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Published on: May 14, 2013
Comparison of Clinical Outcomes Following Single versus Multivessel Percutaneous Coronary Intervention Using
Prakash Chandwani1, Puneet Verma, Sudheer Saxena
1Heart and General Hospital, 7, Vivekanand Marg, C-Scheme, Jaipur- 302001, Rajasthan, India. chandwanipc@gmail.com.
Insights
The Supraflex sirolimus-eluting stent (SES) demonstrates comparable safety and effectiveness in both single and multivessel percutaneous coronary intervention (PCI) patients. This study found no significant difference in major adverse cardiac events (MACE) at 12 months for SES use in treating complex coronary artery disease.
Area of Science:
- Interventional Cardiology
- Cardiovascular Medicine
- Biomedical Engineering
Background:
- Drug-eluting stents (DES) are established for single-vessel coronary interventions, reducing complications and revascularization needs.
- The efficacy of DES in complex multivessel disease remains a subject of ongoing clinical debate.
- This study investigates the Supraflex sirolimus-eluting stent (SES) in an all-comers population for both single and multivessel percutaneous coronary intervention (PCI).
Purpose of the Study:
- To compare clinical outcomes between single-vessel and multivessel PCI using the Supraflex SES.
- To evaluate the safety and effectiveness of SES in an all-comers patient cohort undergoing PCI.
Main Methods:
- A retrospective, multicenter, observational study included 995 patients undergoing single-vessel (n=769) or multivessel (n=226) PCI with Supraflex SES.
- The primary endpoint was major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction, and target lesion revascularization, assessed at 12 months.
- Stent thrombosis (ST) was evaluated as a safety endpoint according to Academic Research Consortium (ARC) criteria.
Main Results:
- No significant difference in in-hospital MACE was observed between single-vessel and multivessel PCI groups (0.4% vs. 0.4%, p=1.000).
- At 12 months, MACE rates were 3.2% for single-vessel PCI and 5.5% for multivessel PCI (p=0.109), with no significant difference in cumulative incidence curves.
- The incidence of stent thrombosis was low in both groups, indicating a favorable safety profile.
Conclusions:
- The Supraflex SES demonstrates favorable clinical outcomes and a low revascularization rate in both single and multivessel coronary artery disease.
- The study supports the use of Supraflex SES in complex lesion morphologies and multivessel interventions, showing comparable results to single-vessel treatments.
- Supraflex SES offers a viable treatment option for a broad spectrum of patients undergoing PCI.
Background:
Drug-eluting stents (DES) have been shown to reduce the rate of acute complications and the need for subsequent revascularization in cases where single-vessels are treated. The performance of DES in patients with multivessel disease and complex lesions, however, remains controversial. This study assessed and compared clinical outcomes following single vs. multivessel percutaneous coronary intervention (PCI), using the Supraflex sirolimus-eluting stent (SES), in an all-comers patient population.
Methods:
We conducted retrospective, multicenter, all-comers, observational study of 995 patients, who underwent either single-vessel PCI (n=769 patients; group-I) or multivessel PCI (n=226 patients; group-II), treated with the biodegradable polymer coated Supraflex SES, between July-2013 and May-2014 at nine different centers in India. Pre-specified primary endpoint, rate of major adverse cardiac events (MACE) [defined as composite of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR) and non-target lesion target vessel revascularization (non-TL TVR)], was analyzed during 12 months after the post-index procedure. We also analyzed the incidence of stent thrombosis (ST) as a safety endpoint during the follow-up period, as defined by the Academic Research Consortium (ARC).
Results:
Of the whole study group, 1,242 lesions were treated in 995 patients (mean age 61.6±10.8 years; 80.0% male) with average stent length of 26.8±9.3 mm. Multivessel PCI patients were older, had a higher prevalence of arterial hypertension, were smoker, had a family history of coronary artery disease, previous stroke and previous PCI compared to single-vessel PCI patients. Follow-up was available in 99.0% (761/769) of patients with single-vessel intervention and 96.9% (219/226) of patients with multivessel intervention at the end of 12 months. In-hospital MACE was similar for both the groups [group-I, 3 (0.4%) vs. group-II, 1 (0.4%); p=1.000]. The observed MACE for group-I and group-II, at 30 days, 6 and 12 months follow-up were 9 (1.2%) vs. 2 (0.9%); p=1.000, 15 (2.0%) vs. 7 (3.2%); p=0.302 and 24 (3.2%) vs. 12 (5.5%); p=0.109, respectively. The cumulative incidence curves for MACE showed no significant differences between the two groups, at the end of 12 months (p=0.109).
Conclusion:
Our study shows that use of the Supraflex SES in single and multivessel coronary artery disease produces good clinical outcomes during 12 months of follow-up with a low rate of revascularization, despite complex lesion morphology.
