Since the introduction of clotting factor concentrates, life expectancy of haemophilia patients is increasing and now approaches that of the general male population. Increasingly, haemophilia patients are confronted with age-related co-morbidity, including ischaemic cardiovascular disease. Treatment of stable angina pectoris and the acute coronary syndrome with antithrombotic therapy and percutaneous coronary intervention in haemophilia patients is feasible, but requires a tight co-operation between all specialists involved. As evidence-based guidelines are lacking, we developed a protocol on how we will treat haemophilia patients with ischaemic heart disease.
We thank Niccoli et al for their letter, which interestingly suggested that intracoronary administration of abciximab may exert its action in patients with ST-segment elevation myocardial infarction through facilitation of reversible no reflow. Our study was designed to detect a difference in electrocardiographic and angiographic measures of immediate myocardial reperfusion after primary percutaneous coronary intervention, markers that are frequently used in medium-sized randomized studies and show strong correlation with clinical outcome. 1,2 In this regard, we did not include recovery of myocardial perfusion at a later time point as a prespecified end point. It is not our center's routine clinical practice to reevaluate the initial angiographic result and recovery of myocardial perfusion in the infarct-related artery before discharge, either by repeat angiography or by cardiac magnetic resonance imaging. Because the infarct-related artery may have been filmed in additional revascularization procedures only in highly selected cases, we believe that analysis of this small, nonprespecified subset of patients would not produce meaningful results. In fact, an early study has indicated that intracoronary administration of abciximab significantly reduced the primary end point of microvascular obstruction on cardiac magnetic resonance 2 days after primary percutaneous coronary intervention compared with intravenous administration. 3 Therefore, we agree with Niccoli et al that facilitation of reversible no reflow is one of the plausible mechanisms of action of intracoronary abciximab, a hypothesis that may be further tested in ongoing randomized studies on intracoronary versus intravenous abciximab administration that include cardiac magnetic resonance end points. 4 Rationale and design of the INFUSE-AMI study: a 2ϫ2 factorial, randomized, multicenter, single-blind evaluation of intracoronary abciximab infusion and aspiration thrombectomy in patients undergoing percutaneous coronary intervention for anterior ST-segment elevation myocardial infarction.
The use of a drug-eluting balloon in patients with bifurcation lesions was effective and safe up to 4 months following PCI in patients with coronary artery bifurcation lesions.
Background-Administration of the glycoprotein IIb/IIIa inhibitor abciximab is an effective adjunctive treatment strategy during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction. Although small-scale studies have suggested beneficial effects of intracoronary over intravenous administration of abciximab, this has not been investigated in a medium-scale randomized clinical trial. Methods and Results-A total of 534 ST-segment elevation myocardial infarction patients undergoing primary percutaneous coronary intervention with thrombus aspiration within 12 hours of symptom onset were randomized to either an intracoronary or an intravenous bolus of abciximab (0.25 mg/kg). Patients were pretreated with aspirin, heparin, and clopidogrel. The primary end point was the incidence of restored myocardial reperfusion, defined as complete ST-segment resolution. Secondary end points included myocardial reperfusion as assessed by myocardial blush grade, enzymatic infarct size, and major adverse cardiac events at 30 days. The incidence of complete ST-segment resolution was similar in the intracoronary and intravenous groups (64% versus 62%; Pϭ0.562). However, the incidence of myocardial blush grade 2/3 was higher in the intracoronary group than in the intravenous group (76% versus 67%; Pϭ0.022). Furthermore, enzymatic infarct size was smaller in the intracoronary than in the intravenous group (Pϭ0.008). The incidence of major adverse cardiac events was similar in both groups (5.5% versus 6.1%; Pϭ0.786). Conclusions-In ST-segment elevation myocardial infarction patients undergoing primary percutaneous coronary intervention with thrombus aspiration, intracoronary administration of abciximab compared with intravenous administration does not improve myocardial reperfusion as assessed by ST-segment resolution. However, intracoronary administration is associated with improved myocardial reperfusion as assessed by myocardial blush grade and a smaller enzymatic infarct size. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00927615.
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