Quantitative flow ratio computed from invasive coronary angiography as a predictor for cardiac allograft vasculopathy after cardiac transplant.

Cardiac allograft vasculopathy (CAV) is a significant determinant of long-term survival in heart transplant recipients. Standard CAV screening typically utilizes invasive coronary angiography (ICA). Quantitative flow ratio (QFR) is a computational method for functional testing of coronary stenosis, and may add diagnostic value to ICA in assessing CAV. Consecutive subjects who received heart transplantation and underwent two separate routine coronary angiograms between January 2013 and April 2016 were enrolled. Coronary angiograms and IVUS were performed per local protocol at 1, 2, 3 and 5 years post-transplant. QFR was calculated offline. CAV was assessed semi-quantitively based on coronary angiogram results. Twenty-two patients were enrolled. Mean time from transplant to first included ICA was 2.1 years. QFR in at least 1 coronary vessel was interpretable in 19/22 (86%) of initial ICA (QFR1). QFR1 correlated well with the CAV score derived from the second ICA (CAV2) with a clustering of CAV at lower QFR values. In a receiver-operating characteristic (ROC) analysis, an optimal QFR threshold of 0.88 yielded 0.94 sensitivity and 0.67 specificity (AUC of 0.79) for at least non-obstructive subsequent CAV. Initial angiographically and intravascular ultrasound derived CAV severity poorly predicted subsequent CAV severity. QFR derived from invasive coronary angiography predicts subsequent development of CAV more accurately than angiography and intravascular ultrasound. This novel method of coronary flow assessment in recipients of heart transplantation may be useful to diagnose and predict subsequent CAV development.

Relation of Sex and Race to Outcomes in Patients Undergoing Percutaneous Intervention With Drug-Eluting Stents.

Cardiovascular disease is the leading cause of death in men and women, black and white. However, there exists limited outcomes data for women and blacks after percutaneous coronary intervention (PCI). The aim of this study was to evaluate the 1-year major cardiovascular events in patients who underwent PCI based on gender and race. We retrospectively analyzed data that were prospectively collected over 13 years at a large tertiary hospital in the United States. There were 12,050 patients who underwent PCI for both stable disease and acute coronary syndrome from 2003 to 2016. Of those, 1,952 were black men, 6,013 white men, 1,619 black women, and 2,466 white women. Major cardiovascular events at 1 year were assessed, and proportional Cox hazard model analyses were performed to assess outcome adjusted for confounding factors (i.e., age, body mass index, presentation with acute myocardial infarction, diabetes, smoking, history of coronary artery disease, family history of coronary artery disease, hyperlipidemia, hypertension, previous cardiovascular intervention, and chronic kidney disease). At 1 year, white men had significantly lower major cardiovascular events driven by lower rate of death compared with the other groups. Adjusted for confounders, major cardiovascular events were 1.3 to 1.5 times more likely to occur in black men and women and white women than in white men. There was a significant race by gender interaction (p <0.001).

Coronary perfusion pressure and left ventricular hemodynamics as predictors of cardiovascular collapse following percutaneous coronary intervention.

BACKGROUND/PURPOSE: Appropriate patient selection for mechanical circulatory support following percutaneous coronary intervention (PCI) remains a challenge. This study aims to evaluate the role of coronary perfusion pressure and other left ventricular hemodynamics to predict cardiovascular collapse following PCI. METHODS/MATERIALS: We retrospectively analyzed all patients who underwent PCI for acute coronary syndrome (ACS) from 2003 to 2016. Coronary perfusion pressure was calculated for each patient and defined as the difference in mean arterial pressure and left ventricular end diastolic pressure (LVEDP). Logistic regression analysis was performed to determine predictor of composite outcome of in-hospital mortality, myocardial infarction (MI), congestive heart failure (CHF), and cardiogenic shock. RESULTS: Nine hundred twenty-two patients were analyzed. Two-hundred twenty-eight (25%) presented with ST-elevation MI (STEMI) while 694 (75%) underwent PCI for unstable angina or non-Q-wave MI. The mean LVEDP was significantly higher in the STEMI patients (24 ±â€¯9 vs. 19 ±â€¯8 mm Hg, p < 0.05) and perfusion pressure significantly lower (68 ±â€¯24 vs. 74 ±â€¯18 mm Hg, p < 0.05). Eighty-seven (9.4%) reached the composite endpoint, and there was no difference between the STEMI and Not-STEMI groups. Neither LVEDP nor coronary perfusion pressure was a predictor of the composite outcome following multivariable logistic regression analysis for either STEMI or Not-STEMI patients. Increasing age, chronic renal insufficiency (CRI), CHF, and low left ventricular ejection fraction were predictors of the composite outcome for Not-STEMI patients, whereas only history of cerebrovascular accident and CRI were predictors for STEMI patients. CONCLUSIONS: In hemodynamically stable patients presenting with ACS, LVEDP and coronary perfusion pressure are not predictive of in-hospital cardiovascular collapse. SUMMARY: The authors retrospectively analyzed 922 patients from a single center who underwent percutaneous coronary intervention (PCI) for acute coronary syndromes to evaluate the role of coronary perfusion pressure and other left ventricular hemodynamics to predict cardiovascular collapse following PCI. They found that neither coronary perfusion pressure nor left ventricular end diastolic pressure was predictive of in-hospital cardiovascular collapse.

In-Stent Restenosis of Drug-Eluting Stents Compared With a Matched Group of Patients With De Novo Coronary Artery Stenosis.

Drug-eluting stents (DES) significantly reduced the incidence of in-stent restenosis (ISR). However, ISR still exists in the contemporary DES era. Previously deemed to be a benign process, ISR leads to complex presentation and intervention. This study aimed to compare the presentation and outcome of DES-ISR versus de novo lesions. We performed a retrospective analysis of 11,666 patients receiving percutaneous coronary intervention from 2003 to 2017 and divided them into 2 groups by de novo stenosis and ISR. They were matched based on common cardiovascular risk factors at a 4:1 ratio, respectively. After matching, a total of 1,888 patients with 3,126 de novo lesions and 472 patients with 508 ISR lesions were analyzed. Patients with ISR presented more often with unstable angina (61% vs 45%, p <0.001) and less often with myocardial infarction (6% vs 14%, p <0.001). One-year composite major adverse cardiovascular event, defined as death, Q-wave myocardial infarction, and target vessel revascularization, was 10% in the de novo group and 17% in the ISR group (hazard ratio 1.98, 95% confidential interval 1.58 to 2.46, p <0.001). After adjusting for myocardial infarction presentation, hazard ratio of major adverse cardiovascular events was still higher for the ISR group at 1 year (2.03, 95% confidential interval 1.62 to 2.55, p <0.001). ISR of DES remains a therapeutic challenge and leads to complex presentation and worse outcomes compared with matched de novo patients. These data show that DES-ISR demands better appreciation and prevention with more precise stent technique and should motivate the continued development of fully bioresorbable scaffolds.

Comparison of transradial and transfemoral access in patients undergoing percutaneous coronary intervention for complex coronary lesions.

OBJECTIVE: Comparison of transradial versus transfemoral access for complex percutaneous coronary intervention (PCI) with regard to both complications and long-term outcomes. BACKGROUND: Radial access has been shown to confer superior results in patients undergoing PCI, especially in patients with acute coronary syndromes. However, radial access has limitations of sheath and device size, which may increase procedure time and result in inferior outcomes. METHODS: Patients undergoing PCI for complex lesions, defined as type C according the ACC/AHA classification system, were included in this study. Propensity matching was performed to adjust for differences in baseline characteristics. Transradial patients were then compared to transfemoral patients in regard to procedural, in-hospital, and 6-month outcomes. RESULTS: Among 2142 patients with 2591 lesions treated, 1876 had femoral access and 267 had radial access. Radial access patients were more likely to be male (75% vs. 66%, P = 0.003) and less likely to present with acute myocardial infarction (27% vs. 42%, P < 0.001). Procedural characteristics demonstrated lower use of heparin in the femoral group (17% vs. 73%, P < 0.001) with similarly low use of glycoprotein inhibitors (5.6% vs. 3.4%, P = 0.14). Patients in the femoral group had higher rates of transfusions (3.7% vs. 0%, P = 0.004) and vascular complications (1.7% vs. 0%, P = 0.03). Following propensity matching, there was no difference in mid-term outcomes between radial and femoral groups. CONCLUSIONS: In patients with complex coronary lesions undergoing PCI, the radial approach demonstrates similar mid-term outcomes as the femoral approach with a potentially lower rate of complications. © 2016 Wiley Periodicals, Inc.

Frequency of Angina Pectoris After Percutaneous Coronary Intervention and the Effect of Metallic Stent Type.

Although metallic coronary stents significantly reduce angina pectoris compared with optimal medical therapy, angina after percutaneous coronary intervention (PCI) remains frequent. We, therefore, sought to compare the incidence of any angina during the 1 year after PCI among the spectrum of commercially available metallic stents. Metallic stent type was classified as bare metal stent, Cypher, Taxus Express, Xience V, Promus Element, and Resolute. The primary end point was patient-reported angina within 1 year of PCI. Multivariable logistic regression was performed to assess the independent association of stent type with any angina at 1 year. Overall, 8,804 patients were queried in regard to angina symptoms; 32.3% experienced angina at some point in the first year after PCI. Major adverse cardiovascular events, a composite of all-cause mortality, target vessel revascularization, and Q-wave myocardial infarction, increased with angina severity: 6.8% for patients without angina, 10.0% for patients with class 1 or 2 angina, and 19.7% for patients with class 3 or 4 angina (p <0.001 for trend). After multivariable adjustment, there was no significant association between stent type and angina at 1 year after PCI. Baseline Canadian Cardiovascular Society class 3 or 4 angina, history of coronary artery bypass grafting, and history of PCI were associated with a higher likelihood of angina at 1 year; increasing age, male gender, presentation with acute coronary syndrome, and higher stented length were associated with less angina. In conclusion, metallic stent type is not associated with the occurrence of angina at up to 1 year after PCI.

The influence of lipid-containing plaque composition assessed by near-infrared spectroscopy on coronary lesion remodelling.

AIMS: Vessel remodelling is commonly observed in coronary atherosclerosis, but factors influencing remodelling, such as plaque lipid content, remain poorly described. METHODS AND RESULTS: Remodelling index (RI) was calculated as the ratio of lesion to proximal and distal references external membrane area and was categorized as follows: positive (PR; RI > 1.05), intermediate (IR; RI 0.95-1.05), and negative remodelling (NR; RI < 0.95). RI was studied by near-infrared spectroscopy (NIRS) as a function of lipid content metrics, including the maximal 4 mm lipid core burden index of the segment (maxLCBI4 mm) and intravascular ultrasound (IVUS) lesion plaque burden (PB). The authors further stratified the analysis according to obstructive (≥50%) and non-obstructive (<50%) lesions using quantitative coronary angiography. Receiver-operating characteristic curves were performed to describe the maxLCBI4 mm level associated with PR. From May 2012 to November 2014, 100 de novo lesions from 67 patients underwent simultaneous NIRS-IVUS. PR was found in 28% of the lesions. There was a positive linear correlation between RI and maxLCBI4 mm (ρ = 0.58; P < 0.001). Although PR lesions had a larger PB than NR or IR (P < 0.001), the correlation of RI with maxLCBI4 mm was stronger compared with plaque volume (ρ = 0.18; P = 0.07) and with per cent PB (ρ = 0.41; P < 0.001). This relationship remained significant for obstructive (ρ = 0.72; P < 0.001) and non-obstructive lesions (ρ = 0.48; P < 0.001). By receiver-operating characteristic curve analysis, values of maxLCBI4 mm ≥ 439 were predictive for PR (area under the curve = 0.79, 95% confidence interval: 0.69-0.89). CONCLUSION: In vivo coronary lesion remodelling is positively correlated with lipid plaque content assessed by NIRS rather than simply PB. Thus, the use of NIRS can potentially aid in further stratifying vulnerable lesions.

Contemporary Use of Veno-Arterial Extracorporeal Membrane Oxygenation for Refractory Cardiogenic Shock in Acute Coronary Syndrome.

BACKGROUND: Refractory cardiogenic shock (RCS) in acute myocardial infarction (AMI) is associated with high rates of mortality. Smaller ventricular assist devices, such as the intraaortic balloon pump, provide limited support. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) offers more robust mechanical ventricular support, but is not widely utilized by interventional cardiologists. This study aimed to evaluate the patient characteristics and outcomes of VA-ECMO with RCS in the setting of AMI. METHODS AND RESULTS: A retrospective chart review of all VA-ECMO cannulations between 2009 and 2014 was performed, and patients with an indication of RCS in AMI were identified. A total of 15 patients underwent VA-ECMO placement for AMI with RCS. One-third of these patients presented with out-of-hospital cardiac arrest, and 60% had ST-elevation myocardial infarction. The Intraaortic balloon pump was placed in addition to VA-ECMO in 60% of patients. Median duration of VA-ECMO support was 45 hours. Successful wean off VA-ECMO was obtained in 50% of the patients, and vascular complications occurred in 53% of patients. The survival rate at discharge was 47%, and all survivors were alive at 30 days post discharge. CONCLUSION: VA-ECMO is infrequently used in patients for cardiopulmonary resuscitation in the AMI setting. When used judiciously, it has good clinical outcomes in this group of patients. However, use of VA-ECMO should be individualized based on vascular anatomy for best results. Close cooperation among interventional cardiologists, cardiovascular surgeons, cardiologists, cardiac intensivists, and perfusionists is essential for success of this therapy for RCS in AMI.

The influence of advancing age on implantation of drug-eluting stents.

BACKGROUND: The influence of age upon the use of drug-eluting stents (DES) in patients aged ≥ 65 years is uncertain. The aim of this study is to investigate the impact of age increase in patients aged ≥ 65 years in the use of DES in patients undergoing percutaneous coronary intervention (PCI). METHOD: The study cohort comprised 8,598 patients ≥ 65 years of age who underwent stent implantation from April 2003 to March 2014. We defined the first DES era as the period April 2003 to July 2008 and the second DES era as the period July 2008 to March 2014. Multivariable logistic regression was performed for both eras to assess the impact of age increase and analyze independent factors associated with DES implantation. RESULTS: In the first DES era cohort, the two groups of patients differed in their risk factor profile with lower rates of male sex, diabetes, smokers, and hypercholesterolemia in those aged ≥ 75 years. There were more Caucasian and less African-Americans in this age group. Furthermore, patients aged ≥ 75 years had lower left ventricular ejection fraction (LVEF) and baseline haematocrit concentration were more likely to present with an acute myocardial infarction (MI) than stable or unstable angina and had higher rates of a previous history for congestive heart failure (CHF), chronic renal insufficiency (CRI), and peripheral vascular disease (PVD). These differences were broadly similar for patients in the second DES era except for similarities in LVEF, presentation with unstable angina, and PVD, as well as a lower rate for previous PCI. DES use was reduced with increasing age in both the first (OR=0.78; 95% CI=0.69-0.89) and second DES era (OR=0.53; 95% CI=0.47-0.58). In both eras, DES use was less likely in current smokers, patients presenting with acute MI and cardiogenic shock, and those with a previous history of CHF. CONCLUSION: In patients aged ≥ 65 years, the use of DES decreased with increasing age. This observation was apparent in both the first and second DES era. © 2015 Wiley Periodicals, Inc.

Comparison of clinical outcomes in patients presenting with an acute coronary syndrome due to stent thrombosis or saphenous vein graft occlusion and undergoing percutaneous coronary intervention.

OBJECTIVE: To compare the clinical outcomes of patients undergoing percutaneous intervention for stent thrombosis (ST) or saphenous vein graft (SVG) occlusion. BACKGROUND: Patients presenting with ST or SVG occlusion are at increased risk of adverse outcomes. There is limited literature comparing the outcome of such patients. METHODS: A cohort of 415 consecutive patients presenting to the MedStar Washington Hospital Center undergoing percutaneous coronary intervention (PCI) for an acute coronary syndrome secondary to ST (n=136) or SVG occlusion (n=279) was studied. The SVG group was subdivided into patients who underwent PCI in the occluded SVG (SVG-PCI: n=75) or in the subtended native coronary artery (NC-PCI: n=204). The analyzed clinical parameters were in-hospital complications as well as 30-day and 1-year major adverse cardiac events (MACE). MACE was defined as all-cause mortality, Q-wave myocardial infarction, or target vessel revascularization. RESULTS: The rates of death, major bleeding, and length of hospital stay were significantly different between the ST and NC-PCI groups. The SVG-PCI group had a shorter hospital stay. The 30-day MACE rate was significantly different in the ST and NC-PCI groups (18.9% vs. 7.5%; risk ratio=0.40, 95% CI=0.20-0.81, p=0.03) but not in the ST and SVG-PCI groups (18.9% vs. 15.1%; p=0.55, risk ratio=0.80, 95% CI=0.38-1.68). There were no differences in the 1-year MACE rate. CONCLUSIONS: As compared to patients undergoing NC-PCI, patients with ST have greater rates of in-hospital mortality and major bleeding as well as 30-day MACE rate. The 1-year MACE rate is similar in patients with ST and SVG occlusion who undergo PCI.

The effect of complete percutaneous revascularisation with and without intravascular ultrasound guidance in the drugeluting stent era.

AIMS: Our aim was to compare the outcomes of complete revascularisation (CR) and incomplete revascularisation (IR) in multivessel coronary artery disease (CAD), with and without intravascular ultrasound (IVUS) guidance, in the drug-eluting stent (DES) era. METHODS AND RESULTS: Overall, 2,132 consecutive patients with multivessel CAD, defined as at least two epicardial vessels with >70% stenosis, had at least one DES implant. Chronic total occlusions were not analysed. Successful treatment of epicardial vessels and significant branches was termed CR; otherwise, treatment was defined as IR. CR and IR were further categorised according to the use of IVUS. The primary outcome was death or Q-wave myocardial infarction (QWMI). Secondary outcomes included the rates of non-QWMI and repeat revascularisation, the latter assessed as either target vessel revascularisation (TVR) or target lesion revascularisation (TLR) at one year. CR was associated with lower rates of death/QWMI (HR 0.66 [0.4-0.9]; p=0.048) and non-QWMI at one year (1.1% vs. 2.6%; p=0.017). Completeness of revascularisation was not independently associated with repeat intervention, but rates of both TVR (89% vs. 93%; p<0.001) and TLR (91% vs. 95%; p<0.001) were higher with CR than IR. IVUS decreased the rates of TLR irrespective of completeness of revascularisation (p-interaction=0.75). CONCLUSIONS: CR in selected patients gives better outcomes than IR in multivessel CAD at one year. IVUS guidance can further improve results by reducing rates of repeat intervention irrespective of completeness of revascularisation.

Comparison of Rotational Atherectomy, Plain Old Balloon Angioplasty, and Cutting-Balloon Angioplasty Prior to Drug-Eluting Stent Implantation for the Treatment of Heavily Calcified Coronary Lesions.

BACKGROUND: The optimal technique for lesion preparation in heavily calcified coronary lesions (HCCL) prior to drug-eluting stent (DES) implantation has not been described. The aim of this study was to compare the clinical outcomes of lesion preparation with rotational atherectomy (ROTA), plain old balloon angioplasty (POBA), or cutting-balloon angioplasty (CBA) in patients with HCCL who were treated with DES. METHODS: The study cohort comprised 737 consecutive patients (874 lesions) who underwent RA (n = 264), POBA (n = 220), or CBA (n = 253) for HCCL at our institution and were treated with DES. Patients with mild or moderate calcified lesions, restenotic lesions, treatment with bare-metal stent (BMS), or history of prior coronary artery bypass graft (CABG) were excluded. The analyzed clinical parameters were the 1-month, 6-month, and 12-month rates of death (all-cause and cardiac), Q-wave myocardial infarction (MI), target-lesion revascularization (TLR), definite stent thrombosis (ST), and major adverse cardiac event (MACE), defined as the composite of death, Q-wave MI, or TLR. RESULTS: The patients were well matched for their baseline characteristics except for age (RA = 71.9 ± 10.4 years; POBA = 68.0 ± 10.8 years; CBA = 68.7 ± 11.8 years; P<.001) and hypertension (RA = 90.9%; POBA = 80.9%; CBA = 84.2%; P=.01), which were different among the three cohorts. The three cohorts had similar clinical outcomes at both short-term and long-term follow-up. The 12-month results were all-cause death (RA = 9.8%; POBA = 8.2%; CBA = 4.5%; P=.18), cardiac death (RA = 3.1%; POBA = 2.5%; CBA = 1.3%; P=.61), Q-wave MI (RA = 0%; POBA = 0%; CBA = 0.7%; P>.99), TLR (RA = 5.2%; POBA = 3.5%; CBA = 3.9%; P=.76), ST (RA = 0%; POBA = 0%; CBA = 0.6%; P=.63) and MACE (RA = 14.6%; POBA = 12.3%; CBA = 8.3%; P=.20). The 1-year MACE-free survival rates were also similar among the three cohorts (log-rank P=.20). CONCLUSION: A strategy of lesion preparation with RA, POBA, or CBA in HCCL may be associated with similar clinical outcomes in patients undergoing percutaneous intervention with DES. The RA group had a trend toward greater MACE, death, and TLR.

Comparison of Bleeding Outcomes After Percutaneous Coronary Intervention in Patients With Versus Without Aortic Stenosis.

Aortic stenosis (AS) is associated with an increased risk of bleeding, but little is known about the risk of bleeding during percutaneous coronary intervention (PCI) in patients with AS. In the era of transcutaneous aortic valve implantation, understanding the bleeding risks associated with AS is critical. This retrospective study included 7,926 patients who underwent PCI from 2004 to 2013. Patients were categorized according to the presence of significant AS: moderate or severe AS (n = 354) and mild or no AS (n = 7,572). The National Cardiovascular Data Registry (NCDR) definition of a bleeding event (transfusion, prolonged hospital stay, or decrease in hemoglobin >3.0 mg/dl) was used as the primary outcome, and the NCDR PCI Bleeding Risk Score was used to control for the underlying risk of bleeding because of baseline characteristics. Patients with AS had significantly higher NCDR PCI Bleeding Risk Scores and higher rates of bleeding events. Logistic regression showed that the NCDR PCI Bleeding Risk Score did predict bleeding outcomes. There was not, however, an independent association between AS and bleeding outcomes. The addition of AS to the risk score using net reclassification improvement did not enhance the model's ability to predict bleeding (p = 0.71). These data suggest that the NCDR PCI Bleeding Risk Score appropriately adjusts for bleeding risks in patients with AS. In conclusion, although patients with AS are more likely to have bleeding complications after PCI, the increased risk of bleeding is driven by the patients' baseline co-morbidities rather than their AS.

Role of near-infrared spectroscopy in intravascular coronary imaging.

Near-infrared spectroscopy is an intracoronary imaging modality that has been validated in preclinical and clinical studies to help quantify the lipid content of the coronary plaque and provide information regarding its vulnerability. It has the potential to develop into a valuable tool for the risk stratification of a vulnerable plaque and, furthermore, a vulnerable patient. In addition, in the future this technology may help in the development of novel therapies that impact vascular biology.

Reversal of pulmonary hypertension after percutaneous closure of congenital renal arteriovenous fistula in a 74-year old woman.

We report the case of a large right renal arteriovenous fistula (AVF) in a 74-year old woman who presented with heart failure. Transthoracic echocardiography revealed normal left ventricular size and systolic function (ejection fraction 60-65%), moderately dilated right ventricle with severely depressed systolic function, and severe pulmonary hypertension. Right heart catheterization confirmed the elevated pulmonary pressures and showed a high cardiac output. Physical examination was remarkable for a right flank bruit. An abdominal ultrasound revealed an AVF originating from the distal right renal artery and dilated suprarenal inferior vena cava and hepatic veins. These findings were confirmed with an abdominal MRI. Percutaneous endovascular closure of the right renal AVF was successfully performed, with immediate reduction of pulmonary pressures and normalization of cardiac output. The patient's symptoms improved, and a post intervention echocardiogram revealed normalization of right ventricular size.

Clinical impact of second-generation everolimus-eluting stents compared with first-generation drug-eluting stents in diabetic patients undergoing multivessel percutaneous coronary intervention.

OBJECTIVES: This study aimed to evaluate the safety and efficacy of everolimus-eluting stent (EES) use compared with first-generation drug-eluting stent (DES) use in diabetic patients undergoing multivessel percutaneous coronary intervention (PCI). BACKGROUND: Although the benefits of EES over first-generation DES were demonstrated for the general population, there is a paucity of data in diabetic patients with multivessel disease. METHODS: The retrospective study cohort included 429 consecutive diabetic patients who underwent native multivessel PCI, defined as ≥2 same-generation DESs in ≥2 different native vessel territories during the index procedure. The primary safety endpoint was the combined incidence of death, non-fatal Q-wave myocardial infarction, and definite stent thrombosis (ST) at 1 year. RESULTS: At 1 year, the primary safety endpoint was reached in 2.9% of the patients in the EES group, which was significantly lower than the 9.3% noted with first-generation DES (P=.03). The occurrence of definite or probable ST was lower in the EES group (0% vs. 3.7%; P=.04). Similarly, there was a trend toward lower all-cause mortality (2.9% vs. 8.5%; P=.05) and cardiac death (1% vs. 4.9%; P=.08) in the EES group. However, there were no significant differences in the rates of target lesion revascularization (12.6% vs. 9.3%; P=.33) between groups. In a multivariate model, EES was independently associated with a lower risk of composite primary endpoint compared with first-generation DES (hazard ratio, 0.28; 95% confidence interval, 0.09-0.94). CONCLUSION: In diabetic patients undergoing native multivessel PCI, the use of EES was associated with superior 1-year safety as compared with use of first-generation DES.

Safety and efficacy of everolimus-eluting stents for bare-metal in-stent restenosis.

OBJECTIVE: The aim of this study was to compare the safety and efficacy of the everolimus-eluting stents (EES) with the paclitaxel-eluting stent (PES) and sirolimus-eluting stent (SES) for the treatment of bare-metal in-stent restenosis. BACKGROUND: The optimal treatment for bare-metal in-stent restenosis remains controversial. METHODS: The study cohort comprised 322 consecutive patients (543 lesions) who presented with bare-metal in-stent restenosis to our institution and underwent coronary artery stent implantation with EES (114 patients; 181 lesions), PES (65 patients; 116 lesions) and SES (143 patients; 246 lesions). The analyzed clinical parameters were the 1-year rates of death, Q-wave myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), definite stent thrombosis (ST) and major adverse cardiac events (MACE) defined as the composite of death, MI, or TLR at 1-year. RESULTS: The three groups were well matched for the conventional risk factors except for age and chronic kidney disease. The 1-year analyzed clinical parameters were similar in the three groups: death (EES=3.5%, PES=4.6%, SES=4.2%; p=0.94), MI (EES=3.5%, PES=6.3%, SES=2.1%; p=0.31), TLR (EES=9.8%, PES=9.5%, SES=5.7%; p=0.42), TVR (EES=14.3%, PES=11.1%, SES=11.3%; p=0.74), definite ST (EES=0.9%, PES=3.1%, SES=3.5%; p=0.38) and MACE (EES=14.0%, PES=15.4%, SES=10.5%; p=0.54). Male gender (hazard ratio=0.47; 95% confidence interval=0.25-0.88) and number of treated lesions (hazard ratio=1.47; 95% confidence interval=1.06-2.05) were found to be independent predictors of MACE. CONCLUSION: The results of the present study indicate that EES may provide similar safety and efficacy as first generation DES for the treatment of patients presenting with bare-metal in-stent restenosis.

Clinical outcomes of first- and second-generation drug-eluting stents in patients undergoing rotational atherectomy for heavily calcified coronary lesions.

BACKGROUND: There is paucity of data regarding the clinical outcome of second generation drug- eluting stents (DES) post rotational atherectomy (RA) for heavily calcified coronary lesions (HCCL). METHODOLOGY: The study cohort comprised 99 (116 lesions) consecutive patients who underwent RA for HCCL at our institution and received either a first generation DES (40 patients, 53 lesions) or a second generation DES (59 patients, 63 lesions). The analyzed clinical parameters were the 12-month rates of death (all cause and cardiac), Q-wave MI, target lesion revascularization (TLR), definite stent thrombosis (ST) and major adverse cardiac events (MACE) defined as the composite of death, Q-wave MI, or TLR. RESULTS: The two groups were well matched for their baseline characteristics except for a lower left ventricular ejection fraction in the second generation DES group (46.0±23.0% vs. 55.0±9.0%; p=0.02). The group receiving second generation DES had more type C lesions (81.0% vs. 58.8%; p=0.01), shorter stent length (19.9±6.1 mm vs. 22.7±7.3 mm; p=0.04) and was more likely to undergo stent postdilatation (52.4% vs. 23.1%; p=0.001). The 1-year analyzed clinical parameters were similar in the two groups: all cause death (8.5% vs. 10.3%; p=1.0), cardiac death (8.5% vs. 2.5%; p=0.40), Q-wave MI (0% vs. 0%), TLR (3.6% vs. 2.7%; p=1.0), ST (0% vs. 0%), and MACE (11.9% vs. 12.8%; p=1.0). The 1-year MACE-free survival rate was also similar in the two cohorts. CONCLUSION: The use of second generation DES, following RA for HCCL, is associated with similar short and long-term clinical outcomes to first generation DES.

Safety and efficacy of limus-eluting stents and balloon angioplasty for sirolimus-eluting in-stent restenosis.

OBJECTIVES: The aim of this study was to compare the safety and efficacy of everolimus-eluting stent (EES), sirolimus-eluting stent (SES), and plain old balloon angioplasty (POBA) for the treatment of SES in-stent restenosis (S-ISR). BACKGROUND: The optimal treatment for drug-eluting in-stent restenosis remains controversial. METHODS: The study cohort comprised 310 consecutive patients (444 lesions) who presented with S-ISR to our institution and underwent treatment with EES (43 patients), SES (102), or POBA (165). The analyzed clinical parameters were the 1-year rates of death, Q-wave myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), definite stent thrombosis (ST) and major adverse cardiac event (MACE) defined as the composite of death, MI, or TLR at 1-year. RESULTS: The three groups were well matched for the conventional risk factors for coronary artery disease except for smoking. The 1-year analyzed clinical parameters were similar in the three groups: MACE (EES=14%, SES=18%, POBA=20%; p=0.65), death (EES=2.3%, SES=6.2%, POBA=6.1%; p=0.61), MI (EES=4.8%, SES=2.1%, POBA=2.5%; p=0.69), TLR (EES=11.9%, SES=12.1%, POBA=24%; p=0.78), and TVR (EES=11.9%, SES=24.8%, POBA=22.2%; p=0.23). There were no cases of definite ST. MACE-free rate was significantly lower in patients with recurrent in-stent restenosis (log-rank p=0.006). Presentation with acute MI, number of treated lesions and a previous history of MI were found to be independent predictors of MACE. CONCLUSIONS: In patients presenting with S-ISR, treatment with implantation of an EES, SES, or POBA is associated with similar clinical outcomes. Patients presenting with recurrent ISR may have a poorer clinical outcome.