PRIMARY PCI : Part 1

PRIMARY PCI : Part 1

Speaker: Dr Sandeep MohananSenior Resident

Department of CardiologyGovernment Medical College Calicut

JOURNAL REVIEW

TOPIC OVERVIEW

• COMPARISON OF PRIMARY PCI TO THROMBOLYSIS

• ASPIRATION THROMBECTOMY IN PRIMARY PCI

• DISTAL PROTECTION DEVICES IN PRIMARY PCI

• STENT USAGE IN PRIMARY PCI

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

Efficacy of primary PCI vs thrombolysis• 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.

Keeley et al. Lancet 2003



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 center within 2 hours.

• 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

DANAMI 2 study(Danish trial in acute MI)- (AHJ2003, EHJ 2008, Circulation 2010)

High-risk ST elevation MI patients (>4 mm elevation), Sx < 12 hrs5 PCI centers (n=443) and 22 referral hospitals (n=1,129), transfer criteria < 3 hrs

High-risk ST elevation MI patients (>4 mm elevation), Sx < 12 hrs5 PCI centers (n=443) and 22 referral hospitals (n=1,129), transfer criteria < 3 hrs

Lytic therapyFront-loaded tPA 100

mg

(n=782)

Lytic therapyFront-loaded tPA 100

mg

(n=782)

Death / MI / Stroke at 30 DaysDeath / MI / Stroke at 30 Days

Primary PCIwith transfer

(n=567)

Primary PCIwith transfer

(n=567)

Primary PCIwithout transfer

(n=223)

Primary PCIwithout transfer

(n=223)

14%

8%

0%

4%

8%

12%

16%

Dea

th /

MI /

Str

oke

(%)

Dea

th /

MI /

Str

oke

(%)

LyticLytic Primary PCIPrimary PCI

P=0.0003P=0.0003 P=0.002P=0.002CombinedCombined Transfer SitesTransfer Sites

P=0.048P=0.048Non-Transfer SitesNon-Transfer Sites

DANAMI-2: Primary Results

RRR 45%RRR 45%

LyticLytic Primary PCIPrimary PCI LyticLytic Primary PCIPrimary PCI

14%

9%

0%

4%

8%

12%

16%

12%

7%

0%

4%

8%

12%

16%

RRR 40%RRR 40%

RRR 45%RRR 45%

2.0%

1.1%

0%

2%

4%

6%

8%

6.3%

1.6%

0%

2%

4%

6%

8%7.6%

6.6%

0%

2%

4%

6%

8%


P=0.35P=0.35DeathDeath

DANAMI-2: Primary outcomes


P=0.15P=0.15StrokeStroke


P<0.0001P<0.0001Recurrent MIRecurrent MI

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

DANAMI2 Long term follow up

DANAMI2 subgroup analysis (Circ 2010)

PPCI in DIABETICS

• 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),

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.

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 yrs55% 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).

PPCI in the very elderly (>85yrs)

• 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.

Omar Rana et al. Percutaneous Coronary Intervention in the Very Elderly (≥85 Years)Trends and Outcomes. Br J Cardiol. 2013;20(1):27-31

Guideline statement on PPCI vs Thrombolysis

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”

THROMBECTOMY in PPCI

• Evidence on efficacy• Thrombosuction devices*Mechanical thrombectomy (Angiojet, Rescue, Xsizer)

* Manual aspiration thrombectomy (TVAC, Diver, Export, Pronto)

Early trials on Aspiration thrombectemy

Trial N Primary outcome TA / MT Result

1. AJC 2004 100 Early STR Rheolytic MT 90% vs 72% (P=0.02)

2. JACC 2005 Jul 19;46(2):246-52.X AMINE ST trial

201RCT

STR after 1 hour MT(X-Sizer catheter system)

STR>50% (68% vs. 53%; p = 0.037).

3. JACC2005 Jul 19;46(2):371-6REMEDIA trial

100RCT

Combined MBG>/=2+ STR>70%

TA[ Diver CE (Invatec)] 46% vs 24.5%, OR 2.6 (p = 0.025)

4. JACC 2006Oct 17;48(8):1552-9. DEAR-MI trial

148RCT

STR>70%, MBG=3 TA[Pronto extraction catheter (Vasc.solutions)]

STR>70: 68% versus 50% (p < 0.05);MBG-3 88% versus 44% (p<0.0001)

5. JACC 2006.Jul 18;48(2):244-52.AIMI trial

480RCT

Infarct size by SPECT(30 day MACE)

Rheolytic MT[5-F LF140 RT catheter (Possis Medical)] –no DP

-Infarct size larger for RT (P=.03)-MACE & mortality higher for RT (P=0.01/ 0.02)

6. Circulation. 2006 Jul 4;114(1):40-7

215RCT

Infarct size by SPECT TA(Rescue catheter (Boston Scientific)

Infarct size larger for TA(15%vs 8%)P=0.006

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.

TAPAS primary endpoint

3741

46

32

26

17

0

10

20

30

40

50

60

0/123

Patie

nts

(%)

Thrombus aspiration Conventional PCI

P < 0.001

TAPAS- ST resolution

1318

31

38

57

44

0

10

20

30

40

50

60< 30%

30-70%

> 70%

Patie

nts

(%)

Thrombus aspiration Conventional PCI

P < 0.001

TAPAS 30-day outcomes

1.1

2.9

5.7

1.6

3.9

8.1

0

2

4

6

8

10

3 2 0 or 1

Death

Death/reinfarction

P = 0.001

Myocardial blush grade

Conclusion: TA results in better reperfusion and clinical outcomes than conventional PCI

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.

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.

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.

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 thrombectomy was 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).

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).

Angiojet rheolytic thrombectomy for PPCI

• VeGAS 1 & 2 trials (AJC 2002) :- RT vs intracoronary UKEncouraging results for Angiojet

• AIMI (JACC 2006): Negative results

Comparison of AngioJet Rheolytic Thrombectomy 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.

Major features of the 2 largest trials on Angiojet RT

In light of the often superior thrombus extraction efficiency with mechanical thrombectomy, what explains the

disappointing 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.

Current guidelines on thrombectomy

AHA STEMI 2013:

ESC STEMI 2012:

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).

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).

Consistency of the findings among all subgroups

A REVISION OF CURRENT GUIDELINES ??

Awaiting:1) 1 year f/uresults2) TOTAL trial in the late stages

EMBOLIC PROTECTION DEVICES in PPCI

Filter wire sytem

Proxis catheter system

Guard wire occlusion-aspiration system

Proven role of EPDs in SVGs and carotid interventions

• Carotid : CABERNET

• SVG: BLAZE, BLAZE II, FIRE (Filter wire), SAFER (Guard wire), PROXIMAL (Proxis)

Early trials with EPDs- Balloon occlusion devices

Trial N Primary outcome Particluars Result

2. Am J Cardiol. 2003 Dec 1;92(11):1331-5

- TIMI flow, MBG, 30 day MACE

vs adjunctive tirofiban

Benefit in all outcomes

1. Catheter Cardiovasc Interv.2004 Apr;61(4):503-11.

42Vs 101

-TIMI 3 flow- Combined 30-day MACE+ distal thrombemb events+ vasc compli

-Radial vs Femoral control at separate periods- Large IRAs + HBTF

-95% vs 79% (P=0.005)

- P <0.05 for 20 endpoints

3. Catheter Cardiovasc Interv. 2005 Jan;64(1):35-42.

74(48 vs 26)RCT

-TIMI flow

-6 month angiographic results

- -Improved immediate TIMI flow.-Favourable 6 month results* Late stenosis at site of balloon

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

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 Cardiovasc Interv 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).

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.

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.”

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

Role of Proximal embolic protection-aspiration system (PROXIS)

• Proven role for SVG graft interventions in the PROXIMAL trial

• PREPARE trial (JACC cardiovasc interv 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

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 Coll Cardiol. 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.

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.

STENT USAGE IN PPCI

• POBA vs Stent

• BMS vs DES

• Newer stent designs in PPCI

POBA vs Stent in PPCI• No remaining dispute on the superiority of stenting

Trial Publication Favouring Stenting

STENT PAMI

Circulation 1999 √

FRESCO JACC 1998 √

GRAMI AJC 1998 √

PASTA Catheter Cardiovasc interv 1999 √

STENTIM2 JACC 2000 √

CADILLAC NEJM 2002 √

- 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)

• 1979-2002, 9 trials ---4433 patients.• Stenting vs POBA

• Mortality: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)

• Reinfarction at 1, 6 and 12 m: 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)

• Target vessel revascularization0.46 (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 increased bleeding complications

===> No definite mortality benefit upto 1 year for Stenting vs 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

• To study the long term outcome of stenting vs POBA• 2,087 patients enrolled from various PAMI trials • 692 (33%) underwent stenting.

• Absolute difference in mortality rates favoured stent usage- In-hospital (2.2% vs 3.3%), - 1-year (3.3% vs 5.2%), and - 5-year (10% vs 13%)

• Regression model identified significant 5 yr mortality reduction with stenting vs POBA (HR 0.60, 95% confidence interval 0.42 to 0.85).

• The absolute reduction in mortality was greatest in the highest risk group.

ESC 2012 and AHA 2013 --- Primary stenting preferred to balloon angioplasty (Class I A)

BMS vs DES in PPCI

• PES versus BMS --- PASSION trial, NEJM 2006

• SES versus BMS --- TYPHOON trial , NEJM 2006 --- SESAMI trial , JACC 2007

• EES versus BMS --- EXAMINATION trial, LANCET 2012

• METAANALYSIS --- EHJ 2012

Laarman et al.Paclitaxel-Eluting versus Uncoated Stents in Primary Percutaneous Coronary Intervention

: PASSION (NEJM 2006)• 619 patients with STEMI, PES (TAXUS)vs BMS • Primary end point-- composite of death from cardiac causes, recurrent

myocardial infarction, or target-lesion revascularization at 1 year• Included LMCA, bifurcation and high thrombus burden lesions

12.6%

8.7%

0

5

10

15

Paclitaxel-eluting stent Bare-metal stent

Dea

th, r

einf

arcti

on, o

r TLR

(%

)

p=0.12

PASSION results (contd)%

Dea

th/M

I and

TLR

0

2

4

6

8

10

Death/MI TLR

Paclitaxel-eluting stent Bare-metal stent

p=0.39p=0.39p=0.23p=0.23

4.8%

6.5%6.2%

7.4%

Stent thrombosis at 1 year – 1% in PES and DES

All individual endpoints revealed a trend for benefit with PES – statistically NS

Spaulding et al, Sirolimus-Eluting versus Uncoated Stents in Acute Myocardial Infarction:

TYPHOON, NEJM 2006

• 712 STEMI at 48 centres, SES (CYPHER) vs BMS• Primary EP – Target vessel failure (TVR, Reinfarction, death)

Target Vessel Failure at one year

TVF

7.3%

14.3%

0%

10%

20%

Cyper stent Bare-metal stent

p=0.003

TYPHOON results(contd)Rate of Target Lesion Revascularization (%)

p<0.0001

3.7%

12.6%

0%

5%

10%

15%

Cyper stent Bare-metal stent

TLR

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 patientsFreedom 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)

• RCT of 320 STEMI , SES vs BMS • Primary end point was binary restenosis (>50% stenosis) at 1yr

RESULTS:• Binary restenosis was 9.3% vs. 21.3%,; p = 0.032), • TLR 4.3% vs. 11.2%; p = 0.02, • MACE 6.8% vs. 16.8%; p = 0.005, • Definite stent thrombosis was 1.2% vs 0.6%

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

• Multicentre RCT 1504 patients EES vs BMS ....1 yearRESULTS• The primary endpoint – 11.9% vs 14.2% (0.19)

• Rates of TLR was significantly lower in the EES group– 2% vs 5% (0.007)

• Other endpoints were similar.

• Stent thrombosis rates EES 0.5% vs BMS 1.9% (0.019)

• Primary endpoints were significantly better for LAD-plasty (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)

• 15 RCTs with 7867 patients 1st gen DES vs BMS in STEMI

• Stent thrombosis at 5 years was similar for DES and BMS RR- 1.08, 95% CI 0.82– 1.43].

• ST for 1st yr --RR of 0.80 (95% CI 0.58 –1.12) • ST after 1st year 2.1(95% CI1.20 –3.69 )

• TVR was less for DES (RR 0.51, 95% CI 0.43–0.61) – benefit greater in 1st yr

• Other endpoints(30D,6m & 1yr) were similar for both

• NNT to prevent 1 TVR till 5 years = 15• NNH to produce 1 ST till 5 years = 79

Guideline statements on DES vs BMS in PPCI

AHA 2013

ESC 2012

M-Guard

• A novel Co-Cr stent wrapped with ultra thin polymer mesh

• Excellent Deliverability and Flexibility

• Built in embolic protection• Plaque stabilization• Rapid exchange deliverysystem

Stone et al. Prospective, Randomized, Multicenter Evaluation of a Polyethylene Terephthalate Micronet Mesh-Covered Stent (MGuard) in STEMI

: The MASTER Trial (J Am Coll Cardiol 2012 Sep 28)

• Multicentre RCT -- 433 patients with STEMI • The primary endpoint was the rate of complete (≥70%) STR measured

60 to 90 min post-procedure.RESULTS:• Complete STR was (57.8% vs. 44.7%;; p = 0.008). • Superior rates of TIMI3 flow (91.7% vs. 82.9%, p = 0.006)• MBG 2 or 3 (83.9% vs. 84.7%, p = 0.81). • MACE at 30 days were similar

Long term results awaited

MAGICAL trial - unpublished-Data of 54 patients who underwent PPCI with M Guard stent- Comparison with a matched cohort from TAPAS trial presented at ESC interventional conference.

Closed vs Open cell stent for high-risk PCI in STEMI

:COCHISE study (AHJ 2013)• Ongoing quest to tackle the no-reflow

phenomenon after PPCI.• An attempt to assess the effect of free-cell

area.• Coronary flow patterns by MBG and TFC

after PPCI between both stent designs• RCT of 223 patients.

Significantly higher TFC, lower TIMI 3 flow and lower MBG3 in open stent group.

Closed stent design has better angiographic results following PPCI.

THANK YOU....

Documents

PRIMARY PCI : Part 1