1 SUPPLEMENTARY MATERIALS SUPPLEMENTARY TABLE 1 DESCRIPTION OF DES

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1 SUPPLEMENTARY MATERIALS SUPPLEMENTARY TABLE 1 DESCRIPTION OF DES
1 SUPPLEMENTARY TABLE 1 CATEGORIZATION OF THE 120 NODULES

Title: *

1


Supplementary Materials


Supplementary Table 1. Description of DES studies considered for the narrative systematic review by patient category- comparison with alternatives other than BMS

DES

DES patients (N)

Total of N

Range of the longest F/U

Study type

Studies (N)

Balloon alone as reference treatment

BMS in-stent restenosis

CYPHER TAXUS CYPHER or TAXUS

435 295 618

730†

9 - 12 mo 9 - 24 mo 12 mo

Meta-analysis (S6) Meta-analysis (S6), RCT (S7) Meta-analysis (S24)

1 2 1

CABG as reference treatment

Multivessel disease at a low-to-moderate surgical risk

TAXUS


CYPHER or TAXUS

903 192 179 11,906

13,180

1 yr 1 yr 1 yr 1 - 3 yr

RCT (S31)

Cohort (S31‡) RCT (S14) Cohort (S3,S13,S19,S26,S30)

1 1 1 5

Unprotected left main stenosis at a low-to-moderate surgical risk

CYPHER or TAXUS

396

396

3 yr

Cohort (S32)

1

Abbreviations: DES: drug-eluting stent; BMS: bare-metal stent; CABG: coronary artery bypass grafting; RCT: randomised controlled trial; Cohort: prospective cohort study; F/U: follow-up

†Total excluded 618 patients from the meta-analysis (S24) as already analysed in the meta-analyses (S6-7)

‡one parallel nested prospective observational cohort study of the RCT (S31)

Supplementary Table 2. DES efficacy - comparison with alternatives other than BMS

DES

DES patients (N)

Longest F/U (yr)

Clinical efficacy criteria

Relative Risk RR [95% CI]

Balloon alone as reference treatment

BMS in-stent restenosis

CYPHER

435 (S6)

1

TLR (clinically documented or with planned angiographic F/U)

0.27 [0.18-0.41]

TAXUS

295 (S6-7)

2


From 0.45 [0.26-0.77] to 0.47 [0.30-0.75]

CYPHER or TAXUS

618 (S24)

1


0.42 [0.29-0.62]

CABG as reference treatment

Multivessel disease at a low-to-moderate surgical risk

TAXUS

905 (S31)

1

Global revascularisation (no planned angiographic F/U)

2.29 [1.67-3.14]

CYPHER or TAXUS

11,860 (S3, S13-14, S19,S26)

3


From 2.05 [1.12-3.75] to 2.81 [2.11-3.75]

Unprotected left main stenosis at a low-to-moderate surgical risk

CYPHER or TAXUS

396 (S32)

3

TLR (no planned angiographic F/U)

2.98 [1.17-7.75]

Abbreviations: DES: drug-eluting stent; BMS: bare-metal stent; CABG: coronary artery bypass grafting; CI: confidence interval; F/U: Follow-Up; TLR: Target lesion revascularisation

Supplementary Table 3. DES safety - comparison with alternatives other than BMS

DES

DES patients (N)

Longest F/U (yr)

Clinical safety criteria Relative Risk RR [95% CI] (unless %DES vs Reference indicated)

Death

MI

In-stent thrombosis†

Balloon alone as reference treatment

BMS in-stent restenosis

CYPHER or TAXUS

730 (S6-7,S24)

2

from 0.46 [0.11-1.90] to 0.63 [0.22-1.85]

from 0.58 [0.23-1.47] to 1.50 [0.41-5.60]


CABG as reference treatment

Multivessel disease at a low-to-moderate surgical risk

CYPHER or TAXUS

13,180 (S3,S13-14, S19,S26,S30-31)

3

from 0.95 [0.75-1.53] to 1.24 [0.78-1.98]

from 1.00 [0.50-2.05] to 1.46 [0.99-2.33]



%DES vs Reference: from 1.10 to 3.50


Diabetic patients

4,095 (S3,S13-14, S19,S26,S31)



1.88 [0.89-3.97] %DES vs Reference: 3.90 vs 3.30,  p>0.05 10.0 vs 8.00 ; p>0.05


1.59 [0.57-4,43]

%DES vs Reference: 5.90 vs 5.00; p>0.05


Death and MI: 1.20 [0.99-1.45]

Unprotected left main stenosis at a low-to-moderate surgical risk

CYPHER or TAXUS

396 (S32)

3

1.36 [0.80-2.30]



Death and MI: 1.40 [0.88-2.22]

Abbreviations: DES: drug-eluting stent; BMS: bare-metal stent; CABG: coronary artery bypass grafting; MI: myocardial infarction; CI: confidence interval; F/U: Follow-up

†Definite and probable according to Academic Research Consortium definition (5)

Supplementary Figure legends

Supplementary Figure 1: Flow chart of selected studies

Abbreviations: HTA report: health technology assessment report; RCT: randomised controlled trial; Cohort: prospective cohort study

1.List associated of Key words: drug-eluting stents (DES), coronary, stent.

2.Inclusion criteria: (i) the most recent study from the same source; HTA reports published after 2005, meta-analyses published after the search period covered by the selected HTA report (or published after 2002 in the absence of a HTA report); RCTs published after the search period covered by the selected meta-analyses or HTA report (or RCTs published after 2002 in absence of a meta-analysis or HTA report); prospective cohort studies of more than 100 patients followed up for at least 6 months (design and population defined) published after the search period covered by the selected HTA report or published after 2002 in the absence of a HTA report; (ii) at least one of the following relevant endpoints defined before bibliographic search of data [repeat revascularisation of a treated lesion (target lesion revascularisation, TLR) particularly driven by the documented return of clinical symptoms (i.e. Myocardial Infarction MI or unstable angina, recurrence of angina pectoris), angiographic restenosis (Late Loss LL), global revascularisation (targeted and non-targeted revascularisation of the initial lesion), overall mortality and Stent Thrombosis ST (Academic Research Consortium (ARC) definition), MI, stroke], (iii) patients’ clinical feature and lesion types as follows: lesions at high risk of restenosis (long lesions, small vessels, diabetic patients), ST-segment elevation MI (STEMI), total coronary chronic occlusion, in-stent restenosis, multivessel lesions, unprotected left main stenosis, vein graft stenosis, (iv) comparison of DES (CYPHER, TAXUS, ENDEAVOR or XIENCEV/PROMUS) with alternative treatments (medication alone, coronary artery bypass grafting surgery or bare-metal stent placement).


Supplementary Figure 2. Choice of type of revascularisation and therapeutic position of drug-eluting stents DES for reimbursement – Single vessel lesions: Particular case

Abbreviations: DES: drug-eluting stent; BMS: bare-metal stent; CABG: coronary artery bypass grafting;.

1. CABG is the standard treatment in most cases.

2. If estimated success rate of access to lesion is reasonable.

3. If second restenosis with extensive myocardial ischaemia or if poor access to lesion, CABG surgery is the preferred option.




Supplementary Figure 3. Choice of type of revascularisation and therapeutic position of drug-eluting stents DES for reimbursement – Multivessel lesions

Abbreviations: DES: drug-eluting stent; BMS: bare-metal stent; CABG: coronary artery bypass grafting.

Supplementary Figure 1

1 SUPPLEMENTARY MATERIALS SUPPLEMENTARY TABLE 1 DESCRIPTION OF DES

Supplementary Figure 2

1 SUPPLEMENTARY MATERIALS SUPPLEMENTARY TABLE 1 DESCRIPTION OF DES



Supplementary Figure 3

1 SUPPLEMENTARY MATERIALS SUPPLEMENTARY TABLE 1 DESCRIPTION OF DES

Supplementary References

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S2. Brar SS, Kim J, Brar SK et al. Long-term outcomes by clopidogrel duration and stent type in a diabetic population with de novo coronary artery lesions. J Am Coll Cardiol 2008;51(23):2220-7.

S3. Briguori C, Condorelli G, Airoldi F et al. Comparison of coronary drug-eluting stents versus coronary artery bypass grafting in patients with diabetes mellitus. Am J Cardiol 2007;99(6):779-84.

S4. Cucherat M. Drug eluting stents. A systematic review and meta-analysis of randomized clinical trials. Prepared for HAS. Saint-Denis La Plaine: HAS; 2008. http://www.has-sante.fr/portail/jcms/c_867966/evaluation-des-endoprotheses-coronaires-a-liberation-de-principe-actif.

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S10. Gao RL, Xu B, Chen JL et al. Immediate and long-term outcomes of drug-eluting stent implantation for unprotected left main coronary artery disease: comparison with bare-metal stent implantation. Am Heart J 2008;155(3):553-61.

S11. Garg P, Normand SLT, Silbaugh TS et al. Drug-eluting or bare-metal stenting in patients with diabetes mellitus. Results from the Massachusetts data analysis center registry. Circulation 2008;118(22):2277-84.

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S13. Hannan EL, Wu C, Walford G et al. Drug-eluting stents vs. coronary-artery bypass grafting in multivessel coronary disease. N Engl J Med 2008;358(4):331-41.

S14. Kapur A, Hall RJ, Malik IS et al. Randomized comparison of percutaneous coronary

intervention with coronary artery bypass grafting in diabetic patients. 1-year

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S15. Kastrati A, Dibra A, Spaulding C et al. Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction. Eur Heart J 2007;28(22):2706-13.

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S19. Lee MS, Jamal F, Kedia G et al. Comparison of bypass surgery with drug-eluting stents for diabetic patients with multivessel disease. Int J Cardiol 2007;123(1):34-42.

S20. Maeng M, Jensen LO, Kaltoft A et al. Comparison of stent thrombosis, myocardial infarction, and mortality following drug-eluting versus bare-metal stent coronary intervention in patients with diabetes mellitus. Am J Cardiol 2008;102(2):165-72.

S21. Mauri L, Silbaugh TS, Garg P et al. Drug-eluting or bare-metal stents for acute myocardial infarction. N Engl J Med 2008;359(13):1330-42.

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S23. Okabe T, Lindsay J, Buch AN et al. Drug-eluting stents versus bare metal stents for narrowing in saphenous vein grafts. Am J Cardiol 2008;102(5):530-4.

S24. Oliver LN, Buttner PG, Hobson H, Golledge J. A meta-analysis of randomised controlled trials assessing drug-eluting stents and vascular brachytherapy in the treatment of coronary artery in-stent restenosis. Int J Cardiol 2008;126(2):216-23.

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