The CIAO (Coronary Interventions Antiplatelet-based Only) Study Eugenio Stabile, MD, PHD, FESC, FAHA, Wail Nammas, MD, Luigi Salemme, MD, Giovanni Sorropago, MD, Angelo Cioppa, MD, Tullio Tesorio, MD, Vittorio Ambrosini, MD, Esther Campopiano, MD, Gregory Popusoi, MD, Giuseppe Biondi Zoccai, MD, Paolo Rubino, MD Mercogliano and Turin, Italy JACC 2008;52: R3. 조병현

Page  2  UFH  The most commonly used agent during PCI  Significant debate remains about correlation between the effects of UFH and ischemic and hemorrhagic complications  Guidelines about heparin  70~100IU/kg  aPTT: 250~350s (no GPI)  aPTT: 200s ( with GPI) Background

Page  3  Multiple trials about heparin use in elective PCI  Only minute doses of UFH are needed in uncomplicated lesion  Minimal heparin dose with GPI use  Nonemergency PCI could be done w/o anticoagulation in patients with aspirin, thienopyridine, GPI  Aspirin, clopidogrel and GPI w/o anticoagulation can decrease bleeding Cx in elective PCI  Degree of anticoagulation(aPTT) had no effect on ischemic event Background The safety and efficacy of elective PCI of uncomplicated lesions, with adjunctive pharmacotherapy consisting of antiplatelet therapy alone, without scheduled unfractionated heparin or other antithrombin therapy

Page  4 Research Design and Method  Study double-blind, randomized, prospective study  Patients June 2005~January 2007 elective PCI of single target lesion with inclusion criteria Inclusion criteria 1) Located in a native coronary artery segment >2.5 mm in diameter 2) >70% diameter Stenosis 3) <33 mm in length 4) Noncalcified 5) Without important side branches (<2.5 mm) 6) Nonostial or left main 7) Free of visible thrombus 8) No chronic occlusion Exclusion criteria 1) Acute coronary syndromes 2) Recent MI (<2 weeks) 3) Refused to sign informed consent before enrollment 4) >90 years old 5) Received UFH within 12 h, LMWH within 24 h, or warfarin within 3 days 6) An INR>1.3 7) Ix for long-term anticoagulation 8) CIx to aspirin and/or thienopyridines

Page  5 Research Design and Method  Antiplatelet therapy –Aspirin(75~160mg/d)+ticlopidine(250mg bid)/clopidogrel(75mg/d) for at least 7 days –Clopidogrel preload(300mg) 24h before procedure –GPI use was allowed at the operator’s discretion  Study design –700 patients were enrolled –Control(anticoagulation with UFH, aPTT<250s) VS placebo(saline) –Catheter were flushed with UFH saline(7.5 UI/ml and <100ml)  Angiographic assessment  Post-procedural patient management –ECG(Before procedure and immediately after procedure) –CK-MB and CBC(Before procedure/6/12/24h after procedure)

Page  6 Research Design and Method  F/U –At 30 days –Clinical examination and a structured questionaaire  Study end point –Procedural success: <30% residual stenosis & TIMI flow grade 3 –Clinical success: procedural success w/o target vessel related death, AMI, CABG, stroke, urgent revascularization within 7 days –Primary end point: composite of death, AMI, need for urgent revascularization within 30 days –Secondary end point: bleeding Cx(TIMI, GUSTO, STEEPLE, ACUITY)

Page  7 RESULTS

Page  8 RESULTS

Page  9 RESULTS

Page  10 RESULTS

Page  11 RESULTS

Page  12 RESULTS 3.1% VS 1.7% (P<0.05)

Page  13 RESULTS

Page  14 Discussion  In our study, the absence of systemic anticoagulation was shown to be noninferior to standard therapy in terms of postprocedural ischemic events.  The experience with wire thrombus in the OASIS trials but none in this trial suggests that in a simple and elective procedure, the use of anticoagulation is not crucial. –Enrolled patients undergoing PCI for ACS –Not all OASIS patients were taking aspirin and thienopyridines

Page  15 Discussion  The minimal incidence of bleeding that occurred in this study may be related to use of 5-F system(>95%).  A meta-analysis suggested that there were increased ischemic complications among non-GPI patients undergoing PCI with lower ACTs –ACS represented a substantial proportion –>1 h was observed in 27%(average was 11 min in our study)  A study limitation is intraprocedural use of heparinized flush –Not likely to have significantly affected activated clotting times

Page  16 Conclusion  In the treatment of uncomplicated lesions and in the presence of dual antiplatelet therapy, elective PCI can be safely performed without systemic anticoagulation and is associated with a reduced incidence of bleeding complications.