Time to Abandon Facilitated PCI: Results from the FINESSE trial

May 22, 2008 By Vijayalakshmi Kunadian MBBS MD MRCP [mailto:vkunadian@perfuse.org]

NEJM-Cleveland, OH: The FINESSE trial demonstrates no clinical benefit with pre-PCI dosing of reteplase plus abciximab or abciximab alone in the setting of ST elevation myocardial infarction compared with primary PCI plus abciximab at the time of the procedure.

Because pharmacotherapy may open closed arteries before the procedure, one would expect to see greater benefit by administering fibrinolytic agents or glycoprotein IIb/IIIa inhibitors prior to primary percutaneous coronary intervention. However, despite angiographic benefits, the clinical benefits of "facilitated PCI" have thus far been disappointing. The negative clinical outcomes have been observed despite the fact that early administration of fibrinolytic agents and glycoprotein IIb/IIIa inhibitors did significantly improve pre PCI coronary artery patency and early ST segment resolution. FINESSE (Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events) is yet another trial that confirms facilitation of primary PCI using reteplase and abciximab or abciximab alone does not improve clinical outcomes compared with primary PCI.

The results of this trial are reported in the latest issue of the NEJM by Ellis and colleagues [1]. FINESSE is an international, double-blind, placebo-controlled study consisting of ST elevation myocardial infarction patients who presented within ≤6 hours of symptom onset. 2452 patients enrolled from 20 countries between August 2002 and December 2006 were randomized to receive combination facilitated PCI (reteplase + abciximab, n=828), abciximab-facilitated PCI (n=818) or primary PCI including abciximab at the time of the procedure (n=806). Reteplase was administered at a dose of two 5U boluses at an interval of 30 minutes and intravenous abciximab was administered at a dose of 0.25 mg/kg. Unfractionated heparin or enoxaparin prior to PCI and 12 hour infusion of abciximab were administered to all patients. This study was terminated early due to a slow rate of recruitment.

The median door-to-balloon time was 2.2 hours. The primary endpoint which consisted of a composite of death from all causes, ventricular fibrillation occurring >48 hours following randomization, cardiogenic shock and congestive heart failure during the first 90 days following randomization occurred in 9.8% vs. 10.5% vs. 10.7% (p=0.55) in the combination group, the pre-PCI abciximab group and the primary PCI groups respectively. Likewise, there was no difference in the 90-day mortality rates between the three groups respectively (5.2% vs. 5.5% vs. 4.5%, p=0.49). There was no benefit in the primary endpoint despite the fact that there was significantly better early ST segment resolution in the combined group compared with the pre-PCI abciximab and primary PCI groups [43.9% vs. 33.1% (p=0.01), vs. 31% (p=0.003)].

Furthermore, the incidence of major/minor bleed (4.8% vs. 4.1% vs. 2.6%, p<0.05/9.7% vs. 6% vs. 4.3%, p<0.05) and transfusion (6.4% vs. 3.9% vs. 3%, p<0.05) was significantly greater in the combined group compared with the other groups.

The investigators conclude that facilitation with combined reteplase plus abciximab and pre-PCI abciximab alone did not improve clinical outcomes among patients with ST segment elevation myocardial infarction compared to the administration of abciximab at the time of the primary PCI. This trial tested whether a fibrinolytic can improve primary PCI outcomes, and it did not test whether performing rescue/adjunctive PCI in patients already given a fibrinolytic improves outcomes.

Source

 * 1) Ellis, Tendera, de Belder et al. Facilitated PCI in patients with ST-elevation myocardial infarction. NEJM 2008;358:2205-17.