Current Treatment of In-Stent Restenosis Alfonso, Fernando, MD, PhD; Byrne, Robert A., MB, BCh, PhD; Rivero, Fernando, MD ...
Journal of the American College of Cardiology,
06/2014, Letnik:
63, Številka:
24
Journal Article
Recenzirano
Odprti dostop
Management of patients with in-stent restenosis (ISR) remains an important clinical problem. Although drug-eluting stents (DES) have drastically reduced the incidence of ISR, treatment of DES-ISR is ...particularly challenging. ISR mainly results from aggressive neointimal proliferation, but recent data also suggest that neoatherosclerosis may play an important pathophysiological role. Intracoronary imaging provides unique insights to unravel the underlying substrate of ISR and may be used to guide repeated interventions. In this paper, we systematically reviewed clinical trial data with currently available therapeutic modalities, including DES and drug-coated balloons, in patients presenting with ISR within bare-metal stents or DES.
Abstract Background The prognostic value of high-sensitivity troponin T (hs-TnT) elevation after elective percutaneous coronary intervention (PCI) in patients with or without raised baseline hs-TnT ...levels is unclear. Objectives The goal of this study was to assess whether the prognostic value of post-procedural hs-TnT level after elective PCI depends on the baseline hs-TnT level. Methods This study included 5,626 patients undergoing elective PCI who had baseline and peak post-procedural hs-TnT measurements available. The primary outcome was 3-year mortality (with risk estimates calculated per SD increase of the log hs-TnT scale). Results Patients were divided into 4 groups: nonelevated baseline and post-procedural hs-TnT levels (hs-TnT ≤0.014 μg/l; n = 742); nonelevated baseline but elevated post-procedural hs-TnT levels (peak post-procedural hs-TnT >0.014 μg/l; n = 2,721); elevated baseline hs-TnT levels (hs-TnT >0.014 μg/l) with no further rise post-procedure (n = 516); and elevated baseline hs-TnT levels with a further rise post-procedure (n = 1,647). A total of 265 deaths occurred: 6 (1.6%) in patients with nonelevated baseline and post-procedural hs-TnT levels; 54 (3.8%) in patients with nonelevated baseline but elevated post-procedural hs-TnT levels; 50 (16.0%) in patients with elevated baseline hs-TnT levels with no further rise post-procedure; and 155 (18.2%) in patients with elevated baseline hs-TnT levels with a further rise post-procedure (p < 0.001). After adjustment, baseline hs-TnT levels (hazard ratio HR: 1.22; 95% confidence interval CI: 1.09 to 1.38; p < 0.001) but not peak post-procedural hs-TnT levels (HR: 1.04; 95% CI: 0.85 to 1.28; p = 0.679) were associated with an increased risk of mortality. Peak post-procedural hs-TnT findings were not associated with mortality in patients with nonelevated (HR: 0.93; 95% CI: 0.69 to 1.25; p = 0.653) or elevated (HR: 1.24; 95% CI: 0.91 to 1.69; p = 0.165) baseline hs-TnT levels. Conclusions In patients with coronary artery disease undergoing elective PCI, an increase in post-procedural hs-TnT level did not offer prognostic information beyond that provided by the baseline level of the biomarker.
We compared the outcomes of a novel, thin-strut, cobalt-chromium, absorbable, polymer sirolimus-eluting stent (APSES; MiStent) to the durable polymer cobalt-chromium everolimus-eluting stent (EES; ...Xience). A propensity-matched analysis was performed comparing data from the DES With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesions in the Native Coronary Arteries (DESSOLVE) I and II studies, evaluating the APSES to the EES arm of the Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents-4 study. Target lesion failure (TLF) and its components were evaluated at 12 months and annually to 3 years; 805 patients (APSES = 153; EES = 652) were included with propensity matching in 204 patients (APSES = 102; EES = 102). APSES compared with EES had lower TLF at 1 year (3.0% vs 8.0%, p = 0.12) driven by a difference in target lesion revascularization (TLR; 1% vs 6%, p = 0.05), with no difference in target vessel myocardial infarction (p = 0.56) or stent thrombosis (p = 0.31). At 3 years, TLF (5.0% vs 12.5%, p = 0.07) and TLR (2.0% vs 8.4%, p = 0.04) remained lower with APSES. By landmark analysis, there was no significant difference in TLF between 1 and 3 years (p = 0.36). In conclusion, in a propensity-matched analysis, the APSES demonstrated reduced clinically indicated TLR rates at 1 and 3 years compared with the durable polymer EES, with minimal accrual of events between 1 and 3 years.
Background Fractional flow reserve (FFR) measured by coronary computed tomography angiography (FFRCT ) has been validated against invasive FFR. However, there are no data on how the use of FFRCT ...affects patient care and outcomes. The aim of this study is to compare standard practice guided by usual care testing to FFRCT -guided management in symptomatic subjects with suspected coronary artery disease (CAD). Methods In this prospective nonrandomized trial, symptomatic patients with suspected CAD will be enrolled in 2 consecutive cohorts: a usual care-guided pathway (cohort 1) and an FFRCT -guided pathway (cohort 2). Each cohort is divided into 2 groups according to whether noninvasive or invasive diagnostic testing was planned before enrollment. In all subjects, the patient's clinical team will review all diagnostic test results and determine a treatment strategy. A total sample size of 580 subjects will be enrolled and followed up for 12 months. Results The primary end point is the comparison of the percentage of patients with planned invasive testing who have a catheterization (invasive coronary angiography) within 90 days from initial assessment, which does not show a significant stenosis (defined as coronary artery stenosis >50% or invasive FFR ≤0.80). Secondary end points include the rate of invasive coronary angiography without obstructive CAD in those with planned noninvasive testing and, in all groups, noninferiority of resource use, quality of life, medical radiation exposure, and major adverse cardiac events up to 365 days of follow-up. Conclusions The study compares clinical and economic outcomes based on diagnostic evaluation using FFRCT with that based on standard diagnostic strategies
Background The Resolute zotarolimus-eluting stent (R-ZES) utilizes the same metallic platform and anti-restenotic drug as the Endeavor zotarolimus-eluting stent (E-ZES) but is coated with a more ...biocompatible polymer with enhanced drug-release kinetics. The aim of this study was to compare the long-term clinical outcomes of 2 zotarolimus-eluting stent generations. Methods In two randomized trials with broad inclusion criteria (ISAR-TEST 2 and ISAR-TEST 5), 1,000 patients were treated with R-ZES and 339 patients treated with E-ZES. In both trials follow-up angiography was scheduled at 6 to 8 months. The efficacy endpoint of interest was target lesion revascularization and the safety endpoints were the combined incidence of cardiac death or myocardial infarction related to target vessel as well as the incidence of definite stent thrombosis at 2-year follow-up. Results The incidence of target lesion revascularization at 2 years was 12.0% in the R-ZES group and 16.0% in the E-ZES (HR 0.72 95% CI: 0.52-1.00, P = .052). The incidence of cardiac death or myocardial infarction was 5.5% vs. 4.8% (HR 1.15, 95% CI: 0.66-2.02, P = .62) and of definite stent thrombosis was 0.4% vs. 0.6% (HR 0.68, 95% CI: 0.12-3.72, P = .66), respectively. All measures of angiographic restenosis were in favor of the R-ZES; in-stent late lumen loss was 0.29 ± 0.56 with the R-ZES versus 0.58 ± 0.55 with the E-ZES ( P < .0001). Conclusions Comparison of the 2 Food and Drug Administration–approved zotarolimus-eluting stents suggested that the R-ZES as compared to the E-ZES displayed overall superior antirestenotic efficacy. Both devices were associated with a similar low risk of adverse safety events through 2 years.
Abstract Objectives The aim of this study was to report clinical outcomes in patients treated in routine practice 2 years after everolimus-eluting bioresorbable stent (BRS) implantation. Background ...Long-term results in patients undergoing BRS implantation in routine clinical practice are sparse, and existing evidence from randomized trials considers mostly selected patients. Methods The ISAR-ABSORB registry enrolled consecutive patients undergoing BRS implantation in routine clinical practice at 2 high-volume centers in Germany. Angiographic follow-up was scheduled after 6 to 8 months and clinical follow-up to 24 months. The primary endpoint was the composite of death, myocardial infarction, or target lesion revascularization, and secondary endpoints included individual components of the primary endpoint and definite stent thrombosis. Event rates were calculated using the Kaplan-Meier method. Results A total of 419 patients were included. The mean age was 66.6 ± 10.9 years, 31.5% had diabetes, and 39.0% presented with acute coronary syndrome. Forty-nine percent of lesions were considered complex (American College of Cardiology/American Heart Association type B2 or C), and 13.1% were bifurcation lesions. The mean reference vessel diameter was 2.89 ± 0.46 mm. At 2 years, the primary endpoint had occurred in 21.6% of patients: death in 6.3%, myocardial infarction in 3.9%, target lesion revascularization in 16.0%, and definite stent thrombosis in 3.8%. Conclusions Long-term follow-up of patients treated with BRS in routine practice showed higher event rates than expected. Future studies are required to determine the impact of changes in implantation technique and to define the optimal duration of dual antiplatelet therapy in these patients.
Abstract Background Fractional flow reserve estimated using computed tomography (FFRCT ) might improve evaluation of patients with chest pain. Objectives The authors sought to determine the effect on ...cost and quality of life (QOL) of using FFRCT instead of usual care to evaluate stable patients with symptoms suspicious for coronary disease. Methods Symptomatic patients without known coronary disease were enrolled into 2 strata based on whether invasive or noninvasive diagnostic testing was planned. In each stratum, consecutive observational cohorts were evaluated with either usual care or FFRCT . The number of diagnostic tests, invasive procedures, hospitalizations, and medications during 90-day follow-up were multiplied by U.S. cost weights and summed to derive total medical costs. Changes in QOL from baseline to 90 days were assessed using the Seattle Angina Questionnaire, the EuroQOL, and a visual analog scale. Results In the 584 patients, 74% had atypical angina, and the pre-test probability of coronary disease was 49%. In the planned invasive stratum, mean costs were 32% lower among the FFRCT patients than among the usual care patients ($7,343 vs. $10,734 p < 0.0001). In the noninvasive stratum, mean costs were not significantly different between the FFRCT patients and the usual care patients ($2,679 vs. $2,137; p = 0.26). In a sensitivity analysis, when the cost weight of FFRCT was set to 7 times that of computed tomography angiography, the FFRCT group still had lower costs than the usual care group in the invasive testing stratum ($8,619 vs. $ 10,734; p < 0.0001), whereas in the noninvasive testing stratum, when the cost weight of FFRCT was set to one-half that of computed tomography angiography, the FFRCT group had higher costs than the usual care group ($2,766 vs. $2,137; p = 0.02). Each QOL score improved in the overall study population (p < 0.0001). In the noninvasive stratum, QOL scores improved more in FFRCT patients than in usual care patients: Seattle Angina Questionnaire 19.5 versus 11.4, p = 0.003; EuroQOL 0.08 versus 0.03, p = 0.002; and visual analog scale 4.1 versus 2.3, p = 0.82. In the invasive cohort, the improvements in QOL were similar in the FFRCT and usual care patients. Conclusions An evaluation strategy based on FFRCT was associated with less resource use and lower costs within 90 days than evaluation with invasive coronary angiography. Evaluation with FFRCT was associated with greater improvement in quality of life than evaluation with usual noninvasive testing. (Prospective Longitudinal Trial of FFRCT : Outcomes and Resource Impacts PLATFORM; NCT01943903 )
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