永久、可降解、无聚合物涂层支架在冠状动脉无保护左主干病变介入治疗中的临床分析
|
摘要
目的比较永久、可降解及无聚合物涂层3种支架治疗无保护左主干病变的安全性及有效性。方法本研究纳入了2013年1月-2017年6月于陆军军医大学(第三军医大学)第二附属医院心血管内科经冠状动脉造影诊断为冠状动脉无保护左主干病变,并行支架植入术的患者共259例,按照左主干植入支架的不同分为永久性聚合物涂层支架组(PP-DES,n=153)、可降解聚合物涂层支架组(BP-DES,n=54)和无聚合物涂层支架组(PF-DES,n=52),随访至术后12个月,比较3组患者支架植入术后12个月内靶血管失败(心源性死亡、靶血管相关性心肌梗死、靶血管再次血运重建)和主要心血管不良事件(心源性死亡、非致死性心肌梗死、再次血运重建)的发生情况。结果 3组患者在性别、年龄、临床诊断、合并高危因素及病变类型、支架术式、真性分叉病变比例等方面的差异无统计学意义(P>0.05),术后12个月内靶血管失败(P=0.596)及主要心血管不良事件发生率差异无统计学意义(P=0.210)。多因素COX回归分析显示:支架类型与患者术后12个月内发生靶血管失败及主要心血管不良事件无显著相关性(P>0.05)。结论可降解聚合物涂层支架、无聚合物涂层支架治疗无保护左主干病变的靶血管失败及主要心血管不良事件发生率与永久性聚合物涂层支架相当,这两种新型支架治疗无保护左主干病变安全有效。
Objective To compare the safety and efficacy of 3 kinds of permanent, biodegradable and polymer free drug eluting stents in the treatment of unprotected left main coronary artery disease(UPLM). Methods A total of 259 UPLM patients diagnosed by coronary angiography and underwent percutaneous coronary intervention(PCI) in our institute from January 2013 to June 2017 were recruited in this study. These cases were divided into 3 groups according to stent-type of left main implantation: permanent(PP-DES, n=153), biodegradable(BP-DES, n=54) and polymer free(PF-DES, n=52) groups. All the patients were followed up for 12 months. The target vessel failure(TVF), including cardiac death(CD), target vessel myocardial infarction(TVMI), target vessel revascularization(TVR), and major adverse cardiovascular events(MACE), including CD, nonfatal myocardial infarction(NFMI) and revascularization at 12 months after PCI were observed. Results There were no significant differences in sex, age, complicated high risk factors, lesions, stenting procedures, ratio of bifurcation lesions among the 3 groups(P>0.05). And no significant difference was seen in the incidences of TVF(P=0.596) and MACE(P=0.210) according to stent-type of left main implantation. Multivariate COX regression analysis showed that after 12-month follow-up, the risk of TVF and MACE had no significant correlation with stent-type of left main implantation(P>0.05). Conclusion Biodegradable and polymer free drug eluting stents have similar effects on the incidences of TVF and MACE in the treatment of UPLM when compared with permanent polymer drug eluting stent, and they are safe and effective for left main implantation.
Objective To compare the safety and efficacy of 3 kinds of permanent, biodegradable and polymer free drug eluting stents in the treatment of unprotected left main coronary artery disease(UPLM). Methods A total of 259 UPLM patients diagnosed by coronary angiography and underwent percutaneous coronary intervention(PCI) in our institute from January 2013 to June 2017 were recruited in this study. These cases were divided into 3 groups according to stent-type of left main implantation: permanent(PP-DES, n=153), biodegradable(BP-DES, n=54) and polymer free(PF-DES, n=52) groups. All the patients were followed up for 12 months. The target vessel failure(TVF), including cardiac death(CD), target vessel myocardial infarction(TVMI), target vessel revascularization(TVR), and major adverse cardiovascular events(MACE), including CD, nonfatal myocardial infarction(NFMI) and revascularization at 12 months after PCI were observed. Results There were no significant differences in sex, age, complicated high risk factors, lesions, stenting procedures, ratio of bifurcation lesions among the 3 groups(P>0.05). And no significant difference was seen in the incidences of TVF(P=0.596) and MACE(P=0.210) according to stent-type of left main implantation. Multivariate COX regression analysis showed that after 12-month follow-up, the risk of TVF and MACE had no significant correlation with stent-type of left main implantation(P>0.05). Conclusion Biodegradable and polymer free drug eluting stents have similar effects on the incidences of TVF and MACE in the treatment of UPLM when compared with permanent polymer drug eluting stent, and they are safe and effective for left main implantation.
引文
[1] WIJNS W, KOLH P, DANCHIN N, et al. Guidelines on myocardial revascularization: The task force on myocardial revascularization of the european society of cardiology (ESC) and the european association for cardio-thoracic surgery (EACTS)[J]. Eur Heart J,2010,31:2501-2555.DOI:10.1093/eurheartj/ehq277.
[2] LEVINE G N, BATES E R, BLANKENSHIP J C,et al.2011 ACCF/AHA/SCAI Guideline for percutaneous coronary intervention: a report of the american college of cardiology foundation/american heart association task force on practice guidelines and the society for cardiovascular angiography and interventions[J].Circulation,2011,124(23):e574-651.DOI:10.1161/CIR.0b013e31823ba622.
[3] LEE P H, KANG S H, HAN S, et al. Generalizability of EXCEL and NOBLE results to a large registry population with unprotected left main coronary artery disease[J]. Coron Artery Dis, 2017, 28(8): 675-682. DOI:10.1097/MCA.0000000000000543.
[4] MORICE M, SERRUYS P W, KAPPETEIN P, et al. Outcomes in patients with de novo left main disease treated with either percutaneous coronary intervention using paclitaxel-eluting stents or coronary artery bypass graft treatment in the synergy between percutaneous coronary intervention with TAXUS and cardiac surgery (SYNTAX) trial[J]. Circulation, 2010,121:2645-2653.DOI:10.1161/CIRCULATIONAHA.109.899211.
[5] PARK D W,PARK S J.Percutaneous coronary intervention of left main disease: pre- and Post-EXCEL (evaluation of XIENCE everolimus eluting stent versus coronary artery bypass surgery for effectiveness of left main revascularization) and NOBLE (Nordic-Baltic-British left main revascularization study) era[J].Circ Cardiovasc Interv,2017,10(6).pii: e004792.DOI:10.1161/CIRCINTERVENTIONS.117.004792.
[6] R?BER L, MAGRO M, STEFANINI G G, et al. Very late coronary stent thrombosis of a newer-generation everolimus-eluting stent compared with early-generation drug-eluting stents: a prospective cohort study[J]. Circulation, 2012, 125(9): 1110-1121. DOI:10.1161/CIRCULATIONAHA.111.058560.
[7] DE LUCA G, DIRKSEN M T, SPAULDING C, et al. Drug-eluting vs bare-metal stents in primary angioplasty: a pooled patient-level meta-analysis of randomized trials[J]. Arch Intern Med, 2012, 172(8): 611-621. DOI:10.1001/archinternmed.2012.758.
[8] LAGERQVIST B, JAMES S K, STENESTRAND U,et al.Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden[J].N Engl J Med,2007,356(10):1009-1019. DOI:10.1056/NEJMoa067722.
[9] STEFANINI G G, BYRNE R A, SERRUYS P W, et al. Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention: a pooled analysis of individual patient data from the ISAR-TEST 3, ISAR-TEST 4, and LEADERS randomized trials[J]. Eur Heart J, 2012, 33(10): 1214-1222. DOI:10.1093/eurheartj/ehs086.
[10] WANG Y, LIU S, LUO Y, et al. Safety and efficacy of degradable vs. permanent polymer drug-eluting stents: a meta-analysis of 18,395 patients from randomized trials[J]. Int J Cardiol, 2014, 173(1): 100-109. DOI:10.1016/j. ijcard.2014.02.023.
[11] PEDERSEN S H, PFISTERER M, KAISER C, et al. Drug-eluting stents and bare metal stents in patients with NSTE-ACS: 2-year outcome from the randomised BASKET-PROVE trial[J]. EuroIntervention, 2014, 10(1): 58-64. DOI:10.4244/EIJV10I1A11.
[12] MA Q, ZHOU Y, NIE X, et al. Rapamycin affects tissue plasminogen activator and plasminogen activator inhibitor I expression: a potential prothrombotic mechanism of drug-eluting stents[J]. Angiology, 2012, 63(5): 330-335. DOI:10.1177/0003319711418219.
[13] GUAGLIUMI G, SIRBU V, MUSUMECI G, et al. Examination of the in vivo mechanisms of late drug-eluting stent thrombosis: findings from optical coherence tomography and intravascular ultrasound imaging[J]. JACC Cardiovasc Interv, 2012, 5(1): 12-20. DOI:10.1016/j.jcin.2011.09.018.
[14] NAKAZAWA G, FINN A V, VORPAHL M, et al. Coronary responses and differential mechanisms of late stent thrombosis attributed to first-generation sirolimus- and paclitaxel-eluting stents[J]. J Am Coll Cardiol, 2011, 57(4): 390-398. DOI:10.1016/j.jacc. 2010.05.066.
[15] JONER M, FINN A V, FARB A, et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk[J]. J Am Coll Cardiol, 2006, 48(1): 193-202. DOI:10.1016/j.jacc.2006.03.042.
[16] ABIZAID A, COSTA J R Jr. New drug-eluting stents: an overview on biodegradable and polymer-free next-generation stent systems[J]. Circ Cardiovasc Interv, 2010, 3(4): 384-393. DOI:10.1161/CIRCINTERVENTIONS.109.891192.
[17] ELLIS S G, COLOMBO A, GRUBE E, et al. Incidence, timing, and correlates of stent thrombosis with the polymeric paclitaxel drug-eluting stent: a TAXUS II, IV, V, and VI meta-analysis of 3,445 patients followed for up to 3 years[J]. J Am Coll Cardiol, 2007, 49(10): 1043-1051. DOI:10.1016/j.jacc.2007.01.015.
[18] DANZI G B, PICCOLO R, CHEVALIER B, et al. Five-year clinical performance of a biodegradable polymer-coated biolimus-eluting stent in unselected patients[J]. Heart, 2017, 103(2): 111-116. DOI:10.1136/heartjnl-2016-309283.
[19] BAQUET M, JOCHHEIM D, MEHILLI J. Polymer-free drug-eluting stents for coronary artery disease[J]. J Interv Cardiol, 2018, 31(3): 330-337. DOI:10.1111/joic.12499.
[20] LEE P H, KWON O, AHN J M, et al. Safety and effectiveness of Second-Generation Drug-Eluting stents in patients with left main coronary artery disease[J]. J Am Coll Cardiol, 2018, 71(8): 832-841. DOI:10.1016/j.jacc.2017.12.032.
[2] LEVINE G N, BATES E R, BLANKENSHIP J C,et al.2011 ACCF/AHA/SCAI Guideline for percutaneous coronary intervention: a report of the american college of cardiology foundation/american heart association task force on practice guidelines and the society for cardiovascular angiography and interventions[J].Circulation,2011,124(23):e574-651.DOI:10.1161/CIR.0b013e31823ba622.
[3] LEE P H, KANG S H, HAN S, et al. Generalizability of EXCEL and NOBLE results to a large registry population with unprotected left main coronary artery disease[J]. Coron Artery Dis, 2017, 28(8): 675-682. DOI:10.1097/MCA.0000000000000543.
[4] MORICE M, SERRUYS P W, KAPPETEIN P, et al. Outcomes in patients with de novo left main disease treated with either percutaneous coronary intervention using paclitaxel-eluting stents or coronary artery bypass graft treatment in the synergy between percutaneous coronary intervention with TAXUS and cardiac surgery (SYNTAX) trial[J]. Circulation, 2010,121:2645-2653.DOI:10.1161/CIRCULATIONAHA.109.899211.
[5] PARK D W,PARK S J.Percutaneous coronary intervention of left main disease: pre- and Post-EXCEL (evaluation of XIENCE everolimus eluting stent versus coronary artery bypass surgery for effectiveness of left main revascularization) and NOBLE (Nordic-Baltic-British left main revascularization study) era[J].Circ Cardiovasc Interv,2017,10(6).pii: e004792.DOI:10.1161/CIRCINTERVENTIONS.117.004792.
[6] R?BER L, MAGRO M, STEFANINI G G, et al. Very late coronary stent thrombosis of a newer-generation everolimus-eluting stent compared with early-generation drug-eluting stents: a prospective cohort study[J]. Circulation, 2012, 125(9): 1110-1121. DOI:10.1161/CIRCULATIONAHA.111.058560.
[7] DE LUCA G, DIRKSEN M T, SPAULDING C, et al. Drug-eluting vs bare-metal stents in primary angioplasty: a pooled patient-level meta-analysis of randomized trials[J]. Arch Intern Med, 2012, 172(8): 611-621. DOI:10.1001/archinternmed.2012.758.
[8] LAGERQVIST B, JAMES S K, STENESTRAND U,et al.Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden[J].N Engl J Med,2007,356(10):1009-1019. DOI:10.1056/NEJMoa067722.
[9] STEFANINI G G, BYRNE R A, SERRUYS P W, et al. Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention: a pooled analysis of individual patient data from the ISAR-TEST 3, ISAR-TEST 4, and LEADERS randomized trials[J]. Eur Heart J, 2012, 33(10): 1214-1222. DOI:10.1093/eurheartj/ehs086.
[10] WANG Y, LIU S, LUO Y, et al. Safety and efficacy of degradable vs. permanent polymer drug-eluting stents: a meta-analysis of 18,395 patients from randomized trials[J]. Int J Cardiol, 2014, 173(1): 100-109. DOI:10.1016/j. ijcard.2014.02.023.
[11] PEDERSEN S H, PFISTERER M, KAISER C, et al. Drug-eluting stents and bare metal stents in patients with NSTE-ACS: 2-year outcome from the randomised BASKET-PROVE trial[J]. EuroIntervention, 2014, 10(1): 58-64. DOI:10.4244/EIJV10I1A11.
[12] MA Q, ZHOU Y, NIE X, et al. Rapamycin affects tissue plasminogen activator and plasminogen activator inhibitor I expression: a potential prothrombotic mechanism of drug-eluting stents[J]. Angiology, 2012, 63(5): 330-335. DOI:10.1177/0003319711418219.
[13] GUAGLIUMI G, SIRBU V, MUSUMECI G, et al. Examination of the in vivo mechanisms of late drug-eluting stent thrombosis: findings from optical coherence tomography and intravascular ultrasound imaging[J]. JACC Cardiovasc Interv, 2012, 5(1): 12-20. DOI:10.1016/j.jcin.2011.09.018.
[14] NAKAZAWA G, FINN A V, VORPAHL M, et al. Coronary responses and differential mechanisms of late stent thrombosis attributed to first-generation sirolimus- and paclitaxel-eluting stents[J]. J Am Coll Cardiol, 2011, 57(4): 390-398. DOI:10.1016/j.jacc. 2010.05.066.
[15] JONER M, FINN A V, FARB A, et al. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk[J]. J Am Coll Cardiol, 2006, 48(1): 193-202. DOI:10.1016/j.jacc.2006.03.042.
[16] ABIZAID A, COSTA J R Jr. New drug-eluting stents: an overview on biodegradable and polymer-free next-generation stent systems[J]. Circ Cardiovasc Interv, 2010, 3(4): 384-393. DOI:10.1161/CIRCINTERVENTIONS.109.891192.
[17] ELLIS S G, COLOMBO A, GRUBE E, et al. Incidence, timing, and correlates of stent thrombosis with the polymeric paclitaxel drug-eluting stent: a TAXUS II, IV, V, and VI meta-analysis of 3,445 patients followed for up to 3 years[J]. J Am Coll Cardiol, 2007, 49(10): 1043-1051. DOI:10.1016/j.jacc.2007.01.015.
[18] DANZI G B, PICCOLO R, CHEVALIER B, et al. Five-year clinical performance of a biodegradable polymer-coated biolimus-eluting stent in unselected patients[J]. Heart, 2017, 103(2): 111-116. DOI:10.1136/heartjnl-2016-309283.
[19] BAQUET M, JOCHHEIM D, MEHILLI J. Polymer-free drug-eluting stents for coronary artery disease[J]. J Interv Cardiol, 2018, 31(3): 330-337. DOI:10.1111/joic.12499.
[20] LEE P H, KWON O, AHN J M, et al. Safety and effectiveness of Second-Generation Drug-Eluting stents in patients with left main coronary artery disease[J]. J Am Coll Cardiol, 2018, 71(8): 832-841. DOI:10.1016/j.jacc.2017.12.032.