AngioJet Rheolytic Thrombectomy During Rescue PCI for Failed Thrombolysis: A Single-Center Experience

Transcription

1 AngioJet Rheolytic Thrombectomy During Rescue PCI for Failed Thrombolysis: A Single-Center Experience Dimitri A. Sherev, MD, David M. Shavelle, MD, Murrad Abdelkarim, MD, Thomas Shook, MD, Guy S. Mayeda, MD, Steven Burstein, MD, Ray V. Matthews, MD ABSTRACT: Background. Previous studies have shown the efficacy of AngioJet Rheolytic Thrombectomy () in reducing thrombus burden and improving coronary flow in acute myocardial infarction (MI). No study has specifically evaluated the use of AngioJet in patients undergoing rescue percutaneous coronary intervention (PCI) for failed thrombolysis, a setting that may be particularly beneficial given the extensive thrombus burden. The objective of this study was to evaluate the efficacy and safety of AngioJet during rescue PCI for failed thrombolysis. Methods. 24 consecutive patients were transferred to Good Samaritan Hospital to undergo rescue PCI for failed thrombolysis from January 2000 to October From this cohort, 32 patients (age 57 ± 9, 30% male) undergoing AngioJet for rescue PCI ( group) were identified and matched by initial TIMI flow and infarct related artery (IRA) location to 32 patients (age 60 ± 2, 24% male) undergoing rescue PCI without AngioJet ( group). TIMI frame count and TIMI thrombus grade were assessed at initial and final angiography. Angiographic success (TIMI 3 flow, < 50% residual stenosis) and in-hospital clinical events, including bleeding complications and major adverse cardiac events (MACE) such as death, recurrent MI, target vessel revascularization and emergent bypass surgery were evaluated. Clinical success was defined as angiographic success in the absence of MACE. Results. Baseline clinical characteristics were similar in both groups, except patients undergoing AngioJet were more likely to be males and less likely to be intubated on transfer. 30/32 (94%) patients achieved a TIMI thrombus grade of 0 in the group, compared to 22/32 (69%) in the group. Final IRA TIMI frame count was similar in the compared to the group (33 ± 2 vs. 38 ± 23, p NS, respectively). The occurrence of no reflow was significantly lower in the compared to the group (3% vs. 56%, p < 0.00, respectively). There was a trend for higher angiographic success in the compared to the control group (93% vs. 78%, p = 0.07, respectively). Clinical success was higher in the compared to the group (9% vs. 7%, p = 0.05, respectively). There were no differences in bleeding complications or MACE between the groups. Conclusion. AngioJet in high-risk patients undergoing rescue PCI for failed thrombolysis is safe and more effective in decreasing thrombus burden and preventing no reflow than conventional PCI. 4C J INVASIVE CARDIOL 2006;8:2C 6C Percutaneous coronary intervention (PCI) for acute myocardial infarction (MI) in the setting of angiographic thrombus is associated with an increased risk of reocclusion and recurrent infarction.,2 Distal embolization of thrombus during PCI is thought to be a major contributor to impaired From the Division of Cardiology, Good Samaritan Hospital, Los Angeles, California. Address for correspondence: Ray Matthews, MD, FACC, FSCAI, Division of Cardiology, Good Samaritan Hospital, 225 Wilshire Blvd., Los Angeles, CA rmatthew@lacard.com tissue level perfusion. Previous studies have shown the efficacy of AngioJet Rheolytic Thrombectomy (Possis Medical, Minneapolis, Minnesota) in reducing thrombus burden and improving coronary flow. 3,4 However, no study to date has specifically evaluated the use of AngioJet Rheolytic Thrombectomy () in patients undergoing rescue PCI for failed thrombolytics. Given the high thrombus burden in this setting, AngioJet would be expected to be particularly useful and associated with marked improvements in thrombus burden and coronary flow. The objectives of this study were to characterize the safety and efficacy and to perform a detailed angiographic analysis of AngioJet in patients undergoing rescue PCI for failed thrombolysis. Methods Study population. Two hundred and fourteen consecutive patients were transferred to Good Samaritan Hospital in Los Angeles, California from January 2000 through October 2004 to undergo rescue PCI for failed thrombolysis. The definition of failed thrombolysis was established on clinical grounds and made by the referring physician. All patients had ongoing chest pain, continued ST-segment elevation, hemodynamic instability or malignant ventricular arrhythmias and required transfer for emergent coronary angiography. All patients (n=24) underwent emergent coronary angiography within 6 hours of arrival. Thirty-two patients (5%) underwent Angio- Jet because of intracoronary thrombus per physician discretion ( group, n=32). A group of 32 control patients were identified by matching patients based on infarct related artery (IRA) location and initial TIMI flow grade (control group, n = 32). Interventional procedures and definitions. Cardiogenic shock was defined as systolic blood pressure < 80 mm Hg despite fluid boluses or dependence on vasopressor agents. All patients were treated with thrombolytic therapy prior to transfer (streptokinase 2%; tenecteplase 65%; tissue-type plasminogen activator 26%; retevase 7%). At the time of PCI, heparin was administered following arterial access to maintain an activated clotting time (ACT) of 200 to 250 if a glycoprotein (GP) IIb/IIIa inhibitor was used and 250 to 300 if a GP IIb/IIIa inhibitor was not used. Coronary angioplasty and stent placement were performed using standard techniques. AngioJet rheolytic thrombectomy was performed if significant thrombus was present at the discretion of the operator. Vascular access sheaths were removed 0 to 2 hours following the procedure if the fibrinogen level was greater than 200. After PCI, all patients received 325 mg aspirin and either ticlopidine 250 mg twice

2 AngioJet During Rescue PCI daily or clopidogrel 75 mg once per day for month if a bare metal stent was placed and for 6 months if a drugeluting stent was placed. Recurrent ischemia was defined as anginal chest pain and electrocardiogram (ECG) changes (ST-segment depression or T-wave changes) occurring after the index PCI procedure and not accompanied by elevated cardiac enzymes. Recurrent MI was defined as anginal chest pain and ST-segment reelevation on ECG occurring after the index PCI procedure associated with elevated cardiac enzymes. No reflow was defined as transient or permanent reduction of TIMI flow grade to 0 or from a higher flow grade, at any point during the procedure. Bleeding events were classified as severe or moderate according to the definitions of the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO 2b) Trial. 5 Severe bleeding was defined as intracranial bleeding or bleeding resulting in hemodynamic compromise. Moderate bleeding was defined as bleeding that required blood transfusion but that did not lead to hemodynamic compromise. Major adverse cardiac events (MACE) were defined as the composite of death, recurrent MI or ischemia, emergent coronary artery bypass grafting (CABG) or repeat target vessel revascularization (TVR). Emergent CABG was defined as CABG within 24 hours of an unsuccessful PCI. Angiographic success was defined as restoration of TIMI 3 flow in the IRA with 50% residual stenosis. Clinical success was defined as angiographic success with freedom from MACE. Angiographic analysis. Angiograms were reviewed by two investigators blinded to clinical information and outcome. The initial injection of the IRA was used to determine initial TIMI flow grade and final TIMI flow grade was assessed following guidewire removal. 6 Thrombus grade was evaluated by the methods of the TIMI study group. 7 TIMI frame count (TFC) was measured at the initial and final angiogram by the methods of Gibson et al. 8 The culprit coronary lesion was classified by American College of Cardiology (ACC)/American Heart Association (AHA) criteria. 9 Statistical analysis. Analyses were performed using SAS 3.0 Statistical Software (SAS Institute Inc, Cary, North Carolina). Continuous variables are presented as means ± standard deviations and were compared using student s t-test and frequencies were compared using the chi-square test. A p-value of < 0.05 was considered significant. Results Baseline characteristics. Characteristics of the study groups are shown in Table. In general, the groups were similar, except the group had a higher prevalence of males and the group had a higher prevalence of patients intubated prior to transfer. Time from thrombolytic therapy to angiography and the use of GP IIb/IIIa inhibitors, percutaneous transluminal coronary angioplasty and coronary stents also were similar between the groups. Length of implanted stent was similar among the two groups. Angiographic findings. The prevalence of ACC/AHA type C lesion and initial percent stenosis were similar among Vol. 8, Supplement C, 2006 Table. Baseline clinical characteristics of AngioJet Rheolytic Thrombectomy and groups. Age, years 57±9 60±2 NS Male, n (%) 30 (94) 24 (75) 0.04 Body Mass Index 28±4 29±6 NS Diabetes Mellitus, n (%) 5 (6) (34) 0.08 Hypertension, n (%) 20 (63) 7 (53) NS Prior MI, n (%) 6 (9) 7 (22) NS Prior coronary bypass, n (%) 2 (6) 3 (9) NS Multi-vessel CAD, n (%) (34) 5 (47) NS Prior cardiac arrest, n (%) 3 (9) 3 (9) NS Intubated on transfer, n (%) (3) 7 (22) 0.02 Cardiogenic shock, n (%) 2 (6) 5 (6) NS Infarct Related Artery LAD 6 (50) 6 (50) NS Left Circumflex 2 (6) 2 (6) NS RCA (34) (34) NS Left Main (3) (3) NS Vein Graft 2 (6) 2 (6) NS Time from thrombolytic to angiography, hours 6.5± ±5.7 NS Glycoprotein IIb/IIIa Inhibitor, n (%) 30 (94) 3 (97) NS PTCA 29 (9) 30 (94) NS Stent 29 (9) 29 (9) NS Stent length (mm) NS Intraaortic balloon pump 5 (6) 7 (22) NS mean±standard deviation; PTCA = percutaneous transluminal coronary angioplasty; MI = myocardial infarction; CAD = coronary artery disease; LAD = left anterior descending artery; RCA = right coronary artery. the 2 groups (Table 2). Final angiography showed a trend for a higher prevalence of TIMI grade 3 flow in the compared to the group (94% vs. 78%, p = 0.07, respectively) (Figure ). At initial angiography, there was a higher prevalence of combined TIMI thrombus grade 4 and 5 in the compared to the group (84% vs. 59%, p = 0.03, respectively), indicating a higher thrombus burden in the compared to the group prior to PCI. At final angiography, more patients in the group achieved TIMI thrombus grade 0 compared to those in the group (94% vs. 69%, p = 0.0, respectively) (Figure ). Distal embolization and coronary performation occurred equally in both groups (Table 2) No reflow was significantly reduced in the compared to the group (3% vs. 56%, p = , respectively). TIMI frame count was similar between both groups at initial and at final angiography (Table 2). The improvement in TIMI frame count from initial to final angiography was similar between both groups: 48 ± 33 for the group and 46 ± 32 for the group (Figure ). Clinical outcome. Major bleeding events, stroke, need for emergent bypass surgery, recurrent MI, emergent TVR and death occurred equally in both groups (Table 3). More patients in the group developed renal failure compared to the group (9% vs. 3%, p = 0.05, respectively). 5C

3 MATTHEWS, et al. Table 2. Angiographic findings of AngioJet Rheolytic Thrombectomy and groups. ACC/AHA Type C lesion, n(%) 6 (50) 0 (3) NS Initial Percent Stenosis 94±9 96±6 NS Distal Embolization, n(%) 2 (6) 3 (9) NS Coronary Perforation, n(%) 0 0 No reflow, n(%) 4(3) 8 (56) Contrast volume (ml) 82±94 68±62 NS Fluoroscopy time (minutes) 9.± 6.9±0 NS TIMI Flow Grade Initial Angiography TIMI NS TIMI 3 3 NS TIMI 2 NS TIMI 3 NS Final Angiography TIMI NS TIMI 2 NS TIMI TIMI TIMI Thrombus Grade Initial Angiography TIMI TG NS TIMI TG TIMI TG TIMI TG NS TIMI TG 2 3 NS TIMI TG 0 0 NS Final Angiography TIMI TG NS TIMI TG 4 0 NS TIMI TG NS TIMI TG 2 0 NS TIMI TG TIMI TG TIMI Frame Count Initial 8±28 83±25 NS Final 33±2 38±23 NS Improvement 48±33 46±32 NS Angiographic Success, n(%) 30 (94) 23 (72) 0.07 mean±standard deviation; ml = milliliters The contrast volume and fluoroscopy times were similar among both groups (Table 2). Angiographic success showed a trend to be higher in the compared to the group (94% vs. 78%, p = 0.07, respectively). Clinical success was higher in the compared to the group (9% vs. 72%, p = 0.05, respectively). Discussion The treatment of thrombus-containing lesions during PCI remains problematic. 0 A variety of devices have been reported to remove angiographically apparent coronary thrombus. The Pronto catheter (Vascular Solutions Inc, Minneapolis, Minnesota), allows manual aspiration of clot, but lacks a safety and/or efficacy trial of significant size in the coronary 6C Table 3. Procedural complications and in-hospital clinical outcome of AngioJet Rheolytic Thrombectomy and groups. Death, n(%) (3) 3 (9) NS Recurrent MI, n(%) (3) 2 (6) NS Emergent TVR, n(%) 0 0 Death, MI or TVR, n(%) (3) 4 (3) NS Stroke, n(%) 0 (3) NS Major bleeding events, n(%) (3) 4 (3) NS Emergent bypass surgery, n(%) 0 (3) NS Renal failure, n(%) (3) 6 (9) 0.05 Clinical success, n(%) 29 (9) 23 (72) 0.05 mean±standard deviation; MI = myocardial infarction; TVR = target vessel revascularization. circulation. The X-sizer catheter system (EndiCOR Medical Inc., San Clemente, California) 2 employs a mechanical clot removal mechanism and has been studied in the coronary circulation, but lacks FDA approval for coronary use. The AngioJet system performs a mechanical thrombectomy and has been validated as an effective method to remove thrombus in the setting of acute MI. 3,4 In the current study, these observations were extended by characterizing the use of AngioJet in a consecutive series of patients undergoing rescue PCI for failed thrombolysis. Patients undergoing AngioJet achieved more effective thrombus removal as indicated by a higher prevalence of TIMI 0 thrombus grade at final angiography. This thrombus removal superiority occurred despite the unfair bias of more extensive thrombus burden in the AngioJet group at initial angiography as demonstrated by a higher prevalence of TIMI thrombus grade 4 and 5, compared to the group. GP IIb/IIIa inhibitors have also been advocated as a treatment for thrombus containing lesions. 7,5 However, GP IIb/IIIa inhibitors have not been specifically studied in the setting of rescue PCI for failed thrombolysis 6 and their use may be associated with increased bleeding complications. 7 The use of AngioJet was associated with a significantly lower incidence of the no reflow phenomenon, higher clinical success and a trend toward higher angiographic success. Reducing the occurrence of no reflow is clearly beneficial during rescue PCI for failed thrombolysis, given the critical nature of these patients and the detrimental effects of no reflow on clinical outcome In addition, there were no cases of coronary perforation and major bleeding events were similar compared to the control group, indicating the safety of AngioJet during rescue PCI. Two recently reported randomized trials have sought to validate rescue PCI as a viable clinical strategy following failed thrombolysis. 2,22 Both the Middlesbrough Early Revascularization to Limit Infarction (MERLIN) Trial and the Rescue Angiography after Failed Thrombolysis (REACT) Trial were randomized studies which found a benefit for rescue PCI compared to conservative therapy. The findings of the REACT Trial were more compelling as both recurrent

4 AngioJet During Rescue PCI MI and the combined endpoint for rescue PCI were reduced. In contrast, the MERLIN Trial only found a benefit of rescue PCI for the combined endpoint that was driven primarily by a reduction in revascularization rates. Differences in trial design may partially explain these findings as the use of streptokinase as the thrombolytic agent was significantly lower in REACT compared to the MERLIN Trial (59% vs. 96%). In addition, there was a significantly higher use of coronary stents and GP IIb/IIIa agents in the REACT Trial. Our study attempts to gain additional insight into whether further technical refinement during rescue PCI, with mechanical thrombus removal using AngioJet, might yield further improvements in clinical outcome. It was found that Angio- Jet achieved more effective thrombus removal with the achievement of TIMI thrombus grade 0 in 94% of patients (compared to 69% in the group) and markedly reduced the incidence of no-reflow to 3% (compared to 59% in the group). While the results using AngioJet during rescue PCI are encouraging, the current study is limited by a relatively small subgroup and larger trials will be required to verify these results. Study limitations This report represents a single-center, observational, prospective study of consecutive patients undergoing rescue PCI for failed thrombolysis treated at institution by a single group of interventional cardiologists. The use of AngioJet was not pre-specified, but was done at operator discretion for thrombus-containing lesions. Conclusions AngioJet with rescue PCI for failed thrombolysis in this study was safe and effectively removed thrombus, reduced the occurrence of no re-flow and tended to improve procedural outcomes. Physicians should consider AngioJet in the setting of angiographic thrombus during rescue PCI. Figure. Improvement in TIMI frame count. Vol. 8, Supplement C, 2006 References. Ellis SG, Roubin GS, King SB, III, et al. Angiographic and clinical predictors of acute closure after native vessel coronary angioplasty. Circulation 988;77(2): Singh M, Berger PB, Ting HH, et al. Influence of coronary thrombus on outcome of percutaneous coronary angioplasty in the current era (the Mayo Clinic experience). Am J Cardiol 200;88(0): Silva JA, Ramee SR, Cohen DJ, et al. Rheolytic thrombectomy during percutaneous revascularization for acute myocardial infarction: Experience with the AngioJet catheter. Am Heart J 200;4(3): Kuntz RE, Baim DS, Cohen DJ, et al. A trial comparing rheolytic thrombectomy with intracoronary urokinase for coronary and vein graft thrombus (the Vein Graft AngioJet Study [VeGAS 2]). Am J Cardiol 2002;89(3): An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. The GUSTO investigators. N Engl J Med 993;329(0): Chesebro JH, Knatterud G, Roberts R, et al. Thrombolysis in Myocardial Infarction (TIMI) Trial, Phase I: A comparison between intravenous tissue plasminogen activator and intravenous streptokinase. Clinical findings through hospital discharge. Circulation 987;76(): Gibson CM, de Lemos JA, Murphy SA, et al. Combination therapy with abciximab reduces angiographically evident thrombus in acute myocardial infarction: A TIMI 4 substudy. Circulation 200;03(2): Gibson CM, Cannon CP, Daley WL, et al. TIMI frame count: A quantitative method of assessing coronary artery flow. Circulation 996;93(5): Ryan TJ, Faxon DP, Gunnar RM, et al. Guidelines for percutaneous transluminal coronary angioplasty. A report of the American College of Cardiology/American 7C

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