在2008年进展中的亮点

Highlights of Advances in PCI Highlights of Advances in PCI - -20082008 Runlin Gao, MD, FACC Cardiovascular Institute and Fu Wai Hospital, Beijing, China 2008年5月29日，Shanghai From TCT 2006 From TCT 2006 Long-Term Safety and Efficacy of DES and New Generation of DES Time after Initial Procedure (years)Time after Initial Procedure (years) 0 0 1 1 2 2 3 3 4 4 Time after Initial Procedure (years)Time after Initial Procedure (years) TAXUS I, II, IV, V, VITAXUS I, II, IV, V, VI (n=3,513)(n=3,513) RAVEL, SIRIUS, E-SIRIUS, and C-SIRIUSRAVEL, SIRIUS, E-SIRIUS, and C-SIRIUS (n=1,748)(n=1,748) CYPHER stent (n=870) Bare metal stent (n=878) Stone GW et al. NEJM 2007;356:998-1008Stone GW et al. NEJM 2007;356:998-1008 0 0 1 1 2 2 3 3 4 4 TAXUS stent (n=1,755) Bare metal stent (n=1,758) 9 Prospective, Double-Blind, Randomized Trials Freedom From (Protocol) Stent Thrombosis P=0.20 99.4% (5) 98.8% (10) P=0.30 99.1% (14) 98.7% (20) Time after Initial Procedure (years)Time after Initial Procedure (years) 0 0 1 1 2 2 3 3 4 4 Time after Initial Procedure (years)Time after Initial Procedure (years) TAXUS I, II, IV, V, VITAXUS I, II, IV, V, VI (n=3,513)(n=3,513) RAVEL, SIRIUS, E-SIRIUS, and C-SIRIUSRAVEL, SIRIUS, E-SIRIUS, and C-SIRIUS (n=1,748)(n=1,748) CYPHER stent (n=870) Bare metal stent (n=878) Stone GW et al. NEJM 2007;356:998-1008Stone GW et al. NEJM 2007;356:998-1008 0 0 1 1 2 2 3 3 4 4 TAXUS stent (n=1,755) Bare metal stent (n=1,758) 9 Prospective, Double-Blind, Randomized Trials Freedom From (Protocol) Stent Thrombosis P=0.20 99.4% (5) 98.8% (10) P=0.30 99.1% (14) 98.7% (20) 5 vs. 0, P=0.025 After 1 yearAfter 1 year 9 vs. 2, P=0.028 After 1 yearAfter 1 year Time after Initial Procedure (years)Time after Initial Procedure (years) 0 0 1 1 2 2 3 3 4 4 Time after Initial Procedure (years)Time after Initial Procedure (years) TAXUS I, II, IV, V, VITAXUS I, II, IV, V, VI (n=3,513)(n=3,513) RAVEL, SIRIUS, E-SIRIUS, C-SIRIUSRAVEL, SIRIUS, E-SIRIUS, C-SIRIUS (n=1,748)(n=1,748) P=0.23 94.7% (45) 93.3% (57) CYPHER stent (n=870) Bare metal stent (n=878) Stone GW et al. NEJM 2007;356:998-1008Stone GW et al. NEJM 2007;356:998-1008 0 0 1 1 2 2 3 3 4 4 P=0.68 93.4% (92) 93.9% (86) TAXUS stent (n=1,755) Bare metal stent (n=1,758) 9 Prospective, Double-Blind, Randomized Trials Freedom From All Cause Death Time after Initial Procedure (years)Time after Initial Procedure (years) 0 0 1 1 2 2 3 3 4 4 Time after Initial Procedure (years)Time after Initial Procedure (years) TAXUS I, II, IV, V, VITAXUS I, II, IV, V, VI (n=3,513)(n=3,513) RAVEL, SIRIUS, E-SIRIUS, C-SIRIUSRAVEL, SIRIUS, E-SIRIUS, C-SIRIUS (n=1,748)(n=1,748) P=0.86 93.8% (53) 93.6% (55) CYPHER stent (n=870) Bare metal stent (n=878) Stone GW et al. NEJM 2007;356:998-1008Stone GW et al. NEJM 2007;356:998-1008 0 0 1 1 2 2 3 3 4 4 P=0.66 93.7% (105) 93.0% (115) TAXUS stent (n=1,718) Bare metal stent (n=1,727) 9 Prospective, Double-Blind, Randomized Trials Freedom From Myocardial Infarction Time after Initial Procedure (years)Time after Initial Procedure (years) 0 0 1 1 2 2 3 3 4 4 Time after Initial Procedure (years)Time after Initial Procedure (years) TAXUS I, II, IV, V, VITAXUS I, II, IV, V, VI (n=3,513)(n=3,513) RAVEL, SIRIUS, E-SIRIUS, C-SIRIUSRAVEL, SIRIUS, E-SIRIUS, C-SIRIUS (n=1,748)(n=1,748) P 24 hrs later 24 hrs later Standard TreatmentStandard Treatment Repatriation of stable patients within 24 hrs of PCIRepatriation of stable patients within 24 hrs of PCI RandomizationRandomization Cantor et al, ACC/i2 2008 UrgentUrgent Transfer to PCI Centre Transfer to PCI Centre Treatment Medical Therapies TNK Heparin or Enoxaparin in pts 75 yrs of age ASA 160-325 mg Clopidogrel 300mg bolus (75 mg if 75 years of age) All other meds as per ACC/AHA STEMI guidelines PCI PCI of culprit lesion if 70% stenosis or 50- 70% stenosis with high-risk features (thrombus, ulceration, spontaneous dissection) Stents used whenever technically possible GP IIb/IIIa inhibitors left to operators discretion Cantor et al, ACC/i2 2008 0 0 2 2 4 4 6 6 8 8 1010 1212 1414 1616 1818 0 0 5 5 10101515202025253030 10.610.6 16.616.6 Days from RandomizationDays from Randomization % of Patients% of Patients Standard (n=496)Standard (n=496) Pharmacoinvasive (n=508)Pharmacoinvasive (n=508) n=496n=496 n=508n=508 422422 468468 415415 466466 415415 463463 414414 461461 414414 460460 412412 457457 OR=0.537 (0.368, 0.783); p=0.0013 Primary Endpoint: 30-day combined death, re- MI, CHF, severe recurrent ischemia, shock Cantor et al, ACC/i2 2008 Components of Primary Endpoint DeathDeath ReinfarctionReinfarction Recurrent IschemiaRecurrent Ischemia New/worsening CHFNew/worsening CHF Cardiogenic ShockCardiogenic Shock Death/MI/IschemiaDeath/MI/Ischemia Standard Standard TreatmentTreatment (n=498)(n=498) 3.63.6 6.06.0 2.22.2 5.25.2 2.62.6 11.711.7 PharmacoPharmaco -invasive-invasive (n=512)(n=512) 3.73.7 3.33.3 0.20.2 2.92.9 4.5 4.5 6.56.5 P P 0.940.94 0.0440.044 0.0190.019 0.0690.069 0.110.11 0.0040.004 Safety Endpoints Intracranial hemorrhageIntracranial hemorrhage TIMI scaleTIMI scale MajorMajor Major Major (non-CABG-related)(non-CABG-related) GUSTO scaleGUSTO scale SevereSevere Severe Severe (non-CABG-related)(non-CABG-related) TransfusionsTransfusions Standard Standard TreatmentTreatment (n=498)(n=498) 1.21.2 4.64.6 3.23.2 1.41.4 1.21.2 5.55.5 PharmacoPharmaco- - invasiveinvasive (n=512)(n=512) 0.20.2 4.34.3 2.22.2 0.60.6 0.60.6 7.17.1 P P 0.0660.066 0.880.88 0.330.33 0.220.22 0.340.34 0.310.31 Cantor et al, ACC/i2 2008 Take Home Messages High-risk STEMI patients treated with fibrinolysis who undergo PCI within 6 hours have lower rates of adverse ischemic outcomes without significant increase in bleeding risk Transfer should be initiated as soon as possible without awaiting results of fibrinolysis Benefit seen in the setting of clopidogrel loading and glycoprotein IIb/IIIa inhibitor use Acute Myocardial Infarction Emerging role of aspiration thrombectomy in a large trial from Europe TAPAS Trial: 1071 STEMI patients randomized 535 were assigned to thrombus aspiration 33 did not undergo PCI 502 underwent primary PCI 295underwent TA followed by direct stenting 153 underwent TA with additional balloon dilation 54had crossover to conventional PCI 536 were assigned to conventional PCI 33 did not undergo PCI 503 underwent primary PCI 485underwent balloon dilation followed by stenting 12underwent conventional PCI with additional TA 6had crossover to TA 530 complete follow-up at 1 year530 complete follow-up at 1 year Ziljstra et al, NEJM 2008 TAPAS Primary endpoint Myocardial blush grade P 0.001 Patients (%) Thrombus aspirationConventional PCI Ziljstr