Prof. Holger Thiele
Prof. Uwe Zeymer,
Uwe Zeymer, and Holger Thiele Klinikum Ludwigshafen and Institut für Herzinfarktforschung Ludwigshafen, GermanyUniversitätsklinikum Schleswig Holstein, Campus Lübeck, Germany
Multivessel disease is present in about 40-50 % of hemodynamically stable patients and about 70-80 % of patients with cardiogenic shock treated with primary PCI for STEMI. Previous ESC guidelines recommended culprit lesion only PCI in stable patients which – based on the PRAMI trial - was recently changed to a class IIb B recommendation in the ESC revascularization guidelines to perform PCI of other lesions. In patients with cardiogenic shock recommendations remained identical with a class IIa B recommendation to perform immediate multivessel PCI in patients with cardiogenic shock.These recommendations are now once again challenged by the relatively small CvLPRIT trial presented at the annual meeting of the ESC in Barcelona in August 2014. Both relatively small trials suggest that immediate PCI of all angiographic non-culprit stenoses of >50% in PRAMI and >70% in CvLPRIT is superior to culprit lesion only PCI. However, in contrast to PRAMI in CvLPRIT PCI of additional lesions could be performed immediately or during the index hospital stay. A total of 296 patients were randomized during PCI of the infarct related artery (IRA) to complete revascularization or PCI of the IRA only. Patients with chronic total occlusions as the only non-IRA artery were excluded. The results were in favor of multivessel PCI with a 12-month MACE rate (total mortality, recurrent infarction, heart failure and ischemia-driven revascularization at 12 months) of 10 % (n=15 ) versus 21 % (n=31). The difference in mortality was 1.3 % (n=2) versus 4.1 % (n=6). However, 11 and 8 patients in the two groups were lost to follow-up.The patients in the culprit lesion only group did not undergo ischemia testing and potentially subsequent PCI, a strategy recommended in the ESC guidelines. Thus, the patients in the culprit lesion only group were treated not optimal and not to current clinical standards. PCI of all lesions > 50% or 70% without any proof of the hemodynamic significance of the lesion, e.g. by FRR, will certainly lead to interventions in a number of insignificant stenoses. Nothing was mentioned in the presentation about the success and completeness of multivessel PCI. As in PRAMI the differences between multivessel PCI and culprit PCI in mortality are greater than between reperfusion and no reperfusion or between primary PCI and fibrinolysis in large clinical trials, which is highly unlikely.
Therefore, a play of chance finding cannot be ruled out, despite the fact that all endpoints hinted in the same direction. Before we adopt immediate multivessel PCI in stable STEMI patients as routine treatment in our daily clinical practice a larger trial confirming the surprising results of PRAMI and CvLPRIT is required. This trial named COMPLETE (clinicaltrials.gov: NCT01740479) is currently under way and will enroll 3900 patients. The primary endpoint is the combination of cardiovascular death or myocardial infarction during 4-year follow-up. Until then culprit lesion PCI with subsequent staged PCI of lesions after proof of hemodnamic relevance with FFR or a stress test should remain standard of care. A similar European multicenter trial powered for hard clinical endpoints is currently performed in the cardiogenic shock setting (CULPRIT-SHOCK: clinicaltrials.gov: NCT01927549), testing if culprit lesion only PCI with subsequent staged PCI is superior to immediate multivessel PCI.
Hot Line IV - Myocardial InfarctionESC Congress 2014, Barcelona - press conferenceRefers to sessions - Hot Line IV - Myocardial InfarctionESC Congress 2014, Barcelona
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