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Randomized Comparison of Elective Stent Implantation and Coronary Balloon Angioplasty Guided by Online Quantitative Coronary Angiography and Intracoronary Doppler - Randomized Comparison of Elective Stent Implantation and Coronary Balloon Angioplasty and Intracoronary Doppler
Description:
Randomized Comparison of Elective Stent Implantation and Coronary Balloon Angioplasty Guided by Online Quantitative Coronary Angiography and Intracoronary Doppler.
Hypothesis:
The objective of this study was to compare the outcomes of PTCA and provisional stenting (stenting limited to lesions with inadequate angiographic or physiological results) with elective stenting.
Study Design
Study Design:
Patients Enrolled: 738
Drug/Procedures Used:
Patients were randomized to elective stent implantations (370 patients, 386 lesions) or to PTCA guided by quantitative coronary angiography (QCA) and Doppler coronary flow velocity reserve analysis (CFR) (368 patients, 384 lesions). The PTCA result was accepted if all of the following three conditions were met: 1) final lesion diameter by QCA <35%; 2) absence of NHLBI classification type C through F dissection; 3) CFR distal to the stenosis >2.0. If any of these criteria was not met, investigators could chose between the use of bigger balloon or higher inflation pressure or crossing over to stent implantation (provisional stenting). The primary end point was a combined major adverse cardiac event endpoint (MACE) including death, MI and target lesion revascularization (TLR) at 12 months follow-up.
Principal Findings:
Optimal PTCA was achieved in 166 lesions (43%). The most common reasons for sub-optimal PTCA in the remaining 218 lesions were a Doppler CFR 30% residual stenosis (44% of cases). These lesions were managed with stent implantation (provisional stenting group). At 12 months follow-up, the MACE rate was 17.8% in the elective stent group and 18.9% in the guided PTCA group, while TLR was respectively 14.9% and 15.6%. When compared with provisional stenting, optimal PTCA was associated with a similar incidence of TLR (17.6% for optimal PTCA and 14.1% for provisional stenting, p = ns) and with a similar incidence of MACE (20.1% and 18.0%, respectively; p = ns).
When compared to elective stenting, PTCA guided by angiographic and physiologic parameters with provisional stenting reserved for suboptimal results is associated with similar acute and long-term outcomes.
Interpretation:
The results of this study are compelling and show excellent acute and long-term outcomes with optimal PTCA. Unfortunately, optimal PTCA could be achieved only in 43% of cases. In addition the methodology used for lesion assessment (evaluation of CFR) is not available in every interventional lab and it requires both operator and laboratory experience.
References:
1. Di Mario C, Moses JW, Anderson TJ, et al. Circulation 2000;102:2938-44.
Keywords: National Heart, Lung, and Blood Institute (U.S.), Follow-Up Studies, Coronary Angiography, Research Personnel, Crossing Over, Genetic, Coronary Disease, Constriction, Pathologic, Angioplasty, Balloon, Coronary, Stents
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