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uropean Society of Cardiology Congress 2009pdate in Interventional Cardiology

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he 31st Congress of the European Society ofardiology was held in Barcelona, Spain, fromugust 29, 2009, to September 2, 2009, revealing

everal breaking trials in the field of interventionalardiology. Three years after the World Congressf Cardiology ignited controversy in the same cityegarding the risk of stent thrombosis with drug-luting stents (DES), ESC Congress 2009 appro-riately began their annual session with a review ofollow-up registry and trial data on stent throm-osis risk with DES.

CAAR

lthough the initial data from the SCAAR (Swed-sh Coronary Angiography and Angioplasty Reg-stry) presented during the 2006 U.S. Food and

rug Administration hearing on the concerns ofES indicated that combined rates of death andyocardial infarction (MI) 6 months after percu-

aneous coronary intervention (PCI) were signifi-antly higher among DES compared with bare-etal stent (BMS)-treated patients (1), new

CAAR data presented on almost 61,000 patientsreated with stents from 2003 to 2006 showed thathe rates beyond the 1-year mark have been noifferent between the 2 arms (2). This furthermphasized the need for dual antiplatelet therapyntil complete vascular endothelialization has oc-urred or for at least 1 year. While there waseneral acknowledgment of the flaws of registryata, there was consensus that the outpouring ofurther data since 2006 have been reassuring forhe continued use of DES. However, the safetynd efficacy can be variable based on the type ofES stent used as previously elucidated by various

rials, most recently the ZEST (Zotarolimus-luting Stent Versus Sirolimus-Eluting Stent andaclitaxel-Eluting Stent for Coronary Lesions)

rom the *Division of Cardiovascular Medicine, Deborah Heart andung Center, Browns Mills, New Jersey; and the †Cardiovascular

cesearch Foundation, Columbia University Medical Center, New York,ew York.

rial presented at the American College of Cardi-logy Scientific Session 2009 (3).

SAR-TEST-4

n the emerging field of bioabsorbable DES, re-ults from the ISAR-TEST-4 (Intracoronarytenting and Angiographic Results: Test Efficacyf 3 Limus-Eluting Stents) study found a novelirolimus-eluting stent with a biodegradable poly-er to be equally as effective as Cypher (Cordis,iami Lakes, Florida) and Xience (Abbott, Ab-

ott Park, Illinois) stents with their standard per-anent polymers. The trial of 2,603 patients ran-

omized patients to Cypher, Xience, or a stainlessteel stent coated with a biodegradable polymeroaded with sirolimus and coated with a bio-ompatible shellac resin (4). At 1 year, theiodegradable polymer stent was noninferior tohe combined Cypher/Xience group for the pri-ary end point of a composite of death, MI, or

arget lesion revascularization (TLR) without anytatistically significant differences in stent throm-osis or restenosis.

YNTAX

n the debate between coronary artery bypassrafting (CABG) versus percutaneous coronaryntervention (PCI) for complex coronary disease,he 2-year follow up from the SYNTAX (Synergyetween PCI with Taxus and Cardiac Surgery)rial reported continued divergence from the initial-year data: The 1,800-patient trial found thatajor adverse cardiac and cerebrovascular events

MACCE) after 1 year occurred significantly moreften among PCI-treated than among CABG-reated patients driven by repeat revascularizationn the PCI group (5). Although the compositeafety end point of death/cerebrovascular accidentCVA)/MI rates were almost identical in bothroups, the CVA rate was significantly higher inhe CABG group. At 2 years, MACCE rates

ontinued to be significantly different favoring the

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ABG arm, again driven by the repeat revascularizationate in the PCI arm (6). The higher rate of CVA seen in theABG group after the first year did not increase in the

econd year. Furthermore, the trend towards higher MIoted in the PCI arm at 1 year became statistically signif-

cant at 2 years. Although various reasons for this differenceave been offered, further data regarding the types ofesultant MI have not been reported.

RACE

espite equivocal results for PCI in complex coronary diseaserom the SYNTAX trial, new data from the GRACE (Globalegistry of Acute Coronary Events) shows that PCI is an

cceptable revascularization strategy in patients with unpro-ected left main coronary artery disease (LMCAD) presentingith acute coronary syndrome (ACS). Although unprotectedMCAD in ACS is a rare entity, it is associated with highortality and is primarily treated with PCI rather than being

eferred for CABG or medical therapy which confers greaterisk. The results of 1,799 patients with ACS and LMCAD,epresenting 4% of patients included in GRACE between000 and 2007, showed that PCI was associated with a 55%eduction in the risk of death compared with medical therapyespite being performed in higher-risk patients that wereeemed poor candidates for surgery (7). Although CABGrocedures were also associated with a reduction in the risk ofeath, they had higher rates of stroke at 6 months in compar-

son to medical therapy or PCI.

TTEMPT

he results of the ATTEMPT (Pooled Analysis of Trialsn Thrombectomy in Acute MI based on Individual Patientata) reaffirmed the benefit of thrombectomy during PCI

or ST-segment elevation myocardial infarction (STEMI).he grouped results of 11 randomized trials on 2,686atients with a median follow-up of 365 days found thatandomization to thrombectomy was associated with signif-cantly lower all-cause mortality and MACE rates (8).urther subanalysis revealed that the survival benefit was

imited to patients that underwent manual thrombectomy aspposed to mechanical thrombectomy.

RIANA

he Spanish TRIANA (Tratamiento del Infarto Agudo deiocardio en Ancianos) trial that compared PCI with

hrombolysis in elderly patients 75 years of age and olderith acute MI found that primary angioplasty was better in

educing the need for future revascularization with a non-ignificant trend in favor of reducing death and MI (9). Therial randomized patients with STEMI of 6 h or less in

uration to thrombolysis with tenecteplase and unfraction-

ted heparin or to primary angioplasty. Patients receivinghrombolysis fared worse in all primary end point compo-ents: death, reinfarction, and disabling stroke. However,he trial was underpowered enrolling only 266 patients ofhe 570 that were initially planned, due to reluctance on theart of clinicians to refer for randomization out of concernsor bleeding from thrombolysis.

LATO

he PLATO (Platelet Inhibition and Patient Outcomes)tudy compared the treatment of patients with ACS withhe investigational oral antiplatelet agent ticagrelor againstlopidogrel. Patients (n � 18,624) admitted with ACS in 43ountries were randomized to receive either drug with aoading dose and maintenance in addition to aspirin (10).he primary end point—a composite of death, MI, orVA—was significantly lower in the ticagrelor group com-ared with the clopidogrel group. Moreover, there were noignificant differences in the rates of major bleeding betweenoth agents. Further results on the PCI cohort to beresented at a later meeting.

URRENT OASIS-7

hile PLATO announced the superiority of ticagrelor, theURRENT OASIS-7 (Clopidogrel Optimal Loadingose Usage to Reduce Recurrent Events Optimal Anti-

latelet Strategy for Investigators-7) trial showed that dou-ling the doses of clopidogrel for the first week in ACSatients undergoing planned PCI reduced stent thrombosisnd cardiovascular events. The trial of 17,232 patients whonderwent PCI, demonstrated a significant reduction ofardiovascular death, MI, and CVA in the double-dose armhat was driven primarily by the reduction in MI (11). Inddition, there was no significant difference in major bleed-ng despite doubling the dosage of clopidogrel.

UMMARY

he 2009 Congress of the ESC was the venue for new data onreaking clinical trials and established follow-up on somerevious trials in interventional cardiology. Complete coveragef ESC Congress 2009 can be accessed at the Americanollege of Cardiology’s Cardiosource website (12).

eprint requests and correspondence: Dr. Jon C. George,ivision of Cardiovascular Medicine, Deborah Heart and Lungenter, 200 Trenton Road, Browns Mills, New Jersey 08015.-mail: jcgeorgemd@hotmail.com.

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EFERENCES

1. Lagerqvist B, James SK, Stenestrand U, et al. Long-term outcomeswith drug-eluting stents versus bare-metal stents in Sweden. N EnglJ Med 2007;356:1009–19.

2. James SK, Stenestrand U, Lindback J, et al. Long-term safety andefficacy of drug-eluting versus bare-metal stents in Sweden. N EnglJ Med 2009;360:1933–45.

3. Comparison of Sirolimus and Paclitaxel-eluting stents versus Zotarolimus-eluting stents in real world practice. Cardiosource. Available at: http://www.cardiosource.com/clinicaltrials/trial.asp?trialID�1799. AccessedSeptember 18, 2009.

4. Byrne RA, Kastrati A, Kufner S, et al. Randomized, non-inferioritytrial of three limus agent-eluting stents with different polymer coatings:the Intracoronary Stenting and Angiographic Results: Test Efficacy of3 Limus-Eluting Stents (ISAR-TEST-4) trial. Eur Heart J 2009 Aug30 [E-pub ahead of print].

5. Serruys PW, Morice MC, Kappetein P, et al. Percutaneous coronaryintervention versus coronary-artery bypass grafting for severe coronaryartery disease. N Engl J Med 2009;360:961–72.

6. Optimal revascularization strategy in patients with three vessel

disease and/or left main disease: 2 year outcomes of the SYNTAX

trial. Cardiosource. Available at: http://www.cardiosource.com/rapidnewssummaries/summary.asp?SumID�457. Accessed September18, 2009.

7. Montalescot G, Brieger D, Eagle KA, et al. Unprotected left mainrevascularization in patients with acute coronary syndromes. EurHeart J 2009 Aug 30 [E-pub ahead of print].

8. Burzotta F, De Vita M, Gu YL, et al. Clinical impact of thrombectomyin acute ST-elevation myocardial infarction: an individual patient-datapooled analysis of 11 trials. Eur Heart J 2009;30:2193–203.

9. Primary angioplasty versus fibrinolysis in the very elderly. Cardio-source. Available at: http://www.cardiosource.com/clinicaltrials/trial.asp?trialID�1859. Accessed September 18, 2009.

0. Wallentin L, Becker RC, Budahj A, et al. Ticagrelor versus clopidogrelin patients with acute coronary syndromes. N Engl J Med 2009;361:1045–57.

1. Clopidogrel optimal loading dose usage to reduce recurrent events–Organization to assess strategies in ischemic syndromes. Cardiosource.Available at: http://www.cardiosource.com/clinicaltrials/trial.asp?trialID�1854. Accessed September 18, 2009.

2. ESC Congress 2009 Meeting Coverage. Cardiosource. Available at:http://www.cardiosource.com/rapidnewssummaries/esc09.asp. Accessed

September 18, 2009.