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Percutaneous coronary intervention guidelines: new aspects for the interventional treatment of acute coronary syndromes
Albrecht Elsässer and
Christian W. Hamm*
Kerckhoff Heart Center, Bad Nauheim, Germany
* Corresponding author. Tel: +49 6032 9962202; fax: +49 6032 9962298. E-mail address: c.hamm{at}kerckhoff-klinik.de
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Abstract
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In March 2005, the European Society of Cardiology (ESC) guidelines
on percutaneous coronary intervention (PCI) were published,
in which the management of patients with acute coronary syndromes
(ACSs) was presented in detail for the interventional cardiologist.
These guidelines supplement previous guidelines from the ESC
on ACS with and without ST-elevation. Patients presenting with
non-ST-segment elevation ACS should be treated according to
the risk of progressing to myocardial infarction (MI) or death.
Immediate (<2.5 h) or early (<48 h) coronary
angiography and PCI are advised, particularly in patients with
elevated troponin levels or diabetes mellitus. Coronary intervention
in high-risk patients should be performed with triple antiplatelet
therapy (aspirin, clopidogrel, and glycoprotein IIb/IIIa inhibitors).
In patients with ST-segment elevation MI, primary PCI is the
preferred treatment option, particularly >3 h after
onset of clinical symptoms. Adjunctive therapy should include
abciximab. Patients treated with thrombolysis should undergo
invasive evaluation within 24 h. If this cannot be achieved,
ischaemia-driven angiography is recommended.
Key Words: Acute coronary syndrome • Percutaneous coronary intervention
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Introduction
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With a large increase in the number of available publications,
guidelines issued by national societies become increasingly
important in their function as a guide for routine decision-making,
providing the best, most up-to-date care of patients. The European
Society of Cardiology (ESC) has a long tradition of publishing
annual reports and analyses regarding interventional cardiology
across Europe. However, until recently, guidelines on the use
of percutaneous coronary intervention (PCI) had been made available
only by other national societies. The ESC guidelines on the
use of PCI were covered in their guidelines on the management
of patients with acute coronary syndromes (ACSs) with
1 and without
2 ST-elevation. The ESC have now, however, published guidelines
on the use of PCI in ACS, particularly for the interventional
cardiologist.
3
The PCI guidelines were developed by an expert panel on the basis of currently available data derived from randomized and non-randomized clinical trials. On the basis of the level of evidence (A, B, and C), different classes of recommendations (I, IIa, and IIb) for performing PCI are defined. For example, if the scientific evidence is not sufficient, but the experts regard the indication as beneficial, then class I, level of evidence C (I-C), is recommended.
The ESC guidelines on PCI distinguish between ACS without ST-elevation (NSTE-ACS) and with ST-elevation MI (STEMI), because they require different management strategies. The strategies are summarized in algorithms, as presented in Figures 1 and 2.
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Figure 1 Flow chart of the treatment strategy for patients with unstable angina or non-ST-segment elevation MI acute coronary syndromes (NSTE-ACS). ASA, aspirin; UFH, unfractionated heparin; GPI, GP IIb/IIIa inhibitors.
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Figure 2 Flow chart of the treatment strategy for patients with acute STEMI. (Asterisk) Thrombolysis is a possible alternative to primary PCI within 3 h of the onset of symptoms; PCI is indicated for patients who present >3 h after the onset of symptoms.
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ACS without ST-segment elevation
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Treatment of NSTE-ACS should be based on a patient's risk of
progressing to MI or death. Criteria qualifying patients for
the acute high-risk group are:
- recurrent resting angina,
- dynamic ST-segment changes [ST-segment depression >0.1 mV or transient (<30 min) ST-segment elevation <0.1 mV],
- elevated troponin-I, troponin-T, or creatine kinase-myocardial bound (CK-MB) levels,
- haemodynamic instability within the observation period,
- major arrhythmias (ventricular tachycardia and ventricular fibrillation),
- early post-infarction unstable angina, and
- diabetes mellitus.
In addition, other parameters indicating a high long-term risk are used for risk assessment in NSTE-ACS:4–18
- age >65–70;
- history of known coronary artery disease, previous MI, prior PCI, or coronary artery bypass graft;
- congestive heart failure, pulmonary oedema, and new mitral regurgitation murmur;
- elevated inflammatory markers (C-reactive protein, fibrinogen, and interleukin-6);
- brain natriuretic peptide (BNP) or N-terminal pro-BNP in the upper quartiles; and
- renal insufficiency.
Patients classified as high risk benefit from an early angiography and PCI in contrast to patients in the low-risk group (Figure 1).4–6,19,20 On the basis of the results of three trials [i.e. FRISC II (Fragmin and Fast Revascularization During Instability in Coronary Artery Disease),21 TACTICS-TIMI 18 (Treat Angina with Aggrastat and Determine Cost of Therapy with Invasive or Conservative Strategy—Thrombolysis in Myocardial Infarction 18),22 and RITA-3 (Randomised Intervention Trial of Unstable Angina 3)],23 the invasive procedure should be performed within 48 h of the onset of symptoms (so-called early PCI: recommendation I-A). The ISAR-COOL (Intracoronary Stenting with Antithrombotic Regimen Cooling-Off) trial showed that an immediate PCI (within <2.5 h) could improve the outcome of death from any cause and large non-fatal MI at 30 days when compared with a primary ‘cooling down’ strategy in patients with high-risk ACS.24 However, this finding is from a single study; the final results of other studies are still pending. Immediate PCI is therefore given an IIa-B recommendation.
Adjunctive therapy
With respect to ancillary treatment, the choice of heparin is left open. Unfractionated heparins have the advantage of easier control and better reversibility by protamin. Enoxaparin is advised only if an invasive strategy is not applicable (I-C). On the basis of the results of the SYNERGY (Superior Yield of the New Strategy of Enoxaparin, Revascularization, and Glycoprotein IIb/IIIa Inhibitors) study, heparins should not be switched, to avoid bleeding complications. The data for bivalirudin are regarded as not yet sufficient to support its replacement of heparin, except with the intention to reduce bleeding complications (IIa-C).
Antiplatelet pre-treatment before PCI in high-risk patients should consist of a triple regimen: aspirin, clopidogrel, and GP IIb/IIIa inhibitors. Abciximab or eptifibatide is recommended when the treatment is initiated in the catheterization laboratory (I-C). Tirofiban or eptifibatide should be given in a ‘drip-and-ship’ strategy (e.g. if the PCI is unlikely to be performed within 2.5 h). Antithrombotic treatment should be continued after PCI for 12 h in the case of abciximab and for 16 h in the case of eptifibatide25–28 (Table 1).
Clopidogrel is recommended at a loading dose of 600 mg
immediately after first medical contact on top of aspirin (100 mg)
(I-C) (
Table 2). The high dose may be debatable, because
it is not yet supported by the results of larger trials, but
appears to be justified on the basis of pharmacodynamic data.
The benefit of triple antiplatelet treatment was considered
to outweigh the bleeding risk when patients have to undergo
urgent bypass surgery.
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ACS with ST-segment elevation
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Two treatment concepts are available for patients presenting
with STEMI, namely, PCI or thrombolysis, as well as the combination
of both. The ESC guidelines on acute MI already recommended
PCI as the preferred treatment option, if it can be performed
within 90 min. The PCI guidelines give the same recommendation
for primary PCI (I-A) but take a stronger position for patients
presenting >3 h after symptom onset. The results of
several trials suggest that the benefit of thrombolysis in late
presenters is small and that PCI should be strongly preferred
29–32 (
Figure 2).
Primary PCI is also recommended on the basis of expert opinion, in patients with contraindications to thrombolytics, patients in cardiogenic shock, and as rescue PCI after failed thrombolysis (i.e. failure of resolution of ST-segment elevations 45–60 min after initiating thrombolytic drugs) (Table 3). Further, the use of stents in primary PCI is recommended (I-A).
Following successful thrombolysis, patients should undergo invasive
evaluation and stenting of the culprit lesion within 24 h
(I-A). The aim is to prevent recurrent infarction, as documented
in several randomized trials. If this cannot be achieved within
24 h, ischaemia-driven angiography is advised (I-B).
Adjunctive medication in primary PCI
Most of the data on the effects of GP IIb/IIIa inhibitors in patients with STEMI are available for abciximab. Documented in five randomized trials, abciximab as adjunctive therapy to PCI reduces mortality, target vessel revascularization, and the incidence of major adverse cardiac events significantly at 6 months after STEMI (IIa-A) (Table 1). At present, a recommendation for the use of direct thrombin inhibitors is not evidence based.
Dual antiplatelet therapy with aspirin and clopidogrel should be initiated as soon as possible. A loading dose of 600 mg of clopidogrel followed by 75 mg daily for 9–12 months is recommended (I-C and I-B, respectively) (Table 2). Unfractionated heparins are the standard concomitant therapy (I-C).
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Conclusion
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The ESC guidelines on PCI offer interventional cardiologists
a guide to decision-making when choosing the optimal time course
and type of intervention for patients presenting with NSTE-ACS
or STEMI, with the aims of maximizing patient outcome and reducing
mortality.
Conflict of interest: none declared.
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Abstract
Introduction