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(Chest. 2003;124:962-968.)
© 2003 American College of Chest Physicians

Impact of Tirofiban on Angiographic Morphologic Features of High-Burden Thrombus Formation During Direct Percutaneous Coronary Intervention and Short-term Outcomes*

Hon-Kan Yip, MD; Chiung-Jen Wu, MD; Hsueh-Wen Chang, PhD; Yuan-Kai Hsieh, MD; Chih-Yuan Fang, MD; Shyh-Ming Chen, MD and Mien-Cheng Chen, MD

* From the Division of Cardiology (Drs. Yip, Wu, Hsieh, Fang, S.-M. Chen, and M.-C. Chen), Chang Gung Memorial Hospital, Kaohsiung, Taiwan, Republic of China; and the Department of Biological Sciences (Dr. Chang), National Sun Yat-Sen University, Kaohsiung, Taiwan, Republic of China.

Correspondence to: Mien-Cheng Chen, MD, Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Kaohsiung, 123, Ta Pei Rd, Niao Sung Hsiang, Kaohsiung Hsien, 83301, Taiwan, Republic of China; e-mail: chenmien{at}kinghenry.com.tw


   Abstract
TOP
 Abstract
Introduction
 Materials and Methods
 Results
 Discussion
 References
 
Background: Recently, we demonstrated that angiographic morphologic features of high-burden thrombus formation are independent predictors of combined slow flow (ie, Thrombolysis in Myocardial Infarction [TIMI] grade 2) and no reflow (ie, <= TIMI grade 1) in the infarct-related artery (IRA) after direct percutaneous coronary intervention (d-PCI) for the treatment of acute myocardial infarction (AMI). Current data have demonstrated that when administered in conjunction with PCI for acute coronary syndrome, platelet glycoprotein IIb/IIIa inhibitors can provide additional clinical benefits. Thus, we hypothesized that after pretreatment with tirofiban, angiographic morphologic features of high-burden thrombus formation would no longer be independent predictors of combined slow flow and no reflow after treatment with d-PCI.

Methods and results: Between January 2001 and April 2002, tirofiban was administered to 210 consecutive patients with ST-segment elevated AMI before coronary angiography was performed, and 84 patients (40.0%) were found to have high-burden thrombus formation in the IRA. The TIMI flow grade of the IRA was assessed immediately after the performance of d-PCI, and the 30-day clinical outcomes were evaluated prospectively. The incidence of restoration of normal coronary flow in the IRA was 83.6%. Three baseline angiographic morphologic features indicating high-burden thrombus formation, including (1) the cutoff pattern of occlusion in the IRA (p = 0.0001), (2) the accumulated thrombus proximal to the occlusion (p = 0.0001), and (3) a reference lumen diameter of the IRA of >= 4.0 mm (p = 0.001), were independent predictors of combined slow flow and no reflow. In stratified analysis, the rates of slow flow and no reflow after d-PCI rose rapidly as the number of independent predictors increased (0 predictors, 3.8%; 1 predictor, 29.0%; and 2 predictors, 70.6%). The overall 30-day mortality rate was 6.7%. The mortality rate was significantly higher in patients with TIMI flow lower than or equal to grade 2 than in those with TIMI grade 3 flow (15% vs 1.3%, respectively; p = 0.003).

Conclusions: Tirofiban did not provide additional clinical benefits when administered in conjunction with d-PCI for AMI, even in the subgroup of patients with a high-burden thrombus. Those distinct angiographic morphologic features of high-burden thrombus formation remained as independent predictors of combined slow flow and no reflow after d-PCI, and were independent of the use of tirofiban.

Key Words: acute myocardial infarction • angioplasty • high-burden thrombus • platelet


   Introduction
TOP
 Abstract
 Introduction
Materials and Methods
 Results
 Discussion
 References
 
The benefit of direct percutaneous coronary intervention (d-PCI) is limited by a 5 to 20% incidence of combined slow flow (ie, Thrombolysis in Myocardial Infarction [TIMI] grade 2) and no reflow (ie, less than or equal to TIMI grade 1) phenomena.1 2 3 4 5 Either the slow-flow or no-reflow phenomenon is associated with relatively more extensive myocardial necrosis,6 and consequently left ventricular dilatation, with poor regional and global contractile function, and a poor prognosis.1 7 8 the putative mechanisms for failure to achieve normal coronary flow in the infarct-related artery (IRA) include distal embolization of the thrombus and debris, microvascular damage or edema, reperfusion injury, and microvascular dysfunction resulting from the intervention-induced release of lipid pool-like plaque contents.9 10 11 12 13 However, no specific and efficacious method has been suggested to promptly reverse slow flow or no reflow in the IRA after d-PCI.

Recently, we demonstrated14 that high-burden thrombus formation (ie, angiographic morphologic features such as the cutoff pattern of occlusion in the IRA, the presence of a floating thrombus, accumulated thrombus proximal to the occlusion, persistent dye stasis distal to the occlusion, incomplete occlusion with accumulated thrombus more than three times the reference lumen diameter [RLD], and RLD of the IRA of >= 4.0 mm) played a pivotal role in combined slow flow and no reflow in the IRA after d-PCI.

Growing evidence suggests that when administered in conjunction with d-PCI for the treatment of acute myocardial infarction (AMI), abciximab, a platelet glycoprotein (PG) IIb/IIIa inhibitor, can improve the patency rate in the IRA and provide substantial additional clinical benefits.15 16 In 1999, an investigation of the Platelet Receptor Inhibition for Ischemic Syndrome Management in Patients Limited by Unstable Signs and Symptoms trial17 demonstrated that the addition of tirofiban to heparin reduced the thrombus burden of the culprit lesion and improved distal perfusion in patients with unstable angina or Q-wave myocardial infarction. Whether the effects of tirofiban in that trial can be extrapolated to patients with ST-segment elevated AMI and high-burden thrombus formation in the IRA is unknown. Therefore, the purposes of this study were to determine whether those angiographic morphologic features of high-burden thrombus formation remained as independent predictors of no reflow after d-PCI after pretreatment with tirofiban and whether the administration of tirofiban could reduce the short-term mortality of patients with high-burden thrombus formation in the IRA.


   Materials and Methods
TOP
 Abstract
 Introduction
 Materials and Methods
Results
 Discussion
 References
 
Study Population
Between January 2001 and April 2002, tirofiban was administered before the performance of coronary angiography to 210 consecutive patients (group 1) who presented with ST-segment-elevated AMI of < 12 h duration in our hospital (patients with cardiogenic shock within 18 h also were enrolled into the study) and had no contraindications for tirofiban (12 patients were excluded from the study due to active upper GI bleeding, syncope with head injury, or prolonged resuscitation). Eighty-four patients (40%) had angiographic morphologic features, indicating high-burden thrombus formation in the IRA.14 All of these patients were identified prospectively and were entered into a computerized database. Previous studies4 15 16 have demonstrated the clinical benefit of PG IIb/IIIa inhibitor therapy when administered in conjunction with d-PCI for the treatment of AMI. Therefore, it would have been unethical to perform a randomized study to determine whether those angiographic morphologic features of high-burden thrombus formation14 remained as independent predictors of no reflow after d-PCI after pretreatment with tirofiban. Thus, 794 consecutive patients who had AMI and received d-PCI without adjunctive PG IIb/IIIa inhibitor therapy served as control subjects (group 2).

Procedure and Protocol
PG IIb/IIIa receptor antagonists have been available in our country since August 2001. At the time of our study, our government medical insurance paid for tirofiban only for patients with AMI. In our hospital, all patients with AMI were considered eligible for d-PCI, and tirofiban was administered after informed consent was obtained, unless there were contraindications (ie, exclusion criteria of active upper GI bleeding, bleeding diathesis, AMI followed by syncope with head injury, prolonged resuscitation, neoplasm, recent stroke, major surgery within the preceding 2 months, oral anticoagulant therapy, or uremia). The protocol-designated dosage was a bolus dose of 10 µg/kg body weight given to patients on presentation in the emergency department. Another bolus dose of tirofiban was administered at least 10 min before the first balloon inflation, followed by a maintenance infusion of 0.15 µg/min for 18 to 24 h. Heparin was given as an initial bolus of 70 U/kg (maximum dose, 7,500 U). If necessary, an additional bolus was administered to achieve an activated clotting time of >= 250 s. Stent implantation was strongly encouraged unless the IRA had heavy calcification, an RLD of < 2.5 mm, or postcoronary angioplasty with stent-like results on the treatment site. Early femoral sheath removal was performed when the activated clotting time was < 180 s. Continuous heparin infusion for a further 18 to 24 h was administered only to patients who had received balloon angioplasty. Ticlopidine was administered for 2 weeks to patients who had undergone primary stenting, and aspirin (100 mg orally once a day) was administered to each patient indefinitely.

Angiographic Analysis
Coronary angiographic morphology of the IRA was classified by at least the two best projections immediately after the angiograms and TIMI flow grade18 were assessed, and consensus was reached immediately after the performance of d-PCI by two interventional cardiologists. The angiographic results were further reviewed by another two interventional cardiologists who were unaware of the procedure and the patient’s clinical information. If a consensus was not reached, the final decision was made during the catheterization conference meeting on Saturday. Quantitative angiographic analysis of the percentage of minimal lumen diameter stenosis, lesion length, and RLD was performed by using a digital edge-detection algorithm19 and by selecting end-diastolic frames demonstrating the stenosis in its most severe and nonforeshortened projection. With the contrast-filled guiding catheter used as the calibration standard, the reference and minimal lumen diameters were calculated before and after angioplasty. The angiographic features of high-burden thrombus formation of the IRAs were morphologically classified as follows based on the quantitative and qualitative analyses.14

  1. Type II lesion (ie, incomplete obstruction with an angiographic thrombus with the greatest linear dimension more than three times the RLD)
  2. Cutoff pattern (ie, lesion morphology with an abrupt cutoff at the obstructive level)
  3. Presence of accumulated thrombus (ie, > 5 mm of linear dimension) proximal to the occlusion
  4. Presence of floating thrombus proximal to the occlusion
  5. Persistent dye stasis distal to the obstruction
  6. RLD of the IRA of >= 4.0 mm

Other angiographic morphologies, such as type I lesion (ie, incomplete obstruction with an angiographic thrombus with a greatest linear dimension less than or equal to three times the RLD), taper pattern (ie, lesion morphology with a tapering end before occlusion), and taper cutoff pattern (ie, lesion morphology with proximal tapering and distal abrupt cutoff pattern filled with some thrombus before the occlusion), were categorized as low-burden thrombus formation.

Definitions
AMI was defined as typical chest pain lasting for > 30 min with ST-segment elevation of > 1 mm in two consecutive precordial or inferior leads. Reperfusion time was defined as the time from the symptom onset of chest pain to first balloon inflation. Procedural success was defined as a reduction to residual stenosis of < 50% by balloon angioplasty or successful stent deployment at the desired position with a residual stenosis of < 20% followed by TIMI grade 3 flow in the IRA. Angiographic thrombus was defined as the presence of a luminal filling defect in the IRA. Multivessel disease was defined by stenoses of > 50% in two or more major epicardial coronary arteries. Recurrent ischemia was defined as recurrent chest pain of > 20 min with new ischemic ECG changes. If these findings were associated with at least a 50% increase in the previous creatine kinase isoenzyme MB trough level, reinfarction was diagnosed. Restenosis was defined as a >= 50% stenosis of the previous targeted lesion of the IRA. Distal embolization was defined as the presence of filling defects in or the cutoff of a distal branch or vessel.

Data Collection
In our hospital, all patients with AMI underwent d-PCI after informed consent was obtained. For the purposes of the study, all patients undergoing d-PCI were prospectively identified. Detailed in-hospital and follow-up data including age, sex, coronary risk factors, Killip score on hospital admission, reperfusion time, preintervention and postintervention TIMI flow grades, angiographic morphologic features and results, the number of diseased vessels, and the number of in-hospital adverse events were obtained. These data were collected prospectively and were entered into a computer database.

Statistical Analysis
The data were expressed as the mean ± SD. Continuous variables were compared using the Wilcoxon rank-sum test. Categoric variables were compared using {chi}2 test or Fisher exact test. Stepwise logistic regression analysis was used to determine the independent predictors of combined slow flow and no reflow after d-PCI. A stratified analysis was performed using the covariates that were significant in the multivariate model. Statistical analysis was performed using a statistical software package (SAS for Windows, version 6.12; SAS Institute; Cary, NC). A probability value of < 0.05 was considered to be statistically significant.


   Results
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
Discussion
 References
 
Comparison of Baseline Characteristics, Clinical Features, Angiographic Results, and Combined Major Cardiac Events Between the Two Groups
Relevant patient baseline characteristics, angiographic findings and results, and 30-day major untoward cardiac events are summarized in Tables 1 and 2 . There were no significant differences in terms of age, sex, coronary risk factors, previous myocardial infarctions, previous strokes, infarction locations, the incidences of cardiogenic or noncardiogenic shock, and reperfusion time between group 1 and group 2 patients. The mean duration between the administration of the first loading dose of tirofiban and the first balloon inflation was 25 ± 13.8 min.


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  		Table 1.. Baseline Characteristics of 1,004 Patients*

 

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  		Table 2.. Angiographic Findings, Angioplasty Results, and Clinical Outcomes*

 
Angiographic findings demonstrated that there were no significant differences in the IRA, the incidence of multivessel disease, and the preinterventional TIMI flow grades between group 1 and group 2 patients. Furthermore, angiographic results demonstrated that there were no significant differences in successful or unsuccessful reperfusion rates between group 1 and group 2 patients. However, there were significantly more stent implantations in group 1 than in group 2 patients. There were no significant differences in 30-day mortality or combined major cardiac events between group 1 and group 2 patients.

Angiographic findings demonstrated that the incidence of each of the angiographic morphologic features of high-burden thrombus formation in the IRA was similar between groups except vessel size of the RLD of >= 4.0 mm, which was significantly higher in group 1 than in group 2 patients (Table 3 ). In addition, the incidence of combined slow flow and no reflow after d-PCI in patients with high-burden thrombus formation in the IRA was not different between the two groups.


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  		Table 3.. Incidences of Angiographic Morphologic Features of High-Burden Thrombus Formation and No-Reflow Phenomenon During d-PCI in Both Groups*

 
Comparison of Baseline Characteristics, Clinical Features, Angiographic Results, and Combined Major Cardiac Events Between Patients With Low-Burden Thrombus and High-Burden Thrombus in Group 1
In group 1 patients, the incidence of high-burden intracoronary thrombus was 40% (ie, 84 of 210 patients). There were no significant differences in terms of age, sex, coronary risk factors, previous myocardial infarction, old stroke, incidence of cardiogenic or noncardiogenic shock, and reperfusion time between patients with angiographic morphologic features indicating high-burden thrombus formation and low-burden thrombus formation. However, the incidence of combined slow flow and no reflow in patients with low-burden thrombus was significantly lower than that of patients with high-burden thrombus (3 of 126 patients [2.4%] vs 32 of 84 patients [38.1%], respectively; p = 0.001). In addition, the combined 30-day cardiac events (ie, death, recurrent ischemia, recurrent infarction, and re-PCI) were significantly lower in patients with low-burden thrombus than in patients with high-burden thrombus (6 of 126 patients [4.8%] vs 14 of 84 patients [16.7%], respectively; p = 0.005).

Determinants of Unsuccessful Reperfusion in Group 1 Patients
Univariate analysis of the factors associated with combined slow flow and no reflow after d-PCI is shown in Table 4 . Among the baseline characteristics, only inferior wall infarction and cardiogenic shock were significantly related to higher combined slow flow and no reflow after d-PCI. Further analysis demonstrated that the incidence of right coronary artery infarction was significantly higher (42 of 84 patients [50.0%] vs 32 of 126 patients [25.4%], respectively; p = 0.001) and the incidence of left anterior descending artery infarction was significantly lower (35 of 84 patients [41.7%] vs 86 of 126 patients [68.3%], respectively; p = 0.001) in patients with high-burden thrombus formation than in those without. Moreover, the incidence of an RLD of the IRA of >= 4.0 mm was significantly higher in the right coronary artery than in the left anterior descending artery (35 of 85 patients [41.2%] vs 17 of 122 patients [13.9%], respectively; p < 0.001). Angiographic findings demonstrated that preintervention a TIMI flow grade of 1 or lower was associated with a significantly higher incidence of combined slow flow or no reflow after d-PCI. All of the angiographic morphologic features indicating high-burden thrombus formation in the IRA were associated with a significantly higher incidence of combined slow flow or no reflow after d-PCI. There was no significant difference in successful reperfusion between balloon angioplasty and stenting in group 1 patients.


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  		Table 4.. Univariate Logistic Regression Analysis of Baseline Characteristics and Angiographic Features Relevant to Combined Slow-Flow and No-Reflow Phenomena in Group 1 Patients*

 
By multiple stepwise logistic regression analysis (Table 5 ), only an RLD of the IRA of >= 4.0 mm, cutoff pattern, and type II lesion in the IRA were significant independent predictors of unsuccessful reperfusion.


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  		Table 5.. Multiple Stepwise Logistic Regression Analysis of Angiographic Morphologic Features of IRA in Predicting Slow-Flow or No-Reflow Phenomenon after d-PCI in Group 1 Patients*

 
In a stratified analysis (Table 6 ), the rates of failure to achieve normal flow in the IRA rose rapidly as the number of independent predictors increased (no predictors, 3.8%; one predictor, 29.0%; and two predictors, 70.6%). None of the patients had more than two predictors.


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  		Table 6.. Rates of Slow-Flow or No-Reflow Stratified by Number of Predictors*

 

   Discussion
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
References
 
Comparison With Previous Studies
The ReoPro and Primary PTCA [percutaneous transluminal coronary angioplasty] Organization and Randomized Trial4 demonstrated that abciximab administered in conjunction with primary percutaneous transluminal coronary angioplasty for the treatment of AMI can further improve clinical outcome. However, additional clinical benefits were found only in terms of urgent target vessel revascularization or combined major cardiac events. In addition, there was no difference between balloon angioplasty alone and balloon angioplasty plus abciximab (85.0% vs 85.0%, respectively) in terms of the complete reperfusion of the epicardial coronary artery in that trial. Recently, the Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) trial20 demonstrated that abciximab administered in conjunction with primary stenting for AMI did not provide additional clinical benefits. In the present study, patients who received adjunctive tirofiban therapy did not differ from patients without tirofiban therapy in terms of successful reperfusion and short-term cardiac events, although the percentage of patients receiving primary stenting was slightly higher in group 1 patients than group 2 patients. In addition, those angiographic morphologic features indicating high-burden thrombus formation in the IRA were still independent predictors of combined slow flow and no reflow after d-PCI, and were independent of the use of tirofiban. Furthermore, there was no difference in the incidence of combined slow flow and no reflow after d-PCI between group 1 and group 2 patients with high-burden thrombus formation in the IRA. Therefore, our study demonstrated that tirofiban could not reduce combined slow flow and no reflow in AMI patients with high-burden thrombus formation in the IRA.

Possible Mechanism of Ineffectiveness of Tirofiban in Reducing No-Reflow Phenomenon in Patients With High-Burden Intracoronary Thrombus
Using quantitative and immunohistochemical analysis of intracoronary thrombus aspirated by a PT catheter (Rescue; Boston Scientific; Natick, MA) in patients with AMI, Fujii et al21 showed that > 70% of the surface area of a high-burden intracoronary thrombus consists of RBCs and that > 70% of the surface area of a low-burden intracoronary thrombus consists of platelets. Therefore, this may explain the ineffectiveness of PG IIb/IIIa inhibitors in reducing the no-reflow phenomenon in patients with a high-burden intracoronary thrombus. This observation was supported by the TIMI 14 study,22 which demonstrated that adjunctive therapy with abciximab in patients with AMI results in only partial lysis of the thrombus.

Possible Mechanism of Larger IRA in Predicting No Reflow
Recently, Tanaka and associates13 demonstrated that large vessels with a lipid pool-like image are at high risk for no reflow after d-PCI and suggested that lesions in large vessels are able to contain large amounts of plaque content. During coronary intervention, artificial plaque rupture is induced, which in turn leads to the release of lipid pool-like contents. These contents subsequently cause microembolization, microvascular dysfunction, and the no-reflow phenomenon. PG IIb/IIIa receptor blockades have no effect on reducing the no-reflow phenomenon in this circumstance. In our previous study,14 we demonstrated that an RLD of the IRA of >= 4.0 mm is an independent predictor of combined slow flow and no reflow. In the present study, we also demonstrated that an RLD of the IRA of >= 4.0 mm was an independent predictor of combined slow flow and no reflow, and was independent of the use of tirofiban.

There are several limitations in our study. First, due to ethical reasons, we used a prospective, nonrandomized study design. However, to the best of our knowledge, this is the first study to use tirofiban as adjunctive therapy in patients who have undergone d-PCI for AMI. Second, the optimal dosage and timing of tirofiban administration to achieve inhibition of the majority (85%) of platelet activity in the clinical setting of AMI are unknown. Although a double loading dose of tirofiban was used in this study, and the mean duration between the administration of the first loading dose of tirofiban and the first balloon inflation was 25 ± 13.8 min, the incidences of successful reperfusion and short-term cardiac events were not different between patients who had and had not received adjunctive tirofiban therapy. In addition, the incidence of combined slow flow and no reflow after d-PCI in patients with high-burden thrombus formation in the IRA was not different between the two groups. Third, the effectiveness of adjunctive mechanical removal of intracoronary thrombi with a rheolytic thrombectomy catheter (Angioject; Possis Medical Inc; Minneapolis, MN),23 a distal balloon protection device (GuardWire; PercuSurge; Sunnyvale, CA),24 or an emboli capture guidewire system (AngioGuard; Minneapolis, MN)25 to overcome the no-reflow phenomenon was not assessed in this study.

In conclusion, tirofiban did not provide additional clinical benefits when administered in conjunction with d-PCI for AMI, even in the subgroup of patients with high-burden thrombi. Those distinct angiographic morphologic features of high-burden thrombus formation remained as independent predictors of no reflow after d-PCI and were independent of the use of tirofiban. The rates of slow flow or no reflow after d-PCI rose rapidly as the number of independent predictors increased.


   Footnotes
 
Abbreviations: AMI = acute myocardial infarction; d-PCI = direct percutaneous coronary intervention; IRA = infarct-related artery; PG = platelet glycoprotein; RLD = reference lumen diameter; TIMI = Thrombolysis in Myocardial Infarction

Received for publication September 25, 2002. Accepted for publication January 8, 2003.


   References
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 References
 

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