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PRIMARY PCI : Part 1

JOURNAL REVIEW. PRIMARY PCI : Part 1. Speaker: Dr Sandeep Mohanan Senior Resident Department of Cardiology Government Medical College Calicut. TOPIC OVERVIEW. COMPARISON OF PRIMARY PCI TO THROMBOLYSIS ASPIRATION THROMBECTOMY IN PRIMARY PCI DISTAL PROTECTION DEVICES IN PRIMARY PCI

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PRIMARY PCI : Part 1

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  1. JOURNAL REVIEW PRIMARY PCI : Part 1 Speaker: Dr SandeepMohanan Senior Resident Department of Cardiology Government Medical College Calicut

  2. TOPIC OVERVIEW • COMPARISON OF PRIMARY PCI TO THROMBOLYSIS • ASPIRATION THROMBECTOMY IN PRIMARY PCI • DISTAL PROTECTION DEVICES IN PRIMARY PCI • STENT USAGE IN PRIMARY PCI

  3. PRIMARY PCI vs THROMBOLYSIS • Efficacy • Subgroups - Diabetics and Elderly • Pre-hospital fibrinolysis(Pharmacoinvasive) : TRANSFER AMI, STREAM • Facilitated PCI : CARESS in AMI, FINESSE-2, ASSENT-4 -- Inferior to PPCI -- IIa B in AHA 2013

  4. Efficacy of primary PCI vsthrombolysis • Keeley et al. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials . :Lancet. 2003;361:13–20. • 23 RCT trials ever since advent of PPCI for AMI till 2003. • Well matched for heterogeneity and accepted as the reference for recommendations in the AHA and ESC guidlines.

  5. Keeley et al. Lancet 2003

  6. Keeley et al. Lancet 2003

  7. Keeley et al. Lancet 2003

  8. Andersen HR et al. A comparison of coronary angioplasty with fibrinolytic therapy in acute myocardial infarction. N Engl J Med. 2003;349:733– 42. • 1572 patients with AMI—PPCI vs iv alteplase • RESULTS: • Primary end point was reached in 8.5% for PPCI vs 14.2% of the patients for TT (P=0.002) (30 days) • The better outcome after angioplasty was driven primarily by a reduction in the rate of reinfarction(1.6% vs. 6.3%, P<0.001); • No significant differences in the rate of death (6.6% vs 7.8%, P=0.35) or the rate of stroke (1.1% vs 2%, P=0.15). • 96% were transferred from referral hospitals to an invasive-treatment centerwithin 2hours. • CONCLUSIONS: A strategy for reperfusion involving the transfer of patients to an invasive-treatment center for primary angioplasty is superior to fibrinolysis, provided that the transfer takes two hours or less.  Strong basis for present AHA/ESC guideline recommendation on timing of PPCI

  9. DANAMI 2 study(Danish trial in acute MI)- (AHJ2003, EHJ 2008, Circulation 2010) High-risk ST elevation MI patients (>4 mm elevation), Sx < 12 hrs 5 PCI centers (n=443) and 22 referral hospitals (n=1,129), transfer criteria < 3 hrs Primary PCI without transfer (n=223) Primary PCI with transfer (n=567) Lytic therapy Front-loaded tPA 100 mg (n=782) Death / MI / Stroke at 30 Days

  10. DANAMI-2: Primary Results Non-Transfer Sites Transfer Sites Combined P=0.048 P=0.0003 P=0.002 RRR 40% RRR 45% RRR 45% Death / MI / Stroke (%) Lytic Primary PCI Lytic Primary PCI Primary PCI Lytic

  11. DANAMI-2: Primary outcomes Stroke Death Recurrent MI P=0.15 P<0.0001 P=0.35 Lytic Primary PCI Lytic Primary PCI Primary PCI Lytic

  12. DANAMI conclusion • Median D2B time was 114 mins. • For such patients, the incidence of the composite endpoint of death, recurrent MI, and stroke is reduced compared with the administration of tPA and heparin

  13. DANAMI2 Long term follow up

  14. DANAMI2 subgroup analysis (Circ 2010)

  15. PPCI in DIABETICS Timmer JR. Primary percutaneous coronary intervention compared with fibrinolysis for myocardial infarction in diabetes mellitus: Arch Intern Med. 2007 Jul 9;167(13):1353-9. • A pooled 19 trials comparing primary PCI with fibrinolysis for treatment of STEMI. RESULTS: • Of 6315 patients, 877 (14%) had diabetes. • 30 day mortality (9.4% vs 5.9%; P < .001) --higher in diabetes. • Mortality was lower after PPCI compared to TT in both groups -- with diabetes(OR- 0.49, 95% CI, 0.31-0.79; P = .004) and -- without diabetes (OR- 0.69; 95% CI 0.54-0.86, P = .001),

  16. PPCI in the Elderly • GUSTO IIB trial was one of the first to report that PCI is superior to fibrinolysis. • De Boer et al. JACC 2002 : -- 87 patients , >75yrs PPCI vs SK.  RR of the primary composite end point of death, reinfarction, or stroke at 30 days of 4.3 (95% CI 1.2-20) for SK vs PCI. • SENIOR PAMI -largest RCT for elderly undergoing PPCI vs TT by Grines et al(2005) -- 481 patients >70 yrs 55% reduction in the combined end point of death, stroke, or reinfarction (P = 0.0093) associated with PCI. However, no advantage of one strategy over the other was found among those older than 80 years. •  Meta-analysis of 22 randomized trials comparing primary PCI with fibrinolysis, de Boer et al. showed a mortality/stroke reduction favoring primary PCI in all age strata. 1) de Boer, M. J. et al. for the Myocardial Infarction Study Group. Reperfusion therapy in elderly patients with acute myocardial infarction: a randomized comparison of primary angioplasty and thrombolytic therapy. J. Am. Coll. Cardiol. 39, 1723-1728 (2002). 2) Grines, C. L. SENIOR PAMI: a prospective randomized trial of primary angioplasty and thrombolytic therapy in elderly patients with acute myocardial infarction. Presented at the 17th Annual Transcatheter Cardiovascular Therapeutics Symposium, October 16-21, 2005. 3) de Boer, S. P et al. for the PCAT-2 Trialists Collaborators Group. Mortality and morbidity reduction by primary percutaneous coronary intervention is independent of the patient's age. JACC Cardiovasc. Interv. 3, 324-331 (2010).

  17. PPCI in the very elderly (>85yrs) Omar Rana et al. Percutaneous Coronary Intervention in the Very Elderly (≥85 Years) Trends and Outcomes. Br J Cardiol. 2013;20(1):27-31 • Single centre retrospective analysis. • B/w 2006 and 2010, 294 patients PCI (mean age 88 ± 2 years, 56% male) • 62% underwent PPCI and 38% elective PCI • 30-day mortality (5.6% vs. 3.4%, p=0.24) and • 1 year mortality (20.0% vs. 14.0%, p=0.19) • Male sex, previous PCI and shock – independent predictors • PCI is a safe option for the very elderly with ACS. RCTs further required.

  18. Guideline statement on PPCI vsThrombolysis AHA 2013 : I A “ In the absence of contraindications, fibrinolytic therapy should be given to patients with STEMI and onset of ischemic symptoms within the previous 12 hours when it is anticipated that primary PCI cannot be performed within 120 minutes of FMC”

  19. THROMBECTOMY in PPCI • Evidence on efficacy • Thrombosuction devices *Mechanical thrombectomy (Angiojet, Rescue, Xsizer) * Manual aspiration thrombectomy (TVAC, Diver, Export, Pronto)

  20. Early trials on Aspiration thrombectemy

  21. TAPAS trial (NEJM 2008)-Thrombus Aspiration during Percutaneous coronary intervention in AMI Study • Single centre RCT • 1071 patients: 535 Manual thrombus aspiration(6-French Export Aspiration Catheter) + PCI vs 536 PCI • Aspiration success by histopathological assessment • Angiographic (myocardial blush score) and ECG STE resolution assessment • The primary end point was a myocardial blush grade of 0 or 1 (defined as absent or minimal myocardial reperfusion, respectively). Results • Histopathological examination confirmed successful aspiration in 72.9% of patients. • Predilatation was done in 207 of 502 (41·2%) of the patients randomly assigned aspiration.

  22. TAPAS primary endpoint P < 0.001 Patients (%) Thrombus aspiration Conventional PCI

  23. TAPAS- ST resolution P < 0.001 Patients (%) Thrombus aspiration Conventional PCI

  24. TAPAS 30-day outcomes P = 0.001 Myocardial blush grade Conclusion: TA results in better reperfusion and clinical outcomes than conventional PCI

  25. Pieter et al. Cardiac death and reinfarction after 1 year in the TAPAS trial: a 1-year follow-up study. (Lancet 2008) • Cardiac death at 1 year was 3·6% (19 of 535 patients) in TA group and 6·7% (36 of 536) in the conventional PCI group ( [HR] 1·93; 95% CI 1·11—3·37; p=0·020). • 1-year cardiac death or non-fatal reinfarction occurred in 5·6% (30 of 535) in TA group and 9·9% (53 of 536) in conventional PCI group (HR 1·81; 95% CI 1·16—2·84; p=0·009). Compared with conventional PCI, thrombus aspiration before stenting of the infarcted artery seems to improve the 1-year clinical outcome after PCI for ST-elevation myocardial infarction.

  26. Ikari et al. Upfront thrombus aspiration in primary coronary intervention for patients with ST-segment elevation acute myocardial infarction: :VAMPIRE trial (JACC Cardiovasc interventions 2008) • Performance of the TVAC(Nipro) during PPCI The study showed a trend toward improved myocardial perfusion and lower clinical events in patients treated with aspiration. Patients presenting late after STEMI appear to benefit the most from thrombectomy.

  27. Thrombectomy with export catheter in infarct-related artery during primary percutaneous coronary intervention – a prospective, randomized trial.EXPIRA trial -- JACC 2009 • Impact of TA on myocardial perfusion and infarct size as by CE-MRI analysis Thrombectomy prevents thrombus embolization and preserves microvascular integrity reducing infarct size, and it therefore represents an useful adjunctive therapy in PPCI.

  28. De Luca G et al. Adjunctive manual thrombectomy improves myocardial perfusion and mortality in patients undergoing primary percutaneous coronary intervention for ST-elevation myocardial infarction: a meta-analysis of randomized trials.Eur Heart J.2008 • 9 RCTs with 2417 patients • Adjunctive manual aspiration thrombectomywas associated with significantly improved • postprocedural TIMI 3 flow (87.1 vs. 81.2%, P < 0.0001), • postprocedural MBG 3 (52.1 vs. 31.7%, P < 0.0001), • less distal embolization(7.9 vs. 19.5%, P < 0.0001), • significant benefits in terms of 30-day mortality (1.7 vs. 3.1%, P = 0.04).

  29. Tamhane et al. Safety and efficacy of thrombectomy in patients undergoing primary percutaneous coronary intervention for Acute ST elevation MI: A Meta-Analysis (BMC Cardiovascular Disorders 2010) • 17 RCTs (3909 patients) • Aspiration/Thrombectomy PCI vs conventional PCI • No difference in risk of 30-day mortality (OR 0.84, 95% CI 0.54-1.29, P = 0.42) • Thrombectomy was associated with a significantly greater likelihood of TIMI 3 flow (OR 1.41, P = 0.007), MBG 3 (OR 2.42, P < 0.001), STR (OR 2.30, P < 0.001), and with a higher risk of stroke (OR 2.88, 95% CI 1.06-7.85, P = 0.04). • Outcomes differed significantly between different device classes with a trend towards lower mortality with manual aspiration thrombectomy (MAT) (OR 0.59, 95% CI 0.35-1.01, P = 0.05), whereas mechanical devices showed a trend towards higher mortality (OR 2.07, 95% CI 0.95-4.48, P = 0.07).

  30. Angiojetrheolyticthrombectomy for PPCI • VeGAS 1 & 2 trials (AJC 2002) : - RT vs intracoronary UK • Encouraging results for Angiojet • AIMI (JACC 2006):  Negative results

  31. Comparison of AngioJetRheolyticThrombectomy Before Direct Infarct Artery Stenting With Direct Stenting Alone in Patients With Acute Myocardial Infarction : The JETSTENT Trial (JACC 2010) • Multicenter international RCT (December 2005 to September 2009) • Coprimary endpoints : STR and Tc-SPECT infarct size • Clinical endpoints: MACE at 1,6 and 12m • 501 patients with angio evidence of thrombus (BMS) Results: • STR was 85.8% vs 78.8% (p = 0.043), • 6m MACE was 11.2% vs 19.4% (p = 0.011). • The 1-year event-free survival rates were 85.2 ± 2.3% for the RT arm, and 75.0 ± 3.1% for the DS alone arm (p = 0.009). The results of the study support the use of RT before infarct artery stenting in patients with acute myocardial infarction and evidence of coronary thrombus.

  32. Major features of the 2 largest trials on Angiojet RT

  33. In light of the often superior thrombus extraction efficiency with mechanical thrombectomy, what explains thedisappointing outcomes with mechanical devices in general? • JACC 2010 editorial on the JETSTENT trial • Rheolytic MT: - Bulkier, complicated use, bigger learning curve, - requires favourable coronary anatomy, • longer procedure times, • propensity to initially impair distal microcirculation, • high incidence of symptomatic bradycardia and need for TPI. • MAT: User friendly, quick and easier to learn.

  34. Current guidelines on thrombectomy AHA STEMI 2013: ESC STEMI 2012:

  35. Frobert et al. Thrombus Aspiration during ST-Segment Elevation Myocardial Infarction TASTE trial -(NEJM September 2013) • Prospective multicentre RCT from the Swedish registry(SCAAR) • 7244 patients –PCI+TA vs conventional PCI • Primary endpoint—mortality at 30 days • Secondary endpoints – Stent thrombosis, hospitalization, reinfarction Conclusion: Routine thrombus aspiration before PCI as compared with PCI alone did not reduce 30-day mortality among patients with STEMI. -There were no significant differences between the groups with respect to the rate of stroke or neurologic complications at the time of discharge (P=0.87).

  36. TASTE - Endpoints P=0.63 P=0.09 --Rates of stent thrombosis were 0.2% and 0.5%, respectively (HR, 0.47 (0.20 to 1.02); P=0.06). 

  37. Consistency of the findings among all subgroups A REVISION OF CURRENT GUIDELINES ?? Awaiting: 1 year f/u results 2) TOTAL trial in the late stages

  38. EMBOLIC PROTECTION DEVICES in PPCI Guard wire occlusion-aspiration system Filter wire sytem Proxis catheter system

  39. Proven role of EPDs in SVGs and carotid interventions • Carotid : CABERNET • SVG: BLAZE, BLAZE II, FIRE (Filter wire), SAFER (Guard wire), PROXIMAL (Proxis)

  40. Early trials with EPDs- Balloon occlusion devices

  41. Stone GW et al. Distal microcirculatory protection during percutaneous coronary intervention in acute ST-segment elevation myocardial infarction: a randomized controlled trial. EMERALD trial (JAMA 2005 Mar 2;293(9):1063-72.). • Prospective RCT on 501 patients of STEMI for PCI • PCI with a balloon occlusion and aspiration distal microcirculatory protection system (GUARD WIRE)vs angioplasty without distal protection. OUTCOME MEASURES: • STR 30 minutes after PCI by continuous Holter monitoring and • Infarct size measured by technetium Tc 99m sestamibi imaging between days 5 and 14. • Secondary end points included major adverse cardiac events. RESULTS: • Visible debris was retrieved from 73% (182/250). • Complete STR 63.3% vs 61.9% , P = .78, • Left ventricular infarct size was similar in both groups (12.0% vs 9.5% ; P = .15). • MACE at 6m were 10.0% vs 11.0%, P = .66 CONCLUSIONS: Distal embolic protection did not result in improved microvascular flow, greater reperfusion success, reduced infarct size, or enhanced event-free survival. The use of GuardWire device increased procedural time by 14 min on average and, due to the occlusive nature of the device, such an increase almost completely translated into a reperfusion delay ----- likely additive muscle loss

  42. Muramatsu T et al. Comparison of myocardial perfusion by distal protection before and after primary stenting for acute myocardial infarction: angiographic and clinical results of a randomized controlled trial.: ASPARAGUS trial (Catheter CardiovascInterv 2007) • Multicenter prospective RCT of  341 AMI • +/- Guard wire system Results: • The rates of slow flow and no-reflow immediately after PCI were 5.3 and 11.4% in the GuardWire Plus and control groups, respectively (P = 0.05).

  43. Gick M at al. Randomized evaluation of the effects of FILTER-BASED DISTAL PROTECTION on myocardial perfusion and infarct size after primary percutaneous catheter intervention in myocardial infarction with and without ST-segment elevation.PROMISE trial Circulation. 2005 • First major trial on Filter devices • 200 patients – RCT • The primary end point was the maximal adenosine-induced Doppler flow velocity in the recanalized infarct artery; • The secondary end point was infarct size estimated by the volume of delayed enhancement on nuclear MRI. • Thirty-day mortality was 2% in filter-wire group and 3% in the control group.

  44. Cura FA et al. Protection of Distal Embolization in High-Risk Patients with Acute ST-Segment Elevation Myocardial Infarction (PREMIAR).: PREMIAR trial (Am J Cardiol 2007) • 140 patients with AMI • +/- Filter device system Results: • Rate of STR 61% vs 60% (0.85) • MBG 67 vs 70% (0.73) • In-hospital LVEF 47% vs 45% (0.29) • MACE at 6 m 14% vs 15% (0.8) “The use of filter-based distal protection is safe and effectively retrieves debris; however, such use does not translate into an improvement of myocardial reperfusion, left ventricular performance, or clinical outcomes.”

  45. Role of adjunctive thrombectomy and embolic protection devices in acute myocardial infarction: a comprehensive meta-analysisof randomized trials:European Heart Journal (2008) • Primary objective was to assess clinical outcomes • 30 trials -6415 patients • Mean follow-up of 5.0 months, • Overall Mortality was 3.2% for the adjunctive device group vs. 3.7% for PCI alone (rr-0.87; 95% confidence interval, 0.67– 1.13). • Thrombus aspiration- 2.7% vs 4.4% (0.018) [ NNT = 59 ] • Mechanical thrombectomy - 5.3 vs 2.8% (0.05) [ NNH = 38 ] • Embolic protection devices - 3.1% vs 3.4% (0.69) – Neutral effect

  46. Role of Proximal embolic protection-aspiration system (PROXIS) • Proven role for SVG graft interventions in the PROXIMAL trial • PREPARE trial (JACC cardiovascinterv 2009, Heart 2010)  284 patients , PROXIS system vs conventional PCI • STR at 60 min -- 80% vs 72% (0.14) • MACCE at 30 days and 6m (8% vs 10%) were similar • No difference in finnal infarct size/ LVEF on CMR •  No definite benefit

  47. Kelbæk H et al. Randomized Comparison of Distal Protection Versus Conventional Treatment in Primary Percutaneous Coronary Intervention: The Drug Elution and Distal Protection in ST-Elevation Myocardial Infarction : (DEDICATION) Trial. J Am CollCardiol. 2008 • 626 patients Filter wire system vs conventional • 50% underwent DES implantation • Endpoints --STR, MACCE at 30 days, WMI, Trop I, CK-MB • All endpoints were similar. • (MACCE) 1 month –5.4% vs 3.2% (p = 0.17). • Routine use of a filterwire system during primary PCI does not seem to improve microvascular perfusion, limit infarct size, or reduce the occurrence of MACCE.

  48. Guideline statement on EPDs in STEMI • ESC 2012- : Routine use of distal protection devices is not recommended. (III C) Int J Cardiol 2013:Effect on MVO of DPDs after PPCI • 126 patients , prospective RCT • Evaluation of MVO by cMRI after PCI for STEMI • MVO ratio was larger when DPDs were used. • DPDs should not be used for PPCI.

  49. STENT USAGE IN PPCI • POBA vs Stent • BMS vs DES • Newer stent designs in PPCI

  50. POBA vs Stent in PPCI • No remaining dispute on the superiority of stenting - However no conclusive mortality benefit in any study

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