Cardiac Level 1

All major society guidelines are now recommending against facilitated PCI when full dose fibrinolytics are used. (1,2) A nice editorial regarding this is “Facilitated angioplasty: paradise lost.”  (3)

There are some definitions that come into play when making this recommendation. 

“Facilitated PCI” (the approach where immediate PCI was done on every patient who received fibrinolytics) is different and contrasted to electively doing PCI prior to discharge which is now called either “adjunctive PCI” or “early elective PCI”.   This whole range of treatments is encompassed when using the term Pharmocoinvasive Strategies.

Usually “adjunctive PCI” refers to PCI more than 3 hours after, but still within 24 hours of fibrinolytic administration whereas “early elective PCI” implies PCI more than 24 hours after thrombolytics.  The definitions are still in flux, and most of ASSENT-4 (4)  complications were seen when PCI was done within 2 hours of fibrinolysis so “adjunctive PCI” may start to be within 2 hours of thrombolytic administration. 

The quantitative review of primary and facilitated angioplasty (5) which suggested significant increases in short term mortality rates, non-fatal re-infarction rates, urgent revascularization, stroke and included a trend towards increase in major bleeding, helped “facilitated angioplasty” lose favor.

However, hospitals that were not PCI capable, often had more than a 2 hour delay in transport so “adjunctive PCI” started emerging as the defacto treatment strategy.  In comparison to “facilitated PCI” , “adjunctive PCI” appears beneficial and safe.  Probably the two trials quoted most often are GRACIA-2 (6) and Fast-MI (7).  This trend recognizes that “adjunctive PCI” has been directly compared to strategies of fibrinolysis and standard care (usually PCI for indications or routine late PCI) and shown to be better.

Although the days of facilitated PCI have come and gone, the Pharmocoinvasive Strategies are here to stay and appear to be best patient care. 

Bryan E Fuhs MD

1. 2007 focused update of the ACC/AHA 2004 guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Group to Review New Evidence and Update the ACC/AHA 2004 Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction). J Am Coll Cardiol 2008;51:210–47 http://content.onlinejacc.org/cgi/reprintframed/55/2/111

2.  Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation The Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology http://www.escardio.org/guidelines-surveys/esc-guidelines/GuidelinesDocuments/guidelines-AMI-FT.pdf&sa=U&ei=3FVRTq_8OKjjiAKp2ayYAQ&ved=0CA8QFjAA&usg=AFQjCNH7cah6t1h9mxRwexlOnsf47fkb_Q 

3.  Facilitated Angioplasty: paradise lost. Stone GW, Gersh BJ ( doi:10.1016/S0140-6736(06)68149-X ) http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(06)68149-X/fulltext

4.  Primary versus tenecteplase-facilitated percutaneous coronary intervention in patients with ST-segment elevation acute myocardial infarction (ASSENT-4 PCI): randomised trial http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(06)68147-6/fulltext

5. Comparison of primary and facilitated percutaneous coronary interventions for ST-elevation myocardial infarction: quantitative review of randomised trials http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(06)68148-8/fulltext

6. Primary angioplasty vs. early routine post-fibrinolysis angioplasty for acute myocardial infarction with ST-segment elevation: the GRACIA-2 non-inferiority, randomized, controlled trial  Eur Heart J (2007) doi: 10.1093/eurheartj/ehl461  http://eurheartj.oxfordjournals.org/content/early/2007/01/23/eurheartj.ehl461

7.  Comparison of thrombolysis followed by broad use of percutaneous coronary intervention with primary percutaneous coronary intervention for ST-segment-elevation acute myocardial infarction: data from the french registry on acute ST-elevation myocardial infarction (FAST-MI). doi: 10.1161/​CIRCULATIONAHA.107.762765  http://circ.ahajournals.org/content/118/3/268.full

The FINESSE trial will probably end the experiment with half-dose lytic therapy in acute MI.  The FINESSE trial tested this strategy directly.  The study compared primary PCI with facilitated PCI (either lytics with GPIIb/IIIa or a GPIIb/IIIa agent alone).  The study enrolled 2,452 patients with 1:1:1 randomization and looked at the primary composite endpoints:  all-cause mortality, readmission for heart failure, ventricular fibrillation, or cardiogenic shock, without any differences being demonstrated. 

• There were no differences in all-cause mortality, complications of MI, or any of the independent components of the primary composite endpoints.
• The bleeding complications, both major and minor were higher in the facilitated PCI strategies.
• There was a stong trend towards intracranial hemorrhage in the lytic treated group.

Implications for Cardiac Level One approaches:

The strategy of the lytic facilitated cath lab interventional approach has now been shown to be no better, and most likely worse in tested studies including ASSENT V and now the FINESSE trial. 

The good news is that PCI alone does better in the first 4 hours then originally anticipated and may change the 90 minute window used for making a decision about angioplasty vs. lytic therapy. 

The strategy of facilitated PCI is probably no longer supportable by available science, but lytic therapy and PCI remain cornerstones of Acute STEMI therapy.  The addition of Plavix to lytic therapy also appears to be an emerging new standard.

The importance of fast transport is probably even more critical if a 4 hour window exists for direct angioplasty, effectively widening the geographic area for acute angioplasty treatment. 

CARESS, another trial presented at the ESC appears to support transfer after thrombolysis to a facility that could do rescue angioplasty.  The strategy of giving thrombolysis and transferring only the failures of thrombolytic therapy, was shown to lead to worse patient outcomes.

So in summary the data supports rapid transfer of patients presenting in rural settings to angioplasty (and presumptively surgical) capable hospitals. The improved transport time and protocols are necessary to provide best care. This is independent of whether thrombolytics are or are not given.

Primary-PCI without giving lytics or IIB/IIIA agents appears to be better than any facilitated approach tested to date, if done within the first 4 hours.  However, if thrombolytics are given, the data favors full dose therapy (with plavix) and only doing PCI to rescue the failures of thrombolytic therapy.  

Plavix dosing is still not completely standardized.  I currently support the 600mg dose.

This is the strategy that was suggested initially by Spokane Cardiology and has been a source of vigorous debate as Cardiac Level One protocols were developed.  It is anticipatable the publication of these studies will change the current Cardiac Level One protocols.  It is not surprising that the previously excellent cardiac STEMI outcomes seen in Spokane are now supported by science. 

This article was submitted by Bryan E Fuhs MD FACC Spokane Cardiology from data available 12/2007.