Key result
Sirolimus-eluting stents yield ~0.08 higher 6-month FFR compared to bare metal stents.
Why the study?
This study aimed to evaluate fractional flow reserve, hyperaemic trans-stent gradient, and wall shear stress at implantation and at 6-month follow-up in paired drug-eluting sirolimus stents and bare metal counterparts within the same patient.
Does a sirolimus-eluting stent improve coronary physiologic parameters (FFR, HTG, and WSS) at 6 months compared to a bare metal stent in patients undergoing PCI of at least two comparable coronary arteries?
RCT (n=20)
Within-patient paired randomization
Does a sirolimus-eluting stent improve coronary physiologic parameters (FFR, HTG, and WSS) at 6 months compared to a bare metal stent in patients undergoing PCI of at least two comparable coronary arteries?
Sirolimus-eluting stents demonstrate superior coronary haemodynamic and physiologic profiles at 6 months compared to bare metal stents, maintaining higher fractional flow reserve, lower trans-stent gradients, and normal wall shear stress.
Sirolimus-eluting stents improve physiologic parameters versus bare metal stents; confirms DES superiority in randomized PCI.
AIMS: The aim of this study was to investigate the physiologic parameters: fractional flow reserve (FFR), hyperaemic trans-stent gradient (HTG), and wall shear stress (WSS) at implantation and at 6-month follow-up in the drug-eluting sirolimus stent and in its bare metal counterpart implanted in pairs within the same patient. METHODS AND RESULTS: Twenty patients, accepted for percutaneous coronary intervention of at least two coronary arteries with comparable vessel and stenosis characteristics, received at random one sirolimus-eluting stent and one bare metal stent (BMS). Coronary pressure, FFR, HTG, and WSS were measured just after stent implantation and at 6-month follow-up. At 6-month follow-up, FFR was significantly higher in the sirolimus group compared with the bare metal group (0.91+/-0.05 vs. 0.83+/-0.10, P=0.027) and HTG was significantly lower (1.2+/-1.2 vs. 7.5+/-8.1 mmHg, P<0.001). In-stent WSS at 6 months remained normal in the sirolimus group but was elevated in the bare metal group (1.6+/-0.7 vs 3.9+/-3.1 Pa, respectively, P=0.003). CONCLUSION: The physiologic characteristics of the drug-eluting sirolimus stents were superior to those of the equivalent BMS. Six months after implantation, FFR was significantly higher, HTG was significantly lower in arteries treated by a sirolimus stent, and normal WSS was maintained within the drug-eluting stent.
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Marcel van ’t Veer (2006) conducted an RCT in Coronary artery disease requiring percutaneous coronary intervention (n=20). Sirolimus-eluting stent vs. Bare metal stent (BMS) was evaluated on Fractional flow reserve (FFR) at 6-month follow-up (p=0.027). Sirolimus-eluting stents resulted in significantly higher FFR (0.91 vs 0.83, P=0.027) and lower hyperaemic trans-stent gradient (1.2 vs 7.5 mmHg, P<0.001) at 6 months compared to bare metal stents.
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