Why do we need prospective registries in patients with acute myocardial infarction?

Uwe Zeymer* and Jochen Senges

Herzzentrum Ludwigshafen, Medizinische Klinik B, Ludwigshafen, Germany

* Corresponding author. Priv. Doz. Dr. Uwe Zeymer, FESC, Herzzentrum Ludwigshafen, Medizinische Klinik B, Bremserstrasse 79, D-67063 Ludwigshafen, Germany. Tel.: +49-621-503-4045; fax: +49-621-503-4002
E-mail address: Uwe.Zeymer{at}t-online.de

Received 10 July 2003; accepted 10 July 2003

See doi:10.1016/S1095-668X(03)00278-1for the article to which this editorial refers

The results of recent randomized clinical trials performed in patients with acute ST elevation myocardial infarction suggest that the short-term mortality of these patients is around 5–6% or even less. That would imply that there is little room for improvement in our efforts to reduce mortality in patients with acute myocardial infarction. Unfortunately, this is not the case in the ‘real world’ situation in Europe and there are still many things to improve. This insight comes from well designed prospective national and international registries performed in patients with acute coronary syndromes.

A large number of randomized studies with several thousands of patients was performed in patients with acute myocardial infarction (AMI) over the last two decades. The results of these trials form the basis of the Guidelines from National and International Cardiology Societies for the treatment of these patients. Just recently the European Society of Cardiology has published Guidelines for the management of acute coronary syndromes in patients presenting without1and with ST-segment elevation.2It has been well recognised that patients enrolled in randomized clinical trials are highly selected and represent in most cases a low risk subgroup of patients with AMI. Therefore, the results of these studies do not necessarily reflect the ‘real world’situation of patients with AMI and may not apply to about 50% of patients in clinical practice. A more realistic view of mortality and morbidity from AMI arises from well performed prospective clinical registries. From here we can learn that the ‘real’ mortality from an acute myocardial infarction after hospital admission ranges from 10% to 15%, therefore, it is more than two-times higher as in randomized clinical trials. In addition these registries show us, if we adhere to guidelines in the treatment of our patients with AMI and what we need to improve. Therefore, these registries are the link between randomized clinical trials and guidelines and daily clinical practice.

In patients presenting with ST elevation myocardial infarction the immediate initiation of reperfusion with either fibrinolysis or primary percutaneous coronaryintervention is the cornerstone of the therapy. Registries remind us that we need a continuous effort to educate our patients to call for early help in case of typical signs of an AMI. In randomized clinical trials the median time delay between onset of symptoms and hospital admission was approximately 2, 5–3h and remained stable over the last decade. In the recent Italian BLITZ Registry3a slightly shorter pre-hospital delay of 2h and 10min was reported, however, there is still room for improvement in reducing the patient related time delay and to increase the rate of patients treated within the first ‘Golden hour’. One way to achieve this goal might be the pre-hospital administration of fibrinolysis, a therapy which was not used in the BLITZ Registry and which is still only rarely used in Europe, despite encouraging results in randomized trials. Another time-issue relates to the in-hospital delay. In the BLITZ Registry only one-third of patients received fibrinolysis within 30min, and only one quarter underwent primary PCI within 60min, time delays usually considered as standard of care and recommended in current guidelines. Unfortunately, these figures compare well with the results from other large registries from France, Germany, Sweden, the Euro Heart Survey of Acute coronary surveys4and registries from the Unites States. Here, the median door-to-needle time ranged from 30–60min and the median door-to-balloon time from 90 to 120min. This gives much room for improvement and therefore, educational programs and local in-hospital guidelines to shorten these time-delays are urgently needed.

Another important effort should be to increase the rate of patients receiving early reperfusion therapy. In contemporary registries the rate of patients with STEMI not receiving reperfusion therapy ranges from 40% to 50%. That means that every other patient does not receive a potentially life saving therapy. The consequences are dramatic, since the in hospital mortality of these patients is about 2–3 times higher compared to the mortality of patients treated with early reperfusion therapy. In the large MIR-Plus registry from Germany, containing nearly 30 000 patients with ST elevation myocardial infarction, the 1-year mortality of these patients was nearly 50–60%, regardless of infarct location.5The reasons for not treating with early reperfusion therapy are not uniform and include longer time-delays, age, relative contra-indications, unavailability of fibrinolysis or PCI and lack of a clear indication. In this respect registries might be helpful to increase the rate of patients receiving reperfusion therapy, since in most of these registries the individual investigator is asked why he withholds this therapy from the patient. In addition he can compare his results with the results of the whole registry and can therefore, appreciate if his results are within the normal range of the standard of care. So, these registries might increase the awareness of the importance of early reperfusion therapy and lead to an increase in its use.

The use of coronary angiography and revascularization procedures after acute myocardial infarction is increasing over the last years, both in Europe and the United States. However, there is no relationship between the patients risk profile and the use of invasive procedures. The highest predictive factor for an invasive procedure is still the availability of catherization facilities.3,4In contrast, the current guidelines recommend systematic risk stratification and revascularization in patients with high risk characteristics, such as recurrent ischaemia, impaired left ventricular function or elevated troponins. In times of limited resources the treatment with invasive and expensive procedures should be focused on patients, who might have the greatest benefit. The real world experience from registries demonstrates to us, that we are far away from adopting this approach in clinical practice.

Not only revascularization but also drugs such as beta-blockers, platelet-inhibitors, statins and ACE-inhibitors are able to improve the prognosis of patients with AMI. It has been shown that in registries, in which the single investigator is asked why he does not prescribe drugs proven to improve the long-term prognosis, it is helpful to increase the number of patients treated with guideline adherent therapies. For this reason registries which are continuing over several years or are repeated at regular time intervals are helpful to evaluate time trends in the quality of care, the adherence to guidelines, the implementation of new therapies and the impact of all of these components on the outcome of patients with acute myocardial infarction.

In summary, we still need well designed and properly performed prospective registries in patients with AMI. These registries should adhere to certain quality criteria to be really useful.6If these criteria are fulfilled registries are an integral and important part of our continuing efforts to improve the quality of care and ultimately the outcome of our patients with acute myocardialinfarction.

References

  1. Bertrand ME, Simoons ML, Fox KAA et al. Management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2002;23:1809–1840.[Free Full Text]
  2. Van de Werf F, Ardissino D, Betriu A et al. Management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2003;24:29–66.
  3. Di Chiara A, Chirella F, Savonitto S et al. Epidemiology of acute myocardial infarction in the Italian CCU network. The BLITZ Study. Eur Heart J. 2003;24:1616–1629.[Abstract/Free Full Text]
  4. Hasdai D, Behar S, Wallentin L et al. A prospective survey of the characteristics, treatments and outcomes of patients with acute coronary syndromes in Europe and the Mediterrean basin. The Euro Heart Survey of Acute Coronary Syndromes. Eur Heart J. 2002;23:1190–1201.[Abstract/Free Full Text]
  5. Zeymer U, Schiele R, Gitt A et al. High in-hospital and 1-year mortality regardless of infarct location in patients with ST elevation myocardial infarction not receiving repefusion therapy. Results of the MIR-Plus Registry. Eur Heart J. 2003;24(Abstract supplement):.
  6. Alpert JS. Acute coronary syndromes observed from an international perspective. Eur Heart J. 2002;23:1139–1140.[Free Full Text]

Related articles in EHJ:

Epidemiology of acute myocardial infarction in the Italian CCU network: The BLITZ Study
Antonio Di Chiara, Francesco Chiarella, Stefano Savonitto, Donata Lucci, Leonardo Bolognese, Stefano De Servi, Cesare Greco, Alessandro Boccanelli, Pietro Zonzin, Stefano Coccolini, Aldo P. Maggioni, and on behalf of the BLITZ Investigators
EHJ 2003 24: 1616-1629. [Abstract] [Full Text]  




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