Impact of Patient and Lesion Complexity on Long-Term Outcomes Following Coronary Revascularization With New-Generation Drug-Eluting Stents

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• 作者：Konstantinos C. Koskinas ; MD ; MSc^a ; Masanori Taniwaki ; MD^a ; Fabio Rigamonti ; MD^b ; Dik Heg ; PhD^c ; Marco Roffi ; MD^b ; David Tü ; ller ; MD^d ; Olivier Muller ; MD^e ; Andre Vuillomenet ; MD^f ; Stephane Cook ; MD^g ; Daniel Weilenmann ; MD^h ; Christopher Kaiser ; MDⁱ ; Peiman Jamshidi ; MD^j ; Peter Jü ; ni ; MD^k ; Stephan Windecker ; MD^a ; ^{stephan.windecker@insel.ch} ; Thomas Pilgrim ; MD^a
• 刊名：The American Journal of Cardiology
• 出版年：2017
• 出版时间：15 February 2017
• 年：2017
• 卷：119
• 期：4
• 页码：501-507
• 全文大小：1107 K
• 卷排序：119

文摘

Long-term clinical outcomes of new-generation drug-eluting stents in complex anatomic and clinical settings are not well defined. This study assessed the impact of patient and lesion complexity on 2-year outcomes after coronary revascularization with ultrathin strut biodegradable-polymer (BP) sirolimus-eluting stents (SES) versus durable-polymer (DP) everolimus-eluting stents (EES). In a prespecified analysis of the BIOSCIENCE randomized trial (NCT01443104), complex patients (911 of 2,119; 43%) were defined by the presence of acute ST-elevation myocardial infarction (MI); left ventricular ejection fraction ≤30%; renal dysfunction; insulin-treated diabetes; treatment of ostial lesion, bypass graft, unprotected left main lesion; or 3-vessel intervention. The primary end point was target lesion failure (TLF), a composite of cardiac death, target vessel MI, and clinically indicated target lesion revascularization. At 2 years, complex compared with simple patients had a greater risk of TLF (14.5% vs 7.4%, risk ratio 2.05, 95% confidence interval 1.56 to 2.69; p <0.001). The difference was sustained beyond 1 year on landmark analysis. Complex patients had higher rates of the patient-oriented composite end point of death, any MI, or any revascularization (23% vs 14.4%; p <0.001) as well as definite stent thrombosis (1.6% vs 0.4%, p = 0.006). There were no differences in TLF and patient-oriented composite end point between the BP-SES versus DP-EES, consistently among simple and complex patients. In conclusion, patient and lesion complexity had a durable adverse impact on clinical outcomes throughout 2 years of follow-up in this all-comers randomized trial. Safety and efficacy of new-generation BP-SES and DP-EES were comparable, irrespective of complexity status.