seen in non-diabetic patients.
Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) remains a major challenge.
This study evaluated the comparative efficacy of drug-eluting balloons (DEB) and ...everolimus-eluting stents (EES) in patients presenting with DES-ISR.
The study design of this multicenter randomized clinical trial assumed superiority of EES for the primary endpoint, in-segment minimal lumen diameter at the 6- to 9-month angiographic follow-up.
A total of 309 patients with DES-ISR from 23 Spanish university hospitals were randomly allocated to DEB (n = 154) or EES (n = 155). At late angiography (median 247 days; 90% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p < 0.01) (absolute mean difference: 0.23 mm; 95% CI: 0.07 to 0.38) corrected, net lumen gain (1.28 ± 0.7 mm vs. 1.01 ± 0.7 mm; p < 0.01), and lower percent diameter stenosis (23 ± 22% vs. 30 ± 22%; p < 0.01) and binary restenosis rate (11% vs. 19%; p = 0.06), compared with patients in the DEB arm. Consistent results were observed in the in-lesion analysis. At the 1-year clinical follow-up (100% of patients), the main clinical outcome measure (composite of cardiac death, myocardial infarction, and target vessel revascularization) was significantly reduced in the EES arm (10% vs. 18%; p = 0.04; hazard ratio: 0.58; 95% CI: 0.35 to 0.98), mainly driven by a lower need for target vessel revascularization (8% vs. 16%; p = 0.035).
In patients with DES-ISR, EES provided superior long-term clinical and angiographic results compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent RIBS IV; NCT01239940).
To the Editor, Although the use of new stents has improved the results after coronary angioplasty, the development of in-stent restenosis (ISR) is still one of the leading problems following these ...interventions. ISR is defined as a stenosis > 50% developing in a segment or border of the stent (up to 5 mm). It is often due to progressive neointimal proliferation and has been reported in up to 30% of the patients with conventional stents and 10% of drug-eluting stent carriers.1-3
Introduction and objectives: Recent publications suggest that bioresorbable vascular scaffolds (BVS) are associated with an excess of thrombotic complications. We present the real-world, long-term ...results of a series of patients who received the BVS Absorb (Abbott Vascular, United States).
Methods: A total of 213 consecutive patients who received at least 1 BVS between May 2012 and December 2016 were analyzed. The main objective of the study was the rate of target vessel failure, a composite endpoint of infarction or target vessel revascularization and cardiac death.
Results: Seventy-five per cent of the patients were men (mean age, 61.4 years). The most common cause for admission was non-ST-elevation myocardial infarction (53.52%). The median follow-up was 44 months 28 months, the rate of the primary endpoint was 6.57% for the first 24 months and 7.98% at the end of the follow-up. Regarding the device, there were 6 cases (2.81%) of thrombosis (definitive, probable or possible) and 10 cases (4.69%) of restenosis. Patients with a past medical history of diabetes mellitus (HR, 1.72; 95%CI, 1.01-2.95; P = .05) and/or chronic oral anticoagulation (HR, 5.71; 95%CI, 1.12-28.94; P = .04) had a higher risk of target vessel failure.
Conclusions: In this series of patients, the rate of target vessel failure was similar to the one previously described by randomized clinical trials. Events were more common during the first 2 years of follow-up and in the presence of greater cardiovascular comorbidity.
Introducción y objetivos: Las publicaciones sugieren que los armazones vasculares bioabsorbibles (AVB) conllevan un exceso de complicaciones trombóticas. Se describen los resultados en la vida real y a largo plazo de una serie de pacientes a los que se implantó un AVB Absorb (Abbott Vascular, EE.UU.).
Métodos: Se analizaron 213 pacientes consecutivos que recibieron al menos un AVB entre mayo de 2012 y diciembre de 2016. El objetivo principal del estudio fue la incidencia de fracaso del vaso diana, un evento compuesto que incluye infarto de miocardio, revascularización del vaso diana y muerte cardiaca.
Resultados: El 75% de los pacientes eran varones (edad media, 61,4 años). La causa más común de ingreso fue el infarto sin elevación del ST (53,52%). La mediana de seguimiento fue de 44 meses 28 meses. La incidencia del evento primario fue del 6,57% durante los primeros 24 meses y del 7,98% al final del seguimiento. Respecto al dispositivo, hubo 6 casos (2,81%) de trombosis (definitiva, probable o posible) y 10 casos (4,69%) de reestenosis. Los pacientes con antecedentes de diabetes mellitus (HR = 1,72; IC95%, 1,01-2,95; p = 0,05) o con anticoagulación oral crónica (HR = 5,71; IC95%, 1,12-28,94; p = 0,04) tuvieron mayor riesgo de fracaso del vaso diana.
Conclusiones: En esta serie de pacientes, la incidencia de fracaso del vaso diana fue comparable a la descrita previamente en ensayos clínicos aleatorizados. Los eventos adversos fueron más frecuentes en los primeros 2 años de seguimiento y en presencia de mayor comorbilidad cardiovascular.
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