Randomized study on provisional stenting with sirolimus-eluting stent vs. bare metal stent for the treatment of true coronary bifurcations. the PROSUMER (PROvisional with sirolimus-eluting vs. bare metal stents in truE bifuRcations) study

Percutaneous treatment of coronary bifurcations with stent implantation is still a matter of debate. Despite the implementation of numerous techniques to stent both branches, none has shown clinical and angiographic superiority to the main branch (MB) stent technique with provisional T-stenting of the side branch (SB) in case of dissection or residual severe disease.In addition, concerns have been raised about safety of drug-eluting stents (DES) because of the greater late and very late stent thrombosis and mortality as compared to bare metal stents (BMS). Also, technical characteristics of stents (i.e. high radial force, favorable vessel wall covering percentage and larger patency of SBs) seem to be crucial factors in case of provisional T-stenting strategy. To address these issues,we designed the PROSUMER (PROvisional with sirolimus-eluting vs. bare metal stents in truE bifuRcations) study in order to prospectively and randomly compare the safety and efficacy of sirolimus-eluting stent (SES) vs. a BMS in case of treatment of true coronary bifurcation lesions with provisional T-stenting. The study was designed as a prospective, single-center pilot trial, and included consecutive angina patients with a de novo true coronary artery bifurcation lesion (Medina classifications 1,1,1 or 1,0,1 or 0,1,1) who were allocated to SES or a novel BMS.In conclusion, the PROSUMER study is a prospective and randomized investigation that shows that a BMS with favorable characteristics for bifurcations is a good alternative to SES when the provisional stenting technique is applied, thus suggesting that stent design and technical features are crucial factors in case of provisional stenting of coronary bifurcations. These findings, however, should be considered hypothesis-generating and other larger trials are needed to identify the best option for treating coronary bifurcations.