TY - JOUR
T1 - Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention
T2 - A pooled analysis of individual patient data from the ISAR-TEST 3, ISAR-TEST 4, and LEADERS randomized trials
AU - Stefanini, Giulio G.
AU - Byrne, Robert A.
AU - Serruys, Patrick W.
AU - De Waha, Antoinette
AU - Meier, Bernhard
AU - Massberg, Steffen
AU - Jni, Peter
AU - Schömig, Albert
AU - Windecker, Stephan
AU - Kastrati, Adnan
N1 - Funding Information:
The ISAR-TEST 3 and ISAR-TEST 4 trials were industry independent; funding was provided in part by the Bavarian Research Foundation (BFS-ISAR Aktenzeichen AZ: 504/02 and BFS-DES Aktenzeichen AZ: 668/05). The LEADERS trial was funded by Biosensors Europe SA, Switzerland. Funding for the current analysis was provided in part by the Swiss National Science Foundation (Grant 33CM30-124112). G.G.S. is recipient of a research grant from the European Association of Percutaneous Cardiovascular Interventions of the European Society of Cardiology. No other sources of funding were used for the current analysis.
PY - 2012/5
Y1 - 2012/5
N2 - Aims The efficacy of durable polymer drug-eluting stents (DES) is delivered at the expense of delayed healing of the stented vessel. Biodegradable polymer DES aim to avoid this shortcoming and may potentially improve long-term clinical outcomes, with benefit expected to accrue over time. We sought to compare long-term outcomes in patients treated with biodegradable polymer DES vs. durable polymer sirolimus-eluting stents (SES). Methods and results We pooled individual patient data from three large-scale multicentre randomized clinical trials (ISAR-TEST 3, ISAR-TEST 4, and LEADERS) comparing biodegradable polymer DES with durable polymer SES and assessed clinical outcomes during follow-up through 4 years. The efficacy endpoint of interest was target lesion revascularization and the safety endpoint of interest was definite stent thrombosis. Out of 4062 patients included in the present analysis, 2358 were randomly assigned to treatment with biodegradable polymer DES (sirolimus-eluting, n 1501; biolimus-eluting, n 857) and 1704 patients to durable polymer SES. No heterogeneity across the trials was observed in analyses of the primary and secondary endpoints. At 4 years, the risk of target lesion revascularization was significantly lower among patients treated with biodegradable polymer DES vs. durable polymer SES (hazard ratio 0.82, 95 CI 0.680.98, P = 0.029). In addition, the risk of stent thrombosis was significantly reduced with biodegradable polymer DES vs. durable polymer SES (hazard ratio 0.56, 95 CI 0.350.90, P = 0.015), driven by a lower risk of very late stent thrombosis (hazard ratio 0.22, 95 CI 0.080.61, P = 0.004). In keeping with this, in landmark analysis between 1 and 4 years, the incidence of myocardial infarction was lower for patients treated with biodegradable polymer DES vs. durable polymer SES (hazard ratio 0.59, 95 CI 0.730.95, P = 0.031). Conclusion Biodegradable polymer DES improve safety and efficacy compared with durable polymer SES during long-term follow-up to 4 years.
AB - Aims The efficacy of durable polymer drug-eluting stents (DES) is delivered at the expense of delayed healing of the stented vessel. Biodegradable polymer DES aim to avoid this shortcoming and may potentially improve long-term clinical outcomes, with benefit expected to accrue over time. We sought to compare long-term outcomes in patients treated with biodegradable polymer DES vs. durable polymer sirolimus-eluting stents (SES). Methods and results We pooled individual patient data from three large-scale multicentre randomized clinical trials (ISAR-TEST 3, ISAR-TEST 4, and LEADERS) comparing biodegradable polymer DES with durable polymer SES and assessed clinical outcomes during follow-up through 4 years. The efficacy endpoint of interest was target lesion revascularization and the safety endpoint of interest was definite stent thrombosis. Out of 4062 patients included in the present analysis, 2358 were randomly assigned to treatment with biodegradable polymer DES (sirolimus-eluting, n 1501; biolimus-eluting, n 857) and 1704 patients to durable polymer SES. No heterogeneity across the trials was observed in analyses of the primary and secondary endpoints. At 4 years, the risk of target lesion revascularization was significantly lower among patients treated with biodegradable polymer DES vs. durable polymer SES (hazard ratio 0.82, 95 CI 0.680.98, P = 0.029). In addition, the risk of stent thrombosis was significantly reduced with biodegradable polymer DES vs. durable polymer SES (hazard ratio 0.56, 95 CI 0.350.90, P = 0.015), driven by a lower risk of very late stent thrombosis (hazard ratio 0.22, 95 CI 0.080.61, P = 0.004). In keeping with this, in landmark analysis between 1 and 4 years, the incidence of myocardial infarction was lower for patients treated with biodegradable polymer DES vs. durable polymer SES (hazard ratio 0.59, 95 CI 0.730.95, P = 0.031). Conclusion Biodegradable polymer DES improve safety and efficacy compared with durable polymer SES during long-term follow-up to 4 years.
KW - Biodegradable polymer
KW - Biolimus A9
KW - Drug-eluting stent
KW - Meta-analysis
KW - Sirolimus
KW - Stent thrombosis
UR - https://www.scopus.com/pages/publications/84861371093
U2 - 10.1093/eurheartj/ehs086
DO - 10.1093/eurheartj/ehs086
M3 - Article
C2 - 22447805
AN - SCOPUS:84861371093
SN - 0195-668X
VL - 33
SP - 1214
EP - 1222
JO - European Heart Journal
JF - European Heart Journal
IS - 10
ER -