In Hospital Outcomes for High-Risk Percutaneous Coronary Intervention (PCI) in Patients Referred From a Rural Centre to Metropolitan Sites.

BACKGROUND: Cardiac Society of Australia and New Zealand (CSANZ) guidelines recommend elective high-risk percutaneous coronary intervention (PCI) is not performed in sites greater than 1 hour from cardiac surgery. METHODS: In hospital outcomes for all patients from Orange Health Service (OHS) from January 2017 to January 2020 who were transferred electively to tertiary centres in Sydney for high risk PCI were examined. RESULTS: One hundred and fourteen (114) patients were identified, with 1,259 PCIs performed at OHS over the same period without transfer. The mean age of these 114 patients was 71 years, with 74.6% male. Receiving hospitals were Royal Prince Alfred Hospital, Sydney, NSW (66.7%), Concord Repatriation General Hospital, Concord, NSW (19.3%) and Strathfield Private Hospital, Strathfield, NSW (14%). The definition of high risk and indication for transfer included at least one of: moderate or greater calcification of the target lesion or proximal segment (34%), single or multiple target lesions that in aggregate jeopardised over 50% of remaining viable myocardium (27%), degenerated saphenous vein grafts (14.8%), chronic total occlusions (7.0%) and severe left ventricular (LV) impairment (3.9%). American Heart Society/American College of Cardiology (AHA/ACC) lesion types were A (1%), B1 (4.2%), B2 (40.2%), and C (54.6%). PCI was performed via the femoral route in 96.2%. The mean procedure duration was 72 minutes, mean combined fluoroscopy time was 19 minutes and mean radiation dose as defined by Reference Air Kerma was 1,630 mGy. Complications occurred in 13 patients and were: acute vessel dissection requiring stenting (4), perforation (2), acute vessel closure (4), puncture site related (1), and life-threatening arrhythmia (2). There were no cases of emergent coronary artery bypass graft (CABG) or death. CONCLUSION: This contemporary cohort of high-risk patients transferred electively from a regional PCI centre to a tertiary cardiac unit underwent lengthy PCI procedures, with high radiation doses, and a modest rate of peri-procedural complications, but had otherwise excellent procedural and clinical outcomes.

Elevated high-sensitivity C-reactive protein as a risk marker of the attenuated relationship between serum cholesterol and cardiovascular events at older age. The ARIC Study.

The relationship between cholesterol and coronary heart disease (CHD) is attenuated at older age. We analyzed cholesterol level as a predictor of CHD in 8,947 participants from the Atherosclerosis Risk in Communities (ARIC) Study, a large multicenter cohort study that enrolled participants in 1987-1989 at 4 field centers in Washington County, Maryland; Forsyth County, North Carolina; Jackson, Mississippi; and Minneapolis, Minnesota. Participants in the present analysis had no history of CHD and were stratified by age (<65 or ≥65 years) and high-sensitivity C-reactive protein (hs-CRP) level (<2 or ≥2 mg/L). Visit 4 (1996-1997) was the baseline for this analysis, with follow-up through 2008. Cholesterol level was significantly associated with CHD among younger participants, and cholesterol level was similarly predictive of CHD among older participants with an hs-CRP level of <2 mg/L. In contrast, among older participants with an hs-CRP level of 2 mg/L or higher, the association of CHD with total cholesterol level was borderline significant (hazard ratio = 1.14, 95% confidence interval: 1.00, 1.29), and the association of CHD with low-density lipoprotein cholesterol level was nonsignificant (hazard ratio = 1.10; 95% confidence interval: 0.96, 1.26). Among older persons with an elevated hs-CRP level, cholesterol level was significantly less predictive of CHD (P < 0.05), whereas for those with an hs-CRP level of <2 mg/L, there was no significant difference compared with younger participants. In conclusion, we found that among the young-old, the association of cholesterol level with CHD was strong when hs-CRP level was not elevated and weak when hs-CRP level was elevated. Therefore, hs-CRP level could be useful for stratifying the young-old to assess the strength of cholesterol level in CHD risk prediction.

Decline in platelet count in patients treated by percutaneous coronary intervention: definition, incidence, prognostic importance, and predictive factors.

AIMS: We investigated the incidence, predictors, and prognostic impact of a decline in platelet count (DPC) in patients treated by percutaneous coronary intervention (PCI). METHODS AND RESULTS: A total of 10 146 consecutive patients treated by PCI from 2003 to 2006 were included. According to the magnitude of the DPC, the population was divided into four groups: no DPC (<10%), minor DPC (10-24%), moderate DPC (25-49%), and severe DPC (>or=50%). The primary haemorrhagic endpoint was a composite of post-procedure surgical repair major bleeding. The primary ischaemic endpoint was 30-day all-cause mortality-non-fatal myocardial infarction. Among the total population, 36% had a DPC <10%, 47.7% had a DPC of 10-24%, 14% had a DPC of 25-49%, and 2.3% had a DPC >or=50%. On multivariate analysis, moderate and severe DPC were independent predictive factors of the ischaemic outcome. Two procedural practices were identified that, if modified, might reduce the incidence of acquired thrombocytopaenia. Both the intraprocedural use of heparin (as opposed to bivalirudin) and of low molecular weight contrast material were independently associated with severe acquired thrombocytopaenia. CONCLUSION: Moderate and severe DPC are independent predictors of adverse bleeding and ischaemic outcomes in PCI. Adoption of intraprocedural anticoagulant other than heparin and avoidance of a low molecular weight contrast agent could potentially decrease the occurrence of severe acquired thrombocytopaenia.

Prognostic value of procedure-related myocardial infarction according to the universal definition of myocardial infarction in saphenous vein graft interventions.

BACKGROUND: In the recently published universal definition of myocardial infarction (MI), a troponin elevation above 3x above the 99th percentile of normal after percutaneous coronary intervention (PCI) is a procedure-related (type 4a) MI. Although troponin rise is common after saphenous vein graft (SVG) PCI, its prognostic value remains undetermined. We aimed to investigate the prognostic value of the universal definition of PCI-related MI in SVG interventions. METHODS: A cohort of 589 unselected consecutives patients with normal preprocedural troponin Ic undergoing isolated SVG PCI with drug-eluting stent implantation was included. Patients were divided into 2 groups according to the peak troponin value post PCI: those with MI defined as a peak troponin value above 3x the 99th percentile of normal post-PCI (MI group, n = 166) and those without (no MI group, n = 423). The primary end point was the rate of major adverse cardiac events including death, MI, and target vessel revascularization at 1-year follow-up. RESULTS: Baseline characteristics were similar between the 2 groups. In the MI group, patients had more complex angiographic features (type C lesions: 44.7 vs 34.8%; P = .006). The rate of direct stenting and distal protection use were similar in the 2 groups (MI vs no MI: 29.2 vs 28.7%; P = .9 and 32 vs 37.5%; P = .24, respectively). Patients in the MI group had a worse inhospital course but a similar 1-year rate of major adverse cardiac events (22.3 vs 19.1%; P = .39). CONCLUSION: Procedure-related MI after PCI, as defined by the universal definition, is associated with an adverse inhospital course but may not predict long-term outcome in SVG PCI.

Prognosis of patients suffering an acute coronary syndrome while already under chronic clopidogrel therapy.

OBJECTIVE: To assess the prognosis of patients presenting with an acute coronary syndrome (ACS) despite chronic clopidogrel therapy (CCT). BACKGROUND: CCT has been shown to be beneficial in decreasing the frequency of major adverse cardiovascular events (MACE) in patients after an ACS or drug-eluting stent (DES) implantation. Some patients, however, still suffer thrombotic events while on CCT. The outcome of this particular subgroup of patients is unknown. METHODS: A cohort of 1,281 patients undergoing percutaneous coronary intervention (PCI) for an ACS was studied. They were divided according to their treatment prior to the ACS. The CCT group was composed of all patients who had been taking clopidogrel for >or=30 days before the onset of the ACS (n = 175) and the no CCT group of all patients not on clopidogrel before the ACS (n = 1,106). Rates of cardiovascular death and myocardial infarction at 6 months' follow-up were compared. RESULTS: Patients in the CCT group were older (66 +/- 11 vs. 63 +/- 13; P< 0.001), and more often diabetic (46.8 vs. 31.9%; P < 0.01). In-hospital outcomes were similar, including the rate of death and myocardial infarction (no CCT vs. CCT group: 4.2 vs. 2.3%; P = 0.2). At 6 months, patients already taking clopidogrel before the ACS had a higher rate of MACE than patients who were not (18.3 vs. 11.8%; P = 0.02). In multivariate analysis, CCT before the ACS was associated with a hazard ratio of 1.7 for MACE. CONCLUSION: This study suggests that patients suffering an ACS while under on CCT have a poor long-term prognosis, which could be linked to clopidogrel low-response.

Prognostic value of the Syntax score in patients undergoing coronary artery bypass grafting for three-vessel coronary artery disease.

BACKGROUND: The Syntax score prognostic value has recently been highlighted in patients undergoing percutaneous coronary intervention (PCI) for multivessel coronary artery disease (CAD), however its prognostic value in patients undergoing coronary artery bypass grafting (CABG) for multivessel CAD is still unknown. The aim of this study was to evaluate the prognostic value of the Syntax score in patients undergoing CABG for 3-vessel CAD. METHODS: A cohort of 320 consecutive patients with multivessel (3-vessel) CAD who were subjected for CABG were included in this study and divided into tertiles according to the Syntax score (<24.5, 24.5-34, and >34). During the 1-year follow-up, cardiovascular events including death, myocardial infarction (MI), and stroke were systematically indexed. The primary end point was the composite criteria death/MI/stroke. RESULTS: The Syntax score ranged from 11-74 with a mean of 31.2 +/- 12.6 and a median of 28.5 [22-38]. Baseline clinical characteristics were similar among the tertiles. No statistical difference was found for the composite criteria death/MI/stroke: 9.4% versus 7.5% versus 10.4% in the groups with a Syntax score <24.5, 24.5-34, and >34, respectively (P = 0.754). CONCLUSION: Unlike for PCI, the Syntax score has a poor prognostic value for severe cardiovascular events in patients undergoing CABG for 3-vessel CAD. Other risk scores should be used to predict the outcome of this population.

Impact of bivalirudin use on outcomes in nonagenarians undergoing percutaneous coronary intervention.

BACKGROUND: With an aging population, nonagenarians constitute an increasing percentage of patients with coronary artery disease. The aim of this study was to determine the predictors and outcome of nonagenarians undergoing percutaneous coronary intervention (PCI) for symptomatic coronary artery disease. METHODS: From 2002 to 2007, a cohort of 171 consecutive nonagenarians underwent PCI and stent implantation in our center. Patients given bivalirudin (n = 79) during the procedure were compared to those given heparin (n = 92). In-hospital and 6-month rates of major adverse cardiovascular events (MACE) including death, myocardial infarction (MI), and target lesion revascularization were indexed. In-hospital bleedings were also indexed. RESULTS: The mean age was 92.5 +/- 2.5 years. The population was 52% female. Nearly 30% of patients had diabetes mellitus and >25% had renal failure. The mean left ventricular ejection fraction was 45%+/- 14%. The clinical presentation was an acute MI in 59% of the cases. The in-hospital rates of death and bleedings were 4.1% and 17.5%, respectively. Clinical presentations as MI or cardiogenic shock were associated with high rates of in-hospital death: 19.3% and 30%, respectively. Bivalirudin use was associated with a 41.5% decrease in in-hospital bleedings. The 6-month incidence of MACE was 13.6% and was driven by death. Predictors of 6-month outcomes were clinical presentations as MI or cardiogenic shock, renal failure, and total stent length. CONCLUSION: Nonagenarians represent a particular population with a high percentage of females and a high incidence of comorbidities. In this study, we highlighted that nonagenarians have logically a worse prognosis than is reported in younger patients, with especially high rates of in-hospital bleedings. Bivalirudin use was associated with an important decrease in in-hospital bleedings; thus, it should be systematically considered in such patients to improve early outcome.

The potential clinical utility of intravascular ultrasound guidance in patients undergoing percutaneous coronary intervention with drug-eluting stents.

AIMS: To assess the impact on clinical outcomes of intravascular ultrasound (IVUS) guidance during drug-eluting stent (DES) implantation. IVUS guidance during percutaneous coronary intervention (PCI) has been demonstrated to be useful in optimizing stent deployment. However, it is not proved that routine use of IVUS guidance with DES implantation can prevent stent thrombosis or restenosis. METHODS AND RESULTS: The clinical outcomes of 884 patients undergoing IVUS-guided intracoronary DES implantation from April 2003 to May 2006 were compared with the outcomes of a propensity-score matched population undergoing DES implantation with angiographic guidance alone. The primary endpoint of the study was definite stent thrombosis at 12 months. The secondary endpoint was major adverse cardiac events (MACE). After propensity-score matching, the two groups were well matched for clinical and angiographic characteristics. Patients undergoing IVUS-guided DES implantation underwent less direct stenting, more post-dilation, and had greater cutting balloon and rotational atherectomy use. At 30 days and at 12 months, a higher rate of definite stent thrombosis was seen in the No IVUS group (0.5 vs. 1.4%; P = 0.046) and (0.7 vs. 2.0%; P = 0.014), respectively. There were no major differences in late stent thrombosis and MACE (14.5 vs. 16.2%; P = 0.33) at 12 month follow-up between the groups. Rates of death and Q-wave myocardial infarction were similar, and there was no significant difference between groups in target vessel revascularization. However, a trend was seen in favour of the IVUS group in target lesion revascularization (5.1 vs. 7.2%; P = 0.07). IVUS guidance was an independent predictor of freedom from cumulative stent thrombosis at 12 months (adjusted HR 0.5, CI 0.1-0.8; P = 0.02). CONCLUSION: IVUS guidance during DES implantation has the potential to influence treatment strategy and reduce both DES thrombosis and the need for repeat revascularization.

Outcomes of coronary artery bypass grafting versus percutaneous coronary intervention with drug-eluting stents for patients with multivessel coronary artery disease.

BACKGROUND: Advances in coronary artery bypass grafting (CABG) surgery and percutaneous coronary intervention (PCI) with drug-eluting stents have dramatically improved results of these procedures. The optimal treatment for patients with multivessel coronary artery disease is uncertain given the lack of prospective, randomized data reflecting current practice. This study represents a "real-world" evaluation of current technology in the treatment of multivessel coronary artery disease. METHODS AND RESULTS: A total of 1680 patients undergoing revascularization for multivessel coronary artery disease were identified. Of these, 1080 patients were treated for 2-vessel disease (196 CABG and 884 PCI) and 600 for 3-vessel disease (505 CABG and 95 PCI). One-year mortality, cerebrovascular events, Q-wave myocardial infarction, target vessel failure, and composite major adverse cardiovascular and cerebrovascular events were compared between the CABG and PCI cohorts. Outcomes were adjusted for baseline covariates and reported as hazard ratios. The unadjusted major adverse cardiovascular and cerebrovascular event rate was reduced with CABG for patients with 2-vessel disease (9.7% CABG versus 21.2% PCI; P<0.001) and 3-vessel disease (10.8% CABG versus 28.4% PCI; P<0.001). Adjusted outcomes showed increased major adverse cardiovascular and cerebrovascular event with PCI for patients with 2-vessel (hazard ratio 2.29; 95% CI 1.39 to 3.76; P=0.01) and 3-vessel disease (hazard ratio 2.90; 95% CI 1.76 to 4.78; P<0.001). Adjusted outcomes for the nondiabetic subpopulation demonstrated equivalent major adverse cardiovascular and cerebrovascular event with PCI for 2-vessel (hazard ratio 1.77; 95% CI 0.96 to 3.25; P=0.07) and 3-vessel disease (hazard ratio 1.70; 95% CI 0.77 to 3.61; P=0.19). CONCLUSIONS: Compared with PCI with drug-eluting stents, CABG resulted in improved major adverse cardiovascular and cerebrovascular event in patients with 2- and 3-vessel coronary artery disease, primarily in those with underlying diabetes. Coronary artery bypass surgery may be the preferred revascularization strategy in diabetic patients with multivessel coronary artery disease.

Impact of "off-label" utilization of drug-eluting stents on clinical outcomes in patients undergoing percutaneous coronary intervention.

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

Drug-eluting stents versus bare metal stents for narrowing in saphenous vein grafts.

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

Impact of optimal medical therapy and revascularization on outcome of patients with chronic kidney disease and on dialysis who presented with acute coronary syndrome.

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

Incidence, predictors, and outcomes of post-percutaneous coronary intervention nephropathy in patients with diabetes mellitus and normal baseline serum creatinine levels.

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

Outcomes after sirolimus- and paclitaxel-eluting stent implantation in patients with insulin-treated diabetes mellitus.

Insulin-treated diabetic patients undergoing drug-eluting stent implantation are prone to high rates of adverse cardiac events. The efficacy of the sirolimus- (SES) and paclitaxel-eluting stent (PES) in this population was analyzed. Registry data for 434 consecutive patients with insulin-treated diabetes who underwent SES or PES implantation were analyzed. The end point, major adverse cardiac events (MACEs) at 1 year, was high for patients with SESs and PESs (20.6% vs 20.2%; p=0.91). Cox regression and propensity analysis were used to compare outcomes. The adjusted hazard ratio (HR) for MACEs according to stent type (Cox model) was 1.0 (95% confidence interval [CI] 0.64 to 1.76, p=0.82). The propensity score-adjusted (C statistic=0.66) HR was 0.95 (95% CI 0.56 to 1.61, p=0.84). Stent thrombosis rates were relatively high at 2.0% for SESs and 1.5% for PESs (p=0.49). The propensity score-adjusted HR for stent thrombosis was 2.7 (95% CI 0.31 to 23.6, p=0.37). In conclusion, SESs and PESs are similarly efficacious in insulin-treated diabetic patients. The high MACE and stent thrombosis rates are of concern. Additional studies in this group of patients are required to determine the optimal mode of revascularization and minimize the overall stent thrombosis rate.

Bivalirudin with provisional glycoprotein IIb/IIIa inhibitors in patients undergoing primary angioplasty in the setting of cardiogenic shock.

In patients undergoing percutaneous coronary intervention (PCI), clinical trials have demonstrated that the use of bivalirudin with provisional glycoprotein IIb/IIIa inhibitors is not inferior to heparin with systematic glycoprotein IIb/IIIa inhibitors on major adverse cardiac events and is associated with lower rates of bleeding in various clinical settings. Patients with cardiogenic shock (CS), however, have been excluded from all pivotal trials. A retrospective analysis of 86 consecutive patients undergoing PCI for acute myocardial infarction complicated by CS in our center from April 2003 to September 2007 was performed. In-hospital death, major adverse cardiac events, and bleeding rates were compared in 37 patients who received bivalirudin with or without glycoprotein IIb/IIIa inhibitors and 49 patients who were treated with heparin and glycoprotein IIb/IIIa inhibitors as anticoagulation management. Baseline demographic, clinical, and biological characteristics were similar in the 2 groups. The in-hospital death rate was significantly lower in the bivalirudin group (5.4 vs 32.7%, p = 0.002). There were no differences in the rate of major hematoma between the bivalirudin group and the heparin group (3 vs 2.6%, p = 0.46). In conclusion, bivalirudin with provisional use of glycoprotein IIb/IIIa inhibitors appears to be a safe and effective anticoagualtion strategy in patients undergoing primary PCI for acute myocardial infarction complicated by CS.

Observations and outcomes of definite and probable drug-eluting stent thrombosis seen at a single hospital in a four-year period.

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

Two-year outcome of patients treated with sirolimus- versus paclitaxel-eluting stents in an unselected population with coronary artery disease (from the REWARDS Registry).

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

Bleeding risk and outcomes of Bivalirudin versus Glycoprotein IIb/IIIa inhibitors with targeted low-dose unfractionated Heparin in patients having percutaneous coronary intervention for either stable or unstable angina pectoris.

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

Adjunct thrombus aspiration reduces mortality in patients undergoing percutaneous coronary intervention for ST-elevation myocardial infarction with high-risk angiographic characteristics.

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

Can direct stenting in selected saphenous vein graft lesions be considered an alternative to percutaneous intervention with a distal protection device?

BACKGROUND: Distal embolization during percutaneous coronary intervention (PCI) of saphenous vein graft (SVG) lesions is associated with a high rate of myonecrosis. Although direct stenting (DS) is feasible with less catheter manipulations, its ability to prevent distal embolization in SVG lesions compared with distal protection devices (DPD) is unknown. METHODS: The study included 188 SVG lesions subjected to PCI, 101 patients with 101 lesions treated with DPD, and 87 patients with 87 lesions by DS without DPD. Major adverse cardiovascular events (MACE) in-hospital and at 30 days were compared. RESULTS: Baseline characteristics were comparable, except for higher frequencies of unstable angina (53% vs. 67%, P = 0.045) and prior myocardial infarction (38% vs. 53%, P = 0.07) in the DS group. There was no difference in lesion type aside from more restenotic lesions in the DS group (7% vs. 16%, P = 0.047). Drug-eluting stent deployment was similar. Stent length in the DPD group (22.8 +/- 7.2 mm) was significantly longer than that in the DS group (17.6 +/- 8.0 mm, P < 0.001). Although maximum creatine kinase (CK)-MB value in the DPD group (2.5 +/- 5.8 ng/ml) was significantly larger than in the DS group (1.3 +/- 1.5 ng/ml, P = 0.039), the frequency of CK-MB rise >2 times the upper limit of normal did not differ (11% vs. 6%, P = 0.2). There were no differences in MACE rates in-hospital and at 30 days. By multivariate analysis, neither DPD nor DS was a significant predictor for maximum CK-MB value. CONCLUSION: DS should be considered an alternative treatment to PCI with DPD for selected SVG lesions.