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ESC Congress 2003: Stenting for acute myocardial infarction
September 01, 2003IMPORTANT: This press release accompanies a poster or oral session given at the ESC Congress 2003. Written by the investigator himself/herself, this press release does not necessarily reflect the opinion of the European Society of Cardiology
ESC Congress 2003: We have found that in patients with acute myocardial infarction (AMI) treated with primary angioplasty, additional coronary stenting does not improve clinical outcome at 1-year follow-up, when compared to balloon angioplasty.
Our study was carried out at "De Weezenlanden" Hospital in Zwolle, The Netherlands, between April 1997 and October 2001. It was known as the "Zwolle 6 randomised trial". To overcome limitations of previous randomized trials, we included a consecutive, unselected series of patients with AMI, randomised before angiography to stenting or balloon angioplasty. Clinical data were prospectively collected. Quantitative coronary angiography was analysed by an independent core laboratory (DIAGRAM BV). All patients were reviewed at our outpatient clinic. For patients who died during follow-up, hospital records and necropsy data were reviewed. No patient was lost to follow-up. A total of 1683 patients were randomised to coronary stenting or balloon angioplasty. Our results showed that additional stenting does not reduce mortality, re-infarction, target-vessel revascularisation and all combined events at 1-year follow-up when compared to balloon angioplasty.
Several randomised trials previously conducted in primary angioplasty, and a recent pooled analysis of these trials, have shown that stenting is superior to balloon angioplasty, mainly by a significant reduction in restenosis rate and target vessel revascularisation. But several factors still limit the application and extension of these results to the daily clinical practice. In fact, a late randomisation strategy (after coronary flow was extablished or after optimal balloon angioplasty) selected only patients with an infarct-related artery technically and anatomically suitable for stenting, with only few trials enrolling patients with cardiogenic shock. Furthermore, in most of these trials, the majority of patients underwent angiographic follow-up. In fact, as previously demonstrated, planned angiographic follow-up is associated with a higher rate of repeat revascularisation, in comparison with patients without planned angiographic follow-up. This may have potentially overstated the benefits, shown in these trials, in terms of target vessel revascularisation associated with stenting.
This is the first randomised trial investigating the role of stenting in the "real world" of primary angioplasty. In fact, to overcome the potential limitations of previous conducted studies, we used an early randomisation strategy (before the angiogram), with a planned angiographic follow-up only in a minority of patients. This strategy allowed the inclusion of a consecutive series of patients undergoing primary angioplasty, with a clear picture and description of the daily clinical practice, including patients in cardiogenic shock (1.6%), patients over 75 years old (9.6%), patients with culprit lesions located in graft or left main coronary artery (2.5%).
Several factors may explain the results of the current study. Several randomised trials conducted in the last two decades in patients with AMI, have shown a relevant reduction in mortality and reinfarction, with the use of thrombolysis in comparison with medical therapy, and subsequently with the use of primary angioplasty in comparison with thrombolysis. These studies have found that optimal coronary flow (TIMI 3 flow) is the main determinant of outcome. Since no benefits in terms of coronary flow between stenting and balloon angioplasty have been shown in previous randomised trials and in the current study, and since the very low mortality nowadays observed with mechanical reperfusion, it is conceivable that it is difficult to beat the excellent results obtained with balloon angioplasty in AMI. Furthermore, the absence of benefits in terms of target vessel revascularisation is mainly related to the higher complexity of coronary lesions included in the current study (since the were no exclusion criteria) and to the fact that only a minority of patients underwent angiographic follow-up.
This is the first randomised trial comparing stenting and balloon angioplasty in a large cohort of unselected, consecutive patients. The results suggest that provisional stenting (in case of suboptimal result with balloon angioplasty) is perhaps still the best option in the management of patients with AMI.
Giuseppe De Luca, MD
De Weezenlanden Hopsital, Zwolle,
The Netherlands
European Society of Cardiology (ESC)
Several randomised trials previously conducted in primary angioplasty, and a recent pooled analysis of these trials, have shown that stenting is superior to balloon angioplasty, mainly by a significant reduction in restenosis rate and target vessel revascularisation. But several factors still limit the application and extension of these results to the daily clinical practice. In fact, a late randomisation strategy (after coronary flow was extablished or after optimal balloon angioplasty) selected only patients with an infarct-related artery technically and anatomically suitable for stenting, with only few trials enrolling patients with cardiogenic shock. Furthermore, in most of these trials, the majority of patients underwent angiographic follow-up. In fact, as previously demonstrated, planned angiographic follow-up is associated with a higher rate of repeat revascularisation, in comparison with patients without planned angiographic follow-up. This may have potentially overstated the benefits, shown in these trials, in terms of target vessel revascularisation associated with stenting.
This is the first randomised trial investigating the role of stenting in the "real world" of primary angioplasty. In fact, to overcome the potential limitations of previous conducted studies, we used an early randomisation strategy (before the angiogram), with a planned angiographic follow-up only in a minority of patients. This strategy allowed the inclusion of a consecutive series of patients undergoing primary angioplasty, with a clear picture and description of the daily clinical practice, including patients in cardiogenic shock (1.6%), patients over 75 years old (9.6%), patients with culprit lesions located in graft or left main coronary artery (2.5%).
Several factors may explain the results of the current study. Several randomised trials conducted in the last two decades in patients with AMI, have shown a relevant reduction in mortality and reinfarction, with the use of thrombolysis in comparison with medical therapy, and subsequently with the use of primary angioplasty in comparison with thrombolysis. These studies have found that optimal coronary flow (TIMI 3 flow) is the main determinant of outcome. Since no benefits in terms of coronary flow between stenting and balloon angioplasty have been shown in previous randomised trials and in the current study, and since the very low mortality nowadays observed with mechanical reperfusion, it is conceivable that it is difficult to beat the excellent results obtained with balloon angioplasty in AMI. Furthermore, the absence of benefits in terms of target vessel revascularisation is mainly related to the higher complexity of coronary lesions included in the current study (since the were no exclusion criteria) and to the fact that only a minority of patients underwent angiographic follow-up.
This is the first randomised trial comparing stenting and balloon angioplasty in a large cohort of unselected, consecutive patients. The results suggest that provisional stenting (in case of suboptimal result with balloon angioplasty) is perhaps still the best option in the management of patients with AMI.
Giuseppe De Luca, MD
De Weezenlanden Hopsital, Zwolle,
The Netherlands
European Society of Cardiology (ESC)
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Stent for life initiative
Primary angioplasty (with stent implantation) is the most effective therapy for acute myocardial infarction (AMI), but it is not available to many patients, even though most European countries have sufficient resources (ie, catheterisation laboratories) for its wider use.
Otamixaban for the treatment of patients with non-ST-elevation acute coronary syndromes
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New strategies for reperfusion therapy
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