1. Dr Sandeep Mohanan SR Cardiology Calicut Medical College JOURNAL REVIEW

2. OVERVIEW  Introduction  Evidence on Cutting balloons (CBA), Directional atherectomy (DCA) and Laser angioplasty  Evidence on Rotational atherectomy (PTRA)  Current guidelines and scope of PTRA

3. INTRODUCTION - Acute lumen gain and its implications on restenosis

4. Importance of acute lumen diameter in determining restenosis after coronary atherectomy or stenting. - Kuntz et al. Circulation 1992 - However no difference in restenosis rates post-DCA or routine PTCA. - The better the acute gain the lower the chance of restenosis

5. ADJUNCT DEVICES  Cutting Balloon Angioplasty (CBA)  Directional Coronary Atherectomy (DCA)  Laser angioplasty  Percutaneous Transluminal Rotational Atherectomy (PTRA)

6. CUTTING BALLOON ANGIOPLASTY  Makes controlled microincisions into the atheromatous plaque (radial atherectemy)  Lesser barotrauma to vessel

7. EVIDENCE ON CBA  For routine angioplasty: - Several small trials in late 1990s and 2000 (N<200) – possibly decreed restenosis - GRT(AJC 2002) : N= 1238, No difference - REDUCE 1 and 2 (JACC 2004) --- CBA increased restenosis - REDUCE 3 (Circ 2007) – N =228-- CBA decreased restenosis  For ISR: - JACC 2001: N=648 – CBA better results than PTCA - RESCUT (JACC 2004) ---N=428, No difference in ISR rate – use of fewer balloons, less balloon slippage, less requirement for additional stenting.  For bifurcation lesions: - J Interv Cardiol 2004 – N=84--Better procedural success and lesser ISR.  For ostial lesions: - Clin Cardiol (2009) – BMS+CBA vs DES (N=101)  Similar 2yr results

8. GUIDELINES on CBA (ACC/AHA 2011) *Bittl et al. Meta-Analysis of RCTs of percutaneous transluminal coronary angioplasty versus atherectomy, cutting balloon atherotomy, or laser angioplasty. JACC 2004;43(6):936-942. * RESCUT, *REDUCE1, *GRT

9. DIRECTIONAL ATHERECTOMY - Apposes a cutting device to a section of the plaque. - Manually advances the cutting cup - Debulking procedure

10. EVIDENCE ON DCA  CAVEAT 1 and 2 (NEJM 1993, Circulation 1995)  BOAT (Circulation 1993)  AMIGO (AJC 2004) - Similar TVR, MACE rates and restenosis rates - More periprocedural MI - All trials had similar non-encouraging results. - Currently not marketed

11. LASER ANGIOPLASTY  Laser beam is channelled in pulse/continuous from to help in debulking.  Photo-thermal effect, photo- acoustic effect, photo- chemical dissociation

12. EVIDENCE ON LASER ANGIOPLASTY  LAVA trial (AJC1997, N=256): No benefit over routine PTCA - more complicated hosp course  ERBAC trial (Circ1997, N=454): No benefit, Higher TVR and restenosis  Metanalysis (JACC 2004) : Routine Laser-PTCA is inferior to conventional PTCA 1.Stone et al. Prospective, Randomized, Multicenter Comparison of Laser-Facilitated Balloon Angioplasty Vs Stand- Alone Balloon Angioplasty in Patients With CAD. J Am Coll Cardiol.1997;30(7):1714-1721. 2. Reifart et al. Randomized comparison of angioplasty of complex coronary lesions at a single center. Excimer Laser, Rotational Atherectomy, and Balloon Angioplasty Comparison (ERBAC) Study.Circulation.1997 Jul 1;96(1):91-8.

13. LASER for ISR:  LARS trial (JACC1999): Prospective trial, N=527 patients, --- LASER was effective.  Angiology 2006; N=125 patients: RCT with PTCA Laser used for longer, more Type C and more complex lesions than PTCA. -1 year follow up results of MACE, TVR and restenosis were similar. LASER for CTO and complex calcified lesions Several reports and few prospective trials identified the utility in lesions unyielding to routine PTCA (However not advised in heavily calcified lesions) 1.Köster et al. Laser angioplasty of restenosed coronary stents: results of a multicenter surveillance trial. The Laser Angioplasty of Restenosed Stents (LARS) Investigators.J Am Coll Cardiol. 1999 Jul;34(1):25-32. 2. Batyraliev et al. Current role of laser angioplasty of restenotic coronary stents. Angiology. 2006 Jan-Feb;57(1):21-32.

14. GUIDELINES on LASER (ACC/AHA 2011)

15. ROTABLATION (PTRA)  Invented by David Auth and in clinical trials since 1988.  “Differential cutting” & “orthogonal displacement of friction”  Abrades the plaque to produce millions of microparticles <5microns

16. Rotablator burr and ‘differential cutting’

17. Lesion preparation before PTCA

18.  N=685, Elective PCI for symptomatic CAD  POBA vs ELCA vs PTRA  Procedural success (diameter stenosis < 50%, absence of death, QWMI/CABG)  PTRA had a higher rate of procedural success than ELCA or POBA (89% versus 77% and 80%, P =.0019)  No difference in major in-hospital complications (3.2% versus 4.3% versus 3.1%, P =.71).  At 6-months follow-up, TVR more in PTRA (42.4%) and the ELCA (46.0%) than in POBA(31.9%, P =.013).  Procedural success of PTRA though superior to laser angioplasty and balloon angioplasty; does not result in better late outcomes. Randomized comparison of angioplasty of complex coronary lesions at a single center. Excimer Laser, Rotational Atherectomy, and Balloon Angioplasty Comparison. Circulation. 1997 Jul 1;96(1):91-8. : ERBAC study ROTABLATION for complex lesions

19.  RCT, N=502  70-99% stenosis, absolute criteria- 1mm and > 5mm length  Secondary criterion– heavy calcification, ostial, bifurcation, diffuse, eccentric, >45deg angulation  Procedural success 78% (PTCA) vs 85% (rotablation) (P=0·038)  Crossover from PTCA to rotablation was 4% and 10% vice versa (P=0·019).  No difference in MACE at 6months  However, more stents were required after PTCA (14·9% versus 6·4%, P<0·002), predominantly for bailout or unsatisfactory results.  At 6 months symptomatic outcome, TVR and restenosis rates (PTCA 51% versus rotablation 49%,P=0·33) were not different  PTRA has higher procedural success with comparable long-term efficacy A randomized comparison of balloon angioplasty versus rotational atherectomy in complex coronary lesions.EHJ 2000: COBRA study

20. ROTABLATION in routine PCI  N=446, Coronary diam 2-3mm, <20mm lesion  Primary endpoint-- TV failure(death, QWMI, TVR) at 12 months  Acute procedural success (91.6% for PTRA, 94.1% for POBA, P =.36)  TVF at 12 months -- (30.5% vs 31.2%, P =.98).  Similar MLD(1.28 +/- 0.63 mm vs 1.19 +/- 0.54 mm, P =.26), restenosis rates (50.5% vs 50.5%, P = 1.0), MACE and no mortality.  Though PTRA appeared safe, no definite advantage over POBA in PCI to small vessels. Comparison of PTRA with conventional POBA in the prevention of restenosis of small coronary arteries: results of the Dilatation vs Ablation Revascularization Trial. Am Heart J. 2003 May;145(5):847-54. :DART trial

21.  Large burr(Burr: artery>0.7 -Lesion debulking) vs small burr (Burr:artery≤0.7 – lesion modification)  N=222,  No differences in procedural success, the extent of immediate lumen enlargement, in hospital complications, or late TVR.  Large burrs were more likely to experience serious angiographic complications (5.1% vs. 12.7%, P < 0.05) immediately after atherectomy.  Small burrs have similar early and late efficacy with fewer angiographic complications Coronary angioplasty and Rotablator atherectomy trial: immediate and late results of a prospective multicenter randomized trial. Catheter Cardiovasc Interv. 2001 Jun : CARAT trial ROTABLATION in routine PCI – Burr size

22.  N=249; Aggressive (B:A>0.7) vs Routine (B:A≤0.7+4atm)  Patient age was 62 +/- 11 years, ~15%each were restenotic lesions; lesion length ~13.5 mm.  Final MLD and residual stenosis were 1.97 mm & 26% for routine vs 1.95 mm and 27% for aggressive strategy.  Clinical success-- 93.5% for routine strategy vs 93.9% for the aggressive strategy.  CK-MB >5 times normal in 7% of the routine versus 11% of the aggressive group. This was associated with a decrease in rpm of >5,000 from baseline for >5 seconds, p = 0.002.  At 6 months, 22% of the routine patients versus 31% of the aggressive strategy patients had TLR.  Dichotomous restenosis was 52% for the routine strategy versus 58% for the aggressive strategy.  aggressive rotational atherectomy strategy offers no advantage over more routine burr sizing plus routine angioplasty. Results of the study to determine rotablator and transluminal angioplasty strategy Am J Cardiol. 2001 Mar 15;87(6):699-705. : STRATAS trial ROTABLATION in routine PCI – Burr size

23.  Multicentre RCT  N=298, POBA vs PTRA  ISR(>70%, mean~14mm, ≥3m)  Restenosis rates of 51% (PTCA) and 65% (ROTA) (P=0.039).  Six-month event-free survival was significantly higher after PTCA (91.3%) compared with ROTA(79.6%, P=0.0052)  The results showed that, in the long term PTCA was a significantly better strategy than ROTA. Rotational atherectomy does not reduce recurrent in-stent restenosis: angioplasty versus rotational atherectomy for treatment of diffuse in-stent restenosis trial Circulation. 2002 Feb 5;105(5):583-8. : ARTIST trial. ROTABLATION for ISR

24.  N=200, Diffuse ISR, Single centre  PTCA(high pressure POBA) vs PRCA  A higher rate of repeat stenting occurred in the PTCA group (31% vs 10%; P <.001).  IVUS analysis--- lower residual intimal hyperplasia area after PRCA versus PTCA (2.1 +/- 0.9 mm2 vs. 3.3 +/- 1.8 mm2; P =.005).  1 yr f/u – Similar mortality and MACE.  TLR -- 32% in the PRCA vs 45% in the PTCA group (P =.042)  In diffuse ISR, PRCA is safe, effective and lesser TLR Randomized trial of Rotational Atherectomy Versus Balloon Angioplasty for Diffuse In-stent Restenosis. Am Heart J. 2004 Jan;147(1):16-22. : ROSTER trial.

25. Effectiveness of Rotablation in 90’s and early 2000s Current Overview of Rotational Atherectomy. Does Rotablator Make Sense? Emodynamica 2000. ~95% <30% ~28-57%

26. In-hospital complications ~0.2- 1.8% ~0.5- 4.8% ~0.6- 8.8%

27. Angiographic complications after Rotablation ~1.1- 11% ~1-9% ~0- 1.7% ~4- 15%

28. ROTASTENTING strategy  Background– poor results in the POBA era  N=75 (106 lesions), rota-stenting (BMS) (IVUS-guided)  Indications –calcified(70%), long lesions(10%), Inability to pass balloon(20%)  Majority (>90%) B to C lesions  Procedural success was achieved in 93.4% of lesions.  Acute stent thrombosis -2 lesions (1.9%), and subacute ST in 1lesion (0.9%).  Angiographic follow-up at 6m -- restenosis rate of 22.5%.  6m TVR of 18%, QWMI in 1.3%, CABG in 4% and mortality in 1.3%  Rotastenting in calcified/complex lesions had high success rate, with acceptable complication and relatively low restenosis rates. Mousse et al.Coronary stenting after rotational atherectomy in calcified and complex lesions. Angiographic and clinical follow-up results. : Circulation. 1997 Jul 1;96(1):128-36.

29. Meta-Analysis of Randomized Trials of Percutaneous Transluminal Coronary Angioplasty Versus Atherectomy,Cutting Balloon Atherotomy, or Laser Angioplasty. JACC 2004  N=2434, PTRA vs routine PTCA  Pre-DES era data   Mechanical plaque modification by itself has no beneficial effect in terms of MACE, mortality or restenosis. 30 day mortality 30 day MACE Angiographic restenosis 1 year TVR Cumulative MACE at 1y

30. Facts from trials in pre-DES era  ROTA helps in lesion preparation and improves procedural success in ‘difficult’ lesions in complex/calcified coronary lesions  ROTA improves the acute gain in lumen diameter  ROTA has no effect/worsens restenosis rates compared to routine PTCA ( 20-58%)  No definite mortality benefit documented.

31. ROTABLATION in the DES era  DES-era has significantly decreased the restenosis rates and 1- yr TVR rates.  However for best results, the lesion needs to be completely tackled and stents optimally deployed.  Optimal stent deployment is affected in calcified coronary plaques– disruption of stent polymer during dilatation, poor drug elution, underexpansion.  Questions that need to be addressed: - Effect of ROTA for routine ‘difficult’ lesions in DES-era? - Effect of ROTA for complex/calcified lesions compared to routine PCI? - Effect of ROTA for PTCA-failed patients vs GDMT/CABG?

32.  Prospective study of Heavily calcified coronary lesions  Depending on clinician decision and procedural difficulty  N=150--- 69 PTCA with SES, 81 with ROTA-SES  Clinical success >98% in both groups  No in-hospital outcome differences.  6m TLR -- 4.9% in SES vs. 4.2% in ROTA-SES ( P = NS).  6m mortality 7.9% in SES vs 6.8% in ROTA-SES (NS)  Lesions requiring ROTA to facilitate dilation and stenting had similar outcomes after SES implantation to those that did not require ROTA Clavijo et al. SES and calcified coronary lesions: Clinical outcomes of patients treated with and without rotational atherectomy. : Cathet. Cardiovasc. Intervent. 2006, 68: 873–878.

33.  Single-center prospective study, N=27, ROTASTENTING with DES  Angiographically heavily calcified lesions,  Compared with a historical control of 34 patients treated by rotablation followed by BMS  Angiographic success was 100% for both.  At 9 months, Late lumen loss (0.11 +/- 0.7 mm in DES group & 1.11 +/- 0.9 mm in the BMS group, P = 0.001).  Cumulative MACE at 9m was 7.4% in the DES and 38.2% in the BMS ; P = 0.004).  No survival advantage  ROTA-DES is superior to ROTA-BMS for calcified lesions Khattab et al. DES versus BMS following rotational atherectomy for heavily calcified coronary lesions: late angiographic and clinical follow-up results : J Interv Cardiol. 2007 Apr;20(2):100-6.

34.  Prospective study on ROTA-DES  N=150, heavily calcified lesions  A 2-burr stepped approach was selected in most of the cases.  The mean follow up period was 3 years (max. 78 months).  Recurrent angina and MI during follow up was low (3.3%)  Overall MACE rate was 11.3%. (No MACE occurred during hospitalization  combined approach of RA-DES has a favourable effect when dealing with heavily calcified lesions in both the angiographic and clinical outcomes. Mezilis et al. Rotablation in the drug eluting era: immediate and long-term results from a single center experience. :J Interv Cardiol.2010 Jun;23(3):249-53.

35.  To assess utility of ROTA for CTOs.  Single centre  From Jan 2006 to Oct 2009-- 45/648 (7%) consecutive patients with CTO taken yp for ROTA (failed with routine PTCA)  All 45 were high risk– longer duration of CTO, more older, more CKD  43/45 successfully recanalised  Peri-procedural MI was more in the Rotablator group (35% vs. 22%; P = 0.044).  No difference in perforation/significant dissection/ mortality  Rotational atherectomy is a safe and effective technique to overcome the frustrating situation of failure to cross lesion with balloon catheter. Pagnotta et al. Rotational atherectomy in resistant chronic total occlusions. : Catheter Cardiovasc Interv.2010 Sep 1;76(3):366-71.

36.  Prospective series, N=516, Rotastenting strategy  BMS and DES were compared for 6m results  Procedural success was achieved in 97.1%.  Low in hospital adverse events (death in 1.1%, Q MI in 1.3%, Non Q MI in 5.3%, and urgent repeat PCI in 0.4%).  Binary restenosis rates at 6m following Rota + DES vs Rota + BMS was (11% vs. 28.1%, P < 0.001  TLR of Rota-DES vs BMS (10.6% vs. 25%, P = 0.001)  Ostial lesions, CTOs, and use of BMS were predictors of restenosis.   PTRA can be performed with high success rates and low complications, and rotational atherectomy followed by drug eluting stent implantation significantly reduces binary restenosis rates in fibrocalcific lesions. Rathore et al. Rotational atherectomy for fibro-calcific CAD in DES era: procedural outcomes and angiographic follow-up results. : Catheter Cardiovasc Interv.2010 May 1;75(6):919-27.

37.  Retrospective analysis, N= 158 patients (236 lesions)  Between January 2004 and December 31, 2009, tertiary referral hospital.  112 patients (158 lesions) with DES implantation,  19 patients (28 lesions) with BMS, and 27 patients (50 lesions) with no stent. (23% no DES --- <2.25mmvessel, contraindication for DAPT)  RA indication: 1)Modify heavily calcified plaque (84%), 2) Bail-out therapy (16%), 3) preserve the patency of sidebranches (25%), 4) debulking therapy for chronic total occlusion (13 lesions) and 5) in-stent restenosis (7 lesions).  Angio success: 99.1% for DES vs 95% for BMS vs 63% for POBA stent; p < 0.05;  Procedural success: 96.4% for DES vs 95% for BMS vs 63% for POBA; p < 0.05).  In the DES era, RA remains utilized primarily to modify heavily calcified plaque. Procedural success appears high with subsequent stent placement (DES or BMS) versus RA alone. Schwartz et al. Rotational Atherectomy in the Drug-Eluting Stent Era: A Single-Center Experience. : J INVASIVE CARDIOL 2011;23:133–139.

38.  N=205, Complex calcified lesions, largest European data in DES era (2003- 2009)  Mean age~70 yrs, 31% had DM and 10% had CKD.  Lad -595, LCX-21%, RCA-21%  Mean stent length/patient was 32 mm.  64% PES, 30% SES  Angiographic success rate was 98%.  In-hospital MACE - 4.4%  15m MACE – Death in 4.4%, MI in 3.4%, TVR in 9.9%, 2 ST (1def)  Low ejection fraction (<40%) was the only independent predictor of MACE  Both age and diabetes were independent predictors of TLR.  RA followed by DES implantation in calcified coronary lesions is feasible and effective, with a high rate of procedural success and low incidence of TLR and MACE at long term in a high risk cohort. Abdel-Wahab et al. Long-term clinical outcome of rotational atherectomy followed by DES implantation in complex calcified coronary lesions. : Catheter Cardiovasc Interv.2013 Feb;81(2):285-91.

39. ROTA for bifurcation lesions  Pre-DES era  Retrospective analysis of 150 bifurcation lesions  HSRA- 32, POBA-118 ± stenting  The HSRA/stent group had a high primary success rate of 97%  HSRA: MACE at 15m – 22.5%; TLR-18.7%  PTCA Procedural success in the BA/stent group was 81%  PTCA: MACE rate was 27.5% with a TLR rate of 23%.  Significantly greater acute gain in MLD  HSRA with provisional stenting provided a safe and effective means of treating bifurcation lesions. Nageh et al. High-speed rotational atherectomy in the treatment of bifurcation-type coronary lesions. : Cardiology. 2001;95(4):198-205.

40. ROTA for ostial side branch lesions  Retrospective case-review study of bifurcation lesions  N=40, Rota of side branches in medina 1,1,1, lesions. (2003- 2007)  22(55%) had ROTA only to side branch; 18 (45%) ROTA to main and side-br  93% had DES to main vessel; 20% (n=8) had side branch stents.  No acute closure of the side branch or coronary perforation  MACE at ~ 2 year ( 1 death,1 nonfatal MI, 2 TVR s  ROTA to side branch ostium is a safe option for complex bifurcation lesions Ito et al. Long-Term Outcomes of Plaque Debulking with Rotational Atherectomy in Side-Branch Ostial Lesions to Treat Bifurcation Coronary Disease. :J INVASIVE CARDIOL 2009;21:598–601

41. ROTA for jailed side branches  N=32 lesions, ROTA +POBA  53.9% were diagonals, 86.5% were previously dilated prior to RA.  Mean stenosis (QCA) of the side branch prior to revascularization was 77.8% +/- 12.6%  Angiographic success (residual stenosis < 50% and TIMI 3 flow) in the side branch occurred in 36 of 39 lesions (92.3%).  Procedural success was achieved in 33 of 38 cases (86.8%) (1 MI, 1 a/c ST)  Estimated freedom from any target lesion revascularization was 47.7% at 1 yr.  RA in conjunction with BA can effectively treat stent-jailed ostial side branch stenosis with excellent acute angiographic and procedural results. However ---- a high rate of repeat revascularization Sperling et al. Treatment of stent-jailed side branch stenoses with rotational atherectomy. : J Invasive Cardiol. 2006 Aug;18(8):354-8.

42.  N=240, RCT, ROTA-DES vs routine PTCA with DES High-speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions. : JACC Cardiovasc Interv. 2013 Jan;6(1):10-9. (ROTAXUS trial)

43. ROTA+PESPES onlyP value Location0.06 Left main (protected)3 (2.1%)2 (1.1%) Left anterior descending101 (69.2%)111 (63.1%) Left circumflex7 (4.8%)22 (12.5%) Right coronary artery35 (24.0%)41 (23.3%) Reference vessel diameter (mm) 3.1±0.43.1±0.30.54 Lesion length (mm)20.6±9.318.5±9.20.04 Diameter stenosis %)81.5±10.280.0±10.80.23 Ostial location27 (18.5%)31 (17.6%)0.84 Bifurcation72 (49.3%)82 (46.6%)0.63 Moderate/severe tortuosity67 (46.2%)83 (47.2%)0.82 Severe calcification65 (44.5%)86 (49.1%)0.38 B2/C lesion137 (93.8%)152 (86.3%)0.03 ROTAXUS trial – lesion characteristics

44. Rota + PES n = 146 PTCA + PES n = 176 P Value 7 Fr guiding catheter122 (83.6%)50 (28.4%)<0.001 Balloon predilatation130 (89.0%)160 (90.9%)0.58 Max. predil. balloon size (mm)2.5±0.32.6±0.40.37 Max. predil. balloon pressure (atm)13.6±5.115.8±4.90.04 Starting burr size (mm)1.5±0.2-- Max. burr size (mm)1.5±0.2-- Use of > 1 burr8 (5.5%)-- Rotational speed (RPM)165,947±8,919-- No. of stents / lesion1.3±0.6 0.25 Total stent length / lesion (mm)27.7±12.225.2±11.50.06 Balloon postdilatation92 (63.0%)116 (65.9%)0.86 Max. postdil. balloon size (mm)3.3±0.53.3±0.40.88 Max. postdil. balloon pressure (atm)21.7±5.821.5±5.80.76 ROTAXUS trial – procedure characteristics

45. Rota + PES n = 120 PTCA + PES n = 120 P Value Procedural duration (min) 66.4±44.557.4±34.50.05 Fluoroscorpy time (min)22.8±21.918.1±16.70.04 Contrast amount (ml)201.0±113.6181.8±93.60.11 Dissections4 (3.3%) 1.0 Perforations2 (1.7%)1 (0.8%)0.56 No/slow flow01 (0.8%)0.32 ROTAXUS trial – procedure details

46. Procedural Outcomes p = 0.03 p = 0.08 p = 1.0 * Defined as <20% residual stenosis + TIMI 3 flow ** Defined as angiographic success with no crossover or stent loss p = 0.02

47. QCA data: Index procedure Rota + PES n = 123 PTCA + PES n = 132 P Value Before procedure Lesion length (mm)19.56±9.6418.63±9.700.44 Refernce vessel diameter (mm)2.67±0.412.77±0.370.04 Minimal lumen diameter (mm)1.01±0.361.10±0.390.05 Diameter stenosis (%)62.05±11.9260.18±12.740.17 Immediately after procedure Minimal lumen diameter (mm) In-stent2.58±0.372.56±0.400.61 In-segment2.27±0.502.27±0.490.98 Diameter stenosis (%) In-stent10.43±5.2511.82±5.210.03 In-segment17.68±8.9819.38±16.670.18 Acute gain (mm) In-stent1.57±0.431.46±0.460.03 In-segment1.26±0.541.17±0.530.18

48. Primary Endpoint p = 0.01 In-Stent Late Lumen Loss at 9 Months

49. QCA data: 9-month reangiography Rota + PES n = 123 PTCA + PES n = 132 P Value Minimal lumen diameter (mm) In-stent 2.14±0.632.25±0.620.15 In-segment 1.91±0.572.02±0.650.16 Diameter stenosis (%) In-stent 22.01±19.9219.86±19.640.26 In-segment 27.92±18.9726.99±1.730.44 Late lumen loss (mm) In-stent 0.44±0.580.31±0.520.01 In-segment 0.36±0.570.25±0.570.04 Binary restenosis (%) In-stent 14 (11.4%)14 (10.6%)0.84 In-segment 15 (12.2%)17 (12.9%)0.87

50. 9 month f/u clinical events Death TVR MI MACE

51. CONCLUSIONs from the ROTAXUS trial: - 1 st RCT on the subject in DES-era - A complex patient population - Routine RA strategy before PES implantation for severely calcific complex lesions is not superior to conventional PTCA. - Improved early acute gain -- offset by a higher late lumen loss. - PTRA is appears safer in the current PCI era however requiring a higher procedure time. - Short study duration, <50% had severe calcification, Optimal burr parameters unknown in the DES era, CTOs and ISRs not included, ?IVUS, Only 80% had angio f/u. - The DES era appears to have corrected for higher restenotic rates earlier noted with PTRA

52. ACC/AHA GUIDELINES on ROTABLATION in PCI

53. BOTTOMLINE on ROTABLATION  ROTAXUS – In routine PTCA for complex lesions the default strategy must be provisional use of ROTA before DES-ing.  In the current era and in good hands, ROTA related procedural complications are very low.  There has been a resurgence in ROTA-procedures in the last 5 years ( even via radial route)  DES has tackled most of the restenosis concerns

54.  ROTA burr selection protocols and other standard procedure guidelines should be followed  ROTA is definitely a part of PCI in uncrossable and undilatable lesions after the decision of DESing has been taken.  However no trials compare the clinical outcomes of ROTA- DESing vs GDMT/ CABG in specific populations which may be relevant to a large chunk of real-world practice. BOTTOMLINE on ROTABLATION

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