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Francesco Burzotta

Francesco Burzotta. Z-SEASIDE: resolute Zotarolimus-eluting vs Sirolimus- or Everolimus- eluting stent for treatment of bifurcated lesions. Institute of Cardiology, Catholic University of the Sacred Heart, Rome - Italy. STUDY KEY FEATURES.

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Francesco Burzotta

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  1. Francesco Burzotta Z-SEASIDE: resolute Zotarolimus-eluting vs Sirolimus- or Everolimus- eluting stent for treatment of bifurcated lesions Institute of Cardiology,Catholic University of the Sacred Heart, Rome - Italy

  2. STUDY KEY FEATURES ACRONYM: Z-SEA-SIDE, Sirolimus vs Everolimus –eluting stent randomized Assessment in bifurcated lesions and clinical SIgnificance of residual siDE-branch stenosis DESIGN: single centre, non sponsored, open label prospective study comparing Resolute vs Cypher and Xience in unselected bifurcated lesions REGISTRATION: www.clinicaltrials.org (NCT00697372) CO-INVESTIGATORS: Trani, Todaro, Mariani, Talarico, Mongiardo, Mazzari, Porto, Niccoli, Leone, Tommasino, Schiavoni, Crea

  3. BACKGROUND • Provisional stenting with drug-eluting stents (DES) is the gold standard for treatment of coronary bifurcated lesions • Different DES platforms have remarkable differences which may influence the procedural performance and post-PCI angiographic results • Thus, head to head comparisons of different DES in bifurcated lesions may be clinically useful

  4. SES EES R-ZES * * * BACKGROUND * Courtesy by P. Mortier

  5. SES R-ZES EES PCI with Provisional TAP-stenting strategy PROSPECTIVE EVALUATION OF PROCEDURAL PERFORMANCE OFF-LINE, BLIND, 3DQCA ANALYSIS OF PROCEDURAL RESULTS WITH A BIFURCATION-DEDICATED SOFTWARE PROSPECTIVE EVALUATION OF CLINICAL OUTCOME STUDY FLOW-CHART 225 CONSECUTIVE UNSELECTED PATIENTS WITH BIFURCATED LESION UNDERGOING DES IMPLANTATION (only exclusion criteria: contraindication to prolonged double antiplatelet therapy, STEMI, TIMI<3) PERIOD 1 (150 PTS) 1:1 RANDOMIZATION TO PERIOD 2 (75 PTS) SYSTEMATIC IMPLANTATION OF

  6. P ns Pts 75 75 75 ns Age (mean+SD) 65±9 65±11 65±11 Diabetes Mellitus (%) 25 (33.3) 19 (25.3) 19 (25.3) ns • Target Bifurc: • Distal Left Main (%) • LAD/Diag (%) ns 11 (14.7) 15 (20.0) 11 (14.7) ns 48 (64.0) 45 (60.0) 36 (48.0) • Bifurcation type: • 1,1,1 or 1,0,1 or 0,1,1 (%) • other types (%) 30 (40.0) 30 (40.0) 45 (60.0) 0.02 45 (60.0) 45 (60.0) 30 (40.0) ns Treatment of other vessels (%) 26 (34.7) 24 (32.0) 27 (36.0) STUDY POPULATION

  7. ns 75 (100%) 75 (100%) 75 (100%) 0.05 0.01 ns 50 (66.7%) 51 (68.0%) 55 (73.3%) ns 6 (8.0%) 6 (8.0%) 10 (13.3%) RESULTS: PROCEDURAL PERFORMANCE P STEPS OF PROVISIONAL-TAP MV Stent according to randomization / intention 7 (9.3%) 8 (10.7%) 3 (4.0%) 0.11 SB flow <3 after MV stent ns 52 (69.3%) 55 (73.3%) 58 (77.3%) SB re-wiring attempted (BMW) Need of guidewires different from BMW for SB re-wiring 6 (8.0%) 3 (4.0%) 1(1.3%) ns 2 (2.7%) 3 (4.0%) 0 Failure of SB re-wiring 1 (1.3%) 1 (1.3%) 0 ns Failure of SB dilation ANY SB “TROUBLE” (composite of green items) * 12 (16.0%) 8 (10.7%) 3 (4.0%) Kissing inflation performed SB stent implantation followed by final kissing (TAP) * pre-defined end-point

  8. ns 80.0% 75.8% 75.5% ns 1.0 mm2 1.2 mm2 1.2 mm2 ns 50.2% 54.6% 50.5% ns 1.7 mm2 2.0 mm2 2.1 mm2 ns 67° 64° 65° ns 29.3% 30.7% 31.4% ns 5.2 mm2 5.8 mm2 5.7 mm2 ns 2.9 mm 3.1 mm 3.0 mm ns 2.8 mm 3.0 mm 2.9 mm 43.9% 39.5% 36.3% <0.01 2.4 mm2 3.3 mm2 3.5 mm2 0.01 1.8 mm 2.7 mm 2.7 mm -5.3° -4.4° -3.2° RESULTS: 3DQCA ANGIOGRAPHIC RESULTS P MV area stenosis MV Min. Lum. Area SB area stenosis BEFORE PCI SB Min. Lum area Bifurcation angle MV area stenosis MV Min. Lum area MAIN VESSEL POST-PCI MV MLD prox to bif MV MLD distal to bif 0.07 SB area stenosis SB Min. Lum area SIDE BRANCH POST PCI SB MLD at ostium* ns Angle modification * pre-defined end-point

  9. P=0.28 12% 10.7% 10% 9.3% 8% 7.5% 6% 5.3% 4.0% 4.0% 4% 2.7% 2.7% 2.7% 2% 1.3% 1.3% 0 Cardiac Death MI* TVR TBF *all non-q, half periprocedural RESULTS: 12-MONTH CLINICAL OUTCOME Angio FU rate: 40% 12-month clinical FU rate: 100% Predefined end-point: TARGET BIFURCATION FAILURE (TBF): MACE or, in the absence of MACE, angiographic FU showing restenosis >50% in the MV or TIMI<3 in the SB

  10. CONCLUSIONS In unselected patients with bifurcated lesions undergoing DES implantation according to a “provisional-TAP” strategy… - the procedural outcome may be influenced by DES selection (Z-RES better than SES for “SB troubles”) - the acute angiographic result in the SB ostium may be influenced by DES selection (Z-RES and EES better than SES for SB ostium diameter / area) - the 12-month clinical outcome is good using the 3 DES (very low adverse event rate observed with Z-RES deserves more investigations)

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