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Background: Among patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse limb outcomes from restenosis. The effect of the use of drug-eluting resorbable scaffolds on these outcomes remains unknown., Methods: In this multicenter, randomized, controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting resorbable scaffold or angioplasty. The primary efficacy end point was freedom from the following events at 1 year: amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion. The primary safety end point was freedom from major adverse limb events at 6 months and from perioperative death., Results: The primary efficacy end point was observed (i.e., no events occurred) in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan-Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety end point was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, -3 percentage points; 95% CI, -6 to 0; one-sided P<0.001 for noninferiority). Serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group., Conclusions: Among patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point. (Funded by Abbott; LIFE-BTK ClinicalTrials.gov number, NCT04227899.)., (Copyright © 2023 Massachusetts Medical Society.)

Objective: To perform a meta-analysis of two concordant randomized controlled trials (RCTs) examining the long-term, 4-year safety profile of the Stellarex drug-coated balloon (DCB) vs percutaneous transluminal angioplasty (PTA) for the treatment of peripheral artery disease., Methods: An independent, third-party, meta-analysis of homogeneous, patient-level data from the ILLUMENATE Pivotal and ILLUMENATE EU RCTs was performed to assess mortality (time to death) in patients treated for symptomatic femoropopliteal disease. The Kaplan-Meier (KM) methodology was used to estimate hazard rates [HRs] of all-cause mortality, and Cox proportional hazard modeling was used to assess predictors of mortality. All serious adverse events, including deaths, were adjudicated by an independent, blinded clinical events committee., Results: In total, 589 (419 DCB; 170 PTA) patients were included in the pooled analysis of the ILLUMENATE Pivotal and ILLUMENATE EU RCTs. The median follow-up was 1735 days (interquartile range, 1434-1829 days), equivalent to 4.75 years. Vital status compliance was >95% in each RCT. The total number of deaths through 4 years was 81 of 589 (13.8%): 58 of 419 (13.8%) in the DCB arm and 23 of 170 (13.5%) in the PTA arm. The 1-year KM estimate of all-cause mortality was 1.9% ± 0.7% (estimate ±standard error) in those treated with DCB vs 1.2% ± 0.9% in those treated with PTA. At 2, 3, and 4 years, the respective KM estimates were 6.6% ± 1.2% vs 4.9% ± 1.7%, 9.3% ± 1.4% vs 9.9% ± 2.4%, and 14.0% ± 1.7% vs 14.4% ± 2.8% (P = .864). There were no significant differences in clinical events committee-adjudicated deaths between the two cohorts. In multivariate analysis, predictors of 4-year mortality were age (HR, 1.048; 95% confidence interval [CI], 1.026-1.071; P < .0001), renal insufficiency (HR, 2.440; 95% CI, 1.566-3.800; P < .0001), and lesion length (HR, 1.004; 95% CI, 1.000-1.008; P = .041). Neither paclitaxel exposure (DCB vs PTA; HR, 1.086; 95% CI, 0.709-1.664; P = .705) nor dose (mg; HR, 1.043; 95% CI, 0.971-1.119; P = .248) was the predictor of all-cause mortality at 4 years., Conclusions: This systematic meta-analysis of two concordant ILLUMENATE RCTs shows no difference in all-cause mortality through 4 years between Stellarex DCB and PTA, confirming the acceptable, long-term safety profile of the Stellarex DCB., (Copyright © 2021. Published by Elsevier Inc.)

Objective: Neck radiation therapy (XRT) can induce carotid artery stenosis and may increase the technical difficulty of endarterectomy. It is considered a relative indication for carotid angioplasty and carotid artery stenting (CAS). This study sought to evaluate differences in CAS embolic potential and restenosis performed on XRT and non-XRT patients., Methods: At three institutions, 366 CAS procedures were performed on 321 patients (XRT, n = 43; non-XRT, n = 323). Mean follow-up was 410 days (median, 282 days; range, 7-1920 days). Patients were observed with duplex ultrasound to assess for restenosis. Additional end points included target lesion revascularization (TLR), myocardial and cerebrovascular events, and perioperative complications. Captured particulate from embolic protection filters was analyzed with photomicroscopy and image analysis software for 27 XRT and 214 non-XRT filters., Results: XRT patients were more likely to be male and had lower rates of hypertension, coronary artery disease, and diabetes mellitus, although the mean age at procedure did not differ. There was no increase in severe internal carotid tortuosity among XRT patients (XRT: 50% vs non-XRT: 34.7%; P = .06). Indication for CAS did not differ between the two groups, including the number of CAS procedures performed for symptomatic carotid stenosis (XRT: 39.7% vs non-XRT: 39.0%; P = NS). Perioperative outcomes, including the composite 30-day stroke, myocardial infarction, and mortality, were not significantly different (XRT: 2.6% vs non-XRT: 3.9%; P = NS.) There were no significant differences in restenosis rate at the 50% (XRT: 9.4% vs non-XRT: 8.6%; P = NS) or 70% (XRT: 3.5% vs non-XRT: 8.6%; P = NS) threshold. Filter particle analysis revealed that filters from XRT patients had more numerous large particles per filter (1.4 vs 0.7; P < .05) and larger mean particle size (464.1 μm vs 320.0 μm; P < .05). TLR did not differ significantly between the groups., Conclusions: In contrast to earlier studies, this analysis reveals that there are significant differences in XRT and non-XRT patients undergoing CAS in terms of medical comorbidities and embolic material captured in embolic protection filters. The decreased incidence of atherosclerotic risk factors was observed in XRT patients probably because XRT was the primary factor responsible for carotid stenosis. Despite increased embolic particle size, CAS can be performed safely with no increased morbidity, TLR, or restenosis in XRT patients., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Drug-coated balloons (DCBs) have shown promise in improving the outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and popliteal artery disease., Methods and Results: The IN.PACT SFA Trial is a prospective, multicenter, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain attributable to superficial femoral and popliteal peripheral artery disease were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The primary efficacy end point was primary patency, defined as freedom from restenosis or clinically driven target lesion revascularization at 12 months. Baseline characteristics were similar between the 2 groups. Mean lesion length and the percentage of total occlusions for the DCB and PTA arms were 8.94 ± 4.89 and 8.81 ± 5.12 cm (P=0.82) and 25.8% and 19.5% (P=0.22), respectively. DCB resulted in higher primary patency versus PTA (82.2% versus 52.4%; P<0.001). The rate of clinically driven target lesion revascularization was 2.4% in the DCB arm in comparison with 20.6% in the PTA arm (P<0.001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA [P=0.10]). There were no device- or procedure-related deaths and no major amputations., Conclusions: In this prospective, multicenter, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal peripheral artery disease., Clinical Trial Registration Url: http://www.clinicaltrials.gov. Unique Identifiers: NCT01175850 and NCT01566461., (© 2014 The Authors.)

Objective: We sought to determine the effects of open (O) and closed (C) cell stents on the size and number of embolic particles generated during carotid artery stenting (CAS) and assess the impact on outcome., Methods: Embolic debris from carotid filters after CAS was analyzed using photomicroscopy and imaging software. Patient comorbidities, preoperative cerebrovascular symptoms, stent type, and outcomes (perioperative major adverse events) were examined., Results: Carotid filters from 173 consecutive CAS procedures (O, 125 and C, 48) were reviewed. The mean age was 70.9 ± 9.2 years; 58% were men. Mean stenosis was 88.2% ± 8.1%; 36.6% had neurological symptoms preprocedurally. There was no difference in preoperative symptoms between the two groups (O, 38.7% vs C, 31.3%; P = not significant [NS]). However, closed cell stent use was associated with higher degree of stenosis (O, 87.2% ± 8.0% vs C, 90.6% ± 7.8%; P = .01), an older age (O, 70.0 ± 8.6 years vs C, 73.4 ± 10.2 years; P = .03), and peripheral arterial disease (21.1% vs 43.5%; P = .01). A larger mean particle size was observed in patients treated with open cell stents compared to closed cell stents (O, 416.5 ± 335.7 μm vs C, 301.1 ± 251.3 μm; P = .03). There was no significant difference in the total number of particles (O, 13.8 ± 21.5 vs C, 17.6 ± 19.9; P = NS), periprocedural stroke (P = NS), and major adverse events between the two groups (P = NS)., Conclusions: Open cell stents are associated with a larger mean particle size compared to closed cell stents. No impact on procedural outcomes based on stent type was observed., (Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.)

Background--Randomized controlled trials have reported favorable 1-year outcomes with drug-coated balloons (DCBs) for the treatment of symptomatic peripheral arterial disease when compared with standard percutaneous transluminal angioplasty (PTA). Evidence remains limited on the durability of the treatment effect with DCBs in the longer term. Methods and Results--IN.PACT SFA is a single-blind, randomized trial (Randomized Trial of IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty [PTA] Balloon Catheter vs Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery [SFA] and/or Proximal Popliteal Artery [PPA]) that enrolled 331 patients with symptomatic (Rutherford 2-4) femoropopliteal lesions up to 18 cm in length. Patients were randomized 2:1 to receive treatment with DCB or PTA. The 36-month assessments included primary patency, freedom from clinically driven target lesion revascularization, major adverse events, and functional outcomes. At 36 months, primary patency remained significantly higher among patients treated with DCB compared with PTA (69.5% versus 45.1%; log rank P<0.001). The rates of clinically driven target lesion revascularization were 15.2% and 31.1% (P=0.002) for the DCB and PTA groups, respectively. Functional outcomes were similarly improved between treatment groups even though subjects in the DCB group required significantly fewer reinterventions versus those in the PTA group (P<0.001 for target lesion revascularization, P=0.001 for target vessel revascularization). There were no device- or procedure-related deaths as adjudicated by an independent Clinical Events Committee. Conclusions--Three-year results demonstrate a durable and superior treatment effect among patients treated with DCB versus standard PTA, with significantly higher primary patency and lower clinically driven target lesion revascularization, resulting in similar functional improvements with reduced need for repeat interventions. [ABSTRACT FROM AUTHOR]

Background: Drug-coated balloons (DCBs) are a predominant revascularization therapy for symptomatic femoropopliteal artery disease. Because of the differences in excipients, paclitaxel dose, and coating morphologies, varying clinical outcomes have been observed with different DCBs. We report the results of 2 studies investigating the pharmacokinetic and clinical outcomes of a new DCB to treat femoropopliteal disease.Methods: In the ILLUMENATE Pivotal Study (Prospective, Randomized, Single-Blind, U.S. Multi-Center Study to Evaluate Treatment of Obstructive Superficial Femoral Artery or Popliteal Lesions With A Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon), 300 symptomatic patients (Rutherford class 2-4) were randomly assigned to DCB (n=200) or standard angioplasty (percutaneous transluminal angioplasty [PTA]) (n=100). The primary safety end point was freedom from device- and procedure-related death through 30 days, and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months. The primary effectiveness end point was primary patency through 12 months. In the ILLUMENATE PK study (Pharmacokinetic Study of the Stellarex Drug-Coated Angioplasty Balloon), paclitaxel plasma concentrations were measured after last DCB deployment and at prespecified times (at 1, 4, 24 hours and at 7 and 14 days postprocedure) until no longer detectable.Results: In the ILLUMENATE Pivotal Study, baseline characteristics were similar between groups: 50% had diabetes mellitus, 41% were women, mean lesion length was 8.3 cm, and 44% were severely calcified. The primary safety end point was met (92.1% for DCB versus 83.2% for PTA, P=0.025 for superiority) and the primary patency rate was significantly higher with DCB (76.3% for DCB versus 57.6% for PTA, P=0.003). Primary patency per Kaplan-Meier estimates at day 365 was 82.3% for DCB versus 70.9% for PTA (P=0.002). The rate of clinically driven target lesion revascularization was significantly lower in the DCB cohort (7.9% versus 16.8%, P=0.023). Improvements in ankle-brachial index, Rutherford class, and quality of life were comparable, but the PTA cohort required twice as many revascularizations. Pharmacokinetic outcomes showed that all patients had detectable paclitaxel levels after DCB deployment that declined within the first hour (54.4±116.9 ng/mL to 1.4±1.0 ng/mL).Conclusions: The data demonstrate superior safety and effectiveness of the Stellarex DCB in comparison with PTA, and plasma levels of paclitaxel fall to low levels within 1 hour.Clinical Trial Registration: URL: http://clinicaltrials.gov. Unique identifiers: NCT01858428 and NCT01912937. [ABSTRACT FROM AUTHOR]

The article presents a study that investigated the incidence of acute and subacute stent thrombosis (ST) during the initial period of treatment with generic clopidogrel at a single percutaneous coronary intervention (PCI) center. Four cases of definite acute or subacute ST treated with generic clopidogrel were observed. Results showed an unexpected increase in ST coincident with the use of the drug.

Objectives: This study evaluated the outcomes of patients discharged the day of percutaneous coronary intervention (PCI) by analyzing the data from a single-center, large, multioperator registry of interventions. Background: Although same-day discharge is likely safe after interventions on low-risk stable patients, there is limited data to guide selection of a broader population of patients. Due to numerous patient variables and physician preferences, standardization of the length of stay after PCI has been a challenge. Most of the reported studies on same-day discharge have strict inclusion criteria and hence do not truly reflect a real-world population. Methods: We analyzed the outcomes of consecutive same-day discharge in 2,400 of 16,585 patients who underwent elective PCI without any procedural or hospital complication. Composite end point included 30-day major adverse cardiac cerebral events and bleeding/vascular complications. Results: The mean age of the study population was 57.0 ± 23.7 years with 12% aged over 65 years. Twenty-eight percent received glycoprotein IIb/IIIa inhibitor with closure devices in 90.5%. Clinical and angiographic success was noted in 97% of all PCIs. The average length-of-stay following PCI was 8.2 ± 2.5 h. The composite end point was reached in 23 patients (0.96%). Major adverse cardiac cerebral events occurred in 8 patients (0.33%) and vascular/bleeding complications in the form of Thrombolysis In Myocardial Infarction minor bleeding in 14 patients (0.58%) and pseudoaneurysm in 1 patient (0.04%). Conclusions: When appropriately selected, with strict adherence to the set protocol, same-day discharge after uncomplicated elective PCI is safe despite using femoral access in a wide spectrum of patients. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is available in the text. Background: While randomized trials have demonstrated the superiority of drug-coated balloon (DCB) angioplasty versus standard percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal peripheral artery disease, the long-term durability of DCB angioplasty remains uncertain. Methods and Results: IN.PACT SFA is a prospective, multicenter, randomized single-blinded trial (Randomized Trial of IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty [PTA] Balloon Catheter vs Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery [SFA] and/or Proximal Popliteal Artery [PPA]) that enrolled 331 subjects with symptomatic (Rutherford 2–4) femoropopliteal lesions. Subjects were randomly assigned 2:1 to the IN.PACT Admiral DCB or PTA. Assessments through 5 years included freedom from clinically driven target lesion revascularization, the primary safety end point, and major adverse events. Through 5 years, patients treated with the IN.PACT Admiral DCB demonstrated a sustained treatment effect with superior freedom from clinically driven target lesion revascularization when compared with PTA (Kaplan-Meier estimate of 74.5% versus 65.3%; log-rank P =0.020). The primary safety composite was achieved in 70.7% of subjects in the DCB and 59.6% in the PTA groups (P =0.068). The major adverse event rate was 42.9% for DCB and 48.1% for PTA (P =0.459). There were no device- or procedure-related deaths in either group as adjudicated by an independent and blinded Clinical Events Committee. Conclusions: The IN.PACT SFA randomized trial demonstrates that the IN.PACT Admiral DCB continues to perform better than PTA through 5 years with higher freedom from clinically driven target lesion revascularization. The sustained safety and effectiveness profile of this DCB supports its use as a preferred treatment choice compared with PTA for femoropopliteal lesions. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01175850 (IN.PACT SFA phase I) and NCT01566461 (IN.PACT SFA phase II). [ABSTRACT FROM AUTHOR]

Background: Endovascular treatment of femoropopliteal artery disease has shifted toward drug-coated balloons (DCB). However, limited data are available regarding the safety and efficacy of DCB vs bare-metal stents (BMS).Objectives: To compare DCB vs BMS outcomes in a propensity-adjusted, pooled analysis of 4 prospective, multicenter trials.Methods: Patient-level data were pooled from 4 prospective, multicenter studies: the IN.PACT SFA I/II and IN.PACT SFA Japan randomized controlled DCB trials and the Complete SE and DURABILITY II single-arm BMS studies. Outcomes were compared using inverse probability of treatment weighting (IPTW). Clinical endpoints were 12-month primary patency, freedom from 36-month clinically driven target lesion revascularization, and cumulative 36-month major adverse events (MAE).Results: The primary analysis included 771 patients (288 DCB, 483 BMS). IPTW-adjusted demographic, baseline lesion, and procedural characteristics were matched between groups. The adjusted mean lesion length was 8.1 ± 4.7 cm DCB and 7.9 ± 4.5 cm BMS. The IPTW-adjusted Kaplan-Meier estimates of 12-month primary patency (90.4% DCB, 80.9% BMS, P = 0.007), freedom from 36-month clinically driven target lesion revascularization (85.6% DCB, 73.7% BMS, P = 0.001), and cumulative incidence of 36-month MAE (25.3% DCB, 38.8% BMS, P < 0.001) favored DCB. There were no statistically significant differences observed in all-cause mortality, target limb major amputation, or thrombosis through 36 months.Conclusions: In a patient-level, IPTW-adjusted pooled analysis of prospective, multicenter pivotal studies, DCB demonstrated significantly higher patency, lower revascularization and MAE rates, and no statistically significant differences in mortality, amputation, or thrombosis versus BMS. This analysis supports DCB use vs BMS in moderately complex femoropopliteal lesions amenable to both treatments. [ABSTRACT FROM AUTHOR]

The article discusses research which investigated use of paclitaxel-coated angioplasty balloons in treating patients with femoropopliteal peripheral artery disease. Topics explored include the compliance of this study to U.S. Food and Drug Administration (FDA) protocols, the patient selection and treatment process, and a comparison between paclitaxel-coated angioplasty balloons and standard angioplasty balloons in terms of safety.

Patients with atrial fibrillation (AF) who underwent percutaneous coronary intervention (PCI) are at elevated risk for bleeding and thromboembolic ischemic events. Currently, guidelines on antithrombotic treatment for these patients are based on weak consensus. We describe patterns and determinants of antithrombotic prescriptions in this population. The Antithrombotic Strategy Variability in Atrial Fibrillation and Obstructive Coronary Disease Revascularized with PCI Registry was an international observational study of 859 consecutive patients with AF who underwent PCI from 2009 to 2011. Patients were stratified by treatment at discharge with either dual antiplatelet therapy (DAPT; aspirin plus clopidogrel) or triple therapy (TT; warfarin plus DAPT). Bleeding and thromboembolism risks were assessed by the HAS-BLED and CHADS2 scores, respectively, and predictors of TT prescription at discharge were identified. Major adverse cardiovascular events and clinically relevant bleeding (Bleeding Academic Research Consortium score ≥2) at 1-year follow-up were compared across antithrombotic regimens. Compared with patients on DAPT (n = 488; 57%), those given TT (n = 371; 43%) were older, with higher CHADS2 scores, lower left ventricular ejection fraction, and more often had permanent AF, single-vessel coronary artery disease, and bare-metal stents. In multivariate analysis, increasing thromboembolic risk (CHADS2) was associated with a higher rate of TT prescription at discharge (intermediate vs low CHADS2: odds ratio 2.2, 95% confidence interval [CI] 2.0 to 3.3, p <0.01; high vs low CHADS2: odds ratio 1.6, 95% CI 2.6 to 4.3, p <0.01 for TT). However, there was no significant association between bleeding risk and TT prescription in the overall cohort or within each CHADS2 risk stratum. The rates of major adverse cardiovascular events were similar for patients discharged on TT or DAPT (20% vs 17%, adjusted hazard ratio 0.8, 95% CI 0.5 to 1.1, p = 0.19), whereas the rate of Bleeding Academic Research Consortium ≥2 bleeding was higher in patients discharged on TT (11.5% vs 6.4%, adjusted hazard ratio 1.8, 95% CI 1.1 to 2.9, p = 0.02). In conclusion, the choice of the intensity of antithrombotic therapy correlated more closely with the risk of ischemic rather than bleeding events in this cohort of patients with AF who underwent PCI. [ABSTRACT FROM AUTHOR]

Bleeding complications after percutaneous coronary intervention (PCI) have been associated with higher short and long-term mortality. Bivalirudin has been shown to reduce bleeding complications in patients who underwent PCI; however, the impact of anemia on bleeding complications and long-term mortality has not been studied. A total of 11,991 patients who underwent PCI over a period of 8 years with bivalirudin as the primary antithrombotic agent were included. Anemia was defined according to the World Health Organization definition. Bleeding complications were prospectively collected. Survival analysis was performed using multivariable Cox proportional hazards models. Of the 11,991 patients, 4,815 patients (40%) had baseline anemia. Major bleeding occurred in 3.3% of patients with anemia compared with 0.7% of patients without anemia (p <0.001) driven largely by transfusion events. In the overall study population, major bleeding was a significant predictor of mortality (hazard ratio [HR] 1.4, 95% confidence interval [CI] 1.04 to 1.8, p = 0.027) at a mean follow-up of 2.6 years (interquartile range 1.4 to 3.5). In patients with anemia, major bleeding remained an independent predictor of mortality (HR 1.5, 95% CI 1.1 to 2.0, p [ 0.008); however, in patients without anemia, it did not (HR 1.25, 95% CI 0.52 to 3.03, p [ 0.62). In patients who underwent PCI with bivalirudin therapy, major bleeding is associated with early and long-term mortality, which is more pronounced in patients with baseline anemia. [ABSTRACT FROM AUTHOR]

High-density lipoprotein (HDL) cholesterol level is a strong predictor of morbidity and mortality in the general population. Conflicting data exist on the protective effects of high HDL cholesterol in patients with optimal low-density lipoprotein (LDL) cholesterol levels. To determine the association of high HDL cholesterol with mortality in patients with LDL cholesterol levels <70 mg/dl who undergo percutaneous coronary intervention, 3,616 consecutive patients with LDL cholesterol levels <70 mg/dl who underwent percutaneous coronary intervention from July 1, 1999, to June 1, 2007, were retrospectively analyzed and followed through July 1, 2007. All-cause mortality was identified using the National Death Index. The mortality rates was 34.7, 25.2, 23.7, and 18.8 per 1,000 person-years in patients with HDL cholesterol levels of <40, 40 to 49, 50 to 59, and ≥60 mg/dl, respectively (p for trend <0.001). After multivariate adjustment for demographic characteristics, cigarette smoking, biochemical variables, and co-morbid conditions, the hazard ratios for mortality in patients with HDL cholesterol levels of 40 to 49, 50 to 59, and ≥60 mg/dl, compared with their counterparts with HDL cholesterol levels <40 mg/dl, were 0.68 (95% confidence interval [CI] 0.50 to 0.93), 0.55 (95% CI 0.35 to 0.85), and 0.45 (95% CI 0.27 to 0.74), respectively. For each 1-SD increase in HDL cholesterol level (14 mg/dl), the multivariate-adjusted hazard ratio for all-cause mortality was 0.68 (95% CI 0.58 to 0.79). In conclusion, in patients with LDL cholesterol levels <70 mg/dl who underwent percutaneous coronary intervention, a strong inverse association was present between HDL cholesterol level and all-cause mortality. [Copyright &y& Elsevier]