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The fractional flow reserve (FFR) cut-off values of 0.75 or 0.8 have been widely used; however, whether they apply to patients on hemodialysis remains unknown. We aimed to investigate the cut-off value of FFR associated with clinical outcomes in patients on hemodialysis. Using the Japanese multicenter registry, we analyzed data of patients on hemodialysis with measured FFR between January 2010 and December 2016. Survival classification and regression tree analysis for the composite primary outcome of cardiovascular mortality, myocardial infarction, and target vessel revascularization revealed a threshold FFR of 0.83. Multivariate Cox regression analyses were performed for the clinical outcomes. Additionally, the primary outcome was analyzed using propensity score matching by dividing the patients into complete and incomplete revascularization groups according to the presence of residual lesions with an FFR of ≤0.83 after the intervention. Of the 212 included patients, 112 (52.8%) had lesions with an FFR of ≤0.83. After adjusting for confounders, an FFR of ≤0.83 was associated with a higher risk for the primary outcome (adjusted hazard ratio 2.01, 95% confidence interval 1.11 to 3.66, p = 0.021). Propensity score matching showed that complete revascularization for lesions with an FFR of ≤0.83 was associated with a reduced risk for the primary outcome compared with incomplete revascularization (hazard ratio 0.38, 95% confidence interval 0.20 to 0.71, log-rank p = 0.0016). In conclusion, an FFR of ≤0.83 was an independent predictor of clinical events in patients on hemodialysis. Furthermore, complete revascularization was associated with better clinical outcomes. Thus, this population may require a distinct FFR cut-off value., Competing Interests: Declaration of Competing Interest Dr. Shiono receives lecture fees from Phillips Japan, Zeon Medical Inc., and Abbott Medical Japan. Dr. Kawase receives lecture fees from Phillips Japan, Zeon Medical Inc., Boston Scientific Corporation and Abbott Medical Japan. Dr. Yamashita is affiliated with an endowed department sponsored by Abbott Medical Japan and receives consultation fee and lecture fees from Kaneka Medix and Phillips Japan. Dr. Amano receives lecture fees from Astellas Pharma, Astra Zeneca, Bayer, Daiichi-Sankyo, and Bristol-Myers Squibb. Dr. Tanaka receives lecture fees from Abbott Medical Japan and Daiichi-Sankyo. Dr. Akasaka receives lecture fees from Abbott Medical Japan and is Medical Advisor of Terumo Corporation. The remaining authors have no competing interests to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Even after successful revascularization with primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI), subsequent adverse events still occur. Previous studies have suggested potential benefits of intravascular imaging, including optical coherence tomography (OCT). However, the feasibility of OCT-guided primary PCI has not been systematically examined in these patients. The ATLAS-OCT (ST-elevation Acute myocardial infarcTion and cLinicAl outcomeS treated by Optical Coherence Tomography-guided percutaneous coronary intervention) trial was designed to investigate the feasibility of OCT guidance during primary PCI for STEMI in experienced centers with expertise on OCT-guided PCI as a prospective, multicenter registry of consecutive patients with STEMI who underwent a primary PCI. The sites' inclusion criteria are as follows: (1) acute care hospitals providing 24/7 emergency care for STEMI, and (2) institutions where OCT-guided PCI is the first choice for primary PCI in STEMI. All patients with STEMI who underwent primary PCI at participating sites will be consecutively enrolled, irrespective of OCT use during PCI. The primary end point will be the rate of successful OCT imaging during the primary PCI. As an ancillary imaging modality to angiography, OCT provides morphologic information during PCI for the assessment of plaque phenotypes, vessel sizing, and PCI optimization. Major adverse cardiac events, defined as a composite of all-cause death, myocardial infarction, and target vessel revascularization at 1 year, will also be recorded. The ATLAS-OCT study will clarify the feasibility of OCT-guided primary PCI for patients with STEMI and further identify a suitable patient group for OCT-guided primary PCI., Competing Interests: Declaration of Competing Interest Dr. Ako received a speaking honorarium from Abbott Medical Japan, LLC. Dr. Minami received speaking honorarium and consultant fees from Abbott Medical Japan, LLC. Dr. Shite has received honoraria from Abbott Medical Japan, Nipro, and Terumo. Dr. Kozuki has received honoraria from Abbott Medical (Japan). Dr. Shishido received remuneration for lectures from Abbott Medical, Japan. Dr. Uemura received remuneration from Abbott Vascular Japan, Daiichi-Sankyo, Novartis Pharma, Bayer, and Amgen and scholarship funds from Abbott Vascular Japan. Dr. Kume received remuneration from Abbott Vascular (Japan). Dr. Nanasato received remuneration for lectures from Boston Scientific (Japan). Dr. Otake received a speaking honorarium and research grant from Abbott Vascular, Japan. Dr. Shinke received personal fees and research grants from Abbott Medical Japan, LLC. The remaining authors have no competing interests to declare., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Computed tomographic angiography (CTA) is considered to have limited accuracy for quantifying exact percent diameter stenosis in coronary arteries. However, most studies evaluating CTA use quantitative coronary angiography (QCA) as the gold standard, a technique with its own limitations. We sought to determine whether CTA measurements of stenosis severity correlate better with intravascular ultrasound (IVUS) than with QCA. Luminal dimensions of 67 de novo coronary lesions were measured by CTA, IVUS, and QCA. IVUS was performed when lesion severity by angiography was equivocal. Mean percent diameter stenosis by QCA was 51 +/- 9.8% and mean IVUS minimal luminal area was 3.8 +/- 1.8 mm(2). There was a moderate correlation between CTA minimal luminal area and IVUS minimal luminal area (r(2) = 0.41, p <0.001), but no relation between CTA and QCA measurements of minimal luminal diameter (r(2) = 0.01, p = 0.57) or diameter stenosis (r(2) = 0.02, p = 0.31). There was also no relation between IVUS minimal luminal area and QCA diameter stenosis (r(2) = 0.01, p = 0.50). When lesions with moderate or severe calcification were excluded, the correlation between CTA minimal luminal area and IVUS minimal luminal area was good (r(2) = 0.68, p <0.001). In conclusion, in this cohort of patients with intermediate-grade lesions on cardiac catheterization, absolute measurements of stenosis severity on CTA correlated with IVUS but not with QCA. Our findings suggest that limitations of quantitative coronary angiography as a gold standard need to be considered in studies evaluating the accuracy of coronary CTA.

The distribution of stent struts is critical to drug deposition and, therefore, may affect the amount of neointima and the risk of thrombosis after drug-eluting stent (DES) implantation. The aim of our study was to evaluate stent strut distribution in the setting of a drug-eluting stent thrombosis (ST). We retrospectively analyzed postprocedural intravascular ultrasound (IVUS) images of 13 patients who subsequently developed ST (14 DES thrombotic lesions) and a control group of 27 patients (30 DES lesions) matched for stent type and presence of chronic renal failure. In addition to standard IVUS measurements, visible struts were counted and maximum interstrut angle was measured at 1-mm intervals. Early ST was defined as < or =30 days after DES deployment and late ST as >30 days after DES deployment. Compared with DES controls, the ST group had a larger maximum interstrut angle (60.8 +/- 8.3 degrees vs 55.7 +/- 4.8 degrees , p = 0.014) and a similar number of stent struts (8.4 +/- 0.6 vs 8.7 +/- 0.6, p = NS). Maximum interstrut angle tended to be larger in late ST than in early ST (66.1 +/- 10.8 degrees vs 57.8 +/- 5.0 degrees , p = 0.071). The incidence of maximum interstrut angles > or =90 degrees and > or =120 degrees observed continuously for > or =2 mm of stent length was higher in the ST group (p = 0.009 and p = 0.096, respectively). In conclusion, DES-treated lesions leading to ST had larger maximum interstrut gaps distributed circumferentially and longitudinally, but a similar number of struts at the time of DES implantation compared with DES controls.

Performance of percutaneous coronary intervention (PCI) at centers without cardiothoracic surgery is a contentious issue. Although this practice allows greater access to care, there are safety concerns. The aim was to assess the requirement for emergent coronary artery bypass grafting (CABG) after PCI and characterize patients at highest risk using independent predictors. The study population consisted of 21,957 unselected patients who underwent PCI from August 1994 (Food and Drug Administration stent approval) to January 2008 at a single medical center. Patients requiring emergent CABG (defined as within 24 hours of the index procedure) were identified. Logistic regression analysis was performed to assess for independent correlates of emergent CABG. Emergent CABG was required in 90 patients (cumulative incidence 0.41%). Indications for CABG included triple-vessel disease, dissection, acute closure, perforation, and failure to cross. These patients had significantly higher in-hospital cardiac death rates (7.8% vs 0.7%; p <0.01) and higher rates of Q-wave myocardial infarction, neurologic events, and renal insufficiency. Independent correlates of emergent CABG after PCI were acute ST-segment elevation myocardial infarction presentation, cardiogenic shock, triple-vessel disease, and type C lesion. Risk assessment based on these predictors identified 0.3% of the patient population to have a 9.3% cumulative incidence of emergent CABG. In conclusion, the need for emergent CABG after PCI in the stent era was low and was associated with poor in-hospital outcomes. Risk was nonuniform, with 0.3% of the study population, characterized by acute presentation and complex coronary disease, at heightened risk of emergent surgery.

The risk of late thrombotic events and the need for prolonged dual antiplatelet therapy detract from the clinical advantage offered by drug-eluting stents (DESs). Short-term studies have shown premature clopidogrel cessation to be a strong predictor of stent thrombosis (ST) after DES implantation. Data pertaining to the utility of clopidogrel therapy and its optimal duration to prevent late ST remain limited. The study population consisted of 2,889 patients who underwent unrestricted intracoronary DES implantation from April 2003 to January 2007 for whom clopidogrel compliance data were available. Definite ST proved by angiography or autopsy within 12 months of the index procedure occurred in 61 patients. Comparisons of clinical and procedural characteristics in addition to outcomes (death and Q-wave myocardial infarction) were made between the ST and no-ST (2,828 patients) groups. Clopidogrel compliance was assessed at all follow-up time points. For patients in the ST group, clopidogrel compliance status for the remaining study period was defined as that at the time of ST. Logistic regression analysis was performed at 30 days, 6 months, and 12 months to identify independent predictors of cumulative ST. Patients with ST were more likely to have previous congestive heart failure and worse left ventricular ejection fraction. ST was associated with significantly higher mortality at 12 months (23.5% vs 3.2%, p <0.001). Clopidogrel compliance was 80.2% in the overall population and 73.8% in patients presenting with ST (82.6% in patients presenting with early ST and 43.8% in those with late ST). By logistic regression analysis, clopidogrel cessation was an independent predictor of cumulative ST at 30 days and 6 months but not at 12 months. In conclusion, high rates of clopidogrel compliance can be achieved in contemporary practice. Clopidogrel cessation by 12 months is no longer predictive of ST, thus suggesting the optimal duration of therapy for the prevention of ST to be 6 to 12 months.

Previous research has documented that African-Americans compared with non-African-Americans have higher rates of adverse cardiac outcomes and are less likely to be referred for an invasive cardiac procedure. These differences persist even after controlling for co-morbidities and socioeconomic status. We sought to compare 1-year outcomes between African-American and non-African-American patients in a clinical registry of patients after percutaneous coronary intervention receiving drug-eluting stents. We compared 1,221 African-American patients with 4,335 non-African-American patients referred for percutaneous coronary intervention. Patients were followed for 1 year with regard to major adverse cardiac events, including death, Q-wave myocardial infarction, and target vessel revascularization. We performed multivariable Cox proportional hazards regression to adjust for confounding variables, including median household income by zip code, to assess the contribution of African-American race to 1-year outcomes. At 1 year, African-American patients had significantly higher rates of overall major adverse cardiac events (17.7% African-American vs 12.4% non-African-American, p <0.001) and each component of death (7.8% African-American vs 5.4% non-African-American, p = 0.001), Q-wave myocardial infarction (1.2% African-American vs 0.2% non-African-American, p <0.001), and target vessel revascularization (10.7% African-American vs 7.5% non-African-American, p <0.001). Stent thrombosis was also higher in the African-American population at 1 year (2.5% African-American vs 0.7% non-African-American, p <0.001). After multivariable analysis and adjustment for socioeconomic status, however, African-American race was not a significant predictor of major adverse cardiac events. In conclusion, in this referral population, traditional risk factors and socioeconomic status accounted for the disparity between African-American and non-African-American patients.

The efficacy of contrast-enhanced multislice computed tomography (MSCT) for assessment of ambiguous lesions is unknown. We compared both quantitative coronary angiography (QCA) and MSCT to the gold standard for a significant stenosis-minimum luminal area (MLA) by intravascular ultrasound (IVUS)-in 51 patients (64 +/- 10 years old, 19 men) with 69 angiographically ambiguous, nonleft main lesions. The MSCT was performed 17 +/- 18 days before IVUS analysis. Overall diameter stenosis by QCAwas 51.0 +/- 9.8%; 39 of 51 patients (76%) eventually underwent revascularization (38 by percutaneous coronary intervention and 1 by coronary artery bypass graft). By univariate analysis, minimum luminal diameter, MLA, lumen visibility by MSCT, and minimum luminal diameter by QCA were significant predictors of MLA by IVUS

Conflicting data exist regarding an advantage of drug-eluting stents (DES) over bare metal stents (BMS) in catheter-based treatment of saphenous vein graft (SVG) stenoses. This study was undertaken to compare the efficacy of these modalities in that lesion subset. The DES group consisted of 138 cases with 183 lesions (sirolimus-eluting stents, n = 117; paclitaxel-eluting stents, n = 66) and the BMS group consisted of 344 cases with 478 lesions that were followed to 1 year. We examined a composite end point that comprised death, Q-wave myocardial infarction, and target lesion revascularization. More BMS were deployed per patient (p <0.001) and the diameters of BMS deployed was significantly greater (p <0.001). Peak postprocedure values of creatine kinase-MB (p = 0.003) and troponin I (p = 0.05) were higher in BMS. At 1 year there was no significant superiority of DES over BMS with regard to hard end points (death and Q-wave myocardial infarction). In conclusion, this study indicates that both DES and BMS for SVG disease provide acceptably safe and efficacious results, but unlike the case in native coronary arteries, DES use does not reduce the frequency of the need for repeat revascularization.

Coronary artery disease is the main cause of death in patients with chronic kidney disease (CKD). The poor prognosis associated with acute coronary syndrome (ACS) in these patients has been related to therapeutic nihilism. This study included 2,357 patients with ACS who had percutaneous coronary intervention. According to their creatinine clearance and medical history, they were divided into 3 groups: dialysis (n = 73); CKD (n= 293); and control (n= 1,991). Rates of cardiovascular events were recorded during a 1-year follow-up period. Patients in all groups received similar contemporary therapy for ACS, including percutaneous coronary intervention and optimal medial therapy. On admission, patients with CKD and patients on dialysis more often presented with cardiogenic shock (p = 0.05 and 0.02, respectively). A graded increase in the rate of major adverse cardiovascular events at 1 year was observed with decreasing renal function (control 13%, CKD 22.9%, dialysis 45.2%, p <0.001 for all comparisons). In multivariate analysis, patients with CKD and on dialysis were significantly associated with 1-year major adverse cardiac events with adjusted hazard ratios of, respectively, 1.5 (95% confidence interval 1.1 to 2.1; p = 0.009) and 2.7 (95% confidence interval 1.7 to 4.1; p <0.001). In conclusion, despite optimal contemporary medical therapy and revascularization, the prognosis of patients with CKD and, in particular, of patients undergoing dialysis, remains poor.

Stent thrombosis (ST) is a major safety concern after drug-eluting stent (DES) deployment, resulting in significant morbidity and mortality. The goal of this study was to examine the incidence, timing, clinical correlates, and outcomes after DES thrombosis in a real-world population. A retrospective analysis of 8,402 patients who underwent percutaneous coronary intervention and received a DES was performed. After DES implantation, 84 definite (DST) and 127 probable ST events occurred. The incidence of early DST was 0.8%, late DST was 0.4%, and very late DST was 0.4%. Multivariate analysis showed that a history of diabetes mellitus, myocardial infarction during admission, number of stents, and DES placement in a restenotic lesion were independently associated with DST. The incidence of early definite or probable ST (DPST) was 1.9%, late DPST was 1.4%, and very late DPST was 0.7%. Multivariate analysis showed that a history of diabetes, myocardial infarction during admission, cardiogenic shock, number of stents, and DES use in a restenotic lesion were independently associated with DPST. Both types of ST were associated with significantly higher rates of all-cause death, Q-wave myocardial infarction, and revascularization up to 24 months after DES implantation. In conclusion, ST after DES implantation in contemporary practice continues to occur from 30 days to 2 years at a rate > or =0.36%/year and is associated with high rates of morbidity and mortality. Diabetes mellitus, myocardial infarction, and DES use in a restenotic lesion were strongly associated with DST; therefore, careful consideration should apply when deploying a DES in these populations.

Multiple studies comparing sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in patients with coronary artery disease have been performed. Despite these comparisons, it remains uncertain whether a differential in long-term efficacy and safety exists. Unselected patients treated exclusively with 1 drug-eluting stent type were enrolled in the Registry Experience at the Washington Hospital Center with Drug-Eluting Stents. There were 2,099 patients (3,766 lesions) treated with SES and 1,079 patients (1,850 lesions) treated with PES. Patients were followed at 30 days, 1 year, and 2 years for the clinical endpoints of death, myocardial infarction, target vessel revascularization, and definite and definite/probable stent thrombosis. Patients in the SES group had more dyslipidemia, history of congestive heart failure, and ostial lesions; patients treated with PES had more previous coronary artery bypass surgery, unstable angina, and type C lesions. At 2 years, unadjusted major adverse cardiac events (MACE) (22.6% vs 21.1%, p = 0.3) and target vessel revascularization (13.3% vs 11.2%, p = 0.1) were comparable. The incidence of definite stent thrombosis was higher in the SES group (1.8% vs 0.9%, p = 0.05) driven by early events. Similar results were seen after adjustment for baseline differences: MACE (hazard ratio 1.1, 95% confidence interval [CI] 0.9 to 1.3, p = 0.5), definite stent thrombosis (hazard ratio 2.3, 95% CI 1.0 to 5.2, p = 0.05), and target vessel revascularization (hazard ratio 1.1, 95% CI 0.9 to 1.4, p = 0.4). The incidence and rate of late stent thrombosis (>30 days) were similar (0.7% vs 0.5%, p = 0.4 and 0.24%/year, both groups, respectively). In conclusion, no major differential in long-term safety or efficacy was detected between SES and PES; both stent types were efficacious in reducing revascularization but were limited by a small continual increase in late stent thrombosis.

For patients undergoing elective percutaneous coronary intervention (PCI), procedural anticoagulation with bivalirudin was previously shown to significantly reduce bleeding complications at the cost of a modest increase in ischemic events compared with unfractionated heparin (UFH) and glycoprotein IIb/IIIa inhibitors (GPIs). However, the excess bleeding in patients treated with UFH and GPIs may have been caused by excessively high UFH doses and increased activated clotting times. This study sought to determine the bleeding risk of targeted low-dose UFH with GPIs compared with bivalirudin in patients undergoing elective PCI. Of 1,205 patients undergoing elective PCI, 602 underwent PCI with adjunctive UFH and GPIs with the UFH dose targeted to an activated clotting time of approximately 250 seconds, and 603 patients matched for baseline characteristics underwent PCI with bivalirudin. Outcomes were analyzed for major bleeding (hematocrit decrease >15%, gastrointestinal bleed, or major hematoma) and 6-month major adverse cardiac events (death, myocardial infarction, and target-lesion revascularization). The maximum activated clotting time achieved was 261.7 +/- 61.6 seconds in the UFH/GPI group and 355.4 +/- 66.6 in the bivalirudin group (p <0.001). In-hospital major bleeding rates were similar between groups (1.8% UFH/GPI vs 1.7% bivalirudin; p = 0.83), as were transfusion requirements (1.2% UFH/GPI vs 0.5% bivalirudin; p = 0.61). The 6-month major adverse cardiac event rate was also similar between groups (9.5% UFH/GPI vs 9.0% bivalirudin; p = 0.81). In conclusion, there were no significant differences in major bleeding and 6-month major adverse cardiac events for patients undergoing elective PCI treated with targeted low-dose UFH and GPIs compared with those treated with bivalirudin.

Diabetes mellitus is an independent predictor of nephropathy after percutaneous coronary intervention (PCI). The outcomes of patients with diabetes with normal baseline serum creatinine who undergo PCI remain underevaluated. The aim of the present study was to assess the incidence, outcomes, and correlates of post-PCI nephropathy in this subset. The study cohort consisted of 570 patients with diabetes with normal serum creatinine (< or =1.3 mg/dl) who underwent PCI from August 2004 to December 2006. Patients aged >75 years and those presenting with either acute myocardial infarctions or cardiogenic shock were excluded. Post-PCI nephropathy was defined as a > or =25% increase in baseline creatinine. The study end points were post-PCI nephropathy and major adverse cardiac events at 6 months. Logistic regression was performed to identify independent predictors. Post-PCI nephropathy occurred in 70 patients (incidence 12.3%). These patients were more likely to be women (55.7% vs 35.5%, p = 0.001) and to have histories of congestive heart failure (24.2% vs 14.7%, p = 0.048). Entry-site complications (hematoma, pseudoaneurysm) and the need for blood transfusion (16.7% vs 1.7%, p <0.001) were more common in this group. In-hospital mortality (8.6% vs 0.2%, p <0.001) and length of stay (4.51 +/- 5.2 vs 2.23 +/- 2.9 days, p <0.001) were significantly higher in the group with post-PCI nephropathy. No study patient required dialysis. At 6 months, major adverse cardiac events were markedly higher in patients with post-PCI nephropathy (21.4% vs 6.0%, p <0.001), driven by death and revascularization. Independent predictors of post-PCI nephropathy were lower body mass index and blood transfusion. Post-PCI nephropathy independently predicted major adverse cardiac events (hazard ratio 4.3, 95% confidence interval 2.1 to 8.6, p <0.001). In conclusion, post-PCI nephropathy occurred in 12.3% of patients with diabetes with normal baseline serum creatinine and carried a significant detrimental impact on prognosis. The requirement for blood transfusions was the strongest correlate identified.

Routine aspiration thrombectomy (AT) in percutaneous coronary intervention for patients with ST-segment elevation myocardial infarction (STEMI) has not proved effective in randomized trials. However, in patients undergoing primary percutaneous coronary intervention with severely reduced flow or visible thrombus, AT remains an intuitively attractive option. The use of adjunctive AT in a high-risk cohort of 158 consecutive patients with STEMI and Thrombolysis In Myocardial Infarction (TIMI) 0 to 1 flow or visible thrombus on baseline angiography was examined. Of these, 80 patients underwent AT as an adjunct to primary percutaneous coronary intervention, and 78 underwent percutaneous coronary intervention without AT (non-AT). TIMI 3 flow rates, residual thrombus after percutaneous coronary intervention, and major adverse cardiac events (mortality and nonfatal Q-wave myocardial infarction) at 30 days, 6 months, and 1 year were compared. Baseline characteristics were similar between groups. The AT group more frequently achieved TIMI 3 flow after the intervention (91.3% AT vs 67.9% non-AT; p <0.001) and had less residual thrombus (7.5% AT vs 19.2% non-AT; p = 0.03). AT was associated with reduced major adverse cardiac events at 6 months (6.8% AT vs 24.0% non-AT; p = 0.004) and 1 year (16.6% AT vs 29.2% non-AT; p = 0.009), and decreased mortality rates in the AT group at 6 months (5.4% AT vs 21.3% non-AT; p = 0.004) and 1 year (7.7% AT vs 26.2% non-AT; p = 0.005). In conclusion, for patients with STEMI and TIMI 0 or 1 flow or visible thrombus on baseline angiography, AT was associated with increased TIMI 3 flow rates, decreased residual thrombus, and decreased clinical events, including mortality.

The utilization of drug-eluting stents (DES) in "real world" practice has deviated from Food and Drug Administration-approved indications. Safety concerns have arisen from recent reports that suggested increased mortality and nonfatal myocardial infarction (MI) with DES usage. Little is known about the clinical outcomes of patients undergoing intracoronary DES implantation for unapproved indications as a group compared with outcomes after bare metal stent (BMS) placement. The clinical outcomes of 546 patients undergoing DES implantation for >or=1 non-Food and Drug Administration-approved ("off label") indication since the approval of the device were assessed. The group was then matched by propensity score with 546 patients receiving BMSs prior to DES approval for the same indications. The primary endpoint was major adverse cardiac events (cardiac death, nonfatal Q-wave myocardial infarction [MI], and target vessel revascularization) at 12 months. Baseline clinical and angiographic characteristics were well matched between BMS and DES groups. The use of debulking devices was higher in the BMS group. Patients in the BMS group were more likely to be treated with larger diameter and shorter stents. There was no significant difference in the rate of in-hospital and 30-day adverse cardiac events. At 12 months, the primary endpoint of major adverse cardiac events was significantly reduced in the DES group (23.6% vs 16.7%, p=0.004), driven by reductions in the need for repeat revascularization (target lesion revascularization: 16.4% vs 7.8%, p<0.001; target vessel revascularization: 20.2% vs 13.1%, p=0.003). There was no significant difference in freedom from cardiac death or nonfatal Q-wave MI between groups (p=0.27). In conclusion, the utilization of DES for non-Food and Drug Administration-approved indications proved to be efficacious and safe when compared with a BMS cohort matched by propensity score. The advantage for DES was driven by reductions in repeat revascularization. "Off-label" DES use was not associated with increased rates of cardiac death and nonfatal MI at 12 months.

We are aware of no studies of peri-stent disease progression or luminal compromise in saphenous vein graft (SVG) lesions. We used serial intravascular ultrasound (IVUS) to assess disease progression in peri-stent saphenous vein bypass graft reference segments. We studied 37 peri-stent SVG reference segments in 21 patients; 16 were proximal and 21 were distal to the stent. The same anatomic image slice was analyzed after the intervention and at follow-up; this site was 3.68 +/- 2.22 mm from the stent edge. Graft age was 10.1 +/- 5.4 years, and mean follow-up duration was 13 months (range 3 to 61). Overall, change in SVG area, change in lumen area, and change in plaque burden correlated with postintervention plaque burden (r = 0.448, p = 0.005; r = -0.584, p <0.001; and r = 0.507, p = 0.001, respectively). For the proximal edge, change in lumen area correlated with change in plaque area (r = -0.951, p <0.001), but not with change in SVG area (r = -0.337, p = 0.201). For the distal edge, change in lumen area correlated more strongly with change in plaque area (r = -0.982, p <0.001) than with change in SVG area (r = -0.624, p = 0.003). When peri-stent reference segments were divided into 2 groups according to postintervention plaque burden (>50% [n = 20] vs <50% [n = 17]), there was a greater decrease in lumen area (-1.12 +/- 0.81 vs -0.33 +/- 0.26 mm(2), p <0.001) and greater increases in SVG area (0.26 +/- 0.29 vs 0.09 +/- 0.09 mm(2), p = 0.027), plaque area (1.37 +/- 0.96 vs 0.42 +/- 0.30 mm(2), p <0.001), and plaque burden (8.2 +/- 5.6% vs. 2.8 +/- 1.6%, p <0.001) in segments with a plaque burden >50%. In conclusion, peri-stent reference segment SVG disease progression and lumen loss were more significant in segments with a greater postintervention plaque burden after implantation of a bare metal stent or drug-eluting stent.

Although drug-eluting stents reduce restenosis and target lesion revascularization compared with bare metal stents (BMSs), the specter of late stent thrombosis has curbed enthusiasm for the widespread use of drug-eluting stents. Alternatively, increasing BMS use would increase restenosis and potentially increase adverse events. The presentation and outcomes of BMS restenosis are controversial. We evaluated 2,539 patients with BMS restenosis referred for repeat revascularization. Major adverse cardiac events, including mortality and myocardial infarction (MI), were assessed at clinical presentation, 30 days, and 6 months. Patients with acute presentation (i.e., unstable angina requiring hospitalization or MI) were compared with patients with stable presentation. At presentation, 19.2% of patients were asymptomatic, 27.5% had exertional angina, 46.6% had unstable angina, and 6.7% had MI. Mortality and MI rates were 1.1% and 1.4%, respectively, at 30 days and 3.3% and 4.5%, respectively, at 6 months. Patients with acute coronary syndrome (ACS) and those without ACS had similarly low mortality rates at 30 days (1.2% ACS vs 1.0% non-ACS, p = 0.65) and 6 months (3.4% ACS vs 3.3% non-ACS, p = 0.93) and MI rates at 30 days (1.3% ACS vs 1.4% non-ACS, p = 0.87) and 6 months (4.7% ACS vs 4.3% non-ACS, p = 0.65). Combined major adverse cardiac events were similar at 30 days (2.5% vs 2.1%, p = 0.53) and 6 months (7.4% ACS vs 6.9%, non-ACS, p = 0.65). In conclusion, although BMS restenosis often manifests as an ACS, it is associated with a low incidence of 6-month major adverse cardiac events and does not predict a negative outcome.

Despite significant decreases in restenosis and repeated intervention achieved using drug-eluting stents (DESs), the benefit has not been homogenous across all patient and lesion subsets. Identification of correlates of DES restenosis may allow a differing management approach and lead to improved patient outcomes. The study population consisted of 3,535 consecutive patients (5,046 lesions) who underwent successful sirolimus- or paclitaxel-eluting stent implantation for >or=1 native coronary artery or bypass graft lesion from April 2003 to September 2006. From this cohort, 197 patients (237 lesions) were identified to have in-stent restenosis (ISR) requiring revascularization within 12 months of stent implantation. This group was compared with the remainder of the patient population. Logistic regression analysis was performed to identify independent predictors of DES ISR. Independent correlates of DES ISR using multivariate analysis included both clinical and procedural factors. Clinical predictors were age, hypertension, and unstable angina. Procedural predictors were left anterior descending artery intervention, number of stents implanted, stented length/lesion, and lack of intravascular ultrasound guidance. Implantation of >or=3 stents was associated with a significantly higher restenosis risk (9.7% vs 5.1%; p=0.0003). A 10-mm increase in stented length was associated with an adjusted odds ratio of 1.18 (95% confidence interval 1.03 to 1.35). Diabetes, stent diameter, and stent type were found not to be predictive of DES ISR. In conclusion, correlates of DES ISR included both clinical and procedural factors. Limiting the number of stents and stented length, in addition to intravascular ultrasound guidance, may minimize DES ISR.

Drug-eluting stent (DES) thrombosis (ST) can be devastating. The study aim was to evaluate intravascular ultrasound (IVUS) predictors for DES thrombosis by comparing IVUS studies after implantation in 13 patients with 14 DES thrombosis lesions with a group of controls (30 lesions in 27 patients) matched for history of chronic renal failure and type of DES. Five patients (38%) discontinued dual antiplatelet therapy at the time of ST. There were 3 in-stent restenosis lesions (21%) treated using DESs in the ST group compared with 0 in the control group (p <0.05). Compared with the control group, IVUS studies in the ST group showed a smaller minimum stent area (4.6 +/- 1.1 vs 5.6 +/- 1.7 mm(2), p = 0.0489). In the ST group, 11 of 14 stents had a minimum stent area < or =5.0 mm(2) compared with 12 of 30 in the control group (p = 0.0392). Minimum stent area in patients who stopped clopidogrel therapy and developed ST (5.30 +/- 1.15 mm(2)) tended to be larger compared with that in patients who developed ST while using clopidogrel (4.24 +/- 0.96 mm(2), p = 0.091). Within the 5-mm-long proximal and distal reference segments analyzed, the ST group had larger proximal reference maximum plaque burdens and smaller minimum lumen areas, along with a tendency toward similar findings in the distal reference segments. In conclusion, IVUS findings at the time of DES implantation in patients who subsequently developed ST showed a smaller minimum stent area (especially in patients who developed ST while using clopidogrel) and more residual disease at the stent edges.

Drug-eluting stents (DESs) are superior to bare metal stents (BMSs) in decreasing restenosis rates across a wide range of patient and lesion subsets. However, widespread utilization of DESs raises concerns with regard to risks of prolonged dual antiplatelet therapy, the potential for late adverse events such as late thrombosis, and cost. Vessel diameter and lesion length have been previously identified as predictors for restenosis for DESs and BMSs. This study compared the clinical outcomes of DESs versus BMSs in large coronary arteries (> or =3.5 mm). A cohort of 233 patients who underwent single-vessel angioplasty with DES implantation in large vessels was compared with 233 propensity-matched patients who received BMSs in vessels with similar reference vessel diameters. Clinical outcomes at 30 days, 6 months, and 1 year were compared between groups. Baseline clinical and procedural characteristics were similar. Target lesion revascularization and target vessel revascularization rates and the incidence of major adverse cardiac events were low and comparable between the 2 groups at all follow-up intervals. At 1 year, the primary outcome occurred in 8.5% of patients with DESs and 7.7% of patients with BMSs (p = 0.80). There were no episodes of subacute stent thrombosis or late thrombosis in either group. In conclusion, implantation of DESs in large coronary arteries confers no additional benefit compared with BMSs, and the 2 approaches are associated with equally favorable clinical outcomes at 1 year.

The aim of this study was to determine whether a stented coronary artery might be positively remodeled, which factors predict this phenomenon, and whether positive remodeling has an association with late outcome. The study population consisted of 230 lesions in 230 patients who received bare-metal stents. We performed intravascular ultrasound analyses before and after the procedure and at follow-up. An artery was defined as positively remodeled if the ratio of follow-up to postvessel area was > or =1.1. The following indexes were calculated and defined: (1) late loss = postluminal area - follow-up luminal area; (2) percent plaque area = ([vessel area - luminal area]/vessel area x 100), (3) Delta% plaque area = follow-up percent plaque area - postprocedure percent plaque area. Although late loss in the positively remodeled group was significantly smaller than that in the nonremodeled group (p<0.05), d% plaque area in the former group was significantly larger than that in the latter group (p<0.05). The rate of restenosis in the positive remodeling group (16.4%) was significantly lower than that in the nonremodeling group (28.2%) (p<0.05). In multivariate analysis, postprocedure percent plaque area was the only powerful independent predictor for peristent positive remodeling and was inversely associated with this phenomenon in both groups (odds ratio 0.944, 95% confidence interval 0.914 to 0.975, p=0.0004). This study indicates that postprocedure percent plaque area could predict the occurrence of peristent positive remodeling at follow-up and that this phenomenon might influence late outcome.

The acute elastic recoil of 5 types of stents immediately after deployment by intravascular ultrasound and quantitative coronary angiography measurements was analyzed. Successfully implanted stents were: Palmaz-Schatz in 104 lesions, Gianturco-Roubin in 65, Wiktor in 45, gfx in 22, and Multi-Link stents in 22. Before and after stenting, the cross section of the smallest luminal area and vessel area was measured with intravascular ultrasound. The postdilatation balloon area was calculated by quantitative coronary angiography. Percent recoil was calculated as: [1-(preluminal area)/balloon area)] x 100. The ratio of balloon area-to-vessel area was also compared. Although preluminal areas in Gianturco-Roubin and Palmaz-Schatz stents were similar (2.4 +/- 0.1 vs 2.5 +/- 0.1 mm2, p = NS), postluminal area in the Gianturco-Roubin was significantly smaller than the area in the Palmaz-Schatz (6.3 +/- 0.2 vs 8.3 +/- 0.3 mm2, p <0.05). Although both the balloon area/vessel area (0.68 +/- 0.05, 0.80 +/- 0.08 vs 0.83 +/- 0.02, p <0.05) and the preluminal area (2.1 +/- 0.4, 1.6 +/- 0.2 vs 2.5 +/- 0.1 mm2, p <0.05) were smaller in gfx and Multi-Link than in the Palmaz-Schatz, postluminal area was comparable to the area in the Palmaz-Schatz (7.8 +/- 0.4, 7.4 +/- 0.4 vs 8.3 +/- 0.3 mm2, p = NS). Percent recoil in the Gianturco-Roubin was poorest among these 5 groups. More favorable initial gain can be obtained with Palmaz-Schatz, Wiktor, gfx, and Multi-Link stents than with the Gianturco-Roubin stent.