Five-year clinical outcomes using the bioresorbable vascular scaffold: Insights from the FRANCE ABSORB registry.

BACKGROUND: Randomized trials comparing the first-generation absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA, USA) with a drug-eluting stent showed a moderate but significant increase in the rate of 3-year major adverse cardiac events and scaffold thrombosis, followed by a decrease in adverse events after 3 years. AIM: The objective of this study was to assess the 5-year outcomes of patients treated with at least one absorb BVS and included in the FRANCE ABSORB registry. METHODS: All patients treated in France with an absorb BVS were prospectively included in a large nationwide multicentre registry. The primary efficacy outcome was the occurrence of 5-year major adverse cardiac events. Secondary efficacy outcomes were the rates of 5-year target vessel revascularization and definite/probable scaffold thrombosis. RESULTS: Between September 2014 and April 2016, 2,070 patients were included in 86 centres (mean age 55±11 years; 80% men; 49% with acute coronary syndrome). The rates of 1-, 3- and 5-year major adverse cardiac events were 3.9%, 9.4% and 12.1%, respectively (including cardiac death in 2.5% and target vessel revascularization in 10.4%). By multivariable analysis, diabetes, oral anticoagulation, the use of multiple Absorb BVSs and the use of a 2.5mm diameter absorb BVS were associated with 5-year major adverse cardiac events. The rates of 1-, 3- and 5-year definite/probable scaffold thrombosis were 1.5%, 3.1% and 3.6%, respectively. By multivariable analysis, older age, diabetes, anticoagulation at discharge and the use of a 2.5mm diameter absorb BVS were associated with 5-year scaffold thrombosis. CONCLUSIONS: Absorb BVS implantation was associated with low rates of 1-year major adverse cardiac events, which increased significantly at 3-year follow-up. There was a clear decrease in the rates of scaffold thrombosis and major adverse cardiac events after 3 years.

Evaluation of the safety and efficacy of the Cobra PzF NanoCoated coronary stent in routine, consecutive, prospective, and high-risk patients: The e-Cobra study.

BACKGROUND: The Cobra PzF coronary stent is cobalt chromium with flat thin struts, nano-coated with Polyzene-F that enhance rapid reendothelialization and reduce the risk of stent thrombosis and restenosis. It is designed to overcome shortfalls of BMS and DES in patients requiring short DAPT duration. AIMS: To report procedural and 1-year clinical outcomes following Cobra PzF stent implantation in routine practice PCI. METHODS: e-Cobra registry is a multicenter prospective study to evaluate Cobra PzF stent in routine practice in patients deemed appropriate for short DAPT after PCI. The primary endpoint was MACE rate at 12 months (Cardiac death, MI, TLR). The secondary endpoint was definite stent thrombosis at 12 months. RESULTS: Among 940 patients (72% men, 72.8 ± 13.4 years) with multiple co-morbidities, 47% had acute coronary syndromes, and 62% were defined as high bleeding risk. A total of 1,229 lesions were treated with 1,314 stents. 36% of patients had lesion type B2 or C classification. Angiographic success was achieved in all cases. One-year follow-up was available for 97% of patients. The primary endpoint occurred in 9.0% of patients, including cardiac death 3.7%, MI 4.8%, and TLR 4.3%. Definite stent thrombosis occurred in six out of 915 (0.7%). CONCLUSION: The Cobra PzF stent was safe and effective in routine practice patients and seems feasible in situations when short DAPT or Mono Antiplatelet Therapy (MAPT) is needed. One-year follow-up was associated with satisfactory clinical outcomes and validate previously reported data.

Prognostic impact of non-compliance with guidelines-recommended times to reperfusion therapy in ST-elevation myocardial infarction. The FAST-MI 2010 registry.

AIMS: Current guidelines recommend short time delays from qualifying ECG to reperfusion therapy in ST-elevation myocardial infarction (STEMI) patients. Recently, however, it has been suggested that shortening door-to-balloon times might not result in lower mortality, thereby questioning the relevance of current guidelines. The aim of this study was to assess in-hospital and one-year mortality in patients with fibrinolysis or primary percutaneous coronary intervention (PPCI) according to guidelines-recommended times to reperfusion therapy. METHODS AND RESULTS: FAST-MI 2010 is a nationwide French registry including 4169 patients, of whom 1580 had ST-elevation myocardial infarction and had PPCI ( n=1289) or fibrinolysis ( n=291) as part of a pharmaco-invasive strategy. Four groups were constituted: Gr1 (within recommended times from ECG to PPCI; n=708), Gr2 (beyond recommended times from ECG to PPCI; n=581), Gr3 (time from ECG to lysis ⩽30 min, n=196), and Gr4 (time from ECG to lysis >30 min, n=95). In-hospital mortality was 3.6% in Gr2 vs. 1.0% in Gr1 and 3.2% in Gr4 vs. 1.0% in Gr3. After adjustment, hospital mortality was higher for reperfusion therapy beyond recommended times: odds ratio (OR) 3.29, 95% confidence interval (CI) 1.32-8.18; for PPCI, OR: 4.13; 95% CI: 1.50-11.35 and for fibrinolysis, OR: 2.72; 95% CI: 0.34-21.96. Likewise, one-year mortality was higher in patients with reperfusion beyond recommended times (hazard ratio 2.13, 95% CI:1.29-3.50). The results were confirmed by propensity score analyses. CONCLUSIONS: Early and one-year mortality were lower for ST-elevation myocardial infarction patients when the recommended timelines for reperfusion therapy were met, suggesting that, in spite of recent interrogations, compliance with current guidelines remains a clinically relevant objective.

High on-treatment platelet reactivity after prasugrel loading dose and cardiovascular events after percutaneous coronary intervention in acute coronary syndromes.

OBJECTIVES: The aim of this study was to investigate the relationship between platelet reactivity (PR) after a loading dose (LD) of prasugrel and thrombotic events. BACKGROUND: Post-treatment PR has been shown to be strongly associated with the occurrence of major adverse cardiac events (MACE) after percutaneous coronary intervention (PCI) in the clopidogrel era. Prasugrel is a new P2Y(12)-adenosine diphosphate receptor with a higher potency on PR. METHODS: A prospective multicenter study included patients who underwent successful PCI for acute coronary syndromes and received prasugrel therapy. Vasodilator-stimulated phosphoprotein (VASP) index was measured after the prasugrel LD. High on-treatment PR was defined as a VASP index ≥50%. MACE included cardiovascular death, myocardial infarction, and definite stent thrombosis at 1 month. RESULTS: Three hundred one patients were enrolled. The mean VASP index after 60 mg of prasugrel was 34.3 ± 23.1%. High on-treatment PR was observed in 76 patients (25.2%). Patients experiencing thrombotic events after PCI had significantly higher VASP indexes compared with those free of events (64.4 ± 14.4% vs. 33.4 ± 22.7%; range: 51% to 64% and 5% to 47.6%, respectively; p = 0.001). Kaplan-Meier analysis comparing good responders and patients with high on-treatment PR demonstrated a significantly higher rate of MACE in patients with suboptimal PR inhibition (log-rank p < 0.001). Receiver-operating characteristic curve analysis found a cutoff value of 53.5% of the VASP index to predict thrombotic events at 1 month (r = 0.86, p < 0.001). Patients with minor or major Thrombolysis In Myocardial Infarction unrelated to coronary artery bypass grafting bleeding and those without had similar VASP indexes (30 ± 17.8% vs. 34.3 ± 23%, p = 0.70). CONCLUSIONS: Despite the use of prasugrel, a significant number of patients undergoing PCI in the setting of acute coronary syndromes do not achieve optimal PR inhibition. Such patients have a higher risk for MACE after PCI.

Genotypic and phenotypic assessment of platelet function and response to P2Y12 antagonists.

The P2Y12-ADP receptor antagonists are the cornerstone of oral antiplatelet therapy in the secondary prevention of coronary artery disease, especially after acute coronary syndrome or percutaneous coronary intervention. Currently, the therapeutic agents available to block the receptor include clopidogrel and prasugrel; ticagrelor is not available everywhere. Clopidogrel was the gold standard, but recently it has been challenged by prasugrel and ticagrelor. One pitfall of clopidogrel is that in some patients it cannot induce optimal platelet reactivity inhibition in connection with several factors, including some genetic polymorphisms of enzymes participating in its bioabsorption or metabolism. This variability of response can be evaluated by platelet reactivity monitoring. This comprehensive review provides the available data regarding the genotypic and phenotypic interaction with the response to P2Y12-ADP receptor antagonists and discusses the concept of personalized antiplatelet therapy based on a genotypic or phenotypic profile.

Relation between clopidogrel discontinuation and early cardiovascular events after percutaneous coronary intervention with drug-eluting stents.

AIMS: Clopidogrel discontinuation after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation has been reported to correlate with stent thrombosis. Whether these events are a consequence of the rebound phenomenon or a lack of protection in unhealed vessels is unclear. This study aimed to determine the link between clopidogrel cessation and cardiovascular events after PCI with DES. METHODS AND RESULTS: The population included 1,903 patients who underwent PCI with DES implantation from 2003 to 2007. We compared patients who stopped their clopidogrel within the first month (group 1, n=97), from one to six months (group 2, n=344), from six to 12 months (group 3, n=468), and after 12 months (group 4, n=994) following the PCI. In each group, the composite of death, myocardial infarction and stent thrombosis at 30 days and between 31 and 60 days after clopidogrel cessation was indexed. Baseline characteristics were similar among groups. The event rate observed in the 0-30 day interval following cessation was higher only in group 1 (5.2%) compared to all other groups: 1.2% (group 2), 0.9% (group 3) and 0.6% (group 4) (p=0.004). The event rates from 31 to 60 days following cessation were low and similar among the four groups. When the elapsed time between the index PCI and the clopidogrel cessation was analysed as a continuous variable, the probability of events occurring within the first 30 days became similar to that observed in the 31-60 day interval following cessation after a minimum of 10.2 months. CONCLUSIONS: Cardiac events seen immediately after clopidogrel cessation are not related to a rebound phenomenon, but are more likely influenced by the lack of healing at the time of cessation, which decreases over time. This increased risk related to the lack of healing seems to disappear after 10.2 months.

Outcomes in diabetic versus nondiabetic patients who present with acute myocardial infarction and are treated with drug-eluting stents.

Patients with diabetes mellitus (DM) are at a greater risk of mortality and cardiovascular events after percutaneous coronary intervention than those without DM. We aimed to determine whether differences exist in the long-term mortality of patients with versus without DM who present with acute myocardial infarction and receive drug-eluting stents. Data were collected on 161 patients with and 395 without DM referred for primary percutaneous coronary intervention for acute myocardial infarction and treated with drug-eluting stents. The patients with cardiac arrest or cardiogenic shock were excluded. The 1-year major cardiac event (MACE) rates, defined as death, Q-wave myocardial infarction, or target lesion revascularization, were compared between the 2 groups. The patients with DM were sicker at baseline. The MACE rates at 1 year were significantly increased in those with DM compared to those without DM. This was primarily driven by all-cause mortality. No differences in Q-wave myocardial infarction, target lesion revascularization, stent thrombosis, type of drug-eluting stents used, or procedure-related renal failure were seen. No differences were found in death or MACE rates at 1 year after adjusting for age, gender, race, systemic hypertension, peripheral artery disease, and a history of chronic renal failure between the 2 groups (weighted log-rank statistic, p = 0.37 and p = 0.37, respectively). In patients presenting with acute myocardial infarction, those with DM were sicker than those without DM. In conclusion, after correction for co-morbid conditions, no difference was seen in the 1-year MACE or death rates between those with and without DM who presented with acute myocardial infarction and were treated with drug-eluting stents.

Antithrombotic treatment and the risk of death and stroke in patients with atrial fibrillation and a CHADS2 score=1.

In patients with atrial fibrillation (AF) and an intermediate risk of stroke (CHADS2 score =1), available evidence from clinical trials is inconclusive and the present guidelines for the management of AF indicate that the choice between oral anticoagulant and aspirin in these patients is open. Our goal was to evaluate whether, in patients with AF and only one moderate risk factor for thromboembolism, treatment with an oral anticoagulant is appreciably more beneficial than treatment with an antiplatelet agent. Among 6,517 unselected patients with AF, 1,012 of them (15.5%) had a CHADS2 score of 1 and were liable to treatment with an antiplatelet agent or an anticoagulant. An oral anticoagulant was prescribed for 606 patients (59.9%) and an antiplatelet agent or no antithrombotic treatment for 406 (40.1%). During follow-up (median=793 days, interquartile range=1,332 days), 105 deaths (10.4%) and 19 strokes (1.9%) were recorded. The administration of an anticoagulant was associated with a lower rate of events (relative risk=0.42, 95% confidence interval 0.29-0.60, p<0.0001) than when no anticoagulant was prescribed. Results remained similar after adjustment for age and other confounding factors. In contrast, prescription of an antiplatelet agent was not associated with a lower risk of events. Factors independently associated with an increased risk of events were older age (p<0.0001), concomitant heart failure (p=0.0002), diabetes (p=0.0025), lack of prescription of an anticoagulant (p<0.0001) and permanent AF (p=0.04). Thus, prescription of an anticoagulant is independently associated with a decreased risk of death or stroke among patients with AF and a CHADS2 score =1.

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.

Personalized antiplatelet therapy for coronary artery disease patients: is this the future?

Clopidogrel has decreased the rate of thrombotic events in patients undergoing percutaneous coronary intervention. However, two major limitations of the drug have been involved in the persistence of a relatively high rate of adverse events. The recent literature suggested that improved platelet reactivity inhibition using a higher or tailored dose of clopidogrel, or a more potent agent, could reduce the rate of events. The development of new antiplatelet agents and the increasing availability of platelet assays are likely to profoundly modify current practice and favor personalized antiplatelet therapy.

Relation of body mass index to high on-treatment platelet reactivity and of failed clopidogrel dose adjustment according to platelet reactivity monitoring in patients undergoing percutaneous coronary intervention.

High on-treatment platelet reactivity (HTPR) after a clopidogrel loading dose predicts the risk of thrombotic events after percutaneous coronary intervention. We have demonstrated that HTPR could be overcome in most cases using dose adjustment according to PR monitoring resulting in an improved clinical outcome. However, this strategy failed in nearly 10% of patients with HTPR. Cytochrome P450 (CYP) 2C19 polymorphism was a major determinant of the response to clopidogrel and could be responsible for a failure of dose adjustment. We aimed to determine the clinical and genetical predictors of a failure of the dose-adjustment strategy. Seventy-three patients undergoing percutaneous coronary intervention were included in this prospective multicenter study. A vasodilator phosphoprotein index >or=50% after a 600-mg loading dose of clopidogrel defined HTPR. Dose adjustment was performed according to PR monitoring to reach a vasodilator phosphoprotein index <50%. Genetic polymorphism of CYP2C19 was determined by direct sequencing. Clinical predictors of HTPR were body mass index (BMI; p = 0.01), diabetes mellitus (p = 0.03), and acute coronary syndrome (p = 0.02). The mutant 2 allele of CYP2C19 681A > G loss of function polymorphism was also significantly associated with HTPR (p = 0.04). The rate of successful dose adjustment was similar in carriers of the CYP2C19 2 allele and carriers of the wild-type allele. The only independent predictor of a failed dose adjustment was a high BMI (p = 0.01). In conclusion, high BMI, acute coronary syndrome, diabetes mellitus, and CYP2C19 2 are associated with HTPR after a 600-mg loading dose of clopidogrel. Dose adjustment overcomes HTPR in carriers of the CYP2C19 2 allele. BMI is the only independent predictor of failed dose adjustment. Thus, drug underdosage seems to be the main determinant of HTPR.

Head-to-head comparison of bivalirudin versus heparin without glycoprotein IIb/IIIa inhibitors in patients with acute myocardial infarction undergoing primary angioplasty.

BACKGROUND: In patients receiving primary percutaneous coronary intervention for ST elevation myocardial infarction (STEMI), bivalirudin with provisional glycoprotein (GP) IIb/IIIa inhibitors has been demonstrated to be noninferior to heparin plus systematic GP IIb/IIIa inhibitors in preventing recurrent ischemic events with improved safety in terms of bleeding. However, no study has been performed comparing head-to-head bivalirudin with heparin without GP IIb/IIIa inhibitor infusion in STEMI patients. METHODS: We retrospectively studied 899 consecutive patients who presented with STEMI treated by primary angioplasty within 12 h after symptoms. Among them, 566 received bivalirudin and 333 received unfractionated heparin. Their in-hospital outcome in terms of efficacy and safety was assessed using rates of major adverse cardiac events (MACE) and major bleeding, respectively. Clinical, angiographic and procedural characteristics were well matched between the two groups. RESULTS: Patients in the heparin group more frequently required intra-aortic balloon pumping (6.6% vs. 3.6%, P=.037). Regarding the safety end point, the MACE rate, including death, ischemic stroke and urgent repeated revascularization, was low and similar in both groups (2.7% bivalirudin vs. 1.2% heparin, P=.15). The rate of major bleeding, including major hematoma, gastrointestinal bleeding and hematocrit drop >15% during hospitalization, was high and identical in the two groups (4.1% bivalirudin vs. 4.2% heparin, P=.92). CONCLUSION: This study suggests that bivalirudin and heparin present similar safety and efficacy profiles when used without GP IIb/IIIa inhibitor infusion during primary angioplasty.

Prognostic value of hemoglobin A1C levels in patients with diabetes mellitus undergoing percutaneous coronary intervention with stent implantation.

The optimal glycosylated hemoglobin (HbA1C) target in diabetic patients is a subject of ongoing controversy that may be especially pertinent in diabetic patients with coronary artery disease. This study aimed to determine the prognostic value of preprocedural HbA1C levels in diabetic patients undergoing percutaneous coronary intervention (PCI) with stent implantation. From 2002 to 2007, a cohort of 952 consecutive diabetic patients underwent PCI with stent implantation in our center. We compared patients with a normal preprocedural HbA1C (< or = 7%, n = 429) with patients with an increased HbA1C (>7%, n = 523). One-year rate of major adverse cardiovascular events (MACEs) including death, myocardial infarction, and target vessel revascularization was indexed. Baseline characteristics were similar between groups, except for body mass index, which was higher in the high HbA1C group (32.2 vs 31.2 kg/m(2), p = 0.03). Patients in the high HbA1C group were more likely insulin dependent (45.5% vs 26.3%, p <0.001). Rates of MACEs were similar (23.7% vs 20.8%) in the high HbA1C and low HbA1C groups (p = 0.45). By multivariate analysis, age, renal failure, clinical presentation as myocardial infarction, and history of congestive heart failure were independently associated with MACEs. In contrast, HbA1C was not associated with patient outcome. In conclusion, this study suggests that HbA1C is not a predictor of cardiac events in diabetic patients with advanced coronary artery disease. These results could explain, at least in part, recent findings of randomized clinical trials that suggest the absence of benefit in macrovascular complications of a strict glycemia control.

Clinical manifestation and prognosis of early versus late stent thrombosis of drug-eluting stents.

BACKGROUND: Stent thrombosis (ST) is a serious complication of drug-eluting stents (DES), leading to catastrophic events. ST can occur early or late following the percutaneous coronary intervention (PCI) with different possible consequences. METHODS: The records of 91 consecutive patients who presented with a definite ST (as defined by the Academic Research Consortium) from 2003 to 2007 were reviewed. Clinical presentation and outcome were compared based on the time of the event. Fifty-one patients presented with an early ST versus 40 with a late ST. The primary end-point was a composite of death-recurrent myocardial infarction (MI)-recurrent ST at 1 year. RESULTS: Baseline characteristics were similar. Patients with early ST had more initial stent implantation for an acute MI indication and presented more with cardiogenic shock when compared to patients with late ST: 43.1% versus 17.5% (P = 0.007) and 39.2% versus 20% (P = 0.042), respectively. There was no difference in the ST treatment except for more intraaortic balloon pump (IABP) use in the early ST group (28% vs. 10%, P = 0.034). Angiographic success rates were similar. The incidence of the composite primary end-point was 52.9% in the early ST group versus 30% in the late ST group (P = 0.034). CONCLUSION: Early definite ST is associated with more dramatic presentation and worse long-term prognosis when compared with definite late ST. This could be explained at least in part by the occurrence of two successive MIs within 30 days in almost 45% of the patients with early ST, leading to a higher rate of cardiogenic shock.

Comparison of degree of stenosis and plaque volume for the assessment of carotid atherosclerosis using 2-D ultrasound.

The degree of carotid stenosis (%ST) remains the most frequently used parameter for identifying patients with high risk of stroke but the relationship between %ST and the occurrence of stroke remains controversial. The objectives of this study were to check (1) the relationship between the %ST and the plaque volume index (PVI) as measured by echography and Doppler, (2) the relationship between the intima media thickness (IMT), a vessel wall remodeling index and the PVI an atheromatous growth index. For each of the 128 patients, (165 carotid stenosis), we measured the % ST (section or diameter), the max stenosis velocity (V(max)), the PVI and the common carotid IMT. The %ST (section) ranged from 10% to 93% (mean 66+/-18), V(max) from 0.3m/s to 3m/s (mean 1.2+/-0.8), PVI from 0.61cm(3) to 1.17cm(3) (mean 0.41+/-0.21) and the IMT from 0.08cm up to 0.31cm (mean 0.12+/-0.03). There was no significant correlation between either PVI and %ST (section or diameter), PVI and minimal stenosis section area (S1) or between PVI and V(max). There was no significant correlation between IMT and both %ST area and PVI. PVI was significantly correlated with the whole artery section area (S2) and the plaque length (L). The %ST (section or diameter) was significantly correlated with S1 but not with S2. The absence of correlation between the PVI and the %ST confirm that these two parameters describe two different processes of the atheromatous development.

Incidence, predictors, and outcome of new, subsequent lesions treated with percutaneous coronary intervention in patients presenting with myocardial infarction.

Despite improving strategies for control of risk factors, progression of atherosclerosis may lead to recurrent cardiac events related to a lesion other than that treated with initial percutaneous coronary intervention (PCI) after ST-elevation myocardial infarction (STEMI). Of 1,007 consecutive patients undergoing primary or rescue PCI for STEMI, 897 who were discharged alive were followed for up to 3 years. Those who underwent nontarget lesion revascularization (non-TLR) were compared with those who did not. Those who underwent a second procedure were followed for an additional 1 year. Altogether, 94 patients (10.5%) required a non-TLR. The median time from the first to the second PCI was 396 days (interquartile range 131 to 533). Subsequent PCI was required for non-STEMI in 46.1% and STEMI in 9.7% of cases. Independent predictors of need for non-TLR were diabetes mellitus, history of coronary bypass surgery, or peripheral vascular disease. By 1 year after the second PCI, 9 patients (9.6%) died, 4 (4.3%) had sustained MI, and 4 (4.3%) had TLR. One of these major adverse events had occurred in 17 (18%). In conclusion, after STEMI, nearly 10% of patients will develop an event that requires subsequent PCI to an unrelated lesion. Patients with diabetes mellitus, history of coronary bypass surgery, or peripheral vascular disease are at increased risk for this event. Aggressive preventive and medical management should be applied to this population for prevention of these subsequent events.

Impact of thrombus aspiration use for the treatment of stent thrombosis on early patient outcomes.

BACKGROUND: Recent data suggest a clinical benefit with the systematic use of thrombus aspiration (TA) for the treatment of ST-elevation myocardial infarction (STEMI). Nevertheless, the impact of TA as a treatment strategy for stent thrombosis (ST) is unknown. This study aimed to analyze the impact of TA use for the treatment of ST on patient outcomes. METHODS: From 2003 to 2008, 91 consecutive patients who presented with a definite ST were included in this analysis. We compared procedural success rates and the incidence of the composite criteria death-recurrent MI-recurrent ST at 30 days in patients who were treated with TA (TA group, n = 36) versus those who were not (No-TA group, n = 55). RESULTS: Baseline characteristics were similar between the two groups except for the body mass index: 26.2 +/- 5.4 vs. 29.3 +/- 6.2 in the TA and No- TA groups, respectively (p = 0.028). ST presented more likely as STEMI in the TA group: 86.1% vs. 67.3% (p = 0.043). Except for TA use, there was no difference in the treatment therapeutics between groups, including for glycoprotein IIb/IIIa inhibitors. The rate of procedural success was higher in the TA group than in the No-TA group: 88.9% vs. 70.9% (p = 0.043). The incidence of the endpoint of death-recurrent MI-recurrent ST was significantly lower in the TA group: 22.2% vs. 47.2% (p = 0.026). By multivariate analysis, TA use was independently associated with a decrease in the composite criteria (HR = 0.45, p = 0.039). CONCLUSION: This study suggests that TA use for ST treatment permits an improvement in patient outcomes at 30 days with a significant decrease in the incidence of the composite criteria death-recurrent MI-recurrent ST. Further prospective studies are needed, however, to definitively address the benefit of TA use in this particular setting.

Impact of bivalirudin on in-hospital bleeding and six-month outcomes in octogenarians undergoing percutaneous coronary intervention.

OBJECTIVES: This study aimed to analyze the impact of replacing heparin with bivalirudin in octogenarians undergoing percutaneous coronary intervention (PCI) on postprocedure hemorrhage and 6-month mortality. BACKGROUND: Randomized trials comparing the antithrombin agent bivalirudin with heparin as the intraprocedural anticoagulant identify a reduction in periprocedural bleeding after PCI. Further, the occurrence of such bleeding seems to predict an increased risk of death or myocardial infarction both in-hospital and at long-term follow-up. Importantly, elderly people who are at the greatest risk of post-PCI bleeding complications are underrepresented in these randomized trials. METHODS: From 2000 to 2007, 2,766 consecutive patients from our center who were > or = 80 years of age underwent PCI with stent implantation and were included in this analysis. Bivalirudin was used in 1,207 (43.6%) patients and heparin in 1,559 (56.4%). We compared the rates of post-PCI bleeding complications and 6-month mortality. RESULTS: The overall in-hospital bleeding and 6-month mortality rates were 4.6% and 11.8%, respectively. By multivariate logistic regression and after adjustment by propensity score analysis, bivalirudin was associated with a significant decrease in in-hospital bleedings (HR = 0.41, 95% CI = 0.23-0.73, P = 0.003). By multivariate Cox analysis, bivalirudin was also associated with a significant decrease (HR = 0.6, 95% CI = 0.4-0.9, P = 0.01) and in-hospital bleedings with a significant increase in the 6-month mortality (HR = 2.5, 95% CI = 1.6-3.9, P < 0.001). CONCLUSION: This study suggests an important subset for use of bivalirudin in lieu of heparin that will benefit the very elderly.

Clinical presentation and outcome of patients hospitalized for symptomatic in-stent restenosis treated by percutaneous coronary intervention: comparison between drug-eluting stents and bare-metal stents.

BACKGROUND: In-stent restenosis remains the major limitation of percutaneous coronary intervention (PCI), particularly after bare-metal stent (BMS) implantation. Drug-eluting stents (DES) decrease in-stent restenosis, which is thought to have minimal clinical consequences, but may increase the risk of stent thrombosis and its attendant high mortality rate. AIMS: To assess the clinical consequences of in-stent restenosis, including severity of associated illness and acute and 1-year outcomes and to compare DES and BMS in-stent restenosis. METHODS: Using our prospective PCI registry, we compared data from 1958 consecutive patients hospitalized with BMS in-stent restenosis between January 2000 and April 2003 and all 190 patients with DES in-stent restenosis admitted between April 2003 and September 2006. Risk-adjusted outcomes were calculated using propensity-score matching. RESULTS: An unstable presentation was noted in 78.1% of 2148 patients. Patients with DES in-stent restenosis presented more often with acute myocardial infarction (4.3% versus 1.6%, p<0.001). At 1 year, mortality for all patients was 5.7% and target-vessel revascularization was 21.5%. After risk adjustment, target-vessel revascularization and target-vessel revascularization-major adverse cardiac events were greater in patients with DES in-stent restenosis (respectively, 27.8% versus 19.7%, p=0.05; 32.5% versus 24.3%, p=0.06). CONCLUSION: In-stent restenosis is associated with unstable presentation and a higher 1-year adverse events rate than expected in patients undergoing elective PCI. For an identical level of cardiac risk, it seems that DES in-stent restenosis outcomes are slightly worse than BMS in-stent restenosis outcomes.