Lower Risk of Stent Thrombosis and Restenosis With Unrestricted Use of 'New-generation' Drug-eluting Stents

A Report From the Nationwide Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

Giovanna Sarno; Bo Lagerqvist; Ole Fröbert; Johan Nilsson; Göran Olivecrona; Elmir Omerovic; Nawzad Saleh; Dimitris Venetzanos; Stefan James

Disclosures

Eur Heart J. 2012;33(5):606-613. 

In This Article

Abstract and Introduction

Abstract

Aims To compare the long-term outcome after percutaneous coronary intervention with 'new-generation' drug-eluting stents (n-DES) to 'older generation' DES (o-DES), and bare-metal stents (BMS) in a real-world population.
Methods and Results We evaluated 94 384 consecutive stent implantations (BMS, n = 64 631; o-DES, n = 19 202; n-DES, n = 10 551) in Sweden from November 2006 to October 2010. All cases of definite stent thrombosis (ST) and restenosis were documented in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Older generation DES were classified as: Cypher and Cypher Select (Cordis Corporation, Miami, FL, USA), Taxus Express and Taxus Liberté (Boston Scientific Corporation), and Endeavor (Medtronic Inc.) and n-DES as: Endeavor Resolute (Medtronic Inc.), XienceV, Xience Prime (Abbott Laboratories) and Promus, Promus Element (Boston Scientific Corporation). The Cox regression analyses unadjusted and adjusted for clinical and angiographic covariates showed a statistically significant lower risk of restenosis in n-DES compared with BMS [adjusted hazard ratio (HR) 0.29; 95% confidence interval (CI): 0.25–0.33] and o-DES (HR 0.62; 95% CI: 0.53–0.72). A lower risk of definite ST was found in n-DES compared with BMS (HR 0.38; 95% CI: 0.28–0.52) and o-DES (HR, 0.57; 95% CI: 0.41–0.79). The risk of death was significantly lower in n-DES compared with o-DES (adjusted HR: 0.77; 95% CI: 0.63–0.95) and BMS (adjusted HR: 0.55; 95% CI: 0.46–0.67).
Conclusion Percutaneous coronary intervention with n-DES is associated with a 38% lower risk of clinically meaningful restenosis, a 43% lower risk of definite ST, and a 23% lower risk of death compared with o-DES in this observational study from a large real-world population.

Introduction

Although many randomized trials and studies support the overall early and long-term safety and efficacy of the first-generation drug-eluting stents (DES),[1,2] concern has been raised on long-term safety, especially regarding the potential risk of late stent thrombosis (ST).[3–5]

New-generation DES (n-DES) have been developed with an improved design that may help to overcome the current limitations of the older generation DES (o-DES). Thin, more biocompatible polymers, higher flexibility, conformability, and deliverability of the cobalt–chromium and platinum–chromium stent alloys associated with alternative anti-proliferative-eluting drugs may have contributed to the low late loss and thrombotic risk with their restricted use in randomized trials.[6–9] Long-term results from the unrestricted use of n-DES are limited to few clinical trials[10,11] and single-centre experiences[12] evaluating only one type of n-DES.

The purpose of our study was to compare the long-term outcome of percutaneous coronary intervention (PCI) with n-DES with o-DES and bare-metal stents (BMS), in a large unselected population from a national registry with complete consecutive enrolment, the Swedish Coronary Angiography and Angioplasty Registry (SCAAR).

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