CCI: Taxus and SES perform similarly in STEMI patients
In STEMI patients, there were no statistically significant differences for adverse events between the Cypher sirolimus-eluting stent (SES) and the Taxus paclitaxel-eluting stent (PES), but binary angiographic in-segment restenosis and in-segment late loss were significantly lower in the SES group, according to a randomized trial in the July issue of Catheterization and Cardiovascular Interventions.
The PROSIT (Prospective Randomized cOmparison of SIrolimus- versus pacliTaxel-eluting stents for the treatment of acute STEMI) trial is the first randomized trial to compare Johnson & Johnson’s Cordis’ Cypher SES and Boston Scientific’s Taxus PES in STEMI patients.
Jae-Hwan Lee, MD, PhD, from the Cardiovascular Center at Chungnam National University Hospital in Daejeon, South Korea, and colleagues said that SES and PES reportedly have been more effective than bare-metal stents (BMS) in reducing restenosis and cardiac events in a broad range of patients with coronary artery disease.
However, the researchers said they began the study because it is unknown whether there may be differences between these two drug-eluting stents (DES) in terms of efficacy in the setting of acute STEMI.
To find out if such differences exist, investigators examined 308 acute STEMI patients undergoing primary angioplasty that were randomly assigned to SES (154 patients) or PES (154 patients) deployment. They performed routine angiographic follow-up at six months and obtained a clinical follow-up data at 12 months.
The authors wrote that the primary endpoint was major adverse cardiac events (MACE) including death, reinfarction, stent thrombosis and target lesion revascularization at 12 months.
Lee and colleagues reported that the baseline clinical, angiographic and procedural characteristics were similar between the two groups. Two patients from the PES group experienced stent thrombosis (one acute and one subacute), according to the researchers.
The investigators found that the SES group revealed lower in-segment restenosis (5.9 vs. 14.8 percent) and in-segment late loss (0.09 vs. 0.33 mm) than PES group on follow-up angiography. Twelve-month TLR rates (2.6 vs. 6.5 percent) were similar between two groups, the authors wrote.
Overall, Lee and colleagues reported that MACE rates were lower in the SES group than in the PES group, but did not reach statistical significance (5.8 vs. 11.7 percent).
The PROSIT authors concluded that the clinical outcomes were “somewhat promising” the larger question of whether DES are appropriate for treating patients with STEMI. The results are comparable to trials evaluating BMS in this patient population, suggesting “that use of either [Taxus] or [Cypher] might be a feasible approach as an initial reperfusion strategy in the setting of acute STEMI,” they noted.
An accompanying editorial questioned the authors’ conclusion. “It is still unclear whether DES should be used routinely or selectively during STEMI,” according to Ran Kornowski, MD, of the Rabin Medical Center in Petach Tikva, Israel. Although the strongest and most consistent element of PROSIT was its angiographic findings. He wrote that the “actual clinical relevance of these angiographic findings relative to the observed clinical endpoints remains a topic of further investigation.”
Kornowski acknowledged the “remarkable achievement” of the PROSIT trial, being the first to randomly compare different DES in STEMI patients. Even so, he said that larger trials with longer follow-ups are needed to fully assess the overall safety and efficacy of DES for STEMI patients, as well as to clearly demonstrate the superiority of one device over another.
The PROSIT (Prospective Randomized cOmparison of SIrolimus- versus pacliTaxel-eluting stents for the treatment of acute STEMI) trial is the first randomized trial to compare Johnson & Johnson’s Cordis’ Cypher SES and Boston Scientific’s Taxus PES in STEMI patients.
Jae-Hwan Lee, MD, PhD, from the Cardiovascular Center at Chungnam National University Hospital in Daejeon, South Korea, and colleagues said that SES and PES reportedly have been more effective than bare-metal stents (BMS) in reducing restenosis and cardiac events in a broad range of patients with coronary artery disease.
However, the researchers said they began the study because it is unknown whether there may be differences between these two drug-eluting stents (DES) in terms of efficacy in the setting of acute STEMI.
To find out if such differences exist, investigators examined 308 acute STEMI patients undergoing primary angioplasty that were randomly assigned to SES (154 patients) or PES (154 patients) deployment. They performed routine angiographic follow-up at six months and obtained a clinical follow-up data at 12 months.
The authors wrote that the primary endpoint was major adverse cardiac events (MACE) including death, reinfarction, stent thrombosis and target lesion revascularization at 12 months.
Lee and colleagues reported that the baseline clinical, angiographic and procedural characteristics were similar between the two groups. Two patients from the PES group experienced stent thrombosis (one acute and one subacute), according to the researchers.
The investigators found that the SES group revealed lower in-segment restenosis (5.9 vs. 14.8 percent) and in-segment late loss (0.09 vs. 0.33 mm) than PES group on follow-up angiography. Twelve-month TLR rates (2.6 vs. 6.5 percent) were similar between two groups, the authors wrote.
Overall, Lee and colleagues reported that MACE rates were lower in the SES group than in the PES group, but did not reach statistical significance (5.8 vs. 11.7 percent).
The PROSIT authors concluded that the clinical outcomes were “somewhat promising” the larger question of whether DES are appropriate for treating patients with STEMI. The results are comparable to trials evaluating BMS in this patient population, suggesting “that use of either [Taxus] or [Cypher] might be a feasible approach as an initial reperfusion strategy in the setting of acute STEMI,” they noted.
An accompanying editorial questioned the authors’ conclusion. “It is still unclear whether DES should be used routinely or selectively during STEMI,” according to Ran Kornowski, MD, of the Rabin Medical Center in Petach Tikva, Israel. Although the strongest and most consistent element of PROSIT was its angiographic findings. He wrote that the “actual clinical relevance of these angiographic findings relative to the observed clinical endpoints remains a topic of further investigation.”
Kornowski acknowledged the “remarkable achievement” of the PROSIT trial, being the first to randomly compare different DES in STEMI patients. Even so, he said that larger trials with longer follow-ups are needed to fully assess the overall safety and efficacy of DES for STEMI patients, as well as to clearly demonstrate the superiority of one device over another.