Background Primary percutaneous coronary intervention (PCI) is effective in opening the infarctrelated 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.)

https://www.medpagetoday.com/upload/2008/2/7/557.pdf

Thrombus Aspiration during Primary Percutaneous Coronary Intervention

BackgroundThe clinical effect of routine intracoronary thrombus aspiration before primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI ...

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Thrombus aspiration during ST-segment elevation myocardial infarction.

Coronary microembolization from the erosion or rupture of a vulnerable atherosclerotic plaque occurs spontaneously in acute coronary syndromes and iatrogenically during percutaneous coronary interventions. Typical consequences of coronary microembolization are microinfarcts with an inflammatory response, contractile dysfunction, and reduced coronary reserve. Apart from transient elevations of creatine kinase and troponin, microemboli can be visualized by intracoronary Doppler and the resulting microinfarcts by late-enhancement nuclear magnetic resonance. Statins, antiplatelet agents, and coronary vasodilators protect against microembolization and microinfarction when started before percutaneous coronary interventions. Distal protection devices can retrieve atherothrombotic debris and prevent its embolization into the microcirculation, but their effect on clinical outcome has been disappointing so far, except for saphenous vein bypass grafts. Devices for aspiration of thrombi and thrombus-derived vasoconstrictor, thrombogenic, and inflammatory substances, however, reduce thrombus burden, improve perfusion, and provide protection in patients with acute myocardial infarction.

Coronary microembolization: from bedside to bench and back to bedside.

Aims Thrombectomy in patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) is associated to better myocardial reperfusion. However, no single trial was adequately powered to asses the impact of thrombectomy on long-term clinical outcome and to identify patients at higher benefit. Thus, we sought to assess these issues in a collaborative individual patient-data pooled analysis of randomized studies (study acronym: ATTEMPT, number of registration: NCT00766740).

Methods and results Individual data of 2686 patients enrolled in 11 trials entered the pooled analysis. Primary endpoint of the study was all-cause mortality. Major adverse cardiac events (MACE) were considered as the occurrence of all-cause death and/or target lesion/vessel revascularization and/or myocardial infarction (MI). Subgroups analysis was planned according to type of thrombectomy device (manual or non-manual), diabetic status, IIb/IIIa-inhibitor therapy, ischaemic time, infarct-related artery, pre-PCI TIMI flow. Clinical follow-up was available in 2674 (99.6%) patients at a median of 365 days. Kaplan–Meier analysis showed that allocation to thrombectomy was associated with significantly lower all-cause mortality ( P = 0.049). Thrombectomy was also associated with significantly reduced MACE ( P = 0.011) and death + MI rate during the follow-up ( P = 0.015). Subgroups analysis showed that thrombectomy is associated to improved survival in patients treated with IIb/IIIa-inhibitors ( P = 0.045) and that the survival benefit is confined to patients treated in manual thrombectomy trials ( P = 0.011).

Conclusion The present large pooled analysis of randomized trials suggests that thrombectomy (in particular manual thrombectomy) significantly improves the clinical outcome in patients with STEMI undergoing mechanical reperfusion and that its effect may be additional to that of IIb/IIIa-inhibitors.

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Clinical impact of thrombectomy in acute ST-elevation myocardial infarction: an individual patient-data pooled analysis of 11 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.

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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

X-Sizer for Thrombectomy in Acute Myocardial Infarction Improves ST-Segment Resolution: Results of the X-Sizer in AMI for Negligible Embolization and Optimal ST Resolution (X AMINE ST) Trial

BACKGROUND: Various stent coatings have been shown to significantly reduce restenosis rates in comparison to non-coated devices. Therefore, the short- and mid-term performance of the new polyphosphazene-coated Coroflex Theca-Stent was investigated. METHODS: 103 patients [63.9 +/- 11 yrs, 5/103 (4.9%) lesion type A, 52/103 (50.5%) type B1, and 46 of 103 (44.6%) type B2] were enrolled for elective single stent deployment into de-novo coronary lesions (stenoses: greater than or equal to 70%, < 100%; reference diameter greater than or equal to 2.75 mm, less than or equal to 4 mm; lesion length: < 16 mm). RESULTS: Deployment and procedural success were 100%, in 57/103 (55.3%) patients without pre-dilatation. 3/103 (2.9%) patients were lost to follow-up. During the 7.1 +/- 2.3 months clinical follow-up, 3 of 100 (3.0%) patients underwent premature target lesion revascularizations, 4 /100 (4%) had non-target lesion-related deaths, and 1 of 100 (1%) suffered myocardial infarction. Among the 77 of 100 (77.0%) patients who underwent angiographic follow-up, the initial stenosis declined from 87.3 +/- 5.7% to 14.2 +/- 8.3% after stenting, and increased to 32.8 +/- 22.7% after 6.4 +/- 1.3 months. The late loss and late loss index were 0.6 +/- 0.7 mm and 0.2 +/- 0.4, respectively; the recurrence rate was 12 of 77 (15.6%), with reintervention required in 11 of 77 (14.3%) of these patients. CONCLUSION: The Coroflex Theca-Stent provides excellent procedural results and a low restenosis rate. Further development of this polymer as the final coating and as the basis for drug-eluting stents seems justified.

Eulegio Garcia

Papers

X-Sizer for Thrombectomy in Acute Myocardial Infarction Improves ST-Segment Resolution: Results of the X-Sizer in AMI for Negligible Embolization and Optimal ST Resolution (X AMINE ST) Trial

Evaluation of the Coroflex Theca-Stent for reduction of restenosis (ECORI).