Bivalirudin versus heparin as an antithrombotic agent in patients treated with a sirolimus-eluting stent

Bivalirudin (Angiomax) is increasingly used as a substitute for heparin in a variety of percutaneous coronary interventions. This retrospective, observational study aimed to evaluate the efficacy and safety of bivalirudin compared with heparin as an antithrombotic regimen in patients treated with sirolimus-eluting stents (Cypher) and found that bivalirudin is clinically safe and feasible, with fewer vascular and ischemic complications compared with heparin.     

Guiding-catheter thrombectomy combined with distal protection during primary percutaneous coronary intervention of a saphenous vein graft

Primary percutaneous intervention of saphenous vein grafts is associated with a high risk of distal embolization and no reflow. We report a case of acute myocardial infarction with a large intragraft thrombus, successfully treated with a technique combining thrombectomy with a 6 Fr guiding catheter and distal protection with the FilterWire EZ.     

Initial clinical experience with distal protection using the FilterWire in patients undergoing coronary artery and saphenous vein graft percutaneous intervention.

Percutaneous coronary intervention (PCI) of saphenous vein grafts (SVG) and native coronary arteries may be associated with embolization of particulate debris into the distal microcirculation. The FilterWire uses a polyurethane filter bag contained on a radiopaque loop to trap embolic debris during native vessel and SVG intervention. The objectives of this study were to assess the feasibility and safety of the FilterWire during PCI and to examine the size and content of the particulate debris captured during SVG and native vessel intervention. Early angiographic, in-hospital, and 30-day clinical outcomes were reviewed in 35 patients with 36 lesions treated with the FilterWire during PCI. Lesions were located in 22 (61%) native coronary arteries and in 14 (39%) SVGs. Multivessel coronary artery disease was present in 75% of patients. Lesions were complex (ACC/AHA complexity B2 or C) in 81% of cases. The FilterWire was successfully delivered and deployed distal to the site of coronary intervention in 92% of lesions, including 95% of native vessels and 82% of SVG lesions. Embolic debris was entrapped in 82% of these cases. The average particulate debris had a mean major axis of 490 microm (range, 45-3,302 microm) and minor axis of 226 microm (range, 33-1,677 microm). Although reduced flow was common (36.1%) when the FilterWire was in place, there were no sustained episodes of abrupt closure and only one (2.8%) patient developed sustained no-reflow after FilterWire removal. Distal branch vessel embolization was found in four (11.1%) cases. Major adverse cardiac events occurred in 5 (14%) of 35 patients treated with the device, although 2 of these patients were evolving an acute myocardial infarction at the time of the procedure; in patients meeting the prospectively defined inclusion criteria, the major adverse cardiac event was 6%. These results suggest that the FilterWire is a feasible and safe method of collecting particulate debris released during SVG and native vessel coronary intervention. Its benefit over conventional therapy and other distal protection devices is currently under study.     

A randomized, controlled trial of saphenous vein graft intervention with a filter-based distal embolic protection device: TRAP trial

The purpose of this prospective, multicenter trial was to evaluate the safety and effectiveness of the TRAP Vascular Filtration System (VFS) to reduce embolic complications during stenting of diseased saphenous vein grafts (SVGs). Patients with SVG lesions were randomly assigned to undergo stenting with or without the TRAP device. The trial was designed to enroll 752 randomized patients. However, the sponsor terminated the study after a total of 467 patients (358 randomized) were enrolled because of poor recruitment once another distal protection device was approved for clinical use. The primary study endpoint, major adverse cardiac events at 30 days, occurred in 17.3% of control patients and 12.7% of patients treated with the TRAP device (P = 0.24). There was a trend toward a lower incidence of myocardial infarction in the TRAP group compared with the control group (16.2% vs 10.5%, P = 0.12). This difference was predominantly due to a lower incidence of moderate-large infarction (CKMB >5x) in the TRAP group. Use of the TRAP VFS during SVG intervention was safe and was associated with a trend toward a lower incidence of adverse events, however, due to low enrollment the study lacked sufficient power to detect a significant benefit with the device.     

Determinants of 30-day adverse events following saphenous vein graft intervention with and without a distal occlusion embolic protection device

Distal balloon occlusion was approved as a means of embolic protection during saphenous vein graft intervention based on its ability to decrease major adverse clinical events (MACEs) by 42% in the 801-patient Saphenous Vein Graft Angioplasty Free of Emboli Randomized (SAFER) trial. However, the cost and technical complexity of this device have limited its widespread use and prompted some to avoid its use in cases that appear at "low risk" for complications. If predictors of MACEs and their potential decrease by distal balloon occlusion could be identified, this would have important clinical implications in this challenging population. We therefore used standard demographic and angiographic variables and 2 new angiographic markers (extent of graft degeneration and estimated volume of plaque in the target lesion) to construct multivariable logistic regression models of 30-day of MACEs in the SAFER trial. Independent correlates of increased 30-day MACEs were more extensive vein graft degeneration (p = 0.0001) and bulkier lesions (larger estimated plaque volume, p = 0.0005). Use of a distal balloon occlusion device was independently predictive of lower 30-day rates of MACE (p = 0.01), with uniform benefit across risk strata (no significant interaction between device use and independent angiographic risk factors). Thus, the risk of 30-day MACEs after percutaneous intervention in aortocoronary saphenous vein grafts is increased in more diffusely diseased grafts and in bulkier lesions, but a significant benefit of the GuardWire was seen across all levels of MACE risk rather than just those perceived to be at highest risk.     

Rheolytic thrombectomy with distal filter embolic protection as adjunctive therapies to high-risk saphenous vein graft intervention.

Percutaneous intervention of saphenous vein graft (SVG), especially those with heavy atherothrombotic load, presents high risk for distal embolization and no-reflow. Using the distal filters alone may occasionally be disadvantageous because of the large debris burden and the inability to assess the underlying culprit lesions and vessel size accurately. We present a case of intervention of an occluded SVG using a combination of rheolytic thrombectomy and distal filter embolic protection as a pretreatment before stenting. This strategy has the potential to reduce further the risk of no-reflow and to provide visualization for proper assessment of the underlying anatomy especially in clot-laden vessels.     

Percutaneous saphenous vein graft intervention with sequential embolic protection devices: Complementing lesion anatomy with embolic protection device

Saphenous vein graft (SVG) percutaneous coronary intervention (PCI) carries unique technical challenges requiring the utilization of embolic protection devices (EPDs) to reduce the adverse events associated with distal embolization. Distal embolization is a common and almost ubiquitous consequence of SVG PCI due to the soft and friable nature of the SVG lesions. We describe a case of revascularizing a SVG with tandem stenoses employing the use of two different EPDs that complemented their respective lesion's location within the SVG. © 2008 Wiley‐Liss, Inc.     

GuardWire emboli protection device is associated with improved myocardial perfusion grade in saphenous vein graft intervention

Background

Use of emboli protection devices (EPD) during saphenous vein graft percutaneous coronary intervention (SVG-PCI) has been proven to reduce major adverse cardiac events (MACE). However, the impact of EPD on the microcirculation using Thrombolysis in Myocardial Infarction myocardial perfusion grade (TMP) has not been fully characterized. We sought to analyze TMP after SVG-PCI with and without EPD and determine its impact on inhospital MACE.

Methods

From August 2001 to December 2002, 305 patients had SVG-PCI suitable for EPD; 210 (69%) had an angiogram appropriate for TMP evaluation. Of those, 46 (22%) had an EPD (GuardWire, Medtronic, Minneapolis, Minn) deployed during the coronary intervention. Both groups were similar with regard to most demographic and clinical features.

Results

A TMP score of 2.5 or 3 was obtained in 98% of the EPD group versus 85% of the unprotected SVG-PCI (P = .01). There was a trend towards reduction in MACE when using EPD (15% vs 27%, respectively, P = .07). Peak postprocedural creatine kinase-MB was somewhat lower in the EPD group (6.03 ± 7.8 ng/mL vs 14.87 ± 42 ng/mL, P = .17) Patients with a TMP grade of 2.5 or 3 had a statistically significant reduction in MACE (OR 0.36, 95% CI 0.14-0.87, P = .02).

Conclusions

Compared with SVG-PCI without emboli protection, EPD significantly improved TMP and trended towards a reduction in MACE.     

Bivalirudin versus unfractionated heparin in patients undergoing percutaneous coronary intervention after acute myocardial infarction.

BACKGROUND: Bivalirudin is replacing heparin as the anticoagulant agent of choice for elective percutaneous coronary intervention (PCI). This study aimed to assess the safety and clinical outcomes of bivalirudin versus unfractionated heparin (UFH) in patients undergoing PCI for acute myocardial infarction (AMI). METHODS: A cohort of 672 consecutive patients presenting with AMI without prior thrombolytic therapy were treated with either bivalirudin (216 patients) or UFH (456 patients). Platelet glycoprotein IIb/IIIa inhibitors were administered at the operator's discretion. The in-hospital, 30-day, and 6-month outcomes of the two groups were compared. RESULTS: Baseline clinical and angiographic characteristics were similar between the groups. In-hospital complications were similar, although there was a trend of a less major hematocrit drop in the bivalirudin group (0.9% vs. 3.1%, P=.09). All clinical outcomes were similar between the groups at 30-day and 6-month follow-ups. There was no statistical significance for acute thrombosis and subacute thrombosis between the groups, and there was no late thrombosis from either group. The event-free survival rate was similar between the groups (P=.41). CONCLUSION: The use of bivalirudin in patients undergoing PCI after AMI is safe and feasible. Bivalirudin should be considered as an alternative anticoagulant agent during PCI to treat patients presenting with AMI.     

远端保护装置FilterWire EXTM在冠状动脉旁路移植术后大隐静脉桥病变介入治疗中的临床效果

目的 远端血栓栓塞是冠状动脉旁路移植术后大隐静脉桥的介入治疗过程中常见的并发症,本研究在大隐静脉桥病变的介入治疗中应用新颖的FilterWire EXTM远端保护装置,评价其临床疗效与安全性。方法 选择73例冠状动脉旁路移植术后大隐静脉桥病变患者为研究对象。其中39例患者在FiherWire EXTM的保护下行介入治疗(FilterWire EXTM组),而另34例患者进行无保护的常规介入治疗(对照组)。比较两组患者介入治疗前后的FIMI血流,院内及30 d心脏不良事件发生率。结果 Filter-Wire EXTM在全部病例均成功释放。FiherWire EXTM组经皮冠状动脉介入治疗后TIMI3级血流发生率显著高于对照组(89.74％比76.47％,P<0.05),“无血流”(TIMI 0/1级血流)或“慢血流”(TIMI 2级血流)发生率显著低于对照组(分别为2.56％比8.82％及7.69％比14.70％,P<0.05),院内及30 d心脏不良事件发生率均显著降低(7.69％比17.65％及5.13％比14.71％,P<0.05);未见与装置有关的并发症。结论 在大隐静脉桥病变的介入治疗中联合应用FilterWire EXTM远端保护装置可安全有效,简便易行地预防远端血栓栓塞并发症的发生,显著降低患者院内及30 d心脏不良事件发生率。     

Percutaneous saphenous vein graft interventions with and without distal filter wire protection

BACKGROUND: Embolic protection during SVG interventions using distal balloon occlusion and aspiration has shown to reduce periprocedural complications compared to unprotected SVG interventions. A similar effect is expected from filter wires. PATIENTS AND METHODS: A total of 174 SVG interventions carried out with (group A; n=87) or without distal filter wire protection (group B; n=87) were retrospectively matched for the location of distal graft anastomosis and analyzed for baseline and procedural characteristics, for TIMI flow grade before and after PCI, for the post-procedural CK elevation, and for major adverse cardiac events at 30 days and 6 months (primary end point). Location of distal graft anastomosis was the left anterior descending artery in 19.6%, the left diagonal branch in 6.9%, the left marginal branch in 17.2%, the left posterolateral branch in 24.2%, the mid-segment of the right coronary artery in 28.7%, and the posterior descending artery in 3.4%. RESULTS: Baseline clinical demographics showed no relevant differences between both the groups. Mean age of vein grafts was 11.7+/- 4.3 years in group A versus 10.6+/- 4.9 years in group B (P=0.15). The number of stents per lesion was 1.4+/- 0.8 in group A versus 1.0+/- 0.8 in group B (P<0.01). The total length of stents was 32.2+/- 16.2 mm in group A versus 20.9+/-12.1 mm in group B (P<0.01). TIMI flow grade pre was 2.5+/-0.8 in group A versus 2.7+/- 0.6 in group B (P<0.05). TIMI flow grade post was 2.9+/- 0.3 versus 2.9+/- 0.2. Improvement of TIMI flow grade after SVG intervention was 0.4+/- 0.7 in group A versus 0.2+/- 0.6 in group B (P<0.05). Post-procedural CK-MB elevations were observed in 17 patients of group A versus 14 patients of group B (P=0.18). At 30 days, there were no myocardial infarctions (MIs) and no deaths in either group. One patient of group A had to be reoperated and four patients of group A underwent repeat PCI (4.6%) versus one patient of group B (1.2%). At 6 months, there were again no MIs and no deaths in either group. Target lesion revascularization rate was 17.3% in group A versus 11.5% in group B (P <0.02). CONCLUSION: When distal filter wire protection is used in high risk SVG lesions, the clinical outcome of percutaneous interventions may be equal to low risk SVG lesions without filter wire protection.     

Bivalirudin versus heparin for percutaneous coronary intervention: an updated meta-analysis of randomized controlled trials

AimsGiven controversy over anticoagulation regimens for percutaneous coronary intervention (PCI), we performed an updated meta-analysis of randomized controlled trials (RCTs) to compare bivalirudin versus heparin.Methods and resultsMedline/Pubmed and Cochrane CENTRAL were searched for all RCTs comparing bivalirudin with provisional glycoprotein IIb/IIIa inhibitor (GPI) use versus heparin with provisional or routine GPI use for PCI. Pooled estimates of 30 day outcomes, presented as risk ratios (RR) [95% confidence intervals], were generated with random-effect models. Our analysis included 14 studies with 30,446 patients that were randomized to bivalirudin with provisional GPI use (n = 14,869) versus heparin with provisional (n = 6451) or routine GPI use (n = 9126). There was no significant difference between anticoagulation with bivalirudin compared with heparin for death (RR 0.95 [0.78–1.14]) or myocardial infarction (RR 1.10 [0.97–1.25]). Early stent thrombosis was significantly greater with bivalirudin compared with heparin (RR 1.61 [1.18–2.20], p = 0.003), especially in patients undergoing primary PCI (2.15 [1.15–4.03], p = 0.02). However, bivalirudin reduced the risk of major bleeding (RR 0.59 [0.51–0.70], p < 0.0001) and TIMI major bleeding (RR 0.59 [0.48–0.72], p < 0.0001) compared with heparin. Meta-regression analysis demonstrated that bleeding risk with use of heparin significantly increases with increasing GPI use (p = 0.02).ConclusionMeta-analysis of 14 RCTs with 30,446 patients demonstrated that bivalirudin is associated with higher risk of stent thrombosis but lower risk of major bleeding compared with heparin.     

Outcomes of patients with acute myocardial infarction rom a saphenous vein graft culprit undergoing percutaneous coronary intervention

Objectives : We sought to describe characteristics of patients presenting with an acute MI from a SVG culprit, compared with a native culprit. Background : Percutaneous coronary intervention (PCI) of saphenous vein grafts (SVG) results in worse outcomes than native vessel PCI, but outcomes of such patients with acute myocardial infarction (MI) setting are not well‐described. Methods : Patients presenting with ST‐elevation or non‐ST‐elevation MI undergoing PCI from 2000 to 2010 were retrospectively analyzed to identify the culprit as a SVG vs. native vessel. Multiple linear regression was used to identify predictors of peak troponin‐I level. Cox proportional hazards regression was used to identify predictors of 30‐day mortality and 1‐year major adverse cardiac events (MACE). Results : 192 patients underwent PCI for a SVG culprit, compared with 4,001 with a native culprit. After multivariable adjustment, SVG culprit remained significantly associated with lower levels of the logarithm of the peak troponin (β = ?0.17, SE = 0.07, P = 0.02). The likelihood of MACE was higher in SVG vs. native culprits in patients with small to modest troponin elevations. Patients with a SVG culprit also suffered higher unadjusted rates of mortality at 30 days (14.3% vs. 8.4%, P = 0.03) and MACE at 1 year (36.8% vs. 24.5%, P = 0.005); a modest effect upon mortality and MACE remained after multivariable adjustment. Conclusion : Even minimal elevations of troponin in patients with a SVG culprit may portend a poorer prognosis than in patients with a native culprit. The risk of PCI in this setting is driven by mortality and arises from both substantial comorbidities and the SVG itself. © 2011 Wiley‐Liss, Inc.     

Influence of vessel diameter on the efficacy of distal protection devices during saphenous vein graft intervention

We sought to determine the influence of vessel diameter on the efficacy of distal protection devices during saphenous vein graft intervention. From the Filterwire EX Randomized Evaluation trial, in which patients who underwent saphenous vein graft stenting were randomized to distal protection with the GuardWire or FilterWire EX, outcomes in 572 patients were examined in vessel size tertiles. The 30-day composite incidence of major adverse cardiac events (MACEs) increased with vessel size and was 6.9%, 9.7%, and 14.9% in the smallest, middle, and largest tertiles, respectively (p = 0.04). MACE rates were relatively vessel size independent for the GuardWire but increased steadily with vessel size with the FilterWire EX. In the smallest tertile, MACEs were reduced by 71% with the FilterWire EX compared with the GuardWire (p = 0.05), with the devices showing similar event rates in the other tertiles.