Randomized comparison of elective stent implantation and coronary balloon angioplasty guided by online quantitative angiography and intracoronary Doppler

Background-The purpose of this study was to compare long-term outcomes of c oronary stenting in all lesions (elective stenting) or only in lesions with inadequate morphological and functional results after balloon angioplasty (guided PTCA). Methods and Results-Treatment of multivessel disease, with any lesion lengt h and vessel size, was allowed provided that all lesions were suitable for stent implantation. Patients were randomized to elective stent implantation (n=370) or guided PTCA (n=365). An optimal PICA result (residual diameter stenosis less than or equal to 35%, coronary flow reserve measured with a D oppler guidewire >2.0, absence of threatening dissections) was achieved in 166 lesions (43%). The remaining 218 lesions underwent stent implantation ( provisional stenting). Final residual diameter stenosis was lower in the el ective and provisional stent groups (9.3% and 10.2%) than in the optimal PT CA group (24.8%, P<0.00001). On an intention-to-treat analysis, the probabi lity of <greater than or equal to>1 major adverse cardiac event at 12 month s was 17.8% in the elective stenting group and 18.9% in the guided PTCA gro up (20.1% for optimal PICA and 18.0% for the provisional stenting subgroup, P=NS). The incidence of repeat target lesion revascularization at 1 year w as 14.9% in the elective stent group and 15.6% in the guided PTCA group (17 .6% for optimal PTCA and 14.1% for the provisional stenting subgroup, P=NS) . Conchsions-When balloon angioplasty is guided by online quantitative angiog raphy and Doppler-derived coronary flow reserve, with provisional stenting reserved for suboptimal results, early and late clinical outcomes are compa rable to those achieved by elective stenting of all patients.