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Bare Metal vs Drug Eluting Stents

Bare Metal vs Drug Eluting Stents. Should DES be the chosen one?. Class 22, 1st year Adviser : Prof. Filipa Almeida. Authors: Aguiar, A.; Alves, R.; Baptista, M.J.; Domingues, A.; Durão, N.; Máximo, J.F.; Neto, N.; Pereira, S.; Pinto, D.; Rodrigues, I.; Sousa, D. Summary. Background

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Bare Metal vs Drug Eluting Stents

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  1. Bare Metal vsDrugElutingStents Should DES be the chosen one? Class 22, 1st year Adviser: Prof. Filipa Almeida Authors: Aguiar, A.; Alves, R.; Baptista, M.J.; Domingues, A.; Durão, N.; Máximo, J.F.; Neto, N.; Pereira, S.; Pinto, D.; Rodrigues, I.; Sousa, D.

  2. Summary • Background • ResearchQuestion • Aims • ParticipantsandMethods • Results • Conclusion

  3. Importanceofthestudy Background • Cardiovascular diseases are the most common cause of death in Europe, being coronary disease (CD) the most frequent one1 • The relevance of this study resides in the fact that there are no previous studies comparing the use of the two different types of stents in Portugal • A study based in the complications as well as success rates of bare-metal and drug-eluting stents could be significantly useful, since it would provide an evaluation on efficacy and costs. ResearchQuestion Aims ParticipantsandMethods Results Conclusion • [1] Rayner M, Allender S, Scarborough P. Cardiovascular disease in Europe. European Journal of Cardiovascular Prevention and Rehabilitation. 2009

  4. CoronaryDisease Background • Occurs when the arteries that supply blood to the heart muscle (coronary arteries) become hardened and narrowed due to the build-up of cholesterol and other material, called plaque, on the inner walls of the arteries • Less blood may flow through the arteries consequently leading to the lack of oxygen in the heart muscle, causing chest pain (angina) and ultimately acute coronary syndrome (heart attack)2 ResearchQuestion Aims ParticipantsandMethods Results Conclusion [2]Camm A, Luscher T, Serruys P. The ESC Textbook of Cardiovascular Disease.

  5. PercutaneousCoronaryIntervention Background • Procedure in which a special tubing with an attached deflated balloon is threaded up to the coronary arteries3 • Balloon is inflated to widen blocked areas where blood flow to the heart muscle has been reduced or completely blocked • According to the Euro-Heart Survey 2006, in the great majority of situations (94%), PCI is combined with implantation of a stent 4 ResearchQuestion Aims ParticipantsandMethods Results Conclusion [3]American Heart Association. Cardiac Procedures and Surgeries - Nov 2010 [4] British Heart Foundation.[2008 May] Managing patients with coronary stents.

  6. IntracoronaryStenting (IS) Background ResearchQuestion • Stent: a tiny wire mesh tube that is left in the artery permanently to help maintain the artery unblocked and decrease the chance of another blockage5 Aims ParticipantsandMethods Results Conclusion [5] Scholte op Reimer WJM, Gitt AK, Boersma E, Simoons ML (eds.). Cardiovascular Diseases in Europe.

  7. IntracoronaryStenting (IS) Background • There are twomaintypesofstentscurrentlyin use 6: ResearchQuestion Aims ParticipantsandMethods Results Conclusion • [6] American Heart Association. Drug-eluting stents beat bare metal stents in diabetics

  8. IntracoronaryStenting (IS) Background • The relative percentages of the use of the two kinds of stents vary worldwide • Data from 2005/2006 5, in Europe, showed a high use of DES in: • Switzerland 70% • United Kingdom 67% • On the contrary, Germany had the lowest percentage of use with only 21% ResearchQuestion Aims ParticipantsandMethods Results Conclusion [5] Scholte op Reimer WJM, Gitt AK, Boersma E, Simoons ML (eds.). Cardiovascular Diseases in Europe.

  9. ResearchQuestion Background What is the proportion of bare-metal and drug- eluting stents used in Portuguese patients over the period between 2006 and 2009 and what are the complications associated to the use of each? ResearchQuestion Aims ParticipantsandMethods Results Conclusion

  10. Aims Background • Compare the CHD-associated complications or severity indicators, such as mortality of any cause, myocardial infarction and hospital readmission of patients admitted with acute coronary syndrome • Evaluate the rate of implantation of each of the two different types of stents - bare-metal and drug-eluting - during the period between 2006 and 2009, in angioplasties performed on the patients mentioned above ResearchQuestion Aims ParticipantsandMethods Results Conclusion

  11. StudyParticipants Background • The population with Coronary Heart Disease, as main diagnosis, living in the Portuguese mainland • The sample for the study is selected in a non-randomized, convenience manner from within an available clinical records database ResearchQuestion Aims Patientswith CD ParticipantsandMethods Patientssubmitted to PCI Results Intracoronary Stenting (DES/BMS) Conclusion

  12. StudyParticipants Background • Inclusion Criteria • All the state hospital admissions by cardiovascular disease, as main diagnosis, are selected according to the International Classification of Diseases 9th revision (ICD-9) codes • Exclusion Criteria • All the admissions that do not contain the outcome information are excluded ResearchQuestion Aims ParticipantsandMethods Results Conclusion

  13. Study Design Background • Observational, retrospective and longitudinal, once the gap considered is between 2006 and 2009 • The unit of observation is the population with CHD living in Portugal ResearchQuestion Aims ParticipantsandMethods Results Conclusion

  14. Data CollectionMethods Background • The data wasaccessed from a database with records of all Portuguese State Hospitals, from 2000 to September of 2009 • Availablevariables: • Age • Sex • Date of entry • Date of discharge • Diagnostics • Procedures • Result of admission (outcome) ResearchQuestion Aims ParticipantsandMethods Results Conclusion ICD-9 Codes

  15. Data CollectionMethods Background • ICD-9 is an international standard diagnostic and procedures classification for health management purposes, epidemiological and clinical use • The codes for the cardiovascular procedures/technology are: • 36.01 – 36.07 – Percutaneous coronary intervention • 36.07 – Drug eluting stent • 36.01, 36.06 – Bare metal stent ResearchQuestion Aims ParticipantsandMethods Results Conclusion

  16. Data CollectionMethods Background • The ICD-9 codes for Diseases of the Circulatory system are: ResearchQuestion Aims ParticipantsandMethods Results Conclusion

  17. StatisticalAnalysis Background • Software used: • SPSS software (v. 19.0.0; SPSS Inc) ResearchQuestion Aims ParticipantsandMethods Results Conclusion

  18. StatisticalAnalysis Background • The period between 2000 and 2005 was eliminated because it does not have comparable data • The patients implanted with both BMS and DES were excluded, since, in those cases, it would not be possible to relate the complications to one specific type ResearchQuestion Aims DES wereintroducedin Portugal in 2006 ParticipantsandMethods Results EpectedResults Conclusion

  19. StatisticalAnalysis Background • The variables were analysed annually • Comparison BMS vs DES in each year • Comparison of consecutive years for each type of stent • Significance for the entire statistical analysis was accepted at p < 0,05 ResearchQuestion Aims ParticipantsandMethods Results EpectedResults Conclusion

  20. StatisticalAnalysis Background • Categorical Variables Analyzed: • Implantation of BMS or DES • Myocardial Infarction (during hospitalisation) • Haemorrhagic complications • Readmissions * (due to Ischemic Heart Disease) • Mortality ResearchQuestion PercentageandFrequency Aims ParticipantsandMethods Chi-squareTest Results Conclusion * Analysedusingthenumberofrepeatedepisodes, for thesamepatient, inthesameyearand hospital (due to limitations on the database)

  21. StatisticalAnalysis Background • Numerical Variable Analyzed: • Period of hospitalisation (measured in days; cases whose number of days of hospitalisation assumed negative values in the database were dismissed ) ResearchQuestion Median Aims Percentiles 5 and 95 ParticipantsandMethods Results Mann-Whitney U Test Conclusion

  22. Results Background 34 272 patients ResearchQuestion Aims 25 666 8 605 ParticipantsandMethods Results Conclusion Agedbetween 9 and 102 years (median= 64)

  23. BMS vs DES Background ResearchQuestion • BMS werethemostfrequentlyaplliedeveryyear • However, theywerein a remarkable decline, givingway to DES Aims ParticipantsandMethods Results Conclusion * p < 0,05 Graphic 1: Percentage of implantation of each type of stent per year

  24. BMS vs DES Background • Theobtainedresults agree with Spinler et al ‘s study that also states that the use of DES have been increasing since their introduction 7 ResearchQuestion Aims • In the last two years , the percentage of DES cases seems similar • This can be related to the fact that our statistical analysis does not include cases of simultaneous implantation of both BMS and DES ParticipantsandMethods Results Conclusion [7] ] Spinler SA. PercutaneousCoronaryIntervention: AssessingCoronary Vascular RiskAssociatedWithBare-MetalandDrug-ElutingStents. Am J ManagCare. March 2009; 15(2 Suppl):S42-7

  25. Period of Hospitalisation Background • Median: • BMS 4 days, in all 4 years • DES 2 days, 2006 1 day, 2007 and 2008 3 days, 2009 • The median of the period of hospitalisation was lower in the DES than in the BMS in all 4 years (2006-2009) • Comparison using the Mann-Whitney U Test demonstrated that the difference is significant (p < 0,05) ResearchQuestion Aims ParticipantsandMethods Results Conclusion

  26. Period of Hospitalisation Background • The Percentile 5 was 0days for every year analysed, for both BMS and DES • Percentile 95: • BMS 15 days, 2006 and 2007 14 days, 2008 and 2009 • DES 14 days, 2006 9 days, 2007 12 days, 2008 13 days, 2009 • BMS presented higher values than DES for the Percentile 95 ResearchQuestion Aims ParticipantsandMethods Results Conclusion

  27. Period of Hospitalisation Background ResearchQuestion Aims DES DES ParticipantsandMethods Results • Theimplantationof DES hashighcosts, butthiscostscanbecompensatedbytheirsmallperiodofhospitalisation • Thereasonwhythishappenscouldbe a motive for furtherstudies, as there are notanyknownreferencesaboutthis particular matter Conclusion

  28. Readmissions Background • DES displayedsignificantlyhigherresultsbetween 2006 and 2008 • Comparisonbetweenconsecutiveyears, ineachtypeofstent: ResearchQuestion Aims ParticipantsandMethods 2006-2007 Results 2007-2008 2008-2009 Conclusion * p < 0,05 Graphic 2: Percentage of patients readmitted per type of stent and per year

  29. Readmissions Background • In a global vision, the percentage of readmissions decreases over the years, independently of the type of stent ResearchQuestion Why? Aims ParticipantsandMethods Improvement of PCI techniques Evolution of post-surgical treatments Results Conclusion

  30. HaemorrhagicComplications Background ResearchQuestion • Higherpercentage for BMS inthefirst 2 years • Samepercentage for bothin 2008 • Higherpercentage for DES in 2009 • TheDifferences are notstatisticallysignificant Itcannotbeconcludedthatthereis a link betweenthetypeofstentimplantedandthedevelopmentofhaemorrhagiccomplications Aims ParticipantsandMethods Results Conclusion Graphic 3: Percentage of patients who had haemorrhagic complications during hospitalization per type of stent and per year

  31. MyocardialInfarction Background • BMS cases showed a higherincidencebetween 2006 and 2008 • In 2009, theincidenceincreasedin DES cases, beingsignificantwhencomparedwith 2008 (p=0,003) ResearchQuestion Aims ParticipantsandMethods Results Conclusion * p < 0,05 Graphic 4: Percentage of patients who had myocardial infarction during hospitalization per type of stent and per year

  32. MyocardialInfarction Background • Thesignificantaugmentofmyocardialinfarction for DES in 2009 couldbeexplainedbythereductionofthesamplesize, comparingwiththetwopreviousyears • Over-increased the percentages of both myocardial infarction and haemorrhagic complications for DES ResearchQuestion Aims ParticipantsandMethods Results Conclusion

  33. Mortality Background • Mortalityissignificantlyhigherin BMS cases, withtheexceptionof 2006 • Thedifferencein 2006 isnotstatisticallysignificant • Comparisonofconsecutiveyears, ineachtypeofstent: ResearchQuestion Aims ParticipantsandMethods Results Discussion DES 2006-2007 * p < 0,05 Graphic 5: Percentage of patients deceased per type of stent and per year

  34. Mortality Background • DES has a lower mortality rate than BMS • This result is supported by various works 8,9,10 and could be related to a long-lasting antiplatelet therapy associated to DES 9 • Therelevantdecreasebetween 2006 and 2007 in DES mortalitycouldberelated to itsrecentintroductionin Portugal , resultingin a verysmallsampleonthefirstyear ResearchQuestion Aims ParticipantsandMethods Results Discussion • The small augment in the mortality rate in 2009, though not significant, can be related to the similar increase in myocardial infarction for both types of stent [8]Mauri L, Silbaugh TS, Wolf RE, et al. Long-Term Clinical Outcomes Following Drug-eluting and Bare Metal Stenting in Massachusetts. Circulation. 2008;118(18):1817-27. [9] Tamburino C, Salvo M, Capodanno D, et al. Are drug-eluting stents superior to bare-metal stents in patients with unprotected non-bifurcational left main disease? Insights from a multicentre registry. European Heart Journal. 2009; 30:1171-1179 [10] Marroquin O, Selzer F, Mulukutla S, et al. A Comparison of Bare-Metal and Drug-Eluting Stents for Off-Label Indications. N Engl J Med. 2008; 358:342-352

  35. Limitations Background • The non-inclusion of patients admitted and treated in private institutions/hospitals as well as in autonomous regions (Madeira and Azores) • Errors in the database (negative values for period of hospitalisation) • Exclusion of cases of simultaneous implantation of both BMS and DES ResearchQuestion Aims ParticipantsandMethods Results Conclusion

  36. Limitations Background • Readmissions are only considered for the same hospital, and in the same year (due to limitations on the database) • Co-morbidities that could act as confusion bias were not taken into account for any of the analysed variables (This is a pertinent limitation of this study, which may affect all available outcomes, with particular relevance for mortality 9 ) ResearchQuestion Aims ParticipantsandMethods Results Conclusion • [9] Tamburino C, Salvo M, Capodanno D, et al. Are drug-eluting stents superior to bare-metal stents in patients with unprotected non-bifurcational left main disease? Insights from a multicentre registry. European Heart Journal. 2009; 30:1171-1179

  37. Final Conclusions Background • BMS have been the most frequently applied stents in Portugal • The use of DES has been rapidly increasing since 2006 • DES show a lower percentage of mortality and myocardial infarction, and a shorter period of hospitalisation • DES show a higher percentage of readmissions ResearchQuestion Aims ParticipantsandMethods Results Conclusion

  38. Final Conclusions Background • No link was found between the development of haemorrhagic complications and the type of stent implanted • All in all, even though in a short-term analysis it can be concluded that DES are more beneficial than BMS, despite the higher costs, presently, we cannot make a long-term analysis to further study our economic objective ResearchQuestion Aims ParticipantsandMethods Results Conclusion

  39. Acknowledgements Background • Prof. Altamiro Pereira • Prof. Filipa Almeida • Prof. JoãoAntunes • Prof. José Alberto Freitas ResearchQuestion Aims ParticipantsandMethods Results Conclusion

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