Efficacy and safety of bivalirudin in patients receiving clopidogrel therapy after diagnostic angiography for percutaneous coronary intervention in acute coronary syndromes

Objectives : This study sought to investigate if the efficacy of bivalirudin monotherapy is similar to heparin plus GP IIb/IIIa inhibition in patients with acute coronary syndromes (ACS) treated with clopidogrel following diagnostic angiography. Background : Prior trials have demonstrated that peri‐procedural bivalirudin therapy confers similar efficacy as heparin plus GP IIb/IIIa inhibitors, while lowering the risk of bleeding complications in ACS patients undergoing percutaneous coronary intervnetions (PCI). However, the incidence of adverse ischemic events post‐PCI appeared to be higher in patients receiving bivalirudin without adequate pretreatment with clopidogrel. Methods : Using the 2004/2005 Cornell Angioplasty Registry, we evaluated 980 consecutive patients undergoing urgent PCI for UA/NSTEMI who were treated with either bivalirudin or UFH plus GP IIb/IIIa inhibitor. We excluded patients who were on chronic clopidogrel therapy or received clopidogrel pretreatment prior to angiography. All patients received a clopidogrel load (≥300‐mg dose) immediately before or after the PCI. Long‐term all‐cause mortality was obtained for 100% of patients, with a mean follow‐up of 24.6 ± 7.7 months. Results : Of the 980 study patients, 461 (47.0%) were treated with bivalirudin and 519 (53.0%) patients received UFH plus GP IIb/IIIa inhibitor. DES were used in 88% of PCI; 45% of patients presented with NSTEMI. The incidence of in‐hospital death (0.4% vs. 0.2%, P = 0.604), post‐procedural MI (6.9% vs. 5.4%, P = 0.351), and MACE including death, stroke, emergent CABG/PCI, and MI (7.6% vs. 5.8%, P = 0.304) were similar in patients treated with bivalirudin versus UFH plus GP IIb/IIIa inhibitors, respectively. The incidence of in‐hospital stent thrombosis was similar (0.7% vs. 0%, P = 0.104), while major (0.9% vs. 2.9%, P = 0.034) and minor bleeding (10.4% vs. 18.9%, P < 0.001) was reduced in the bivalirudin‐treated group. By two‐years of follow‐up, after propensity‐score adjusted multivariate Cox regression analysis, there was no significant difference in long‐term mortality between the two groups (HR 1.18; 95%CI 0.64–2.19, P = 0.598). Conclusions : In patients presenting with ACS and receiving clopidogrel treatment after angiography (before or within 30 min of PCI), peri‐procedural bivalirudin monotherapy suppresses acute and long‐term adverse events to a similar extent as does UFH plus GP IIb/IIIa inhibitors, while significantly lowering the risk of bleeding complications. © 2010 Wiley‐Liss, Inc.     

Clinical outcomes associated with per‐operative discontinuation of aspirin in patients with coronary artery disease: A systematic review and meta‐analysis

Background: Postoperative state is characterized by increased thrombotic risk by virtue of platelet activation. Whether aspirin ameliorates this risk in patients with established coronary artery disease undergoing cardiac or noncardiac surgery is unknown. We conducted a systematic review and meta‐analysis to compare the risk of major adverse cardiac events (MACE) and the risk of bleeding in patients with early (3–5 or more days before surgery) vs. late discontinuation(<3–5 days)/no discontinuation of aspirin. Methods: Multiple databases were searched from inception of these databases until March 2015 to identify studies that reported discontinuation of aspirin in patients undergoing surgery. The outcomes measured were all cause mortality, nonfatal myocardial infarction and other relevant thrombotic events (MACE) which also may include, fatal and nonfatal MI, stent thrombosis and restenosis, stroke, perioperative cardiovascular complications (heart failure, MI, VTE, acute stroke) and perioperative bleeding during the perioperative period to up to 30 days after surgery. Results: A total of 1,018 titles were screened, after which six observational studies met the inclusion criteria. Our analysis suggests that there is no difference in MACE with planned discontinuation of aspirin (OR = 1.17, 95% CI = 0.76–1.81; P = 0.05; I² = 55%). Early discontinuation of aspirin showed a decreased risk of peri‐operative bleeding (OR 0.82, 95% CI = 0.67–0.99; P = 0.04; I² = 42%). Conclusion: Our analysis suggests that planned short‐term discontinuation in the appropriate clinical setting appears to be safe in the correct clinical setting with no increased risk of thrombotic events and with a decreased risk of bleeding. © 2016 Wiley Periodicals, Inc.     

Long term efficacy of abciximab bolus‐only compared to abciximab bolus and infusion after transradial coronary stenting

Background: No data are available on the long term efficacy of abciximab bolus‐only with aspirin and clopidogrel pretreatment and systematic coronary stenting. Our objective was to evaluate the 3‐year clinical outcomes in the EASY trial. Methods: After a bolus of abciximab (0.25 mg/kg) and uncomplicated transradial coronary stenting, 1,005 patients were randomized either to same‐day home discharge and no infusion (bolus‐only group, n = 504) or to overnight hospitalization and 12 hours abciximab infusion (bolus + infusion group, n = 501). In contrast, 343 patients were not randomized after stenting for safety reasons and received abciximab bolus and infusion (not‐randomized group). The rate of major adverse cardiovascular events (MACE), including death, myocardial infarction (MI) and target vessel revascularization (TVR) after percutaneous coronary intervention (PCI) was evaluated. Results: Up to 3 years, the incidence of MACE remained similar in the two randomized groups, 14% in bolus‐only vs. 17% in bolus + infusion (P = 0.38). Similar efficacy was observed in subgroups analysis including higher‐risk patients such as those with diabetes, unstable angina or non‐ST elevation MI. Conversely, the incidence of MACE remained significantly higher in patients not‐randomized post‐PCI at all time intervals (P < 0.0001). The difference in outcomes between randomized and not‐randomized patients was mostly accounted by the higher rates of MI, TVR as survival rate remained similar. Conclusion: In patients pretreated with aspirin and clopidogrel and undergoing uncomplicated coronary artery stenting, abciximab bolus‐only was associated with similar outcomes compared with bolus followed by infusion, up to 3 years after PCI. Conversely, patients with suboptimal results or clinical complications during PCI remained at higher risk of late revascularization or MI. © 2009 Wiley‐Liss, Inc.     

Comparison of 2‐year outcomes between zotarolimus‐eluting and everolimus‐eluting new‐generation cobalt–chromium alloy stents in real‐world diabetic patients

Background : To date, it remains unknown whether different types of new‐generation drug‐eluting stents have a differential impact on long‐term outcomes in diabetic patients. Methods and Results : In this historical cohort study (two Italian centers), we analyzed 400 diabetic patients with 553 coronary lesions treated with new‐generation CoCr zotarolimus‐eluting stents (R‐ZES: 136 patients, 196 lesions) or everolimus‐eluting stents (EES: 264 patients, 357 lesions) between October 2006 and August 2012. Primary endpoint was the occurrence of major adverse cardiac events (MACE) over a 2‐year follow‐up period. MACE was defined as all‐cause mortality, any myocardial infarction (MI) and/or target lesion revascularization (TLR). Multivessel revascularization, intervention for restenotic lesion and use of intravascular ultrasound were significantly higher in the R‐ZES group, whereas small stent (≤2.5 mm) deployment was significantly higher in the EES group. At 2‐year follow‐up, there was no significant difference in occurrence of MACE (R‐ZES vs EES: 22.8% vs 18.9%, P = 0.39). Similarly, no significant differences were observed in the composite endpoint of all‐cause mortality/MI (10.0% vs 10.3%, P = 0.86) or TLR (12.4% vs 7.4%, P = 0.11). Adjustment for confounders and baseline propensity‐score matching did not alter the aforementioned associations. Conclusion : After 2 years of follow up similar outcomes (MACE, all‐cause mortality/MI, TLR) were observed in real‐world diabetic patients, including those with complex lesions and patient characteristics, treated with R‐ZES and EES. © 2015 Wiley Periodicals, Inc.     

Elective Percutaneous Coronary Intervention: The Relationship between Preprocedural Blood Glucose Levels and Periprocedural Myocardial Injury

Regardless of the diabetic status of patients with coronary artery disease, hyperglycemia and hypoglycemia are adversely associated with cardiovascular events. The relationship between glucose levels and increased mortality risk in acute myocardial infarction has been shown through various glucose metrics; however, there is a dearth of multivariate analysis of the relationship between elective coronary angioplasty and preprocedural blood glucose levels.We evaluated the relationship between preprocedural blood glucose levels and myocardial injury in 1,012 consecutive patients who underwent elective percutaneous coronary angioplasty. The patients were classified into 4 glycemic groups on the basis of blood glucose levels measured immediately before the procedure: hypoglycemic, euglycemic, mildly hyperglycemic, and hyperglycemic. Samples for troponin I and creatine kinase–MB fraction were collected before each procedure and at 8, 16, and 24 hours after each procedure.Bivariate analysis revealed that postprocedural troponin I levels were significantly higher in the hyperglycemic group (P=0.027). Although postprocedural levels of creatine kinase–MB fraction rose insignificantly in the hypoglycemic patients, our results showed that these patients were more likely to have postprocedural levels 2 to 5 times the upper limit of normal (P=0.013). We tentatively conclude that abnormally low preprocedural plasma glucose levels—together with a recent history of smoking—are associated with an increased incidence of periprocedural myocardial injury in patients undergoing elective percutaneous coronary intervention.Key words: Biological markers/blood, blood glucose/analysis, coronary angioplasty/adverse effects, creatine kinase, MB form/blood, hyperglycemia/complications, hypoglycemia/complications, myocardial infarction, percutaneous coronary intervention/adverse effects, prospective studies, troponin I/bloodHyperglycemia and hypoglycemia are associated with cardiovascular events in patients with coronary artery disease (CAD), regardless of their diabetic status.¹ The relationship between glucose levels and increased mortality risk in cases of acute myocardial infarction (MI) has been established through various glucose metrics. Admission and fasting glucose levels are known predictors of unfavorable outcomes in association with ST-elevation myocardial infarction (STEMI).² In acute MI patients treated with primary percutaneous coronary intervention (PCI), there is a strong relationship between hyperglycemia and major adverse cardiac events (MACE) within 30 days of that treatment.³ Numerous studies have concluded that hyperglycemia is common in diabetic and nondiabetic patients with STEMI and is associated with a higher risk of death and in-hospital complications.^3,4 In patients with STEMI who are undergoing primary PCI, diabetes mellitus is independently correlated with decreased myocardial reperfusion, larger infarct size, development of congestive heart failure, and decreased length of survival.⁵ Some data suggest that myocardial ischemia is more likely to be allied with hypoglycemia than with euglycemia or hyperglycemia.⁶ Nonetheless, there is a paucity of multivariate analysis of the relationship between blood glucose levels at the time of elective PCI and the 30-day results of that procedure. Because it is not clear whether cardiac events are more likely to be associated with hyperglycemia or hypoglycemia than with euglycemia, we set out to evaluate the relationship between preprocedural blood glucose levels and myocardial injury in patients who have undergone PCI.     

Safety and efficacy of second‐generation drug‐eluting stents compared with bare‐metal stents: An updated meta‐analysis and regression of 9 randomized clinical trials

The efficacy of second‐generation drug‐eluting stents (DES; eg, everolimus and zotarolimus) compared with bare‐metal stents (BMS) in patients undergoing percutaneous coronary intervention was challenged recently by new evidence from large clinical trials. Thus, we aimed to conduct an updated systematic review and meta‐analysis of randomized clinical trials (RCTs) evaluating the efficacy and safety of second‐generation DES compared with BMS . Electronic databases were systematically searched for all RCTs comparing second‐generation DES with BMS and reporting clinical outcomes. The primary efficacy outcome was major adverse cardiac events (MACE); the primary safety outcome was definite stent thrombosis. The DerSimonian and Laird method was used for estimation of summary risk ratios (RR). A total of 9 trials involving 17 682 patients were included in the final analysis. Compared with BMS, second‐generation DES were associated with decreased incidence of MACE (RR: 0.78, 95% confidence interval [CI]: 0.69‐0.88), driven by the decreased incidence of myocardial infarction (MI) (RR: 0.67, 95% CI: 0.48‐0.95), target‐lesion revascularization (RR: 0.47, 95% CI: 0.42‐0.53), definite stent thrombosis (RR: 0.57, 95% CI: 0.41‐0.78), and definite/probable stent thrombosis (RR: 0.54, 95% CI: 0.38‐0.80). The incidence of all‐cause mortality was similar between groups (RR: 0.94, 95% CI: 0.79‐1.10). Meta‐regression showed lower incidences of MI with DES implantation in elderly and diabetic patients (P = 0.026 and P < 0.0001, respectively). Compared with BMS, second‐generation DES appear to be associated with a lower incidence of MACE, mainly driven by lower rates of target‐lesion revascularization, MI, and stent thrombosis. However, all‐cause mortality appears similar between groups.     

The EXTREME registry: Titanium‐nitride‐oxide coated stents in small coronary arteries

Objectives : We sought to explore the immediate results of Titan2^® stent implantation in small coronary arteries, as well as the incidence of major adverse cardiac events (MACE) at six months follow‐up. Background : The safety of Titan2^® stent has been confirmed in several studies in real‐life unselected populations. Methods : We enrolled 311 consecutive patients admitted for percutaneous intervention for at least one significant (50%) de novo lesion in a native small coronary artery (2.0–2.75 mm). All lesions were treated with Titan2^® stent implantation. Patients were prospectively followed up for at least six months. The primary endpoint was MACE at six months follow‐up [death, myocardial infarction (MI), or target vessel revascularization (TVR)]. Secondary endpoints included angiographic and clinical procedural success, in‐hospital MACE, target lesion revascularization (TLR) during follow‐up, and stent thrombosis. Results : The mean age was 67.3 ± 10.9 years (65.9% males). A total of 356 Titan2^® stents were implanted in 353 lesions. Angiographic and clinical procedural success was achieved in 344 (97.5%) patients. No case of in‐hospital MACE or acute stent thrombosis was reported. Clinical follow‐up was completed for an average of 8 ± 2 months. Two patients (0.7%) died, and 6 (2.1%) developed MI. TLR was performed in 12 (4.2%) and TVR in 16 (5.5%) patients, all were clinically driven. Cumulative MACE occurred in 20 (6.9%) patients. One patient suffered subacute stent thrombosis, but no late stent thrombosis. Conclusions : Titan2^® stent implantation in small coronary arteries achieves excellent immediate outcome, with a low incidence of MACE at mid‐term follow‐up. © 2010 Wiley‐Liss, Inc.     

Comparison of a polymer‐free rapamycin‐eluting stent (YUKON) with a polymer‐based paclitaxel‐eluting stent (TAXUS) in real‐world coronary artery lesions

Background : In selected patient cohorts the polymer‐free rapamycin‐eluting YUKON stent (A) has demonstrated noninferiority compared with the polymer‐based paclitaxel‐eluting TAXUS stent (B). To test for equivalency in unselected real‐world patients with coronary lesions of various complexities, we retrospectively compared both stent designs. Methods : A total of 410 patients with symptomatic CAD were successfully treated with A (n = 205) or with B (n = 205). Baseline clinical characteristics, coronary lesion location, lesion length, and the number of stents implanted per lesion were equally distributed between the treatment groups. All patients underwent QCA‐analysis at baseline. Clinical follow‐up with assessment of MACE and noncardiac deaths was obtained at 30 days and 6 months. Results : Nominal stent diameter was 2.96 ± 0.38 mm in Group A vs. 3.05 ± 0.42 mm in Group B (P = 0.2); nominal length of stented segmentwas 22.97 ±13.0 mm vs. 23.63 ± 10.0 (P = 0.56). Analysis of MACE after 6 months resulted in one angiographically documented stent thrombosis causing MI in B (0.2%) vs. none in A. No other MI or cardiac deaths occurred in either group, while two noncardiac deaths in A (1.0%) were reported. Fifteen target lesion revascularizations (7.3%) were performed in A vs. 7 (3.4%) in B. Differences in study endpoints at 6 months did not reach statistical significance (P > 0.05). Conclusions : Up to 6 months after PCI of real‐world coronary lesions, there were no statistically significant differences in MACE between patients treated with the polymer‐free rapamycin‐eluting YUKON stent and the polymer‐based paclitaxel‐eluting TAXUS stent. © 2008 Wiley‐Liss, Inc.     

Comparison of door‐to‐balloon times for primary PCI using transradial versus transfemoral approach

Objectives: The objective of this study was to compare door‐to‐balloon times and other variables in ST‐segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) using transfemoral or transradial approaches. Background: Transradial PCI has been shown to lower the risk of access site complications but the procedure is not applied to STEMI patients, due to concerns of procedural complexity adversely affecting prompt reperfusion. There is paucity of real‐world data comparing TRI with TFI in patients with STEMI. Methods: Three hundred sixteen consecutive patients with STEMI undergoing primary PCI were studied. Patients were divided in two groups, Group I (n = 204) undergoing PCI transfemorally and Group II (n = 109) patients transradially. Demographic data, door‐to‐balloon times, procedural variables, predischarge adverse events, access site complications, and 1 year follow‐up major adverse cardiac events (MACE) were recorded. Results: Door‐to‐balloon time was 72 ± 14 min in Group I compared with 70 ± 17 min in Group II, the difference was not statistically significant (t = 1.096, P > 0.27). Group II patients had significantly fewer access site complications compared with Group I (20 vs. 1 patient, χ² = 10.8, P < 0.05). Demographics, predischarge adverse events, and MACE at 1 year follow‐up were comparable between the two groups. Conclusions: Transradial approach to primary PCI provides similar door‐to‐balloon times to transfemoral approach, and significantly lowers access site related complications, in patients presenting with STEMI. © 2010 Wiley‐Liss, Inc.     

Percutaneous left main coronary disease treatment without on‐site surgery back‐up in patients with acute coronary syndromes

Background : Best revascularization strategy in patients with acute coronary syndromes (ACS) and unprotected left main (ULM) coronary disease is still debate reflecting lack of convincing data. Objectives : To assess clinical feasibility and efficacy of ULM percutaneous coronary intervention (PCI) in patients with ACS and describe the practice of a center without on‐site surgical back‐up over a 7‐year period. Methods : Data on high‐risk patients with ACSs undergoing percutaneous ULM treatment were prospectively collected in an independent registry. Primary end‐points of this study were immediate and long‐term outcomes expressed as target lesion failure (TLF, composite of cardiac death, myocardial infarction (MI), and target lesion revascularization). Results : Between January 2003 and January 2010, 200 consecutive patients were included in this study. Angiographic success was obtained in 95% of patients but procedural success was 87% primarily affected by an 11% of in‐hospital cardiac mortality. At median follow‐up of 26 months (IQ 10–47), the overall TLF rate was 28.5%, with 16.0% of cardiac death, 7.0% of MI, and 10.5% of clinically driven target lesion revascularization rates. Cumulative definite/probable stent thrombosis was 3.5%. Elevated EuroSCORE value and pre‐procedural hemodynamic instability were the strongest predictors of TLF. Temporal trend analysis showed progressive but not significant improvement for both immediate (P = 0.110) and long‐term (P = 0.073) outcomes over the study period. Conclusions : This single‐center study based on current clinical practice in patient with ULM disease and ACS confirmed PCI as feasible revascularization strategy in absence of on‐site cardio‐thoracic support. Nevertheless, the outcome of these high‐risk patients is still hampered by a sensible in‐hospital mortality rate. © 2011 Wiley Periodicals, Inc.     

A comparative analysis of major clinical outcomes using drug‐eluting stents versus bare metal stents in diabetic versus nondiabetic patients

Objectives: We aim to explore the clinical outcome of drug‐eluting stents (DES) versus bare‐metal stents (BMS) implantation in diabetics versus nondiabetic patients. Background: Diabetic patients sustain worse long‐term clinical outcomes after percutaneous coronary interventions (PCI) when compared with nondiabetics. The use of DES decreases the rate of repeat revascularization in this population but data concerning long‐term clinical benefits, such as myocardial infarction (MI) or mortality is scant. Methods: We analyzed data from a comprehensive registry of 6,583 consecutive patients undergoing PCI at our center. A propensity score was used for analysis of outcomes and for matching (DES vs. BMS). Outcome parameters were total mortality, MI, repeat target vessel revascularization (TVR) rates, and risk‐adjusted event‐free survival. Within this cohort, we identified 2,571 nondiabetic patients and these were compared with 1,826 diabetic coronary patients. Results: Mean and median follow up time was 3 and 3.25 years, respectively. Overall, diabetics had higher rates of major‐adverse cardiovascular events (MACE) at 4 years compared with nondiabetics (23.03 vs. 31.96 P > 0.001). DES use was associated with lower rates of TVR in both groups [diabetics hazard ratio (HR) = 0.56, 95% confidence interval (CI): 0.42–0.76, P < 0.001, nondiabetics HR = 0.73, 95% CI: 0.55–0.97, P = 0.03] while sustained decreased rates of both mortality and MI were evident solely among diabetics (HR = 0.71, 95% CI: 0.56–0.89, P = 0.004 in diabetic vs. HR = 0.88, 95% CI: 0.69–1.13, P = 0.3). Conclusions: In a “real‐world,” unselected population and extended clinical use, DES in diabetics was associated with sustained decreased rates of MI, death, TVR, and MACE while this benefit was attenuated in the nondiabetic population. © 2011 Wiley‐Liss, Inc.     

Comparison of single‐ versus two‐stent techniques in treatment of unprotected left main coronary bifurcation disease

Background : This study sought to compare 3‐year outcomes of single‐ versus two‐stent techniques in patients with distal unprotected left main coronary artery (LMCA) disease treated with drug‐eluting stents (DES). Methods and Results : A total of 392 patients with distal unprotected LMCA disease who underwent DES implantation with single‐ (n = 234) or two‐ (n = 158) stent techniques were evaluated. The primary end point was major adverse cardiac events (MACE), defined as the composite of death, myocardial infarction (MI), and target lesion revascularization (TLR). The two‐stent group was more likely to have extensive coronary artery stenosis. After adjustment with weighted Cox model using the inverse probability of treatment weighting, the 3‐year risk of death was similar in the single‐ and two‐stent groups (hazard ratio [HR], 0.77, 95% confidence interval [CI], 0.28–2.13, P = 0.62). However, the 3‐year risks of MI (HR, 0.38, 95% CI, 0.19–0.78, P = 0.008), TLR (HR, 0.16, 95% CI, 0.05–0.57, P = 0.005), and MACE (HR, 0.89, 95% CI, 0.22–0.67, P = 0.0007) were significantly lower in the single‐stent group. Conclusion : Compared with the two‐stent technique, the single‐stent technique showed more favorable long‐term clinical outcomes in patients with distal unprotected LMCA disease who received DES. © 2011 Wiley‐Liss, Inc.     

Impact of Acute Coronary Syndrome Classification and Procedural Technique on Clinical Outcomes in Patients With Coronary Bifurcation Lesions Treated With Drug‐Eluting Stents

Background:

We examined the impact of non–ST‐segment elevation acute coronary syndrome (NSTE‐ACS) on clinical outcomes in patients with bifurcation lesions treated with drug‐eluting stents.

Hypothesis:

We hypothesized that NSTE‐ACS would be attributable to the increased risk of major adverse cardiac events (MACE) in bifurcation percutaneous coronary intervention.

Methods:

We enrolled 1668 patients, using data from a multicenter real‐world bifurcation registry. The primary objective was to compare the 2‐year cumulative risk of MACE in patients with NSTE‐ACS to those with stable angina. Major adverse cardiac events were defined as the composite endpoint of cardiac death, myocardial infarction (MI), and target‐lesion revascularization.

Results:

Non–ST‐segment elevation acute coronary syndrome was seen in 969 (58.1%) patients and stable angina in 699. Major adverse cardiac events occurred in 7.3% of NSTE‐ACS patients and in 5.2% with stable angina (P = 0.042). However, cardiac death, MI, and target‐lesion revascularization were similar between the 2 groups. We stratified patients with NSTE‐ACS into those with non–ST‐segment elevation MI and those with unstable angina. Cumulative risks of 2‐year MACEs were 7.0% in non–ST‐segment elevation MI patients and 7.5% in unstable angina patients (P = 0.87). In the NSTE‐ACS cohort, the baseline lesion length in the side branch (adjusted hazard ratio [HR]: 1.04, 95% confidence interval [CI]: 1.01‐1.07, P = 0.022), paclitaxel‐eluting stents in the main vessel (adjusted HR: 2.02, 95% CI: 1.21‐3.40, P = 0.008), and final kissing ballooning (adjusted HR: 1.88, 95% CI: 1.10‐3.21, P = 0.021) were independent predictors of MACE.

Conclusions:

Compared with stable angina patients, the NSTE‐ACS patients who underwent bifurcation percutaneous coronary intervention had an increased risk of MACE during the 2‐year follow‐up. Clin. Cardiol. 2012 doi: 10.1002/clc.22020 Drs Pil Sang Song and Dong Ryeol Ryu contributed equally to this work. Coronary Bifurcation Stenting (COBIS) Registry in South Korea, US Department of Health and Human Services, US National Institutes of Health, ClinicalTrials.gov no. NCT00851526. This work was supported by the Korean Society of Interventional Cardiology, Seoul, South Korea. The authors have no other funding, financial relationships, or conflicts of interest to disclose.     

Preprocedural hemoglobin predicts mortality following peripheral vascular interventions

Background : Serum hemoglobin (H) level is a well‐known predictor of all‐cause mortality in patients undergoing percutaneous coronary interventions but has not been studied in patients undergoing peripheral vascular interventions (PVI). We sought to determine the prognostic significance of serum H in patients undergoing PVI. Methods : We identified 346 consecutive patients undergoing PVI who had a documented a baseline and a postprocedural serum H level over a 33‐month period. A multivariate analysis of predictors of 9‐month mortality was performed. Results : Of 346 patients identified, there were 28 deaths (8.1%) over a 9‐month follow‐up period. Periprocedural H change was not associated with death [OR: 1.12 (95% CI: 0.71–1.79), P = NS]. In a multivariate model independent predictors of all‐cause mortality were clinical bleeding [OR: 10.7 (95% CI: 0.012–0.769), P = 0.026], emergency intervention [OR: 4.5 (95% CI: 0.07–0.71), P = 0.011], ejection fraction [OR: 1.02 (95% CI: 1.01–1.05), P = 0.020], and preprocedural H [OR: 1.56 (95% CI: 1.19–2.04) P = 0.001]. Conclusion : In patients undergoing PVI, preprocedural H was a significant predictor of 9‐month all‐cause mortality. The highest mortality rate was seen in patients with a preprocedural H level ≤ 10 g/dl. Preprocedural H level can be used in clinical practice to risk stratify patients being considered for PVI. Further investigation is needed to assess if optimization of H level preprocedure improves midterm mortality. © 2011 Wiley‐Liss, Inc.     

Real‐life data regarding acute procedural success and 1‐year clinical outcome of desolve bioresorbable scaffolds

Objectives

We aimed to evaluate the peri‐procedural success of DESolve bio‐resorbable scaffolds (BRSs) and analyzed real‐life data about major cardiac events during 1‐year follow‐up.

Background

There is little information about real‐life data of DESolve BRS which is a novel stent technology offering various advantages over drug eluting stents and commonly used in daily cardiology practice.

Methods

We conducted this single‐center and non‐randomized cross‐sectional study from June 2015 through August 2016 in Medipol University Department of Cardiology and included 117 patients undergoing single or multivessel percutaneous coronary interventions (PCI) with novolimus‐eluting BRS devices (152 scaffolds) (Elixir Medical Corporation). Study end points were acute device and procedural success, scaffold thrombosis and major adverse cardiac event (MACE) rates of DESolve BRS.

Results

Device success was 96.7% and procedural success was 99.3%. We detected MACE rate as 0.9% while clinical‐driven target lesion revascularization was performed in one patient. None of the patients experienced scaffold thrombosis or death. Peri‐procedural complications were reported in three patients.

Conclusions

High rates of successful scaffold implantations, low rates of peri‐procedural complications, and major cardiac events in long‐term suggest that DESolve scaffolds can safely and effectively be used in daily intervention practice by particularly experienced operators.

     

Multicenter international registry of unprotected left main coronary artery percutaneous coronary intervention with drug‐eluting stents in patients with myocardial infarction

Background: Patients who present with myocardial infarction (MI) and unprotected left main coronary artery (ULMCA) disease represent an extremely high‐risk subset of patients. ULMCA percutaneous coronary intervention (PCI) with drug‐eluting stents (DES) in MI patients has not been extensively studied. Methods: In this retrospective multicenter international registry, we evaluated the clinical outcomes of 62 consecutive patients with MI who underwent ULMCA PCI with DES (23 ST‐elevation MI [STEMI] and 39 non‐ST‐elevation MI [NSTEMI]) from 2002 to 2006. Results: The mean age was 70 ± 12 years. Cardiogenic shock was present in 24%. The mean EuroSCORE was 10 ± 8. Angiographic success was achieved in all patients. Overall in‐hospital major adverse cardiac event (MACE) rate was 10%, mortality was 8%, all due to cardiac deaths from cardiogenic shock, and one patient suffered a periprocedural MI. At 586 ± 431 days, 18 patients (29%) experienced MACE, 12 patients (19%) died (the mortality rate was 47% in patients with cardiogenic shock), and target vessel revascularization was performed in four patients, all of whom had distal bifurcation involvement (two patients underwent repeat PCI and two patients underwent bypass surgery). There was no additional MI. Two patients had probable stent thrombosis and one had possible stent thrombosis. Diabetes [hazard ratio (HR) 4.22, 95% confidence interval (CI) (1.07–17.36), P = 0.04), left ventricular ejection fraction [HR 0.94, 95% CI (0.90–0.98), P = 0.005), and intubation [HR 7.00, 95% CI (1.62–30.21), P = 0.009) were significantly associated with increased mortality. Conclusions: Patients with MI and ULMCA disease represent a very high‐risk subgroup of patients who are critically ill. PCI with DES appears to be technically feasible, associated with acceptable long‐term outcomes, and a reasonable alternative to surgical revascularization for MI patients with ULMCA disease. Randomized trials are needed to determine the ideal revascularization strategy for these patients. © 2008 Wiley‐Liss, Inc.     

Long‐term outcomes of rotational atherectomy for the percutaneous treatment of chronic total occlusions

Objectives . To study the long‐term outcomes of rotational atherectomy (RA) for chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Background . There is little evidence on the incidence, procedural results and long‐term outcomes of RA for CTO PCI. Methods . This registry included data from consecutive patients undergoing CTO PCI at four specialized centers. Major adverse cardiac events (MACE: cardiac death, target‐vessel myocardial infarction and ischemia‐driven target‐vessel revascularization) on follow‐up were the primary endpoint. Results . A total of 1003 patients were included. Of these, 35 (3.5%) required RA. As compared with Conventional PCI, RA patients were older (68.9 ± 9.5 vs. 64.6 ± 10.7 years, P = 0.02), had higher prevalence of diabetes (58% vs. 37%, P = 0.01) and of a J‐CTO score ≥2 (80% vs. 58%, P = 0.009), driven by severe calcification. Antegrade wire escalation was used more frequently in RA (74% vs. 53%, P = 0.08). RA was performed for balloon failure‐to‐cross in 51% and failure‐to‐expand in 49%. One burr was utilized in 86%. The 1.25‐mm burr was the largest burr used in 43%. Slow flow/no‐reflow was observed in 17%. No other serious RA‐related complications were observed. Procedural success was 77% vs. 89% (P = 0.04) in RA vs. Conventional PCI. After a mean follow‐up of 658 ± 412 days, MACE rates were similar between groups (15% vs. 13%, P = 0.70). Conclusions . The use of RA in CTO PCI was safe, despite a worse patient risk profile and higher procedural complexity, as compared with conventional techniques. Although procedural success was lower in the RA group, there were no differences in long‐term clinical outcomes between groups. © 2016 Wiley Periodicals, Inc.     

Prospective randomized comparison of sirolimus‐ versus paclitaxel‐eluting stents for the treatment of acute ST‐elevation myocardial infarction

Objective: The aim of this study was to compare effectiveness of the Sirolimus‐ (SES) and Paclitaxel‐eluting stent (PES) in primary angioplasty for acute ST‐elevation myocardial infarction (STEMI). Background: It has been reported that SES and PES have been more effective than bare‐metal stents in reducing restenosis and cardiac events in a broad range of patients with coronary artery disease. However, it is unknown whether there may be differences between these two drug‐eluting stents in terms of efficacy in the setting of acute STEMI. Methods: Acute STEMI patients (n = 308) undergoing primary angioplasty were randomly assigned to SES (n = 154) or PES (n = 154) deployment. The routine angiographic follow‐up was performed at 6 months and clinical follow‐up data was obtained at 12 months. The primary end point was major adverse cardiac events (MACE) including death, reinfarction, stent thrombosis, and target lesion revascularization (TLR) at 12 months. Results: The baseline clinical, angiographic, and procedural characteristics were similar between the 2 groups. Two patients (all from the PES group) experienced stent thrombosis (1 acute and 1 subacute). The SES group revealed lower in‐segment restenosis (5.9% vs. 14.8%, P = 0.03) and in‐segment late loss (0.09 ± 0.45 vs. 0.33 ± 0.68 mm, P = 0.002) than PES group on follow‐up angiography. Twelve‐month TLR rates (2.6% vs. 6.5%, P = 0.17) were similar between two groups. MACE rates were lower in the SES group than in the PES group, but it did not reach statistical significance (5.8% vs. 11.7%, P = 0.07). Conclusion: In the setting of primary angioplasty for STEMI, there were no statistically significant differences between the SES and the PES in terms of 12‐month MACE. However, binary angiographic in‐segment restenosis and in‐segment late loss were significantly lower in the SES group. © 2008 Wiley‐Liss, Inc.     

Reduced antiplatelet therapy after drug‐eluting stenting: Multicenter janus flex carbostent implantation with short dual antiplatelet treatment for 2 or 6 months—matrix study

Objectives : The Multicentre registry with Antiplatelet TReatment two–sIX months (MATRIX) evaluated safety and efficacy at 12‐month follow‐up of Janus Flex stenting with 2‐ or 6‐month dual antiplatelet therapy (DAT) period. Background : There are no data of Janus Flex stent (Carbostent and Implantable Devices—CID, Saluggia, Italy), a polymer‐free, tacrolimus‐eluting coronary stent, followed by short‐term DAT, in daily practice. Methods : Patients were prospectively enrolled at 12 high‐volume procedures centres. After stenting, four sites prescribed 2‐month DAT, eight sites 6‐month DAT. Major adverse cardiac events (MACE) and stent thrombosis (ST) rate was evaluated at 12‐month follow‐up, for entire population, as well as for 2‐ and 6‐month DAT groups, distinctly. MACE included cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). Results : From March 2007 to June 2008, 572 patients (mean age 64.91 ± 11 years, 77.45% males) were enrolled. After successful stenting, 12‐month follow‐up showed a 12.74% MACE occurrence (cardiac death 0.98%; MI 3.13%; TLR 8.62%), with good Janus Flex safety profile confirmed by only two (0.39%) ST. After adjustment for potential confounding, no significant differences were noted at 12‐month follow‐up among 2‐ or 6‐month DAT groups (MACE—8.99% versus 12.47%, P = 0.16; cardiac death—0.54% versus 1.14%, P = 0.52; MI—2.38% versus 2.71%, P = 0.83; TLR—5.66% versus 10.60%, P = 0.20; ST—0% versus 0.55%, P = 0.99). At multivariable analysis, DAT time duration was not an independent risk factor for adverse events (adjusted HR 0.47, 95% confidence interval 0.16–1.35, P = 0.16). Conclusions : Janus Flex coronary stenting, followed by short DAT, is safe and feasible, without differences between 2‐ and 6‐month DAT groups. A randomized trial confirming these encouraging data is needed. © 2011 Wiley Periodicals, Inc.     

Comparison of medical treatment and coronary revascularization in patients with moderate coronary lesions and borderline fractional flow reserve measurements

Objectives : (1) To evaluate the clinical outcomes of patients with moderate coronary lesions and borderline fractional flow reserve (FFR) measurements (between 0.75 and 0.80), comparing those who underwent coronary revascularization (CR) to those who had medical treatment (MT), and (2) to determine the predictive factors of major adverse cardiac events (MACE) at follow‐up. Methods : A total of 107 consecutive patients (mean age 62 ± 10 years) with at least one moderate coronary lesion (mean percent diameter stenosis 47 ± 12%) evaluated by coronary pressure wire with FFR measurement between 0.75 and 0.80 (mean 0.77 ± 0.02) were included in the study. MACE [CR, myocardial infarction (MI), cardiac death) and the presence of angina were evaluated at follow‐up. Results : Sixty‐three patients (59%) underwent CR and 44 patients (41%) had MT, with no clinical differences between groups. At a mean follow‐up of 13 ± 7 months, MACE related to the coronary lesion evaluated by FFR were higher in the MT group compared with CR group (23% vs. 5%, P = 0.005). Most MACE consisted of CRs, with no differences between groups in MI and cardiac death rate at follow‐up. Both MT and FFR measurements in an artery supplying a territory with previous MI were independent predictive factors of MACE at follow‐up, respectively (hazard ratio 5.2, 95% CI 1.4–18.9, P = 0.01; hazard ratio 4.1, 95% CI 1.1–15.3, P = 0.03). The presence of angina at follow‐up was more frequent in the MT group compared with the CR group (41% vs. 9%, P = 0.002). Conclusions : In patients with moderate coronary lesions and borderline FFR measurements deferral of revascularization was associated with a higher rate of MACE (CR) and a higher prevalence of angina at follow‐up, especially in those with previous MI in the territory evaluated by FFR. Further prospective randomized studies should confirm whether or not an FFR cut‐off point of 0.80 instead of 0.75 would be more appropriate for deferring CR in these cases. © 2008 Wiley‐Liss, Inc.