A comparative analysis of primary stenting and optimal balloon coronary angioplasty in acute myocardial infarction. Six month results from the STENT PAMI trial

Abstract

Objective -To compare the outcome of balloon PT-CA with final coronary stenosis diameter (SD) ≤30%, with elective coronary stenting. Methods -We performed a comparative analysis of the 6 month outcomes in patients treated with primary stenting and those who obtained an optimal balloon PT-CA result treated during the first 12 hours of AMI onset included in the STENT PAMI randomized trial. Results -The results were analysed into 3 groups: primary stenting (441 patients, SD=22±6%), optimal PTCA (245 patients), and nonoptimal PTCA (182 patients, SD= 37±5%). At the end of the 6 months primary stent group presented with the lowest restenosis (23 vs. 31 vs. 45%, p=0.001, respectively). Ischemia-driven target vessel revascularization rate (TVR) (7 vs. 15.5 vs. 19%, p=0.001, respectively). A series of randomized trials were performed to obtain a comparative analysis between two percutaneous revascularization methods, primary coronary stent implantation and primary balloon PTCA [1][2][3] , available for the treatment of acute myocardial infarction (AMI) in the first 12 hours of its onset. The STENT PAMI trial randomized a greater number of AMI patients than did the previous trials (900) in 62 centers worldwide, concluding that primary heparin-coated Palmaz-Schatz stent implantation offered greater final luminal diameter, a lower restenosis rate and fewer ischemia-driven target vessel revascularization (TVR) procedures at the end of the first 180 days when compared with balloon PTCA 4 . The BENESTENT I trial 5 compared the elective coronary stent implantation strategy with balloon PTCA in non-AMI patients showing that 36% of patients randomized to the balloon obtained a final procedural stenosis diameter lower than 30%, and with reduced restenosis rates with fewer occurrences of major coronary events at the long-term follow-up, benefits similar to those obtained with routine stenting. Serruys et al referred to these optimal balloon PTCA results as a stent-like procedure 6,7 . The clinical and cost-effectiveness implications of these findings have stimulated the specific design of trials capable of proving or disproving this conclusions. Conclusion -In the first 12 hours of AMI onset, this comparison was not yet realized. The objective of this study was to perform the comparative analysis of the clinical and angiographic results at the end of the first 6 months after AMI of patients who had been submmited to a routine coronary stent implantation and those who obtained an optimal primary balloon PTCA angiographic result, and were included in the STENT PAMI trial. MethodsThis analysis follows the protocol determined for the

Influence of balloon pressure inflation in patients undergoing primary coronary stent implantation during acute myocardial infarction: a quantitative coronary angiography analysis

“…Quantitative coronary angiography with automatic edge detection was used to analyze the luminal changes [28][29][30] . Since 1994, all randomized series that tested the efficacy of stenting in AMI used the same technique, confirming its accuracy and reproducibility 2,[15][16][17][18][40][41][42][43] .…”