Incidence Of Ischemic Complications Research Articles

Flow diversion of ruptured intracranial aneurysms: a single-center study with a standardized antithrombotic treatment protocol

BackgroundThe use of antithrombotic medication following acute flow diversion for a ruptured intracranial aneurysm (IA) is challenging with no current guidelines. We investigated the incidence of treatment-related complications and patient outcomes after flow diversion for a ruptured IA before and after the implementation of a standardized antithrombotic medication protocol.MethodsWe conducted a single-center retrospective study including consecutive patients treated for acutely ruptured IAs with flow diversion during 2015–2023. We divided the patients into two groups: those treated before the implementation of the protocol (pre-protocol) and those treated after the implementation of the protocol (post-protocol). The primary outcomes were hemorrhagic and ischemic complications. A secondary outcome was clinical outcome using the modified Ranking Scale (mRS).ResultsTotally 39 patients with 40 ruptured IAs were treated with flow diversion (69% pre-protocol, 31% post-protocol). The patient mean age was 55 years, 62% were female, 63% of aneurysms were in the posterior circulation, 92% of aneurysms were non-saccular, and 44% were in poor grade on admission. Treatment differences included the use of glycoprotein IIb/IIIa inhibitors (pre-group 48% vs. post-group 100%), and the use of early dual antiplatelets (pre-group 44% vs. 92% post-group). The incidence of ischemic complications was 37% and 42% and the incidence of hemorrhagic complications was 30% and 33% in the pre- and post-groups, respectively, with no between-group differences. There were three (11%) aneurysm re-ruptures in the pre-group and none in the post-group. There were no differences in mortality or mRS 0–2 between the groups at 6 months.ConclusionWe found no major differences in the incidence of ischemic or hemorrhagic complications after the implementation of a standardized antithrombotic protocol for acute flow diversion for ruptured IAs. There is an urgent need for more evidence-based guidelines to optimize antithrombotic treatment after flow diversion in the setting of subarachnoid hemorrhage.

Left subclavian artery coverage during endovascular repair of thoracic aorta injury in trauma and non-trauma patients.

In thoracic endovascular aortic repair (TEVAR), the left subclavian artery (LSA) is often occluded. Although most patients tolerate this, some develop ischemic symptoms to the brain or left upper extremity (LUE). A revascularization procedure may be associated with significant complications. The purpose of this review was to assess the incidence of LSA occlusion, resulting ischemic symptoms, and complications related to revascularization operations in trauma patients compared to non-trauma patients. Studies from 2010 to 2020 were fully reviewed if they discussed incidence of LSA coverage, LUE ischemia, carotid-subclavian bypass, or complications associated with carotid-subclavian bypass. Seventeen articles were included in this analysis. A total of 167 patients were identified as trauma cases. Incidence of LSA occlusion in trauma was 91/167 (54%) compared to 281/1446 (19%) in the population exclusive of trauma (p < 0.001). Following LSA occlusion, the rate of LUE claudication/ischemia was 21/56 (38%) for trauma, compared to 12/193 (6%) in non-trauma cases (p < 0.001). The overall complication rate after carotid-subclavian rescue bypass was 29.2% (33/112), with phrenic nerve palsy (24%), recurrent laryngeal nerve palsy (5%), and pseudoaneurysm (1.7%) being the most common. LSA coverage following TEVAR is common and associated with significant complications, often requiring operative management. The incidence of ischemic complications after occlusion of the LSA is significantly higher in the trauma population. Revascularization procedures to correct the occlusion have a high rate of complications.

Comparison of stent-assisted and non-stent-assisted coils in the treatment of ruptured wide-necked anterior communicating artery aneurysm in acute stage

Objective To compare the safety and efficacy of stent-assisted and non-stent-assisted coil embolization in the treatment of anterior communicating ruptured wide-necked aneurysms in acute phase. Methods The clinical data of 76 patients with anterior traffic rupture wide-necked aneurysm treated by interventional embolism from January 2014 to December 2018 were collected in the People's Hospital of Dezhou.According to whether or not stents were assisted during the operation, 76 cases were divided into stent group (41 cases) and non-stent group (35 cases). The stent group selected the Solitaire AB neurovascular remodoring device or the LVIS support for the corresponding size according to the diameter of the patients’ artery, and the non-stent group used a single catheter, a double catheter, or a balloon assist.The perioperative complications, mortality and clinical prognosis between the two groups were compared. Results There were no statistically significant differences in bleeding complications, symptomatic vasospasm, mortality and clinical prognosis between the two groups (all P>0.05). The incidence of ischemic complications in the stent group was 17.07%(7/41), which was significantly higher than that in the non-stent group[2.86%(1/35)](χ2=4.052, P<0.05). The overall complication rate of the stent group was 21.95%(9/41), which was significantly higher than 5.71%(2/35) of the non-stent group (χ2=4.021, P<0.05). Conclusion Both stent-assisted and non-stent-assisted coils can achieve good clinical results in the treatment of anterior communicating ruptured wide-necked aneurysms in acute phase.Stent-assisted embolism has a high incidence of ischemic complications and needs caution in clinical application. Key words: Intracranial aneurysm; Subarachnoid hemorrhage; Embolization, therapeutic; Tissue scaffolds; Postoperative complications; Prognosis

Intraoperative neuromonitoring during microsurgical clipping for unruptured anterior choroidal artery aneurysm

ObjectiveTo investigate the safety and unexpected finding of the intraoperative neuromonitoring (IONM) including somatosensory evoked potentials (SSEPs) and motor evoked potentials (MEPs) during microsurgical clipping of an unruptured anterior choroidal artery (AChA) aneurysm. Patients and methodsFrom January 2011 to March 2018, the neurophysiological, clinical, and radiological data of 115 patients who underwent microsurgical clipping for an unruptured AChA aneurysm under IONM were retrospectively analyzed. The incidence of ischemic complications after microsurgical clipping of unruptured AChA aneurysms as well as the false-negative rate, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of IONM during surgery were calculated. ResultsIschemic complications after the microsurgical clipping of an AChA aneurysm under IONM occurred in 7 of 115 patients (6.08%). Among them, 3 were symptomatic (2.6%). The false-negative rate of IONM for ischemic complications was 6.08% (7 patients). High specificity; 100% (95% confidence interval [95% CI] = 0.972–1.000), PPVs; 100% (95% CI = 0.055–1.000), and NPVs; 93% (95% CI = 0.945–0.973) with low sensitivity; 11.1% (95% CI = 0.006–0.111) were calculated. ConclusionsIONM including transcranial MEP during microsurgical clipping of unruptured AChA aneurysm might have limited usefulness. Therefore, other MEP monitoring using direct cortical stimulation or modified transcranial methodology should be considered to compensate for it.

出血発症椎骨動脈解離性動脈瘤の治療成績─血管内手術に伴う虚血性合併症について─

出血発症椎骨動脈解離性動脈瘤の治療成績─血管内手術に伴う虚血性合併症について─

Accumetrics-based clopidogrel dosing in endovascular neurosurgery

Introduction:The role of the VerifyNow test to guide clopidogrel therapy in neurosurgical patients is still unclear. This study compared outcomes in patients undergoing neurointerventional procedures on either standard clopidogrel or tailored clopidogrel regimens.Methods:Adult patients undergoing neurointerventional procedures from 1 May 2002 to 31 December 2012 at the University of Illinois Hospital and Health Sciences System were included if they were receiving dual antiplatelet therapy (DAPT) for their procedure. Patients were categorised based on the use of VerifyNow to guide therapy. The primary endpoint was the incidence of thromboembolic complications within 6 months post procedure. Secondary endpoints included the incidence of haemorrhagic complications and death. P2Y12 reaction units (PRU) were recorded when available and categorised based on relation to procedures and/or events.Results:A total of 228 patients were screened with 130 meeting inclusion criteria. Ninety patients were grouped into the standard therapy arm and 30 patients into the tailored therapy arm. There were no differences in the incidence of ischaemic complications (1.1 vs 2.5%, P = 0.522), haemorrhagic complications (17.8 vs 15.0%, P = 0.455) or death (3.0 vs 0%, P = 0.552). Seventeen of 32 patients (53.1%) with PRUs were clopidogrel resistant defined as a PRU >180.Discussion:Use of the VerifyNow test to guide clopidogrel therapy in patients undergoing neurointerventional procedures did not result in a decrease in the incidence of thromboembolic complications compared to standard therapy. There was no difference in the incidence of haemorrhagic complications or death. Further studies are needed to evaluate the impact of tailored therapy using VerifyNow.

Transcatheter Arterial Embolization with N-Butyl Cyanoacrylate for Nonvariceal Upper Gastrointestinal Bleeding in Hemodynamically Unstable Patients: Results and Predictors of Clinical Outcomes

PurposeTo assess the safety, efficacy, clinical outcomes, and prognostic factors associated with transcatheter arterial embolization (TAE) with N-butyl cyanoacrylate (NBCA) for nonvariceal upper gastrointestinal (GI) hemorrhage in hemodynamically unstable patients. Materials and MethodsBetween January 2008 and December 2012, 49 hemodynamically unstable patients (systolic blood pressure < 90 mm Hg and ongoing transfusion requirement) underwent emergency TAE with NBCA for nonvariceal upper GI bleeding and were included in the study. The technical (cessation of extravasation) and clinical (no residual bleeding within 7 d) success rates, incidence of ischemic complications, and clinical and technical predictors of recurrent bleeding within 30 days were analyzed. ResultsThe technical and clinical success rates were 98% and 71%, respectively. There were no ischemic bowel complications; one patient experienced hepatic infarction with elevated liver enzymes. The incidence of major complications was 2%. The incidence of rebleeding within 30 days was 39%. Hematologic malignancies (P = .017), coagulopathy (P = .003), steroid pulse therapy (P = .025), and the absence of NBCA in the target lesions (P = .003) were associated with recurrent bleeding. ConclusionsNBCA embolization can be safely performed in hemodynamically unstable patients with active nonvariceal upper GI bleeding. The clinical factors associated with rebleeding might influence the clinical outcome.

Angioplasty and Stenting for Intracranial Stenosis

Of the patients enrolled in the Japanese Registry of Neuroendovascular Therapy (JR-NET), a surveillance study in Japanese, 1133 patients who underwent intracranial percutaneous transluminal angioplasty (PTA)/stenting for intracranial stenosis during the period from 2005 to 2009 were investigated. A technical success was achieved in 98.3% of the patients, and 70.5% and 7.5% had a residual stenosis of < 30% and ≥ 50%, respectively. The incidence of ischemic complications and hemorrhagic complications was as low as 7.7% and 2.5%, respectively, but tended to increase in patients who underwent stenting. While a significant correlation with ischemic complications was observed in previously untreated patients and patients who underwent stenting followed by post-dilatation, a significant correlation with hemorrhagic complications was observed in patients who received emergency treatment and those treated between 24 hours and 14 days of the onset. Flexible intracranial stents are expected to contribute to improvement in the treatment outcome.

Prophylactic Distal Revascularization and Interval Ligation Procedure During Femoral Vein Transposition Fistula Creation in Patients at High Risk for Ischemic Complications

Femoral vein transposition arteriovenous fistula (FVt AVF) is a viable autologous option when upper extremity dialysis access sites have become compromised. High volume flow through the AVF can lead to ischemic complications, including steal syndrome (SS), and may threaten access and limb viability. Risk factors for SS include: age >60 years, female sex, diabetes, atherosclerosis, hypertension, and previous limb procedures. Two dialysis patients, who were at high risk for SS in their lower extremities as assessed during the preoperative evaluation for an elective FVt AVF, had a distal revascularization and interval ligation (DRIL) procedure concurrently performed. At 42 and 24 months from their respective surgeries, both patients are reliably using their lower extremity autologous access sites and have not developed any signs or symptoms of ischemia. DRIL may represent an effective surgical strategy that can prophylactically be used to minimize the incidence of ischemic complications during FVt AVF in carefully selected, high-risk patients.

Safety and Efficacy of Prolonged Use of Unfractionated Heparin After Percutaneous Coronary Intervention

The current guidelines for percutaneous coronary intervention do not address the prolonged postprocedural use of unfractionated heparin (UFH) to prevent acute occlusion. However, recently published small studies have yielded mixed results, leaving the question unanswered. Hence, we performed a meta-analysis of the existing evidence to assess the safety and efficacy of prolonged infusion of UFH after percutaneous coronary intervention. A systematic review of literature revealed seven studies involving 2412 patients. End points analyzed were ischemic complications (acute closure, myocardial infarction, and repeat revascularization) and major vascular complications (hematoma, arteriovenous fistula, pseudoaneurysm, and retroperitoneal bleed). Because the studies were homogenous for outcomes, combined relative risks across all the studies and the 95% confidence intervals were computed using the Mantel-Haenszel fixed-effect model. A two-sided alpha error <0.05 was considered to be statistically significant. There were no significant differences in patient demographics between both groups. Compared with placebo, the risk of major vascular complication was significantly higher in patients getting postprocedural UFH for prolonged hours (relative risk, 2.24; confidence interval, 1.68-3.48; P = 0.001). However, the risk of ischemic complications was similar in both groups (relative risk, 0.95; confidence interval, 0.46-1.96; P = 0.89). The meta-analysis suggests that routine infusion of UFH after uncomplicated percutaneous coronary intervention may result in increased vascular complications without any reduction in incidence of ischemic complications.

Heparin infusion after successful percutaneous coronary intervention: A prospective, randomized trial

Objective — The aim of this randomized trial was to evaluate whether omission of heparin infusion after successful coronary interventions increased the incidence of ischaemic complications. Continuous heparin infusion after percutaneous coronary interventions could increase the occurrence of bleeding; however, the probable advantages of prolonged heparin infusion are unknown.Methods and results — A total of 200 consecutive patients who underwent successful PTCA were randomly assigned to receive either prolonged heparin (heparin group) or no post-procedural heparin (control group). The two treatment groups were comparable with respect to clinical and angiographic characteristics.The primary end point of the study was in-hospital bleeding and vascular events and secondary end points included in-hospital ischaemic events. Ischaemic complications occurred in 17 (8.5%) patients; ten patients (10%) in the control group and seven patients (7%) in the heparin group. Chest pain with new ECG changes was seen in 11 (5.5%) patients (4% in the heparin group vs. 7% in the control group).Two patients (2%) in the control group had a Q-wave myocardial infarction and one patient in the control group died as a result of ischaemic complications. In the heparin group 2 (2%) patients developed non-Q-wave myocardial infarction and one patient (1%) underwent emergency CABG during the same hospitalization.The difference between groups regarding secondary end points was not statistically significant (P = 0.44).Conclusion — Heparin infusion after successful coronary interventions could increase the occurrence of bleeding and vascular injury; however, omission of heparin after a successful procedure did not significantly increase the incidence of ischaemic complications. Thus routine post-procedure heparin is not recommended.

Abstract 4590: Safety and Efficacy of Prolonged Use of Unfractionated Heparin After Percuatneous Coronary Intervention: A Meta-Analysis

The current guidelines for percutaneous coronary intervention (PCI) do not address the prolonged post-procedural use of unfractionated heparin (UFH) to prevent acute occlusion. However, recently published small studies have yielded mixed results, leaving the question unanswered. Hence a meta-analysis was performed to evaluate safety and efficacy of prolonged use of UFH after PCI. A systematic review of literature revealed 7 studies (Juergens et al, Rabah et al, Garachemani et al, Pizzulli et al, Freidman et al, Tanajura et al and Ellis et al) involving 2412 patients. End points analyzed were ischemic complications (acute closure, myocardial infarction and repeat revascularization) and major vascular complications (hematoma, arterio-venous fistula, pseudo-aneurysm and retroperitoneal bleed). Since the studies were homogenous for outcomes, combined relative risks (RR) across all the studies and the 95% confidence intervals were computed using the Mantel-Haenszel fixed-effect model. A two-sided alpha error &lt; 0.05 was considered to be statistically significant. There were no significant differences in patient demographics between both groups. Compared with placebo the risk of major vascular complication was significantly higher in patients getting post-procedural UFH for prolonged hours (RR: 2.24, CI: 1.68 – 3.48; p=0.001). However, the risk of ischemic complications was similar in both groups (RR: 0.95, CI: 0.46 – 1.96; p=0.89). The meta-analysis suggests that prolonged use of UFH after PCI may result in increased major vascular complications, even though the incidence of ischemic complications may not decrease.

Bleeding during percutaneous intervention: tailoring the approach to minimise risk

The incidence of ischaemic complications during percutaneous intervention (PCI) has reduced over recent years. As a result, bleeding has now emerged as one of the most common complications of PCI...

Effectiveness and safety of bivalirudin during percutaneous coronary intervention in a single medical center

A recent large-scale, randomized trial demonstrated the noninferiority of a strategy of bivalirudin with provisional glycoprotein (GP) IIb/IIIa inhibition compared with routine GP IIb/IIIa inhibition. There is a paucity of outcome data with bivalirudin use in the setting of real-world experience. We evaluated 6,996 patients who underwent percutaneous coronary intervention between January 2001 and December 2004 to compare early and late outcomes with a bivalirudin-based antithrombotic regimen with those with a heparin-based regimen. Propensity adjustment was performed to correct for baseline differences in patient characteristics. Bivalirudin-based therapy was used in 1,070 patients, heparin only in 801 patients, and heparin plus GP IIb/IIIa inhibitors in 5,125 patients. Compared with patients who received heparin or those who received heparin plus GP IIb/IIIa inhibitors, patients who received bivalirudin had lower incidences of bleeding (blood transfusion rate 1.7% vs 4.0%, p <0.001) and periprocedural myonecrosis (creatine kinase-MB >5 times the upper limit of normal 2.7% vs 4.3%, p = 0.016). Differences in bleeding end points remained significant after adjusting for the propensity to receive bivalirudin, but there was no difference in ischemic events. There was no difference in unadjusted long-term survival rate (log-rank test p = 0.46, total number of deaths 412, mean follow-up 17 months) or in propensity-adjusted long-term survival rate (hazard ratio 1.37, 95% confidence interval 0.90 to 2.08, p = 0.14). Compared with heparin with or without GP IIb/IIIa inhibition, the use of bivalirudin in a large consecutive patient registry at a tertiary care center was associated with fewer bleeding events and no evident increase in the incidence of ischemic complications.

Glycoprotein receptor inhibitors in the management of acute coronary syndromes.

Coronary thrombosis and the risk of clinical adverse events remains high despite considerable advances in the management of acute coronary syndromes (ACS) with the combined use of aspirin, heparin, fibrinolytic therapy, and percutaneous coronary intervention (PCI). Platelet aggregation and thrombosis play a key role in the pathogenesis of unstable coronary syndromes. Over the past several years, multiple placebo-controlled trials involving more than 50,000 ACS patients have shown that blockade of the platelet receptor glycoprotein (GP) IIb/IIIa, the final pathway in platelet aggregation, reduces the incidence of ischemic complications among patients with ACS. Three agents (abciximab, eptifibatide, and tirofiban) are currently approved for use with aspirin and heparin in the management of ACS or during percutaneous coronary intervention. They have consistently been shown to reduce the incidence of death or myocardial infarction in the ACS population including the patients not routinely scheduled for early revascularization. They provide an augmented treatment effect among high-risk ACS patients, particularly those who have a baseline troponin-t-positive status. Recently published practice guidelines have recommended their use in high-risk patients with ACS and all those undergoing PCI.

Prolonged heparin after uncomplicated coronary interventions: a prospective randomized trial

Acute ischemic cardiac complications remain a problem in percutaneous transluminal coronary angioplasty (PTCA). The majority of PTCA-related cardiac complications are caused by abrupt vessel closure, which in the majority of cases occurs immediately after the procedure.1,2 Intraprocedural antiplatelet therapy and anticoagulant therapy have been shown to reduce significantly the incidence of ischemic complications occurring during the intervention,3-6 yet it is unclear whether prolonged postprocedural heparin therapy can prevent abrupt vessel closure. Some authors suggest discontinuation of heparin after PTCA,7 whereas in many centers heparin is routinely administered for 12 to 24 hours after the intervention. Prolonged heparin administration increases peripheral vessel complications and prolongs the hospital stay.8 The aim of this study was to evaluate whether discontinuation of heparin after an uncomplicated PTCA increased in-hospital ischemic cardiac complications. Methods Patients with a successful PTCA who had no noncoronary indication for prolonged heparin administration and gave informed consent were randomly assigned into 2 groups. Patients in the first group (heparin group) received continuous heparin infusion of 1000 units/h for 12 to 20 hours. The arterial sheath was removed a few hours after the discontinuation of heparin. The patients were usually discharged the second day after the procedure. In the second group (control group), no heparin was given after the intervention, the sheath was removed 3 to 4 hours after the procedure, and the patients were generally discharged the following day. PTCA procedures were performed by the femoral route according to techniques previously described by using 5F, 6F, or 7F guiding systems. Intraprocedural treatment consisted of oral or intracoronary nitrates, a bolus of 5000 to 20,000 units of heparin, and 250 mg acetylsalicylic acid intravenously for patients who were not already receiving aspirin therapy. Nonionic contrast medium was used in all cases. Sheath removal in both groups was performed with manual or mechanical compression followed by 6 hours of pressure dressing and bed rest. An electrocardiogram (ECG) and creatine kinase (CK) levels were obtained the day after PTCA and in case of prolonged chest pain. In cases of acute prolonged chest pain or new ECG modifications suspicious of abrupt vessel closure, repeat angiography was considered. Primary end points were the occurrence of myocardial From the Department of Cardiology, University Hospital. Submitted Feb. 26, 1997; accepted Feb. 17, 1998. Reprint requests: Bernhard Meier, MD, University Hospital, 3010 Bern, Switzerland. Copyright © 1998 by Mosby, Inc. 0002-8703/98/$5.00 + 0 4/1/90240 Prolonged heparin after uncomplicated coronary interventions: A prospective, randomized trial

Use of low molecular weight heparin in postangioplasty management

The results of using low molecular weight heparin (LMWH) in postangioplasty management are examined. In comparison to intravenous unfractionated heparin, subcutaneous LMWH caused less groin complications and was simpler and cheaper to be administered by the medical personnel. The incidence of ischaemic complications after angioplasty including acute closure and myocardial infarction, however, remained similar and was not excessive. Subcutaneous administration of LMWH provides an alternative simple and cost-effective strategy for postangioplasty management.

Anti-ischaemic therapy during the follow-up phase of acute coronary syndromes. Is there a role for calcium channel blockers?

Various pharmacological strategies are currently being sought to enhance the efficacy of thrombolysis after an acute myocardial infarction (AMI). Apart from the use of new thrombolytic agents, novel anticoagulants and antiplatelet drugs, attention has recently been focused on agents such as the calcium channel blockers (calcium antagonists) traditionally used (prior to the thrombolytic era) for secondary prevention after an AMI. In this context, although calcium channel blockers have not been definitively proven to have any benefit with regard to all-cause mortality or subsequent infarctions, diltiazem has been shown to reduce cardiac mortality, recurrent nonfatal infarction and myocardial ischaemia after non-Q-wave AMI. These benefits have been linked to the drug's effect of lowering heart rate. Since both non-Q-wave AMI and the AMI treated with thrombolytic therapy result in early reperfusion and clinical manifestations of 'incomplete infarction', and are characterised by a similar high incidence of ischaemic complications, it is plausible to hypothesise that prophylactic calcium channel blocker administration to AMI patients post-thrombolysis might decrease the cumulative occurrence of reinfarction and refractory ischaemia during long term follow-up. With this in mind, the Incomplete INfarction Trial of European Research Collaborators Evaluating Prognosis Post-Thrombolysis with Tildiem was initiated in September 1994. This represents the first prospective study to investigate the efficacy of a calcium channel blocker (long-acting diltiazem 300 mg/day) administered as adjunctive therapy with aspirin 160 mg/day in up to 920 patients with an uncomplicated first AMI receiving early thrombolytic therapy. The primary trial objective is to assess the efficacy of blinded therapy on the 6-month cumulative occurrence of a combined clinical end-point (cardiac death, recurrent non-fatal infarction, medically refractory ischaemia)-an end-point identical to that utilised in the assessment of diltiazem in non-Q-wave AMI.

Unrealised potential of calcium antagonists?

Calcium antagonists such as diltiazem may play a promising role in reducing ischaemia during percutaneous transluminal coronary angioplasty (PTCA) and in preventing cardiac events in patients with unstable angina. An ongoing study, the Incomplete INfarction Trial of European Research Collaborators Evaluating Prognosis post-Thrombolysis/Tildiem® (INTERCEPT), also aims to investigate whether prophylactic administration of diltiazem and aspirin can reduce the incidence of ischaemic complications in patients with a first acute myocardial infarction (MI) who are receiving thrombolytic therapy. These and other data were presented at a satellite symposium sponsored by Synthelabo, which was held at the XVIIth Congress of the European Society of Cardiology [Amsterdam, The Netherlands; August 1995].

804-1 Heparin Pretreatment May Confer Additional Benefit in Patients Treated with 7E3 and PTCA for Unstable Coronary Syndromes

Patients undergoing percutaneous intervention for unstable coronary syndromes associated with coronary thrombus are at substantially increased risk of ischemic complications. The incidence of ischemic complications in the EPIC trial was reduced in this subgroup (n = 893) by treatment with the chimeric monoclonal anti-IIb/IIIa antibody 7E3. We assessed the clinical effects of heparin pretreatment in this group. Data were available for 855 patients of whom 583 received 7E3 bolus or bolus and infusion. Of these, 383 (66%) were pretreated with heparin for a mean 55 hours [interquartile range 21, 96]. Outcomes examined included the primary 30 day composite end-point (death, non-fatal infarction, CABG, repeat percutaneous intervention for acute ischemia) components thereof and major bleeding events. Pretreatment Heparin (n = 383) No heparin (n = 200) Odds ratio (95% CI) Primary endpoint 30 (7.8%) 25 (12.5%) 1.7 (0.9, 2.9) Repeat percutaneous intervention or CABG 11 (2.9%) 10 (5.0%) 1.8 (0.7, 4.3) Myocardial infarction 14 (3.7%) 13 (6.5%) 1.8 (0.8, 4.0) Major bleeding event 20 (5.2%) 14 (7.0%) 1.3 (0.7, 2.8) There was a strong trend toward further reduction of ischemic endpoints when patients received heparin pretreatment in addition to 7E3. This effect was not associated with an increased incidence of significant bleeding. These data support further investigation of the potentially additive roles of anti-platelet and anti-thrombotic treatments as adjuncts to percutaneous intervention in unstable coronary syndromes.