Περιστροφικθ αιηρεκτομθ Ανασκόπηση των τελευταίων δεδομζνων - PDF

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Περιστροφικθ αιηρεκτομθ Ανασκόπηση των τελευταίων δεδομζνων Νίκος Μεζίλης, ΜD, FESC Κλινικθ «Άγιος Λουκάς» Calcified lesions Long and diffuse calcification. Ostial lesions Indications Undilatable lesions

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Περιστροφικθ αιηρεκτομθ Ανασκόπηση των τελευταίων δεδομζνων Νίκος Μεζίλης, ΜD, FESC Κλινικθ «Άγιος Λουκάς» Calcified lesions Long and diffuse calcification. Ostial lesions Indications Undilatable lesions / unable to cross with Balloon or CB highly calcified lesions calcified Bifurcation Minimize risk of side branch occlusion Rotablator TM allows debulking and plaque modification. Rota feasibility: NACI registry (1997) Comparison of different debulking strategies with POBA: ERBAC(1997) Technical/procedural isuues: STRATAS(2001) Rota vs POBA: COBRA (2000), DART Rota vs POBA plus stenting: SPORT (unpubl) Rota vs POBA in ISR: ARTIST (unpubl.); BARASTER (2000) ROTAXUS A Prospective, Randomized Trial of High-Speed Rotational Atherectomy Prior to Paclitaxel-Eluting Stent Implantation in Complex Calcified Coronary Lesions Gert Richardt, MD, PhD Herzzentrum Segeberger Kliniken Bad Segeberg, Germany Paclitaxel-Eluting Stent Objective of the ROTAXUS trial.. to evaluate whether routine rotablation prior to PES implantation is more effective than the standard of care (stenting without rotablation) in the setting of complex calcified coronary artery disease. Sample Size Calculation Hypothesis Rotablation prior to paclitaxel-eluting stent treatment will be superior to stenting without rotablation in reducing the late lumen loss at 9 months Assumption Late loss (primary endpoint) will be reduced from 0.5 ± 0.5 mm in the control group to 0.3 mm in the rotablation group Power of 80% One-sided alpha-level of 0.05 Random sequence 1:1 Needed total number of patients/lesions: 198 Analysis by intention-to-treat ROTAXUS: Study Details Design - Prospective, randomized, active-controlled clinical trial Participating Centers - Heart Center, Segeberger Kliniken, Bad Segeberg, Germany - Heart Center Bad Krozingen, Bad Krozingen, Germany - University Hospital Hamburg-Eppendorf, Hamburg, Germany Study Chair Gert Richardt Heart Center Bad Segeberg, Germany Principal Investigators Mohamed Abdel-Wahab Ahmed A. Khattab Independent Data Safety and Monitoring Board Independent QCA Core Lab (ISAR Research Center, Munich, Germany) Independent Statistical Core Lab (Derek Robinson, Sussex, UK) Inclusion Criteria Clinical inclusion criteria 1. Age above 18 years 2. Angina and/or reproducible ischemia 3. Informed written consent Angiographic inclusion criteria First degree criteria (all) 1. De-novo lesion in a native coronary artery 2. Moderate to severe calcification Second degree criteria (at least one) 1. Ostial location 2. Bifurcational lesion 3. Long lesion ( 15mm) Exclusion Criteria Clinical exclusion criteria 1. Myocardial infarction within 4 weeks 2. Left ventricular ejection fraction 30% 3. Limited long term prognosis Angiographic exclusion criteria 1. Unprotected left main lesions 2. Coronary artery bypass graft stenoses 3. In-stent restenoses 4. Chronic total occlusions 5. Target vessel thrombus 6. Target vessel dissection Endpoints Primary endpoint In-stent late lumen loss at 9 months Secondary endpoints 1. Major adverse cardiac events (MACE) 2. Definite stent thrombosis 3. In-segment late lumen loss 4. In-segment binary restenosis 5. Angiographic success 6. Strategy success (angiogr. success without crossover or stent loss) 7. Procedural duration 8. Contrast amount ROTAXUS 240 patients enrolled between August 2006 and March 2010 at 3 clinical sites in Germany 1:1 randomization Rota + PES (N=120) PTCA + PES (N=120) 240 patients analyzed with complete in-hospital follow-up - 2 patients died in-hospital - 6 patients withdrew consent - 5 patients lost at follow-up Clinical follow-up at 9 months in 96.2% (N=227) Angiographic follow-up at 9 months in 80.5% (N=190) Baseline Characteristics (I) Rota + PES n = 120 PTCA + PES n = 120 P Value Age (years) 70.5± ± Males 86 (72.3%) 96 (81.7%) 0.13 BMI (kg/m 2 ) 27.9± ± Diabetes mellitus 33 (27.7%) 32 (26.8%) 0.88 Hypertension 106 (89.1%) 95 (79.8%) 0.05 Dyslipidemia 91 (76.5%) 87 (73.1%) 0.55 Current smokers 24 (20.2%) 16 (13.5%) 0.17 Family history of CAD 39 (32.8%) 44 (37.0%) 0.50 Chronic renal failure 5 (4.2%) 8 (6.7%) 0.40 Previous MI 38 (31.9%) 29 (24.4%) 0.20 Previous PCI 44 (37.0%) 39 (32.8%) 0.50 Previous CABG 9 (7.6%) 15 (12.6%) 0.20 Baseline Characteristics (II) Rota + PES n = 120 PTCA + PES n = 120 P Value Unstable angina 17 (14.3%) 16 (13.4%) 0.85 Left main disease 11 (9.2%) 8 (6.7%) 0.47 Multivessel disease 88 (74.0%) 88 (74.0%) 1.0 LV ejection fraction (%) 55.5± ± Ad-hoc PCI 11 (9.3%) 9 (7.6%) 0.64 Multilesion PCI 23 (19.3%) 32 (27.1%) 0.16 Unfractionated heparin 49 (41.2%) 70 (50.4%) 0.15 Bivalirudin 70 (58.8%) 59 (49.6%) 0.15 GP IIb/IIIa antagonists 4 (3.4%) Angiographic Characteristics Rota + PES n = 146 PTCA + PES n = 176 P Value Location 0.06 Left main (protected) 3 (2.1%) 2 (1.1%) Left anterior descending 101 (69.2%) 111 (63.1%) Left circumflex 7 (4.8%) 22 (12.5%) Right coronary artery 35 (24.0%) 41 (23.3%) Reference vessel diameter (mm) 3.1± ± Lesion length (mm) 20.6± ± Diameter stenosis %) 81.5± ± Ostial location 27 (18.5%) 31 (17.6%) 0.84 Bifurcation 72 (49.3%) 82 (46.6%) 0.63 Moderate/severe tortuosity 67 (46.2%) 83 (47.2%) 0.82 Severe calcification 65 (44.5%) 86 (49.1%) 0.38 B2/C lesion 137 (93.8%) 152 (86.3%) 0.03 Procedural Outcome (I) Rota + PES n = 120 PTCA + PES n = 120 P Value Procedural duration (min) 66.4± ± Fluoroscorpy time (min) 22.8± ± Contrast amount (ml) 201.0± ± Dissections 4 (3.3%) 4 (3.3%) 1.0 Perforations 2 (1.7%) 1 (0.8%) 0.56 No/slow flow 0 1 (0.8%) 0.32 Procedural Outcome (II) p = 1.0 Rota+PES PTCA+PES p = % 80% 96.7% 96.7% 92.5% 83.3% 60% 40% 20% 0% Angiographic success* 0 p = % p = % 12.3% Stent loss Crossover Strategy success** * Defined as 20% residual stenosis + TIMI 3 flow ** Defined as angiographic success with no crossover or stent loss In-Hospital Outcome Rota+PES PTCA+PES 10% 8% 6% 4% 2% 0% 3.4% 4.2% 4.2% 5.9% 1.7% 1.7% 1.7% 0.8% 0.8% 0.8% Death MI TV Re- PCI p = 0.17 CABG MACE* ST Access site compl. * Defined as death, MI and TVR Primary Endpoint In-Stent Late Lumen Loss at 9 Months Rota+PES PTCA+PES p = , mm 0,4 0, mm 0,2 0,1 0,0 Events at Follow-Up Rota+PES PTCA+PES 50% 40% p = % p = 0.73 p = % 24.2% 20% 10% 0% p = 0.78 p = % 18.3% 11.7% 12.5% p = % 5.8% 6.7% 5.8% 0.8% 0 Death MI TVR TLR MACE* Definite ST * Defined as death, MI and TVR Summary (I) Rotablation + PES implantation was not superior to balloon dilatation + PES implantation in reducing the primary endpoint of late lumen loss at 9 months in patients with complex calcified coronary artery disease. Rotablation (probably due to additional vessel trauma) rather decreased the efficacy of PES in reducing neointimal growth. Summary (II) The superior acute gain obtained by rotablation was counterbalanced by an increased late loss resulting in a neutral effect on restenosis. Rotablation remains an important bail-out device for uncrossable or undilatable coronary lesions and can improve overall success of DES implantation. ROTAXUS: No benefit of atherectomy plus DES in calcified lesions Presenting the results of ROTAXUS today at TCT 2011, lead investigator Dr Gert Richardt (Segeberger Kliniken, Germany) noted the results of the study went the other way around, with patients treated with the paclitaxel-eluting stent (Taxus, Boston Scientific) alone having less in-stent late lumen loss than those treated with atherectomy prior to receiving the paclitaxel stent. Although he concluded by stating that rotational atherectomy does not increase the efficacy of drug-eluting stents in calcified lesions, he, as well as others, stressed that provisional atherectomy still has a role in patients with complex, calcified lesions and remains useful as a bailout strategy for lesions that cannot be crossed or dilated. The ROTAXUS study included 240 patients with stable or unstable angina and coronary artery disease. The primary angiographic inclusion criteria included treatment of a lesion in a native coronary artery with moderate to severe calcification. The primary end point of the study in-stent late lumen loss at nine months was 0.44 mm in the atherectomy/paclitaxel-stent arm and 0.31 mm in patients who received the paclitaxel-eluting stent alone. There was no difference in any clinical end points at nine months. Despite the negative results, Dr Roxana Mehran (Mount Sinai School of Medicine, New York), who was not involved in the trial, stressed that rotational atherectomy still plays a role in clinical practice. It's important to note that rotational atherectomy still does have a place in our armamentarium, but it would be in the very severely calcified lesions or complex morphologies that would make our procedures easier. Procedural Outcome (II) p = 1.0 Rota+PES PTCA+PES p = % 80% 96.7% 96.7% 92.5% 83.3% 60% 40% 20% 0% Angiographic success* 0 p = % p = % 12.3% Stent loss Crossover Strategy success** * Defined as 20% residual stenosis + TIMI 3 flow ** Defined as angiographic success with no crossover or stent loss Procedural Outcome (II) p = 1.0 Rota+PES PTCA+PES p = % 80% 96.7% 96.7% 92.5% 83.3% 60% 40% 20% 0% Angiographic success* 0 p = % p = % 12.3% Stent loss Crossover Strategy success** * Defined as 20% residual stenosis + TIMI 3 flow ** Defined as angiographic success with no crossover or stent loss Long-term clinical outcome of rotational atherectomy followed by drug-eluting stent implantation in complex calcified coronary lesions. Abdel-Wahab M, Baev R, Dieker P, Kassner G, Khattab AA, Toelg R, Sulimov D, Geist V, Richardt G Catheter Cardiovasc Interv Mar METHODS AND RESULTS: Two hundred and five patients with de novo complex calcified coronary lesions treated with Rota-DES were analyzed. Mean age was 69.7 ± 9.3 years, 63 patients (31%) had diabetes mellitus and 21 patients (10%) had chronic renal failure. Total stent length/patient was 32 mm. The majority of patients were treated with paclitaxel-eluting stents (64%) or sirolimus-eluting stents (30%). Angiographic success rate was 98%. The incidence of in-hospital major adverse cardiac events (MACE), defined as death, myocardial infarction (MI), and target vessel revascularization (TVR), was 4.4%. Longterm follow-up was available for 188 patients (92%). At a median follow-up period of 15 months (range, 1-84), the cumulative incidence of MACE (Kaplan-Meier estimate) was 17.7%. Death occurred in 4.4%, MI in 3.4%, TVR in 9.9%, and target lesion revascularization (TLR) in 6.8%. One definite (0.5%) and one probable (0.5%) stent thrombosis were observed. In a multivariate analysis, low ejection fraction ( 40%) was the only independent predictor of MACE, and both age and diabetes were independent predictors of TLR CONCLUSION: This study represents the largest European data set of patients treated with RA in the DES era. RA followed by DES implantation in calcified coronary lesions appears to be feasible and effective, with a high rate of procedural success and low incidence of TLR and MACE at long term Long-term clinical outcome of rotational atherectomy followed by drug-eluting stent implantation in complex calcified coronary lesions. Abdel-Wahab M, Baev R, Dieker P, Kassner G, Khattab AA, Toelg R, Sulimov D, Geist V, Richardt G Catheter Cardiovasc Interv Mar Rotational atherectomy in the drug-eluting stent era: a recent single-center experience. [Article in Portuguese] Seca L, Cação R, Silva J, Mota P, Costa M, Leitão Marques A. Source Centro Hospitalar de Coimbra, EPE, Coimbra, Portugal. CONCLUSIONS: This study demonstrates that rotational atherectomy followed by stenting in heavily calcified lesions can nowadays be performed with high success rates and few complications, extending the possibility of coronary revascularization to a greater number of patients. Rev Port Cardiol Jan ROTA DES studies Leonardo C. Clavijo, et.al. Sirolimus Eluting Stents and Calcified Coronary Lesions: Clinical outcome of patients treated with and without rotational Atherectomy. Catheterization and cardiovascular Interventions 68: (2006) Sunil V. Rao, et.al. Clinical outcomes with Drug Eluting stents following Atheroablation therapies. J Invasive Cardiol 2006 Sep; 18 (9): Ahmed A Khattab, et.al. Drug Eluting versus bare metal stents following rotational atherectomy for heavily calcified coronary lesions: Late angiographic and clinical follow-up results. Journal of Interventional Cardiology 2007, 20 (2): Ahmed A Knattab, et.al. Rotational athrectomy followed by Drug-Eluting stent implantation (Rota-DES): a rational approach for complex calcified coronary lesions. Minerva Cardioangiol 2008 Feb; 56 (1): SES after rotational atherectomy further reduce TLR to less than 5% ROTA DES studies Colombo et al. Rotational atherectomy followed by DES in calcified coronary lesions. Eurointervention 2009 Registry 96 pts High procedural success Low TLR Pagnotta et al, Catheter Cardiovasc Interv, 2010 : safety and effectiveness of Rota + DES strategy to tackle HCCL with good long-term clinical outcomes procedure was successful in 97% of cases pts underwent rotablation +des 2. 2 burr stepped approach 3. Mean follow-up 3 years angio f/u 18.7% 4. No MACE during hospitalization 5. Recurrent angina and MI 3.3, MACE No relationship between clopidogrel discontinuation death and MI Rotablator Cases in St. Luke s Hospital Lession Morphology Lesions with localised calcification Diffuse-calcified lesions Calcified bifurcations Ostial lesions Chronic total occlusions with extensive calcification TABLE 2 Short-heavily calcified lesions 25 Diffuse-calcified lesions 86 Calcified bifurcations 38 Ostial lesions 29 Chronic total occlusions with extensive calcification 6 TABLE 3 MACE (11.3%) Death 4% (6/150) Cardiac death 83.3% (5/6) ΜΙ 5.3% (8/150) TLR PTCA 3% CABG 3% Angina 7,3% (11/150) Stroke 2% (3/150)
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