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The Latest on primary PCI

A special session focused on latest clinical data available in primary PCI.

PCAT-2

The PCAT-2 meta-analysis aimed to determine to what extent the mortality reduction by primary PCI, compared to fibrinolysis in STEMI patients, is modulated by the time from symptom onset to treatment.
This meta-analysis is based on individual data of 6,763 patients, included in 22 randomised trials of primary PCI (with or without stenting) versus fibrinolysis (any fibrinolytic agent) in STEMI during the period 1990-2003. Primary endpoint was 30 day all-cause mortality.
Medium time to randomisation was 143 minutes in the fibrinolysis group, 140 minutes in the PCI group. After randomisation, fibrinolysis was performed after a 19 minute delay, and PCI after a 19 + 57 minutes delay.
Overall, primary PCI leads to a 37% reduction in 30 day mortality compared to fibrinolysis. When PCI is performed within a less than 35 min delay, the metanalysis shows a 67% mortality reduction.
“These data support both the greater use of primary PCI and of more timely treatment”, concluded Eic Boersma, for the PCAT-2 collaborators.

REMEDIA TRIAL

Remedia trial (The Randomized evaluation of the effect of MEchanical reduction of DIstal embolization by thrombus-aspiration in primary and rescue Angioplasty trial) was a single centre prospective randomized study comparing thrombus-aspiration versus standard PCI.
The thrombus-aspirating catheter was a 6 F compatible, with a soft non trau- matic tip with multiples holes, first evaluated in the Diver CE pilot study. 100 patients were eligible for ran- domisation (STEMI, less than 12 hours from onset of symptoms to angiography), 50 have undergone thrombus aspiration, 49 standard PCI. Baseline characteristics in the groups were similar.
Primary endpoints were MBG >= 2 and STR >= 70%.
The success rates were similar in the two groups, but direct stenting was more frequent in the aspiration group (69% versus 24%, p = 0,0001). The peaks of CK-MB were not statistically different.
MBG 2 or 3 was achieved in 68% of the patients in the aspiration group versus 44.9% in the standard PCI group; STR > = 70% was achieved in 58% and 36.7% of patients respectively.
30 day clinical outcome was similar in the two groups.
For Francesco Burzotta (Rome, Italy), manual thrombus-aspiration in unselected patients with STEMI undergoing primary or rescue PCI is feasible and increases the rate of direct stenting.
Patients randomized to thrombus-aspiration show better angiographic and ECG myocardial reperfusion rates compared to standard PCI. Patients with higher thrombus burden or with occluded artery seem to have a greater benefit from thrombus-aspiration.
Remedia study has also evaluated the benefits of thromboaspiration in STEMI patients.

EXPORT STUDY

This single centre prospective (from march 2004 to February 2005) study, randomized 50 patients to assess efficacy and safety of thromboaspiration by the Export catheter, followed by PCI, compared to PCI alone.
STEMI patients were treated less than 12 hours after onset of symptoms, with an initial IRA TIMI flow < 3.
Primary endpoint was ST resolution one hour post PCI.
Among the Export group (24 patients), catheter success rate was 96 % (failure to cross a calcified lesion in one case). Debris were aspirated by the device in all patients.
An ST resolution more than 50 % was seen in 88 % of patients of the Export group (versus 62 % of the control PCI group, p < 0,04).
ST resolution more than 70 % was achieved in 50 % of the Export group and 12 % of the control group (p < 0,01).
Compared to conventional PCI approach, thrombo-aspiration is associated with a lower risk of slow-flow, no-reflow or distal embolization during the procedure and improves myocardial tissue reperfusion as assessed by ECG (better ST segment resolution) and MRI (smaller infract size).
“We must however take into account the limitations of this study: single-centre, small number of patients and surrogate endpoints”, stated Bernard Noel (Paris, France).
“Although surrogates-based trials are essential for optimising further clinical designs, our goal is not to improve angiographic parameters or other surrogates, but to improve patients outcomes. Therefore, randomised studies, adequately powered with clinical outcome as primary endpoint, should be preferred for the level of evidence. Remedia and Export suggest a positive role for simple aspiration, but more phase 2B randomised studies, based on surrogates such as microcirculation and long-term LV remodelling are needed before designing large-scale trials based on clinical end-points”, said Francisco Fernandez-Aviles (Valladolid, Spain), while discussing the trials.

SAVE MYOCARDIUM AND PATIENT

Concerning reperfusion delay, PCI has shown to be better than lysis during the first three hours (when time to treatment is critical for myocardial and microvascular salvage) and even more between 3 to 12 hours after onset of symptoms, when artery repair is the primary goal.
In the PCAT-2 metaanalysis, median PCI related delay is 57 minutes, far less than what we can see in the “real world”. A recent study, performed in the US and published in 2005, shows that the mean “door-to-balloon” time is less than 90 minutes in only 4% of cases, 2 hours in 16%, 2-4 hours for 55% of patients and more than 4 hours in 28% of cases.
Increased effort must be made to salvage myocardium…and patients. This means to be able to reduce patients delay, transport delay, and treatment delay.

Fuente: Euro PCR Online 2005

Ultima actualizacion: 31 DE MAYO DE 2005

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