Long-term CV outcomes similar with paclitaxel-eluting, bare-metal stent
MedWire News: Follow-up results from the PASSION trial suggest that similar long-term rates of major adverse cardiac events (MACE) occur when percutaneous coronary intervention (PCI) is performed with paclitaxel-eluting stents (PES) as with bare-metal stents (BMS).
As previously reported by MedWire News, initial findings from the PASSION (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction [MI] with ST-segment Elevation) trial showed no significant difference in 1-year post-PCI rates of MACE (defined as composite cardiac-related death, recurrent MI, or target lesion revascularization [TLR]) with PES compared with BMS.
"The present analysis shows there is still no significant difference observed through 5 years of follow-up," report Maarten Vink (Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands) and team.
The follow-up study, published in the Journal of the American College of Cardiology: Cardiovascular Interventions, involved 619 ST-elevation MI (STEMI) patients randomly allocated to undergo PCI with PES (n=310) or BMS (n=309).
Over a follow-up period of 5 years, MACE occurred at a similar rate of 18.6% versus 21.8% among PES and BMS patients, respectively. This, say Vink and colleagues, is equivalent to a nonsignificant 18% lower risk for MACE with PES compared with BMS.
No significant difference was observed in the overall 5-year rate of definite or probable stent thrombosis (ST) among patients in the PES group compared with those in the BMS group, at respective rates of 4.2% and 3.4%.
However, very late ST, defined as ST occurring beyond 1 year of PCI, was more frequent with the use of PES (3.5%) than BMS (1.1%).
Vink et al highlight that "in current clinical practice guidelines, the use of drug-eluting stents (DES) in acute STEMI is mentioned only as a method to reduce restenosis." But they add that European Society of Cardiology/American Heart Association guidelines "do not make a general recommendation for the use of DES in the setting of STEMI."
The researchers conclude: "The possibility of a higher risk of very late ST in PES supports the ambivalence of the guidelines on this matter, which needs to be substantiated in further clinical research."
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By Lauretta Ihonor