For patients undergoing chronic total occlusion recanalization, drug-eluting stents (DES) proved more effective than bare-metal stents (BMS) during the procedure and resulted in better rates of major adverse cardiac events (MACE), mortality and MI, according to a meta-analysis published in the April 27 issue of the Journal of the American College of Cardiology.
“The long-term effectiveness and safety of DES use in CTO recanalization are unclear, and performance of randomized clinical trials in the field is complex,” the authors wrote.
To better understand this issue, Humberto J. Colmenarez, MD, of the Hospital Clínico San Carlos in Madrid, and colleagues performed a systematic review and meta-analysis using 14 comparative studies that compared the use of DES and BMS during CTO recanalization.
“Recanalization of CTO is one of the most challenging PCIs,” the authors wrote. “Procedural success is hampered by the difficulties associated with crossing the occluded segment with guidewires and recanalization devices, and long-term results are threatened by a high restenosis rate.”
The researchers evaluated rates of mortality, MI, target vessel revascularization, stent thrombosis and MACE. Average clinical follow-up took place 22 months after procedure and average angiographic follow up was six months.
Of the 14 studies, eight were historically controlled, three were retrospective cohort studies, two were randomized controlled trials and one was a nonrandomized comparative study. The studies were identified from various databases including Medline; the Cochrane Library; and from conference sessions of these meetings: American College of Cardiology, American Heart Association, European Society of Cardiology, Transcatheter Cardiovascular Therapeutics and EuroPCR.
Compared to BMS, DES had lower MACE incidence rates, 28.1 and 13.5 percent, respectively. Regarding target vessel revascularization, restenosis and stent reocclusion, rates were overall lower for DES : 11.7 versus 23.9 percent, 10.6 versus 36.8 percent and 2.9 versus 10.3 percent, respectively.
Incidence of MI was also lower in DES versus BMS treated patients, 1.9 versus 3.3 percent, respectively.
During the study 186 deaths occurred—4.1 percent in the DES group and 4.6 percent in the BMS group.
Results did show that rates of stent thrombosis (ST) were higher in the DES arm compared to the BMS arm, 1.28 versus 0.39 percent, respectively.
"The 1.28 percent DES ST rate documented in our analysis is virtually identical to that reported in other off-label indications, probably because in the context of regressed collaterals after CTO recanalization, ST might cause acute ischemia and myocardial necrosis,” the authors wrote.
“The benefit of using DES to ensure long-term success of CTO is confirmed by this meta-analysis,” the authors wrote. “Although a trend toward a higher stent thrombosis rate was observed in the DES-treated patients, further investigation is necessary to confirm this finding,” they concluded.