Purpose: The optimal treatment for patients presenting with in-stent restenosis remains to be defined, given the large spectrum of alternative strategies. We performed a network meta-analysis of randomized controlled trials to compare safety and efficacy of the different treatments for in-stent restenosis. Methods: All randomized controlled trials investigating different treatments for patients presenting with in-stent restenosis were included. Major adverse cardiac events (a composite end point of death, myocardial infarction, target lesion revascularization, myocardial infarction and stent thrombosis) were the primary end point, while its components the secondary ones and where appraised within a hierarchical Bayesian model computing odds ratios. Results: Non compliant/semi compliant balloons were evaluated in 11 studies with 1149 patients, bare metal stent in one study with 224 patients, rotablator in one study with 146 patients, sirolimus eluting stent in 9 with 1017 patients, paclitaxel eluting stent in 7 with 1048 patients, paclitaxel coated balloon in 4 studies with 282 patients, everolimus eluting stent in 1 study with 32 patients, and brachytherapy in 5 with 716 patients. After a median of 12 months (10-14), paclitaxel coated balloon performed not inferior to sirolimus eluting stent, paclitaxel eluting stent and everolimus eluting stent, all of them being superior to non compliant and cutting balloon. This reduction in major adverse cardiac events was mainly driven by reduction in target lesion revascularization obtained by paclitaxel coated balloon, paclitaxel eluting stent, sirolimus eluting stent when compared to other strategies. Rates of myocardial infarction did not differ between various treatments, as those of stent thrombosis, apart from a reduction of stent thrombosis offered by paclitaxel coated balloon when compared to cutting balloon (odds ratio 0.28: 0.02-0.9, all confidence interval 95%). Conclusions: Paclitaxel coated balloon performed similar to first generation drug eluting stent for treatment of in-stent restenosis, being superior to cutting and non compliant balloon.
Safety and efficacy of treatments for in stent restenosis: a network meta-analysis of randomized controlled trials
PERVERSI, JACOPO;D'ASCENZO, FABRIZIO;GAITA, Fiorenzo
2014-01-01
Abstract
Purpose: The optimal treatment for patients presenting with in-stent restenosis remains to be defined, given the large spectrum of alternative strategies. We performed a network meta-analysis of randomized controlled trials to compare safety and efficacy of the different treatments for in-stent restenosis. Methods: All randomized controlled trials investigating different treatments for patients presenting with in-stent restenosis were included. Major adverse cardiac events (a composite end point of death, myocardial infarction, target lesion revascularization, myocardial infarction and stent thrombosis) were the primary end point, while its components the secondary ones and where appraised within a hierarchical Bayesian model computing odds ratios. Results: Non compliant/semi compliant balloons were evaluated in 11 studies with 1149 patients, bare metal stent in one study with 224 patients, rotablator in one study with 146 patients, sirolimus eluting stent in 9 with 1017 patients, paclitaxel eluting stent in 7 with 1048 patients, paclitaxel coated balloon in 4 studies with 282 patients, everolimus eluting stent in 1 study with 32 patients, and brachytherapy in 5 with 716 patients. After a median of 12 months (10-14), paclitaxel coated balloon performed not inferior to sirolimus eluting stent, paclitaxel eluting stent and everolimus eluting stent, all of them being superior to non compliant and cutting balloon. This reduction in major adverse cardiac events was mainly driven by reduction in target lesion revascularization obtained by paclitaxel coated balloon, paclitaxel eluting stent, sirolimus eluting stent when compared to other strategies. Rates of myocardial infarction did not differ between various treatments, as those of stent thrombosis, apart from a reduction of stent thrombosis offered by paclitaxel coated balloon when compared to cutting balloon (odds ratio 0.28: 0.02-0.9, all confidence interval 95%). Conclusions: Paclitaxel coated balloon performed similar to first generation drug eluting stent for treatment of in-stent restenosis, being superior to cutting and non compliant balloon.
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