Giovanna Sarno

Lower risk of stent thrombosis and restenosis with unrestricted use of onew-generation' drug-eluting stents : a report from the nationwide Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

AIMSnTo compare the long-term outcome after percutaneous coronary intervention with new-generation drug-eluting stents (n-DES) to older generation DES (o-DES), and bare-metal stents (BMS) in a real-world population.nnnMETHODS AND RESULTSnWe evaluated 94 384 consecutive stent implantations (BMS, n = 64 631; o-DES, n = 19 202; n-DES, n = 10 551) in Sweden from November 2006 to October 2010. All cases of definite stent thrombosis (ST) and restenosis were documented in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Older generation DES were classified as: Cypher and Cypher Select (Cordis Corporation, Miami, FL, USA), Taxus Express and Taxus Liberté (Boston Scientific Corporation), and Endeavor (Medtronic Inc.) and n-DES as: Endeavor Resolute (Medtronic Inc.), XienceV, Xience Prime (Abbott Laboratories) and Promus, Promus Element (Boston Scientific Corporation). The Cox regression analyses unadjusted and adjusted for clinical and angiographic covariates showed a statistically significant lower risk of restenosis in n-DES compared with BMS [adjusted hazard ratio (HR) 0.29; 95% confidence interval (CI): 0.25-0.33] and o-DES (HR 0.62; 95% CI: 0.53-0.72). A lower risk of definite ST was found in n-DES compared with BMS (HR 0.38; 95% CI: 0.28-0.52) and o-DES (HR, 0.57; 95% CI: 0.41-0.79). The risk of death was significantly lower in n-DES compared with o-DES (adjusted HR: 0.77; 95% CI: 0.63-0.95) and BMS (adjusted HR: 0.55; 95% CI: 0.46-0.67).nnnCONCLUSIONnPercutaneous coronary intervention with n-DES is associated with a 38% lower risk of clinically meaningful restenosis, a 43% lower risk of definite ST, and a 23% lower risk of death compared with o-DES in this observational study from a large real-world population.

Stent thrombosis in new-generation drug-eluting stents in patients with STEMI undergoing primary PCI: a report from SCAAR.

BACKGROUNDnSome concerns still have not been resolved about the long-term safety of drug-eluting stents (DES) in patients with acute STEMI.nnnOBJECTIVESnThe aim of this study was to evaluate the stent thrombosis (ST) rate up to 3 years in patients with ST-segment elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (PCI) with new-generation drug-eluting stents (n-DES) compared with bare-metal stents (BMS) and old-generation drug-eluting stents (o-DES) enrolled in the SCAAR (Swedish Coronary Angiography and Angioplasty Registry).nnnMETHODSnFrom January 2007 to January 2013, 34,147 patients with STEMI were treated by PCI with n-DES (n = 4,811), o-DES (n = 4,271), or BMS (n = 25,065). The risks of early/late (up to 1 year) and very late definite ST (after 1 year) were estimated.nnnRESULTSnCox regression landmark analysis showed a significantly lower risk of early/late ST in patients treated with n-DES (hazard ratio [HR]: 0.65; 95% confidence interval [CI]: 0.43 to 0.99; p = 0.04) and o-DES (HR: 0.60; 95% CI: 0.41 to 0.89; p = 0.01) compared with the BMS group. The risk of very late ST was similar between the n-DES and BMS groups (HR: 1.52; 95% CI: 0.78 to 2.98; p = 0.21), whereas a higher risk of very late ST was observed with o-DES compared with BMS (HR: 2.88; 95% CI: 1.70 to 4.89; p < 0.01).nnnCONCLUSIONSnPatients treated with n-DES have a lower risk of early/late ST than patients treated with BMS. The risk of very late ST is low and comparable between n-DES and BMS up to 3 years of follow-up, whereas o-DES treatment is associated with an increased risk of very late ST. The current STEMI guidelines might require an update in light of the results of this and other recent studies.

Prognosis of elderly patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention in 2001 to 2011 : A report from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) registry

BACKGROUNDnElderly patients constitute a growing part of the population presenting with ST-elevation myocardial infarction (STEMI). The use of primary percutaneous coronary intervention (PCI) in this high-risk population remains poorly investigated.nnnMETHODSnUsing the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), we identified consecutive patients with STEMI 80 years or older undergoing primary PCI during a 10-year period. Temporal trends in care and 1-year prognosis were investigated, and long-term outcome was compared with a reference group of patients with STEMI aged 70 to 79 years. Relative survival was calculated by dividing the observed survival rate with the expected survival rate of the general population. Adjusted end points were calculated using Cox regression.nnnRESULTSnIn total, 4,876 elderly patients with STEMI were included. During the study period, average age and presence of comorbidity increased, as well as the use of antithrombotic therapy. Procedural success remained constant. One-year mortality was exclusively reduced between the most recent vs the earliest cohort, whereas the risk of reinfarction, heart failure, stroke, and bleeding remained similar. The risk of death was higher for elderly patients early after PCI, after which the prognosis was slightly better compared with the general population. Long-term risk of adverse events increased markedly with age.nnnCONCLUSIONSnThe prognosis of patients older than 80 years treated with primary PCI for STEMI was relatively unchanged during the 10-year inclusion period, despite changes in patient characteristics and treatment. Advanced age increased the risk of adverse events, but survivors of the early phase after PCI had a slightly improved prognosis compared with the general population.

Initial clinical experience with an everolimus eluting platinum chromium stent (Promus Element) in unselected patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

BACKGROUNDnThe safety and efficacy of the Promus Element stent have been recently demonstrated in a selected population from one randomized trial. The aim of this study was to describe the initial clinical experience with the everolimus eluting platinum chromium stent (Promus Element) in unselected patients from a real life nationwide registry.nnnMETHODSnThe Promus Element DES was compared to all other DES implanted in Sweden (with more than 500 implants) from November 2009 to March 2011. The results were assessed using Cox regression.nnnRESULTSnA total of 13,577 stents (Promus Element, n=2724, Cypher, n=782; Endeavor, n=747; Taxus Liberté, n=1393, Xience V/Promus, n=4832, Resolute, n=1566, Xience Prime, n=4832) were implanted at 8375 procedures. At one year the restenosis rate in the Promus Element was not significantly different from the overall DES group (2.8% vs. 2.7%, adjusted HR:1.17, 95% CI: 0.75-1.75). A significantly lower restenosis rate was observed in the Promus Element when compared with Endeavor (2.8% vs. 5.8%; adjusted HR: 0.44; 95% CI: 0.26-0.74). The stent thrombosis (ST) rate at one year was not significantly different in the Promus Element as compared with the overall DES group (0.2% vs. 0.5% adjusted HR: 0.59; 95% CI: 025-1.40). ST rate was significantly lower as compared with Endeavor stent (0.2% vs. 0.8%; HR: 0.24; 95% CI: 0.08-0.67).nnnCONCLUSIONSnIn a large unselected population the Promus Element stent appears to be safe and effective with a low risk of restenosis and ST.

Effect of Stent Inflation Pressure and Post-Dilatation on the Outcome of Coronary Artery Intervention. A Report of More than 90 000 Stent Implantations

Background Percutaneous coronary intervention (PCI) stent inflation pressure correlates to angiographic lumen improvement and stent expansion but the relation to outcome is not clarified. Using comprehensive registry data our aim was to evaluate how stent inflation pressure influences restenosis, stent thrombosis and death following PCI. Methods We evaluated all consecutive coronary stent implantations in Sweden during 46 months from 2008 using data from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). We used logistic regression and Cox proportional hazard modeling to estimate risk of outcomes with different balloon pressures. Results In total, 93 697 stents were eligible for analysis and divided into five different pressure interval groups: ≤15 atm, 16–17 atm, 18–19 atm, 20–21 atm and ≥22 atm. The risks of stent thrombosis and restenosis were significantly higher in the ≤15 atm, 18–19 atm and ≥22 atm groups (but not in the 16–17 atm group) compared to the 20–21 atm group. There were no differences in mortality. Post-dilatation was associated with a higher restenosis risk ratio (RR) of 1.22 (95% confidence interval (CI) 1.14–1.32, P<0.001) but stent thrombosis did not differ statistically between procedures with or without post-dilatation. The risk of death was lower following post-dilatation (RR 0.81 (CI 0.71–0.93) Pu200a=u200a0.003) and the difference compared to no post-dilatation was seen immediately after PCI. Conclusion Our retrospective study of stent inflation pressure identified a possible biological pattern—the risks of stent thrombosis and of restenosis appeared to be higher with low and very high pressures. Post-dilatation might increase restenosis risk.

Gender Differences in Outcomes and Predictors of All-Cause Mortality After Percutaneous Coronary Intervention (Data from United Kingdom and Sweden)

To determine gender differences and predictors of all-cause mortality (30 days and 1 year) after percutaneous coronary intervention (PCI) in patients with stable angina pectoris and acute coronary syndrome (non-ST-elevation myocardial infarction/unstable angina pectoris and ST-elevation myocardial infarction) in the British Cardiovascular Intervention Society (BCIS) and Swedish Coronary Angiography and Angioplasty Registry (SCAAR) data sets, an analysis of prospectively collected data from 2007 to 2011 was performed. In total, 458,261 patients (BCIS: nxa0= 368,492 [25.9% women]; Sweden: nxa0= 89,769 [27.2% women]) who underwent PCI were included in this analysis. Using multiple regression analysis, in the BCIS registry, female gender was an independent predictor of all-cause mortality at 30 days (odds ratio [OR] 1.15, 95% CI 1.10 to 1.22, p <0.0001) and at 1 year (OR 1.08, 95% CI 1.04 to 1.12, pxa0<0.0001) after PCI for all patients. Likewise, in the SCAAR registry, female gender was an independent predictor of all-cause mortality at 30 days (OR 1.15, 95% CI 1.05 to 1.26, pxa0= 0.002) and 1 year (OR 1.09, 95% CI 1.03 to 1.17, pxa0= 0.006) after PCI for all patients. In both data sets, there was no statistically significant interaction between age and gender for all-cause mortality at 30 days (BCIS, pxa0= 0.59; SCAAR, pxa0= 0.40) and at 1 year (BCIS, pxa0= 0.11; SCAAR, pxa0= 0.83). In conclusion, despite advances in care, women compared with men continue to experience higher all-cause mortality after PCI for coronary artery disease. The patients age at the time of PCI remains a strong predictive factor of mortality in this population. Strategies and further research are warranted to better address the management of coronary artery disease in women with possibly earlier diagnosis and more tailored treatments.

Real-life clinical outcomes with everolimus eluting platinum chromium stent with an abluminal biodegradable polymer in patients from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

No previous studies have evaluated the performance of the Synergy stent in a large real‐life population.

Impact of thrombus aspiration during ST-Elevation Myocardial Infarction: a six month composite endpoint and risk of stroke analyses of the TASTE trial

BackgroundRoutine thrombus aspiration during primary percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI) did not reduce the primary composite endpoint in the “A Randomised Trial of Routine Aspiration ThrOmbecTomy With PCI Versus PCI ALone in Patients With STEMI Undergoing Primary PCI” (TOTAL) trial. We aimed to analyse a similar endpoint in “The Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia” (TASTE) trial up to 180xa0days.MethodsIn TASTE, 7244 patients with STEMI were randomised to thrombus aspiration followed by PCI or to PCI alone. We analysed the quadruple composite endpoint of cardiovascular death, cardiogenic shock, rehospitalisation for myocardial infarction, or new hospitalisation for heart failure. Furthermore, an extended net-benefit composite endpoint including stent thrombosis, target vessel revascularization or stroke within 180xa0days was analysed.ResultsThe primary quadruple composite endpoint occurred in 8.7xa0% (316 of 3621) in the thrombus aspiration group compared to 9.3xa0% (338 of 3623) in the PCI alone group (hazard ratio (HR), 0.93; 95xa0% confidence interval (CI); 0.80 - 1.09, Pu2009=u20090.36) and the extended net-benefit composite endpoint in 12.0xa0% (436) vs. 13.2xa0% (479) (HR, 0.90; 95xa0% CI; 0.79 - 1.03, Pu2009=u20090.12). Stroke within 30xa0days occurred in 0.7xa0% (27) vs. 0.7xa0% (24) (HR, 0.89; 95xa0% CI; 0.51–1.54, Pu2009=u20090.68).ConclusionsA large and an extended composite endpoint analysis from the TASTE trial did not demonstrate any clinical benefit of routine thrombus aspiration during PCI in patients with STEMI. There was no evidence of an increased risk of stroke with thrombus aspiration.

Stent thrombosis rates the first year and beyond with new- and old-generation drug-eluting stents compared to bare metal stents

ObjectivesOld-generation drug-eluting coronary stents (o-DES) have despite being safe and effective been associated with an increased propensity of late stent thrombosis (ST). We evaluated ST rates in o-DES, new-generation DES (n-DES) and bare metal stents (BMS) the first year (<u20091xa0year) and beyond 1xa0year (>u20091xa0year).MethodsWe evaluated all implantations with BMS, o-DES (Cordis Cypher, Boston Scientific Taxus Liberté and Medtronic Endeavor) and n-DES in the Swedish coronary angiography and angioplasty registry (SCAAR) between 1 January 2007 and 8 January 2014 (nu2009=u2009207 291). All cases of ST (nu2009=u20092 268) until 31 December 2014 were analyzed.ResultsThe overall risk of ST was lower in both n-DES and o-DES compared with BMS up to 1xa0year (n-DES versus BMS: adjusted risk ratio (RR) 0.48 (0.41–0.58) and o-DES versus BMS: 0.56 (0.46–0.67), both pu2009<u20090.001). From 1xa0year after stent implantation and onward, the risk for ST was higher in o-DES compared with BMS [adjusted RR, 1.82 (1.47–2.25], pu2009<u20090.001). N-DES were associated with similar low ST rates as BMS from 1xa0year and onward [adjusted RR 1.21 (0.94–1.56), pu2009=u20090.135].ConclusionNew-generation DES were associated with lower ST rates in comparison to BMS during the first-year post-stenting. After 1 year, n-DES and BMS were associated with similar ST rates.Trial RegistrationThis study was a retrospective observational study and as such did not require clinical trial database registration.

Timing of percutaneous coronary intervention in patients with non-ST-elevation myocardial infarction: a SWEDEHEART study

Aims Although routine invasive management is recommended in NSTEMI patients, the optimal timing of the procedure is not defined. The aim of this study was to assess outcomes in relation to timing of PCI in NSTEMI patients. Methods and results This was an observational, prospective, multicentre cohort study from the SWEDEHEART registry including all Swedish PCI centres. We included 40 494 consecutive PCI-treated patients who were admitted to any coronary care unit from 2006 to 2013. The primary outcome was all-cause death, and secondary outcomes were recurrent myocardial infarction (MI), stent thrombosis, and severe in-hospital bleeding. Outcomes were assessed within 1 year from admission in relation to pre-specified cut-offs to define early PCI: within 1, 2, or 3 days. Patients who received delayed PCI, compared with those who did not, were older, and had a higher prevalence of comorbidities (hypertension, hyperlipidaemia, diabetes, and prior stroke) but showed similar angiographic findings. Cox mixed-effects models showed a lower risk of all-cause death with early PCI across all three cut-offs: HR (95% CI) of 0.88 (0.80–0.98), 0.78 (0.71–0.86), and 0.75 (0.68–0.84), for the 1-, 2-, and 3-day cut-offs, respectively. Early PCI was associated with lower risk of recurrent MI for the 2- and 3-day cut-offs, but not for the 1-day cut-off. The reported rates of severe in-hospital bleeding were low, but tended to be higher in patients receiving delayed PCI. Conclusion In patients undergoing PCI for NSTEMI, early invasive treatment is associated with lower risk of ischaemic outcomes.