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进口与国产雷帕霉素洗脱支架一年临床疗效比较_于淼.pdf

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1、do:i 1013969/ j1 issn11004-8812120111021010T: 100029 nD Sv D(!aaTa N a aua *aR); 3D5 ()YT:, Emai:l yjzhou hotmail1 com# “5# gS !OB M “5r1 于淼 周玉杰 阎赢 王志坚 史冬梅 刘宇扬 赵迎新 成万钧 郭永和=K1 “ y3 “#h s4 3 ( PCI),1 sS 0!O( F irebird) g 0!O(Cypher Select)1 M “5 rbZE 2004 M12006 M12D s S g 0!O( SES)3h2000 , O ,sSFireb

2、irdF( Firebird; 1004 ) gCypherF(Cypher; 996 )b 1 M “5 rb)FO 15 Yq(MACE)? 3 q, y ad #5ybQ)1 M =O = ? 3 qbT 1 M TA U,S g 0!O( SES)FMACE? 3 qsd9il( 1718%11816%, P= 01666)b F ( 417%1511%, P = 01649)a ( 412%1418%, P = 01493)5y q( 910%1816%, P= 01795) (Mb F12 / V ?O = ? 3 qgsnd9il(111%1110%, P= 01841)by B

3、sV , DES 1 M =MACE y b SFirebird SES gCypher SES 1 M = M “5 r b=1oM 0!O; T; Comparison of one-year clinical outcomes of domestic sirolimus-eluting stents versus importedsirolimus-eluting stents for the treatment of coronary artery disease YU M iao, ZHOU Yu-jie, YANYing, WANG Zhi-jian, SH I Dong-m ei

4、, L IU Yu -yang, ZHAO Ying-xin, CHENG Wan- jun, GUO Yong- he1Anzhen H ospital, Capital M ed ical University, B eijing, Ch inaCorresponding author: ZHOU Yu-jie, Email: yjzhou hotma il1 com=Abstract Objective To compare the clinicaloutcomes between treatmentw ith domestic sirolimus-eluting stents ( SE

5、S) and imported SES1M ethods Two thousand consecutive patients treated with SESsfrom January 2004 to December 2006 inAnzhen hospitalwere included in this study1 Based on the differenceof the stents, the patientswere divided into 2 groups including the domestic SES ( Firebird stent) group ( n= 1004)

6、and the imported SES ( Cypher stent) group (n= 996)1 Clinical outcomeswere monitored for oneyear1 The primary endpoint was the incidence of major adverse cardiac events (MACE): a composite ofdeath, nonfatalmyocardial infarction (M I), and target-vesselrevascularization (TVR)1 Secondary endpointwas d

7、efinite/probable stent thrombosis1Results After one-year follow-up, there was no significantdifference inMACE between domestic and imported DES groups ( 1718% vs1 1816%, P = 01666)1 Themortality ( 417% vs1 511%, P = 01649), M I ( 412% vs1 418%, P = 01493) and TVR rate ( 910% vs1816%, P = 01795) were

8、 all sim ilar between the two groups1 The incidence of definite/probable stentthrombosis has no significant difference during one year of follow-up ( 111% vs1110%, P = 01841)1 A fteradjustment for other variates, DES type was not an independent risk factor for one-yearMACE1ConclusionDomestic F irebi

9、rd SES and imported Cypher SES had similar effects and safety in terms of on one-yearclinicaloutcomes1=Keywords Drug-eluting stents; Treatment outcome; Prognosis#95#S #h2011 M419 2 Chin J Intervent Cardio,l April 2011, Vol 19, No12B o 5 f O(BMS)M1,0!O( DES) ?A.N q y q,yNDES 2, CKCK-MB W V; (2)PhM; (

10、 3) X; ( 4)shMO ; ( 5)P i s 30%; ( 6) 8a hal ?ylh h NiY F 0 P;( 7)#M; ( 8) p l12b2.3 T: sDES , h f %PCI TDES b PCI - ( 300mg,i ?300 mg/d, 3h 100 mg /dK b - ( Ho 600mg g,i75mg /d 1 Mb = 100 IU /kg F b f % l(GP)IIb/IIIa s8 F4b31l: c g a “5L+ b: c a Uhaah Nb l“ WPCI m f b 12 “5 rMACE Yq?3b) 1 5 Yq(MACE

11、), y ,d (M I)5y(TVR)b STd ,l / 3HS2H: “5amM#SM 14bQ) V ?O = ,O = ARC(Academ ic Research Consortium)l: ( 1)O = :YV/h O= b( 2) V ?O = :O 30 d=? 3 ? d O 5M1$ 15b41d9s:) SPSS 1310d9 qd9s; M x ? s V U,t_y Zs;d sM 5Z_; Yqi qKaplan-MeierZEd9;By Cox1 BB sbP 0105 sd9ilb T11 “5L +: S2436 ,K O 2000 , 1004 SSES

12、s, 996 gSESsb F g a “5L #3 hM f s (d9il,SSESF ( O( 1183 ? 1190) ; gSESF (O( 1162 ? 2111) (P = 01426),nV1b21 “5: F “5 TnV2m1bFirebirdCypherF) Yq? 3 qsd9il( 1718%11816%, P =01666), FirebirdF q417% ( 47 ),CypherF511% ( 51 ), P = 01649; ?3 qFirebirdF412% (42 ),7CypherF418% ( 48 ), P = 01493;FirebirdF5yq

13、910% ( 90 ), CypherF816% ( 86 ), P =#96#S #h2011 M419 2 Chin J InterventCardio,l April2011, Vol 19, No12V1 g#L “5 /#PCI+ “FirebirdF( 1004 ) CypherF( 996 )d9P“5L M -, x ? s 58. 8? 11. 4 59. 4 ? 10. 5 t= 0. 674 0. 5913, (% ) 238( 23. 7) 207( 20. 8) V2 = 2. 47 0. 116 , (% ) 451( 44. 9) 415( 41. 7) V2 =

14、 2. 16 0. 142, (% ) 595( 59. 3) 586( 58. 8) V2 = 0. 038 0. 846 Uh, (% ) 329( 32. 8) 344( 34. 5) V2 = 0. 701 0. 402, (% ) 228( 22. 7) 240( 24. 1) V2 = 0. 537 0. 642M I, (% ) 181( 18. 0) 208( 20. 9) V2 = 2. 60 0. 277NSTE-ACS, (% ) 303( 30. 2) 312( 31. 3) V2 = 0. 308 0. 579;Ah N, (% ) 99( 9. 9) 110( 11

15、. 0) V2 = 0. 794 0. 387/#PCI+hM5 f 0. 9075hM, (% ) 392( 39. 1) 413( 41. 5)5hM, (% ) 343( 34. 2) 370( 37. 1)5hM, (% ) 269( 26. 8) 276( 27. 7) ( 5 1. 61? 0. 81 1. 53 ? 0. 72 t= 0. 842 0. 353 (O 1. 83? 1. 90 1. 62 ? 2. 11 t= 0. 725 0. 426 hM(20 mm), (% ) 154( 15. 3) 161( 16. 2) V2 = 0. 257 0. 6125(mm)

16、2. 9? 0. 4 2. 9 ? 0. 4 t= 1. 76 0. 072O9(mm) 26. 8? 9. 5 26. 1 ? 8. 5 t= 1. 82 0. 068M10, (% )R 0829( 82. 6) 797( 80. 0) V2 = 2. 138 0. 144B- s8E4710( 70. 7) 669( 67. 2) V2 = 2. 941 0. 086ACEIARB 549( 54. 7) 586( 58. 8) V2 = 3. 515 0. 061: M I, ; NSTE-ACS,dST$3 8; ACEI,5f 4; ARB,5f s8 F4V2 S gSES 1

17、“FirebirdF( 1004 ) CypherF( 996 ) V2P1 5 Yq179( 17. 8) 185( 18. 6) 0. 187 0. 666y 47( 4. 7) 51( 5. 1) 0. 207 0. 649d M I 42( 4. 2) 48( 4. 8) 0. 471 0. 493TVR 90( 9. 0) 86( 8. 6) 0. 068 0. 795O = ( /V ?), (% ) 11( 1. 1) 10( 1. 0) 0. 040 0. 8415( 0. 5) 5( 0. 5) 0. 000 0. 990V ?6( 0. 6) 5( 0. 5) 0. 084

18、 0. 773: TVR,5yV3 Coxy $sMACEYq y0By0HR95% C IPO ( Cypher/F irebird) 1. 36 0. 58 3. 64 0. 178M -1. 12 1. 04 2. 47 0. 046 Uh2. 34 1. 42 6. 76 0. 032dST$3 81. 89 1. 34 2. 76 0. 02751. 96 1. 27 3. 62 0. 03501795b ARCl, FirebirdF? 3O = 11 ( 111% ), O = 5 , V ?O = 6 , CypherF? 3O = 10 m1 S gSESF1 M WMACE

19、 Yq3i q( 110% ), V ?O = sY5bm1Vlog ranks Yq? 3 qKaplan-Meier wLb F1 M 3i q wLsd9il( log rankP = 01620)bCox1 BB sA U, PCI 1 M =MACE Yq? 3 y0 Uha M -adST$3 8a5b7DES i MACE y0b#97#S #h2011 M419 2 Chin J Intervent Cardio,l April 2011, Vol 19, No12) 0!O ?APCI .N qy q 1-4,yN “ -X D 3 nb “ -S =XSDES g,Fire

20、bird(M icropor,t7)aExcel()#Partner( ), N , M #iv bSE 32005) 2006 Ma5#PCICTA U, s0!O 6640 , sS0!O48%, K FirebirdSESsb “ -,SDES gDES “5 r1 Cv“a TbkSDES , O CMW “5 r1,yN 1 KFirebirdSSDESF4b;X Firebird SES rbLiuHB 16B 84 ,?PCI PFirebird SES r, W 1 MMACE Yq? 3 q9 b 6B 67 PCI Firebird SES, M “5 r z 17b l“

21、 Firebird SES, SES1b +3hl5hM r 114 ,1 PCypherFirebird r,A U 6 10 W ($O = ,? #b?eV0 ?bO =.N q818%bSFirebirdO gCypherO1 “5 AY 18bZ984 Cypher SESFirebirdSES 1 M ,A U MACEaO =.N( ISR)O = ? 3 qs (d9il 19b SDES gDES1 “ va “5,4, 12 ?C F1 5 Yqa a a5y#O ? 3qs (d9ilby s9A U, DES 1 M = 5 Yq yb “5TMbTBV ,SSES F

22、irebird gSES CypherM1M “5 r ,yN9 PCI z4b/+ K, n5 a$ad v, B“, 3B W, V ? ?V PCI f ; Q, 12, HW M ,7 SES5y qO = ?3 q f V ?1 HW byN, -Q “5 k ? 4 b I D 1 M orice MC, Serruys PW, Sousa JE, et a.l A random izedcomparison of a sirolimus- eluting stentw ith a standard stent forcoronary revascularization. N En

23、gl J M ed, 2002, 346: 1773-1780. 2 M oses JW, LeonMB, Popma JJ, et a.l Sirolimus- eluting stentsversus standard stents in patients with stenosis in a nativecoronary artery. N Engl JM ed, 2003, 349: 1315-1323. 3 Stone GW, E llis SG, Cox DA, et a.l A polymer-based,paclitaxe-l eluting stent in patients

24、 w ith coronary artery disease.N Engl JM ed, 2004, 350: 221-231. 4 Schampaert E, Cohen EA, SchluterM, et a.l The Canadianstudy of the sirolimus-eluting stent in the treatment of patientsw ith long de novo lesions in small native coronary arteries ( C-SIRIUS). Jam CollCardio,l 2004, 43: 1110-1115. 5

25、Schofer J, SchluterM, Gershlick AH, et a.l Sirolimus-elutingstents for treatment of patientsw ith long atherosclerotic lesions insmall coronary arteries: Double-blind, randomised controlledtrial ( E-SIR IU S). Lancet, 2003, 362: 1093-1099. 6 StoneGW, E llis SG, Cannon L, et a.l Comparison of a polym

26、er-based paclitaxe-l eluting stent with a baremetal stent in patientsw ith complex coronary artery disease: A random ized controlledtria.l JAMA, 2005, 294: 1215-1223. 7 Dawkins KD, GrubeE, Guagliumi G, et a.l C linical efficacy ofpolymer-based paclitaxe-l eluting stents in the treatment ofcomplex, l

27、ong coronary artery lesions from a multicenter,random ized tria.l Support for the use of drug-eluting stents incontemporary clinical practice. Circulation, 2005, 112: 3306-3313. 8 W ijnsW. A random ized trial to evaluate the safety and efficacyoftheM edtronic AVE ABT-578 eluting D river stent in de

28、novonative coronary artery lesions. Presented at: 2005 ScientificSession of the American College of Cardiology; O rlando, FL,2005. 9 Lemos PA, Serruys PW, van Domburg RT, et a.l U nrestrictedutilization of sirolimus-eluting stents compared w ithconventionalbare stent implantation in the “ real world

29、“: Therapamycin-eluting stent evaluated at Rotterdam CardiologyHospital ( RESEARCH ) Registry. C irculation, 2004, 109: 190-195. 10 OngATL, Serruys PW, Aoki J, et a.l The unrestricted use ofpaclitaxe-l versus sirolimus-eluting stents for coronary arterydisease in an unselected population: One-year r

30、esults of theT axus-Stent Evaluated at Rotterdam Cardiology Hospital( TSEARCH ) registry. J Am Coll Cardio,l 2005, 45: 1135-1141. 11 Lemos PA, HoyeA, GoedhartD, et a.l Clinica,l angiographic,and procedural predictors of angiographic restenosis aftersirolimus-eluting stent implantation in complex pat

31、ients.Circulation, 2004; 109: 1366-1370.#98#S #h2011 M419 2 Chin J InterventCardio,l April2011, Vol 19, No12 12 Degertekin M, Arampatzis CA, Lemos PA, et a.l Very longsirolimus-eluting stent implantation for denovo coronary lesions.Am J Cardio,l 2004, 93: 826-829. 13 M aYC, Zuo L, Chen JH, et a.l M

32、odified glomerular filtrationrate estimating equation for Chinese patientsw ith chronic kidneydisease. JAm SocN ephro,l 2006, 17: 2937-2944. 14 Cannon CP, BattlerA, Brindis RG, et a.l American College ofCardiology key data elements and definitions formeasuring theclinicalmanagement and outcomes of p

33、atientswith acute coronarysyndromes. A report of theAmerican College ofCardiologyTaskForce on Clinical Data Standards ( A cute Coronary SyndromesW riting Comm ittee). JAm CollCardio,l 2001, 38: 2114-2130. 15 M auri L, Hsieh WH, M assaro JM, et a.l Stent thrombosis inrandomized clinical trials of dru

34、g-eluting stents. N Engl JM ed,2007, 356: 1020-1029. 16 L iu HB, Xu Bo, Gao RL, et a.l Outcomes of using Firebirdrapamycin eluting stents in routine coronary interventionpractice: one-year results from the pilot study of F irebird inChina registry. ChinM ed J, 2006; 119: 609-611. 17 Xu B, Zhang Q, Y

35、ang YJ, et a.l Sirolimus-eluting cobalt-chrom ium stents: two-yearclinical results from first- in-man studyon theF irebird 2 stent. Chin M ed J, 2008, 121: 492-497. 18 +, O 2,.S0!O3hl5h r.S SD, 2007, 10:702-703 19Z, , ? ,.S g 0!O 3h r1 .5h, 2006, 34:994-996.( l : 2010-02-24)#h#/11Z 75h v0pY= +Dv ZD “5 *Da * S11Z 75h v( OCIN)8S= 75h # W T =Ov( ICS)a6 * v( EACoN ),|2011 M98) 11 S Z Hz 7b E M , o * 5?Zd ,a/ a !# k,S 5 tZ 9XrS= 55 bZ 75h v( OCIN)Te/ T?S707,/

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