Impact of PRECISE-DAPT and DAPT Scores on Dual Antiplatelet Therapy Duration After 2nd Generation Drug-Eluting Stent Implantation.

PURPOSE: Determining the optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation is an important clinical issue. We evaluated the effects of ischemia (by DAPT score) and bleeding (by PRECISE-DAPT score), as well as the impact of DAPT duration, on clinical outcomes. METHODS: From pooled analysis of four randomized clinical trials, 5131 patients undergoing second-generation DES implantation were randomized to short-duration (n = 2575; ≤ 6 months) or standard-duration (n = 2556; ≥ 12 months) DAPT groups. This population was further divided into four subgroups according to PRECISE-DAPT (high bleeding risk ≥ 25) and DAPT (high ischemic risk ≥ 2) scores. RESULTS: Net clinical outcomes (1.3% vs. 1.3%; p = 0.89) and ischemic events (5.0% vs. 4.5%; p = 0.44) did not differ between the two duration groups, although bleeding events were more frequent in patients with standard-duration DAPT (0.4% vs. 0.9%; p = 0.04). Standard-duration DAPT was associated with fewer ischemic events (6.9% vs. 4.0%; p = 0.02) and no increase in bleeding events only among patients at low bleeding risk and high ischemic risk. The other groups show no differences in net clinical outcomes, ischemic events, or bleeding events according to DAPT duration. CONCLUSION: Compared with short-duration DAPT, standard-duration DAPT was associated with similar net clinical outcomes and ischemic events, but more bleeding events at 12 months after second-generation DES implantation. However, standard-duration DAPT reduced ischemic events without increasing bleeding events among patients at low bleeding and high ischemic risk. When determining DAPT duration, considering both ischemic and bleeding risk can help optimize patient benefits. CLINICAL TRIAL REGISTRATION: EXCELLENT (NCT00698607), RESET (NCT01145079), IVUS-XPL (NCT01308281), OPTIMA-C (NCT03056118).

One-Year COMBO Stent Outcomes in Acute Coronary Syndrome: from the COMBO Collaboration.

PURPOSE: The COMBO biodegradable polymer sirolimus-eluting stent includes endothelial progenitor cell capture (EPC) technology for rapid endothelialization, which may offer advantage in acute coronary syndromes (ACS). We sought to analyze the performance of the COMBO stent by ACS status and ACS subtype. METHODS: The COMBO collaboration (n = 3614) is a patient-level pooled dataset from the MASCOT and REMEDEE registries. We evaluated outcomes by ACS status, and ACS subtype in patients with ST segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) versus unstable angina (UA). The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Secondary outcomes included stent thrombosis (ST). RESULTS: We compared 1965 (54%) ACS and 1649 (46.0%) non-ACS patients. ACS presentations included 40% (n = 789) STEMI, 31% (n = 600) NSTEMI, and 29% (n = 576) UA patients. Risk of 1-year TLF was greater in ACS patients (4.5% vs. 3.3%, HR 1.51 95% CI 1.01-2.25, p = 0.045) without significant differences in definite/probable ST (1.1% vs 0.5%, HR 2.40, 95% CI 0.91-6.31, p = 0.08). One-year TLF was similar in STEMI, NSTEMI, and UA (4.8% vs 4.8% vs. 3.7%, p = 0.60), but definite/probable ST was higher in STEMI patients (1.9% vs 0.5% vs 0.7%, p = 0.03). Adjusted outcomes were not different in MI versus UA patients. CONCLUSIONS: Despite the novel EPC capture technology, COMBO stent PCI was associated with somewhat greater risk of 1-year TLF in ACS than in non-ACS patients, without significant differences in stent thrombosis. No differences were observed in 1-year TLF among ACS subtypes.

Overlapping Drug-Eluting Stent Is Associated with Increased Definite Stent Thrombosis and Revascularization: Results from 15,561 Patients in the AUTHENTIC Study.

PURPOSE: This study was to analyze the incidence of definite stent thrombosis (ST) after the implantation of drug-eluting stents (DESs) and cutoff value of overlapping length for predicting definite ST. An overlapping stent is associated with a high rate of clinical events after DES implantation compared with a non-overlapping stent. However, the rates of definite ST and clinical outcomes from a large patient population remain underreported. METHODS: A total of 15,561 patients with 24,183 lesions who underwent DES implantation from January 2005 to February 2017 were retrospectively included in 5 tertiary hospitals in China. The main endpoint was the incidence of definite ST after procedures. RESULTS: With a median of 1932 (IQR = 1194-2929) days, clinical follow-up was available in 7484 patients in the overlap group and in 8077 patients in the non-overlap group. The rates of definite ST were 3.1% in the overlap group and 1.2% in the non-overlap group (HR: 2.67 (95% CI: 2.11-3.38), p < 0.001). Of the 24,183 treated lesions, the incidences of definite ST were 2.4% in the overlap group and 0.9% in the non-overlap group (HR: 2.96 (95% CI: 2.38-3.69), p < 0.001). Stent overlap was associated with a higher rate of target lesion revascularization (TLR) (9.4%) compared with stent non-overlap (6.4%, p < 0.001). The length of overlapping stent ≥ 2.93 mm strongly correlated with definite ST. CONCLUSION: The present study shows that overlapping DES increases definite ST and revascularization in patients during long-term follow-up. In addition, the longer overlapping zone was associated with worse clinical outcomes.

Early Vascular Healing Following Bioresorbable-Polymer Sirolimus-Eluting Stent Placement Compared to That with Durable-Polymer Everolimus-Eluting Stent.

A recent thinner strut drug-eluting stent might facilitate early strut coverage after its placement. We aimed to investigate early vascular healing responses after the placement of an ultrathin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES) compared to those with a durable-polymer everolimus-eluting stent (DP-EES) using optical coherence tomography (OCT) imaging.This study included 40 patients with chronic coronary syndrome (CCS) who underwent OCT-guided percutaneous coronary intervention (PCI). Twenty patients each received either BP-SES or DP-EES implantation. OCT was performed immediately after stent placement (baseline) and at 1-month follow-up.At one month, the percentage of uncovered struts reduced significantly in both the BP-SES (80.9 ± 10.3% to 2.9 ± 1.7%; P < 0.001) and DP-EES (81.9 ± 13.0% to 5.7 ± 1.8%; P < 0.001) groups, and the percentage was lower in the BP-SES group than in the DP-EES group (P < 0.001). In the BP-SES group, the percentage of malapposed struts also decreased significantly at 1 month (4.9 ± 3.7% to 2.6 ± 3.0%; P = 0.025), which was comparable to that of the DP-EES group (2.5 ± 2.2%; P = 0.860). The optimal cut-off value of the distance between the strut and vessel surface immediately after the placement to predict resolved malapposed struts was ≤ 160 µm for BP-SES and ≤ 190 µm for DP-EES.Compared to DP-EES, ultrathin-strut BP-SES demonstrated favorable vascular responses at one month, with a lower rate of uncovered struts and a comparable rate of malapposed struts.

Early Vascular Response to Ultrathin Biodegradable Polymer Sirolimus-Eluting Stents for the Treatment of ST-Elevation Myocardial Infarction After Plaque Rupture.

Recent clinical studies suggest that newer-generation drug-eluting stents that combine ultrathin struts and nanocoating (biodegradable polymer sirolimus-eluting stents, BP-SES) could improve long-term clinical outcomes in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). However, the early vascular response to BP-SES in these patients has not been investigated so far.We examined this response in 20 patients with STEMI caused by plaque rupture using frequency-domain optical coherence tomography (OCT) to understand the underlying mechanisms. Plaque rupture was diagnosed by OCT before PCI with BP-SES implantation was performed. OCT was again performed before the final angiography (post-PCI) and after 2 weeks (2W-OCT).BP-SES placement caused protrusion of atherothrombotic material into the stent lumen and incomplete stent apposition in all patients. After 2 weeks, incomplete stent apposition was significantly reduced (% malapposed struts: post-PCI 4.7 ± 3.3%; 2W-OCT 0.9 ± 1.2%; P < 0.0001), and the percentage of uncovered struts also significantly decreased (% uncovered struts: post-PCI; 69.8 ± 18.3%: 2W-OCT; 29.6 ± 11.0%, P < 0.0001). The maximum protrusion area of the atherothrombotic burden was significantly reduced (post-PCI 1.36 ± 0.70 mm2; 2W-OCT 0.98 ± 0.55 mm2; P = 0.004).This study on the early vascular responses following BP-SES implantation showed rapid resolution of atherothrombotic material and progression of strut apposition and coverage. (UMIN000041324).

Sirolimus-Eluting Balloon for the Treatment of Coronary Lesions in Complex ACS Patients: The SELFIE Registry.

BACKGROUND: Sirolimus-coated balloons (SCBs) represent a novel therapeutic option for both in-stent restenosis (ISR) and de novo coronary lesions treatment, especially in small vessels. Our registry sought to evaluate the procedural and clinical outcomes of such devices in a complex acute coronary syndrome (ACS) clinical setting. METHODS AND RESULTS: We treated 74 consecutive patients with percutaneous coronary intervention (PCI) with at least 1 SCB used for ISR and/or de novo coronary lesion in small vessels at our institution. Sixty-two patients presented with ACS, and their data were included in our analysis. The mean age was 67 ± 10 years, and patients presenting with ST-elevated myocardial infarction (STEMI) were 14 (23%). De novo lesions were 52%, whereas ISR was 48%. Procedural success occurred in 100% of the cases. At the 11 ± 7 months follow-up, major adverse cardiovascular events (MACEs) were 3 (4.8%). Cardiovascular death (CD) occurred in 1 (1.6%) patient and myocardial infarction (MI) in 2 patients (3.2%) as well as ischemia-driven target lesion revascularization (TLR). One probable subacute thrombosis occurred (1.6%) with no major bleedings. In a subgroup analysis, the incidence of MACE did not show significant differences between patients treated for de novo lesions and ISR (HR: 0.239; CI 95%: 0.003-16.761, p=0.509). CONCLUSIONS: In the SELFIE prospective registry, SCB showed a good safety and efficacy profile for the treatment of coronary lesions, both ISR and/or de novo in small vessels, in a complex ACS population of patients at the 11 ± 7 months follow-up.

Clinical and angiographic outcomes of bioabsorbable vs. permanent polymer drug-eluting stents in Sweden: a report from the Swedish Coronary and Angioplasty Registry (SCAAR).

AIMS: Randomized clinical trials have consistently demonstrated the non-inferiority of bioabsorbable polymer drug-eluting stents (BP-DES) with respect to DES having permanent polymers (PP-DES). To date, the comparative performance of BP- and PP-DES in the real world has not been extensively investigated. METHODS AND RESULTS: From October 2011 to June 2016, we analysed the outcomes associated with newer generation DES use in Sweden. After stratification according to the type of DES received at the index procedure, a total of 16 504 and 79 106 stents were included in the BP- and PP-DES groups, respectively. The Kaplan-Meier estimates for restenosis at 2 years were 1.2% and 1.4% in BP- and PP-DES groups, respectively. Definite stent thrombosis (ST) was low in both groups (0.5% and 0.7% in BP- and PP-DES groups, respectively). The adjusted hazard ratio (HR) for either restenosis or definite ST did not differ between BP- and PP-DES [adjusted HR 0.95, 95% confidence interval (CI) 0.74-1.21; P = 0.670 and adjusted HR 0.79, 95% CI 0.57-1.09; P = 0.151, respectively]. Similarly, there were no differences in the adjusted risk of all-cause death and myocardial infarction (MI) between the two groups (adjusted HR for all-cause death 1.01, 95% CI 0.82-1.25; P = 0.918 and adjusted HR for MI 1.05, 95% CI 0.93-1.19; P = 0.404). CONCLUSION: In a large, nationwide, and unselected cohort of patients, percutaneous coronary intervention with BP-DES implantation was not associated with an incremental clinical benefit over PP-DES use at 2 years follow-up.

Comparison of Neointimal Response between Durable-Polymer Everolimus-Eluting Stent and Bioabsorbable-Polymer Everolimus-Eluting Stent for Severely Calcified Lesions Requiring Rotational Atherectomy.

Clinical outcomes after percutaneous coronary intervention (PCI) for severely calcified lesions remain poor. The purpose of this study was to investigate the neointimal response after everolimus-eluting stents (EES) for severely calcified lesions treated with rotational atherectomy (RA) using optical coherence tomography (OCT).We retrospectively analyzed 34 lesions in which PCI was performed with EES deployment following RA and OCT was performed immediately after PCI and at follow-up (nine months). The EES was either durable-polymer (DP) EES (22 lesions) or bioabsorbable polymer (BP) -EES (12 lesions). Strut coverage and malapposition were evaluated at 1-mm intervals of cross-section (CS) by serial OCT analysis. Malapposed strut was defined as having the distance from luminal border > 100 µm.A total of 11,823 struts immediately after PCI and 11,720 struts at follow-up were analyzed. Immediately after PCI, the strut-level analysis showed no significant differences in the percentage of malapposed struts between the DP-EES group and the BP-EES group. At follow-up, the BP-EES group showed a more prevalent covered strut compared with the DP-EES group (strut-level analysis: 95% versus 97%, P = 0.045; CS-level analysis: 97% versus 100%, P < 0.01; lesion-level analysis: 27% versus 83%, P < 0.01, respectively).In severely calcified lesions requiring RA, the BP-EES group achieved better neointimal coverage than the DP-EES group at nine months. Additional prospective studies are needed.

Comparison of Durable-Polymer- and Biodegradable-Polymer-Based Newer-Generation Drug-Eluting Stents in Patients with Acute Myocardial Infarction and Prediabetes After Successful Percutaneous Coronary Intervention.

Hyperglycemia is an important risk factor for poor clinical outcomes in patients with acute myocardial infarction (AMI). The relative superiority of the long-term clinical outcomes of durable-polymer (DP) -based and biodegradable-polymer (BP) -based newer-generation drug-eluting stents (DESs) after successful percutaneous coronary intervention (PCI) in patients with AMI and prediabetes is not well established. We compared the clinical outcomes in such patients between DP-based and BP-based newer-generation DESs.A total of 4,377 patients with AMI and prediabetes were divided into the following two groups: the DP-DES group (n = 3,775; zotarolimus-eluting stents [ZES; n = 1,546] and everolimus-eluting stents [EES; n = 2,229]) and the BP-DES group (n = 602; biolimus-eluting stents [BES]). The primary endpoint was the occurrence of major adverse cardiac events (MACEs), defined as all-cause death, recurrent myocardial infarction (re-MI), or any repeat revascularization. The secondary endpoint was the occurrence of stent thrombosis (ST).The 2-year adjusted hazard ratio (aHR) of MACEs for ZES versus EES, ZES versus BES, EES versus BES, and ZES/EES versus BES (aHR: 1.125; 95% confidence interval [CI], 0.834-1.518; P = 0.440) were similar. The cumulative incidence of ST was also comparable between the DP-DES and BP-DES groups (aHR: 1.407; 95% CI, 0.476-4.158; P = 0.537). Moreover, the 2-year aHRs of all-cause death, CD, re-MI, target lesion revascularization (TLR), target vessel revascularization (TVR), and non-TVR were similar.Patients with AMI and prediabetes who received DP-DES or BP-DES during PCI showed comparable safety and efficacy during the 2-year follow-up period.

Incidence and predictors of target lesion failure in patients undergoing contemporary DES implantation-Individual patient data pooled analysis from 6 randomized controlled trials.

BACKGROUND: Drug-eluting stents (DESs) have improved clinical outcomes of patients undergoing percutaneous coronary intervention (PCI). Nevertheless, adverse events related to previously treated lesion still occur. We sought to evaluate the incidence and predictors of target lesion failure (TLF) in patients undergoing contemporary DES implantation. METHODS: Patient-level data from 6 prospective, randomized trials were pooled, and DES treatment outcomes were analyzed at up to 5 years. Primary outcome was TLF (cardiac death, target lesion revascularization, or target vessel myocardial infarction). Cox proportional-hazards model was used to identify predictors of TLF. RESULTS: Overall, 10,072 patients were included in the analysis. TLF rate was 1.7%, 4.3%, and 11.9% at 30 days, 1 year, and 5 years, respectively. The only independent predictor of TLF at 30 days was stent length (hazard ratio [HR] 1.017, 95% CI 1.011-1.024, P < .0001). Moderate/severe calcification, stent length and post procedural diameter sthenosis were predictors between 30 days to 1 year but not at 1 to 5 years. Reference vessel diameter was the only lesion-related predictor at 5 years (P = .003). Clinical predictors of TLF between 30 days and 1 year were diabetes and hypertension (P < .01 for both), and between 1 and 5 years, diabetes (HR 1.40, 95% CI 1.13-1.73, P = .002), prior coronary artery bypass grafting (HR 2.52, 95% CI 1.92-3.30, P < .0001), and prior PCI (HR 1.29, 95% CI 1.02-1.64, P = .04) predicted TLF. CONCLUSIONS: Predictors of TLF vary in the early, late, and very late postprocedural periods. Reference vessel diameter was the only lesion-related predictor of long-term TLF; clinical predictors were diabetes, prior coronary artery bypass grafting, and prior PCI.

Risks of noncardiac surgery early after percutaneous coronary intervention.

BACKGROUND: Prior registry data suggest that 4%-20% of patients require noncardiac surgery (NCS) within 2 years of percutaneous coronary intervention (PCI). Contemporary data on NCS after PCI in the United States among women and men are limited. We determined the rate of early hospital readmission for NCS and associated outcomes in a large cohort of patients who underwent PCI in the United States. METHODS: Adults undergoing PCI between January 1 and June 30, 2014, were identified from the Nationwide Readmission Database. Patients readmitted for NCS within 6 months of PCI were identified. Outcomes of interest were in-hospital death, myocardial infarction (MI), and bleeding defined by International Classification of Diseases, Ninth Revision, codes. RESULTS: Among 221,379 patients who underwent PCI and survived to hospital discharge, 3.5% (n = 7,696) were readmitted for NCS within 6 months post-PCI, and 41% of these hospitalizations were elective. Early NCS was complicated by MI in 4.7% of cases, and 21% of perioperative MIs were fatal. Bleeding was recorded in 32.0% of patients. All-cause mortality occurred in 4.4% of patients (n = 339) readmitted for surgery. The risk of death or MI was greatest when NCS was performed within the first month after PCI. CONCLUSIONS: Despite clear guidelines to avoid surgery early after PCI, NCS was performed in 1 of every 29 patients with recent PCI, corresponding to as many as ~30,000 patients each year nationwide. Surgical mortality and perioperative MI were high in this setting. Strategies to minimize perioperative thrombotic and bleeding risks during readmission for NCS after PCI are necessary.

Racial differences in long-term outcomes among black and white patients with drug-eluting stents.

BACKGROUND: Some studies suggest that black patients may have worse outcomes after drug-eluting stent (DES) placement. There are limited data characterizing long-term outcomes by race. The objective was to compare long-term outcomes between black and white patients after percutaneous coronary intervention (PCI) with DES implantation. METHODS: We analyzed 915 black and 3,559 white (n = 4,474) consecutive patients who underwent DES placement at Duke University Medical Center from 2005 through 2013. Over 6-year follow up, we compared rates of myocardial infarction (MI), all-cause mortality, revascularization, and major bleeding between black and white patients. A multivariable Cox regression model was fit to adjust for potentially confounding variables. Dual-antiplatelet therapy use over time was determined by patient follow-up surveys and compared by race. RESULTS: Black patients were younger; were more often female; had higher body mass indexes; had more diabetes mellitus, hypertension, and renal disease; and had lower median household incomes than white patients (P < .001). At 6 years after DES placement, black relative to white patients had higher unadjusted rates of MI (12.1% vs 10.1%, hazard ratio 1.25, 95% CI 1.00-1.57, P = .05) and major bleeding (17.8% vs 14.3%, hazard ratio 1.28, 95% CI 1.07-1.54, P = .01), but there were no significant differences in other outcomes. After multivariable adjustment, there were no statistically significant racial differences in any of these outcomes at 6 years. Similarly, dual-antiplatelet therapy use was comparable between racial groups. CONCLUSIONS: Unadjusted rates of MI and major bleeding over long-term follow up were higher among black patients compared to white patients, but these differences may be explained by racial differences in comorbid disease.

Double robust estimation for multiple unordered treatments and clustered observations: Evaluating drug-eluting coronary artery stents.

Postmarket comparative effectiveness and safety analyses of therapeutic treatments typically involve large observational cohorts. We propose double robust machine learning estimation techniques for implantable medical device evaluations where there are more than two unordered treatments and patients are clustered in hospitals. This flexible approach also accommodates high-dimensional covariates drawn from clinical databases. The Massachusetts Data Analysis Center percutaneous coronary intervention cohort is used to assess the composite outcome of 10 drug-eluting stents among adults implanted with at least one drug-eluting stent in Massachusetts. We find remarkable discrimination between stents. A simulation study designed to mimic this coronary intervention cohort is also presented and produced similar results.

Comprehensive analysis of predictive factors for rapid angiographic stenotic progression and restenosis risk in coronary artery disease patients underwent percutaneous coronary intervention with drug-eluting stents implantation.

BACKGROUND: This study aimed to explore the correlation of baseline, procedural, and postprocedure characteristics with the risk of rapid angiographic stenotic progression (RASP) and restenosis in coronary artery disease (CAD) patients after percutaneous coronary intervention (PCI) with drug-eluting stents implantation. METHODS: Two hundred fourteen CAD patients underwent PCI with drug-eluting stents implantation were consecutively enrolled. Baseline, procedural, and postprocedure characteristics of patients were collected for analysis. Coronary angiography was performed to evaluate coronary stenosis before PCI and at 12 months after PCI. RASP of nontarget lesions and restenosis of stent-implanted target lesions were then assessed. RESULTS: 37.8% CAD patients occurred RASP at 12 months after PCI and compared to non-RASP group, RASP group presented with increased diabetes mellitus (DM) complication, higher concentration of serum uric acid (SUA), cardiac troponin I, N-terminal probrain natriuretic peptide, and high sensitive C-reactive protein (hs-CRP) as well as elevated occurrence of multivessel artery lesions. In addition, DM, SUA, hs-CRP, and multivessel artery lesions independently predicted high RASP risk. For restenosis, 21.0% patients occurred restenosis at 12 months after PCI, and patients in restenosis group presented with increased hypertension and DM occurrence, higher concentrations of SUA, LDL-C, and hs-CRP, as well as longer target lesion and length of stent in surgery compared to nonrestenosis group. Also, DM, SUA, LDL-C, hs-CRP, and length of target lesion independently predicted increased restenosis risk. CONCLUSION: Diabetes mellitus, SUA, and hs-CRP are potential predictive factors for increased risk of both RASP and restenosis in CAD patients underwent PCI and drug-eluting stents implantation.

Outcomes of New-Generation Drug-Eluting Stents in Women with Acute Myocardial Infarction.

PURPOSE OF REVIEW: This review discusses the outcomes of percutaneous coronary intervention (PCI) in women who experience acute myocardial infarction (AMI) and are treated with drug-eluting stents (DES). The review also describes the role of the new-generation DES compared with the early generation. RECENT FINDINGS: Recent literature shows that the new-generation DES can be effective in women who present with AMI. Women with AMI may be undertreated and are underrepresented in studies of AMI. Recently, it has been shown that the newer generation DES are effective and beneficial in women with AMI, similar to men. As further generations of DES are created, the future appears promising for continued advancements in women's cardiovascular health.

Propensity Score-Based Methods in Comparative Effectiveness Research on Coronary Artery Disease.

This review examines the conduct and reporting of observational studies using propensity score-based methods to compare coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or medical therapy for patients with coronary artery disease. A systematic selection process identified 48 studies: 20 addressing CABG versus PCI; 21 addressing bare-metal stents versus drug-eluting stents; 5 addressing CABG versus medical therapy; 1 addressing PCI versus medical therapy; and 1 addressing drug-eluting stents versus balloon angioplasty. Of 32 studies reporting information on variable selection, 7 relied exclusively on statistical criteria for the association of covariates with treatment, and 5 used such criteria to determine whether product or nonlinear terms should be included in the propensity score model. Twenty-five (52%) studies reported assessing covariate balance using the estimated propensity score, but only 1 described modifications to the propensity score model based on this assessment. The over 400 variables used in the 48 propensity score models were classified into 12 categories and 60 subcategories; only 17 subcategories were represented in at least half of the propensity score models. Overall, reporting of propensity score-based methods in observational studies comparing CABG, PCI, and medical therapy was incomplete; when adequately described, the methods used were often inconsistent with current methodological standards.

Hemodialysis Arteriovenous Fistula and Graft Stenoses: Randomized Trial Comparing Drug-eluting Balloon Angioplasty with Conventional Angioplasty.

Purpose To compare lesion primary patency and restenosis rates between drug-eluting balloon (DEB) percutaneous transluminal angioplasty (PTA) and conventional balloon PTA (cPTA) in the treatment of arteriovenous fistula (AVF) and arteriovenous graft (AVG) stenosis. Materials and Methods In this prospective study, 119 participants (mean age, 59.2 years; 79 men, 40 women) with failing AVFs (n = 98) or AVGs (n = 21) were randomly assigned to undergo either DEB PTA (n = 59) or cPTA (n = 60) from January 2012 to May 2013. Primary end points were lesion primary patency and restenosis rates at 6 months; secondary outcomes were anatomic and clinical success after PTA, circuit primary patency at 6 months and 1 year, and lesion primary patency at 1 year. Statistical analysis was performed by using the Kaplan-Meier product limit estimator, and hazard ratio was calculated by using Cox proportional hazards regression. Complication rates were assessed in both groups. Results Estimated lesion primary patency in the DEB PTA and cPTA arms was 0.81 and 0.61, respectively, at 6 months (P = .03) and 0.51 and 0.34, respectively, at 1 year (P = .04). Estimated circuit primary patency in the DEB PTA and cPTA arms was 0.76 and 0.56, respectively, at 6 months (P = .048) and 0.45 and 0.32, respectively, at 1 year (P = .16). Restenosis rate was 34.0% (16 of 47) for DEB PTA and 62.9% (22 of 35) for cPTA at 6 months (P = .01). No major complications were noted. Conclusion Drug-eluting balloon angioplasty was effective in prolonging lesion primary patency of dialysis access stenoses at 6 months and 1 year. © RSNA, 2018.

Stent Thrombosis.

The most dreaded complication with percutaneous coronary intervention with stents, either bare-metal or drug-eluting stents is stent thrombosis (ST) and it has a significant detrimental effect on the outcome for the patient. The initial attempts at intervention with bare-metal stents had much higher rates of ST compared with what is currently prevailing in the modern interventional world. Significant changes with respect to the stent technology, pharmacology, and most importantly our understanding of this phenomenon have decreased the risk of ST. There are many factors that can be performed to minimize the risk of ST and this review will describe the incidence, pathophysiology, and contributing risk factors to ST.

Cost-effectiveness analysis of drug-coated therapies in the superficial femoral artery.

OBJECTIVE: Drug-coated balloons (DCBs) may increase durability of endovascular treatment of superficial femoral artery (SFA) disease while avoiding stent-related risks. The purpose of this study was to use meta-analytic data of DCB studies to compare the cost-effectiveness of potential SFA treatments: DCB, drug-eluting stent (DES), plain old balloon angioplasty (POBA), or bare-metal stent (BMS). METHODS: A search for randomized controlled trials comparing DCB with POBA for treatment of SFA disease was performed. Hazard ratios were extracted to account for the time-to-event primary outcome of target lesion revascularization. Odds ratios were calculated for the secondary outcomes of primary patency (PP) and major amputation. Incorporating pooled data from the meta-analysis, cost-effectiveness analysis, assuming a payer perspective, used a decision model to simulate patency at 1 year and 2 years for each index treatment modality: POBA, BMS, DCB, or DES. Costs were based on current Medicare outpatient reimbursement rates. RESULTS: Eight studies (1352 patients) met inclusion criteria for meta-analysis. DCB outperformed POBA with respect to target lesion revascularization over time (pooled hazard ratio, 0.41; P < .001). Risk of major amputation at 12 months was not significantly different between groups. There was significantly improved 1-year PP in the DCB group compared with POBA (pooled odds ratio, 3.30; P < .001). In the decision model, the highest PP at 1 year was seen in the DES index therapy strategy (79%), followed by DCB (74%), BMS (71%), and POBA (64%). With a baseline cost of $9259.39 per patent limb at 1 year in the POBA-first group, the incremental cost per patent limb for each other strategy compared with POBA was calculated: $14,136.10/additional patent limb for DCB, $38,549.80/limb for DES, and $59,748,85/limb for BMS. The primary BMS option is dominated by being more expensive and less effective than DCB. Compared directly with DCB, DES costs $87,377.20 per additional patent limb at 1 year. Based on the projected PP at 1 year in the decision model, the number needed to treat for DES compared with DCB is 20. At current reimbursement, the use of more than two DCBs per procedure would no longer be cost-effective compared with DES. At 2 years, DCB emerges as the most cost-effective index strategy with the lowest overall cost and highest patency rates over that time horizon. CONCLUSIONS: Current data and reimbursements support the use of DCB as a cost-effective strategy for endovascular intervention in the SFA; any additional effectiveness of DES comes at a high price. Use of more than one DCB per intervention significantly decreases cost-effectiveness.

Risk of discontinuation of clopidogrel after 1 month following bare-metal stents: a propensity-score adjusted comparison with continued administration of clopidogrel after drug-eluting stents.

In patients at high risk for bleeding undergoing percutaneous coronary intervention (PCI) the use of bare-metal-stent (BMS) is considered an option that allows discontinuation of clopidogrel after 4 weeks. We sought to investigate the risk of early discontinuation of clopidogrel in patients with BMS as compared with a 6-month course of clopidogrel after DES in patients with or without high on-treatment platelet reactivity (HTPR). In 765 consecutive patients undergoing PCI after loading with clopidogrel 600 mg, HTPR was tested by optical aggregometry and defined as residual platelet reactivity > 14%. On top of aspirin 100 mg, patients received clopidogrel 75 mg for 4 weeks after BMS or 6 months after DES. The primary endpoint was all-cause mortality or myocardial infarction (MI) during 1 year. The 1-year incidence of death or MI was 3.5% with BMS (n = 484), 0.9% with DES and no HTPR (n = 211), and 7.1% with DES and HTPR (n = 70; p = 0.03). Landmark analyses for the first 6 months demonstrated that the risk of patients receiving BMS was similar as in patients receiving a DES with HTPR during this period (2.3 vs. 2.9%) but lowest in patients receiving a DES without HTPR (0.5%). The incidence of bleeding was similar in all three groups. These findings did not change after propensity score adjustment for stent type. After discontinuation of clopidogrel at 1 month, patients treated with BMS are at higher risk for death or MI than patients treated with a DES and sufficiently responding to clopidogrel planned for 6 months.ClinicalTrials.gov number NCT00457236.