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Contemporary treatment options for coronary revascularisation include percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). Over the past decades, PCI has evolved from a treatment for single-vessel coronary artery disease into a real alternative to CABG for treatment of complex multivessel coronary artery disease. The design of coronary stent systems has improved continuously since the introduction of the first commercially available coronary stent, the Palmaz-Schatz stent. From the bare metal stent period we have moved into the present era of drug-eluting stents (DES). Many DES are currently available, all composed of similar components (a stent platform, a polymer carrying the drug and a drug). However, their clinical effectiveness differs widely. The Synergy between PCI with TAXUS and cardiac surgery (SYNTAX) trial investigated whether PCI with DES (paclitaxel-eluting stents [PES], TAXUS, Boston Scientific, Natick, MA) was non-inferior to CABG in the treatment of complex coronary artery disease. The primary clinical endpoint was a composite of major adverse cardiac and cerebrovascular events (MACCE) consisting of death from any cause, stroke, myocardial infarction, or repeat revascularisation. In SYNTAX, PCI was inferior to CABG at one year, entirely due to an increased repeat intervention rate. We hypothesised that the use of a superior next-generation DES could reduce the need for repeat intervention after PCI. To investigate whether the everolimus-eluting stent (EES) (XIENCE V, Abbott Vascular, Santa Clara, CA, also distributed as PROMUS, Boston Scientific, Natick, MA) is superior to the PES we performed a random-effects meta-analysis of the four randomised clinical trials comparing EES with PES for which one-year results have been published. We studied the following safety and efficacy endpoints: death from any cause, myocardial infarction, target lesion revascularisation, and definite or probable stent thrombosis by Academic Research Consortium (ARC) definitions. In the four trials, a total of 4194 patients were randomised to EES and 2489 patients to PES. Results of the meta-analysis are shown in figure 1. At one year, patients treated with the EES had significantly lower rates of myocardial infarction (risk ratio [RR] 0.57), target lesion revascularisation (RR 0.49), and ARC definite or probable stent thrombosis (RR 0.36). These results could be explained by differences between both DES in the underlying stent platforms, differences in the drug and differences in the polymer eluting the drug (table 1).
Figure 1
Outcomes from randomised trials comparing the everolimus-eluting stent (EES) with the paclitaxel-eluting stent (PES). Size of data markers indicates the weight of the study.
Table 1
Differences in stent design between the everolimus-eluting stent (EES) and the paclitaxel-eluting stent (PES).
Underlying stent platform
Strut thickness
Polymer
Polymer thickness
Drug
Drug release kinetics
Multilink Vision stent, made of L-605 cobalt chromium alloy
81 µm
2-layer poly n-butyl methacrylate and polyvinylidene fluoride hexafluoropropylene copolymer
7.8 mm
Everolimus (1µg/mm2): an analogue of sirolimus, an antiproliferative, anti-inflammatory, and immunosuppressive agent which arrests the cell cycle by activation of the mammalian target of rapamycin
Releases 80% of the drug within 30 days after implantation
EXPRESS2 or Liberté, made of 316L stainless steel
EXPRESS2: 132 µm, Liberté 97 µm
3-layer styrene-isobutylene-styrene copolymer
17.8 mm
Paclitaxel (1µg/mm2): an antineoplastic agent which arrests the cell cycle by stabilisation of microtubules
Burst release in the first 48 hours after implantation, slow release over the next 10 days
Would SYNTAX have been a positive trial if XIENCE V had been used instead of TAXUS? A meta-analysis of a first-generation vs. a second-generation drug-eluting stent system
Auteurs
B. E. Claessen G. W. Stone P. C. Smits E. Kedhi W. J. Kikkert J. J. Piek J. P. S. Henriques
