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Intern Emerg Med (2008) 3:8384

DOI 10.1007/s11739-008-0159-6

IM - COMMENTARY

STEMI management: trials, registries, and the real world


Giovanni Melandri Franco Semprini Samuele Nanni
Daniela Calabrese Fabio Vagnarelli Angelo Branzi

Published online: 26 April 2008


SIMI 2008

Primary angioplasty (P-PCI) is the preferred treatment of


patients with ST-segment elevation myocardial infarction
(STEMI) in both American and European guidelines. The
reason for this preference is the evidence that the
mechanical approach improves coronary patency, TIMIflow rates and ultimately the overall survival.
Nevertheless, P-PCI has its own drawbacks: it needs
skill and must be delivered in a timely fashion (two contrasting requirements, in that skill is linked to activity
volume which, in turn, decreases along with catheterization
laboratories proliferation); not to mention the costs.
So far, in no single study has P-PCI been shown to
reduce mortality, a goal whose achievement has been
suggested only in an overview of small trials. Moreover,
the advantage fades when P-PCI is compared with contemporary lytic regimens [1].
Therefore, it may be asked whether this apparent small
advantage of P-PCI may be generalized to the real world.
Indeed, it has been recognized for a long time that trials
show what can be accomplished under careful observation
and certain restricted conditions. The same results may not
invariably or necessarily be observed when the treatment
passes into general use.
The above considerations have stimulated the establishment of registries, which are supposed to monitor
treatment quality by providers. The overview of Italian
registries (BLITZ-1, MISTRAL, VENERE, GESTIMA and
PRIMA) shows that there is no difference in mortality
between P-PCI and thrombolysis (7.0 vs 6.8%, P = NS).

G. Melandri (&)  F. Semprini  S. Nanni  D. Calabrese 


F. Vagnarelli  A. Branzi
Dipartimento Cardio-Toraco-Vascolare, Istituto di Cardiologia,
Policlinico S.Orsola, via Massarenti 9, 40138 Bologna, Italy
e-mail: giovanni.melandri@aosp.bo.it

Registries show interesting data, worth discussing in the


scientific community, but usually are flawed by the voluntary nature of data entry and, often, by the lack of an
audit process. As a result, outcomes in registries are in
between those observed in trials and those taking place in
the real world.
Balzi et al. [2] should be congratulated for their
excellent work, describing in detail the way STEMI
patients are managed in the Florence health district (years
20002001). Not only they have collected all relevant
clinical data, but they have also cross-checked the registry
patients with patients showing a discharge ICD9-CM 410
code in the same area. Data pertaining to those patients
discharged with a 410 code who had not been entered in
the registry, were submitted to an audit process before
final entry.
The most interesting finding of the study is the low
reperfusion rate (with either P-PCI or thrombolysis): 54.4%
overall, 71% among patients less than 65 years old, 60%
for those 6574 years old, 43% in the 7584 age range and
31% for those patients 85 or more years old. It is not clear
what was the reason for such a low reperfusion yield. The
Florence health district is a busy area, well equipped in
transportation facilities, with a short distance from spoke to
hub hospitals, and with a good catheter laboratory available
on a 24-h basis.
Multivariable analysis identified age and co-morbidities
as important constraints upon reperfusion, but also the type
of hospital was strongly associated with the probability of
reperfusion. Being admitted to the hospital where P-PCI
was available increased 5-fold the probability of reperfusion. It may be concluded that the perception of the
importance of reperfusion is different in spoke versus hub
hospitals, particularly for those higher-risk patients with
advanced age and co-morbidity.

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Why does there exist a different perception? There are


no data to answer this question. It may have something to
do with the inherent complexity of P-PCI implementation.
The fact remains that once patients are negated transportation for P-PCI, also thrombolysis will often be omitted (a
sort of post hoc coherence). This is particularly unfortunate, because in this Florence experience the timeinterval from symptoms onset to hospital admission is less
than 3 h in more than 50% of cases, a framework allowing
for thrombolysis use if any barrier exists to quick
transportation.
The second important observation is the time-delay
before P-PCI. The door-to-balloon time was [90 min in
72% of patients admitted to spoke hospitals and in 23% of
patients admitted to the hub. The distance between spoke
hospitals and the hub was short, ranging between 3 and
20 miles, considerably shorter than the distance affecting
the typical American rural hospitals (2888 miles in a
recent experience [3]). Yet, the transportation times (10
35 min) were similar to the above mentioned American
experience (2535 min). Here, we see two major logistic
problems: first, the time-delay awaiting for transportation
availability and second, the typical Italian traffic jam.
So, we are left with the impression that much work has
still to be done in order to benefit all patients who deserve it.
Since year 2001, a step forward has been achieved by
recording the pre-hospital electrocardiogram [4]. This
manoeuvre definitely improves not only the door-to-reperfusion time, but also the general streamline, potentially
curtailing many of the observed obstacles in the Florence
health district experience. Another potential improvement,

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Intern Emerg Med (2008) 3:8384

closely linked to the pre-hospital electrocardiogram, is the


pre-hospital delivery of a modern thrombolytic drug, along
with dual platelet inhibition with aspirin and clopidogrel
and enoxaparin. Pre-hospital thrombolysis in the first 3 h
can really simplify the treatment of many patients for whom
P-PCI is not immediately available.
Finally, efforts to monitor the STEMI pathway, as
beautifully reported in this Florence experience, should be
extended as much as possible across Italy. Quality
improvement initiatives are key to knowledge, prognostic
improvement and also costs containment.

References
1. Melandri G (2003) Primary angioplasty or thrombolysis for acute
myocardial infarction? Lancet 361:966 author reply 9678
2. Balzi D, Barchielli A, Santoro GM, Carrabba N, Buiatti E, Giglioli
C, Valente S, Baldereschi G, Del Bianco L, Monami M, Gensini
GF, Marchionni N (2008) Management of acute myocardial
infarction in the real world: a summary report from The AmiFlorence Italian Registry. Intern Emerg Med. doi:10.1007/
s11739-008-0090-x
3. Aguirre FV, Varghese JJ, Kelley MP, Lam W, Lucore CL, Gill JB,
Page L, Turner L, Davis C, Mikell FL (2008) Rural interhospital
transfer of ST-elevation myocardial infarction patients for percutaneous coronary revascularization: the Stat Heart Program.
Circulation 117:114552
4. Ortolani P, Marzocchi A, Marrozzini C, Palmerini T, Saia F,
Serantoni C, Aquilina M, Silenzi S, Baldazzi F, Grosseto D,
Taglieri N, Cooke RM, Bacchi-Reggiani ML, Branzi A (2006)
Clinical impact of direct referral to primary percutaneous coronary
intervention following pre-hospital diagnosis of ST-elevation
myocardial infarction. Eur Heart J 27:15507

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