Rate Of Subacute Stent Thrombosis Research Articles

Bivalirudin Versus Heparin With or Without Glycoprotein IIb/IIIa Inhibitors in Patients With STEMI Undergoing Primary Percutaneous Coronary Intervention

In the HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction) trial, 3,602 patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) treated with bivalirudin had lower bleeding and mortality rates, but higher acute stent thrombosis rates compared with heparin+ a glycoprotein IIb/IIIa inhibitor (GPI). Subsequent changes in primary PCI, including the use of potent P2Y12 inhibitors, frequent radial intervention, and pre-hospital medication administration, were incorporated into the EUROMAX (European Ambulance Acute Coronary Syndrome Angiography) trial, which assigned 2,218 patients to bivalirudin versus heparin ± GPI before primary PCI. The goal of this study was to examine the outcomes of procedural anticoagulation with bivalirudin versus heparin ± GPI for primary PCI, given the evolution in primary PCI. Databases from HORIZONS-AMI and EUROMAX were pooled for patient-level analysis. The Breslow-Day test evaluated heterogeneity between trials. A total of 5,800 patients were randomized to bivalirudin (n= 2,889) or heparin ± GPI (n= 2,911). The radial approach was used in 21.3% of patients, prasugrel/ticagrelor was used in 18.1% of patients, and GPI was used in 84.8% of the control group. Bivalirudin compared with heparin ± GPI resulted in reduced 30-day rates of major bleeding (4.2% vs. 7.8%; relative risk [RR]: 0.53; 95% confidence interval [CI]: 0.43 to 0.66; p< 0.0001), thrombocytopenia (1.4% vs. 2.9%, RR: 0.48; 95% CI: 0.33 to 0.71; p= 0.0002), and cardiac mortality (2.0% vs. 2.9%; RR: 0.70; 95% CI: 0.50 to 0.97; p= 0.03), with nonsignificantly different rates of reinfarction, ischemia-driven revascularization, stroke, and all-cause mortality. Bivalirudin resulted in increased acute (<24 h) stent thrombosis rates (1.2% vs. 0.2%; RR: 6.04; 95% CI: 2.55 to 14.31; p< 0.0001), with nonsignificantly different rates of subacute stent thrombosis. Composite net adverse clinical events were lower with bivalirudin (8.8% vs. 11.9%; RR: 0.74; 95% CI: 0.63 to 0.86; p< 0.0001). There was no significant heterogeneity between the 2 trials for these outcomes, and results were consistent across major subgroups. Despite increased acute stent thrombosis, primary PCI with bivalirudin improved 30-day net clinical outcomes, with significant reductions in major bleeding, thrombocytopenia, and transfusions comparedwith heparin ± GPI, results that were consistent with evolution in PCI technique and pharmacotherapy. (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction [HORIZONS-AMI]; NCT00433966) (European Ambulance Acute Coronary Syndrome Angiography [EUROMAX]; NCT01087723).

Comprehensive meta-analysis of safety and efficacy of bivalirudin versus heparin with or without routine glycoprotein IIb/IIIa inhibitors in patients with acute coronary syndrome.

The aim of this meta-analysis was to compare the 30-day safety and efficacy of bivalirudin with those of heparin with or without routine administration of a glycoprotein IIb/IIIa inhibitor (GPI) in patients with acute coronary syndrome (ACS). Bivalirudin has been a mainstay of anticoagulation in patients with ACS compared with heparin. The extent to which trial results have been affected by the coadministration of heparin with a GPI, however, remains unclear. A total of 13 randomized, controlled trials involving 24,605 patients were included. There was no significant difference in 30-day mortality or myocardial infarction rate with bivalirudin compared with heparin with or without routine GPI administration. A reduction of 30-day major bleeding was observed with bivalirudin compared with heparin that was significant when GPI was routinely administered (odds ratio [OR]: 0.52, 95% confidence interval [CI]: 0.45 to 0.60), p < 0.001) but not with provisionally administered GPI (OR: 0.66, 95% CI: 0.33 to 1.32; p = 0.24). The occurrence of stent thrombosis (ST) at 30 days was significantly increased with bivalirudin compared with heparin plus routinely administered GPI (OR: 1.67, 95% CI: 1.13 to 2.45, p = 0.02), but not compared with heparin plus provisionally administered GPI (OR: 2.08, 95% CI: 0.35 to 12.32, p = 0.42). The rate of acute ST (≤ 24 h), however, was almost 4.5-fold higher with bivalirudin compared with heparin with or without GPI, whereas the rate of subacute ST (24 h to 30 days) did not differ significantly. Overall, bivalirudin in ACS patients is associated with a significant reduction of major bleeding compared with heparin plus routinely administered GPI, but with a marked increase in ST rates compared with heparin with or without GPI.

Prevention of non-acute stent thrombosis after drug-eluting stent implantation

To decrease acute myocardial infarction (AMI) and incidence of other cardiovascular event after drug-eluting stent (DES) implantation, so as to prevent non-acute stent thrombosis. Patients who had undergone percutaneous coronary intervention with DES from January 2005 to September 2008 were enrolled. All patients were randomly assigned into two groups with different treatment protocols for anti-thrombosis. The patients in control group were treated with aspirin and clopidogrel for anti-thrombosis (double anti-treatment), while those in observation group were treated with tirofiban and warfarin on top of basic treatment with double anti-thromotic drugs. The latter group of patients received warfarin in addition for 6 months, with the international normalized ratio (INR) maintained at 1.5-2.0. The patients in both groups were followed up at 1-3 months after the treatment, and the deadline was October 2012. Stent thrombosis was assessed by the definition of Dublin for Academic Research Consortium. The main ending point indexes were main adverse cardiac and cerebral events (MACCE), and the secondary ending point indexes were incidence of bleeding and other adverse events. A total of 505 consecutive patients treated with DES implantation were enrolled, 245 in the observation group while 260 in the control. The rates of MACCE at 1- 48 months after operation in observational group were significantly lower than those in control group (1 month: 0.41% vs. 3.08%, 2-6 months: 0 vs. 2.31%, 7-12 months: 0.82% vs. 4.23%, 13-24 months: 1.22% vs. 8.85%, 25- 48 months: 2.04% vs. 12.31%, all P<0.05). Cardiac death (13-24 months: 0.41% vs. 3.08%, 25-48 months: 0.82% vs. 4.23%), non-lethal acute myocardial infarction unrelated with target vessels (25-48 months: 0.41% vs. 3.08%), and rates of revascularization of target vessels (13-24 months: 0.41% vs. 3.08%, 25-48 months: 0.82% vs. 4.23%) in observation group were significantly lower than those in the control group (all P<0.05). The rates of sub-acute stent thrombosis, late stent thrombosis, and very late stent thrombosis in observation group were significantly lower than those in control group (0 vs. 2.31%, 0.82% vs. 4.23%, 1.63% vs. 8.46%, all P<0.05). The rate of bleeding in observational group was a litter higher than control group (3.27% vs. 1.54%, P=0.167) and no severe bleeding occurred. Other severe adverse events were not found in both groups. The results indicate that tirofiban and warfarin combined with aspirin and clopidogrel could reduce the rates of MACCE and bleeding, and it could prevent non-acute stent thrombosis safely and effectively after percutaneous coronary intervention with DES.

Gender differences among patients with acute coronary syndromes undergoing percutaneous coronary intervention in the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR)

Although prior studies have demonstrated disparities in the management and outcomes of women with acute coronary syndrome (ACS), there are limited large-scale contemporary data on gender differences in post-intervention outcomes in this population. We analyzed patients according to 2 ACS categories, unstable angina/non-ST-elevation myocardial infarction (UA/NSTEMI) and ST-elevation myocardial infarction (STEMI) who had a percutaneous coronary intervention in the ACC-NCDR from January 1, 2004, to March 30, 2006. Of 199,690 patients, 55,691 women presented with UA/NSTEMI, and 12,335 women presented with STEMI. Clinical and angiographic characteristics, procedural and treatment patterns, and in-hospital outcomes were examined. Women presented more often with UA/NSTEMI than men (82% of women vs 77% of men, P < .0001). Despite having greater comorbidities, women in both ACS categories had fewer high risk angiographic features than men. Women were less likely to receive aspirin or glycoprotein IIb/IIIa inhibitors, and were less often discharged on aspirin or statin. For in-hospital mortality, the adjusted odds ratio for men compared to women was similar (odds ratio 0.97, P = .5). Women had higher rates of cardiogenic shock, congestive heart failure, any bleeding, and any vascular complications. Importantly, rates of subacute stent thrombosis were less in women compared to men (0.43% vs 0.57%, P = .0003). Although women had fewer high-risk angiographic features than men, they continue to have higher rates of in-hospital complications. This suggests the need for gender-tailored techniques to minimize post-intervention complications and maximize application of evidence-based antiplatelet therapies.

Abstract 3202: Gender Differences Among Patients with Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention in the ACC/NCDR PCI Registry

Background : Cardiovascular disease is the leading cause of death in women. Prior studies have demonstrated gender disparities in the management and outcomes of women with acute coronary syndromes (ACS). Objectives : We sought to explore if gender differences exist in a patient population who present with ACS and have a percutaneous coronary intervention (PCI) during hospitalization in a large, contemporary national PCI registry, the American College of Cardiology National Cardiovascular Data Registry (ACC-NCDR). Methods : We analyzed ACS patients who had a PCI in the ACC-NCDR PCI registry from January 1, 2004 to March 30, 2006. Clinical characteristics, procedural and clinical outcomes, and concomitant medical therapies were compared between men and women according to ACS status: unstable angina (UA)/non-ST elevation MI (NSTEMI) and ST elevation MI (STEMI). Results : Of 199,690 patients with ACS who underwent PCI, women more often presented with unstable angina (57.7% vs. 53.9%), equally with NSTEMI (24.2% vs. 23.6%), and less often with STEMI (18.1% vs. 22.6%) compared with men. In both ACS categories, women were older and had a higher incidence of diabetes (insulin or non-insulin dependent), HTN, PVD, CVA, past and current CHF and renal failure. There was also a higher incidence of cardiogenic shock in women among the STEMI population. The use of drug eluting stents was similar among women and men, but women were less likely to receive aspirin, GP IIb-IIIa inhibitors, and discharge aspirin and statins compared with men. While the adjusted rate of in-hospital mortality was similar among women and men, women had higher rates of peri-procedural complications, including more cardiogenic shock, CHF, bleeding and vascular complications. Rates of subacute stent thrombosis were similar between genders. Conclusions : Women with ACS who underwent PCI were older and more likely to have comorbidities compared with men, and were more likely to have procedural complications. Whether these differences were related to the observed differences in a number of evidence-based medications or clinical characteristics among women vs. men will require further study. Adjusted rate of in-hospital mortality was similar among women and men.

The impact of adjunctive eptifibatide therapy with percutaneous coronary intervention for acute myocardial infarction

The role of small molecules anti-glycoprotein (GP) IIb/IIIa pharmacotherapy during acute myocardial infarction (AMI) has not been established. The purpose of our study was to evaluate the clinical outcomes of patients sustaining AMI who underwent emergent percutaneous coronary intervention (PCI) and who were distinguished by the use of the anti-GP IIb/IIIa agent eptifibatide. We studied a consecutive group of 216 patients who underwent PCI for acute ST-elevation myocardial infarction and compared the outcomes of patients who received eptifibatide just prior and following the procedure (n=167) to those who were not on anti GP IIb/IIIa inhibitors (n=49). On average, patients treated using eptifibatide were younger and were more likely to be men, hypertensive, and smokers. The eptifibatide treated patients were less likely to have diabetes and renal failure and had worse angiographic characteristics. There were no significant differences between the groups in any of the clinical outcomes, including the composite endpoint (e.g. death, MI, repeat revascularization) and the rate of sub-acute stent thrombosis. Nonetheless, there was a non-significant trend towards lower 30 day mortality in the eptifibatide group (4.8% versus 12%, P=0.09). We concluded that in our comparative study of periprocedural administration of eptifibatide during emergent AMI angioplasty, there was a non-significant trend towards better short-term survival among eptifibatide treated patients although the composite endpoint did not differ between patients distinguished by the use of anti GP IIb/IIIa small molecule pharmacotherapy.

Comparison of the heparin coated vs the uncoated JostentS?no influence on restenosis or clinical outcome

Heparin coating of stents is thought to reduce stent thrombosis and restenosis rates. However, clinical data comparing coated and uncoated stents of the same model are lacking. We compared the heparin coated (C) and the uncoated (U) version of the Jostent stent with regard to the clinical and angiographic outcome after 6 months. Provisional stenting was done in 277 patients and 306 lesions; only 40 were Benestent-II like lesions. Delivery success rate was 98.4%. Both groups (C/U: n=156/150 lesions) were comparable in clinical and procedural data. Post stenting, reference diameter (C/U: 2.68+/-0.56/2.66+/-0.53 mm) and minimal lumen diameter did not differ (C/U: 2.48+/-0.47/2.48+/-0.52 mm). During follow-up the rate of subacute stent thrombosis (C/U: 1.9%/1.3%) and myocardial infarction did not differ. Angiography at the 6-month follow-up (79.4%) revealed no difference in restenosis rate (C/U: 33.1%/30.3%). Risk factors for restenosis were a type B2/C lesion (P<0.02), a stented segment longer than 16 mm (P<0.006) and a stent inflation pressure <14 bar (P<0.0063). Corline heparin coating of the Jostent has no impact on the in-hospital complication rate, stent thrombosis or restenosis. The Jostent design gives a high procedural success rate and satisfying result at 6 months in an everyday patient population undergoing provisional stenting.

A prospective evaluation of angiography-guided coronary stent implantation with high versus very high balloon inflation pressure

Background High inflation pressure (HP) after coronary stent deployment has become a standard approach because it has been associated with a decreased subacute stent thrombosis (SAT) rate. However, the impact of HP on long-term outcomes is still unclear. We compared the long-term results of a strategy of increasing HP (≥12 atm) until the achievement of angiographic success (<20% residual stenosis) with a prespecified very high inflation pressure (VHP) strategy of 20 atm without intermediate inflations. Methods and Results We conducted a parallel-group, nonrandomized study to evaluate the short- and long-term results in 136 consecutive eligible patients who underwent successful single Palmaz-Schatz stent implantation in vessels ≥3 mm. Major adverse cardiac events (MACE), that is, death, myocardial infarction, and target lesion revascularization (TLR), were monitored for a minimum of 6 months. No significant differences were observed between the two strategies in terms of final minimal lumen diameter (HP, 3.0 ± 0.5 vs VHP, 3.1 ± 0.5 mm) and acute gain (HP, 2.1 ± 0.7 vs VHP, 2.2 ± 0.6). The overall rate of subacute stent thrombosis was 0.7%. During a 405 ± 148-day follow-up, 21 (28.8%) patients in the VHP group and 6 (9.5%) in the HP group (P =.005) had MACE, with a TLR rate of 27.4% versus 7.9% (P =.009), respectively. By multivariate analysis, the use of VHP increased the odds of long-term MACE by a factor of 3.48 (P =.009). Among patients undergoing TLR, those treated with VHP had a greater lumen loss (HP, 1.83 ± 0.57 vs VHP, 2.15 ± 0.36 mm, P =.02) and a more frequent pattern of diffuse restenosis (71% vs 16%, P =.06). Conclusions In our study, the two strategies had similar acute and short-term results, but VHP was associated with a poorer long-term outcome. These data provide a rationale for a less aggressive strategy for stent deployment by optimizing rather than attempting to maximize inflation pressure and stent expansion. (Am Heart J 2000;140:804-12.)

Trombosis subaguda con tratamiento antiagregante en una población no seleccionada de stents intracoronarios: incidencia y predictores

After coronary stenting, the incidence of subacute stent thrombosis have been reduced to 0% using aspirin and ticlopidine, in studies with selected populations and intracoronary ultrasounds. To evaluate the incidence and predictors of subacute stent thrombosis in a nonselected population, using antithrombotic therapy. We studied 285 stents, consecutively and successfully implanted in 268 lesions of 226 patients. We used high pressure balloon inflation without intracoronary ultrasound. Post-stenting protocol included aspirin and ticlopidine during four weeks with no anticoagulation. We defined subacute stent thrombosis as death, acute myocardial infarction myocardial infarction or angiographic occlusion of stent, with TIMI flow 0-1, after the first 24 hours and during the first month. Four patients presented events (1.7%): Three nonfatal myocardial infarction after discharge, with documented angiographic thrombosis of stent, and one death due to in-hospital myocardial infarction. All three non-fatal AMI, occurred in vessels less than 3 mm (p = 0.07) and in patients taking aspirin without ticlopidine (p < 0.001). After discharge, three (17%) of 18 patients with inadvertent discontinuation of ticlopidine presented subacute stent thrombosis, in contrast to none of 25 patients taking ticlopidine without aspirin. Excluded patients with discontinuation of ticlopidine, the incidence of subacute stent thrombosis was 0.5%. After intracoronary stenting in a nonselected population, using antithrombotic treatment with aspirin and ticlopidine, we may expect a rate of subacute stent thrombosis about 1%. Ticlopidine seems to have the main role in preventing subacute stent thrombosis, above all in predisposing circumstances as small vessels.

Reduction of in-hospital complications after elective percutaneous transluminal coronary angioplasty using a combined pretreatment with ticlopidine and aspirin

In a retrospective study the effect of a combined pretreatment using ticlopidine and aspirin (ASA) in patients undergoing elective PTCA procedures was investigated with respect to in-hospital complications of PTCA and with respect to the efficacy in avoiding a subacute stent thrombosis in case of stent implantation. The systematically performed pretreatment with ticlopidine and ASA takes the delayed begin of full antiplatelet effect of ticlopidine into account. 1108 consecutive patients (group 1) underwent elective PTCA without pretreatment with ticlopidine. In case of stent implantation oral anticoagulation was initiated in this group. In 758 consecutive patients (group 2) with elective PTCA, a combined regimen with ticlopidine and ASA was initiated at least 24 h prior to PTCA and was continued in case of stent implantation. The rate of procedural success, necessary reinterventions, cardiac events (myocardial infarction, death) and complications as well as the rate of subacute stent thrombosis in the subgroups with stent implantation were evaluated. The number of patients without in-hospital cardiac complications (myocardial infarction, coronary artery bypass surgery, death) and without re-PTCA interventions was 92.8% in group 1 and 96.3% in group 2 (p < 0.005). Especially the rate of necessary reinterventions was significantly reduced in group 2 compared with group 1 (5.3% vs. 2.4%, p < 0.001). Cardiac events were reduced in group 2 (myocardial infarction: 2.0% vs. 1.1%, coronary artery bypass graft: 0.8% vs. 0.5%, exitus: 0.5% vs. 0%), the incidence of bleeding complications was similar in both groups (2.5% vs. 2.4%). The combined pretreatment with ticlopidine and ASA with a stent implantation rate of 16.4% in group 2 was effective to avoid a subacute stent thrombosis (1.6%, independent of the indication to stent implantation). One patient of 758 in group 2 had allergic reactions to ticlopidine. The "prophylactic" pretreatment with ticlopidine and ASA in combination with a higher rate of stent implantation reduces necessary reinterventions and cardiac events after PTCA and is effective to avoid subacute stent thrombosis without increase of complications, especially bleeding complications. Thus, this pretreatment can be proposed even in patients scheduled for elective PTCA without planned stent implantation to reduce the interval between a necessary unforeseen stent implantation and the full treatment effects of ticlopidine.

Subacute Stent Thrombosis in the Era of Intravascular Ultrasound-Guided Coronary Stenting Without Anticoagulation: Frequency, Predictors and Clinical Outcome

Objectives. This study was performed to determine predictors of subacute stent thrombosis (SST) in the era of intravascular ultrasound (IVUS)-guided coronary stenting without anticoagulation.Background. The incidence of stent thrombosis has declined with the application of high pressure stent deployment with only antiplatelet therapy. However, no data are available on predictors of stent thrombosis in this era.Methods. Between March 30, 1993 and July 31, 1995, 1,042 consecutive patients underwent coronary stenting without anticoagulation. For this analysis, we excluded patients who underwent coronary artery bypass surgery, died or had acute stent thrombosis within the 1st 24 h after stenting (41 patients). A total of 1,001 patients (1,334 lesions) were included: 982 patients (1,315 lesions) without SST and 19 patients (19 lesions) with SST.Results. The rate of SST was 1.9% (per patient). There was no difference between the SST and No SST groups in rescue stenting (12% vs. 13.5%, p = 1.0) or mean ± SD reference diameter (3.11 ± 0.58 vs. 3.19 ± 0.53 mm, p = 0.54). A preexisting thrombus was present in 12% of the SST group and in 4.5% of the No SST group (p = 0.19). Predictors of SST by univariate analysis were low ejection fraction (p = 0.004), more stents per lesion (p = 0.049), use of combination of different stents (p = 0.012), smaller balloon size (p = 0.012) and suboptimal result in terms of smaller lumen dimensions by angiography (p = 0.016) and IVUS (p = 0.004), residual dissections (p = 0.027) and slow flow (p = 0.0001). In stepwise logistic regression analysis, ejection fraction (p = 0.019), use of a combination of different stents (p = 0.013) and postprocedure dissections (p = 0.014) and slow flow (p = 0.0001) were predictive of SST.Conclusions. In the present era of stent implantation, factors that may predispose to SST are low ejection fraction, intraprocedural complications leading to utilization of more stents, particularly with different stent designs, and suboptimal final result in terms of smaller lumen dimensions and persistent slow flow and dissections.(J Am Coll Cardiol 1997;29:6–12)>