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
-- Inferior to PPCI
-- IIa B in AHA 2013
Andersen HR et al. A comparison of coronary angioplasty with fibrinolytic therapy in acute myocardial infarction. N Engl J Med. 2003;349:733– 42.
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
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
Front-loaded tPA 100 mg
Death / MI / Stroke at 30 Days
Death / MI / Stroke (%)
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.
-- 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),
-- 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.
-- 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.
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).
Omar Rana et al. Percutaneous Coronary Intervention in the Very Elderly (≥85 Years)
Trends and Outcomes. Br J Cardiol. 2013;20(1):27-31
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”
*Mechanical thrombectomy (Angiojet, Rescue, Xsizer)
* Manual aspiration thrombectomy (TVAC, Diver, Export, Pronto)
P < 0.001
P < 0.001
P = 0.001
Myocardial blush grade
Conclusion: TA results in better reperfusion and clinical outcomes than conventional PCI
( [HR] 1·93; 95% CI 1·11—3·37; p=0·020).
(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.
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)
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.
Thrombectomy with export catheter in infarct-related artery during primary percutaneous coronary intervention – a prospective, randomized trial.EXPIRA trial -- JACC 2009
Thrombectomy prevents thrombus embolization and preserves microvascular integrity reducing infarct size, and it therefore represents an useful adjunctive therapy in PPCI.
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
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)
- RT vs intracoronary UK
Comparison of AngioJetRheolyticThrombectomy Before Direct Infarct Artery Stenting With Direct Stenting Alone in Patients With Acute Myocardial Infarction : The JETSTENT Trial (JACC 2010)
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.
In light of the often superior thrombus extraction efficiency with mechanical thrombectomy, what explains thedisappointing outcomes with mechanical devices in general?
- Bulkier, complicated use, bigger learning curve,
- requires favourable coronary anatomy,
AHA STEMI 2013:
ESC STEMI 2012:
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).
--Rates of stent thrombosis were 0.2% and 0.5%, respectively (HR, 0.47 (0.20 to 1.02); P=0.06).
A REVISION OF CURRENT GUIDELINES ??
1 year f/u
2) TOTAL trial in
the late stages
Guard wire occlusion-aspiration system
Filter wire sytem
Proxis catheter system
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.).
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
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)
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
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)
“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.”
Role of adjunctive thrombectomy and embolic protection devices in acute myocardial infarction: a comprehensive meta-analysisof randomized trials:European Heart Journal (2008)
(rr-0.87; 95% confidence interval, 0.67– 1.13).
284 patients , PROXIS system vs conventional PCI
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
: Routine use of distal protection devices is not recommended. (III C)
Int J Cardiol 2013:Effect on MVO of DPDs after PPCI
- However no conclusive mortality benefit in any study
Clinical Outcomes of Primary Stenting versus Balloon Angioplasty in Patients with Myocardial Infarction: A Meta-analysis of RCTs (Am J Med 2004)
30 days - 1.17 (95% conﬁdenceinterval [CI]: 0.78 to 1.74)
6m - 1.07 (95% CI: 0.76 to 1.52)
12m - 1.09 (95% CI: 0.80 to 1.50)
0.52 (95% CI: 0.31 to 0.87), 0.67 (95% CI:0.45 to 1.00) & 0.67 (95% CI: 0.45 to 0.99)
0.46 (0.34 to 0.61) at 30 days, 0.42 (0.35 to 0.51) at 6m & 0.48 (0.39 to 0.59) at 12 m
===> No definite mortality benefit upto 1 year for Stentingvs POBA
Mehta RH et al. Comparison of coronary stenting versus conventional balloon angioplasty on five-year mortality in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention.:Am J Cardiol.2005
ESC 2012 and AHA 2013 --- Primary stenting preferred to balloon angioplasty (Class I A)
--- SESAMI trial , JACC 2007
Death, reinfarction, or TLR (%)
% Death/MI and TLR
Stent thrombosis at 1 year – 1% in PES and DES
All individual endpoints revealed a trend for benefit with PES – statistically NS
Target Vessel Failure at one year
Rate of Target Lesion Revascularization (%)
Rate of death - 2.3% and 2.2%, P = 1.00
Reinfarction - 1.1% and 1.4%, P = 1.00
Stent thrombosis -3.4% and 3.6%,P = 1.00
4 year follow up (JACC Cardiovasc 2011) – 580 patients
Freedom from TLR at 4 years 92.4% vs. 85.1%; p = 0.002;
Freedom from cardiac death (97.6% and 95.9%; p = 0.37)
Freedom from repeat myocardial infarction (94.8% and 95.6%; p = 0.85)
Definite/probable stent thrombosis-- SES: 4.4%, BMS: 4.8%, p = 0.83.
The all-cause death rate was 5.8% in the SES and 7.0% in the BMS group (p = 0.61).
Menichelli et al. Randomized trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction:SESAMI trial (JACC 2007)
3 year f/u (JACC 2010) : Similar results
Sabate et al, Everolimus-eluting stent versus bare-metal stent in ST-segment elevation myocardial infarctionEXAMINATION trial: Lancet. 2012
(9.5% vs 18.9%) --(Insights from EXAMINATION- AHJ Sept 2013)
Comparison of drug-eluting stents with bare metal stents in patients with ST-segment elevation myocardial infarction: A METAANALYSIS (EHJ 2012)
RR- 1.08, 95% CI 0.82– 1.43].
Stone et al. Prospective, Randomized, Multicenter Evaluation of a Polyethylene TerephthalateMicronet Mesh-Covered Stent (MGuard) in STEMI: The MASTER Trial (J Am CollCardiol 2012 Sep 28)
Long term results awaited