Felix Zijlstra

Angiographic Assessment of Myocardial Reperfusion in Patients Treated With Primary Angioplasty for Acute Myocardial Infarction Myocardial Blush Grade

BACKGROUND The primary objective of reperfusion therapies for acute myocardial infarction is not only restoration of blood flow in the epicardial coronary artery but also complete and sustained reperfusion of the infarcted part of the myocardium. METHODS AND RESULTS We studied 777 patients who underwent primary coronary angioplasty during a 6-year period and investigated the value of angiographic evidence of myocardial reperfusion (myocardial blush grade) in relation to the extent of ST-segment elevation resolution, enzymatic infarct size, left ventricular function, and long-term mortality. The myocardial blush immediately after the angioplasty procedure was graded by two experienced investigators, who were otherwise blinded to all clinical data: 0, no myocardial blush; 1, minimal myocardial blush; 2, moderate myocardial blush; and 3, normal myocardial blush. The myocardial blush was related to the extent of the early ST-segment elevation resolution on the 12-lead ECG. Patients with blush grades 3, 2, and 0/1 had enzymatic infarct sizes of 757, 1143, and 1623 (P<0.0001), respectively, and ejection fractions of 50%, 46%, and 39%, respectively (P<0.0001). After a mean+/-SD follow-up of 1.9+/-1.7 years, mortality rates of patients with myocardial blush grades 3, 2, and 0/1 were 3%, 6%, and 23% (P<0.0001), respectively. Multivariate analysis showed that the myocardial blush grade was a predictor of long-term mortality, independent of Killip class, Thrombolysis In Myocardial Infarction grade flow, left ventricular ejection fraction (LVEF), and other clinical variables. CONCLUSIONS In patients after reperfusion therapy, the myocardial blush grade as seen on the coronary angiogram can be used to describe the effectiveness of myocardial reperfusion and is an independent predictor of long-term mortality.

Thrombus aspiration during primary percutaneous coronary intervention.

BACKGROUND Primary percutaneous coronary intervention (PCI) is effective in opening the infarct-related artery in patients with myocardial infarction with ST-segment elevation. However, the embolization of atherothrombotic debris induces microvascular obstruction and diminishes myocardial reperfusion. METHODS We performed a randomized trial assessing whether manual aspiration was superior to conventional treatment during primary PCI. A total of 1071 patients were randomly assigned to the thrombus-aspiration group or the conventional-PCI group before undergoing coronary angiography. Aspiration was considered to be successful if there was histopathological evidence of atherothrombotic material. We assessed angiographic and electrocardiographic signs of myocardial reperfusion, as well as clinical outcome. The primary end point was a myocardial blush grade of 0 or 1 (defined as absent or minimal myocardial reperfusion, respectively). RESULTS A myocardial blush grade of 0 or 1 occurred in 17.1% of the patients in the thrombus-aspiration group and in 26.3% of those in the conventional-PCI group (P<0.001). Complete resolution of ST-segment elevation occurred in 56.6% and 44.2% of patients, respectively (P<0.001). The benefit did not show heterogeneity among the baseline levels of the prespecified covariates. At 30 days, the rate of death in patients with a myocardial blush grade of 0 or 1, 2, and 3 was 5.2%, 2.9%, and 1.0%, respectively (P=0.003), and the rate of adverse events was 14.1%, 8.8%, and 4.2%, respectively (P<0.001). Histopathological examination confirmed successful aspiration in 72.9% of patients. CONCLUSIONS Thrombus aspiration is applicable in a large majority of patients with myocardial infarction with ST-segment elevation, and it results in better reperfusion and clinical outcomes than conventional PCI, irrespective of clinical and angiographic characteristics at baseline. (Current Controlled Trials number, ISRCTN16716833.)

Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study

BACKGROUND Percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction can be complicated by spontaneous or angioplasty-induced embolisation of atherothrombotic material. Distal blockage induces microvascular obstruction and can result in less than optimum reperfusion of viable myocardium. The Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS) found that thrombus aspiration resulted in improved myocardial reperfusion compared with conventional PCI, but whether this benefit improves clinical outcome is unknown. We aimed to investigate whether the early efficacy of thrombus aspiration seen in TAPAS translated into clinical benefit after 1 year. METHODS Patients with ST-elevation myocardial infarction enrolled at the University Medical Centre Groningen were randomly assigned in a 1:1 ratio to either thrombus aspiration or conventional treatment, before undergoing initial coronary angiography. Exclusion criteria were rescue PCI after thrombolysis and known existence of a concomitant disease with life expectancy less than 6 months. Of the 1071 patients enrolled between January, 2005, and December, 2006, vital status at or beyond 1 year after randomisation was available for 1060 (99%). The primary endpoint was cardiac death or non-fatal reinfarction after 1 year, and analysis was by intention to treat. The TAPAS trial is registered with Current Controlled Trials number ISRCTN16716833. FINDINGS Cardiac death at 1 year was 3.6% (19 of 535 patients) in the thrombus aspiration group and 6.7% (36 of 536) in the conventional PCI group (hazard ratio [HR] 1.93; 95% CI 1.11-3.37; p=0.020). 1-year cardiac death or non-fatal reinfarction occurred in 5.6% (30 of 535) of patients in the thrombus aspiration group and 9.9% (53 of 536) of patients in the conventional PCI group (HR 1.81; 95% CI 1.16-2.84; p=0.009). INTERPRETATION Compared with conventional PCI, thrombus aspiration before stenting of the infarcted artery seems to improve the 1-year clinical outcome after PCI for ST-elevation myocardial infarction.

Clinical value of 12-lead electrocardiogram after successful reperfusion therapy for acute myocardial infarction

BACKGROUND A simple clinical method to stratify risk for patients who have had successful reperfusion therapy after myocardial infarction is attractive since it facilitates the tailoring of therapy. METHODS We investigated the clinical value of the 12-lead electrocardiogram (ECG), in 403 patients after successful reperfusion therapy by primary coronary angioplasty, in relation to infarct size measured by enzyme activity, left-ventricular function, and clinical outcome. ECGs were analysed to find the extent of the ST-segment-elevation resolution 1 h after reperfusion therapy. FINDINGS A normalised ST segment was seen in 51% of patients, a partly normalised ST segment in 34%, and 15% had no ST-segment-elevation resolution. Enzymatic infarct size and ejection fraction were related to the extent of the early resolution of the ST segment. The relative risk of death among patients with no resolution compared with patients with a normalised ST segment was 8.7 (95% CI 3.7-20.1), and that among patients with partial resolution compared with patients with a normalised ST segment was 3.6 (1.6-8.3). INTERPRETATION Our findings suggest that ECG patterns reflect the effectiveness of myocardial reperfusion. Patients for whom reperfusion therapy by primary angioplasty was successful and who had normalised ST segments had limited damage to the myocardium and an excellent outlook during follow-up. Patients with persistent ST elevation after reperfusion therapy may need additional interventions since they have more extensive myocardial damage and have a higher mortality rate.

Symptom-onset-to-balloon time and mortality in patients with acute myocardial infarction treated by primary angioplasty

OBJECTIVES The aim of the study was to evaluate the relationship between symptom-onset-to-balloon time and one-year mortality in patients with ST-segment elevation myocardial infarction (STEMI) treated by primary angioplasty. BACKGROUND Despite the prognostic implications demonstrated in patients with STEMI treated with thrombolysis, the impact of time-delay on prognosis in patients undergoing primary angioplasty has yet to be established. METHODS Our study population consisted of 1,791 patients with STEMI treated by primary angioplasty from 1994 to 2001. All clinical, angiographic and follow-up data were collected. Subanalyses were conducted according to patient risk profile at presentation and preprocedural Thrombolysis In Myocardial Infarction (TIMI) flow. RESULTS A total of 103 patients (5.8%) had died at one year. Symptom-onset-to-balloon time was significantly associated with the rate of postprocedural TIMI 3 flow (p = 0.012), myocardial blush grade (p = 0.033), and one-year mortality (p = 0.02). A stronger linear association between symptom-onset-to-balloon time and one-year mortality was observed in non-low-risk patients (p = 0.006) and those with preprocedural TIMI flow 0 to 1 (p = 0.013). No relationship was found between door-to-balloon time and mortality. At multivariate analysis, a symptom-onset-to-balloon time >4 h was identified as an independent predictor of one-year mortality (p < 0.05). CONCLUSIONS This study shows that, in patients with STEMI treated by primary angioplasty, symptom-onset-to-balloon time, but not door-to-balloon time, is related to mortality, particularly in non-low-risk patients and in the absence of preprocedural anterograde flow. Furthermore, a symptom-onset-to-balloon time >4 h was identified as independent predictor of one-year mortality.

Randomized Comparison of Coronary Stenting With Balloon Angioplasty in Selected Patients With Acute Myocardial Infarction

BACKGROUND Although the benefits of primary angioplasty in acute myocardial infarction have been demonstrated, several areas for improvement remain. Therefore, a prospective randomized trial comparing primary stenting with balloon angioplasty in patients with acute myocardial infarction was conducted. METHODS AND RESULTS Patients with acute myocardial infarction were randomly assigned to undergo either primary stenting (n=112) or balloon angioplasty (n=115). The clinical end points were death, recurrent infarction, subsequent bypass surgery, or repeat angioplasty of the infarct-related vessel. The overall mortality rate at 6 months was 2%. Recurrent infarction occurred in 8 patients (7%) after balloon angioplasty and in 1 (1%) after stenting (P=0.036). Subsequent target-vessel revascularization was necessary in 19 (17%) and 4 (4%) patients, respectively (P=0.0016). The cardiac event-free survival rate in the stent group was significantly higher than in the balloon angioplasty group (95% versus 80%; P=0.012). CONCLUSIONS In selected patients with acute myocardial infarction, primary stenting can be applied safely and effectively, resulting in a lower incidence of recurrent infarction and a significant reduction in the need for subsequent target-vessel revascularization compared with balloon angioplasty.

Angiographic Assessment of Reperfusion in Acute Myocardial Infarction by Myocardial Blush Grade

Background—Angiographic successful reperfusion in acute myocardial infarction has been defined as TIMI 3 flow. However, TIMI 3 flow does not always result in effective myocardial reperfusion. Myocardial blush grade (MBG) is an angiographic measure of myocardial perfusion. We hypothesized that optimal angiographic reperfusion is defined by TIMI 3 flow and MBG 2 or 3. Methods and Results—In 924 consecutive patients with TIMI 3 flow after angioplasty for acute myocardial infarction, we prospectively studied the value of MBG. End points were death, MACE, enzymatic infarct size, and residual left ventricular ejection fraction. Follow-up was 16±11 months. Of the 924 patients, 101 (11%) patients had MBG 0 or 1. Mortality was significantly higher in patients with MBG 0 or 1 compared with patients with MBG 2 or 3 (relative risk, 4.7; 95% CI, 2.3 to 9.5;P <0.001). The combined incidence of MACE was higher in patients with MBG 0 or 1 compared with patients with MBG 2 or 3 (relative risk, 1.8; 95% CI, 1.1 to 2.8;P =0.009). Enzymatic infarct size was larger (1437±2388 versus 809±1672, P =0.001) and left ventricular ejection fraction was lower (37.7±10.6 versus 43.8±11.1, P <0.001) in patients with MBG 0 or 1 compared with patients with MBG 2 or 3. Conclusions—MBG is a strong angiographic predictor of mortality in patients with TIMI 3 flow after primary angioplasty. Enzymatic infarct size is larger and residual left ventricular ejection fraction is lower in patients with MBG 0 or 1 compared with MBG 2 or 3. Angiographic definition of successful reperfusion should include both TIMI 3 flow as well as MBG 2 or 3.

Reperfusion therapy in elderly patients with acute myocardial infarction: A randomized comparison of primary angioplasty and thrombolytic therapy

OBJECTIVES This study sought to determine the short- and long-term outcome of primary coronary angioplasty and thrombolytic therapy for acute myocardial infarction (AMI) in patients older than 75 years of age. BACKGROUND The benefit of reperfusion therapy in elderly patients with AMI is uncertain, although elderly people account for a large proportion of deaths. METHODS We randomly assigned a total of 87 patients with an AMI who were older than 75 years to treatment with angioplasty or intravenous (IV) streptokinase. Clinical outcome was measured by taking the end points of death and the combination of death, reinfarction or stroke during follow-up. RESULTS The primary end point, a composite of death, reinfarction or stroke, at 30 days had occurred in 4 (9%) patients in the angioplasty group as compared with 12 (29%) in the thrombolysis group (p = 0.01, relative risk [RR]: 4.3, 95% confidence interval [CI]: 1.2 to 20.0). At one year the corresponding figures were 6 (13%) and 18 (44%), respectively (p = 0.001, RR: 5.2, 95% CI: 1.7 to 18.1). CONCLUSIONS In this series of patients with AMI who were older than 75 years, primary coronary angioplasty had a significant clinical benefit when compared with IV streptokinase therapy.

Culprit Vessel Only Versus Multivessel and Staged Percutaneous Coronary Intervention for Multivessel Disease in Patients Presenting With ST-Segment Elevation Myocardial Infarction : A Pairwise and Network Meta-Analysis

OBJECTIVES The purposes of this study were to investigate whether, in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD), percutaneous coronary intervention (PCI) should be confined to the culprit or also nonculprit vessels and, when performing PCI for nonculprit vessels, whether it should take place during primary PCI or staged procedures. BACKGROUND A significant percentage of STEMI patients have MVD. However, the best PCI strategy for nonculprit vessel lesions is unknown. METHODS Pairwise and network meta-analyses were performed on 3 PCI strategies for MVD in STEMI patients: 1) culprit vessel only PCI strategy (culprit PCI), defined as PCI confined to culprit vessel lesions only; 2) multivessel PCI strategy (MV-PCI), defined as PCI of culprit vessel as well as ≥1 nonculprit vessel lesions; and 3) staged PCI strategy (staged PCI), defined as PCI confined to culprit vessel, after which ≥1 nonculprit vessel lesions are treated during staged procedures. Prospective and retrospective studies were included when research subjects were patients with STEMI and MVD undergoing PCI. The primary endpoint was short-term mortality. RESULTS Four prospective and 14 retrospective studies involving 40,280 patients were included. Pairwise meta-analyses demonstrated that staged PCI was associated with lower short- and long-term mortality as compared with culprit PCI and MV-PCI and that MV-PCI was associated with highest mortality rates at both short- and long-term follow-up. In network analyses, staged PCI was also consistently associated with lower mortality. CONCLUSIONS This meta-analysis supports current guidelines discouraging performance of multivessel primary PCI for STEMI. When significant nonculprit vessel lesions are suitable for PCI, they should only be treated during staged procedures.

Adjunctive manual thrombectomy improves myocardial perfusion and mortality in patients undergoing primary percutaneous coronary intervention for ST-elevation myocardial infarction: a meta-analysis of randomized trials

AIMS The benefits of adjunctive mechanical devices to prevent distal embolization in patients with acute myocardial infarction (AMI) are still a matter of debate. Growing interests are on manual thrombectomy devices as compared with other mechanical devices. In fact, they are inexpensive and user-friendly devices, and thus represent an attractive strategy. The aim of the current study was to perform an updated meta-analysis of randomized trials conducted with adjunctive manual thrombectomy devices to prevent distal embolization in AMI. METHODS AND RESULTS The literature was scanned by formal searches of electronic databases [MEDLINE, CENTRAL, EMBASE, and The Cochrane Central Register of Controlled trials (http://www.mrw.interscience.wiley.com/cochrane/Cochrane_clcentral_articles_fs.html)] from January 1990 to May 2008, the scientific session abstracts (from January 1990 to May 2008) and oral presentation and/or expert slide presentations (from January 2002 to May 2008) [on transcatheter coronary therapeutics (TCT), AHA (American Heart Association), ESC (European Society of Cardiology), ACC (American College of Cardiology) and EuroPCR websites]. We examined all randomized trials on adjunctive mechanical devices to prevent distal embolization in AMI. The following keywords were used: randomized trial, myocardial infarction, reperfusion, primary angioplasty, rescue angioplasty, thrombectomy, thrombus aspiration, manual thrombectomy, Diver catheter, Pronto catheter, Export catheter, thrombus vacuum aspiration catheter. Information on study design, type of device, inclusion and exclusion criteria, number of patients, and clinical outcome was extracted by two investigators. Disagreements were resolved by consensus. A total of nine trials with 2417 patients were included [1209 patients (50.0%) in the manual thrombectomy device group and 1208 (50%) in the control group]. Adjunctive manual thrombectomy was associated with significantly improved postprocedural TIMI (thrombolysis in myocardial infarction) 3 flow (87.1 vs. 81.2%, P < 0.0001), and postprocedural MBG 3 (myocardial blush grade 3) (52.1 vs. 31.7%, P < 0.0001), less distal embolization (7.9 vs. 19.5%, P < 0.0001), and significant benefits in terms of 30-day mortality (1.7 vs. 3.1%, P = 0.04). CONCLUSION This meta-analysis demonstrates that, among patients with AMI treated with percutaneous coronary intervention, the use of adjunctive manual thrombectomy devices is associated with better epicardial and myocardial perfusion, less distal embolization and significant reduction in 30-day mortality. Thus, adjunctive manual thrombectomy devices, if not anatomically contraindicated, should be routinely used among STEMI (ST-segment elevation myocardial infarction) patients undergoing primary angioplasty.